WO2022160519A1 - 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 - Google Patents
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 Download PDFInfo
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Classifications
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Definitions
- the invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating cervicogenic shoulder and back pain, and a preparation method and application thereof.
- Cervicogenic shoulder and back pain is a common type of pain disease caused by degenerative changes of the cervical spine in middle-aged and elderly people, mainly in the shoulder and back muscles or soft tissues caused by cervical nerve involvement. Especially when the lesion seriously stimulates or compresses the adjacent nerve roots and dural sac, a series of symptoms such as paresthesia or motor dysfunction in related parts of the head, neck, shoulder, back, upper limbs, etc. bring a huge economic burden. Cervicogenic shoulder and back pain is due to the compression or inflammatory stimulation of a nerve root, which causes the nerve to radiate to the distal end along the innervation area. or make pain worse. For example, radiating pain in the shoulder and back mainly starts from neck 4 or neck 5. When the nerve is injured or compressed, it mainly manifests as pain between the medial border of the scapula and the spinous process.
- the pain is often unbearable for patients, and neither steroid or non-steroidal anti-inflammatory drugs nor opioid analgesics can effectively control the pain.
- Blind use of massage, scraping and other methods of treatment may temporarily relieve the pain, but it is easy to Make the patient lose the best time for treatment.
- the present invention provides a traditional Chinese medicine composition for treating cervicogenic shoulder and back pain, and a preparation method and application thereof.
- the traditional Chinese medicine composition prepared by the invention uses common traditional Chinese medicines as raw materials to be used as medicines, and by selecting reasonable medicines and their mass fractions, a good curative effect on cervicogenic shoulder and back pain can be achieved, and it has good practical application value.
- the present invention relates to the following technical solutions:
- the first aspect of the present invention provides a kind of Chinese medicine composition for the treatment of cervicogenic shoulder and back pain, the Chinese medicine composition, its raw material is composed of:
- the Chinese medicine composition for the treatment of cervicogenic shoulder and back pain, its raw material is composed by weight:
- the Chinese medicine composition for the treatment of cervicogenic shoulder and back pain, its raw material is composed by weight:
- the above-mentioned traditional Chinese medicine composition for treating cervicogenic shoulder and back pain can be used by directly pulverizing the raw materials, mixing evenly, or adding water to decoct, and can also be prepared according to other methods. Therefore the second aspect of the present invention provides the preparation method of the above-mentioned traditional Chinese medicine composition for the treatment of cervicogenic shoulder and back pain, and the preparation method comprises:
- Panax notoginseng is pulverized into 50-80 mesh fine powder
- the organic solvent is ethanol, and the relative density of the clear paste is 1.3-1.5;
- the specific preparation method includes: decocting Paeonia lactiflora, Poria, Scutellaria kudzu root, Cistanche deserticola in water twice, the first time is 0.5-1.5 hours, the second time is 0.5-1.5 hours, the filtrates are combined, concentrated, and alcohol-precipitated. , recover ethanol, and concentrate it into a clear paste with a relative density of 1.1-1.5.
- step S4 after drying, it can be further pulverized into fine powder.
- the application of the above-mentioned traditional Chinese medicine composition in the preparation of a pharmaceutical preparation for treating cervicogenic shoulder and back pain is also within the protection scope of the present invention.
- the fourth aspect of the present invention provides a pharmaceutical preparation for treating cervicogenic shoulder and back pain, which is prepared from the above-mentioned traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials.
- compositions can be made into various pharmaceutical dosage forms, such as decoctions, pills, capsules, tablets, powders, granules or oral liquids.
- diluents include, but are not limited to, sorbitol, mannitol, starch, lactose, powdered or microcrystalline cellulose, dicalcium phosphate, Tricalcium Phosphates, Sugars and Similar; Fillers: Sodium Carboxymethyl Cellulose, PVP-K30, Hydroxypropyl Cellulose, Starch Slurries, Methyl Cellulose, Ethyl Cellulose, Hydroxypropyl Methyl Cellulose , gelatinized starch, etc.; disintegrant: dry starch, crospovidone, croscarmellose sodium, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, etc.; lubricant: magnesium stearate , talc, sodium lauryl sulfate or micropowder silica gel; other excipients include
- the above technical solution provides a traditional Chinese medicine composition for the treatment of cervicogenic shoulder and back pain, the selected medicinal materials are suitable for compatibility, the formula is refined, and the traditional Chinese medicines cooperate with each other and use together according to the compatibility relationship of "monarch, minister, assistant and envoy", so as to act on the lesion and improve the function. It complements each other in terms of medicinal properties, and is easy to use, safe, comfortable, and has no toxic and side effects. It has been proved by animal experiments and clinical trials that it has a good curative effect on cervicogenic shoulder and back pain, so it has a good practical application. value.
- cervicogenic shoulder and back pain is often unbearable for patients.
- Steroidal or non-steroidal anti-inflammatory drugs and opioid analgesics cannot effectively control this pain, and blindly use massage, scraping and other methods to treat it. Although temporary pain relief may be possible, it is easy for patients to lose the best time for treatment.
- a Chinese medicine composition for the treatment of cervicogenic shoulder and back pain the Chinese medicine composition, its raw material is composed of:
- the Chinese medicine composition for the treatment of cervicogenic shoulder and back pain its raw materials are composed by weight:
- the Chinese medicine composition for the treatment of cervicogenic shoulder and back pain its raw materials are composed by weight:
- each raw material component is an organic whole and is indispensable.
- the inventor found that if any one of the raw material components in the above-mentioned composition is reduced, or the raw material components of the traditional Chinese medicine composition of the present invention are replaced with a raw material drug with similar medicinal properties, the overall effect of the traditional Chinese medicine composition is significant. Reduced; other raw material components are added on the basis of the traditional Chinese medicine composition of the present invention, the overall effect of the traditional Chinese medicine composition is not significantly improved, and even the overall effect of the traditional Chinese medicine composition is reduced.
- the above-mentioned traditional Chinese medicine composition for treating cervicogenic shoulder and back pain can be used by directly pulverizing the raw materials, mixing evenly, or adding water to decoct, and can also be prepared according to other methods. Therefore, in another specific embodiment of the present invention, a preparation method of the above-mentioned traditional Chinese medicine composition for the treatment of cervicogenic shoulder and back pain is provided, and the preparation method comprises:
- Panax notoginseng is pulverized into 50-80 mesh fine powder
- the organic solvent is ethanol, and the relative density of the clear paste is 1.3-1.5;
- the specific preparation method includes: decocting Paeonia lactiflora, Poria, Scutellaria kudzu root, Cistanche deserticola in water twice, the first time is 0.5-1.5 hours, the second time is 0.5-1.5 hours, the filtrates are combined, concentrated, and alcohol-precipitated. , recover ethanol, and concentrate it into a clear paste with a relative density of 1.1-1.5.
- step S4 after drying, it can be further pulverized into fine powder.
- a pharmaceutical preparation for treating cervicogenic shoulder and back pain is provided, which is prepared from the above-mentioned traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials.
- compositions can be made into various pharmaceutical dosage forms, such as decoctions, pills, capsules, tablets, powders, granules or oral liquids.
- diluents include, but are not limited to, sorbitol, mannitol, starch, lactose, powdered or microcrystalline cellulose, dicalcium phosphate, Tricalcium Phosphates, Sugars and Similar; Fillers: Sodium Carboxymethyl Cellulose, PVP-K30, Hydroxypropyl Cellulose, Starch Slurries, Methyl Cellulose, Ethyl Cellulose, Hydroxypropyl Methyl Cellulose , gelatinized starch, etc.; disintegrant: dry starch, crospovidone, croscarmellose sodium, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, etc.; lubricant: magnesium stearate , talc, sodium lauryl sulfate or micropowder silica gel; other excipients include
- a pharmaceutical composition for treating cervicogenic shoulder and back pain the raw materials are:
- the preparation method is:
- a pharmaceutical composition for treating cervicogenic shoulder and back pain the raw materials are:
- the preparation method is:
- a pharmaceutical composition for treating cervicogenic shoulder and back pain the raw materials are:
- the preparation method is:
- a pharmaceutical composition for treating cervicogenic shoulder and back pain the raw materials are:
- the preparation method is:
- Corydalis chinensis and Chuanqiong are extracted by refluxing with ethanol, the residue is discarded, and the extraction solution reclaims ethanol, and is concentrated into a clear paste with a relative density of 1.3;
- a pharmaceutical composition for treating cervicogenic shoulder and back pain the raw materials are:
- Notoginseng 3.5 parts Chuanqiong 7.0 parts; Corydalis 9.0 parts; Baishao 12.5 parts; Poria 11.5 parts; Scutellaria baicalensis 13.5 parts;
- the preparation method is:
- a pharmaceutical composition for treating cervicogenic shoulder and back pain the raw materials are:
- the preparation method is:
- 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.
- Example 1-3 and Experimental Example 1-3 decoction each group by intragastric administration of crude drug 3g crude drug/mL at a dose of 40mL/(kg d). Randomly assigned 4 SD rats, half male and female), and observed for two weeks after administration. The results showed that no experimental rats died, so the LD 50 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 (in case of death, anatomical and pathological examinations were performed). Observe for two weeks. After two weeks, the animals were weighed again, 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.
- SD rats were randomly divided into 8 groups with 10 rats in each group; 3 experimental groups: using spinal canal intubation method (Dou Xia Rui et al., Journal of Beijing University of Traditional Chinese Medicine, 2006), after modeling, were given Examples 1-3 by gavage respectively
- the preparations obtained by the prescription (respectively named experimental groups 1-3 in turn); 3 positive control groups: after modeling, the preparations obtained in experimental examples 1-3 were administered by gavage (respectively named experimental groups 4-6);
- 1 Pathological control group model establishment and intragastric administration of normal saline; and sham operation group: no thread insertion treatment, intragastric administration of normal saline; experimental drugs and control drugs were administered on the 2nd day after successful modeling, daily
- the drug was administered once, and the crude drug amount was 3 g crude drug/mL by intragastric administration at a dose of 10 mL/(kg ⁇ d) for 2 weeks.
- the difference between the evoked potential latency measured by the cervical 6 supraspinous ligament and the evoked potential latency measured at Erb's point was used as the spinal cord conduction time (SCT), and the difference between the evoked potential latency in the cortical sensory phase and the potential latency evoked at Erb's point was used as the cortex. conduction time (CCT). Rats were tested 14 days after surgery. The results showed that the time of SST and CCT on the affected side of the rats was significantly prolonged after operation, and there was a significant difference compared with the healthy side. The prolongation phenomenon of experimental group 1-3 was obviously alleviated, and the effect was better than that of experimental group 4-6. show that it has good curative effect.
- SCT spinal cord conduction time
- CCT conduction time
- the present invention has better overall curative effect than the reference substance in treating cervicogenic shoulder and back pain.
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Abstract
一种治疗颈源性肩背痛的中药组合物及其制备方法以及该中药组合物在制备治疗颈源性肩背痛的药物制剂中的应用，该中药组合物由以下重量份的原料组成：三七2-12份、川芎3-15份、延胡索5-15份、白芍5-15份、茯苓5-20份、黄芩1-15份、续断5-10份、葛根5-15份、肉苁蓉5-15份，其可制成汤剂、丸剂、胶囊剂、片剂、散剂、颗粒剂或口服液。
Description
本发明属于中药技术领域，具体涉及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。
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。
颈源性肩背痛是中老年人常见的颈椎退行性改变所引起的一类疼痛性疾病，主要以颈神经受累后所致的肩背部肌肉或软组织疼痛为主。特别是当病变严重刺激或压迫邻近神经根和硬膜囊时可产生头、颈、肩、背、上肢等相关部位感觉异常或运动功能障碍等一系列症状，严重影响人们生活和工作，给社会带来巨大的经济负担。颈源性肩背痛是由于一条神经根受压或炎症刺激，使得该条神经沿着支配区域出现向远端放射的针刺样疼痛，凡增加或牵拉该部位脊神经的试验均可诱发疼痛或使疼痛加重。如肩背放射痛主要从颈4或颈5开始，当该神经损伤或受压后主要表现为肩胛骨内侧缘与棘突之间的疼痛。
该疼痛常令患者无法忍受，甾体或非甾体抗炎药和阿片类镇痛药均不能有效控制这种疼痛，而盲目采用按摩、刮痧等方式治疗，虽然可能暂时缓解疼痛，但是则容易使患者丧失最佳的治疗时机。
发明内容
针对现有技术存在的对颈源性肩背痛的作用效果不明显的问题， 本发明提供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。本发明制备的中药组合物是以常见的中药为原料入药，通过选择合理的药物及其质量份数，从而实现对颈源性肩背痛的良好疗效，具有良好的实际应用之价值。
具体的，本发明涉及以下技术方案：
本发明的第一个方面，提供一种治疗颈源性肩背痛的中药组合物，所述中药组合物，其原料组成为：
三七2-12份；川穹3-15份；延胡索5-15份；白芍5-15份；茯苓5-20份；黄芩1-15份；续断5-10份；葛根5-15份；肉苁蓉5-15份。
所述治疗颈源性肩背痛的中药组合物，其原料按重量份组成为：
三七2-15份；川穹3-15份；延胡索2-18份；白芍3-20份；茯苓1-20份；黄芩1-20份；续断3-15份；葛根2-15份；肉苁蓉1-15份。
所述治疗颈源性肩背痛的中药组合物，其原料按重量份组成为：
三七3.5份；川穹7.0份；延胡索9.0份；白芍12.5份；茯苓11.5份；黄芩13.5份；续断8.5份；葛根7.5份；肉苁蓉10.5份。
上述治疗颈源性肩背痛的中药组合物可直接将各原料粉碎，混合均匀后使用；或加水煎煮；也可以按照其他方法制备。因此本发明的第二个方面，提供上述治疗颈源性肩背痛的中药组合物的制备方法，所述制备方法包括：
S1、将三七粉碎成细粉；
S2、将延胡索、川穹、续断用有机溶剂回流提取，弃去残渣，提取液回收乙醇，浓缩成清膏；
S3、将白芍、茯苓、黄芩、葛根、肉苁蓉加水煎煮，滤液合并、浓缩、醇沉，浓缩成清膏；
S4、将上述清膏合并，加入三七粉，混合均匀，干燥即得。
其中，所述步骤S1中，三七粉碎成50-80目细粉；
所述步骤S2中，所述有机溶剂为乙醇，清膏相对密度为1.3-1.5；
所述步骤S3中，具体制备方法包括：将白芍、茯苓、黄芩葛根、肉苁蓉加水煎煮两次，第一次0.5～1.5小时，第二次0.5～1.5小时，滤液合并、浓缩、醇沉，回收乙醇，浓缩成相对密度1.1-1.5的清膏。
所述步骤S4中，干燥后可进一步粉碎成细粉。
本发明的第三个方面，上述中药组合物在制备治疗颈源性肩背痛的药物制剂中的应用也是本发明保护的范围。
本发明的第四个方面，提供一种治疗颈源性肩背痛的药物制剂，由上述中药组合物和药学上可接受的辅料制备而成。
上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。
本发明中的上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、糖和相似物；填充剂：羧甲基纤维素钠、PVP-K30、羟丙基纤维素、淀粉浆、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、滑石粉、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、释放控制剂、膜衣剂、塑化剂、着色剂、调味剂、甜味剂、黏度增强剂、保存剂或抗氧化剂中的一种或多种。
以上一个或多个技术方案的有益技术效果：
上述技术方案提供一种治疗颈源性肩背痛的中药组合物，所选药材配伍相宜，组方精炼，各中药按照“君臣佐使”的配伍关系相互配合、共同使用，从而作用于病灶，在功能上相辅相成，在药性上相制相佐，使用方便，安全，舒适，无毒副作用，经动物实验和临床试验证明，其针对颈源性肩背痛具有良好的疗效，因此具有良好的实际应用之价值。
应该指出，以下详细说明都是例示性的，旨在对本申请提供进一步的说明。除非另有指明，本文使用的所有技术和科学术语具有与本申请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申请的示例性实施方式。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。
结合具体实例对本发明作进一步的说明，以下实例仅是为了解释本发明，并不对其内容进行限定。如果实施例中未注明的实验具体条件，通常按照常规条件，或按照销售公司所推荐的条件；实施例中所 用的材料、试剂等，如无特殊说明，均可通过商业途径购买得到。
如前所述，颈源性肩背痛常令患者无法忍受，甾体或非甾体抗炎药和阿片类镇痛药均不能有效控制这种疼痛，而盲目采用按摩、刮痧等方式治疗，虽然可能暂时缓解疼痛，但是则容易使患者丧失最佳的治疗时机。
有鉴于此，本发明的一个具体实施方式中，提供一种治疗颈源性肩背痛的中药组合物，所述中药组合物，其原料组成为：
三七2-15份；川穹3-15份；延胡索2-18份；白芍3-20份；茯苓1-20份；黄芩1-20份；续断3-15份；葛根2-15份；肉苁蓉1-15份。
本发明的又一具体实施方式中，所述治疗颈源性肩背痛的中药组合物，其原料按重量份组成为：
三七5-15份；川穹1-10份；延胡索5-15份；白芍5-15份；茯苓1-15份；黄芩5-20份；续断5-10份；葛根2-10份；肉苁蓉5-12份。
本发明的又一具体实施方式中，所述治疗颈源性肩背痛的中药组合物，其原料按重量份组成为：
三七3.5份；川穹7.0份；延胡索9.0份；白芍12.5份；茯苓11.5份；黄芩13.5份；续断8.5份；葛根7.5份；肉苁蓉10.5份。
本发明的治疗颈源性肩背痛的中药组合物中，各原料组分是一个有机的整体，缺一不可。发明人在研发过程中发现，减少上述组合物中的任何一种原料组分，或以具有相似药性的原料药对本发明中药组合物的原料组分进行替换，则中药组合物整体的作用效果显著降低；在本发明的中药组合物的基础上再增加其他的原料组分，中药组合物 的整体效果并未有明显的改善，甚至有中药组合物的整体效果降低的情况出现。
上述治疗颈源性肩背痛的中药组合物可直接将各原料粉碎，混合均匀后使用；或加水煎煮；也可以按照其他方法制备。因此本发明的又一具体实施方式中，提供上述治疗颈源性肩背痛的中药组合物的制备方法，所述制备方法包括：
S1、将三七粉碎成细粉；
S2、将延胡索、川穹、续断用有机溶剂回流提取，弃去残渣，提取液回收乙醇，浓缩成清膏；
S3、将白芍、茯苓、黄芩、葛根、肉苁蓉加水煎煮，滤液合并、浓缩、醇沉，浓缩成清膏；
S4、将上述清膏合并，加入三七粉，混合均匀，干燥即得。
其中，所述步骤S1中，三七粉碎成50-80目细粉；
所述步骤S2中，所述有机溶剂为乙醇，清膏相对密度为1.3-1.5；
所述步骤S3中，具体制备方法包括：将白芍、茯苓、黄芩葛根、肉苁蓉加水煎煮两次，第一次0.5～1.5小时，第二次0.5～1.5小时，滤液合并、浓缩、醇沉，回收乙醇，浓缩成相对密度1.1-1.5的清膏。
所述步骤S4中，干燥后可进一步粉碎成细粉。
本发明的又一具体实施方式中，上述中药组合物在制备治疗颈源性肩背痛的药物制剂中的应用也是本发明保护的范围。
本发明的又一具体实施方式中，提供一种治疗颈源性肩背痛的药物制剂，由上述中药组合物和药学上可接受的辅料制备而成。
上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。
本发明中的上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、糖和相似物；填充剂：羧甲基纤维素钠、PVP-K30、羟丙基纤维素、淀粉浆、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、滑石粉、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、释放控制剂、膜衣剂、塑化剂、着色剂、调味剂、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
一种治疗颈源性肩背痛的药物组合物，其原料为：
三七3.5份；川穹7.0份；延胡索9.0份；白芍12.5份；茯苓11.5份；黄芩13.5份；续断8.5份；葛根7.5份；肉苁蓉10.5份。
制备方法为：
(1)先将三七粉碎成50目细粉；
(2)将延胡索、川穹、续断用乙醇回流提取，弃去残渣，提取液 回收乙醇，浓缩成相对密度1.3的清膏；
(3)将白芍、茯苓、黄芩、葛根、肉苁蓉加水煎煮两次，第一次1小时，第二次1小时，滤液合并、浓缩、醇沉，回收乙醇，浓缩成相对密度1.1的清膏。
将上述清膏合并，加入三七粉，混合均匀，干燥，再粉碎成细粉，即得。
实施例2
一种治疗颈源性肩背痛的药物组合物，其原料为：
三七5.0份；川穹6.0份；延胡索12.0份；白芍10.5份；茯苓10.5份；黄芩7.5份；续断10.5份；葛根6.5份；肉苁蓉8.5份。
制备方法为：
(1)先将三七粉碎成50目细粉；
(2)将延胡索、川穹、续断用乙醇回流提取，弃去残渣，提取液回收乙醇，浓缩成相对密度1.3的清膏；
(3)将白芍、茯苓、黄芩、葛根、肉苁蓉加水煎煮两次，第一次1小时，第二次1小时，滤液合并、浓缩、醇沉，回收乙醇，浓缩成相对密度1.1的清膏。
将上述清膏合并，加入三七粉，混合均匀，干燥，再粉碎成细粉，即得。
实施例3
一种治疗颈源性肩背痛的药物组合物，其原料为：
三七8.5份；川穹4.0份；延胡索5.0份；白芍5.5份；茯苓6.5 份；黄芩10.5份；续断5.5份；葛根6.5份；肉苁蓉6.5份。
制备方法为：
(1)先将三七粉碎成50目细粉；
(2)将延胡索、川穹、续断用乙醇回流提取，弃去残渣，提取液回收乙醇，浓缩成相对密度1.3的清膏；
(3)将白芍、茯苓、黄芩、葛根、肉苁蓉加水煎煮两次，第一次1小时，第二次1小时，滤液合并、浓缩、醇沉，回收乙醇，浓缩成相对密度1.1的清膏。
将上述清膏合并，加入三七粉，混合均匀，干燥，再粉碎成细粉，即得。
实验例1
一种治疗颈源性肩背痛的药物组合物，其原料为：
三七3.5份；川穹7.0份；延胡索9.0份；白芍12.5份；茯苓11.5份；黄芩13.5份；葛根7.5份；肉苁蓉10.5份。
制备方法为：
(1)先将三七粉碎成50目细粉；
(2)将延胡索、川穹用乙醇回流提取，弃去残渣，提取液回收乙醇，浓缩成相对密度1.3的清膏；
(3)将白芍、茯苓、黄芩、葛根、肉苁蓉加水煎煮两次，第一次1小时，第二次1小时，滤液合并、浓缩、醇沉，回收乙醇，浓缩成相对密度1.1的清膏。
将上述清膏合并，加入三七粉，混合均匀，干燥，再粉碎成细粉， 即得。
实验例2
一种治疗颈源性肩背痛的药物组合物，其原料为：
三七3.5份；川穹7.0份；延胡索9.0份；白芍12.5份；茯苓11.5份；黄芩13.5份；续断8.5份；葛根7.5份。
制备方法为：
(1)先将三七粉碎成50目细粉；
(2)将延胡索、川穹、续断用乙醇回流提取，弃去残渣，提取液回收乙醇，浓缩成相对密度1.3的清膏；
(3)将白芍、茯苓、黄芩、葛根加水煎煮两次，第一次1小时，第二次1小时，滤液合并、浓缩、醇沉，回收乙醇，浓缩成相对密度1.1的清膏。
将上述清膏合并，加入三七粉，混合均匀，干燥，再粉碎成细粉，即得。
实验例3
一种治疗颈源性肩背痛的药物组合物，其原料为：
三七3.5份；川穹7.0份；延胡索9.0份；白芍12.5份；茯苓11.5份；黄芩13.5份；续断8.5份；葛根7.5份；威灵仙10.0份；肉苁蓉10.5份。
制备方法为：
(1)先将三七粉碎成50目细粉；
(2)将延胡索、川穹、续断用乙醇回流提取，弃去残渣，提取液 回收乙醇，浓缩成相对密度1.3的清膏；
(3)将白芍、茯苓、黄芩、葛根、威灵仙、肉苁蓉加水煎煮两次，第一次1小时，第二次1小时，滤液合并、浓缩、醇沉，回收乙醇，浓缩成相对密度1.1的清膏。
将上述清膏合并，加入三七粉，混合均匀，干燥，再粉碎成细粉，即得。
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。
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LD
50，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
将SD大鼠随机分为8组，每组10只；3个实验组：采用椎管插线法(窦夏睿等，北京中医药大学学报，2006)造模后分别灌胃给予实施例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：造模后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：造模并灌胃给予生理盐水；以及假手术组：不做插线处理，灌胃给予生理盐水；实验药物及对照药物均于造模成功后第2日给药，每日给药1次，以生药量3g生药/mL按10mL/(kg·d)的剂量灌胃2周。
2.1机械痛阈测定
在术后14天对大鼠进行机械性痛阈测定，结果见表1。
表1
结果表明，造模后大鼠患侧机械痛阈均明显降低，出现了明显了痛觉过敏现象，而给药实验组中，实验组1-3对大鼠的机械痛阈的提高最为显著而迅速，痛觉过敏现象得到明显改善。而实验组4-6对对大鼠痛阈未产生显著影响。
2.2体感诱发电位测定
以颈6棘上韧带测出的诱发电位潜伏期，同Erb’s点测出的诱发电位潜伏期之差作为脊髓传导时间(SCT)，以皮层感觉期诱发电位潜伏期和Erb’s点诱发的电位潜伏期之差作为皮层传导时间(CCT)。术后14天对大鼠进行检测。结果表明，术后大鼠患侧SST和CCT时间均明显延长，同自身健侧相比有显著性差异，而实验组1-3延长现象明显减轻，且效果优于实验组4-6。表明其具有良好疗效。
表2
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、辩证标准确诊的颈源性肩背痛患者进行试验研究。
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：
从上表可以看出，本发明在治疗颈源性肩背痛方面，总体疗效比对照品为优。
最后应说明的是：以上所述仅为本发明的优选实施例而已，并不用于限制本发明，尽管参照前述实施例对本发明进行了详细的说明，对于本领域的技术人员来说，其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换。凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (10)
- 一种治疗颈源性肩背痛的中药组合物，其特征在于，所述中药组合物，其原料按重量份组成为：三七2-12份；川穹3-15份；延胡索5-15份；白芍5-15份；茯苓5-20份；黄芩1-15份；续断5-10份；葛根5-15份；肉苁蓉5-15份。
- 如权利要求1所述的中药组合物，其特征在于，所述治疗颈源性肩背痛的中药组合物，其原料按重量份组成为：三七2-15份；川穹3-15份；延胡索2-18份；白芍3-20份；茯苓1-20份；黄芩1-20份；续断3-15份；葛根2-15份；肉苁蓉1-15份。
- 如权利要求1所述的中药组合物，其特征在于，所述治疗颈源性肩背痛的中药组合物，其原料按重量份组成为：三七3.5份；川穹7.0份；延胡索9.0份；白芍12.5份；茯苓11.5份；黄芩13.5份；续断8.5份；葛根7.5份；肉苁蓉10.5份。
- 权利要求1-3任一项所述治疗颈源性肩背痛的中药组合物的制备方法，其特征在于，所述制备方法包括：S1、将三七粉碎成细粉；S2、将延胡索、川穹、续断用有机溶剂回流提取，弃去残渣，提取液回收乙醇，浓缩成清膏；S3、将白芍、茯苓、黄芩、葛根、肉苁蓉加水煎煮，滤液合并、浓缩、醇沉，浓缩成清膏；S4、将上述清膏合并，加入三七粉，混合均匀，干燥即得。
- 如权利要求4所述的制备方法，其特征在于，所述步骤S1中，三七粉碎成50-80目细粉。
- 如权利要求4所述的制备方法，其特征在于，所述步骤S2中，所述有机溶剂为乙醇，清膏相对密度为1.3-1.5。
- 如权利要求4所述的制备方法，其特征在于，所述步骤S3中，具体制备方法包括：将白芍、茯苓、黄芩葛根、肉苁蓉加水煎煮两次，第一次0.5～1.5小时，第二次0.5～1.5小时，滤液合并、浓缩、醇沉，回收乙醇，浓缩成相对密度1.1-1.5的清膏。
- 权利要求1-3任一项所述中药组合物在制备治疗颈源性肩背痛的药物制剂中的应用。
- 一种治疗颈源性肩背痛的药物制剂，其特征在于，由权利要求1-3任一项所述中药组合物和药学上可接受的辅料制备而成。
- 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。
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| CN102357241A (zh) * | 2011-11-07 | 2012-02-22 | 中国人民解放军第三〇二医院 | 一种化瘀散寒的中药组合物及其制备方法 |
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