WO2022160520A1 - 一种治疗颈椎间盘突出的药物组合物及其制备方法和应用 - Google Patents

一种治疗颈椎间盘突出的药物组合物及其制备方法和应用 Download PDF

Info

Publication number
WO2022160520A1
WO2022160520A1 PCT/CN2021/094683 CN2021094683W WO2022160520A1 WO 2022160520 A1 WO2022160520 A1 WO 2022160520A1 CN 2021094683 W CN2021094683 W CN 2021094683W WO 2022160520 A1 WO2022160520 A1 WO 2022160520A1
Authority
WO
WIPO (PCT)
Prior art keywords
parts
preparation
pharmaceutical composition
disc herniation
pharmaceutical
Prior art date
Application number
PCT/CN2021/094683
Other languages
English (en)
French (fr)
Inventor
刘杰
王莉
崔阳
高超
荆兴华
任雯
刘大勇
郝洪慧
Original Assignee
山东明仁福瑞达制药股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 山东明仁福瑞达制药股份有限公司 filed Critical 山东明仁福瑞达制药股份有限公司
Publication of WO2022160520A1 publication Critical patent/WO2022160520A1/zh

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/63—Arthropods
    • A61K35/64—Insects, e.g. bees, wasps or fleas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232—Angelica
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders

Definitions

  • the invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition for treating cervical intervertebral disc herniation and a preparation method and application thereof.
  • Cervical disc herniation is caused by factors such as age, neck trauma, degenerative diseases, etc. In recent years, the number of patients has increased, which has great damage to people's bodies. If left untreated, it may lead to paralysis. Prompt and targeted treatment can effectively control the disease.
  • Existing drugs cannot fundamentally cure cervical intervertebral disc herniation disease, and patients who take Chinese patent medicines for a long time have a large economic burden, long treatment cycles and poor compliance.
  • the invention patent "a traditional Chinese medicine preparation for the treatment of orthopedic diseases and its preparation method" proposes a traditional Chinese medicine preparation for the treatment of orthopedic diseases, which includes 50-70 parts of Panax notoginseng, 30-50 parts of S. parts, 40-60 parts of peppercorns, 10-30 parts of Jiazhu, 40-60 parts of branches, 60-80 parts of golden seeds.
  • the dosage of Panax notoginseng of the formula is relatively large, the economic cost is relatively high, and the patients who take it for a long time have a heavy economic burden.
  • the invention patent "a traditional Chinese medicine for the treatment of cervical intervertebral disc herniation" discloses a traditional Chinese medicine formula for the treatment of cervical intervertebral disc herniation, including 25-30 parts of Chixueteng, 25-30 parts of Gouji, 25-30 parts of Paeonia lactiflora parts, 10-15 parts of cinnamon, 10-15 parts of Epimedium, 15-20 parts of Lingxian, 12-20 parts of Pueraria, 25-35 parts of turmeric, 15-20 parts of Dilong, 10-15 parts of Tianma, 20-25 parts of Uncaria, 10-15 parts of loofah, 2 centipedes.
  • This formula can be used internally and externally to effectively treat cervical intervertebral disc herniation, but centipede is a common formula for external use, and its safety needs to be verified.
  • the invention patent "Traditional Chinese Medicine Preparation for Treating Orthopedic Diseases for External Use and Its Production Method” (CN107823363A) discloses a traditional Chinese medicine preparation for treating orthopedic diseases and its raw tea method, including 5-10 parts of Turtle bug, 3-10 parts of frankincense, and a final medicine. 5-8 parts, 5-10 parts of Achyranthes, 5-10 parts of Chuanxiong, 5-10 parts of safflower, 5-10 parts of saffron, 5-10 parts of Pinellia ternata, 5-10 parts of Wei Lingxian, mulberry parasite 10-12 parts, 3-6 parts of centipede, 3-6 parts of white snake, spread evenly on the non-woven fabric, and get plaster after cooling.
  • Orthopedic diseases usually use plaster to relieve pain, but there is a serious allergic phenomenon. Some people will have severe allergic phenomenon in the process of contacting the plaster, which will aggravate the patient's discomfort.
  • the present invention provides a pharmaceutical composition for treating cervical intervertebral disc herniation, a preparation method and an application thereof.
  • the present invention selects multi-flavored authentic medicinal materials to prepare oral medicaments, which has high safety and no toxic and side effects. At the same time, it is proved by animal and clinical experiments that it has good curative effect on cervical intervertebral disc herniation, so it has good practical application value.
  • the present invention relates to the following technical solutions:
  • a first aspect of the present invention provides a pharmaceutical composition for the treatment of cervical intervertebral disc herniation.
  • the pharmaceutical composition in parts by mass, comprises the following raw materials:
  • the pharmaceutical composition in parts by mass, comprises the following raw materials:
  • the pharmaceutical composition in terms of parts by mass, consists of raw materials comprising: 5 parts of Radix Tobacco, 4 parts of Scutellaria chinensis, 8 parts of Caowu, 8 parts of Yiduoyun, 5 parts of black medicine, 10 parts of Sophora flavescens, 10 parts of cinnamon, 7 parts of Angelica, 8 parts of Panax notoginseng, 5 parts of Salvia, 5 parts of saffron, 8 parts of Turtle.
  • a second aspect of the present invention provides a preparation method of the above-mentioned pharmaceutical composition, the preparation method comprising:
  • the organic solvent is ethanol, which can be recycled.
  • the soaking time is controlled to be 36-48 hours. By controlling the soaking time, the active ingredients in the API are more easily dissolved.
  • the specific preparation method includes: decocting in water, separating the medicinal liquid and medicinal residues, taking the supernatant, and obtaining the concentrated extract by distillation.
  • the preparation method also includes drying the prepared concentrated extract under reduced pressure and pulverizing it into fine powder for later use.
  • the third aspect of the present invention provides the use of the above-mentioned pharmaceutical composition in the preparation of a pharmaceutical preparation for treating cervical intervertebral disc herniation.
  • a fourth aspect of the present invention provides a pharmaceutical preparation for treating cervical intervertebral disc herniation, which is prepared from the pharmaceutical composition and pharmaceutically acceptable excipients.
  • the pharmaceutical preparation can be made into various pharmaceutical dosage forms, such as decoction, pill, capsule, tablet, powder, granule or oral liquid.
  • the medicinal composition for the treatment of cervical intervertebral disc herniation provided by the above technical scheme has good curative effect, quick effect, good effect on the treatment of cervical intervertebral disc herniation disease, simple preparation process, significant curative effect, short onset time, convenient taking, no Toxic and side effects, safe and effective, so it has good practical application and promotion value.
  • the current traditional Chinese medicine preparations for the treatment of cervical intervertebral disc herniation diseases are mostly external plaster, and some people will have allergic reactions to the external use of the plaster, causing serious patient discomfort; while the oral traditional Chinese medicine preparations for the treatment of cervical intervertebral disc herniation diseases, some formulas contain Contains formulas that are not suitable for oral administration, and the safety of use needs to be verified.
  • a pharmaceutical composition for the treatment of cervical intervertebral disc herniation comprises the following raw materials:
  • the pharmaceutical composition in parts by mass, its raw material composition comprises:
  • the pharmaceutical composition in terms of parts by mass, consists of raw materials comprising: 5 parts of Radix Tobacco, 4 parts of Scutellaria chinensis, 8 parts of Caowu, 8 parts of Yiduoyun, 5 parts of black medicine, 10 parts of Sophora flavescens, 10 parts of cinnamon, 7 parts of Angelica, 8 parts of Panax notoginseng, 5 parts of Salvia, 5 parts of saffron, 8 parts of Turtle.
  • a preparation method of the above-mentioned pharmaceutical composition comprises:
  • step S1 in the step S1,
  • the organic solvent is ethanol, which can be recycled.
  • the soaking time is controlled to be 36-48 hours. By controlling the soaking time, the active ingredients in the API are more easily dissolved.
  • the specific preparation method includes: decocting in water, separating the medicinal liquid and medicinal residues, taking the supernatant, and obtaining a concentrated extract by distillation.
  • the preparation method further includes drying the prepared concentrated extract under reduced pressure and pulverizing it into fine powder for later use.
  • a pharmaceutical preparation for treating cervical intervertebral disc herniation is provided, which is prepared from the pharmaceutical composition and pharmaceutically acceptable excipients.
  • the pharmaceutical preparation can be made into various pharmaceutical dosage forms, such as decoction, pill, capsule, tablet, powder, granule or oral liquid.
  • the pharmaceutically acceptable excipients in the pharmaceutical preparation include but are not limited to: diluents include but are not limited to, sorbitol, mannitol, starch, lactose, powdered or microcrystalline cellulose, dicalcium phosphate, tricalcium phosphate Salt, sugar, etc.; filler: sodium carboxymethyl cellulose, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose, gelatinized starch, etc.; disintegrant: dry starch , crospovidone, croscarmellose sodium, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, etc.; Lubricant: magnesium stearate, sodium lauryl sulfate or micropowder silica gel; other Adjuvants include one or more of binders, flow agents, complex formers, plasticizers, colorants, sweeteners, viscosity enhancers, preservatives or antioxidant
  • a pharmaceutical composition, its preparation method comprises:
  • a pharmaceutical composition, its preparation method comprises:
  • the concentrated extract was dried under reduced pressure and pulverized into fine powder.
  • a pharmaceutical composition, its preparation method comprises:
  • the concentrated extract was dried under reduced pressure and pulverized into fine powder.
  • a pharmaceutical composition, its preparation method comprises:
  • a pharmaceutical composition, its preparation method comprises:
  • a pharmaceutical composition, its preparation method comprises:
  • the animals used in this application are adult SD rats, SPF grade, half male and half male, weighing 180-220 g, and given conventional animal feed. Experiments were carried out after 3 days of adaptive feeding of animals.
  • Example 1-3 and Experimental Example 1-3 decoction (each group) by intragastric administration of crude drug 3 g crude drug/mL at a dose of 40 mL/(kg d). 4 SD rats were randomly assigned, half male and half), and observed for two weeks after administration. The results showed that no experimental rats died, so the LD50 could not be determined conventionally, and the maximum dose determination test was continued.
  • the method was the same as above, and the drug solution containing crude drug 3 g crude drug/mL was administered by intragastric administration at a dose of 80 mL/(kg ⁇ d). After administration, the animals were fed normally.
  • the animals were observed for any abnormal changes in general behavior, fur, diet, body weight, and feces, as well as for symptoms of poisoning and death (if there was death, anatomical and pathological examinations were performed). Observe for two weeks. Two weeks later, the body weight was re-weighed, and the animals were sacrificed for dissection. The heart, lung, liver, kidney, spleen, stomach, intestine, bladder, adrenal gland, thymus, pancreas, thyroid, lymph node, uterus, ovary, testis, prostate, brain and other tissues were observed by dissection. Scientific observation, no abnormal pathological changes were found in the results, suggesting that the clinical application dose of the traditional Chinese medicine composition of the present invention is safe.
  • the SD rats were randomly divided into 7 groups, 10 in each group, including 3 experimental groups: the preparations obtained from the formulations of Examples 1-3 were administered by gavage (respectively named experimental groups 1-3); 3 positive controls Groups: The preparations obtained in experimental examples 1-3 were administered by intragastric administration (respectively named experimental groups 4-6); 1 pathological control group: normal saline was administered by intragastric administration.
  • the drug was administered once a day, and the crude drug amount was 3 g crude drug/mL by intragastric administration at a dose of 10 mL/(kg ⁇ d) for 3 weeks.
  • the pain threshold of rats 1-3h after administration was detected by a self-controlled temperature hot plate instrument (the pain threshold of the selected rats (hot plate temperature 55 ⁇ 0.5°C) within 30 seconds), the results are shown in the table 3.
  • the test results showed that experimental groups 1-3 significantly improved the pain threshold of rats, while experimental groups 4-6 had little effect on the pain threshold of rats.
  • the present invention has a better overall curative effect than the control group in treating cervical intervertebral disc herniation.

Abstract

一种治疗颈椎间盘突出的药物组合物及其制备方法和制药应用，其由如下原料药制成：透骨草3-5份、鸡血藤3-5份、草乌5-10份、一朵云5-10份、乌药5-10份、苦参5-10份、肉桂5-10份、当归5-10份、三七5-10份、丹参5-10份、土鳖5-10份、藏红花3-5份。其制备方法包括：将净选后的各原料使用有机溶剂浸泡；取出各原料加水进行水煎煮处理。可以加入药学上可接受的辅料制备成药物制剂。具有抗炎、镇痛作用，用于治疗颈椎间盘突出患者。

Description

一种治疗颈椎间盘突出的药物组合物及其制备方法和应用 技术领域
本发明属于医药技术领域，具体涉及一种治疗颈椎间盘突出的药物组合物及其制备方法和应用。
背景技术
公开该背景技术部分的信息仅仅旨在增加对本发明的总体背景的理解，而不必然被视为承认或以任何形式暗示该信息构成已经成为本领域一般技术人员所公知的现有技术。
颈椎间盘突出由年龄因素、颈部外伤、退行性病变等因素造成，近年患病人数越来越多，对于人们的身体有着很大的损害性，如果不进行治疗任其发展可能会导致瘫痪，及时针对的治疗可以有效的控制病情。现有药物不能根本治愈颈椎间盘突出疾病，以及长期服用中成药患者经济负担大，治疗周期长，依从性差。
发明专利《一种治疗骨科疾病的中药制剂及其制备方法》(CN105031060A)提出了一种治疗骨科疾病的中药制剂，包括三七50-70份、土鳖虫30-50份、山胡椒40-60份、花椒40-60份、甲珠10-30份、枝子40-60份、黄金籽60-80份。本配方三七用量较大，经济成本较高，长期服用患者经济负担较重。
发明专利《一种治疗颈椎间盘突出病症的中药》(CN102058840A)公开了一种治疗颈椎间盘突出病症的中药配方，包括鸡血藤25-30份、狗脊25-30份、白芍25-30份、桂枝10-15份、淫羊藿10-15份、灵仙15-20份、葛根12-20份、片姜黄25-35份、地龙15-20份、天麻10-15份、钩藤20-25份、丝瓜络10-15份、蜈蚣2条。本配方内服外用，可有效治疗颈椎间盘突出症，但是蜈蚣作为外用药常用配方，安全性有待考证。
发明专利《治疗骨科疾病的外用中药制剂及其生产方法》(CN107823363A)公开了一种治疗骨科疾病的中药制剂及其生茶方法，包括土鳖虫5-10份、乳香3-10份、末药5-8份、牛膝5-10份、川芎5-10份、红花5-10份、鸡血藤5-10份、半夏5-10份、威灵仙5-10份、桑寄生10-12份、蜈蚣3-6份、白花蛇3-6份，均匀涂抹在无纺布上，冷却后得膏药。骨科类疾病通常使用膏药缓解疼痛，但是存在一个严重的过敏现象，一部分人会在接触使用膏药的过程中出现严重的过敏现象，加重患者不适感。
综上，发明人发现，目前治疗颈椎间盘突出疾病的中药制剂大多为外用膏药，部分人群对外用膏药会有过敏反应，造成严重的患者不适感；而治疗颈椎间盘突出疾病的口服中药制剂，部分配方中含有不宜内服的配方，使用安全性有待考证。
发明内容
针对现有技术的不足，本发明提供一种治疗颈椎间盘突出的药物组合物及其制备方法和应用。本发明精选多味地道药材制成口服药剂，其安全性高，无毒副作用，同时经动物和临床实验证明，对颈椎间盘突出具有良好疗效，因此具有良好的实际应用之价值。
为了实现上述目的，本发明涉及以下技术方案：
本发明的第一个方面，提供一种治疗颈椎间盘突出的药物组合物，所述药物组合物，按质量份数计，其原料组成包括：
透骨草3-5份、鸡血藤3-5份、草乌5-10份、一朵云5-10份、乌药5-10份、苦参5-10份、肉桂5-10份、当归5-10份、三七5-10份、丹参5-10份、土鳖5-10份、藏红花3-5份。
本发明的又一具体实施方式中，所述药物组合物，按质量份数计，其原料组成包括：
透骨草4-5份、鸡血藤4-5份、草乌7-10份、一朵云7-10份、乌药5-8 份、苦参8-10份、肉桂8-10份、当归7-10份、三七7-10份、丹参5-8份、土鳖7-10份、藏红花4-5份。
本发明的又一具体实施方式中，所述药物组合物，按质量份数计，其原料组成包括：透骨草5份、鸡血藤4份、草乌8份、一朵云8份、乌药5份、苦参10份、肉桂10份、当归7份、三七8份、丹参5份、藏红花5份、土鳖8份。
本发明的第二个方面，提供上述药物组合物的制备方法，所述制备方法包括：
S1、将净选后的各原料使用有机溶剂浸泡；
S2、取出各原料加水进行水煎处理。
其中，所述步骤S1中，
所述有机溶剂为乙醇，乙醇可循环使用。
浸泡时间控制为36-48小时，通过控制浸泡时间，从而使得原料药中的有效成分更易溶出。
所述步骤S2中，具体制备方法包括：水煎，将药液和药渣进行分离，取上清液，通过蒸馏法得到浓缩浸膏。
所述制备方法还包括将制备得到的浓缩浸膏减压干燥、粉碎成细粉备用。
本发明的第三个方面，提供上述药物组合物在制备治疗颈椎间盘突出的药物制剂中的应用。
本发明的第四个方面，提供一种治疗颈椎间盘突出的药物制剂，由所述药物组合物和药学上可接受的辅料制备而成。
所述药物制剂可以制成各种药物剂型，如汤剂、丸剂、胶囊剂、片剂、散剂、颗粒剂或口服液等。
上述一个或多个技术方案的的有益技术效果：
上述技术方案提供的治疗颈椎间盘突出的药物组合物其疗效好，见效快，对治疗颈椎间盘突出疾病均有很好的效果，且制备工艺简单，疗效显著，起效时间短，服用方便，无毒副作用，安全有效，因此具有良好的实际应用和推广之价值。
具体实施方式
应该指出，以下详细说明都是例示性的，旨在对本发明提供进一步的说明。除非另有指明，本文使用的所有技术和科学术语具有与本发明所属技术领域的普通技术人员通常理解的相同含义。
需要注意的是，这里所使用的术语仅是为了描述具体实施方式，而非意图限制根据本发明的示例性实施方式。如在这里所使用的，除非上下文另外明确指出，否则单数形式也意图包括复数形式，此外，还应当理解的是，当在本说明书中使用术语“包含”和/或“包括”时，其指明存在特征、步骤、操作、器件、组件和/或它们的组合。应理解，本发明的保护范围不局限于下述特定的具体实施方案；还应当理解，本发明实施例中使用的术语是为了描述特定的具体实施方案，而不是为了限制本发明的保护范围。
如前所述，目前治疗颈椎间盘突出疾病的中药制剂大多为外用膏药，部分人群对外用膏药会有过敏反应，造成严重的患者不适感；而治疗颈椎间盘突出疾病的口服中药制剂，部分配方中含有不宜内服的配方，使用安全性有待考证。
本发明的一个具体实施方式中，提供一种治疗颈椎间盘突出的药物组合物，所述药物组合物，按质量份数计，其原料组成包括：
透骨草3-5份、鸡血藤3-5份、草乌5-10份、一朵云5-10份、乌药5-10份、苦参5-10份、肉桂5-10份、当归5-10份、三七5-10份、丹参5-10份、土鳖5-10份、藏红花3-5份。
本发明的又一具体实施方式中，所述药物组合物，按质量份数计，其原 料组成包括：
透骨草4-5份、鸡血藤4-5份、草乌7-10份、一朵云7-10份、乌药5-8份、苦参8-10份、肉桂8-10份、当归7-10份、三七7-10份、丹参5-8份、土鳖7-10份、藏红花4-5份。
本发明的又一具体实施方式中，所述药物组合物，按质量份数计，其原料组成包括：透骨草5份、鸡血藤4份、草乌8份、一朵云8份、乌药5份、苦参10份、肉桂10份、当归7份、三七8份、丹参5份、藏红花5份、土鳖8份。
本发明的又一具体实施方式中，提供上述药物组合物的制备方法，所述制备方法包括：
S1、将净选后的各原料使用有机溶剂浸泡；
S2、取出各原料加水进行水煎处理。
本发明的又一具体实施方式中，所述步骤S1中，
所述有机溶剂为乙醇，乙醇可循环使用。
浸泡时间控制为36-48小时，通过控制浸泡时间，从而使得原料药中的有效成分更易溶出。
本发明的又一具体实施方式中，所述步骤S2中，具体制备方法包括：水煎，将药液和药渣进行分离，取上清液，通过蒸馏法得到浓缩浸膏。
本发明的又一具体实施方式中，所述制备方法还包括将制备得到的浓缩浸膏减压干燥、粉碎成细粉备用。
本发明的又一具体实施方式中，提供上述药物组合物在制备治疗颈椎间盘突出的药物制剂中的应用。
本发明的又一具体实施方式中，提供一种治疗颈椎间盘突出的药物制剂，由所述药物组合物和药学上可接受的辅料制备而成。
所述药物制剂可以制成各种药物剂型，如汤剂、丸剂、胶囊剂、片剂、 散剂、颗粒剂或口服液等。
所述药物制剂中药学上可接受的辅料包括但不限于：稀释剂包括但不限于，山梨醇、甘露醇、淀粉、乳糖、粉状或微晶状纤维素、二钙磷酸盐，三钙磷酸盐、糖等；填充剂：羧甲基纤维素钠、羟丙基纤维素、甲基纤维素、乙基纤维素、羟丙基甲基纤维素、胶化淀粉等；崩解剂：干淀粉、交联聚维酮、交联羧甲基纤维素钠、羧甲基淀粉钠、低取代羟丙基纤维素等；润滑剂：硬脂酸镁、十二烷基硫酸钠或微粉硅胶；其它辅料包括结合剂、流动剂、复合形成剂、塑化剂、着色剂、甜味剂、黏度增强剂、保存剂或抗氧化剂中的一种或多种。
以下通过实施例对本发明做进一步解释说明，但不构成对本发明的限制。应理解这些实施例仅用于说明本发明而不用于限制本发明的范围。
实施例1
一种药物组合物，其制备方法包括：
a、将各味中草药进行筛选，去除杂质；
b、使用粉碎机将上述中草药进行粉碎，粉碎后分别存放待用；
c、将粉碎后的药草备好，逐一称取透骨草5份、鸡血藤4份、草乌8份、一朵云8份、乌药5份、苦参10份、肉桂10份、当归7份、三七8份、丹参5份、藏红花5份、土鳖8份，用乙醇浸泡48小时后，水煎，将药液和药渣进行分离，取上清液，通过蒸馏法得到浓缩浸膏；将浓缩浸膏减压干燥、粉碎成细粉。
实施例2
一种药物组合物，其制备方法包括：
a、将各味中草药进行筛选，去除杂质；
b、使用粉碎机将上述中草药进行粉碎，粉碎后分别存放待用；
c、将粉碎后的药草备好，逐一称取透透骨草4份，鸡血藤5份、草乌5份、一朵云5份，乌药8份、苦参10份、肉桂8份、当归10份、三七10份、丹参10份、藏红花4份、土鳖6份，用乙醇浸泡48小时后，水煎，将药液和药渣进行分离，取上清液，通过蒸馏法得到浓缩浸膏；
将浓缩浸膏减压干燥、粉碎成细粉。
实施例3
一种药物组合物，其制备方法包括：
a、将各味中草药进行筛选，去除杂质；
b、使用粉碎机将上述中草药进行粉碎，粉碎后分别存放待用；
c、将粉碎后的药草备好，逐一称取透透骨草3份，鸡血藤4份、草乌4份、一朵云8份，乌药6份、苦参6份、肉桂8份、当归8份、三七9份、丹参8份、藏红花5份、土鳖6份，用乙醇浸泡48小时后，水煎，将药液和药渣进行分离，取上清液，通过蒸馏法得到浓缩浸膏；
将浓缩浸膏减压干燥、粉碎成细粉。
实验例1
一种药物组合物，其制备方法包括：
a、将各味中草药进行筛选，去除杂质；
b、使用粉碎机将上述中草药进行粉碎，粉碎后分别存放待用；
c、将粉碎后的药草备好，逐一称取透骨草8份、鸡血藤份、草乌8份、一朵云8份、乌药5份、苦参10份、当归7份、三七8份、丹参5份、藏红花5份、土鳖8份，用乙醇浸泡48小时后，水煎，将药液和药渣进行分离，取上清液，通过蒸馏法得到浓缩浸膏；将浓缩浸膏减压干燥、粉碎成 细粉。
实验例2
一种药物组合物，其制备方法包括：
a、将各味中草药进行筛选，去除杂质；
b、使用粉碎机将上述中草药进行粉碎，粉碎后分别存放待用；
c、将粉碎后的药草备好，逐一称取透骨草5份、鸡血藤4份、草乌8份、一朵云8份、乌药5份、苦参10份、肉桂10份、当归7份、三七8份、藏红花5份、土鳖8份，用乙醇浸泡48小时后，水煎，将药液和药渣进行分离，取上清液，通过蒸馏法得到浓缩浸膏；将浓缩浸膏减压干燥、粉碎成细粉。
实验例3
一种药物组合物，其制备方法包括：
a、将各味中草药进行筛选，去除杂质；
b、使用粉碎机将上述中草药进行粉碎，粉碎后分别存放待用；
c、将粉碎后的药草备好，逐一称取透骨草5份、鸡血藤4份、草乌8份，一朵云8份、乌药5份、威灵仙10份、苦参10份、肉桂10份、当归7份、三七8份、丹参5份、藏红花5份、土鳖8份，用乙醇浸泡48小时后，水煎，将药液和药渣进行分离，取上清液，通过蒸馏法得到浓缩浸膏；将浓缩浸膏减压干燥、粉碎成细粉。
效果验证
本申请使用动物为成年SD大鼠，SPF级，雌雄各半，体重180～220g，给予常规动物饲料。动物适应性饲养3天后进行试验。
1.中药组合物安全性试验
取禁食20小时以上的SD大鼠24只，以生药量3g生药/mL按40mL/(kg·d)的剂量灌胃给药实施例1-3及实验例1-3汤剂(每组随机分配4只SD大鼠，雌雄各半)，给药后观察两周，结果显示无试验大鼠死亡，因此无法按常规测定LD50，继续进行最大给药量测定试验。方法同上，按含生药3g生药/mL的药液按80mL/(kg·d)的剂量灌胃给药。给药后正常饲养，试验期间观察动物在一般行为、皮毛、饮食、体重变化、粪便有无异常改变，并观察有无中毒症状及死亡(如有死亡，则进行解剖及病理学检验)，连续观察两周。两周后复称体重，处死动物进行解剖，解剖观察心、肺、肝、肾、脾、胃、肠、膀胱、肾上腺、胸腺、胰腺、甲状腺、淋巴结、子宫、卵巢、睾丸、前列腺、脑等做组织学观察，结果均未发现异常病理性改变，提示本发明的中药组合物临床应用剂量安全。
2.试验方法与结果
将SD大鼠随机分为7组，每组10只，其中包括3个实验组：灌胃给予实施例1-3组方所得制剂(分别依次命名为实验组1-3)；3个阳性对照组：分别灌胃给予实验例1-3所得制剂(分别依次命名为实验组4-6)；1个病理对照组：灌胃给予生理盐水。每日给药1次，以生药量3g生药/mL按10mL/(kg·d)的剂量灌胃3周。
2.1各组对二甲苯所致大鼠耳肿胀的影响
末次给药1.5h后，用二甲苯(0.1ml/只)涂抹大鼠右耳两面致炎。致炎2h后处死大鼠，用直径10mm打孔器在双耳对称部位取下左、右耳片，称重，计算左、右耳片重量差为肿胀度。结果见表2。
表2
Figure PCTCN2021094683-appb-000001
结果表明，实验组1-6均可使大鼠耳肿胀程度减弱，但实验组1-3效果更优。
2.2镇痛作用实验
末次给药1.5h后，采用自控温度热板仪检测大鼠给药后1-3h的疼痛阈值(所选大鼠痛阈(热板温度55±0.5℃)在30秒内)，结果见表3。试验结果表明，实验组1-3对大鼠的痛阈的提高较为明显，而实验组4-6对大鼠痛阈影响并不大。
表3
Figure PCTCN2021094683-appb-000002
Figure PCTCN2021094683-appb-000003
注：与病理对照组相比，*表示P＜0.05。
3.临床试验
根据中药新药临床研究指导原则拟定的中西医诊断、辩证标准确诊的颈椎间盘突出患者进行试验研究。
服用方法：(1)观察组：本发明实施例1制备药物，每次5g，一日两次，三周为一疗程，临床病例随访一个月；(2)对照组：阿司匹林，每次一片，一日两次，三周为一疗程，临床病例随访一个月；
试验结果：
Figure PCTCN2021094683-appb-000004
从上表可以看出，本发明在治疗颈椎间盘突出方面，总体疗效优于对照组。
应注意的是，以上实例仅用于说明本发明的技术方案而非对其进行限制。尽管参照所给出的实例对本发明进行了详细说明，但是本领域的普通 技术人员可根据需要对本发明的技术方案进行修改或者等同替换，而不脱离本发明技术方案的精神和范围。

Claims (10)

  1. 一种治疗颈间盘突出的药物组合物，其特征在于，所述药物组合物按质量份数计，其原料组成包括：
    透骨草3-5份、鸡血藤3-5份、草乌5-10份、一朵云5-10份、乌药5-10份、苦参5-10份、肉桂5-10份、当归5-10份、三七5-10份、丹参5-10份、土鳖5-10份、藏红花3-5份。
  2. 如权利要求1所述的药物组合物，其特征在于，按质量份数计，其原料组成包括：
    透骨草4-5份、鸡血藤4-5份、草乌7-10份、一朵云7-10份、乌药5-8份、苦参8-10份、肉桂8-10份、当归7-10份、三七7-10份、丹参5-8份、土鳖7-10份、藏红花4-5份。
  3. 如权利要求1所述的药物组合物，其特征在于，按质量份数计，其原料组成包括：
    透骨草5份、鸡血藤4份、草乌8份、一朵云8份、乌药5份、苦参10份、肉桂10份、当归7份、三七8份、丹参5份、藏红花5份、土鳖8份。
  4. 权利要求1-3任一项所述药物组合物的制备方法，其特征在于，所述制备方法包括：
    S1、将净选后的各原料使用有机溶剂浸泡；
    S2、取出各原料加水进行水煎处理。
  5. 如权利要求4所述的制备方法，其特征在于，所述步骤S1中，
    所述有机溶剂为乙醇；
    浸泡时间控制为36-48小时。
  6. 如权利要求4所述的制备方法，其特征在于，所述步骤S2中，具体制备方法包括：水煎，将药液和药渣进行分离，取上清液，通过蒸馏法得到浓缩浸膏。
  7. 如权利要求4所述的制备方法，其特征在于，所述制备方法还包括将制备得到的浓缩浸膏减压干燥、粉碎成细粉备用。
  8. 权利要求1-3任一项所述药物组合物在制备治疗颈椎间盘突出的药物制剂中的应用。
  9. 一种治疗颈椎间盘突出的药物制剂，其特征在于，由权利要求1-3任一所述药物组合物和药学上可接受的辅料制备而成。
  10. 如权利要求9所述的药物制剂，其特征在于，所述药物制剂为汤剂、丸剂、胶囊剂、片剂、散剂、颗粒剂或口服液。
PCT/CN2021/094683 2021-01-29 2021-05-19 一种治疗颈椎间盘突出的药物组合物及其制备方法和应用 WO2022160520A1 (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202110130383.4A CN112656877A (zh) 2021-01-29 2021-01-29 一种治疗颈椎间盘突出的药物组合物及其制备方法和应用
CN202110130383.4 2021-01-29

Publications (1)

Publication Number Publication Date
WO2022160520A1 true WO2022160520A1 (zh) 2022-08-04

Family

ID=75414982

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2021/094683 WO2022160520A1 (zh) 2021-01-29 2021-05-19 一种治疗颈椎间盘突出的药物组合物及其制备方法和应用

Country Status (2)

Country Link
CN (1) CN112656877A (zh)
WO (1) WO2022160520A1 (zh)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115137801A (zh) * 2022-09-05 2022-10-04 江西中医药大学附属医院 治疗颈椎病的中药组合物、穴位贴及其制备方法和应用

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112656877A (zh) * 2021-01-29 2021-04-16 山东明仁福瑞达制药股份有限公司 一种治疗颈椎间盘突出的药物组合物及其制备方法和应用

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102058840A (zh) * 2010-11-19 2011-05-18 张民 一种治疗颈椎间盘突出病症的中药
CN103251695A (zh) * 2013-05-28 2013-08-21 王向云 一种治疗痹症的追风化刺酒及其制备方法
CN109498683A (zh) * 2019-01-10 2019-03-22 云南苗心康生物科技有限公司 治疗颈椎腰椎病、风湿性关节炎的中药敷贴及其制备方法
CN112656877A (zh) * 2021-01-29 2021-04-16 山东明仁福瑞达制药股份有限公司 一种治疗颈椎间盘突出的药物组合物及其制备方法和应用

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1228071C (zh) * 2003-03-24 2005-11-23 于少华 一种用于治疗颈椎病的药剂及其制备方法

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102058840A (zh) * 2010-11-19 2011-05-18 张民 一种治疗颈椎间盘突出病症的中药
CN103251695A (zh) * 2013-05-28 2013-08-21 王向云 一种治疗痹症的追风化刺酒及其制备方法
CN109498683A (zh) * 2019-01-10 2019-03-22 云南苗心康生物科技有限公司 治疗颈椎腰椎病、风湿性关节炎的中药敷贴及其制备方法
CN112656877A (zh) * 2021-01-29 2021-04-16 山东明仁福瑞达制药股份有限公司 一种治疗颈椎间盘突出的药物组合物及其制备方法和应用

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
CHEN YUZHANG , YANG SHUXIAN: "Clinical Observation on 188 Cases of Cervical Spondylosis Treated by Jingzhui Xiaotong Powder", NINGXIA MEDICAL JOURNAL, vol. 15, no. 5, 28 October 1993 (1993-10-28), pages 310 - 311, XP055955003 *
LI YINGXIA: "62 Cases of Cervical Spondylosis Treated by Bone Spur Flat Iontophoresis", HENAN TRADITIONAL CHINESE MEDICINE, vol. 26, no. 10, 10 October 2016 (2016-10-10), pages 54 - 55, XP055954999, ISSN: 1003-5028, DOI: 10.16367/j.issn.1003-5028.2006.10.040 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115137801A (zh) * 2022-09-05 2022-10-04 江西中医药大学附属医院 治疗颈椎病的中药组合物、穴位贴及其制备方法和应用
CN115137801B (zh) * 2022-09-05 2022-12-02 江西中医药大学附属医院 治疗颈椎病的中药组合物、穴位贴及其制备方法和应用

Also Published As

Publication number Publication date
CN112656877A (zh) 2021-04-16

Similar Documents

Publication Publication Date Title
CN103340976B (zh) 一种治疗颈肩腰腿痛的药剂
CN101954037B (zh) 一种治疗前列腺炎的中药制剂
WO2022160520A1 (zh) 一种治疗颈椎间盘突出的药物组合物及其制备方法和应用
CN113813347A (zh) 复方紫杉醇抗肿瘤胶囊药片的制备方法及工艺
CN104474473A (zh) 一种治疗妇科炎症的中药组合物及其制备方法
CN1287830C (zh) 一种治疗妇科疾病的中药复方制剂及其制备方法
WO2022160519A1 (zh) 一种治疗颈源性肩背痛的中药组合物及其制备方法和应用
CN102824576B (zh) 治疗牛皮癣的中药组合物及其制备方法
CN104547633A (zh) 一种治疗颈椎病的中药组合物及其制备方法
US10857186B2 (en) Traditional Chinese medicine composition for treating acute stage of cerebral infarction
CN102579748A (zh) 一种治疗妇女乳腺增生的中药制剂
CN112587596A (zh) 一种治疗虚火痰结证淋巴系统疾病的药物组合物
CN112007126A (zh) 一种用于治疗乳腺增生的中药复方及其制备方法和应用
CN104225034B (zh) 一种组合物在制备治疗非感染性尿道综合症药物中的应用
CN112755137B (zh) 一种治疗轻中度膝骨关节炎的中药组合物及其应用
CN110841007B (zh) 一种治疗脑中风后遗症的中药组合物及其应用
CN103251751B (zh) 一种治疗原发性痛经的中药组合物及其制备方法
CN106620070A (zh) 一种治疗骨关节病变的药物组合物及其制备方法和用途
CN100364596C (zh) 一种治疗糖尿病的复方蒙药及制备方法
CN102188548A (zh) 一种治疗牛皮癣的药物组合物及其制备方法
CN101194965B (zh) 一种治疗头痛的咀嚼片及其制备方法
CN105535442A (zh) 一种治疗慢性肾衰竭维持性血液透析患者周围神经病变的中药制剂
CN104306905A (zh) 一种治疗高血压中药组合物及其制备方法
CN103751758A (zh) 一种治疗足跟痛的药物及其制备方法
CN103948783A (zh) 一种预防和/或治疗脑梗塞的药物组合物

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 21922118

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 21922118

Country of ref document: EP

Kind code of ref document: A1