CN108210802A - 一种治疗骨质增生、关节痹痛的组合物及其制备方法 - Google Patents
一种治疗骨质增生、关节痹痛的组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗骨质增生、关节痹痛的组合物及其制备方法,按重量份计,由红土茯苓、红花、青风藤、生扯拢、铁筷子、见血飞各20~40份,天南星、半夏、草乌各2~4份、血竭、海马各4~6份,鲜桑枝、鲜桃枝、鲜榆枝、鲜柳枝、鲜槐枝各40~60份,红丹350~520份及药学上有效的辅料制得。本发明改变了原制剂的提取工艺、基质和制剂成型工艺,避免了原工艺中药物成分易被高温破坏,产生的空气污染等。用新剂型替代原黑膏药剂型,疗效确切、安全性好、易揭易贴、不污染衣物、没有原制剂中含有毒铅元素和皮肤致敏性、对环境无污染投入生产将会带来巨大的经济效益。
Description
技术领域
本发明属于中药制剂技术领域,具体来说,涉及到一种治疗骨质增生、关节痹痛的膏剂及其制备方法。
背景技术
透皮给药系统是药剂学中一个诱人而具有挑战性的新兴领域,据报道,自80年代硝酸甘油贴片问世以来,一直是世界上最畅销的50种药物之一。透皮制剂产品有着其它制剂不可替代的功能优势和广阔的市场前景,医药界人士公认透皮制剂是21世纪最具活力的高速增长的医药产业。随着医药的发展,中药透皮给药制剂的研越来越深入究,中药以具有低毒、低残留、不易产生耐药性等优势,更具有发展成为透皮制剂的潜力。
我国己进入老龄化国家,据有关统计,由于多种原因引起的关节肌肉疼痛和骨质增生发病率高达500,b,其主要患病人群为中老年人,在中老年人中10%的人都有不同程度的颈肩腰腿疼痛及骨质增生症状,严重地影响其正常的生活和工作。骨质增生属于中医痹症范畴,属于无菌性炎症。目前国内治疗骨质增生症的方法
通络骨质宁膏是由贵州同济堂制药股份有限公司生产(批准文号:国药准字252020034),由红土获荃、红花、草乌、血竭、青风藤、海马等16味药组成,具有驱风除湿,活血化疲功效。用于骨质增生,关节痹痛。但黑膏药传统制作工艺过程复杂,高温炼制时,有效成分提取不完全且易被破坏,制剂质量难以控制,油浸药渣造成很大浪费,在生产过程中易污染环境,在使用过程中易粘皮肤、易过敏、污染衣物,使用前需加热软化,且长期使用易出现铅中毒现象。
发明内容
为解决上述技术问题,本发明公开了一种治疗骨质增生、关节痹痛的组合物及其制备方法。
本发明所述的一种治疗骨质增生、关节痹痛的组合物由:按重量份计,红土茯苓、红花、青风藤、生扯拢、铁筷子、见血飞各20~40份,天南星、半夏、草乌各2~4份、血竭、海马各4~6份,鲜桑枝、鲜桃枝、鲜榆枝、鲜柳枝、鲜槐枝各40~60份,红丹350~520份及药学上有效的辅料制得。
优选地,本发明所述的一种治疗骨质增生、关节痹痛的组合物,该组合物由:按重量份计,红土茯苓、红花、青风藤、生扯拢、铁筷子、见血飞各30份,天南星、半夏、草乌各3份、血竭、海马各5份,鲜桑枝、鲜桃枝、鲜榆枝、鲜柳枝、鲜槐枝各50份,红丹440份及药学上有效的辅料制得。
本发明所述中药组合物的制备方法,由处方量药材加入常规辅料,按照常规工艺制成贴剂、散剂、胶囊剂、片剂、颗粒剂,口服液。
本发明所述的贴剂的制备方法为:
1)、草乌、血竭、海马、天南星、半夏粉碎成细粉,过筛,混匀;
2)、其余红土获荃等十一味药材,按处方比例称取药材,加入4.5~7.5倍量56~84%乙醇,回流提取1~3次,第一次提取1~3h,提取物回收乙醇浓缩、干燥,粉碎得膏粉;
3)、取药用辅料基质和促渗剂,加热使融化,继续加热搅拌使完全溶解混匀,高温熬制至滴水成珠后停止加热,冷却至50℃以下加入步骤1)和2)所得细粉和膏粉,低温状态下不断搅拌使其混合均匀,趁热滩涂于裱错材料上,冷却后覆盖保护层即可。
优选地,本发明所述的贴剂的制备方法为:
1)、草乌、血竭、海马、天南星、半夏粉碎成细粉,过筛,混匀;
2)、其余红土获荃等十一味药材,按处方比例称取药材,加入6倍量70%乙醇,回流提取2次,第一次提取2h,提取物回收乙醇浓缩、干燥,粉碎得膏粉;
3)、取药用辅料基质和促渗剂,加热使融化,继续加热搅拌使完全溶解混匀,高温熬制至滴水成珠后停止加热,冷却至50℃以下加入步骤1)和2)所得细粉和膏粉,低温状态下不断搅拌使其混合均匀,趁热滩涂于裱错材料上,冷却后覆盖保护层即可。
上述贴剂制备方法中所述的基质配比为松香:蜂蜡:麻油:羊毛脂=10:2:1:1。
上述贴剂制备方法中所述的促渗剂配比为1%氮酮一1%薄荷脑。
本发明的有益效果为对原黑膏药制剂通络骨质宁膏进行二次开发研究,改变了原制剂的提取工艺、基质和制剂成型工艺,提取有效成分完全程度,避免了原制剂油炸提取工艺中药物成分易被高温破坏,产生的空气污染等。用新剂型替代原黑膏药剂型,疗效确切、安全性好、易揭易贴、不污染衣物、没有原制剂中含有毒铅元素和皮肤致敏性、对环境无污染投入生产将会带来巨大的经济效益。
发明人对本发明组合物进行了药效学实验,具体如下:
1材料
1.1药品和试剂通络骨质宁膏(贵州同济堂,批号:20111203),通络骨质宁贴(自制),通络祛痛膏(河南羚锐制药股份有限公司,批号:110904),生理盐水,0. 6%乙酸,二甲苯。
仪器小鼠笼,GL-8420型热板仪,1mL注射器,棉签,台式天平,打孔器。
实验动物小鼠(雌雄各半,体重18^-22g,由第三军医大学医药实验动物中心提供,许可证:SCX(渝)2007-0005)。
方法
2.1镇痛试验
2.1.1热板法 将雌性小鼠置于已预温到55士0. 5℃的热板仪中,记录自小鼠放置于热板上到出现舔其后足的时间,以该时间作为小鼠的痛阂值。筛选出痛阑值在30s以内的小鼠80只。随机分成8组,每组10只。即正常组,通络祛痛膏阳性对照组,通络骨质贴膏高、中、低剂量组,通络骨质宁膏高、中、低剂量组。用脱毛剂脱去其背部毛发。正常组用生理盐水擦其背部,通络祛痛膏阳性对照组根据计量剪裁相应大小膏药贴于小鼠背部,通络骨质宁膏高、中、低剂量组分别按计量在背部涂搽已融化好的通络骨质宁贴,通络骨质宁膏高、中、低剂量组分别按计量在背部涂搽己融化好的通络骨质宁膏。每天两次,连续给药5次以后,第5次给药一个小时以后,将小鼠放置到热板仪内,一记录出现舔后足的时间。计算痛阂提高百分率。
扭体法 将80只小鼠随机分为8组,每组10只。即正常组,通络祛痛膏阳性对照组,通络骨质宁贴高、中、低剂量组,通络骨质宁膏高、中、低剂量组。用脱毛剂脱去其背部毛发。正常组用生理盐水擦其背部,通络祛痛膏阳性对照组根据计量剪裁相应大小膏药贴于小鼠背部,新型通络骨质宁膏高、中、低剂量组分别按计量在背部涂搽已融化好的通络骨质宁贴,通络骨质宁膏高、中、低剂量组分别按计量在背部涂搽已融化好的通络骨质宁膏。每天两次,连续给药5次,第5次给药一个小时以后,各组均腹腔注射0. 6%乙酸0. 2 mL/ 1摊。观察并记录腹腔注射乙酸溶液后15min内各组小鼠产生扭体反应的只数及各小鼠的扭体次数。
抗炎试验
2.2.1小鼠耳廓肿胀试验
将80只小鼠随机分为8组,每组10只。即正常组,通络祛痛膏阳性对照组,通络骨质宁贴高、中、低剂量组,通络骨质宁膏高、中、低剂量组。用脱毛剂脱去其背部毛发。正常组用生理盐水擦其背部,通络祛痛膏阳性对照组根据计量剪裁相应大小膏药贴于小鼠背部,通络骨质宁贴高、中、低剂量组分别按计量在背部涂搽己融化好的通络骨质宁贴,通络骨质宁膏高、中、低剂量组分别按计量在背部涂搽已融化好的原通络骨质宁膏。每天两次,连续给药5次,第5次给药一个小时以后,用二甲苯0. 03mL均匀涂于各小鼠右耳,30min以后将小鼠脱颈处死,剪下双耳,用打孔器在每只小鼠左耳和右耳打下同一部位的相同大小的耳片,于天平上称重,按下面公式计算各组鼠耳的肿胀度。
实验结果
3.1.1热板法实验结果
表1通络骨质贴对小鼠热板法致痛作用的影响
3.1.2扭体法实验结果
表2通络骨质宁贴对小鼠扭体法致痛作用的影响(‘士S)
3.2抗炎实验结果
表3通络骨质宁贴对二甲苯致小鼠耳廓肿胀的影响
4结论
4. 1从表1和2可以看出通络祛痛膏阳性对照组,通络骨质宁贴高、中、低剂量组,通络骨质宁膏高、中、低剂量组相对于正常组都具有显著性差异。原制剂组和现制剂组就镇痛实验相比较发现,原制剂各组的镇痛作用略高于现制剂各组,但在实验过程中发现原制剂各组小鼠均体重下降、行动缓慢、反应迟钝、四肢僵直且消瘦。疑似通络骨质宁膏中所含铅元素的存在使得实验动物具中毒,从而降低其身体机能,对外界刺激反应迟钝、身逐渐消瘦。
从表3可以看出通络祛痛膏阳性对照组,通络骨质宁贴高、中、低剂量组,通络骨质宁膏高、中、低剂量组相对于正常组都具有显著性差异。且现制剂组和原制剂组就镇痛实验相比较发现,现制剂各组的抗炎作用明显高于原制剂各组,说明新型通络骨质宁膏的抗炎作用明显。通过抗炎作用与镇痛作用实验对比,更加说明原制剂的的镇痛作用并非完全由药物本身引起,而是慢性铅中毒的附加作用。
具体实施方法
实施例1:
处方:红土茯苓、红花、青风藤、生扯拢、铁筷子、见血飞各20g,天南星、半夏、草乌各2g、血竭、海马各4g,鲜桑枝、鲜桃枝、鲜榆枝、鲜柳枝、鲜槐枝各40g,红丹350g
制备方法
1)、草乌、血竭、海马、天南星、半夏粉碎成细粉,过筛,混匀;
2)、其余红土获荃等十一味药材,按处方比例称取药材,加入7.5倍量56%乙醇,回流提取1次,第一次提取3h,提取物回收乙醇浓缩、干燥,粉碎得膏粉;
3)、取药用辅料基质松香:蜂蜡:麻油:羊毛脂=10:2:1:1, 促渗剂1%氮酮一1%薄荷脑,加热使融化,继续加热搅拌使完全溶解混匀,高温熬制至滴水成珠后停止加热,冷却至50℃以下加入步骤1)和2)所得细粉和膏粉,低温状态下不断搅拌使其混合均匀,趁热滩涂于裱错材料上,冷却后覆盖保护层即可。
实施例2:
处方:红土茯苓、红花、青风藤、生扯拢、铁筷子、见血飞各30g,天南星、半夏、草乌各3g、血竭、海马各5g,鲜桑枝、鲜桃枝、鲜榆枝、鲜柳枝、鲜槐枝各50g,红丹440g
制备方法:
1)、草乌、血竭、海马、天南星、半夏粉碎成细粉,过筛,混匀;
2)、其余红土获荃等十一味药材,按处方比例称取药材,加入6倍量70%乙醇,回流提取2次,第一次提取2h,提取物回收乙醇浓缩、干燥,粉碎得膏粉;
3)、取药用辅料基质松香:蜂蜡:麻油:羊毛脂=10:2:1:1, 促渗剂1%氮酮一1%薄荷脑,加热使融化,继续加热搅拌使完全溶解混匀,高温熬制至滴水成珠后停止加热,冷却至50℃以下加入步骤1)和2)所得细粉和膏粉,低温状态下不断搅拌使其混合均匀,趁热滩涂于裱错材料上,冷却后覆盖保护层即可。
实施例3:
处方:红土茯苓、红花、青风藤、生扯拢、铁筷子、见血飞各40g,天南星、半夏、草乌各4g、血竭、海马各6g,鲜桑枝、鲜桃枝、鲜榆枝、鲜柳枝、鲜槐枝各60g,红丹520g
制备方法:
1)、草乌、血竭、海马、天南星、半夏粉碎成细粉,过筛,混匀;
2)、其余红土获荃等十一味药材,按处方比例称取药材,加入4.5倍量84%乙醇,回流提取3次,第一次提取1h,提取物回收乙醇浓缩、干燥,粉碎得膏粉;
3)、取药用辅料基质松香:蜂蜡:麻油:羊毛脂=10:2:1:1, 促渗剂1%氮酮一1%薄荷脑,加热使融化,继续加热搅拌使完全溶解混匀,高温熬制至滴水成珠后停止加热,冷却至50℃以下加入步骤1)和2)所得细粉和膏粉,低温状态下不断搅拌使其混合均匀,趁热滩涂于裱错材料上,冷却后覆盖保护层即可。
Claims (7)
1.一种治疗骨质增生、关节痹痛的组合物,其特征在于,该组合物由:按重量份计,红土茯苓、红花、青风藤、生扯拢、铁筷子、见血飞各20~40份,天南星、半夏、草乌各2~4份、血竭、海马各4~6份,鲜桑枝、鲜桃枝、鲜榆枝、鲜柳枝、鲜槐枝各40~60份,红丹350~520份及药学上有效的辅料制得。
2.根据权利要求1所述的一种治疗骨质增生、关节痹痛的组合物,其特征在于,该组合物由:按重量份计,红土茯苓、红花、青风藤、生扯拢、铁筷子、见血飞各30份,天南星、半夏、草乌各3份、血竭、海马各5份,鲜桑枝、鲜桃枝、鲜榆枝、鲜柳枝、鲜槐枝各50份,红丹440份及药学上有效的辅料制得。
3.一种制备权利要求1-2任一项所述中药组合物的制备方法,其特征在于,由处方量药材加入常规辅料,按照常规工艺制成贴剂、散剂、胶囊剂、片剂、颗粒剂,口服液。
4.根据权利要求3所述的中药组合物的制备方法,其特征在于:贴剂的制备方法为:
1)、草乌、血竭、海马、天南星、半夏粉碎成细粉,过筛,混匀;
2)、其余红土获荃等十一味药材,按处方比例称取药材,加入4.5~7.5倍量56~84%乙醇,回流提取1~3次,第一次提取1~3h,提取物回收乙醇浓缩、干燥,粉碎得膏粉;
3)、取药用辅料基质和促渗剂,加热使融化,继续加热搅拌使完全溶解混匀,高温熬制至滴水成珠后停止加热,冷却至50℃以下加入步骤1)和2)所得细粉和膏粉,低温状态下不断搅拌使其混合均匀,趁热滩涂于裱错材料上,冷却后覆盖保护层即可。
5.根据权利要求4所述的中药组合物的制备方法,其特征在于:贴剂的制备方法为:
1)、草乌、血竭、海马、天南星、半夏粉碎成细粉,过筛,混匀;
2)、其余红土获荃等十一味药材,按处方比例称取药材,加入6倍量70%乙醇,回流提取2次,第一次提取2h,提取物回收乙醇浓缩、干燥,粉碎得膏粉;
3)、取药用辅料基质和促渗剂,加热使融化,继续加热搅拌使完全溶解混匀,高温熬制至滴水成珠后停止加热,冷却至50℃以下加入步骤1)和2)所得细粉和膏粉,低温状态下不断搅拌使其混合均匀,趁热滩涂于裱错材料上,冷却后覆盖保护层即可。
6.根据权利要求4和5任一项所述的中药组合物的制备方法,其特征在于:所述基质配比为松香:蜂蜡:麻油:羊毛脂=10:2:1:1。
7.根据权利要求4和5任一项所述的中药组合物的制备方法,其特征在于:所述促渗剂配比为1%氮酮一1%薄荷脑。
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