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CN104415162B - Treat Chinese medicine composition of leukopenia after chemoradiotherapy and preparation method thereof - Google Patents

Treat Chinese medicine composition of leukopenia after chemoradiotherapy and preparation method thereof Download PDF

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CN104415162B
CN104415162B CN201310366943.1A CN201310366943A CN104415162B CN 104415162 B CN104415162 B CN 104415162B CN 201310366943 A CN201310366943 A CN 201310366943A CN 104415162 B CN104415162 B CN 104415162B
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吕新华
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Abstract

本发明公开了一种治疗放化疗后白细胞减少症的中药组合物及其制备方法,属于中药领域。本发明中药组合物包括以下重量份的原料药:党参10‑20份,茯苓10‑20份,红景天15‑45份,枸杞子10‑20份,女贞子10‑20份,仙灵脾5‑15份,菟丝子5‑15份,陈皮5‑15份。本发明中药组合物具有健脾益气,填精补髓,药性平和,不温不燥的特点,能够有效纠正脏腑功能失调,精气亏虚等病理因素,改善神疲乏力,腰膝酸软,纳差便溏等症状,可以保护骨髓造血功能,升高白细胞,提高放化疗完成率。The invention discloses a traditional Chinese medicine composition for treating leukopenia after radiotherapy and chemotherapy and a preparation method thereof, belonging to the field of traditional Chinese medicines. The traditional Chinese medicine composition of the present invention comprises the following raw materials by weight: Codonopsis 10-20 parts, Poria cocos 10-20 parts, Rhodiola rosea 15-45 parts, Lycium barbarum 10-20 parts, Ligustrum lucidum 10-20 parts, fairy 5‑15 parts of spleen, 5‑15 parts of dodder seed, 5‑15 parts of tangerine peel. The traditional Chinese medicine composition of the present invention has the characteristics of invigorating the spleen and replenishing qi, replenishing essence and nourishing the marrow, and has mild medicinal properties, neither warm nor dry, can effectively correct pathological factors such as visceral dysfunction, deficiency of essence and qi, etc., and improve mental fatigue, weakness of the waist and knees, Symptoms such as anorexia and loose stools can protect bone marrow hematopoietic function, increase white blood cells, and improve the completion rate of radiotherapy and chemotherapy.

Description

治疗放化疗后白细胞减少症的中药组合物及其制备方法Traditional Chinese medicine composition for treating leukopenia after radiotherapy and chemotherapy and preparation method thereof

技术领域technical field

本发明涉及一种治疗放化疗后白细胞减少症的中药组合物,尤其涉及一种治疗恶性肿瘤放化疗后白细胞减少症的中药组合物,本发明还涉及该中药组合物的制备方法,属于中药领域。The invention relates to a traditional Chinese medicine composition for treating leukopenia after radiotherapy and chemotherapy, in particular to a Chinese medicine composition for treating malignant tumor leukopenia after radiotherapy and chemotherapy. The invention also relates to a preparation method of the Chinese medicine composition, which belongs to the field of traditional Chinese medicine .

背景技术Background technique

肿瘤是危害人类健康的重大疾病之一。据WHO2003年公布的数据显示:2000年全球共有恶性肿瘤患者1000万,其中男性530万,女性470万;因恶性肿瘤死亡者高达620万,占总死亡人数的12%,在发达国家这一数字可达25%。在发展中国家,由于城市化进程的加快,生活方式及饮食习惯的改变,与之密切相关的肿瘤的发生也将逐渐转变成经济发达国家的类型。如果这一趋向不能得到改善,预期到2020年,全球每年新发恶性肿瘤病例将达1500万。中西医结合治疗恶性肿瘤是从我国实际出发,融中西医学各自优势为一体,具有中国特色的防癌治癌道路,目前提倡肿瘤的综合治疗,中医药调理经过手术放化疗的肿瘤患者就更显其优势。这种优势疗效是通过截断和扭转恶性肿瘤的病理环节造成的。Tumor is one of the major diseases that endanger human health. According to the data released by WHO in 2003, in 2000, there were 10 million malignant tumor patients in the world, including 5.3 million males and 4.7 million females; 6.2 million deaths due to malignant tumors, accounting for 12% of the total deaths, this figure in developed countries Up to 25%. In developing countries, due to the acceleration of urbanization and changes in lifestyle and eating habits, the occurrence of tumors closely related to them will gradually change to the type of economically developed countries. If this trend cannot be improved, it is expected that by 2020, the number of new malignant tumor cases worldwide will reach 15 million per year. Combination of traditional Chinese and western medicine to treat malignant tumors proceeds from the reality of our country and integrates the advantages of both Chinese and western medicine. its advantages. This superior curative effect is caused by truncating and reversing the pathological links of malignant tumors.

放化疗属中医学“攻伐”范畴,其常见的毒副反应主要表现在两个方面:一方面是骨髓抑制,包括白细胞减少、贫血、血小板减少;另一方面是胃肠道反应,包括食欲下降、恶心呕吐、腹胀腹泻等症状。几乎所有的化疗药物都有不同程度的骨髓抑制,由于白细胞增殖快、寿命短,所以骨髓抑制受影响最大的是白细胞。白细胞减少,常常影响化疗的顺利完成,甚至导致严重感染而死亡。防治化疗引起的骨髓抑制是治疗肿瘤患者急需截断和扭转的环节。一般升白细胞西药如利血生、鲨肝醇等疗效较差。粒细胞集落刺激因子用于化疗所致的白细胞减少症见效快,使因白细胞减少难以继续化疗这一难题得到了很大程度的解决,但价格昂贵,而且部分病人发生反跳现象及发热、骨痛等副反应。不少学者认为,粒细胞集落刺激因子同化疗药一起使用,能降低化疗的疗效,并有刺激某些肿瘤生长的可能。Radiotherapy and chemotherapy belong to the "attack" category of traditional Chinese medicine, and its common toxic and side effects are mainly manifested in two aspects: one is bone marrow suppression, including leukopenia, anemia, and thrombocytopenia; the other is gastrointestinal tract reactions, including appetite Decline, nausea and vomiting, abdominal distension and diarrhea and other symptoms. Almost all chemotherapeutic drugs have varying degrees of myelosuppression. Because white blood cells proliferate rapidly and have a short lifespan, it is the white blood cells that are most affected by myelosuppression. Leukopenia often affects the smooth completion of chemotherapy, and even leads to severe infection and death. Prevention and treatment of myelosuppression caused by chemotherapy is an urgent link in the treatment of cancer patients that needs to be cut off and reversed. Generally, Western medicines for increasing leukocytes, such as leucogen, batyl alcohol, etc., have poor curative effects. Granulocyte colony-stimulating factor is used for leukopenia caused by chemotherapy, and the effect is quick, which solves the difficult problem of continuing chemotherapy due to leukopenia to a large extent, but the price is expensive, and some patients have rebound phenomenon, fever, bone Pain and other side effects. Many scholars believe that the use of granulocyte colony-stimulating factor together with chemotherapy drugs can reduce the efficacy of chemotherapy and may stimulate the growth of certain tumors.

放化疗所致的白细胞减少症主要表现有头晕目眩、神疲乏力、腰膝酸软、心慌气短、虚烦失眠,动则汗出等,属中医“虚劳”范畴。《景岳全书》说:“凡脾肾不足及虚弱失调之人,多有积聚之病”,说明肿瘤的发生,多有脏腑的虚损情况存在,尤以脾肾不足为主,脏腑虚损及功能失调或先天禀赋不足是产生肿瘤的内在因素。中医学理论认为,脾为后天之本,气血生化之源。在五脏之中,脾胃功能尤为重要,对其他四脏起滋养作用,脾胃强健则四脏皆健,机体功能活动维持正常,脾胃衰败则四脏亦衰,百病由生。脾虚在肿瘤发病过程中具有关键作用,脾虚则气血生化无源,气血亏虚则导致机体抗病能力下降;另外脾虚则水湿运化失常,痰浊内生,阻碍气血运行,导致气滞血瘀,痰瘀互结日久,发为癌瘤。肾为先天之本,寓元阴元阳,是生命的本元。肾主藏精生髓,髓居骨中,肾精充足则骨髓生化有源,生血旺盛。肾气虚弱也是肿瘤发生发展的重要因素。虚劳多为脾肾两虚,健脾益肾是治疗的关键,临床治疗尤应重视阴阳双补。正气充沛,各脏腑器官的活力就旺盛,骨髓造血能力亦增强。The main manifestations of leukopenia caused by radiotherapy and chemotherapy are dizziness, mental fatigue, weakness of the waist and knees, palpitation, shortness of breath, fatigue and insomnia, sweating when moving, etc., which belong to the category of "consumptive fatigue" in traditional Chinese medicine. "Jingyue Quanshu" said: "People with spleen and kidney deficiency and weak disorders often have accumulated diseases", which shows that the occurrence of tumors often has the deficiency of viscera, especially the deficiency of spleen and kidney, and the deficiency of viscera And dysfunction or innate endowment deficiency is the intrinsic factor of tumor. The theory of traditional Chinese medicine believes that the spleen is the foundation of acquired constitution and the source of Qi and blood biochemistry. Among the five viscera, the function of the spleen and stomach is particularly important. It nourishes the other four viscera. If the spleen and stomach are strong, the four viscera will be healthy and the body’s functions and activities will remain normal. If the spleen and stomach are weakened, the four viscera will also decline, and all diseases will arise. Spleen deficiency plays a key role in the pathogenesis of tumors. Spleen deficiency leads to passive biochemistry of qi and blood, and deficiency of qi and blood leads to a decline in the body's disease resistance; Qi stagnation and blood stasis, phlegm and blood stasis intertwine with the passing of time, send out into cancerous tumor. The kidney is the foundation of innate nature, containing the essence of yin and yang, and is the origin of life. The kidney stores the essence and produces the marrow, and the marrow resides in the bone. If the kidney essence is sufficient, the bone marrow will be active in biochemistry and generate blood vigorously. Deficiency of kidney qi is also an important factor in the occurrence and development of tumors. Asthenia is mostly due to deficiency of both spleen and kidney, strengthening the spleen and nourishing the kidney is the key to treatment, and clinical treatment should pay special attention to the dual nourishment of yin and yang. When righteousness is abundant, the vigor of the viscera and organs will be vigorous, and the hematopoietic ability of the bone marrow will also be enhanced.

发明内容Contents of the invention

本发明的目的为提供一种治疗放化疗后白细胞减少症的中药组合物及其制备方法,本发明以党参,茯苓,红景天健脾益气,以枸杞子,女贞子滋补肝肾之阴,以仙灵脾,菟丝子温补肾阳,补骨生髓,以陈皮理气和胃,全方药性平和,不温不燥。治疗放化疗后白细胞减少症效果良好。The object of the present invention is to provide a kind of Chinese medicine composition and preparation method thereof for the treatment of leukopenia after radiotherapy and chemotherapy. Yin, with fairy spirit spleen, dodder seed warming and tonifying kidney yang, nourishing bones and promoting marrow, and tangerine peel to regulate qi and harmonize stomach, the whole prescription is mild in nature, neither warm nor dry. The treatment of leukopenia after radiotherapy and chemotherapy has a good effect.

为了达到上述目的,本发明采用如下的技术方案:In order to achieve the above object, the present invention adopts following technical scheme:

治疗放化疗后白细胞减少症的中药组合物,其特征在于,包括以下重量份计的原料药:党参10-20份,茯苓10-20份,红景天15-45份,枸杞子10-20份,女贞子10-20份,仙灵脾5-15份,菟丝子5-15份,陈皮5-15份。The traditional Chinese medicine composition for treating leukopenia after radiotherapy and chemotherapy is characterized in that it includes the following raw materials in parts by weight: Codonopsis 10-20 parts, Poria cocos 10-20 parts, Rhodiola rosea 15-45 parts, Lycium barbarum 10-20 parts 10-20 parts of privet fruit, 5-15 parts of fairy spleen, 5-15 parts of dodder seed, 5-15 parts of tangerine peel.

优选的各原料药的重量份是:党参15份,茯苓15份,红景天30份,枸杞子15份,女贞子15份,仙灵脾10份,菟丝子10份,陈皮10份。The preferred parts by weight of each raw material are: 15 parts of Codonopsis pilosula, 15 parts of Poria cocos, 30 parts of rhodiola rosea, 15 parts of medlar, 15 parts of Ligustrum lucidum, 10 parts of fairy spleen, 10 parts of dodder, and 10 parts of tangerine peel.

党参性味甘平,归肺脾两经,《本草正义》记载:补脾养胃,润肺生津,腱运中气,本与人参不甚相远。其尤可贵者,则健脾运而不燥,滋胃阴而不湿,润肺而不犯寒凉,养血而不偏滋腻,鼓舞清阳,振动中气,而无刚燥之弊。Codonopsis pilosula is sweet and flat in nature, and belongs to the two meridians of the lung and spleen. "Materia Medica Justice" records: nourishing the spleen and nourishing the stomach, nourishing the lungs and promoting body fluid, and tendon transporting Qi. This is not far from ginseng. Especially valuable ones can invigorate the spleen without dryness, nourish stomach yin without dampness, moisten the lungs without coldness, nourish blood without being too greasy, encourage clear yang, and vibrate the middle qi without the disadvantage of rigidity and dryness.

茯苓甘淡平,健脾利湿,宁心安神,为祛湿圣药,对于脾虚运化失常所致泄泻、带下,应用茯苓有标本兼顾之效,常与党参相须使用,共振脾胃元气,补益后天之本。Poria cocos is sweet and flat, invigorates the spleen and dampness, calms the mind and calms the nerves. It is a holy medicine for dispelling dampness. For diarrhea and vaginal discharge caused by spleen deficiency, Poria cocos has the effect of taking care of both specimens. It is often used together with Codonopsis pilosula to resonate the vitality of the spleen and stomach and tonify The day after tomorrow.

红景天性甘、苦、平,益气活血、通脉,用于气虚血瘀、胸痹心痛、中风偏瘫和倦怠神疲等症,最早见于藏医药著作《四部医典》,有“雪域人参”之美称,《本草纲目》记载:本经上品,祛邪,恶气,补诸不足,是已知补益药中所罕见,目前主要是应用红景天来提高机体的免疫功能,保护和促进恢复能力,增强免疫细胞活性。将红景天与化疗药物联合应用,可降低化疗的毒副反应,提高化疗效果,还可增加患者对手术、放疗或化疗等的耐受力,促进手术后机体免疫功能的恢复。现代研究证明红景天苷可能通过间接或直接作用,刺激骨髓抑制贫血小鼠造血祖细胞的增殖,来促进造血功能的恢复。Rhodiola is sweet, bitter, and flat in nature, nourishing qi, activating blood, and dredging the meridians. It is used for qi deficiency and blood stasis, chest pain, heart pain, stroke hemiplegia, and burnout. "Ginseng", the "Compendium of Materia Medica" records: the top grade of this classic, dispelling evil, evil spirits, and supplementing deficiencies, is rare in known tonic medicines. At present, rhodiola is mainly used to improve the immune function of the body, protect and promote Restorative ability, enhance immune cell activity. The combined application of rhodiola and chemotherapy drugs can reduce the toxic and side effects of chemotherapy, improve the effect of chemotherapy, increase the patient's tolerance to surgery, radiotherapy or chemotherapy, and promote the recovery of the body's immune function after surgery. Modern studies have proved that salidroside may stimulate the proliferation of hematopoietic progenitor cells in bone marrow-suppressed anemic mice through indirect or direct effects, so as to promote the recovery of hematopoietic function.

枸杞子性味甘平,功能滋补肝肾,益精明目,为平补肾精肝血之品,《本草汇言》载:“枸杞能使气可充,血可补,阳可生,阴可长,火可降,风湿可去,有十全之妙用焉。”现代研究证明,枸杞子对免疫有调节作用,抗衰老,抗肿瘤,保护肝脏,促进造血功能,对正常健康人也有显著升高白细胞作用。Lycium barbarum is sweet and flat in nature and taste, nourishing the liver and kidney, benefiting essence and improving eyesight. Long-term, fire can be reduced, rheumatism can be removed, and it has all kinds of magical effects." Modern research has proved that wolfberry has a regulatory effect on immunity, anti-aging, anti-tumor, protecting the liver, and promoting hematopoietic function. It also has a significant effect on normal healthy people. High leukocyte function.

女贞子甘苦凉,能补益肝肾之阴,始载于东汉,《神农本草经》列为上品。《本草经疏》载:“女贞子,气味俱阴,正入肾除热补精之要品,肾得补,则五脏自安,精神自足,百病去而身肥健矣。”Ligustrum lucidum is sweet, bitter and cool, which can nourish the Yin of the liver and kidney. It was first recorded in the Eastern Han Dynasty, and it was listed as the top grade in "Shen Nong's Materia Medica". "Compendium of Materia Medica" contains: "Ligustrum lucidum, with a yin smell, is entering the kidney to remove heat and replenish essence. If the kidney is nourished, the five internal organs will be at ease, the spirit will be self-sufficient, all diseases will be eliminated, and the body will be fat and healthy."

仙灵脾即淫羊藿,性味辛甘温,具有补肾壮阳,强筋骨,祛风除湿的作用。《本经》首载“益气力,强志”,李时珍在《本草纲目》中称其有“益精气,坚筋骨,补腰膝,强心力”之功效。现代药理实验研究表明,淫羊藿能促进造血功能、免疫功能及骨代谢,具有抗衰老、抗肿瘤等功效。The fairy spleen is Epimedium, which is pungent, sweet and warm in nature and has the functions of invigorating the kidney and strengthening yang, strengthening muscles and bones, and expelling wind and dampness. "Ben Jing" first recorded "beneficial energy, strong will", Li Shizhen said in "Compendium of Materia Medica" that it has the effect of "benefiting essence, strengthening muscles and bones, strengthening waist and knees, and strengthening heart". Modern pharmacological experimental research shows that Epimedium can promote hematopoietic function, immune function and bone metabolism, and has anti-aging and anti-tumor effects.

菟丝子性味甘辛平,补肾益精,养肝明目。本品辛以润燥,甘以补虚,为平补阴阳之品,功能补肾阳,益肾精,健脾。据《日华子本草》:补五劳七伤,治泄精,尿血,润心肺。Cuscuta is sweet and savory in nature and taste, nourishes kidney and essence, nourishes liver and improves eyesight. This product is pungent to moisten dryness, sweet to invigorate deficiency, and is a product for tonifying yin and yang. According to "Rihuazi Materia Medica": nourish five fatigue and seven injuries, control diarrhea, hematuria, and moisten the heart and lungs.

陈皮性味辛苦温,归脾肺经,理气健脾,燥湿化痰,本品辛行温通,有理气止痛健脾和中之功,辛香而行,善疏理气机,条畅中焦,而使升降有序,以治疗呕吐呃逆。《本草汇言》中载:味辛善散,故能开气;胃苦开泄,故能行痰;其气温平,善于通达,故能止呕、止咳,健脾和胃者也。Tangerine peel has a bitter and warm nature and taste, returns to the spleen and lung meridian, regulates qi and invigorates the spleen, dries dampness and resolves phlegm. Jiao, so that the ascending and descending orderly, to treat vomiting and hiccups. "Materia Medica Huiyan" contains: the taste is pungent and good to loose, so it can open the qi; the stomach is bitter and ventilated, so it can make phlegm;

全方君臣佐使,井井有条,既合古法,又有新意。以上药物融补阴补阳于一体,体现了阴阳互根,阴升阳长之意。党参、茯苓健脾益气,既可改善自汗、乏力症状,又可促进食欲,提高了补血作用;枸杞子、女贞子滋补肝肾之阴,养血;仙灵脾、菟丝子温补肾阳,温而不燥,陈皮理气健脾和胃,既助药行,防滋腻碍胃,又能有效缓解放化疗所致的消化系统的不良反应。此方气血阴阳,肝脾肾俱补,除显著升高白细胞作用外,对缓解神疲乏力、腰膝酸软、心悸失眠、自汗盗汗等临床症状,均有较好的疗效,且无副反应。The whole party's monarchs, ministers and envoys are well organized, which is not only in line with ancient methods, but also has new ideas. The above medicines are integrated to nourish yin and nourish yang, which embodies the meaning that yin and yang are mutually rooted, and yin promotes yang and grows. Codonopsis pilosula and Poria cocos invigorate the spleen and replenish qi, which can not only improve spontaneous sweating and fatigue symptoms, but also promote appetite and enhance the effect of nourishing blood; wolfberry fruit and privet privet fruit nourish the yin of liver and kidney and nourish blood; fairy spleen and dodder seed warm and nourish kidney yang , warm but not dry, tangerine peel regulates qi and invigorates the spleen and stomach, which not only helps the medicine to work, prevents the stomach from being greasy, but also effectively relieves the adverse reactions of the digestive system caused by radiotherapy and chemotherapy. This prescription is qi, blood, yin and yang, and nourishes the liver, spleen and kidney. In addition to significantly increasing the effect of white blood cells, it has good curative effects on relieving clinical symptoms such as mental fatigue, weakness of the waist and knees, palpitations, insomnia, spontaneous sweating and night sweating, and has no side effects. reaction.

本发明还提供了上述中药组合物的制备方法,按所述重量份称取各原料药,将各原料药粉碎,过筛,加入制备不同剂型时所需的各种辅料,例如崩解剂、润滑剂、黏合剂等,以常规的中药制剂方法制备成任何一种适宜的临床制剂,例如可以是胶囊剂、丸剂、散剂、颗粒剂、片剂、口服液或滴丸剂等,优选为颗粒剂。The present invention also provides a preparation method for the above-mentioned traditional Chinese medicine composition. Each raw material is weighed according to the weight portion, each raw material is pulverized, sieved, and various auxiliary materials required for preparing different dosage forms are added, such as disintegrating agent, Lubricants, adhesives, etc., are prepared into any suitable clinical preparations by conventional traditional Chinese medicine preparation methods, such as capsules, pills, powders, granules, tablets, oral liquids or drop pills, etc., preferably granules .

优选的,一种制备本发明中药组合物的方法,包括以下步骤:Preferably, a method for preparing the Chinese medicine composition of the present invention comprises the following steps:

(1)按所述重量份称取各原料药;(1) Weigh each API according to the stated parts by weight;

(2)将仙灵脾、红景天、陈皮分别蒸馏,提取挥发油,将挥发油包被后粉碎,备用;(2) Distill the fairy spleen, rhodiola rosea and tangerine peel respectively to extract the volatile oil, coat the volatile oil and crush it, and set aside;

(3)将党参、枸杞子、女贞子用体积分数为30-95%乙醇提取,将乙醇提取液喷雾干燥,备用;(3) Extract Codonopsis pilosula, Lycium barbarum and Ligustrum lucidum with ethanol with a volume fraction of 30-95%, spray-dry the ethanol extract, and set aside;

(4)将提取挥发油后的仙灵脾、红景天、陈皮药渣与党参,枸杞,女贞子,茯苓,菟丝子一起用水提取,将水提取液喷雾干燥,备用;(4) Extract the fairy spleen, rhodiola rosea, tangerine peel dregs, codonopsis pilosula, wolfberry, privet fruit, poria cocos, and dodder seed with water after extracting the volatile oil, spray the water extract to dry, and set aside;

(5)将步骤(2)、(3)和(4)所得到的产物混合均匀,加入药物制剂辅料混匀制成制剂半成品,再经制剂成型工艺制成制剂成品。(5) Mix the products obtained in steps (2), (3) and (4) evenly, add pharmaceutical preparation auxiliary materials and mix well to make a semi-finished preparation, and then make a finished preparation through the preparation molding process.

优选的,上述步骤(3)中所述的乙醇选用体积分数为95%的乙醇,乙醇加入重量为所述药物总重量的3-5倍,提取2-4次,每次提取1.5-2.5小时。Preferably, the ethanol described in the above step (3) is ethanol with a volume fraction of 95%, and the added weight of ethanol is 3-5 times of the total weight of the drug, extracted 2-4 times, each extraction for 1.5-2.5 hours .

优选的,上述步骤(4)中用水提取二次,第一次加水重量是所述药物总重量的3-5倍,煎煮2-4小时,第二次加水重量是所述药物总重量的1.5-3倍,煎煮0.5-1.5小时。Preferably, the above step (4) is extracted twice with water, the weight of adding water for the first time is 3-5 times of the total weight of the drug, decocting for 2-4 hours, and the weight of adding water for the second time is 3-5 times of the total weight of the drug 1.5-3 times, decocting for 0.5-1.5 hours.

此外,还包括本发明制备的中药组合物在制备治疗放化疗后白细胞减少症药物中的用途。In addition, it also includes the use of the traditional Chinese medicine composition prepared by the invention in the preparation of medicines for treating leukopenia after radiotherapy and chemotherapy.

本发明中药组合物具有保护骨髓,升高恶性肿瘤患者放化疗期间白细胞,增强患者机体免疫力,改善胃肠功能,从而达到减轻放化疗不良反应,提高放化疗完成率的目的。且本发明中药组合物临床使用安全,患者使用后无任何不良反应,且能有效改善患者的全身机能,停用本发明药物后也不会产生任何不良反应。The traditional Chinese medicine composition of the invention has the functions of protecting bone marrow, increasing leukocytes during radiotherapy and chemotherapy in patients with malignant tumors, enhancing the immunity of patients, improving gastrointestinal function, so as to reduce adverse reactions of radiotherapy and chemotherapy and improve the completion rate of radiotherapy and chemotherapy. Moreover, the traditional Chinese medicine composition of the present invention is safe in clinical use, and patients do not have any adverse reactions after use, and can effectively improve the systemic functions of patients, and no adverse reactions will occur after the drug of the present invention is stopped.

具体实施方式Detailed ways

下面结合具体实施例来进一步描述本发明,本发明的优点和特点将会随着描述而更为清楚。但实施例仅是范例性的,并不对本发明的范围构成任何限制。本领域技术人员应该理解的是,在不偏离本发明的精神和范围下可以对本发明技术方案的细节和形式进行修改或替换,但这些修改和替换均落入本发明的保护范围内。The present invention will be further described below in conjunction with specific embodiments, and the advantages and characteristics of the present invention will become clearer along with the description. However, the examples are merely exemplary and do not limit the scope of the present invention in any way. Those skilled in the art should understand that the details and forms of the technical solutions of the present invention can be modified or replaced without departing from the spirit and scope of the present invention, but these modifications and replacements all fall within the protection scope of the present invention.

实施例1硬胶囊剂的制备The preparation of embodiment 1 hard capsule

(1)按以下重量称取各原料饮片:党参1500g,茯苓1500g,红景天3000g,枸杞子1500g,女贞子1500g,仙灵脾1000g,菟丝子1000g,陈皮1000g。(1) Weigh each raw material decoction piece according to the following weight: Codonopsis 1500g, Poria cocos 1500g, Rhodiola rosea 3000g, wolfberry fruit 1500g, privet fruit 1500g, fairy spleen 1000g, dodder seed 1000g, tangerine peel 1000g.

(2)将红景天、仙灵脾、陈皮蒸馏,提取挥发油,取红景天、仙灵脾、陈皮挥发油10倍量的β-环糊精后,再加入β-环糊精3倍量的体积分数为40%的乙醇混匀后,以胶体磨均质15分钟进行包合,将包合后的均质液冷藏24小时后过滤,滤过后的包合物在40℃温度下烘干后粉碎,备用;(2) Distill Rhodiola rosea, Xianlingpi, and tangerine peel to extract volatile oils, take β-cyclodextrin 10 times the amount of volatile oils from Rhodiola rosea, Xianlingpi, and tangerine peel, and then add 3 times the amount of β-cyclodextrin After mixing with ethanol with a volume fraction of 40%, use a colloid mill to homogenize for 15 minutes for clathrate, refrigerate the clathrate homogeneous solution for 24 hours, then filter, and dry the clathrate after filtration at 40°C After crushing, spare;

(3)将党参、女贞子、枸杞子用体积分数为95%乙醇提取,乙醇加入重量是所述药物总重量的4倍,提取3次,每次提取2小时,合并提取液,滤过,滤液浓缩至相对密度1.30-1.35(摄氏55℃)的清膏,喷雾干燥制备细粉,备用;(3) Extract Codonopsis pilosula, Ligustrum lucidum, and Lycium barbarum with 95% ethanol, the weight of ethanol is 4 times the total weight of the drug, extract 3 times, each extraction is 2 hours, combine the extracts, filter , the filtrate is concentrated to a clear paste with a relative density of 1.30-1.35 (55°C), spray-dried to prepare a fine powder, and set aside;

(4)将提取挥发油后的仙灵脾、红景天、陈皮药渣与党参,枸杞,女贞子,茯苓,菟丝子一起用水提取二次,第一次加水重量是所述药物总重量的4倍,煎煮3小时,第二次加水重量是所述药物总重量的2倍,煎煮1小时;将两次煎煮液合并,滤过,滤液浓缩至相对密度为1.30-1.35(摄氏55℃)的清膏,喷雾干燥制备细粉,备用;(4) Extract the fairy spleen, rhodiola rosea, tangerine peel dregs, codonopsis pilosula, wolfberry, privet fruit, poria cocos, and dodder together with water for two times after the volatile oil is extracted, and the weight of adding water for the first time is 4% of the total weight of the drug. times, decocted for 3 hours, the weight of water added for the second time was twice the total weight of the drug, and decocted for 1 hour; the two decoctions were combined, filtered, and the filtrate was concentrated to a relative density of 1.30-1.35 (55 degrees Celsius ℃) clear paste, spray-dried to prepare fine powder, and set aside;

(5)将步骤(2)、(3)和(4)所得到的产物混合均匀,加入糊精、甜菊总甙适量,混匀,加乙醇适量制成颗粒,低温干燥,备用;(5) Mix the products obtained in steps (2), (3) and (4) evenly, add appropriate amount of dextrin and total stevioside, mix evenly, add appropriate amount of ethanol to make granules, dry at low temperature, and set aside;

(6)将(5)中制备的干燥颗粒进行整粒,制备成均匀颗粒,备用;(6) Sizing the dry granules prepared in (5) to prepare uniform granules for later use;

(7)将(6)中制备的均匀颗粒,用胶囊自动填充机填充于硬胶囊壳中,备用;(7) Fill the uniform granules prepared in (6) into the hard capsule shell with an automatic capsule filling machine, and set aside;

(8)将(7)中的硬胶囊进行抛光或封口,即得。(8) Polish or seal the hard capsule in (7).

实施例2散剂的制备The preparation of embodiment 2 powder

按以下重量称取各原料药:党参1500g,茯苓1500g,红景天3000g,枸杞子1500g,女贞子1500g,仙灵脾1000g,菟丝子1000g,陈皮1000g;将上述各原料药粉碎后,过800目筛,即得。Take each bulk drug by the following weight: Codonopsis 1500g, Poria cocos 1500g, Rhodiola rosea 3000g, medlar fruit 1500g, Ligustrum lucidum 1500g, fairy spleen 1000g, dodder seed 1000g, tangerine peel 1000g; Mesh sieve, that is.

实施例3颗粒剂的制备The preparation of embodiment 3 granules

(1)按以下重量称取各原料:党参1500g,茯苓1500g,红景天3000g,枸杞子1500g,女贞子1500g,仙灵脾1000g,菟丝子1000g,陈皮1000g;(1) Weigh each raw material according to the following weight: Codonopsis 1500g, Poria cocos 1500g, Rhodiola rosea 3000g, medlar 1500g, Ligustrum lucidum 1500g, fairy spleen 1000g, dodder 1000g, tangerine peel 1000g;

(2)将红景天和仙灵脾,陈皮提取挥发油,将挥发油包被后粉碎,备用;(2) Extract volatile oil from Rhodiola rosea, fairy spleen, and tangerine peel, coat the volatile oil and crush it, and set aside;

(3)将党参,女贞子,枸杞子、菟丝子用体积分数为95%乙醇提取,乙醇加入重量是所述药物总重量的4倍,提取3次,每次提取2小时,合并提取液,滤过,滤液浓缩至相对密度1.30-1.35(摄氏55℃)的清膏,喷雾干燥制备细粉,备用;(3) Extract Codonopsis pilosula, Ligustrum lucidum fruit, Lycium barbarum fruit and Cuscuta fruit with a volume fraction of 95% ethanol, and the weight of ethanol added is 4 times the total weight of the drug, and the extraction is performed 3 times, each time for 2 hours, and the extracts are combined, Filtrate, concentrate the filtrate to a clear paste with a relative density of 1.30-1.35 (55°C), spray dry to prepare a fine powder, and set aside;

(4)将提取挥发油后的仙灵脾、红景天、陈皮药渣与党参,枸杞,女贞子,茯苓,菟丝子一起用水提取二次,第一次加水重量是所述药物总重量的3倍,煎煮3小时,第二次加水重量是所述药物总重量的2倍,煎煮1小时;将两次煎煮液合并,滤过,滤液浓缩至相对密度为1.30-1.35(摄氏55℃)的清膏,喷雾干燥制备细粉,备用;(4) Extract the fairy spleen, rhodiola rosea, tangerine peel dregs, Codonopsis pilosula, Lycium barbarum, Ligustrum lucidum, Poria cocos, and Cuscuta after extracting the volatile oil with water twice, and the weight of adding water for the first time is 3% of the total weight of the medicine. times, decocted for 3 hours, the weight of water added for the second time was twice the total weight of the drug, and decocted for 1 hour; the two decoctions were combined, filtered, and the filtrate was concentrated to a relative density of 1.30-1.35 (55 degrees Celsius ℃) clear paste, spray-dried to prepare fine powder, and set aside;

(5)将步骤(2)、(3)和(4)所得到的产物混合均匀,加入糊精、甜菊总甙适量,混匀,加乙醇适量制成颗粒,低温干燥后,整粒,分装,即得。(5) Mix the products obtained in steps (2), (3) and (4) evenly, add appropriate amount of dextrin and total stevioside, mix evenly, add appropriate amount of ethanol to make granules, dry at low temperature, granulate, divide Put it on and get it.

试验例1:恶性肿瘤化疗致白细胞减少症患者疗效观察Experimental Example 1: Curative Effect Observation on Patients with Leukopenia Caused by Chemotherapy for Malignant Tumors

1、资料和方法1. Materials and methods

1.1病例来源1.1 Source of cases

2009年1月~2012年12月常州市肿瘤医院,门诊及住院肿瘤患者共计100例。患者随机分为中药治疗组50例,对照组50例。中药治疗组中,男22例,女28例;年龄31-75岁,中位年龄56岁,其中肺癌8例、乳腺癌20例、食管癌3例、胃癌10例、大肠癌6例、宫颈癌3例。对照组中,男24例、女26例;年龄32-75岁,中位年龄55岁;其中肺癌9例、乳腺癌16例,食管癌4例、胃癌10例、大肠癌6例、宫颈癌5例。两组患者性别、年龄、病理类型及分期、化疗前白细胞计数及中性粒细胞数无统计学差异,具有可比性。以上病例均经病理证实。实验室检查白细胞均低于4×109个/L,符合白细胞减少症标准。From January 2009 to December 2012, there were 100 outpatients and inpatients in Changzhou Cancer Hospital. The patients were randomly divided into a Chinese medicine treatment group of 50 cases and a control group of 50 cases. In the traditional Chinese medicine treatment group, there were 22 males and 28 females; aged 31-75 years, with a median age of 56 years, including 8 cases of lung cancer, 20 cases of breast cancer, 3 cases of esophageal cancer, 10 cases of gastric cancer, 6 cases of colorectal cancer, cervical cancer 3 cases of cancer. In the control group, there were 24 males and 26 females; aged 32-75 years, with a median age of 55 years; including 9 cases of lung cancer, 16 cases of breast cancer, 4 cases of esophageal cancer, 10 cases of gastric cancer, 6 cases of colorectal cancer, and cervical cancer. 5 cases. There was no significant difference in gender, age, pathological type and stage, white blood cell count and neutrophil count before chemotherapy between the two groups, and they were comparable. All the above cases were confirmed by pathology. The white blood cells in laboratory tests were all lower than 4×10 9 /L, meeting the standard of leukopenia.

1.2治疗方法1.2 Treatment methods

治疗组:自拟中药方:党参15g,茯苓15g,红景天30g,枸杞子15g,女贞子15g,仙灵脾10g,菟丝子10g,陈皮10g日一剂,水煎两次,共取汁400ml,早晚分两次服。对照组:选用升白药:每次给予鲨肝醇20mg,利血生20mg,维生素B420mg,每日3次。疗程:两组均10天为1个疗程,疗程结束查血常规,统计疗效。全部病例白细胞3.0-4.0×109个/L不停化疗,白细胞低于3.0×109个/L停止化疗。服药期间加强营养,进食高蛋白,高脂肪饮食,预防感染。Treatment group: self-prepared traditional Chinese medicine prescription: Codonopsis 15g, Poria cocos 15g, Rhodiola rosea 30g, medlar fruit 15g, Ligustrum lucidum 15g, fairy spleen 10g, dodder seed 10g, dried tangerine peel 10g, one dose per day, decoction twice, and extract juice altogether 400ml, take twice in the morning and evening. Control group: Shengbaiyao was selected: 20 mg of batyl alcohol, 20 mg of lexogen, and 20 mg of vitamin B4 were given each time, 3 times a day. Course of treatment: 10 days for both groups is a course of treatment. After the course of treatment, the routine blood test is performed and the curative effect is counted. In all cases, the leukocytes were 3.0-4.0×10 9 /L without continuous chemotherapy, and the leukocytes were less than 3.0×10 9 /L and the chemotherapy was stopped. During the period of taking the medicine, strengthen nutrition, eat a high-protein, high-fat diet, and prevent infection.

1.3疗效标准:1.3 Curative effect standard:

参考卫生部制订的《药物临床研究指导原则》中升白细胞药疗效标准。显效:治疗后白细胞总数升至4.0×109个/L以上,并在疗程中能维持疗效直至停药后1周,临床症状显著减轻或消失;有效:治疗后白细胞<4.0×109个/L,但较治疗前上升0.5×109-1.0×109个/L,并在疗程中能维持疗效直至停药后1周,临床症状好转;无效:治疗后白细胞总数上升<0.5×109个/L,临床症状无好转。Refer to the curative effect standard of leukocyte-increasing drugs in the "Guiding Principles of Drug Clinical Research" formulated by the Ministry of Health. Markedly effective: after treatment, the total number of white blood cells rose to over 4.0×10 9 /L, and maintained the curative effect during the course of treatment until 1 week after stopping the drug, and the clinical symptoms were significantly relieved or disappeared; effective: after treatment, white blood cells <4.0×10 9 /L L, but increased by 0.5×10 9 -1.0×10 9 cells/L compared with before treatment, and the curative effect can be maintained during the course of treatment until 1 week after stopping the drug, and the clinical symptoms are improved; invalid: the total number of white blood cells increased by <0.5×10 9 after treatment A/L, the clinical symptoms did not improve.

2、治疗结果2. Treatment results

治疗组50例,显效35例,有效11例,无效4例,总有效率为92%;对照组50例,显效18例,有效17例,无效15例,总有效率为70%;两组疗效经统计学处理有显著性差异(P<0.05)。针对患者自觉症状头晕、乏力、自汗、食欲差、睡眠差等症状,治疗组改善明显。50 cases in the treatment group, 35 cases were markedly effective, 11 cases were effective, 4 cases were ineffective, and the total effective rate was 92%; 50 cases were in the control group, 18 cases were markedly effective, 17 cases were effective, and 15 cases were ineffective, and the total effective rate was 70%. There is a significant difference in curative effect after statistical treatment (P<0.05). For the patients' subjective symptoms such as dizziness, fatigue, spontaneous sweating, poor appetite, and poor sleep, the treatment group improved significantly.

3、结论3. Conclusion

本发明制备的中药组合物具有保护骨髓,升高恶性肿瘤患者化疗期间白细胞,增强患者机体免疫力,改善胃肠功能,从而达到减轻化疗不良反应,提高化疗完成率的目的。The traditional Chinese medicine composition prepared by the invention has the functions of protecting bone marrow, increasing leukocytes of malignant tumor patients during chemotherapy, enhancing immunity of patients, improving gastrointestinal function, so as to reduce adverse reactions of chemotherapy and improve the completion rate of chemotherapy.

Claims (9)

1. treat the Chinese medicine composition of leukopenia after chemoradiotherapy, it is characterised in that by the bulk pharmaceutical chemicals of following parts by weight meter Composition:10-20 parts of Radix Codonopsis, 10-20 parts of Poria cocos, 15-45 parts of rhodiola root, 10-20 parts of the fruit of Chinese wolfberry, 10-20 parts of the fruit of glossy privet, HERBA EPIMEDII 5-15 parts, 5-15 parts of Semen Cuscutae, 5-15 parts of dried orange peel.
2. Chinese medicine composition according to claim 1, it is characterised in that the parts by weight of each bulk pharmaceutical chemicals are:15 parts of Radix Codonopsis, Fu 15 parts of Siberian cocklebur, 30 parts of rhodiola root, 15 parts of the fruit of Chinese wolfberry, 15 parts of the fruit of glossy privet, 10 parts of HERBA EPIMEDII, 10 parts of Semen Cuscutae, 10 parts of dried orange peel.
3. Chinese medicine composition according to claim 1 or 2, it is characterised in that be prepared into according to Chinese medicine preparation and clinically fit Suitable preparation.
4. Chinese medicine composition described in accordance with the claim 3, it is characterised in that the preparation includes capsule, pill, dissipates Agent, granule, tablet, oral liquid or pill.
5. a kind of method for preparing the Chinese medicine composition described in claim 1 or 2, its step include:Weighed by the parts by weight Each bulk pharmaceutical chemicals, each bulk pharmaceutical chemicals are crushed, and sieving, adds the auxiliary material or excipients needed for preparations shaping, be prepared into capsule, ball Agent, powder, granule, tablet, oral liquid or pill.
6. a kind of method for preparing the Chinese medicine composition described in claim 1 or 2, its step include:
(1) each bulk pharmaceutical chemicals are weighed by the parts by weight;
(2) HERBA EPIMEDII, rhodiola root, dried orange peel are distilled respectively, extracts volatile oil, crushed after volatile oil is coated with, it is spare;
(3) it is that 30-95% ethanol extracts with volume fraction by Radix Codonopsis, the fruit of Chinese wolfberry, the fruit of glossy privet, ethanol extract is spray-dried, It is spare;
(4) by HERBA EPIMEDII, rhodiola root, the dried orange peel dregs of a decoction and the Radix Codonopsis after extraction volatile oil, matrimony vine, the fruit of glossy privet, Poria cocos, Semen Cuscutae one Water extraction is reinstated, aqueous extract is spray-dried, it is spare;
(5) step (2), (3) and (4) obtained product is uniformly mixed, adds pharmaceutical preparation auxiliary materials and mixing and preparation half is made Finished product, then finished dosage form is made through preparations shaping technique.
7. preparation method according to claim 6, it is characterised in that the ethanol described in the step (3) selects volume Fraction is 95% ethanol, and ethanol adds 3-5 times that weight is the medicine gross weight, extracts 2-4 times, extract 1.5- every time 2.5 it is small when.
8. preparation method according to claim 6, it is characterised in that the number extracted in the step (4) with water is two Secondary, first time adds 3-5 times that water weight is the medicine gross weight, and when decoction 2-4 is small, for the second time plus water weight is the medicine 1.5-3 times of gross weight, when decoction 0.5-1.5 is small.
9. the Neuroleptic Leukocytopenia disease drug after treatment concurrent chemoradiotherapy of malignant tumor is prepared of the Chinese medicine composition described in claim 1 or 2 In purposes.
CN201310366943.1A 2013-08-21 2013-08-21 Treat Chinese medicine composition of leukopenia after chemoradiotherapy and preparation method thereof Expired - Fee Related CN104415162B (en)

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CN1306848A (en) * 2000-01-26 2001-08-08 中国石化集团齐鲁石油化工公司 Chinese medicine preparation for preventing and treating leucocytopenia and its preparation process
CN1833695A (en) * 2006-01-11 2006-09-20 重庆希尔安药业有限公司 Tonifying speen and tonifying kidney granular and its prepn. method

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CN1306848A (en) * 2000-01-26 2001-08-08 中国石化集团齐鲁石油化工公司 Chinese medicine preparation for preventing and treating leucocytopenia and its preparation process
CN1833695A (en) * 2006-01-11 2006-09-20 重庆希尔安药业有限公司 Tonifying speen and tonifying kidney granular and its prepn. method

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