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CN101612220B - External-application cream for treating osteoarthritis and preparation method thereof - Google Patents

External-application cream for treating osteoarthritis and preparation method thereof Download PDF

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CN101612220B
CN101612220B CN200910100776XA CN200910100776A CN101612220B CN 101612220 B CN101612220 B CN 101612220B CN 200910100776X A CN200910100776X A CN 200910100776XA CN 200910100776 A CN200910100776 A CN 200910100776A CN 101612220 B CN101612220 B CN 101612220B
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詹强
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Hangzhou Chinese Medicinal Hospital
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Abstract

本发明涉及治疗骨关节炎的药剂及制备方法,公开了治疗骨关节炎的外用霜剂及其制备方法,所述外用霜剂每1000克中按照重量份主要采取下列组分的原料:红花20-30g,当归45-55g,桃仁45-55g,制附子45-55g,川芎45-55g,生川乌18-22g,制乳香4-6g,制没药4-6g,冰片8-12g,薄荷脑4-6g。本发明制得的外用霜剂可有效改善骨关节及周围滑膜炎症,加快血液循环,消除关节的肿痛、活动障碍等症状,缓解病情,不良反应极少,患者使用可携带方便。

Figure 200910100776

The invention relates to a medicament for treating osteoarthritis and a preparation method thereof, and discloses an external cream for treating osteoarthritis and a preparation method thereof. The external cream mainly adopts the following components according to weight parts per 1000 grams of raw materials: safflower 20-30g, 45-55g angelica, 45-55g peach kernel, 45-55g aconite, 45-55g Chuanxiong, 18-22g raw Aconitum, 4-6g frankincense, 4-6g myrrh, 8-12g borneol, Menthol 4-6g. The cream for external use prepared by the invention can effectively improve the inflammation of bone joints and surrounding synovium, accelerate blood circulation, eliminate symptoms such as joint swelling and pain, movement disorder, alleviate the disease, have few adverse reactions, and are easy to carry for patients.

Figure 200910100776

Description

治疗骨关节炎的外用霜剂及其制备方法 External cream for treating osteoarthritis and preparation method thereof

技术领域technical field

本发明涉及治疗骨关节炎的药剂及制备方法,尤其涉及治疗骨关节炎的外用药剂及其制备方法。The invention relates to a medicament for treating osteoarthritis and a preparation method thereof, in particular to an externally used medicament for treating osteoarthritis and a preparation method thereof.

背景技术Background technique

骨关节炎是骨科的常见病,目前现代医学对骨关节炎药物的开发方面多还处于研究阶段,一些西医的治疗药物存在很多的不良反应,副作用明显,常给患者带来很大的精神负担,且无法达到对疾病的根治,口服中药又让患者往往怕麻烦也不愿接受,而外用的很多药物多为进口药物或外资药厂药物,不具用本国知识产权,同时疗效也不甚满意。如现有专利文献中,申请号99120466.2、申请日1999年12月27日、授权公告号为CN1301547、公告日为2001年7月4日、专利权人为王振宇的发明专利,公开了一种治疗骨关节炎的止痛膏药,它以明天麻、三七、制杜仲、仙灵脾、土元、川乌、草乌、全虫、蜈蚣、何首乌、穿山甲、水蛭、制乳香、制没药、当归、川芎、丹参、桃仁、赤芍、鸡血藤、红花、血竭、续断、桑寄生、牡丹皮、姜黄、川牛膝、五加皮、乌蛇、象皮、血余炭、麻黄、细辛、防风、独活、白芷、南星、大黄、葛根、米悫、冰片、白芥子等中药为原料,按一定比例熬制,对骨关节炎引起的疼痛其治疗或缓解症状的有一定效果,但有一定的副作用,不能有效改善骨关节及周围滑膜炎症,加快血液循环,疗效也不甚满意,无法达到对疾病的根治;再如现有专利文献中,申请号01131249.、申请日2001年9月5日、公告号为CN1358527、公告日为2002年7月17日、专利权人为吴振刚的发明专利,公开了一种追风健骨止痛膏,是一种具有活血化瘀、祛风散寒、舒筋壮骨、消肿止痛等功能的显效药物。适用于:风湿性关节炎、股骨头坏死、椎间盘突出、颈椎病、骨质增生、坐骨神经痛、骨髓炎、骨结核、骨瘤等所引起的筋骨疼痛、四肢麻木、活动不便等症,该药具有渗透力强、使用方便优点,但也有一定的副作用,不能有效改善骨关节及周围滑膜炎症,加快血液循环,消除关节的肿痛、活动障碍等症状,无法达到对疾病的根治,疗效也不甚满意。Osteoarthritis is a common disease in orthopedics. At present, the development of drugs for osteoarthritis in modern medicine is still in the research stage. Some Western medicine drugs have many adverse reactions, and the side effects are obvious, which often bring great mental burden to patients. , and can not achieve a radical cure for the disease, and oral Chinese medicine makes patients often afraid of trouble and unwilling to accept it, and many medicines for external use are mostly imported medicines or medicines from foreign pharmaceutical companies, which do not have domestic intellectual property rights, and the curative effect is not very satisfactory. For example, in the existing patent literature, the application number is 99120466.2, the application date is December 27, 1999, the authorized announcement number is CN1301547, the announcement date is July 4, 2001, and the patentee is Wang Zhenyu's invention patent. Pain-relief plaster for arthritis, it uses Astragalus, Panax notoginseng, Eucommia ulmoides, Lingpi, Tuyuan, Chuanwu, Aconitum, whole insect, centipede, fleece-flower root, pangolin, leech, frankincense, myrrh, angelica, Rhizoma Chuanxiong, Salvia, Peach Kernel, Paeoniae Rubra, Miltifolia, Safflower, Dried Blood, Dipsacus, Sangjisi, Moutan Bark, Turmeric, Achyranthes Radix, Wujia Bark, Black Snake, Elephant Peel, Blood Charcoal, Ephedra, Asarum, Fangfeng, Duhuo, Baizhi, Nanxing, Rhubarb, Pueraria lobata, Miku, borneol, white mustard seeds and other traditional Chinese medicines are used as raw materials, boiled in a certain proportion, and have a certain effect on the pain caused by osteoarthritis or in relieving symptoms. But there are certain side effects, can not effectively improve bone joints and surrounding synovial inflammation, accelerate blood circulation, curative effect is not very satisfactory, can't reach the radical cure of disease; On September 5, 2002, the announcement number was CN1358527, the announcement date was July 17, 2002, and the patentee was Wu Zhengang's invention patent, which disclosed a kind of Zhuifeng Jiangu Pain Relief Ointment, which has the functions of promoting blood circulation, removing blood stasis, expelling wind It is an effective drug with the functions of dispelling cold, relaxing tendons and strengthening bones, reducing swelling and relieving pain. Applicable to: rheumatoid arthritis, femoral head necrosis, herniated intervertebral disc, cervical spondylosis, hyperosteogeny, sciatica, osteomyelitis, bone tuberculosis, osteoma, etc. It has the advantages of strong penetration and convenient use, but it also has certain side effects. It cannot effectively improve the inflammation of the bone joints and surrounding synovium, accelerate blood circulation, eliminate joint swelling and pain, movement disorders and other symptoms, and cannot achieve a radical cure for the disease. Not very satisfied.

发明内容Contents of the invention

本发明针对现有技术存在的治疗骨关节炎药物无法达到对疾病的根治、无法有效改善骨关节及周围滑膜炎症、消除关节的肿痛、活动障碍症状,且很多药物副作用明显、疗效也不甚满意的问题,提供了治疗骨关节炎的外用霜剂及其制备方法。The present invention aims at treating osteoarthritis drugs in the prior art, which cannot cure the disease, effectively improve the inflammation of bone joints and surrounding synovium, eliminate joint swelling and pain, and symptoms of movement disorders, and many drugs have obvious side effects and low curative effect. Very satisfactory problem, the topical cream for treating osteoarthritis and its preparation method are provided.

为了解决上述技术问题,本发明通过下述技术方案得以解决:In order to solve the above technical problems, the present invention is solved through the following technical solutions:

治疗骨关节炎的外用霜剂每1000克中按照重量份主要采取下列组分的原料:红花20-30g,当归45-55g,桃仁45-55g,制附子45-55g,川芎45-55g,生川乌18-22g,乳香4-6g,制没药4-6g,冰片8-12g,薄荷脑4-6g。这些原料按此重量份配制的治疗骨关节炎的外用霜剂可有效改善骨关节及周围滑膜炎症、消除关节的肿痛、活动障碍症状。The external cream for the treatment of osteoarthritis mainly adopts the raw materials of the following components according to parts by weight in every 1000 grams: 20-30g of safflower, 45-55g of angelica, 45-55g of peach kernel, 45-55g of aconite, 45-55g of chuanxiong, Raw Aconitum 18-22g, frankincense 4-6g, myrrh 4-6g, borneol 8-12g, menthol 4-6g. The external cream for treating osteoarthritis prepared by these raw materials according to the weight portion can effectively improve the inflammation of bone joints and surrounding synovium, and eliminate joint swelling and pain and movement disorder symptoms.

作为优选,所述的治疗骨关节炎的外用霜剂每1000克中按照重量份主要采取下列组分的原料:红花25g,当归50g,桃仁50g,制附子50g,川芎50g,生川乌20g,制乳香5g,制没药5g,冰片10g,薄荷脑5g。这些原料按此重量份配制的治疗骨关节炎的外用霜剂可有效改善骨关节及周围滑膜炎症、消除关节的肿痛、活动障碍症状。As a preference, the external cream for the treatment of osteoarthritis mainly adopts the raw materials of the following components in parts by weight per 1000 grams: 25g of safflower, 50g of angelica, 50g of peach kernel, 50g of aconite, 50g of Chuanxiong, and 20g of raw Aconiti , frankincense 5g, myrrh 5g, borneol 10g, menthol 5g. The external cream for treating osteoarthritis prepared by these raw materials according to the weight portion can effectively improve the inflammation of bone joints and surrounding synovium, and eliminate joint swelling and pain and movement disorder symptoms.

作为优选,所述的治疗骨关节炎的外用霜剂每1000克中按照重量份采取下列组分的原料:红花23g,当归48g,桃仁47g,制附子46g,川芎47g,生川乌19g,制乳香5.5g,制没药5.5g,冰片9g,薄荷脑5.5g。这些原料按此重量份配制的治疗骨关节炎的外用霜剂更加有效改善骨关节及周围滑膜炎症、消除关节的肿痛、活动障碍症状。As a preference, the external cream for treating osteoarthritis adopts the raw materials of the following components in parts by weight per 1000 grams: 23g of safflower, 48g of angelica, 47g of peach kernel, 46g of aconite, 47g of Rhizoma Chuanxiong, 19g of raw Aconitum aconitum, Made frankincense 5.5g, made myrrh 5.5g, borneol 9g, menthol 5.5g. The external cream for treating osteoarthritis prepared by these raw materials according to the weight part is more effective in improving the inflammation of bone joints and surrounding synovium, and eliminating joint swelling and pain and movement disorder symptoms.

作为优选,所述的治疗骨关节炎的外用霜剂每1000克中按照重量份采取下列组分的原料:红花28g,当归53g,桃仁52g,制附子53g,川芎54g,生川乌21g,制乳香4.5g,制没药4.5g,冰片9g,薄荷脑4.5g。这些原料按此重量份配制的治疗骨关节炎的外用霜剂可更加有效改善骨关节及周围滑膜炎症、消除关节的肿痛、活动障碍症状。As preferably, the external cream for treating osteoarthritis adopts the raw materials of the following components in parts by weight per 1000 grams: 28g of safflower, 53g of angelica, 52g of peach kernel, 53g of aconite, 54g of Chuanxiong, 21g of raw aconitum, Made frankincense 4.5g, made myrrh 4.5g, borneol 9g, menthol 4.5g. The external cream for treating osteoarthritis prepared by these raw materials according to the weight portion can more effectively improve the inflammation of bone joints and surrounding synovium, and eliminate joint swelling and pain and movement disorder symptoms.

因为上述原料中,红花药用效果有善通利经脉,为血中气药,能泻而又能补,各有妙义;当归药用效果有补血活血,调经止痛,润肠通便;桃仁的功效有破血行瘀,润燥滑肠。治经闭,症瘕,热病蓄血,风痹,疟疾,跌打损伤,瘀血肿痛,血燥便秘;制附子有祛寒止痛,温中去寒的功能;川芎具有活血行气、祛风止痛、开郁燥湿等功效;祛风除湿,温经止痛。生川乌用于风寒湿痹、关节疼痛、心腹冷痛、寒疝作痛;乳香辛温香润,能行血中之气,止痛力强,兼能舒筋活络;制没药可以散血去瘀,消肿定痛,治跌损,金疮,筋骨,心腹诸痛,症瘕,经闭,痈疽肿痛,痔漏,目障;冰片有通诸窍,散郁火,去翳明目,消肿止痛的功效;薄荷脑能选择性地刺激人体皮肤或黏膜的冷觉感受器,产生冷觉反射和冷感,引起皮肤黏膜血管收缩,对深部组织的血管也可引起收缩而产生治疗作用,外用可以消炎,止痛,止痒,促进血液循环,减轻浮肿等;所以此原料的组合制得的治疗骨关节炎的外用霜剂可有效改善骨关节及周围滑膜炎症、消除关节的肿痛、活动障碍症状,疗效满意。Because among the above-mentioned raw materials, the medicinal effect of safflower is good at dredging the meridians, and it is a medicine for qi in the blood. It can relieve and nourish, and each has its own wonderful meaning; The effect of removing blood stasis, moistening dryness and smoothing intestines is arranged. Treatment of amenorrhea, abdominal mass, febrile disease, blood accumulation, wind arthralgia, malaria, bruises, blood stasis, swelling and pain, blood dryness and constipation; Aconite has the functions of dispelling cold and relieving pain, warming the middle and removing cold; Chuanxiong has the functions of promoting blood circulation, Expelling wind and relieving pain, opening depression and drying dampness and other effects; expelling wind and removing dampness, warming meridian and relieving pain. Shengchuanwu is used for wind-cold-damp arthralgia, joint pain, cold pain in trusted subordinates, and pain caused by cold colic; frankincense is pungent, warm and fragrant, can promote the qi in blood, has strong pain relief, and can relax tendons and activate collaterals; making myrrh can disperse blood and remove blood stasis, Reducing swelling and relieving pain, treating falls, gold sores, muscles and bones, all pains in trusted subordinates, lumps in the abdomen, amenorrhea, carbuncle, swelling and pain, hemorrhoids, and visual impairment; Analgesic effect; menthol can selectively stimulate the cold receptors of human skin or mucous membranes, produce cold reflex and cold sensation, cause skin and mucous membrane blood vessels to constrict, and also cause contraction of blood vessels in deep tissues to produce therapeutic effects. External use can Anti-inflammatory, relieve pain, relieve itching, promote blood circulation, reduce edema, etc.; therefore, the external cream for treating osteoarthritis made by the combination of this raw material can effectively improve the inflammation of bone joints and surrounding synovium, eliminate joint swelling and pain, and movement disorders Symptoms, satisfactory curative effect.

治疗骨关节炎的外用霜剂的制备方法具体步骤如下:The specific steps of the preparation method of the external cream for the treatment of osteoarthritis are as follows:

第一步:称取红花,当归,桃仁,制附子,川芎,生川乌,制乳香,制没药,冰片,薄荷脑,备用;Step 1: Weigh safflower, angelica, peach kernel, make aconite, chuanxiong, raw chuanwu, make frankincense, make myrrh, borneol, menthol, set aside;

第二步:将制乳香、制没药粉碎后用水杨酸甲酯浸渍,吸取上清液,备用;Step 2: after pulverizing frankincense and myrrh, soak them in methyl salicylate, absorb the supernatant, and set aside;

第三步:将当归、川芎用共水蒸馏法,提取挥发油,备用;Step 3: extract volatile oil from Angelica and Rhizoma Chuanxiong by co-water distillation, and set aside;

第四步:将当归、川芎用共水蒸馏法所得的药渣与所述重量配比的红花、桃仁、制附子、生川乌加水煎煮、过滤得煎煮液,将煎煮液减压浓缩至相对密度为1.08的流浸膏,备用;Step 4: decoct the dregs of Angelica Sinensis and Rhizoma Chuanxiong obtained by the co-water distillation method with the safflower, peach kernel, aconite, and raw Chuanwu in water, and filter to obtain the decoction, and reduce the decoction Concentrate under pressure to the liquid extract whose relative density is 1.08, set aside;

第五步:将所得的上清液、挥发油,与已粉碎的薄荷脑和冰片混合,再加入油相基质;Step 5: Mix the obtained supernatant and volatile oil with pulverized menthol and borneol, and then add the oil phase matrix;

第六步:将所得的流浸膏中加入水相基质;The sixth step: add the aqueous matrix to the liquid extract obtained;

第七步:把第五步和第六步骤中所得的溶液放一起混合、搅匀,制成乳膏剂,再包装成治疗骨关节炎的外用霜剂成品。Step 7: Mix and stir the solutions obtained in the fifth and sixth steps together to make a cream, and then pack it into a finished cream for external use for treating osteoarthritis.

作为优选,所述的油相基质可为十八醇、单甘醇或液状石脂甘中的任一种。Preferably, the oil phase base can be any one of stearyl alcohol, monoethylene glycol or liquid petrolatum.

作为优选,所述的水相基质为甘油。Preferably, the aqueous phase matrix is glycerin.

作为优选,治疗骨关节炎的外用霜剂的制备方法中的乳膏剂为O型或W型。Preferably, the cream in the preparation method of the external cream for treating osteoarthritis is O-type or W-type.

按照本发明的技术方案,可有效改善骨关节及周围滑膜炎症,加快血液循环,消除关节的肿痛、活动障碍等症状,缓解病情,不良反应极少,患者使用可携带方便。According to the technical solution of the present invention, it can effectively improve the inflammation of bone joints and surrounding synovium, accelerate blood circulation, eliminate symptoms such as joint swelling, pain, and movement disorders, relieve the disease, have very few adverse reactions, and can be used by patients and is convenient to carry.

附图说明Description of drawings

图1是治疗骨关节炎的外用霜剂的制备工艺图。Fig. 1 is a preparation process diagram of a topical cream for treating osteoarthritis.

具体实施方式Detailed ways

下面结合附图1与具体实施方式对本发明作进一步详细描述:Below in conjunction with accompanying drawing 1 and specific embodiment the present invention is described in further detail:

实施例1,治疗骨关节炎的外用霜剂,每1000克中按照重量份主要采取下列组分的原料:红花25g,当归50g,桃仁50g,制附子50g,川芎50g,生川乌20g,制乳香5g,制没药5g,冰片10g,薄荷脑5g,将上述原料配制成1000g外用霜剂筋舒霜。Embodiment 1, the external cream for the treatment of osteoarthritis, the raw materials of the following components are mainly taken according to parts by weight in every 1000 grams: safflower 25g, angelica 50g, peach kernel 50g, aconite 50g, chuanxiong 50g, raw aconitum 20g, Make frankincense 5g, make myrrh 5g, borneol 10g, menthol 5g, and above-mentioned raw material is mixed with 1000g external cream Sijinshu cream.

治疗骨关节炎的外用霜剂制备方法,如附图1所示,具体步骤如下:The external cream preparation method for the treatment of osteoarthritis, as shown in Figure 1, the concrete steps are as follows:

第一步:称取红花25g,当归50g,桃仁50g,制附子50g,川芎50g,生川乌20g,制乳香5g,制没药5g,冰片10g,薄荷脑5g,备用;Step 1: Weigh 25g safflower, 50g angelica, 50g peach kernel, 50g aconite, 50g chuanxiong, 20g raw aconitum, 5g frankincense, 5g myrrh, 10g borneol, 5g menthol, set aside;

第二步:将5g制乳香、5g制没药粉碎后用水杨酸甲酯浸渍,取上清液1,备用;Step 2: crush 5 g of frankincense and 5 g of myrrh and impregnate with methyl salicylate, take supernatant 1 and set aside;

第三步:将50g当归、50g川芎通过共水蒸馏法,提取挥发油2,备用;Step 3: Extract volatile oil 2 from 50g Angelica sinensis and 50g Chuanxiong Rhizoma Rhizoma Chuanxiong through co-water distillation, and set aside;

第四步:将当归、川芎用共水蒸馏法所得的药渣与25g红花、50g桃仁、50g制附子、20g生川乌加水煎煮后,再提取、过滤得煎煮液,将煎煮液减压浓缩至相对密度为1.08的流浸膏3,备用;Step 4: decoct the dregs obtained from angelica and chuanxiong by co-water distillation with 25g safflower, 50g peach kernel, 50g aconite, 20g raw chuanwu, and then extract and filter to obtain the decoction, and decoct The solution is concentrated under reduced pressure to a liquid extract 3 with a relative density of 1.08, which is set aside;

第五步:将所得的上清液1和挥发油2与粉碎的5g薄荷脑和10g冰片混合,再加入油相基质十八醇;Step 5: Mix the obtained supernatant 1 and volatile oil 2 with crushed 5 g of menthol and 10 g of borneol, and then add the oil phase matrix stearyl alcohol;

第六步:将所得的流浸膏3中加入水相基质;The sixth step: adding the obtained liquid extract 3 to the aqueous matrix;

第七步:把第五步和第六步骤中所得的溶液放一起混合、搅匀,制成乳膏剂,再包装成治疗骨关节炎的外用霜剂成品。Step 7: Mix and stir the solutions obtained in the fifth and sixth steps together to make a cream, and then pack it into a finished cream for external use for treating osteoarthritis.

此方法制得的治疗骨关节炎的外用霜剂可有效改善骨关节及周围滑膜炎症、消除关节的肿痛、活动障碍症状,且疗效满意,不良反应极少,患者使用携带方便。The external cream for treating osteoarthritis prepared by the method can effectively improve the inflammation of bone joints and surrounding synovium, eliminate joint swelling and pain, and movement disorder symptoms, has satisfactory curative effect, few adverse reactions, and is easy to use and carry for patients.

实施例2,治疗骨关节炎的外用霜剂每1000克中按照重量份采取下列组分的原料:红花23g,当归48g,桃仁47g,制附子46g,川芎47g,生川乌19g,制乳香5.5g,制没药5.5g,冰片9g,薄荷脑5.5g。Embodiment 2, the external cream for the treatment of osteoarthritis takes the raw materials of the following components in parts by weight in every 1000 grams: 23g of safflower, 48g of angelica, 47g of peach kernel, 46g of aconite, 47g of Chuanxiong, 19g of raw Aconitum aconitum, and frankincense 5.5g, myrrh 5.5g, borneol 9g, menthol 5.5g.

治疗骨关节炎的外用霜剂制备方法,如附图1所示,具体步骤如下:The external cream preparation method for the treatment of osteoarthritis, as shown in Figure 1, the concrete steps are as follows:

第一步:称取红花23g,当归48g,桃仁47g,制附子46g,川芎47g,生川乌19g,制乳香5.5g,制没药5.5g,冰片9g,薄荷脑5.5g,备用;Step 1: Weigh 23g safflower, 48g angelica, 47g peach kernel, 46g aconite, 47g chuanxiong, 19g raw aconitum, 5.5g frankincense, 5.5g myrrh, 9g borneol, 5.5g menthol, set aside;

第二步:将5.5g制乳香、5.5g制没药粉碎后用水杨酸甲酯浸渍,吸取上清液1,备用;Step 2: crush 5.5g of frankincense and 5.5g of myrrh, impregnate with methyl salicylate, absorb supernatant 1, and set aside;

第三步:将48g当归、47g川芎通过共水蒸馏法,提取挥发油2,备用;Step 3: Extract volatile oil 2 from 48g Angelica sinensis and 47g Chuanxiong Rhizoma Rhizoma Chuanxiong through co-water distillation, and set aside;

第四步:将当归、川芎用共水蒸馏法所得的药渣与23g红花、47g桃仁、46g制附子、19g生川乌加水煎煮后,再提取、过滤得煎煮液,将煎煮液减压浓缩至相对密度为1.08的流浸膏3,备用;The fourth step: decoct the dregs obtained by co-water distillation of angelica and chuanxiong with 23g of safflower, 47g of peach kernels, 46g of aconite, 19g of raw chuanwu, and then extract and filter to obtain the decoction. The solution is concentrated under reduced pressure to a liquid extract 3 with a relative density of 1.08, which is set aside;

第五步:将所得的上清液1和挥发油2与粉碎的5.5g薄荷脑和9g冰片混合,再加入油相基质十八醇;Step 5: Mix the obtained supernatant 1 and volatile oil 2 with crushed 5.5g menthol and 9g borneol, and then add the oil phase matrix stearyl alcohol;

第六步:将所得的流浸膏3中加入水相基质;The sixth step: adding the obtained liquid extract 3 to the aqueous matrix;

第七步:把第五步和第六步骤中所得的溶液放一起混合、搅匀,制成乳膏剂,再包装成治疗骨关节炎的外用霜剂成品。Step 7: Mix and stir the solutions obtained in the fifth and sixth steps together to make a cream, and then pack it into a finished cream for external use for treating osteoarthritis.

此方法制得的治疗骨关节炎的外用霜剂可有效改善骨关节及周围滑膜炎症、消除关节的肿痛、活动障碍症状,且疗效满意,不良反应极少,患者使用携带方便。The external cream for treating osteoarthritis prepared by the method can effectively improve the inflammation of bone joints and surrounding synovium, eliminate joint swelling and pain, and movement disorder symptoms, has satisfactory curative effect, few adverse reactions, and is easy to use and carry for patients.

实施例3,治疗骨关节炎的外用霜剂每1000克中按照重量份采取下列组分的原料:红花28g,当归53g,桃仁52g,制附子53g,川芎54g,生川乌21g,制乳香4.5g,制没药4.5g,冰片9g,薄荷脑4.5g。Embodiment 3, the external cream for treating osteoarthritis takes the raw materials of the following components in parts by weight per 1000 grams: 28g of safflower, 53g of angelica, 52g of peach kernel, 53g of aconite, 54g of Chuanxiong, 21g of raw aconitum, and frankincense 4.5g, myrrh 4.5g, borneol 9g, menthol 4.5g.

治疗骨关节炎的外用霜剂制备方法,如附图1所示,具体步骤如下:The external cream preparation method for the treatment of osteoarthritis, as shown in Figure 1, the concrete steps are as follows:

第一步:称取红花28g,当归53g,桃仁52g,制附子53g,川芎54g,生川乌21g,制乳香4.5g,制没药4.5g,冰片9g,薄荷脑4.5g,备用;Step 1: Weigh 28g safflower, 53g angelica, 52g peach kernel, 53g aconite, 54g chuanxiong, 21g raw aconitum, 4.5g frankincense, 4.5g myrrh, 9g borneol, 4.5g menthol, set aside;

第二步:将4.5g制乳香、4.5g制没药粉碎后用水杨酸甲酯浸渍,吸取上清液1,备用;Step 2: crush 4.5g of frankincense and 4.5g of myrrh, impregnate with methyl salicylate, absorb supernatant 1, and set aside;

第三步:将53g当归、54g川芎通过共水蒸馏法,提取挥发油2,备用;Step 3: Extract volatile oil 2 from 53g Angelica sinensis and 54g Rhizoma Chuanxiong through co-water distillation, and set aside;

第四步:将当归、川芎用共水蒸馏法所得的药渣与28g红花、52g桃仁、53g制附子、21g生川乌加水煎煮后,再提取、过滤得煎煮液,将煎煮液减压浓缩至相对密度为1.08的流浸膏3,备用;Step 4: Decoct the dregs obtained from angelica and chuanxiong by co-water distillation with 28g of safflower, 52g of peach kernel, 53g of aconite, 21g of raw chuanwu, and then extract and filter to obtain the decoction. The solution is concentrated under reduced pressure to a liquid extract 3 with a relative density of 1.08, which is set aside;

第五步:将所得的上清液1和挥发油2与粉碎的4.5g薄荷脑和9g冰片混合,再加入油相基质十八醇;Step 5: Mix the obtained supernatant 1 and volatile oil 2 with pulverized 4.5g menthol and 9g borneol, and then add the oil phase matrix stearyl alcohol;

第六步:将所得的流浸膏3中加入水相基质;The sixth step: adding the obtained liquid extract 3 to the aqueous matrix;

第七步:把第五步和第六步骤中所得的溶液放一起混合、搅匀,制成乳膏剂,再包装成治疗骨关节炎的外用霜剂成品。Step 7: Mix and stir the solutions obtained in the fifth and sixth steps together to make a cream, and then pack it into a finished cream for external use for treating osteoarthritis.

实施例4,治疗骨关节炎的外用霜剂每1000克中按照重量份采取下列组分的原料:红花20g,当归45g,桃仁45g,制附子45g,川芎45g,生川乌18g,制乳香4g,制没药4g,冰片8g,薄荷脑4g。Embodiment 4, the external cream for treating osteoarthritis takes the raw materials of the following components in parts by weight in every 1000 grams: 20g of safflower, 45g of angelica, 45g of peach kernel, 45g of aconite, 45g of Chuanxiong, 18g of raw Aconitum aconitum, and frankincense 4g, myrrh 4g, borneol 8g, menthol 4g.

治疗骨关节炎的外用霜剂制备方法,如附图1所示,具体步骤如下:The external cream preparation method for the treatment of osteoarthritis, as shown in Figure 1, the concrete steps are as follows:

第一步:称取红花20g,当归45g,桃仁45g,制附子45g,川芎45g,生川乌18g,制乳香4g,制没药4g,冰片8g,薄荷脑4g,备用;Step 1: Weigh 20g safflower, 45g angelica, 45g peach kernel, 45g aconite, 45g chuanxiong, 18g raw aconitum, 4g frankincense, 4g myrrh, 8g borneol, 4g menthol, set aside;

第二步:将4g制乳香、4g制没药粉碎后用水杨酸甲酯浸渍,吸取上清液1,备用;Step 2: crush 4 g of frankincense and 4 g of myrrh, impregnate with methyl salicylate, absorb supernatant 1, and set aside;

第三步:将45g当归、45g川芎通过共水蒸馏法,提取挥发油2,备用;Step 3: Extract volatile oil 2 from 45g Angelica sinensis and 45g Chuanxiong Rhizoma Rhizoma Chuanxiong through co-water distillation, and set aside;

第四步:将当归、川芎用共水蒸馏法所得的药渣与20g红花、45g桃仁、45g制附子、18g生川乌加水煎煮后,再提取、过滤得煎煮液,将煎煮液减压浓缩至流浸膏3,备用;Step 4: decoct the dregs obtained from angelica and chuanxiong by co-water distillation with 20g safflower, 45g peach kernels, 45g aconite, 18g raw chuanwu, and then extract and filter to obtain the decoction. The liquid was concentrated under reduced pressure to liquid extract 3, and set aside;

第五步:将所得的上清液1和挥发油2与粉碎的4g薄荷脑和8g冰片混合,再加入油相基质十八醇;Step 5: Mix the obtained supernatant 1 and volatile oil 2 with pulverized 4g menthol and 8g borneol, and then add the oil phase matrix stearyl alcohol;

第六步:将所得的流浸膏3中加入水相基质;The sixth step: adding the obtained liquid extract 3 to the aqueous matrix;

第七步:把第五步和第六步骤中所得的溶液放一起混合、搅匀,制成乳膏剂,再包装成治疗骨关节炎的外用霜剂成品。Step 7: Mix and stir the solutions obtained in the fifth and sixth steps together to make a cream, and then pack it into a finished cream for external use for treating osteoarthritis.

实施例5,治疗骨关节炎的外用霜剂每1000克中按照重量份采取下列组分的原料:红花30g,当归55g,桃仁55g,制附子55g,川芎55g,生川乌22g,制乳香6g,制没药6g,冰片12g,薄荷脑6g。Embodiment 5, the external cream for the treatment of osteoarthritis takes the raw materials of the following components in parts by weight per 1000 grams: 30g of safflower, 55g of angelica, 55g of peach kernel, 55g of aconite, 55g of chuanxiong, 22g of raw aconitum, and frankincense 6g, myrrh 6g, borneol 12g, menthol 6g.

治疗骨关节炎的外用霜剂制备方法,如附图1所示,具体步骤如下:The external cream preparation method for the treatment of osteoarthritis, as shown in Figure 1, the concrete steps are as follows:

第一步:称取红花30g,当归55g,桃仁55g,制附子55g,川芎55g,生川乌22g,制乳香6g,制没药6g,冰片12g,薄荷脑6g,备用;Step 1: Weigh 30g safflower, 55g angelica, 55g peach kernel, 55g aconite, 55g chuanxiong, 22g raw aconitum, 6g frankincense, 6g myrrh, 12g borneol, 6g menthol, set aside;

第二步:将6g制乳香、6g制没药粉碎后用水杨酸甲酯浸渍,吸取上清液1,备用;Step 2: crush 6 g of frankincense and 6 g of myrrh, impregnate with methyl salicylate, absorb supernatant 1, and set aside;

第三步:将55g当归、55g川芎通过共水蒸馏法,提取挥发油2,备用;Step 3: Extract volatile oil 2 from 55g Angelica sinensis and 55g Chuanxiong Rhizoma Rhizoma Chuanxiong through co-water distillation, and set aside;

第四步:将当归、川芎用共水蒸馏法所得的药渣与30g红花、55g桃仁、55g制附子、22g生川乌加水煎煮后,再提取、过滤得煎煮液,将煎煮液减压浓缩至流浸膏3,备用;Step 4: decoct the dregs obtained by co-water distillation of angelica and chuanxiong with 30g of safflower, 55g of peach kernels, 55g of aconite, 22g of raw chuanwu, and then extract and filter to obtain a decoction. The liquid was concentrated under reduced pressure to liquid extract 3, and set aside;

第五步:将所得的上清液1和挥发油2与粉碎的6g薄荷脑和12g冰片混合,再加入油相基质十八醇;Step 5: Mix the obtained supernatant 1 and volatile oil 2 with 6 g of pulverized menthol and 12 g of borneol, and then add the oil phase matrix stearyl alcohol;

第六步:将所得的流浸膏3中加入水相基质;The sixth step: adding the obtained liquid extract 3 to the aqueous matrix;

第七步:把第五步和第六步骤中所得的溶液放一起混合、搅匀,制成乳膏剂,再包装成治疗骨关节炎的外用霜剂成品。Step 7: Mix and stir the solutions obtained in the fifth and sixth steps together to make a cream, and then pack it into a finished cream for external use for treating osteoarthritis.

以下通过试验例来进一步阐述本发明所述药物的有益效果:Further set forth the beneficial effect of medicine of the present invention by test example below:

试验例1,本发明外用霜剂治疗病人骨关节炎的临床观察:Test example 1, the clinical observation of patient's osteoarthritis treated with cream for external use of the present invention:

1.临床资料1. Clinical data

按就诊顺序将受试者分为2组,治疗组30例,对照组10例,病人症状分部如下:The subjects were divided into 2 groups according to the order of treatment, 30 cases in the treatment group and 10 cases in the control group. The symptoms of the patients were divided as follows:

初期:骨硬化或骨赘,无关节间隙狭窄,14例;Early stage: osteosclerosis or osteophyte, no joint space narrowing, 14 cases;

中期:关节间隙狭窄或消失,12例;Mid-term: narrow or disappearing joint space, 12 cases;

晚期:胫骨负重面磨损或缺失,14例。Late stage: wear or loss of tibial load-bearing surface, 14 cases.

2.病人症状2. Patient symptoms

膝关节炎早期以疼痛和僵硬为主,单侧或双侧交替。受累关节深部疼痛、酸胀,长距离走行、剧烈运动、受凉或阴雨天气时加重,双膝发软、无力,易摔倒,下蹲及上下楼困难,不能持重和出现明显的关节胶化现象,体检时关节肿胀,有时伴有关节积液,可为少量积液或大量积液,浮髌实验阳性,关节肌肉萎缩,关节活动时有骨响声及摩擦音,有不同程度的活动受限和肌痉挛,可少数患者后期继发性肌萎缩,严重时出现关节畸形,有时可触及关节内游离体。Knee arthritis is mainly characterized by pain and stiffness in the early stage, alternating unilaterally or bilaterally. Deep pain and soreness in the affected joints, aggravated by long-distance walking, strenuous exercise, cold or rainy weather, weak knees, weakness, easy to fall, difficulty squatting and going up and down stairs, inability to hold steady and obvious joint gelation , joint swelling during physical examination, sometimes accompanied by joint effusion, which can be a small amount of effusion or a large amount of effusion, the floating patellar test is positive, joint muscle atrophy, bone sound and friction sound during joint activities, and there are different degrees of activity limitation and muscle pain. Spasm, secondary muscular atrophy may occur in a small number of patients in the later stage, and joint deformity occurs in severe cases, and sometimes loose bodies in the joint can be touched.

3.治疗方法:分治疗组和对照组,其中治疗组按实施例分三组人,所用的外用霜剂分别按实施例1、2及3的配比原料和方法所制。3. Therapeutic method: sub-treatment group and control group, wherein the treatment group is divided into three groups of people according to the embodiment, and the external cream used is made by the proportioning raw materials and methods of embodiments 1, 2 and 3 respectively.

a)治疗组:使用本发明的治疗骨关节炎的外用霜剂外敷,治疗骨关节炎的外用霜剂为我院自制中药外用制剂,采用循经外敷疗法,外敷部位为大腿前、后、内、外侧及相应的经络穴位而非膝关节,如鹤顶穴、阳陵泉、血海等。外敷1至3天,7天为一个疗程,治疗3-5个疗程。a) Treatment group: use the external application of the external cream for the treatment of osteoarthritis of the present invention, the external application of the external cream for the treatment of osteoarthritis is our hospital's self-made traditional Chinese medicine external preparation, adopt external application therapy along the meridians, and the external application parts are the front, rear and inner thighs. , lateral and corresponding meridian points rather than knee joints, such as Heding point, Yanglingquan, Xuehai, etc. External application for 1 to 3 days, 7 days as a course of treatment, 3-5 courses of treatment.

b)对照组b) control group

给予千山活血膏外敷,千山活血膏,批准文号:国药准字Z20025596,为摊于布上的黑膏药,适应活血化瘀、舒筋活络、消肿止痛。用于关节肿胀、疼痛、活动不利,以及跌打损伤,腰、膝部骨性关节炎见上述症状者。外敷1至3天,7天为一个疗程,治疗3-5个疗程。Give Qianshan Huoxue Plaster for external application, Qianshan Huoxue Plaster, Approval Number: Z20025596, which is a black plaster spread on cloth, is suitable for promoting blood circulation and removing blood stasis, relaxing tendons and collaterals, reducing swelling and relieving pain. For joint swelling, pain, unfavorable activities, and bruises, waist, knee osteoarthritis see the above symptoms. External application for 1 to 3 days, 7 days as a course of treatment, 3-5 courses of treatment.

4.疗效标准4. Curative effect standard

痊愈:疼痛完全消失,功能恢复正常,畸形纠正,无任何不适。Recovery: the pain disappeared completely, the function returned to normal, the deformity was corrected, and there was no discomfort.

显效:疼痛基本消失,功能恢复基本正常,畸形基本纠正、遇有天气变化有不适感。Significant effect: the pain basically disappeared, the function returned to normal, the deformity was basically corrected, and there was discomfort in case of weather changes.

好转:疼痛减轻,生活基本自理,功能未恢复正常,畸形基本纠正,遇有天气变化有不适感。Improvement: Pain relieved, self-care is basic, function has not returned to normal, deformity is basically corrected, and there is discomfort when the weather changes.

无效:疼痛未减轻,症状未改善。Ineffective: Pain was not relieved and symptoms were not improved.

5.治疗结果5. Treatment outcome

治疗组与对照组均于5星期治疗结束后按上述标准评定疗效,两组的治疗效果如下表Both the treatment group and the control group were evaluated according to the above criteria after 5 weeks of treatment. The therapeutic effects of the two groups are as follows:

表1:两组治疗结果比较Table 1: Comparison of treatment results between the two groups

组别        人数    治愈    显效    有效    无效     有效率Group Number of People Cured Significantly Effective Effective Invalid Effective Rate

治疗组:therapy group:

(实施例1)   10      4        4      1       1        90%(Example 1) 10 4 4 1 1 1 90%

(实施例2)   10      5        3      1       1        90%(Example 2) 10 5 3 1 1 1 90%

(实施例3)   10      6        3      1       0        100%(Example 3) 10 6 3 3 1 0 100%

对照组:    10      3        3      2       2        80%Control group: 10 3 3 3 2 2 80%

综合上述,从表1中可见,治疗组总有效率90%,治愈率50%,显效率30%,有效率10%,无效10%,而对照组总有效率为80%,治愈率30%,显效率30%,有效率20%,无效10%,上述表明本发明外用霜剂对膝关节骨性关节炎疗效显著且远期效果好,能缓解病理,阻止病程的发展,对膝骨关节炎疗效优于千山活血膏。In summary, as can be seen from Table 1, the total effective rate of the treatment group is 90%, the cure rate is 50%, the marked rate is 30%, the effective rate is 10%, and the invalid rate is 10%, while the total effective rate of the control group is 80%, and the cure rate is 30%. , effective rate 30%, effective rate 20%, invalid 10%, the above shows that the cream for external use of the present invention has significant curative effect and good long-term effect on knee osteoarthritis, can alleviate pathology, prevent the development of the course of disease, and treat knee joint The curative effect of inflammation is better than that of Qianshan Huoxue Ointment.

总之,以上所述仅为本发明的较佳实施例及试验例,凡依本发明申请专利范围所作的均等变化与修饰,皆应属本发明专利的涵盖范围。In a word, the above descriptions are only preferred embodiments and test examples of the present invention, and all equivalent changes and modifications made according to the scope of the patent application of the present invention shall fall within the scope of the patent of the present invention.

Claims (5)

1. treat the external-application cream of osteoarthritis, it is characterized in that: the every 1000g of described external-application cream takes the crude drug of following component: Flos Carthami 20-30g, Radix Angelicae Sinensis 45-55g, Semen Persicae 45-55g, Radix Aconiti Lateralis Preparata 45-55g, Rhizoma Chuanxiong 45-55g, Radix Aconiti 18-22g, Olibanum (processed) 4-6g, Myrrha (processed) 4-6g, Borneolum Syntheticum 8-12g, Mentholum 4-6g, its preparation method comprises the following steps:
The first step: take by weighing Flos Carthami, Radix Angelicae Sinensis, Semen Persicae, Radix Aconiti Lateralis Preparata, Rhizoma Chuanxiong, Radix Aconiti, Olibanum (processed), Myrrha (processed), Borneolum Syntheticum, Mentholum, standby;
Second step: Olibanum (processed), Myrrha (processed) are pulverized the back with the methyl salicylate dipping, draw supernatant (1), standby;
The 3rd step: Radix Angelicae Sinensis, Rhizoma Chuanxiong with being total to hydrodistillation, are extracted volatile oil (2), standby;
The 4th step: with Radix Angelicae Sinensis, Rhizoma Chuanxiong with Flos Carthami, Semen Persicae, Radix Aconiti Lateralis Preparata, the Radix Aconiti of the medicinal residues of hydrodistillation gained altogether and described weight proportion decoct with water, filter decoction liquor, it is 1.08 fluid extract (3) that decoction liquor is evaporated to relative density, standby;
The 5th step: supernatant (1), volatile oil (2) with gained, mix with Mentholum of having pulverized and Borneolum Syntheticum, add oil phase substrate again, described oil phase substrate is octadecanol or monoethylene glycol;
The 6th step: will add aqueous phase substrate in the fluid extract (3) of gained, described aqueous phase substrate is a glycerol;
The 7th step: the solution of gained in the 5th step and the 6th step put be mixed together, stir evenly, make ointment, be packaged into the external-application cream finished product for the treatment of osteoarthritis again.
2. the external-application cream of treatment osteoarthritis according to claim 1, it is characterized in that: the every 1000g of described external-application cream takes the crude drug of following component: Flos Carthami 25g, Radix Angelicae Sinensis 50g, Semen Persicae 50g, Radix Aconiti Lateralis Preparata 50g, Rhizoma Chuanxiong 50g, Radix Aconiti 20g, Olibanum (processed) 5g, Myrrha (processed) 5g, Borneolum Syntheticum 10g, Mentholum 5g.
3. the external-application cream of treatment osteoarthritis according to claim 1, it is characterized in that: the every 1000g of described external-application cream takes the crude drug of following component: Flos Carthami 23g, Radix Angelicae Sinensis 48g, Semen Persicae 47g, Radix Aconiti Lateralis Preparata 46g, Rhizoma Chuanxiong 47g, Radix Aconiti 19g, Olibanum (processed) 5.5g, Myrrha (processed) 5.5g, Borneolum Syntheticum 9g, Mentholum 5.5g.
4. the external-application cream of treatment osteoarthritis according to claim 1, it is characterized in that: the every 1000g of described external-application cream takes the crude drug of following component: Flos Carthami 28g, Radix Angelicae Sinensis 53g, Semen Persicae 52g, Radix Aconiti Lateralis Preparata 53g, Rhizoma Chuanxiong 54g, Radix Aconiti 21g, Olibanum (processed) 4.5g, Myrrha (processed) 4.5g, Borneolum Syntheticum 9g, Mentholum 4.5g.
5. according to claim 1 or 2 or the preparation method of the external-application cream of 3 or 4 described treatment osteoarthritis, it is characterized in that: it comprises the following steps:
The first step: take by weighing Flos Carthami, Radix Angelicae Sinensis, Semen Persicae, Radix Aconiti Lateralis Preparata, Rhizoma Chuanxiong, Radix Aconiti, Olibanum (processed), Myrrha (processed), Borneolum Syntheticum, Mentholum, standby;
Second step: Olibanum (processed), Myrrha (processed) are pulverized the back with the methyl salicylate dipping, draw supernatant (1), standby;
The 3rd step: Radix Angelicae Sinensis, Rhizoma Chuanxiong with being total to hydrodistillation, are extracted volatile oil (2), standby;
The 4th step: with Radix Angelicae Sinensis, Rhizoma Chuanxiong with Flos Carthami, Semen Persicae, Radix Aconiti Lateralis Preparata, the Radix Aconiti of the medicinal residues of hydrodistillation gained altogether and described weight proportion decoct with water, filter decoction liquor, it is 1.08 fluid extract (3) that decoction liquor is evaporated to relative density, standby;
The 5th step: supernatant (1), volatile oil (2) with gained, mix with Mentholum of having pulverized and Borneolum Syntheticum, add oil phase substrate again, described oil phase substrate is octadecanol or monoethylene glycol;
The 6th step: will add aqueous phase substrate in the fluid extract (3) of gained, described aqueous phase substrate is a glycerol;
The 7th step: the solution of gained in the 5th step and the 6th step put be mixed together, stir evenly, make ointment, be packaged into the external-application cream finished product for the treatment of osteoarthritis again.
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CN105343389B (en) * 2015-11-11 2019-11-29 上海市浦东新区上钢社区卫生服务中心 A kind of drug for the treatment of of arthritis
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