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CN105213905A - A kind of Chinese medicine composition and application thereof preventing and treating postmenopausal osteoporosis - Google Patents

A kind of Chinese medicine composition and application thereof preventing and treating postmenopausal osteoporosis Download PDF

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CN105213905A
CN105213905A CN201510680659.0A CN201510680659A CN105213905A CN 105213905 A CN105213905 A CN 105213905A CN 201510680659 A CN201510680659 A CN 201510680659A CN 105213905 A CN105213905 A CN 105213905A
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朱文茹
周洁
李进英
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Qingdao Municipal Hospital
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Abstract

一种防治绝经后骨质疏松症的中药组合物,所述中药组合物的原料药由白芍、夜交藤、淫羊藿、女贞子、菟丝子、虎杖、红参、墨旱莲、红景天、揉白叶、肉苁蓉、杜仲、枸杞子、破骨风、鸡血藤、桑寄生、制首乌、仙鹤草、红花、秦艽、紫河车、三棱、雪莲、血竭、益母草、三七、葛根、巴戟天、天麻、黑芝麻组成。本发明的中药组合物所选药材配伍相宜,符合中医药学和现代医药学理论,其配伍符合中药“君臣佐使”原则,对绝经后骨质疏松有独特的疗效,该药配伍科学,疗效迅速,见效快、疗程短、治愈率高、费用小的优点。A traditional Chinese medicine composition for preventing and treating postmenopausal osteoporosis. The raw materials of the traditional Chinese medicine composition are Radix Paeoniae Alba, Radix Nocturna, Epimedium, Ligustrum lucidum, Cuscuta, Polygonum cuspidatum, Red Ginseng, Eclipta chinensis, Red Ginseng Sedum, rubbing white leaves, cistanche, eucommia, medlar, Cracker, Milletah, Sangji, Zhishouwu, Agrimony, safflower, Gentiana, Ziheche, Sanleng, snow lotus, dried blood, motherwort , Panax notoginseng, kudzu root, Morinda officinalis, Gastrodia elata, black sesame. The selected medicinal materials of the Chinese medicine composition of the present invention are suitable for compatibility, which conforms to the theory of traditional Chinese medicine and modern medicine, and its compatibility conforms to the principle of "junchenzuoshi" of traditional Chinese medicine, and has a unique curative effect on postmenopausal osteoporosis. The medicine is scientifically compatible, and the curative effect is rapid and effective Fast, short course of treatment, high cure rate, low cost advantages.

Description

一种防治绝经后骨质疏松症的中药组合物及其应用A traditional Chinese medicine composition for preventing and treating postmenopausal osteoporosis and its application

技术领域technical field

本发明属于医药技术领域,涉及一种中药组合物,具体涉及一种防治绝经后骨质疏松症的中药组合物及其应用。The invention belongs to the technical field of medicine and relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition for preventing and treating postmenopausal osteoporosis and its application.

背景技术Background technique

骨质疏松症(osteoporosis)是一种以骨量减少,骨的微细结构破坏为特征,致骨的脆性增加,易于骨折的一种全身性骨病。骨质疏松症可分为三大类:原发性骨质疏松症、继发性骨质疏松症和特发性骨质疏松症。第一类原发性骨质疏松症又可分为绝经妇女的骨质疏松症(I型)和老年性骨质疏松症(II型);第二类为继发性骨质疏松症,它是由其他疾病(如肾衰竭,过量甲状腺荷尔蒙或白血病),或药物(如类固醇)等一些因素所诱发的骨质疏松症;第三类为特发性骨质疏松症,多见于8~14岁的青少年或成人,多半有遗传家庭史,女性多于男性,妇女妊娠及哺乳期所发生的骨质疏松也可列入特发性骨质疏松。Osteoporosis is a systemic bone disease characterized by decreased bone mass and destruction of bone microstructure, resulting in increased bone fragility and easy fractures. Osteoporosis can be divided into three major categories: primary osteoporosis, secondary osteoporosis, and idiopathic osteoporosis. The first type of primary osteoporosis can be divided into postmenopausal women's osteoporosis (type I) and senile osteoporosis (type II); the second type is secondary osteoporosis, which Osteoporosis induced by other diseases (such as renal failure, excessive thyroid hormone or leukemia), or drugs (such as steroids); the third type is idiopathic osteoporosis, which is more common in 8-14 years old Adolescents or adults over 100 years old mostly have a family history of inheritance, and more women than men. Osteoporosis that occurs during pregnancy and lactation in women can also be classified as idiopathic osteoporosis.

骨质疏松症是中老年人常见病、多发病,严重影响该类人群的健康和生活质量,骨质疏松症及其引起的骨折在当前常见疾病中位居第7位,严重威胁着中、老年人的健康,使之成为全球的公共卫生问题。目前,人口老龄化日益严重,提高对骨质疏松症的防治意识具有非常重要的意义。骨质疏松症是以骨量减少,包括骨矿物质和基质等比例的减少、骨组织显微结构退化为特征,表现为骨小梁结构破坏、变细和断裂,进而导致骨的脆性增加,骨力学强度下降,载荷承受力降低,易于发生微细骨折或完全骨折的一种全身性骨骼疾病。临床上骨质疏松症患者主要症状为腰背疼痛、驼背、易骨折,并多伴有肾虚表现,如腰背疼痛、性欲减退等等,严重影响了生活和生命质量。据联合国统计老龄化己成为21世纪不可逆转的世界性趋势。而中国已于1999年进入老龄化社会。中国社会老龄化速度快于全国总人口增长速度,据不完全统计,我国60岁以上的老年人骨质疏松症发病率约为59.89%,因此增加骨密度、有效治疗骨质疏松症已经成为人们广泛关注的重要课题。Osteoporosis is a common and frequently-occurring disease of middle-aged and elderly people, which seriously affects the health and quality of life of this group of people. Osteoporosis and the fractures it causes rank seventh among the current common diseases, seriously threatening The health of the elderly makes it a global public health problem. At present, the aging of the population is becoming more and more serious, and it is of great significance to improve the awareness of prevention and treatment of osteoporosis. Osteoporosis is characterized by decreased bone mass, including the reduction in the proportion of bone mineral and matrix, and the degradation of the microstructure of bone tissue. A systemic skeletal disease in which the mechanical strength of the bone decreases, the load bearing capacity decreases, and microfractures or complete fractures are prone to occur. Clinically, the main symptoms of osteoporosis patients are low back pain, hunchback, and easy fractures, often accompanied by kidney deficiency symptoms, such as low back pain, loss of libido, etc., which seriously affect the quality of life and life. According to United Nations statistics, aging has become an irreversible worldwide trend in the 21st century. China has entered an aging society in 1999. The aging rate of Chinese society is faster than the growth rate of the total population of the country. According to incomplete statistics, the incidence of osteoporosis in the elderly over 60 years old in my country is about 59.89%. Therefore, increasing bone density and effectively treating osteoporosis have become people's important topic of widespread concern.

在国际骨质疏松基金会(IOF)2004年世界骨质疏松大会上,英国谢菲尔德大学WHO代谢性骨病研究中心Johnell等对12个临床研究进行分析,该研究纳入12个人群研究中的3万9千人。发现骨密度值越低,骨质疏松性骨折(和各种类型骨折)的概率越高,这种情况在65岁年龄组中规律最为明显。骨密度(BMD)全称是骨骼矿物质密度,是骨骼强度的一个重要指标,骨组织的强度有75%~85%与骨密度有关。骨密度指骨单位面积的骨质密度,是指骨组织结合的紧密程度,通常指骨矿物含量。是目前衡量骨质疏松的一个客观的量化的指标,也是反映骨量的一个指标,其单位为g/c㎡,骨密度越高,骨质强度越好。它与骨骼结构、骨量、骨矿物含量等因素相关。At the 2004 World Osteoporosis Congress of the International Osteoporosis Foundation (IOF), Johnell et al., the WHO Metabolic Bone Disease Research Center at the University of Sheffield, UK, analyzed 12 clinical studies, which included 3 of the 12 population studies. Ten thousand and nine thousand people. It was found that the lower the BMD value, the higher the probability of osteoporotic fractures (and all types of fractures), and this pattern was most pronounced in the 65-year-old age group. The full name of bone mineral density (BMD) is bone mineral density, which is an important indicator of bone strength, and 75% to 85% of the strength of bone tissue is related to bone density. Bone density refers to the bone density per unit area of bone, which refers to the tightness of bone tissue integration, and usually refers to the bone mineral content. It is an objective and quantitative index to measure osteoporosis at present, and it is also an index to reflect bone mass. Its unit is g/c㎡. The higher the bone density, the better the bone strength. It is related to bone structure, bone mass, bone mineral content and other factors.

现代医学认为绝经后骨质疏松症是一种与衰老有关的常见病,主要发生在绝经后妇女群,由于雌激素缺乏导致骨量减少及骨组织结构变化,使骨脆性增大易于骨折,以及由骨折引起的疼痛、骨骼变形、出现合并症,乃至死亡等问题,严重地影响老年人的身体健康及生活质量,甚至缩短寿命,增加国家及家庭财力与人力负担。骨质疏松症是绝经后妇女的一种常见病,多发病,危害日益严重,被称为“无声无息的流行病”,已经引起全世界的关注。临床病症表现在:最早背疼,随之椎体压缩,还可伴有脊柱畸形,驼背变矮等,严重者可引起胸廓畸形,影响肺功能,并发骨折,并且随着年龄的增加,骨折的危险性增加。目前对此症西医治疗方法多采用补充雌激素、钙剂和维生素,但长期大量服用雌激素有可能引发子宫内膜癌和乳房癌等副作用,且钙剂和维生素的补充在剂量上又难以控制。Modern medicine believes that postmenopausal osteoporosis is a common disease related to aging, which mainly occurs in postmenopausal women. Due to estrogen deficiency, bone mass decreases and bone tissue structure changes, resulting in increased bone fragility and easy fractures, and Pain, bone deformation, complications, and even death caused by fractures seriously affect the health and quality of life of the elderly, and even shorten life expectancy, increasing the financial and human burden of the country and families. Osteoporosis is a common disease in postmenopausal women. It is a frequently occurring disease and its harm is becoming more and more serious. It is called a "silent epidemic" and has attracted worldwide attention. The clinical manifestations are as follows: back pain at the earliest, followed by vertebral body compression, accompanied by spinal deformity, hunchback becoming shorter, etc. In severe cases, it can cause thoracic deformity, affect lung function, and fracture concurrently. Increased risk. At present, Western medicine treatment methods for this disease mostly use estrogen supplementation, calcium and vitamins, but long-term use of large amounts of estrogen may cause side effects such as endometrial cancer and breast cancer, and the supplementation of calcium and vitamins is difficult to control in terms of dosage. .

目前,与绝经相关的骨质疏松症已是不可忽视的重要保健课题。绝经后骨质疏松是多因素性疾病,遗传、生活方式、营养等均与发病有关。具有以下高危因素者易患绝经后骨质疏松症:白人及亚洲妇女、有骨质疏松症家族史或具有影响骨量的特殊基因的妇女、钙摄入不足、缺乏体力活动、大量吸烟及饮酒、早绝经或绝经前行双侧卵巢切除术者。是否发生骨质疏松症,取决于其骨峰值及其骨丢失的速度,骨峰值高及(或)骨丢失慢者,不易发生,骨峰值低及(或)骨丢失快者容易发生。At present, osteoporosis associated with menopause has become an important health care issue that cannot be ignored. Postmenopausal osteoporosis is a multifactorial disease, and heredity, lifestyle, and nutrition are all related to the disease. Postmenopausal osteoporosis is predisposed to developing postmenopausal osteoporosis in people who have the following risk factors: Caucasian and Asian women, women with a family history of osteoporosis or women with specific genes that affect bone mass, insufficient calcium intake, physical inactivity, heavy smoking, and alcohol consumption , Early menopause or premenopausal bilateral oophorectomy. Whether osteoporosis occurs depends on the peak bone mass and the speed of bone loss. Those with high peak bone mass and/or slow bone loss are less likely to develop, while those with low peak bone mass and/or fast bone loss are more likely to develop.

根据骨密度缺少产生原因和作用机理的不同,可以选择不同的方法增加骨密度,目前临床治疗多采用钙剂、活性维生素D、性激素、降钙素、双膦酸盐和氟化物等,虽有一定疗效,但副作用大,费用昂贵,且治标不治本。在治疗方面,西医学尚缺乏有效地措施,药物应用也十分有限。单纯的补钙仅能延缓但不能阻止骨量的丢失,因此研究开发一种高效补充流失钙质并能固本防止骨量流失、且安全无毒副作用,从而从根本上解决骨质疏松的药物已经成为了亟待需要解决的问题。Depending on the cause and mechanism of bone mineral density deficiency, different methods can be chosen to increase bone density. At present, calcium, active vitamin D, sex hormones, calcitonin, bisphosphonates and fluoride are often used in clinical treatment. Certain curative effect, but side effect is big, and expense is expensive, and cures the symptoms but not the root cause. In terms of treatment, Western medicine still lacks effective measures, and the application of drugs is also very limited. Simple calcium supplementation can only delay but not prevent the loss of bone mass. Therefore, research and development of a drug that effectively supplements the lost calcium and can consolidate and prevent bone loss, is safe and has no side effects, so as to fundamentally solve the problem of osteoporosis has become an urgent problem to be solved.

发明内容Contents of the invention

本发明的目的在于解决上述现有技术存在的不足之处,提供一种能够有效防治绝经后骨质疏松而且见效快、疗程短、治愈率高的中药组合物。The purpose of the present invention is to solve the shortcomings of the above-mentioned prior art, and provide a traditional Chinese medicine composition that can effectively prevent and treat postmenopausal osteoporosis, has quick effect, short course of treatment and high cure rate.

本发明的上述目的是通过下述技术方案来实现的:Above-mentioned purpose of the present invention is achieved by following technical scheme:

一种防治绝经后骨质疏松症的中药组合物,所述中药组合物的原料药由白芍、夜交藤、淫羊藿、女贞子、菟丝子、虎杖、红参、墨旱莲、红景天、揉白叶、肉苁蓉、杜仲、枸杞子、破骨风、鸡血藤、桑寄生、制首乌、仙鹤草、红花、秦艽、紫河车、三棱、雪莲、血竭、益母草、三七、葛根、巴戟天、天麻、黑芝麻组成。A traditional Chinese medicine composition for preventing and treating postmenopausal osteoporosis. The raw materials of the traditional Chinese medicine composition are Radix Paeoniae Alba, Radix Nocturna, Epimedium, Ligustrum lucidum, Cuscuta, Polygonum cuspidatum, Red Ginseng, Eclipta chinensis, Red Ginseng Sedum, rubbing white leaves, cistanche, eucommia, medlar, Cracker, Milletah, Sangji, Zhishouwu, Agrimony, safflower, Gentiana, Ziheche, Sanleng, snow lotus, dried blood, motherwort , Panax notoginseng, kudzu root, Morinda officinalis, Gastrodia elata, black sesame.

进一步地,制成所述中药组合物的原料组成及重量份数为:白芍12-20份,淫羊藿10-16份,女贞子3-8份,菟丝子5-12份,夜交藤12-17份,红参7-12份,红花4-9份,墨旱莲15-20份,红景天10-15份,揉白叶8-12份,肉苁蓉2-5份,枸杞子3-7份,鸡血藤11-14份,破骨风9-15份,桑寄生3-6份,制首乌8-13份,雪莲3-5份,杜仲1-3份,仙鹤草5-10份,三七5-10份,虎杖13-16份,秦艽3-10份,紫河车8-13份,三棱3-5份,血竭1-3份,葛根5-10份,益母草3-6份,巴戟天8-13份,天麻3-5份,黑芝麻13-16份。Further, the composition and parts by weight of the raw materials for making the traditional Chinese medicine composition are: 12-20 parts of Radix Paeoniae Alba, 10-16 parts of Epimedium, 3-8 parts of Ligustrum lucidum, 5-12 parts of Cuscuta, 12-17 parts of rattan, 7-12 parts of red ginseng, 4-9 parts of safflower, 15-20 parts of Eclipta, 10-15 parts of rhodiola, 8-12 parts of white leaves, 2-5 parts of Cistanche, 3-7 parts of Lycium barbarum, 11-14 parts of Caulis Spatholobus, 9-15 parts of Gufengfeng, 3-6 parts of Sangjisheng, 8-13 parts of Shouwu, 3-5 parts of Snow Lotus, 1-3 parts of Eucommia, Agrimony 5-10 parts, Panax notoginseng 5-10 parts, Polygonum cuspidatum 13-16 parts, Gentiana chinensis 3-10 parts, Ziheche 8-13 parts, Sanleng 3-5 parts, dried blood 1-3 parts, Pueraria 5 parts -10 parts, Motherwort 3-6 parts, Morinda officinalis 8-13 parts, Gastrodia elata 3-5 parts, black sesame 13-16 parts.

进一步地,制成所述中药组合物的原料组成及重量份数为:白芍12份,淫羊藿16份,女贞子3份,菟丝子12份,夜交藤12份,红参10份,红花9份,墨旱莲15份,红景天15份,揉白叶8份,肉苁蓉5份,枸杞子3份,鸡血藤14份,破骨风9份,桑寄生6份,制首乌8份,雪莲5份,杜仲1份,仙鹤草10份,三七5份,虎杖16份,秦艽10份,紫河车8份,三棱5份,血竭1份,葛根10份,益母草6份,巴戟天8份,天麻3份,黑芝麻13份。Further, the composition and parts by weight of the raw materials for making the Chinese medicine composition are: 12 parts of Radix Paeoniae Alba, 16 parts of Epimedium, 3 parts of Ligustrum lucidum, 12 parts of Cuscuta chinensis, 12 parts of Caulis japonica, and 10 parts of red ginseng , 9 parts of safflower, 15 parts of Eclipta, 15 parts of Rhodiola rosea, 8 parts of white leaves, 5 parts of Cistanche, 3 parts of medlar, 14 parts of Caulis Spatholobus, 9 parts of Cereal, 6 parts of Sangji, 8 parts of Shouwu, 5 parts of Snow Lotus, 1 part of Eucommia, 10 parts of Agrimony, 5 parts of Panax notoginseng, 16 parts of Polygonum cuspidatum, 10 parts of Gentiana chinensis, 8 parts of Ziheche, 5 parts of Sanleng, 1 part of blood jellyfish, and 10 parts of kudzu root 6 parts of Motherwort, 8 parts of Morinda officinalis, 3 parts of Gastrodia elata, and 13 parts of black sesame.

进一步地,制成所述中药组合物的原料组成及重量份数为:白芍20份,淫羊藿10份,女贞子8份,菟丝子5份,夜交藤17份,红参12份,红花4份,墨旱莲20份,红景天10份,揉白叶12份,肉苁蓉2份,枸杞子7份,鸡血藤11份,破骨风15份,桑寄生3份,制首乌13份,雪莲3份,杜仲3份,仙鹤草5份,三七10份,虎杖13份,秦艽3份,紫河车13份,三棱3份,血竭3份,葛根5份,益母草4份,巴戟天10份,天麻4份,黑芝麻16份。Further, the composition and parts by weight of the raw materials for making the Chinese medicine composition are: 20 parts of Radix Paeoniae Alba, 10 parts of Epimedium, 8 parts of Ligustrum lucidum, 5 parts of Cuscuta chinensis, 17 parts of Caulis japonica, 12 parts of red ginseng , 4 parts of safflower, 20 parts of Eclipta, 10 parts of Rhodiola rosea, 12 parts of white leaves, 2 parts of Cistanche, 7 parts of medlar, 11 parts of Caulis Spatholobus, 15 parts of Cragonia, 3 parts of Mulberry, 13 parts of Shouwu, 3 parts of Snow Lotus, 3 parts of Eucommia, 5 parts of Agrimony, 10 parts of Panax notoginseng, 13 parts of Polygonum cuspidatum, 3 parts of Gentiana, 13 parts of Ziheche, 3 parts of Sanleng, 3 parts of blood, and 5 parts of Pueraria 4 parts of Motherwort, 10 parts of Morinda officinalis, 4 parts of Gastrodia elata, 16 parts of black sesame.

进一步地,制成所述中药组合物的原料组成及重量份数为:白芍13份,淫羊藿11份,女贞子4份,菟丝子6份,夜交藤13份,红参7份,红花5份,墨旱莲18份,红景天11份,揉白叶9份,肉苁蓉4份,枸杞子6份,鸡血藤12份,破骨风13份,桑寄生4份,制首乌9份,雪莲4份,杜仲2份,仙鹤草6份,三七6份,虎杖14份,秦艽5份,紫河车10份,三棱4份,血竭2份,葛根6份,益母草5份,巴戟天12份,天麻3份,黑芝麻14份。Further, the composition and parts by weight of the raw materials for making the Chinese medicine composition are: 13 parts of Radix Paeoniae Alba, 11 parts of Epimedium, 4 parts of Ligustrum lucidum, 6 parts of Cuscuta chinensis, 13 parts of Caulis japonica, and 7 parts of red ginseng , 5 parts of safflower, 18 parts of Eclipta, 11 parts of Rhodiola, 9 parts of white leaves, 4 parts of Cistanche, 6 parts of medlar, 12 parts of Milletah, 13 parts of Rhizoma, 4 parts of Mulberry, 9 parts of Shouwu, 4 parts of Snow Lotus, 2 parts of Eucommia, 6 parts of Agrimony, 6 parts of Panax notoginseng, 14 parts of Polygonum cuspidatum, 5 parts of Gentiana chinensis, 10 parts of Ziheche, 4 parts of Sanleng, 2 parts of blood, 6 parts of Pueraria 5 parts of Motherwort, 12 parts of Morinda officinalis, 3 parts of Gastrodia elata, and 14 parts of black sesame.

进一步地,制成所述中药组合物的原料组成及重量份数为:白芍17份,淫羊藿15份,女贞子7份,菟丝子11份,夜交藤16份,红参8份,红花8份,墨旱莲16份,红景天14份,揉白叶11份,肉苁蓉3份,枸杞子5份,鸡血藤13份,破骨风14份,桑寄生5份,制首乌12份,雪莲3份,杜仲1份,仙鹤草10份,三七9份,虎杖13份,秦艽7份,紫河车11份,三棱3份,血竭1份,葛根10份,益母草4份,巴戟天11份,天麻4份,黑芝麻15份。Further, the composition and parts by weight of the raw materials for making the Chinese medicine composition are: 17 parts of Radix Paeoniae Alba, 15 parts of Epimedium, 7 parts of Ligustrum lucidum, 11 parts of Cuscuta chinensis, 16 parts of Caulis japonica, 8 parts of red ginseng , 8 parts of safflower, 16 parts of Eclipta, 14 parts of Rhodiola rosea, 11 parts of white leaves, 3 parts of Cistanche, 5 parts of medlar, 13 parts of Caulis Spatholobus, 14 parts of Cephalosporum, 5 parts of Mulberry, 12 parts of Shouwu, 3 parts of Snow Lotus, 1 part of Eucommia, 10 parts of Agrimony, 9 parts of Panax notoginseng, 13 parts of Polygonum cuspidatum, 7 parts of Gentiana, 11 parts of Ziheche, 3 parts of Sanleng, 1 part of blood, and 10 parts of Pueraria 4 parts of Motherwort, 11 parts of Morinda officinalis, 4 parts of Gastrodia elata, and 15 parts of black sesame.

进一步地,制成所述中药组合物的原料组成及重量份数为:白芍15份,淫羊藿12份,女贞子5份,菟丝子9份,夜交藤15份,红参9份,红花7份,墨旱莲19份,红景天13份,揉白叶10份,肉苁蓉4份,枸杞子4份,鸡血藤11份,破骨风11份,桑寄生5份,制首乌10份,雪莲5份,杜仲3份,仙鹤草8份,三七8份,虎杖14份,秦艽9份,紫河车12份,三棱5份,血竭3份,葛根8份,益母草6份,巴戟天9份,天麻5份,黑芝麻14份。Further, the composition and parts by weight of the raw materials for making the Chinese medicine composition are: 15 parts of Radix Paeoniae Alba, 12 parts of Epimedium, 5 parts of Ligustrum lucidum, 9 parts of Cuscuta chinensis, 15 parts of Caulis japonica, and 9 parts of red ginseng , 7 parts of safflower, 19 parts of Eclipta, 13 parts of rhodiola, 10 parts of white leaves, 4 parts of cistanche, 4 parts of medlar, 11 parts of Milletah, 11 parts of Rhizoma cerana, 5 parts of mulberry, 10 parts of Shouwu, 5 parts of Snow Lotus, 3 parts of Eucommia, 8 parts of Agrimony, 8 parts of Panax notoginseng, 14 parts of Polygonum cuspidatum, 9 parts of Gentiana chinensis, 12 parts of Ziheche, 5 parts of Sanleng, 3 parts of blood jellyfish, and 8 parts of kudzu root 6 parts of Motherwort, 9 parts of Morinda officinalis, 5 parts of Gastrodia elata, and 14 parts of black sesame.

进一步地,制成所述中药组合物的原料组成及重量份数为:白芍19份,淫羊藿14份,女贞子6份,菟丝子7份,夜交藤14份,红参9份,红花6份,墨旱莲17份,红景天13份,揉白叶10份,肉苁蓉4份,枸杞子4份,鸡血藤11份,破骨风11份,桑寄生5份,制首乌10份,雪莲5份,杜仲3份,仙鹤草8份,三七8份,虎杖14份,秦艽4份,紫河车9份,三棱5份,血竭3份,葛根8份,益母草3份,巴戟天8份,天麻5份,黑芝麻16份。Further, the composition and parts by weight of the raw materials for making the Chinese medicine composition are: 19 parts of Radix Paeoniae Alba, 14 parts of Epimedium, 6 parts of Ligustrum lucidum, 7 parts of Cuscuta chinensis, 14 parts of Caulis japonica, and 9 parts of red ginseng , 6 parts of safflower, 17 parts of Eclipta, 13 parts of Rhodiola rosea, 10 parts of white leaves, 4 parts of Cistanche, 4 parts of medlar, 11 parts of Caulis Spatholobus, 11 parts of Rhododendron, 5 parts of Mulberry, 10 parts of Shouwu, 5 parts of Snow Lotus, 3 parts of Eucommia, 8 parts of Agrimony, 8 parts of Panax notoginseng, 14 parts of Polygonum cuspidatum, 4 parts of Gentiana chinensis, 9 parts of Ziheche, 5 parts of Sanleng, 3 parts of blood jellyfish, and 8 parts of Pueraria lobata 3 parts of Motherwort, 8 parts of Morinda officinalis, 5 parts of Gastrodia elata, and 16 parts of black sesame.

进一步地,所述中药组合物按照下述方法进行制备:Further, the traditional Chinese medicine composition is prepared according to the following method:

(1)取所述中药组合物中重量组分的各药材,粉碎成粗粉,按照粗粉总重量的4-10倍加入体积浓度为70%-95%的乙醇溶液,回流提取三次,回流时间为3-5h,滤过,滤液回收乙醇,冷却过滤,用水洗涤,干燥后得干浸膏;(1) Get each medical material of weight component in described Chinese medicine composition, pulverize into coarse powder, add the ethanol solution that volume concentration is 70%-95% according to 4-10 times of the total weight of coarse powder, reflux extraction three times, reflux The time is 3-5h, filter, recover ethanol from the filtrate, cool and filter, wash with water, and dry to obtain a dry extract;

(2)将步骤(1)制得的干浸膏粉碎,加入适量蔗糖、糊精混合,以乙醇为润湿剂,制粒,干燥,整粒,可制得颗粒剂;或者将步骤(1)制得的干浸膏干燥,粉碎,制成散剂;或者将步骤(1)制得的干浸膏粉碎,加入适量微粉硅胶、α-半乳糖混合,以乙醇为润湿剂,制粒,干燥,整粒,装胶囊,制得胶囊剂;或者将步骤(1)制得的干浸膏粉碎,加入适量蔗糖、糊精混合,以乙醇为润湿剂,制粒,干燥,整粒,压片,制得片剂;或者向上述步骤(1)得到的离心后的浓缩液中加入适量蔗糖、香精混合,灭菌,灌装,制得药液剂。(2) Grinding the dry extract prepared in step (1), adding an appropriate amount of sucrose and dextrin to mix, using ethanol as a wetting agent, granulating, drying, and sizing to obtain granules; or step (1) ) dried extract obtained, pulverized, and made into a powder; or the dried extract obtained in step (1) was pulverized, mixed with an appropriate amount of micropowdered silica gel and α-galactose, and granulated with ethanol as a wetting agent, Drying, granulation, packing into capsules to obtain capsules; or crushing the dry extract obtained in step (1), adding appropriate amount of sucrose and dextrin to mix, using ethanol as a wetting agent, granulating, drying, and granulation, Tablets are produced; or an appropriate amount of sucrose and essence are added to the centrifuged concentrate obtained in the above step (1), mixed, sterilized, and filled to obtain a liquid medicine.

本发明还涉及一种防治绝经后骨质疏松症的中药组合物在防治绝经后骨质疏松症药物中的应用。The invention also relates to the application of a traditional Chinese medicine composition for preventing and treating postmenopausal osteoporosis in medicine for preventing and treating postmenopausal osteoporosis.

本发明所提供的防治绝经后骨质疏松症的中药组合物,其以常见的中草药为原料,充分发挥各组分的药性:The traditional Chinese medicine composition for preventing and treating postmenopausal osteoporosis provided by the present invention uses common Chinese herbal medicines as raw materials to give full play to the medicinal properties of each component:

白芍,入肝、脾经,具有养血柔肝,缓中止痛,敛阴收汗的功效。主治胸腹胁肋疼痛,泻痢腹痛,自汗盗汗,阴虚发热,月经不调,崩漏,带下等症。薄荷是中华常用中药之一。它是辛凉性发汗解热药,治流行性感冒、头疼、目赤、身热、咽喉、牙床肿痛等症。外用可治神经痛、皮肤瘙痒、皮疹和湿疹等。光朋温室采摘的薄荷又是春节餐桌上的鲜菜。清爽可口。平常以薄荷代茶,清心明目。现代医学证明薄荷具有很强的抗病毒和抗菌活性,并具有一定的抗过敏活性。Radix Paeoniae Alba, enter liver, spleen meridian, have the effect of nourishing blood and softening liver, relieving pain in the middle, astringing yin and sweating. Indications for chest and abdomen hypochondriac pain, diarrhea and abdominal pain, spontaneous sweating, night sweats, fever due to yin deficiency, irregular menstruation, uterine bleeding, leukorrhea embolism. Peppermint is one of the commonly used traditional Chinese medicines in China. It is a pungent and cool antipyretic medicine for sweating and treating influenza, headache, red eyes, body heat, sore throat and gums. External application can cure neuralgia, itchy skin, rash and eczema, etc. The mint picked in the Guangpeng Greenhouse is another fresh vegetable on the table during the Spring Festival. Refreshing and delicious. Usually use mint instead of tea to clear the heart and improve eyesight. Modern medicine has proved that peppermint has strong antiviral and antibacterial activity, and has certain antiallergic activity.

淫羊藿,辛、甘、温,归肝肾经,《本草纲目》载:“性温不寒,能益精气,乃手足阳明三焦命门药也。”为肾阳虚诸证常用药。《本草备要》载:“补命门,益精气,坚筋骨,利小便。”Epimedium, pungent, sweet, and warm, belongs to the liver and kidney meridians. "Compendium of Materia Medica" contains: "The nature is warm and not cold, and it can benefit essence and energy. It is also the medicine for the three energizers of the hands and feet." It is commonly used for various syndromes of kidney yang deficiency medicine. "Compendium of Materia Medica" contains: "Replenishing the gate of life, benefiting essence, strengthening muscles and bones, and facilitating urination."

女贞子为木犀科植物女贞LigustrumlucidumAit.的干燥成熟果实。冬季果实成熟时采收,除去枝叶,稍蒸或置沸水中略烫后,干燥;或直接干燥。性味甘、苦,凉。归肝、肾经。能滋补肝肾,明目乌发。用于肝肾阴虚,眩晕耳呜,腰膝酸软,须发旱白,目暗不明,内热消渴,骨蒸潮热。Ligustrum lucidum is the dry ripe fruit of Oleaceae plant Ligustrum lucidum Ait. Harvest when the fruit is ripe in winter, remove branches and leaves, steam or put in boiling water for a while, and then dry; or directly dry. Nature and flavor are sweet, bitter, cool. Return liver, kidney channel. Can nourish the liver and kidney, improve eyesight and black hair. For liver and kidney yin deficiency, dizziness and tinnitus, soreness and weakness of the waist and knees, dry beard and hair, dark eyes, internal heat and quenching thirst, bone steaming and hot flashes.

菟丝子:味甘、辛,性平,入肝、肾、脾经,有补肾益精,养肝明目的作用,主要用于肾阳不足之阳痿,遗精早泄,小便频数,头晕耳鸣;肾虚腰疼,妇人带下,胎气不固;肝肾两亏、肝血不足之双目昏花、视物不清;脾肾两虚之便溏腹痛,完谷不化等症状。Cuscutae: sweet, pungent, flat in nature, enters the liver, kidney, and spleen meridian, has the functions of nourishing the kidney and nourishing essence, nourishing the liver and improving eyesight, mainly used for impotence due to deficiency of kidney yang, seminal emission, premature ejaculation, frequent urination, dizziness and tinnitus; kidney deficiency, low back pain, Fetal qi is not solid when taken by a woman; liver and kidney deficiency, dim eyesight and blurred vision due to insufficient liver blood; loose stools and abdominal pain due to deficiency of both spleen and kidney, and inability to dissolve the grain.

夜交藤:甘微苦,平。入心、肝经。具有养心,安神,通络,祛风等功效。治失眠,劳伤,多汗,血虚身痛,痈疽,瘰疬,风疮疥癣。Teng Yejiao: sweet and slightly bitter, flat. Go into the heart, Liver Channel. It has the effects of nourishing the heart, calming the nerves, dredging collaterals, and expelling wind. Control insomnia, overstrain, hyperhidrosis, blood deficiency body pain, carbuncle, scrofula, wind sore and scabies.

虎杖:微苦,微寒。归肝、胆、肺经。功能主治祛风利湿,散瘀定痛,止咳化痰。用于关节痹痛,湿热黄疸,经闭,症瘕,水火烫伤,跌扑损伤,痈肿疮毒,咳嗽痰多。Polygonum cuspidatum: slightly bitter, slightly cold. Return liver, gallbladder, lung meridian. Function cures mainly dispelling wind and dampness, dispelling blood stasis and relieving pain, relieving cough and reducing phlegm. Used for arthralgia, damp-heat jaundice, amenorrhea, lump in the abdomen, water and fire burns, injuries from falls, carbuncles and sores, cough with excessive phlegm.

红参:甘、微苦,温。归脾、肺、心经。功能主治:大补元气,复脉固脱,益气摄血。用于体虚欲脱,肢冷脉微,气不摄血,崩漏下血。Red Ginseng: sweet, slightly bitter, warm. Return spleen, lung, heart channel. Functions and indications: tonify vital energy, restore pulse and solidify, replenish qi and absorb blood. It is used for the weakness of the body and the desire to dislodge, cold extremities and weak pulse, qi not absorbing blood, metrorrhagia and bleeding.

墨旱莲,味甘,酸,性凉,归肝、肾经,补益肝肾;凉血止血。主肝肾不足;头晕目眩;须发早白;吐血;咯血;衄血;便血;血痢;崩;漏;外伤出血。Eclipta japonica, sweet in taste, sour, cool in nature, returns to the liver and kidney channels, nourishes the liver and kidney; cools blood to stop bleeding. Insufficient liver and kidney; dizziness; premature graying of beard and hair; vomiting blood; hemoptysis; epistaxis; blood in stool; bloody dysentery; metrorrhagia; leakage; traumatic bleeding.

红景天:益气活血,通脉平喘。具有改善睡眠、生血活血、抗脑缺氧、抗疲劳、活血止血、清肺止咳、化淤消肿、解热退烧、滋补元气等功效。选用景天科植物大花红景天的干燥根和根茎。Rhodiola rosea: replenishing qi and activating blood circulation, dredging the veins and relieving asthma. It has the effects of improving sleep, promoting blood circulation, anti-brain hypoxia, anti-fatigue, promoting blood circulation and stopping bleeding, clearing lung and relieving cough, reducing stasis and swelling, antipyretic and fever, and nourishing vitality. The dried roots and rhizomes of Rhodiola grandiflora of the Crassulaceae plant were selected for use.

揉白叶,苦,凉。清热解毒。用于痢疾,急性胃肠炎,口腔炎,尿路感染;外用治烧烫伤,疮疡肿毒,皮肤瘙痒。Knead white leaves, bitter, cool. Detoxification. For dysentery, acute gastroenteritis, stomatitis, urinary tract infection; for external use to treat burns, sores, swollen toxins, and itchy skin.

肉苁蓉,甘、咸,温。归肾、大肠经。补肾阳,益精血,润肠通便。用于阳痿,不孕,腰膝酸软,筋骨无力,肠燥便秘。《本经》:“主五劳七伤,补中,除茎中寒热痛,养五脏,强阴,益精气,妇人症瘕。”Herba Cistanche, sweet, salty, warm. Return kidney, large intestine channel. Tonifying kidney yang, benefiting essence and blood, moistening intestines and laxative. For impotence, infertility, soreness of the waist and knees, weakness of muscles and bones, dryness of the intestines and constipation. "The Classic": "Maintains five labors and seven injuries, nourishes the middle, removes cold and heat pain in the stem, nourishes the five internal organs, strengthens yin, benefits essence and qi, and relieves women's abdominal pain."

杜仲:补肝肾,强筋骨,安胎。治腰脊酸疼,具有清除体内垃圾,加强人体细胞物质代谢,防止肌肉骨骼老化,平衡人体血压,分解体内胆固醇,降低体内脂肪,恢复血管弹性,利尿清热,广谱抗菌,兴奋中枢神经,提高白血球数量,增强人体免疫力等显著功效。Eucommia ulmoides: nourishes liver and kidney, strengthens muscles and bones, and prevents miscarriage. It can treat back pain, remove garbage in the body, strengthen the metabolism of human cell substances, prevent musculoskeletal aging, balance human blood pressure, decompose cholesterol in the body, reduce body fat, restore blood vessel elasticity, diuresis and clear away heat, broad-spectrum antibacterial, excite the central nervous system, and improve blood circulation. Significant effects such as increasing the number of white blood cells and enhancing human immunity.

枸杞子:为茄科植物宁夏枸杞LyciumbarbarumL.的干燥成熟果实。性味甘、平。归肝、肾、肺经。功效:养肝,滋肾。Lycium barbarum: It is the dry and mature fruit of Lycium barbarum L., a plant of the family Solanaceae. Nature and flavor are sweet, flat. Return liver, kidney, lung meridian. Efficacy: Nourish the liver, nourish the kidney.

破骨风,苦,温。功能主治:祛风除湿,活血散瘀。用于风湿筋骨痛,腰痛,跌打损伤。Broken bone wind, bitter, temperature. Function cures mainly: expelling wind and removing dampness, promoting blood circulation and removing blood stasis. For rheumatic pain, lumbago, bruises.

鸡血藤:为豆科Leguminosae植物密花豆SpatholobussuberectusDunn的干燥藤茎。性味苦、甘,温。归肝、肾经。功效:补血,活血,通络。Spatholobus Spatholobus suberectus Dunn is the dry cane of the leguminosae plant Spatholobus suberectus Dunn. Nature and flavor are bitter, sweet, warm. Return liver, kidney channel. Efficacy: nourishing blood, promoting blood circulation, dredging collaterals.

桑寄生:为桑寄生科常绿小灌木植物桑寄生Loranthusparasiticus(L.)Merr.或槲寄生Viscumcoloratum(Komar.)Nakai的带叶茎枝。性味苦、甘,平。归肝、肾经。功效:祛风湿,益肝肾,强筋骨。《日华子本草》:助筋骨,益血脉。Mulberry: the leafy stems and branches of Loranthus parasiticus (L.) Merr. or mistletoe Viscumcoloratum (Komar.) Nakai. Nature and flavor are bitter, sweet, flat. Return liver, kidney channel. Efficacy: dispelling rheumatism, benefiting liver and kidney, strengthening muscles and bones. "Nihuazi Materia Medica": Helps muscles and bones, benefits blood vessels.

制首乌:为蓼科植物何首乌PolygonummultiflorumThunb.的干燥块根的炮制加工品。性味苦、甘、涩,微温。归肝、心、肾经。功效:补肝肾,益精血,乌须发,强筋骨。Shouwu: It is a processed product of the dried tuber root of Polygonum multiflorum Thunb. Nature and flavor are bitter, sweet, astringent, slightly warm. Return liver, heart, kidney channel. Efficacy: Nourishing liver and kidney, benefiting essence and blood, black beard and hair, strengthening bones and muscles.

仙鹤草:为蔷薇科植物龙牙草AgrimoniapiloseLedeb.的干燥地上部分。性味苦、涩,平。归心、肝经。功效:收敛止血。Agrimonia pilose: the dry aerial part of Agrimoniapilose Ledeb. Nature and flavor are bitter, astringent, flat. GUIXIN, Liver Channel. Efficacy: astringent to stop bleeding.

红花性温,味辛。功能主治应用于活血通径、散瘀止痛。用于经闭、痛经、恶露不行、症瘕痞块、跌打损伤。《本草汇言》:红花,破血、行血、和血、调血之药也。主胎产百病因血为患,或血烦血晕,神昏不语;或恶露抢心,脐腹绞痛;或沥浆难生,;或胞衣不落,子死腹中,是皆临产诸证,非红花不能治。若产后血晕、口噤指搦;或邪入血室,谵语发狂;或血闷内胀,僵仆如死,是皆产后诸证,非红花不能定。凡如经闭不通而寒热交作,或过期腹痛而紫黑淋漓,或跌扑损伤而气血瘀积,或疮疡痛痒而肿溃不安,是皆气血不和之证,非红花不能调,红花活血通经、消肿止痛,有抑制血栓形成、抗炎、止痛作用,具有消除肾上腺素、去甲肾上腺素的收缩血管作用,有“通利经脉”作用。Safflower is warm in nature and pungent in taste. Functions and indications apply to promoting blood circulation, dispelling blood stasis and relieving pain. For amenorrhea, dysmenorrhea, lochia, lumps in the abdomen, bruises. "Materia Medica Huiyan": Safflower, the medicine for breaking blood, promoting blood circulation, harmonizing blood, and regulating blood. The main fetal birth is caused by various diseases and blood, or blood troubles and blood dizziness, dizziness and silence; or lochia grabs the heart, umbilical abdominal colic; card, non-safflower cannot be cured. If postpartum haemorrhage, mouth silencing and finger pricking; or evil entering the blood chamber, delirium and madness; All such as amenorrhea and cold and heat, or expired abdominal pain with purple and black dripping, or injury from falls and blood stasis, or sores and sores with swelling and ulceration are all symptoms of disharmony between qi and blood, and non-safflower cannot Tune, safflower promotes blood circulation to stimulate menstruation, reduces swelling and relieves pain, has the effects of inhibiting thrombosis, anti-inflammation, and pain relief, has the effect of constricting blood vessels by eliminating adrenaline and norepinephrine, and has the effect of "tongli meridian".

秦艽,苦辛,平。入肝、胃、胆经。功能主治:祛风除湿,和血舒筋,清热利尿。治风湿痹痛,筋骨拘挛,黄疸,便血,骨蒸潮热,小儿疳热,小便不利。Gentiana chinensis, hard work, flat. Go into liver, stomach, gallbladder meridian. Functions and indications: expelling wind and dampness, harmonizing blood and relaxing tendons, clearing away heat and diuresis. Control rheumatic arthralgia, muscle and bone spasms, jaundice, blood in the stool, bone steam hot flashes, infantile malnutrition, dysuria.

紫河车:甘、咸、温、补,安心养血、益气、补精、解毒等,主治虚损、羸瘦、咳血气喘、劳热骨蒸、遗精等。Ziheche: sweet, salty, warm, nourishing, soothing and nourishing blood, nourishing qi, tonifying essence, detoxifying, etc.

三棱:味辛;涩;凉。入肝。脾经。治症瘕,积聚,胁肋胀痛,食积胀痛,痛经,闭经,产后瘀血腹痛,跌打损伤。蒙药治肺热咳嗽,气喘痰多,肝热,脉热,痨热骨蒸,“宝日”病,骨折。Sanleng: spicy; astringent; cool. Into the liver. Spleen meridian. Treatment of lumps in the abdomen, accumulation, hypochondrium distending pain, food accumulation distending pain, dysmenorrhea, amenorrhea, postpartum blood stasis abdominal pain, bruises. Mongolian medicine is used to treat cough due to lung heat, asthma with excessive phlegm, liver heat, pulse heat, tuberculosis heat and bone steaming, "Bao Ri" disease, and bone fractures.

雪莲:雪莲花具有生理活性有效成分。其中伞形花内酯具有明显的抗菌、降压镇静、解痉作用;具有祛风、抗炎、止痛、祛痰和抗肿瘤作用,能抑制癌细胞的增长,临床用以治疗癌症,特别以乳腺癌有一定疗效,对皮肤癌、白血病和何金氏病等亦有一定作用。对痛风急性发作特异功效。Saussurea: Saussurea has physiologically active active ingredients. Among them, umbelliferone has obvious antibacterial, antihypertensive, sedative, and antispasmodic effects; it has wind-dispelling, anti-inflammatory, pain-relieving, expectorant, and anti-tumor effects, and can inhibit the growth of cancer cells. It is clinically used to treat cancer, especially with Breast cancer has a certain effect, and it also has a certain effect on skin cancer, leukemia and He Jin's disease. Specific effect on acute attack of gout.

血竭:内服活血散瘀,定痛,外用止血生肌,敛疮。主治:①淤血经闭、痛经,产后瘀阻。②症瘕痞块,胸腹刺痛。③跌打损伤,淤血肿痛。④外伤出血,溃疡不敛。选用百合科剑叶龙血树或柬埔寨龙血树树脂。Dried blood: oral administration for promoting blood circulation and dissipating blood stasis, analgesic therapy, external application for hemostasis and granulation promoting, astringing sores. Indications: ① Congestion, amenorrhea, dysmenorrhea, and postpartum stasis. ② lump in the abdomen, tingling pain in the chest and abdomen. ③ bruises, congestion, swelling and pain. ④ traumatic bleeding, ulcers are not restrained. Use Liliaceae Dracaena or Cambodian Dracaena resin.

益母草:味辛甘,气微温,无毒。入心、肝、膀胱经。活血,祛瘀,调经,消水。治月经不调,胎漏难产,胞衣不下,产后血晕,瘀血腹痛,崩中漏下,尿血,泻血,痈肿疮疡。Motherwort: spicy and sweet in taste, slightly warm in air, nontoxic. Go into the heart, liver, urinary bladder channel. Promoting blood circulation, dispelling blood stasis, regulating menstruation, eliminating water. Control irregular menstruation, fetal leakage and dystocia, retained afterbirth, postpartum haemorrhage, abdominal pain due to blood stasis, metrorrhagia, hematuria, diarrhea, carbuncle sores.

三七:三七性甘味微苦,性温,归肝、胃经以根、根状茎入药。是名贵中药材,生用可止血化瘀、消肿止痛,具有良好的止血功效、显著的造血功能;能加强和改善冠脉微循环,三七入药历史悠久,作用奇特被历代医家视为药中之宝,故有“金不换”之说法。三七“味微甘而苦,颇似人参之味。”“凡杖扑伤损,瘀血淋漓者,随即嚼烂罨之即止,青肿者即消散。若受杖时,先服一、二钱,则血不冲心,杖后尤宜服之,产后服亦良。大抵此药气温,味甘微苦,及阳明、厥阴血分之药,故能治一切血病”。《本草求真》记载:“三七,世人仅知功能止血止痛。殊不知痛因血瘀而疼作,血因敷散而血止。三七气味苦温,能于血分化其血瘀。”三七能增加冠脉血流量,减慢心率,减少心肌耗氧量,增加心肌耐氧能力,改善微循环,解除平滑肌痉挛的作用。Radix Notoginseng: Radix Notoginseng is sweet in nature, slightly bitter in taste, warm in nature, and returns to the liver and stomach meridians. Its roots and rhizomes are used as medicine. It is a precious Chinese herbal medicine. It can stop bleeding, remove blood stasis, reduce swelling and relieve pain when used raw. It has good hemostatic effect and significant hematopoietic function; it can strengthen and improve coronary microcirculation. Sanqi has a long history of being used as medicine. Therefore, there is a saying that "gold is not exchanged". Notoginseng "slightly sweet and bitter, similar to the taste of ginseng." "Anyone who is injured by a stick and bruised and dripping with blood should stop immediately after chewing, and the bruise will disappear. If you receive a stick, take a dose first. , two coins, the blood does not rush to the heart, it is especially suitable to be taken after the stick, and it is also good to take after giving birth. Generally speaking, this medicine has a warm temperature, sweet and slightly bitter taste, and it is divided into Yangming and Jueyin blood, so it can cure all blood diseases." . "Materia Medica Seeking Truth" records: "Sanqi, the world only knows its function to stop bleeding and relieve pain. They don't know that pain is caused by blood stasis, and blood stops due to application. The smell of Sanqi is bitter and warm, and it can differentiate blood stasis in the blood." Panax notoginseng can increase coronary blood flow, slow down heart rate, reduce myocardial oxygen consumption, increase myocardial oxygen tolerance, improve microcirculation, and relieve smooth muscle spasm.

葛根,味甘、辛,性凉。入脾、胃经。具有升阳解肌,透疹止泻,除烦止温的功效。用于伤寒、温热头痛项强,烦热消渴,泄泻,痢疾,癍疹不透,高血压,心绞痛,耳聋。临床上用来治疗高血压病颈项强痛、冠心病心绞痛,而且还具有降血糖作用。Radix Puerariae, sweet in taste, pungent, cool in nature. Go into spleen, stomach warp. It has the effects of promoting yang and relieving muscles, penetrating rash and stopping diarrhea, eliminating restlessness and stopping temperature. It is used for typhoid fever, warm-heat headache and strong neck, dysphoria and thirst, diarrhea, dysentery, impervious rash, high blood pressure, angina pectoris, and deafness. It is clinically used to treat stiff neck pain in hypertension, angina pectoris in coronary heart disease, and also has hypoglycemic effect.

巴戟天,甘,辛,微温。归肾、肝经。功能主治:补肾阳,强筋骨,祛风湿。用于阳痿遗精,宫冷不孕,月经不调,少腹冷痛,风湿痹痛,筋骨痿软。Morinda officinalis, sweet, pungent, slightly warm. Return kidney, Liver Channel. Function cures mainly: invigorating kidney yang, strengthening muscles and bones, expelling rheumatism. For impotence and nocturnal emission, cold uterine infertility, irregular menstruation, cold pain in the lower abdomen, rheumatism arthralgia, flaccidity of muscles and bones.

天麻:性,平。味,甘。主入肝经。本品息风止痉,平抑肝阳,祛风通络。为治眩晕、头痛之要药;又于肢体麻木、手足不遂、风湿痹痛,筋骨拘挛之佳品。Gastrodia elata: sex, flat. taste, sweet. Mainly enters the Liver Channel. This product relieves wind and spasm, calms liver-yang, dispels wind and dredges collaterals. It is an important medicine for treating dizziness and headache; it is also a good product for numbness of limbs, paralysis of hands and feet, rheumatic arthralgia, and spasm of muscles and bones.

黑芝麻:补肝肾,益精血,润肠燥。用于头晕眼花,耳鸣耳聋,须发早白,病后脱发,肠燥便秘。Black Sesame: Nourishing liver and kidney, benefiting essence and blood, moistening intestines and dryness. For dizziness, tinnitus and deafness, premature graying of beard and hair, hair loss after illness, intestinal dryness and constipation.

本发明的中药组合物中,红景天有补气清肺、益智养心、收涩止血、散瘀消肿的功效,虎杖祛风利湿,散瘀定痛,止咳化痰,紫河车安心养血、益气、补精、解毒,共为君药;In the traditional Chinese medicine composition of the present invention, Rhodiola has the effects of invigorating qi and clearing the lungs, improving intelligence and nourishing the heart, reducing astringency and hemostasis, dissipating blood stasis and reducing swelling, Polygonum cuspidatum dispelling wind and dampness, dissipating blood stasis and relieving pain, relieving cough and reducing phlegm, Zihe Che'anxin nourishes blood, nourishes qi, nourishes essence, detoxifies, and is a king drug;

红参大补元气,复脉固脱,益气摄血,墨旱莲补益肝肾,凉血止血,主肝肾不足,揉白叶用于跌打损伤,风湿筋骨痛,白芍养血柔肝,缓中止痛,敛阴收汗,夜交藤安神,通络,祛风,为方中臣药;Red ginseng nourishes the vital energy, restores the veins and strengthens the veins, nourishes the blood and nourishes the blood, Eclipta tonifies the liver and kidney, cools the blood to stop bleeding, and treats liver and kidney deficiency, rubs the white leaves for bruises, rheumatism and muscle pain, white peony nourishes blood and softens Liver, relieves pain in the middle, restrains yin and absorbs sweat, Tengjiao Tengshen soothes the nerves, dredges collaterals, dispels wind, and is a ministerial drug in the prescription;

佐以破骨风、枸杞子、鸡血藤等为佐药,其中,破骨风主治祛风除湿,活血止痛,治风湿腰腿骨节疼痛,跌打损伤,疮毒,痈疽;枸杞子养肝,滋肾;鸡血藤补血,活血,通络;秦艽祛风湿,清湿热,止痹痛;三棱治症瘕,积聚,胁肋胀痛,食积胀痛,痛经,闭经,产后瘀血腹痛,跌打损伤;雪莲祛风、抗炎、止痛、祛痰,三七止血化瘀、消肿止痛,血竭活血散瘀,定痛,葛根升阳解肌,透疹止泻,除烦止温,天麻息风止痉,平抑肝阳,祛风通络,淫羊藿,辛、甘、温,归肝肾经,为肾阳虚诸证常用药,菟丝子补肾益精,养肝明目,肉苁蓉补肾阳,益精血,杜仲、桑寄生、制首乌补肝肾,强筋骨,安胎,红花活血通径、散瘀止痛,仙鹤草收敛止血。Accompanied by broken bone wind, wolfberry fruit, Caulis Spatholobus, etc. as adjuvant drugs, wherein broken bone wind is mainly used for expelling wind and dampness, promoting blood circulation and relieving pain, treating rheumatism, waist and leg joint pain, bruises, sores, and ulcers; wolfberry fruit nourishes the liver , nourishing the kidney; Caulis Spatholobus tonifies blood, activates blood circulation, dredges collaterals; Gentiana quinquefolium dispels wind-damp, clears damp-heat, relieves arthralgia and pain; Triangle treats lumps in the abdomen, accumulation, hypochondrium pain, dysmenorrhea, amenorrhea, postpartum blood stasis and abdominal pain , bruises; Saussurea expelling wind, anti-inflammation, pain relief, expectorant, notoginseng to stop bleeding, remove blood stasis, reduce swelling and relieve pain, blood exhaustion, promote blood circulation and remove blood stasis, relieve pain, kudzu root promote yang and relieve muscle, penetrate rash and stop diarrhea, eliminate restlessness and relieve pain Warm, Gastrodia elata calms wind and spasm, calms liver yang, dispels wind and dredges collaterals, epimedium, pungent, sweet, and warm, returns to liver and kidney meridians, and is a commonly used medicine for various syndromes of kidney yang deficiency, Cuscuta nourishes kidney and essence, nourishes liver and improves eyesight , Cistanche tonifies kidney yang, nourishes essence and blood, Eucommia, Sangjisheng, Zhishouwu nourishes liver and kidney, strengthens muscles and bones, prevents miscarriage, safflower promotes blood circulation, dissipates blood stasis and relieves pain, agrimony astringes to stop bleeding.

益母草活血,祛瘀,调经,消水,黑芝麻补肝肾,益精血,润肠燥,巴戟天补肾阳,强筋骨,祛风湿,女贞子滋补肝肾,为使药。Motherwort promotes blood circulation, removes blood stasis, regulates menstruation, eliminates water, black sesame nourishes liver and kidney, nourishes essence and blood, moisturizes intestines, Morinda officinalis nourishes kidney yang, strengthens muscles and bones, dispels rheumatism, and Ligustrum lucidum nourishes liver and kidney.

本发明的中药组合物所选药材配伍相宜,符合中医药学和现代医药学理论,其配伍符合中药“君臣佐使”原则,对绝经后骨质疏松有独特的疗效,该药配伍科学,疗效迅速,见效快、疗程短、治愈率高、费用小的优点。The selected medicinal materials of the Chinese medicine composition of the present invention are suitable for compatibility, which conforms to the theory of traditional Chinese medicine and modern medicine, and its compatibility conforms to the principle of "junchenzuoshi" of traditional Chinese medicine, and has a unique curative effect on postmenopausal osteoporosis. The medicine is scientifically compatible, and the curative effect is rapid and effective Fast, short course of treatment, high cure rate, low cost advantages.

具体实施方式detailed description

为使本发明实施例的目的、技术方案和优点更加清楚,下面将结合实施例对本发明的技术方案进行清楚、完整地描述。显然,所描述的实施例是本发明的一部分,而不是全部的实施例。基于所描述的本发明的实施例,本领域普通技术人员在无需创造性劳动的前提下所获得的所有其他实施例,都属于本发明保护的范围。除非另有说明,本发明中的乙醇量的百分数是体积百分数,v/v表示溶液的体积比。In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions of the present invention will be clearly and completely described below in conjunction with the embodiments. Apparently, the described embodiments are part, but not all, of the present invention. Based on the described embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention. Unless otherwise specified, the percentage of ethanol in the present invention is volume percentage, and v/v represents the volume ratio of the solution.

实施例1:Example 1:

本发明的一种防治绝经后骨质疏松症的中药组合物,取下列中药原料药:白芍12克,淫羊藿16克,女贞子3克,菟丝子12克,夜交藤12克,红参10克,红花9克,墨旱莲15克,红景天15克,揉白叶8克,肉苁蓉5克,枸杞子3克,鸡血藤14克,破骨风9克,桑寄生6克,制首乌8克,雪莲5克,杜仲1克,仙鹤草10克,三七5克,虎杖16克,秦艽10克,紫河车8克,三棱5克,血竭1克,葛根10克,益母草6克,巴戟天8克,天麻3克,黑芝麻13克。A kind of Chinese medicine composition of preventing and treating postmenopausal osteoporosis of the present invention, get following Chinese medicine crude drug: Radix Paeoniae Alba 12 grams, Epimedium 16 grams, Ligustrum lucidum 3 grams, Cuscuta 12 grams, Caulis Noctua 12 grams, 10 grams of red ginseng, 9 grams of safflower, 15 grams of Eclipta, 15 grams of rhodiola, 8 grams of rubbed white leaves, 5 grams of Cistanche, 3 grams of medlar, 14 grams of Caulis Spatholobus, 9 grams of Rhododendron, mulberry Parasitic 6 grams, Zhishouwu 8 grams, Saussurea 5 grams, Eucommia 1 gram, Agrimony 10 grams, Panax notoginseng 5 grams, Polygonum cuspidatum 16 grams, Gentiana chinensis 10 grams, Ziheche 8 grams, Sanleng 5 grams, dried blood 1 10 grams of kudzu root, 6 grams of motherwort, 8 grams of Morinda officinalis, 3 grams of Gastrodia elata, and 13 grams of black sesame.

实施例2:Example 2:

本发明的一种防治绝经后骨质疏松症的中药组合物,取下列中药原料药:白芍20克,淫羊藿10克,女贞子8克,菟丝子5克,夜交藤17克,红参12克,红花4克,墨旱莲20克,红景天10克,揉白叶12克,肉苁蓉2克,枸杞子7克,鸡血藤11克,破骨风15克,桑寄生3克,制首乌13克,雪莲3克,杜仲3克,仙鹤草5克,三七10克,虎杖13克,秦艽3克,紫河车13克,三棱3克,血竭3克,葛根5克,益母草4克,巴戟天10克,天麻4克,黑芝麻16克。A kind of traditional Chinese medicine composition of prevention and treatment of postmenopausal osteoporosis of the present invention, get following traditional Chinese medicine crude drug: Radix Paeoniae Alba 20 grams, Epimedium 10 grams, Ligustrum lucidum 8 grams, Cuscuta 5 grams, Caulis Noctua 17 grams, 12 grams of red ginseng, 4 grams of safflower, 20 grams of Eclipta, 10 grams of rhodiola, 12 grams of kneading white leaves, 2 grams of Cistanche, 7 grams of medlar, 11 grams of Caulis Spatholobus, 15 grams of Rhododendron, mulberry 3 grams of Parasitic, 13 grams of Zhishouwu, 3 grams of Snow Lotus, 3 grams of Eucommia, 5 grams of Agrimony, 10 grams of Panax notoginseng, 13 grams of Polygonum cuspidatum, 3 grams of Gentiana chinensis, 13 grams of Ziheche, 3 grams of trigonum, 3 grams of dried blood 5 grams of kudzu root, 4 grams of motherwort, 10 grams of Morinda officinalis, 4 grams of Gastrodia elata, and 16 grams of black sesame.

实施例3:Example 3:

本发明的一种防治绝经后骨质疏松症的中药组合物,取下列中药原料药:白芍13克,淫羊藿11克,女贞子4克,菟丝子6克,夜交藤13克,红参7克,红花5克,墨旱莲18克,红景天11克,揉白叶9克,肉苁蓉4克,枸杞子6克,鸡血藤12克,破骨风13克,桑寄生4克,制首乌9克,雪莲4克,杜仲2克,仙鹤草6克,三七6克,虎杖14克,秦艽5克,紫河车10克,三棱4克,血竭2克,葛根6克,益母草5克,巴戟天12克,天麻3克,黑芝麻14克。A kind of traditional Chinese medicine composition of preventing and treating postmenopausal osteoporosis of the present invention, take following traditional Chinese medicine crude drug: Radix Paeoniae Alba 13 grams, Epimedium 11 grams, Ligustrum lucidum 4 grams, Cuscuta 6 grams, Caulis 13 grams, 7 grams of red ginseng, 5 grams of safflower, 18 grams of Eclipta, 11 grams of rhodiola, 9 grams of rubbed white leaves, 4 grams of Cistanche, 6 grams of medlar, 12 grams of Caulis Spatholobus, 13 grams of Rhododendron, mulberry 4 grams of Parasitic, 9 grams of Zhishouwu, 4 grams of Snow Lotus, 2 grams of Eucommia, 6 grams of Agrimony, 6 grams of Panax notoginseng, 14 grams of Polygonum cuspidatum, 5 grams of Gentiana chinensis, 10 grams of Ziheche, 4 grams of Sanleng, 2 6 grams of kudzu root, 5 grams of motherwort, 12 grams of Morinda officinalis, 3 grams of Gastrodia elata, and 14 grams of black sesame.

实施例4:Example 4:

本发明的一种防治绝经后骨质疏松症的中药组合物,取下列中药原料药:白芍17克,淫羊藿15克,女贞子7克,菟丝子11克,夜交藤16克,红参8克,红花8克,墨旱莲16克,红景天14克,揉白叶11克,肉苁蓉3克,枸杞子5克,鸡血藤13克,破骨风14克,桑寄生5克,制首乌12克,雪莲3克,杜仲1克,仙鹤草10克,三七9克,虎杖13克,秦艽7克,紫河车11克,三棱3克,血竭1克,葛根10克,益母草4克,巴戟天11克,天麻4克,黑芝麻15克。A kind of traditional Chinese medicine composition of prevention and treatment of postmenopausal osteoporosis of the present invention, take following traditional Chinese medicine crude drug: Radix Paeoniae Alba 17 grams, Epimedium 15 grams, Ligustrum lucidum 7 grams, Cuscuta 11 grams, Caulis Noctua 16 grams, 8 grams of red ginseng, 8 grams of safflower, 16 grams of Eclipta, 14 grams of rhodiola, 11 grams of rubbed white leaves, 3 grams of Cistanche, 5 grams of medlar, 13 grams of Caulis Spatholobus, 14 grams of Rhododendron, mulberry 5 grams of Parasitic, 12 grams of Shouwu, 3 grams of Snow Lotus, 1 gram of Eucommia, 10 grams of Agrimony, 9 grams of Panax notoginseng, 13 grams of Polygonum cuspidatum, 7 grams of Gentiana chinensis, 11 grams of Ziheche, 3 grams of trigonum, 1 10 grams of kudzu root, 4 grams of motherwort, 11 grams of Morinda officinalis, 4 grams of Gastrodia elata, and 15 grams of black sesame.

实施例5:Example 5:

本发明的一种防治绝经后骨质疏松症的中药组合物,取下列中药原料药:白芍15克,淫羊藿12克,女贞子5克,菟丝子9克,夜交藤15克,红参9克,红花7克,墨旱莲19克,红景天13克,揉白叶10克,肉苁蓉4克,枸杞子4克,鸡血藤11克,破骨风11克,桑寄生5克,制首乌10克,雪莲5克,杜仲3克,仙鹤草8克,三七8克,虎杖14克,秦艽9克,紫河车12克,三棱5克,血竭3克,葛根8克,益母草6克,巴戟天9克,天麻5克,黑芝麻14克。A kind of Chinese medicine composition of preventing and treating postmenopausal osteoporosis of the present invention, get following Chinese medicine crude drug: Radix Paeoniae Alba 15 grams, Epimedium 12 grams, Ligustrum lucidum 5 grams, Cuscuta 9 grams, Caulis Noctua 15 grams, 9 grams of red ginseng, 7 grams of safflower, 19 grams of Eclipta, 13 grams of rhodiola, 10 grams of white leaves, 4 grams of Cistanche, 4 grams of medlar, 11 grams of Caulis Spatholobus, 11 grams of Rhododendron, mulberry 5 grams of Parasitic, 10 grams of Zhishouwu, 5 grams of Snow Lotus, 3 grams of Eucommia, 8 grams of Agrimony, 8 grams of Panax notoginseng, 14 grams of Polygonum cuspidatum, 9 grams of Gentiana chinensis, 12 grams of Ziheche, 5 grams of trigonum, and 3 grams of blood 8 grams of kudzu root, 6 grams of Motherwort, 9 grams of Morinda officinalis, 5 grams of Gastrodia elata, and 14 grams of black sesame.

实施例6:Embodiment 6:

本发明的一种防治绝经后骨质疏松症的中药组合物,取下列中药原料药:白芍19克,淫羊藿14克,女贞子6克,菟丝子7克,夜交藤14克,红参9克,红花6克,墨旱莲17克,红景天13克,揉白叶10克,肉苁蓉4克,枸杞子4克,鸡血藤11克,破骨风11克,桑寄生5克,制首乌10克,雪莲5克,杜仲3克,仙鹤草8克,三七8克,虎杖14克,秦艽4克,紫河车9克,三棱5克,血竭3克,葛根8克,益母草3克,巴戟天8克,天麻5克,黑芝麻16克。A kind of traditional Chinese medicine composition of prevention and treatment of postmenopausal osteoporosis of the present invention, take following traditional Chinese medicine crude drug: Radix Paeoniae Alba 19 grams, Epimedium 14 grams, Ligustrum lucidum 6 grams, Cuscuta 7 grams, Caulis Noctua 14 grams, 9 grams of red ginseng, 6 grams of safflower, 17 grams of Eclipta, 13 grams of rhodiola, 10 grams of rubbing white leaves, 4 grams of Cistanche, 4 grams of medlar, 11 grams of Caulis Spatholobus, 11 grams of Rhododendron, mulberry 5 grams of Parasitic, 10 grams of Zhishouwu, 5 grams of Snow Lotus, 3 grams of Eucommia, 8 grams of Agrimony, 8 grams of Panax notoginseng, 14 grams of Polygonum cuspidatum, 4 grams of Gentiana chinensis, 9 grams of Ziheche, 5 grams of trigonum, 3 grams of blood 8 grams of kudzu root, 3 grams of Motherwort, 8 grams of Morinda officinalis, 5 grams of Gastrodia elata, and 16 grams of black sesame.

其中,实施例1-6的所述中药组合物的制备方法为:Wherein, the preparation method of the described Chinese medicine composition of embodiment 1-6 is:

(1)取实施例1-6任一所述中药组合物中重量组分的各药材,粉碎成粗粉,按照粗粉总重量的4-10倍加入体积浓度为70%-95%的乙醇溶液,回流提取三次,回流时间为3-5h,滤过,滤液回收乙醇,冷却过滤,用水洗涤,干燥后得干浸膏;(1) Get each medical material of weight component in the Chinese medicine composition described in any one of embodiments 1-6, be ground into coarse powder, add the ethanol that volume concentration is 70%-95% according to 4-10 times of coarse powder gross weight Solution, reflux extraction three times, the reflux time is 3-5h, filter, recover ethanol from the filtrate, cool and filter, wash with water, dry to obtain dry extract;

(2)将步骤(1)制得的干浸膏粉碎,加入适量蔗糖、糊精混合,以乙醇为润湿剂,制粒,干燥,整粒,可制得颗粒剂;或者将步骤(1)制得的干浸膏干燥,粉碎,制成散剂;或者将步骤(1)制得的干浸膏粉碎,加入适量微粉硅胶、α-半乳糖混合,以乙醇为润湿剂,制粒,干燥,整粒,装胶囊,制得胶囊剂;或者将步骤(1)制得的干浸膏粉碎,加入适量蔗糖、糊精混合,以乙醇为润湿剂,制粒,干燥,整粒,压片,制得片剂;或者向上述步骤(1)得到的离心后的浓缩液中加入适量蔗糖、香精混合,灭菌,灌装,制得药液剂。(2) Grinding the dry extract prepared in step (1), adding an appropriate amount of sucrose and dextrin to mix, using ethanol as a wetting agent, granulating, drying, and sizing to obtain granules; or step (1) ) dried extract obtained, pulverized, and made into a powder; or the dried extract obtained in step (1) was pulverized, mixed with an appropriate amount of micropowdered silica gel and α-galactose, and granulated with ethanol as a wetting agent, Drying, granulation, packing into capsules to obtain capsules; or crushing the dry extract obtained in step (1), adding appropriate amount of sucrose and dextrin to mix, using ethanol as a wetting agent, granulating, drying, and granulation, Tablets are produced; or an appropriate amount of sucrose and essence are added to the centrifuged concentrate obtained in the above step (1), mixed, sterilized, and filled to obtain a liquid medicine.

急性毒性试验:Acute toxicity test:

取小鼠60只,体重22-25克,对小鼠灌胃胶囊溶液,对给药的半数致死量(LD50)进行了试验测定,但未测到LD50,因此进行了最大耐受量试验。结果:以最大给药量120g/kg灌胃,相当于成人临床拟日用剂量的280倍,七日内小鼠无一死亡,处死小鼠解剖观察各脏器未发现毒性反应,给药组与对照组小鼠无任何差异。Get 60 mice with a body weight of 22-25 grams. The capsule solution was administrated to the mice, and the median lethal dose (LD50) of the administration was tested and determined, but the LD50 was not detected, so the maximum tolerated dose test was carried out. Result: with the maximum dosage of 120g/kg orally, which is equivalent to 280 times of adult clinical proposed daily dose, no mouse died within seven days, and no toxic reaction was found in the organs of the sacrificed mice. There were no differences in the control mice.

六个月长期毒性试验:取大鼠60只,体重180~220g,将实验药物设定为高、中、低三个剂量,分别为胶囊40g/kg、20g/kg、10g/kg,按人用(75kg为标准)剂量1.1g/kg/天计算,为人用有效剂量的40倍、20倍和10倍;另设一对照组,连续灌胃给药90天、180天和部分动物停药10天后,观察对大鼠各项生理、生化指标的影响。实验结果表明:用不同剂量给大鼠连续口服180天,对大鼠的进食量和体重增长均无影响。对肝肾功能均未发现明显毒性作用。对血常规、血生化、尿液生化及骨髓片等均未见明显影响,各组间与对照组比较无明显差异。Six-month long-term toxicity test: Take 60 rats, weighing 180-220g, set the experimental drug to three doses of high, medium and low, respectively capsules 40g/kg, 20g/kg, 10g/kg, according to human Calculated with (75kg as the standard) dose of 1.1g/kg/day, it is 40 times, 20 times and 10 times of the effective dose for humans; another control group is set up, and it is administered continuously for 90 days, 180 days and some animals stop the drug After 10 days, the effects on various physiological and biochemical indexes of rats were observed. The experimental results show that: continuous oral administration of different doses to rats for 180 days has no effect on the food intake and weight growth of the rats. No significant toxic effects were found on liver and kidney function. There was no obvious effect on blood routine, blood biochemistry, urine biochemistry and bone marrow slices, and there was no significant difference between each group and the control group.

临床试验:Clinical Trials:

为了验证本发明中药组合物的效果,2013年1月-2014年11月,门诊处随机选取绝经后骨质疏松症患者200例,年龄60~82岁,平均66±2.7岁,分为实验组和对照组,每组100例,2组在年龄、绝经年限、身高、体重及骨密度值等方面经统计学分析,差异均无统计学意义(P>0.05),具有可比性。In order to verify the effect of the traditional Chinese medicine composition of the present invention, from January 2013 to November 2014, 200 patients with postmenopausal osteoporosis were randomly selected in the outpatient department, aged 60 to 82 years old, with an average of 66±2.7 years old, and divided into the experimental group And the control group, 100 cases in each group, the two groups were statistically analyzed in terms of age, menopausal years, height, weight and bone density, and the difference was not statistically significant (P>0.05), which was comparable.

诊断标准:Diagnostic criteria:

根据《中药新药临床研究指导原则》标准拟定关于原发性骨质疏松的诊断标准:The diagnostic criteria for primary osteoporosis were formulated according to the "Guiding Principles for Clinical Research of New Chinese Medicines":

(1)有全身无力骨痛、多以腰背部疼痛为明显,逐渐加重,可有脊柱后突畸形,轻微外伤可导致骨折;(1) There is general weakness and bone pain, mostly manifested by low back pain, which gradually worsens, may have kyphosis, and may cause fractures due to minor trauma;

(2)X线表现:骨质普遍稀疏,以脊椎、骨盆、股骨上端明显。脊柱改变最为特殊,椎体可出现鱼尾样双凹形,椎间隙增宽,有Schmorl结节,胸椎呈楔形变,受累椎体多发、散在;(2) X-ray findings: the bones are generally sparse, especially in the spine, pelvis, and upper end of the femur. The changes in the spine are the most special. The vertebral body may appear fishtail-like double concave shape, the intervertebral space is widened, there are Schmorl nodules, the thoracic vertebrae are wedge-shaped, and the affected vertebral bodies are multiple and scattered;

(3)双能X线检查测定骨密度较同性别、同种族健康成人的骨峰值降低大于或等于2.5个标准差。(3) The peak bone density measured by dual-energy X-ray examination is greater than or equal to 2.5 standard deviations lower than that of healthy adults of the same sex and race.

中医的辨证标准:TCM syndrome differentiation criteria:

(1)主症:①腰脊疼痛或全身骨痛;②腰膝酸软。(1) Main symptoms: ① Lumbar spine pain or bone pain all over the body; ② Soreness and weakness of the waist and knees.

(2)次症:①椎体叩痛或压痛;②不能持重;③下肢瘦软或麻木;④眩晕耳鸣;⑤舌质偏红或淡;⑥脉沉细或细。(2) Secondary symptoms: ① Vertebral percussion pain or tenderness; ② Inability to hold weight; ③ Lower limbs are thin or numb; ④ Vertigo and tinnitus; ⑤ Reddish or pale tongue;

具备主症中的2项,次症中①~④项中的一项,即可。It is sufficient to have 2 of the main symptoms and one of the items ①~④ of the secondary symptoms.

排除标准:Exclusion criteria:

排除合并心、脑、肾等重要脏器严重原发性疾病及影响骨代谢性疾病者,近半年服用影响骨代谢药物者,合并新鲜骨折者。Exclude patients with serious primary diseases of important organs such as heart, brain, kidney, and diseases affecting bone metabolism, those who have taken drugs that affect bone metabolism in the past six months, and those with fresh fractures.

治疗方法:treatment method:

实验组和对照组疗程均为12周。The course of treatment for both the experimental group and the control group was 12 weeks.

治疗组:服用本发明实施例3的中药组合物的片剂,每日3次,早中晚各一次,每次3片,每7天为一疗程。Treatment group: take the tablet of the traditional Chinese medicine composition of the embodiment 3 of the present invention, 3 times a day, each time in the morning, noon and evening, 3 tablets each time, every 7 days is a course of treatment.

对照组:用鲑鱼降钙素注射液(北京双鹭药业股份有限公司,国药准字H20020694),经皮试阴性后,第1周:每日1次,每次50U,肌肉注射;第2周:隔日1次,每次50U,肌肉注射;第3~12周:每周1次,每次50U,肌肉注射。Control group: use salmon calcitonin injection (Beijing Shuanglu Pharmaceutical Co., Ltd., H20020694), after the skin test is negative, the first week: once a day, 50U each time, intramuscular injection; the second Week: once every other day, 50U each time, intramuscular injection; 3rd to 12th weeks: once a week, 50U each time, intramuscular injection.

疗效判定标准:Efficacy Judgment Criteria:

根据《中药新药临床研究指导原则》标准拟定:According to the standard of "Guiding Principles for Clinical Research of New Drugs of Traditional Chinese Medicine":

痊愈:无疼痛,腰膝酸软,下肢痿软无力,眩晕耳鸣症状明显改善,骨密度值提高2%以上。Recovery: no pain, sore waist and knees, flaccidity and weakness of lower limbs, dizziness and tinnitus were significantly improved, and bone density increased by more than 2%.

有效:疼痛明显减轻,腰膝酸软,下肢痿软无力、眩晕耳鸣症状部分改善,骨密度值提高(0~2)%之间。Effective: the pain is significantly relieved, the waist and knees are sore and limp, the lower limbs are flaccid and weak, the symptoms of vertigo and tinnitus are partially improved, and the bone density value is increased by (0-2)%.

无效:各方面均无改善。所有患者治疗前后均采用双能X射线吸收法测量腰椎和左股骨颈的骨密度(BMD)。Invalid: No improvement in all aspects. Bone mineral density (BMD) of the lumbar spine and left femoral neck was measured by dual-energy X-ray absorptiometry in all patients before and after treatment.

骨密度疗效标准计算方法:(治疗后T分值百分比一治疗前T分值百分比)×100%。Bone density curative effect standard calculation method: (T score percentage after treatment - T score percentage before treatment) × 100%.

结果:result:

2组疗效对比:治疗组总有效率为96%,对照组总有效率为65%;2组比较差异明显,有统计学意义(P<0.05)。Comparison of curative effects between the two groups: the total effective rate of the treatment group was 96%, and the total effective rate of the control group was 65%; the difference between the two groups was significant and statistically significant (P<0.05).

临床观察结果见表1:The clinical observation results are shown in Table 1:

组别group 病例cases 治愈cure 显效markedly effective 有效efficient 无效invalid 总有效率total effective rate 对照组control group 100100 2525 2929 1111 3535 65%65% 治疗组therapy group 100100 7676 1313 77 44 96%96%

以上结果显示,治疗组的治愈率和总有效率明显高于对照组The above results showed that the cure rate and total effective rate of the treatment group were significantly higher than those of the control group.

表2:2组治疗前后BMD检测结果对比(g·cm-2,x±s)Table 2: Comparison of BMD detection results before and after treatment in the two groups (g·cm-2, x±s)

临床疗效观察结果表明,本发明中药组合物对于防治绝经后骨质疏松症具有显著的疗效;安全性观察发现,没有观察到任何临床不良反应,表明本发明中药组合物临床应用安全、无毒副作用。Clinical curative effect observation results show that the Chinese medicine composition of the present invention has significant curative effect for preventing and treating postmenopausal osteoporosis; Safety observation finds that no clinical adverse reactions are observed, indicating that the Chinese medicine composition of the present invention is safe in clinical application and has no side effects .

最后应说明的是:以上实施例仅用以说明本发明的技术方案,而非对其限制;尽管参照前述实施例对本发明进行了详细的说明,本领域的普通技术人员应当理解:其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本发明各实施例技术方案的范围。Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: it can still be Modifications are made to the technical solutions described in the foregoing embodiments, or equivalent replacements are made to some of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.

Claims (10)

1.一种防治绝经后骨质疏松症的中药组合物,其特征在于:所述中药组合物的原料药由白芍、淫羊藿、女贞子、菟丝子、夜交藤、虎杖、红参、墨旱莲、红景天、揉白叶、肉苁蓉、杜仲、枸杞子、破骨风、鸡血藤、桑寄生、制首乌、仙鹤草、红花、秦艽、紫河车、三棱、雪莲、血竭、益母草、三七、葛根、巴戟天、天麻、黑芝麻组成。1. a Chinese medicine composition for preventing and treating postmenopausal osteoporosis, is characterized in that: the raw material drug of described Chinese medicine composition is made of Radix Paeoniae Alba, Epimedium, Ligustrum lucidum, Cuscuta Semen, Nightingale, Polygonum cuspidatum, Red Ginseng , Eclipta, Rhodiola, rubbing white leaves, Cistanche, Eucommia, medlar, Cracker, Millae, Sangji, Zhishouwu, Agrimony, safflower, Gentiana, Ziheche, Sanleng, Composition of snow lotus, dried blood, motherwort, notoginseng, kudzu root, Morinda officinalis, Gastrodia elata, and black sesame. 2.根据权利要求1所述的防治绝经后骨质疏松症的中药组合物,其特征在于:制成所述中药组合物的原料组成及重量份数为:白芍12-20份,淫羊藿10-16份,女贞子3-8份,菟丝子5-12份,夜交藤12-17份,红参7-12份,红花4-9份,墨旱莲15-20份,红景天10-15份,揉白叶8-12份,肉苁蓉2-5份,枸杞子3-7份,鸡血藤11-14份,破骨风9-15份,桑寄生3-6份,制首乌8-13份,雪莲3-5份,杜仲1-3份,仙鹤草5-10份,三七5-10份,虎杖13-16份,秦艽3-10份,紫河车8-13份,三棱3-5份,血竭1-3份,葛根5-10份,益母草3-6份,巴戟天8-13份,天麻3-5份,黑芝麻13-16份。2. The traditional Chinese medicine composition for preventing and treating postmenopausal osteoporosis according to claim 1, characterized in that: the composition and parts by weight of raw materials for making said Chinese medicine composition are: Radix Paeoniae Alba 12-20 parts, Epimedium 10-16 parts of hydrangea, 3-8 parts of Ligustrum lucidum, 5-12 parts of Cuscuta, 12-17 parts of Noctilucia, 7-12 parts of red ginseng, 4-9 parts of safflower, 15-20 parts of Eclipta chinensis, 10-15 parts of rhodiola, 8-12 parts of kneading white leaves, 2-5 parts of cistanche, 3-7 parts of medlar, 11-14 parts of Caulis Spatholobus, 9-15 parts of broken bones, 3-6 parts of mulberry 8-13 parts of Shouwu, 3-5 parts of Snow Lotus, 1-3 parts of Eucommia, 5-10 parts of Agrimony, 5-10 parts of Panax notoginseng, 13-16 parts of Polygonum cuspidatum, 3-10 parts of Gentiana, Zihe 8-13 parts of car, 3-5 parts of Sanlong, 1-3 parts of dried blood, 5-10 parts of kudzu root, 3-6 parts of Motherwort, 8-13 parts of Morinda officinalis, 3-5 parts of Gastrodia elata, 13- 16 servings. 3.根据权利要求2所述的防治绝经后骨质疏松症的中药组合物,其特征在于:制成所述中药组合物的原料组成及重量份数为:白芍12份,淫羊藿16份,女贞子3份,菟丝子12份,夜交藤12份,红参10份,红花9份,墨旱莲15份,红景天15份,揉白叶8份,肉苁蓉5份,枸杞子3份,鸡血藤14份,破骨风9份,桑寄生6份,制首乌8份,雪莲5份,杜仲1份,仙鹤草10份,三七5份,虎杖16份,秦艽10份,紫河车8份,三棱5份,血竭1份,葛根10份,益母草6份,巴戟天8份,天麻3份,黑芝麻13份。3. The traditional Chinese medicine composition for preventing and treating postmenopausal osteoporosis according to claim 2, characterized in that: the composition and parts by weight of raw materials for making said Chinese medicine composition are: 12 parts of Radix Paeoniae Alba, 16 parts of Epimedium 3 parts of Ligustrum lucidum, 12 parts of dodder, 12 parts of vine, 10 parts of red ginseng, 9 parts of safflower, 15 parts of Eclipta, 15 parts of rhodiola, 8 parts of white leaves, 5 parts of Cistanche, 3 parts of Lycium barbarum, 14 parts of Caulis Spatholobus, 9 parts of Crackers, 6 parts of Sangjisheng, 8 parts of Zhiwu, 5 parts of Snow Lotus, 1 part of Eucommia, 10 parts of Agrimony, 5 parts of Panax notoginseng, 16 parts of Polygonum cuspidatum, 10 parts of Gentiana chinensis, 8 parts of Ziheche, 5 parts of Sanleng, 1 part of dried blood, 10 parts of Pueraria lobata, 6 parts of motherwort, 8 parts of Morinda officinalis, 3 parts of Gastrodia elata, and 13 parts of black sesame. 4.根据权利要求2所述的防治绝经后骨质疏松症的中药组合物,其特征在于:制成所述中药组合物的原料组成及重量份数为:白芍20份,淫羊藿10份,女贞子8份,菟丝子5份,夜交藤17份,红参12份,红花4份,墨旱莲20份,红景天10份,揉白叶12份,肉苁蓉2份,枸杞子7份,鸡血藤11份,破骨风15份,桑寄生3份,制首乌13份,雪莲3份,杜仲3份,仙鹤草5份,三七10份,虎杖13份,秦艽3份,紫河车13份,三棱3份,血竭3份,葛根5份,益母草4份,巴戟天10份,天麻4份,黑芝麻16份。4. The Chinese medicine composition for preventing and treating postmenopausal osteoporosis according to claim 2, characterized in that: the composition and parts by weight of raw materials for making said Chinese medicine composition are: 20 parts of Radix Paeoniae Alba, 10 parts of Epimedium 8 parts of Ligustrum lucidum, 5 parts of Cuscuta, 17 parts of night vine, 12 parts of red ginseng, 4 parts of safflower, 20 parts of Eclipta, 10 parts of Rhodiola rosea, 12 parts of white leaves, 2 parts of Cistanche, 7 parts of Lycium barbarum, 11 parts of Caulis Spatholobus, 15 parts of Bone Rhizoma, 3 parts of Sang Ji Sheng, 13 parts of Radix Polygoni Multiflori, 3 parts of Snow Lotus, 3 parts of Eucommia, 5 parts of Agrimony, 10 parts of Panax notoginseng, 13 parts of Polygonum cuspidatum, 3 parts of Gentiana, 13 parts of Ziheche, 3 parts of Sanleng, 3 parts of blood, 5 parts of Pueraria root, 4 parts of motherwort, 10 parts of Morinda officinalis, 4 parts of Gastrodia elata, and 16 parts of black sesame. 5.根据权利要求2所述的防治绝经后骨质疏松症的中药组合物,其特征在于:制成所述中药组合物的原料组成及重量份数为:白芍13份,淫羊藿11份,女贞子4份,菟丝子6份,夜交藤13份,红参7份,红花5份,墨旱莲18份,红景天11份,揉白叶9份,肉苁蓉4份,枸杞子6份,鸡血藤12份,破骨风13份,桑寄生4份,制首乌9份,雪莲4份,杜仲2份,仙鹤草6份,三七6份,虎杖14份,秦艽5份,紫河车10份,三棱4份,血竭2份,葛根6份,益母草5份,巴戟天12份,天麻3份,黑芝麻14份。5. The traditional Chinese medicine composition for preventing and treating postmenopausal osteoporosis according to claim 2, characterized in that: the composition and parts by weight of raw materials for making said Chinese medicine composition are: 13 parts of Radix Paeoniae Alba, 11 parts of Epimedium 4 parts of Ligustrum lucidum, 6 parts of Cuscuta, 13 parts of night vine, 7 parts of red ginseng, 5 parts of safflower, 18 parts of Eclipta, 11 parts of rhodiola, 9 parts of white leaves, 4 parts of Cistanche, 6 parts of Lycium barbarum, 12 parts of Caulis Spatholobus, 13 parts of Bone Rhizoma, 4 parts of Sang Ji Sheng, 9 parts of Radix Polygoni Multiflori, 4 parts of Snow Lotus, 2 parts of Eucommia, 6 parts of Agrimony, 6 parts of Panax notoginseng, 14 parts of Polygonum cuspidatum, 5 parts of Gentiana, 10 parts of Ziheche, 4 parts of Sanleng, 2 parts of blood, 6 parts of Pueraria root, 5 parts of motherwort, 12 parts of Morinda officinalis, 3 parts of Gastrodia elata, and 14 parts of black sesame. 6.根据权利要求2所述的防治绝经后骨质疏松症的中药组合物,其特征在于:制成所述中药组合物的原料组成及重量份数为:白芍17份,淫羊藿15份,女贞子7份,菟丝子11份,夜交藤16份,红参8份,红花8份,墨旱莲16份,红景天14份,揉白叶11份,肉苁蓉3份,枸杞子5份,鸡血藤13份,破骨风14份,桑寄生5份,制首乌12份,雪莲3份,杜仲1份,仙鹤草10份,三七9份,虎杖13份,秦艽7份,紫河车11份,三棱3份,血竭1份,葛根10份,益母草4份,巴戟天11份,天麻4份,黑芝麻15份。6. The traditional Chinese medicine composition for preventing and treating postmenopausal osteoporosis according to claim 2, characterized in that: the composition and parts by weight of raw materials for making said Chinese medicine composition are: 17 parts of Radix Paeoniae Alba, 15 parts of Epimedium 7 parts of privet privet, 11 parts of dodder, 16 parts of vine, 8 parts of red ginseng, 8 parts of safflower, 16 parts of Eclipta, 14 parts of rhodiola, 11 parts of white leaves, 3 parts of Cistanche, 5 parts of Lycium barbarum, 13 parts of Caulis Spatholobus, 14 parts of Bone Rhizoma, 5 parts of Sang Ji Sheng, 12 parts of Radix Polygoni Multiflori, 3 parts of Snow Lotus, 1 part of Eucommia, 10 parts of Agrimony, 9 parts of Panax notoginseng, 13 parts of Polygonum cuspidatum, 7 parts of Gentiana, 11 parts of Ziheche, 3 parts of Sanleng, 1 part of blood, 10 parts of Pueraria root, 4 parts of motherwort, 11 parts of Morinda officinalis, 4 parts of Gastrodia elata, and 15 parts of black sesame. 7.根据权利要求2所述的防治绝经后骨质疏松症的中药组合物,其特征在于:制成所述中药组合物的原料组成及重量份数为:白芍15份,淫羊藿12份,女贞子5份,菟丝子9份,夜交藤15份,红参9份,红花7份,墨旱莲19份,红景天13份,揉白叶10份,肉苁蓉4份,枸杞子4份,鸡血藤11份,破骨风11份,桑寄生5份,制首乌10份,雪莲5份,杜仲3份,仙鹤草8份,三七8份,虎杖14份,秦艽9份,紫河车12份,三棱5份,血竭3份,葛根8份,益母草6份,巴戟天9份,天麻5份,黑芝麻14份。7. The traditional Chinese medicine composition for preventing and treating postmenopausal osteoporosis according to claim 2, characterized in that: the composition and parts by weight of raw materials for making said Chinese medicine composition are: 15 parts of Radix Paeoniae Alba, 12 parts of Epimedium 5 parts of Ligustrum lucidum, 9 parts of Cuscuta, 15 parts of night vine, 9 parts of red ginseng, 7 parts of safflower, 19 parts of Eclipta, 13 parts of rhodiola, 10 parts of white leaves, 4 parts of Cistanche, 4 parts of Lycium barbarum, 11 parts of Caulis Spatholobus, 11 parts of Bone Rhizoma, 5 parts of Sang Ji Sheng, 10 parts of Radix Polygoni Multiflori, 5 parts of Snow Lotus, 3 parts of Eucommia, 8 parts of Agrimony, 8 parts of Panax notoginseng, 14 parts of Polygonum cuspidatum, 9 parts of Gentiana, 12 parts of Ziheche, 5 parts of Sanleng, 3 parts of blood, 8 parts of Pueraria lobata, 6 parts of motherwort, 9 parts of Morinda officinalis, 5 parts of Gastrodia elata, and 14 parts of black sesame. 8.根据权利要求2所述的防治绝经后骨质疏松症的中药组合物,其特征在于:制成所述中药组合物的原料组成及重量份数为:白芍19份,淫羊藿14份,女贞子6份,菟丝子7份,夜交藤14份,红参9份,红花6份,墨旱莲17份,红景天13份,揉白叶10份,肉苁蓉4份,枸杞子4份,鸡血藤11份,破骨风11份,桑寄生5份,制首乌10份,雪莲5份,杜仲3份,仙鹤草8份,三七8份,虎杖14份,秦艽4份,紫河车9份,三棱5份,血竭3份,葛根8份,益母草3份,巴戟天8份,天麻5份,黑芝麻16份。8. The traditional Chinese medicine composition for preventing and treating postmenopausal osteoporosis according to claim 2, characterized in that: the raw material composition and parts by weight for making said Chinese medicine composition are: 19 parts of Radix Paeoniae Alba, 14 parts of Epimedium 6 parts of Ligustrum lucidum, 7 parts of Cuscuta, 14 parts of night vine, 9 parts of red ginseng, 6 parts of safflower, 17 parts of Eclipta, 13 parts of rhodiola, 10 parts of white leaves, 4 parts of Cistanche, 4 parts of Lycium barbarum, 11 parts of Caulis Spatholobus, 11 parts of Bone Rhizoma, 5 parts of Sang Ji Sheng, 10 parts of Radix Polygoni Multiflori, 5 parts of Snow Lotus, 3 parts of Eucommia, 8 parts of Agrimony, 8 parts of Panax notoginseng, 14 parts of Polygonum cuspidatum, 4 parts of Gentiana, 9 parts of Ziheche, 5 parts of Sanleng, 3 parts of blood, 8 parts of Pueraria lobata, 3 parts of Motherwort, 8 parts of Morinda officinalis, 5 parts of Gastrodia elata, and 16 parts of black sesame. 9.根据权利要求2-8任一所述的防治绝经后骨质疏松症的中药组合物,其特征在于,所述中药组合物按照下述方法进行制备:9. The Chinese medicine composition for preventing and treating postmenopausal osteoporosis according to any one of claims 2-8, characterized in that, said Chinese medicine composition is prepared according to the following method: (1)取权利要求2-8任一所述中药组合物中重量组分的各药材,粉碎成粗粉,按照粗粉总重量的4-10倍加入体积浓度为70%-95%的乙醇溶液,回流提取三次,回流时间为3-5h,滤过,滤液回收乙醇,冷却过滤,用水洗涤,干燥后得干浸膏;(1) Get each medical material of weight component in the arbitrary described Chinese medicine composition of claim 2-8, be ground into coarse powder, add the ethanol that volume concentration is 70%-95% according to 4-10 times of coarse powder gross weight Solution, reflux extraction three times, the reflux time is 3-5h, filter, recover ethanol from the filtrate, cool and filter, wash with water, dry to obtain dry extract; (2)将步骤(1)制得的干浸膏粉碎,加入适量蔗糖、糊精混合,以乙醇为润湿剂,制粒,干燥,整粒,可制得颗粒剂;或者将步骤(1)制得的干浸膏干燥,粉碎,制成散剂;或者将步骤(1)制得的干浸膏粉碎,加入适量微粉硅胶、α-半乳糖混合,以乙醇为润湿剂,制粒,干燥,整粒,装胶囊,制得胶囊剂;或者将步骤(1)制得的干浸膏粉碎,加入适量蔗糖、糊精混合,以乙醇为润湿剂,制粒,干燥,整粒,压片,制得片剂;或者向上述步骤(1)得到的离心后的浓缩液中加入适量蔗糖、香精混合,灭菌,灌装,制得药液剂。(2) Grinding the dry extract prepared in step (1), adding an appropriate amount of sucrose and dextrin to mix, using ethanol as a wetting agent, granulating, drying, and sizing to obtain granules; or step (1) ) dried extract obtained, pulverized, and made into a powder; or the dried extract obtained in step (1) was pulverized, mixed with an appropriate amount of micropowdered silica gel and α-galactose, and granulated with ethanol as a wetting agent, Drying, granulation, packing into capsules to obtain capsules; or crushing the dry extract obtained in step (1), adding appropriate amount of sucrose and dextrin to mix, using ethanol as a wetting agent, granulating, drying, and granulation, Tablets are produced; or an appropriate amount of sucrose and essence are added to the centrifuged concentrate obtained in the above step (1), mixed, sterilized, and filled to obtain a liquid medicine. 10.如权利要求1-9任一所述的防治绝经后骨质疏松症的中药组合物在防治绝经后骨质疏松症药物中的应用。10. The application of the traditional Chinese medicine composition for preventing and treating postmenopausal osteoporosis according to any one of claims 1-9 in the medicine for preventing and treating postmenopausal osteoporosis.
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CN105616761A (en) * 2016-03-01 2016-06-01 青岛市中心医院 Traditional Chinese medicine preparation used for increasing leukocyte and blood platelet after radiation

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Publication number Priority date Publication date Assignee Title
CN105435025A (en) * 2016-01-08 2016-03-30 姜新海 Pure traditional Chinese herbal capsule for effectively treating osteoporosis
CN105616761A (en) * 2016-03-01 2016-06-01 青岛市中心医院 Traditional Chinese medicine preparation used for increasing leukocyte and blood platelet after radiation

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