CN110237226A - 一种中药贴膏剂伤湿祛痛膏的制备方法 - Google Patents

一种中药贴膏剂伤湿祛痛膏的制备方法 Download PDF

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CN110237226A
CN110237226A CN201910648649.7A CN201910648649A CN110237226A CN 110237226 A CN110237226 A CN 110237226A CN 201910648649 A CN201910648649 A CN 201910648649A CN 110237226 A CN110237226 A CN 110237226A
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黄天涯
张伟东
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Siping Sanfan Technology Pharmaceutical Co Ltd
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Abstract

本发明属于医药生产技术领域,公开了一种中药贴膏剂伤湿祛痛膏的制备方法。该方法先将原料中的中药材粉碎,然后利用高压脉冲电场提取器进行提取,提取液再经陶瓷膜处理、分子蒸馏浓缩得到浸膏。将浸膏与薄荷脑、冰片、樟脑、水杨酸甲酯混合搅拌后用均质机处理,然后添加基质,制成涂料,最后进行涂膏,切段,盖衬,切成小块,即得伤湿祛痛膏。本发明专利具有提取收率高、产品品质高、活性成分损失少、产品杂质和有害物质少、成本低、工艺简单易操作、应用前景良好等特点。

Description

一种中药贴膏剂伤湿祛痛膏的制备方法
技术领域
本发明属于医药生产技术领域,涉及一种中药贴膏剂伤湿祛痛膏的制备方法,特别是涉及一种利用高压脉冲电场技术提取、陶瓷膜除杂、分子蒸馏浓缩、均质机混合的中药贴膏剂生产技术。
背景技术
伤湿祛痛膏由生川乌、生草乌、麻黄、苍术、当归、白芷、干姜、山柰、八角茴香、薄荷脑、冰片、樟脑、水杨酸甲酯(冬青油)13味药组成,具有祛风湿、止痛的功效,用于头痛、风湿痛、神经痛、扭伤及肌肉酸痛等症,疗效确切,需求量大。
国家药品标准WS3-B-1534-93中描述的伤湿祛痛膏的制备工艺为:十三味原料中除薄荷脑、冰片、樟脑、水杨酸甲酯外,其余生川乌等九味粉碎成细粉,用85%乙醇回流三次,每次1.5小时,合并提取液,回收乙醇,浓缩至相对密度为1.16~1.21(55~60℃热测)的浸膏,加入薄荷脑等四味,混匀;另加3.7~4倍重量由橡胶、松香等制成的基质,制成涂料。进行涂膏,切段,盖衬,切成小块,即得。
目前市场上的伤湿祛痛膏产品主要采用上述国家药品标准中的方法进行提取,提取率低,不能将药材中的有效成分全部提取出来,还有很多有效成分留在药渣中被扔掉;而且药材中的有效成分暴露在高温下的时间较长,部分有效成分因长时间受热而被破坏,严重影响了该产品的药效;传统制备方法中,由于薄荷脑、冰片、樟脑、水杨酸甲酯都是非水溶性的,与浸膏混合的过程中易造成混合不均匀,影响产品疗效。
发明内容
本发明的目的在于提供一种中药贴膏剂伤湿祛痛膏的制备方法。本发明方法能够克服现有制备方法存在的提取率低、有效成分易遭破坏、产品杂质多、药物成分不均一等缺点,使用效果好,疗效显著。
本发明的技术方案是这样实现的,它包括以下步骤:
(1)按以下药材品种及重量份数配比选用原料:生川乌180份、生草乌180份、麻黄180份、苍术360份、当归360份、白芷229份、干姜485份、山柰146份、八角茴香114份、薄荷脑80份、冰片60份、樟脑40份、水杨酸甲酯60份;
(2)将步骤(1)所取原料中的生川乌、生草乌、麻黄、苍术、当归、白芷、干姜、山柰、八角茴香粉碎,然后全部加入高压脉冲电场提取器中进行提取,收集提取液;
(3)将步骤(2)中的提取液用孔径为200nm的陶瓷膜进行处理,透过液经分子蒸馏浓缩至浸膏的相对密度为1.16~1.21(55~60℃热测)为止;
(4)向步骤(3)的浸膏中加入步骤(1)所选用的薄荷脑、冰片、樟脑、水杨酸甲酯,搅拌后用均质机进行处理,得到混合物;
(5)向步骤(4)中得到的混合物中加入3.7~4倍重量的由橡胶、松香等辅料组成的基质,制成涂料,进行涂膏,切段,盖衬,切成小块,即得伤湿祛痛膏。
本发明较好的技术方案是:所述的步骤(2)中,提取溶剂为70~80%的乙醇溶液,料液比为1∶5~8(m/v),提取温度为45~50℃,提取时间为50~60min,电场强度为11~15kv/cm,脉冲数为13~20,提取2遍。
本发明较好的技术方案是:所述的步骤(3)中,分子蒸馏的压力为20~30Pa,蒸发温度为30~35℃,冷凝温度0~10℃。
本发明较好的技术方案是:所述的步骤(4)中,搅拌后的物料倒入均质机中,先在6~15MPa条件下均质3~5次,再在20~30MPa条件下均质2-4次。
本发明专利具有以下优点:
(1)将原料中的中药材采用高压脉冲电场提取,有助于药效成分提取完全;
(2)将提取液用陶瓷膜处理,可以更彻底的去除微小的药渣、颗粒及有害的微生物;
(3)采用分子蒸馏技术进行浓缩,可以有效的避免活性药效成分受到破坏;
(4)采用均质机对薄荷脑、冰片、樟脑、水杨酸甲酯和浸膏进行混合,能使物料混合更均匀,物料状态更好。
具体实施方案
实施例1
取中药材生川乌180份、生草乌180份、麻黄180份、苍术360份、当归360份、白芷229份、干姜485份、山柰146份、八角茴香114份,用粉碎机粉碎,然后全部投入高压脉冲电场提取器中进行提取,提取溶剂为70%的乙醇溶液,料液比为1∶8(m/v),提取温度为50℃,提取时间为50min,电场强度为15kv/cm,脉冲数为20,提取2遍,提取液用孔径为200nm的陶瓷膜进行处理,透过液经分子蒸馏,分子蒸馏的压力为30Pa,蒸发温度为30℃,冷凝温度0℃,浓缩至液体的相对密度为1.18(58℃热测),得到浸膏。
向浸膏中加入薄荷脑80份、冰片60份、樟脑40份、水杨酸甲酯60份,短暂搅拌后用均质机处理,先在10MPa条件下均质5次,再在20MPa条件下均质4次,得到混合物。然后向混合物中加入混合物重量3.7倍的由橡胶、松香等辅料组成的基质,制成涂料,进行涂膏,切段,盖衬,切成小块,即得伤湿祛痛膏。
实施例2
取中药材生川乌180份、生草乌180份、麻黄180份、苍术360份、当归360份、白芷229份、干姜485份、山柰146份、八角茴香114份,用粉碎机粉碎,然后全部投入高压脉冲电场提取器中进行提取,提取溶剂为75%的乙醇溶液,料液比为1∶7(m/v),提取温度为45℃,提取时间为55min,电场强度为13kv/cm,脉冲数为17,提取2遍,提取液用孔径为200nm的陶瓷膜进行处理,透过液经分子蒸馏,分子蒸馏的压力为25Pa,蒸发温度为35℃,冷凝温度5℃,浓缩至液体的相对密度为1.20(56℃热测),得到浸膏。
向浸膏中加入薄荷脑80份、冰片60份、樟脑40份、水杨酸甲酯60份,短暂搅拌后用均质机处理,先在12MPa条件下均质4次,再在25MPa条件下均质3次,得到混合物。然后向混合物中加入混合物重量4.0倍的由橡胶、松香等辅料组成的基质,制成涂料,进行涂膏,切段,盖衬,切成小块,即得伤湿祛痛膏。
实施例3
取中药材生川乌180份、生草乌180份、麻黄180份、苍术360份、当归360份、白芷229份、干姜485份、山柰146份、八角茴香114份,用粉碎机粉碎,然后全部投入高压脉冲电场提取器中进行提取,提取溶剂为70%的乙醇溶液,料液比为1∶6(m/v),提取温度为45℃,提取时间为60min,电场强度为11kv/cm,脉冲数为15,提取2遍,提取液用孔径为200nm的陶瓷膜进行处理,透过液经分子蒸馏,分子蒸馏的压力为20Pa,蒸发温度为30℃,冷凝温度8℃,浓缩至液体的相对密度为1.19(60℃热测),得到浸膏。
向浸膏中加入薄荷脑80份、冰片60份、樟脑40份、水杨酸甲酯60份,短暂搅拌后用均质机处理,先在15MPa条件下均质3次,再在30MPa条件下均质2次,得到混合物。然后向混合物中加入混合物重量4.0倍的由橡胶、松香等辅料组成的基质,制成涂料,进行涂膏,切段,盖衬,切成小块,即得伤湿祛痛膏。
上述实施例只是为说明本发明的技术构思以及技术特点,并不能以此限制本发明的保护范围。凡根据本发明的实质所做的等效变换或修饰,都应该涵盖在本发明的保护范围之内。

Claims (4)

1.一种中药贴膏剂伤湿祛痛膏的制备方法,其特征在于,包括以下几个步骤:
(1)按以下药材品种及重量份数配比选用原料:生川乌180份、生草乌180份、麻黄180份、苍术360份、当归360份、白芷229份、干姜485份、山柰146份、八角茴香114份、薄荷脑80份、冰片60份、樟脑40份、水杨酸甲酯60份;
(2)将步骤(1)所取原料中的生川乌、生草乌、麻黄、苍术、当归、白芷、干姜、山柰、八角茴香粉碎,然后全部加入高压脉冲电场提取器中进行提取,收集提取液;
(3)将步骤(2)中的提取液用孔径为200nm的陶瓷膜进行处理,透过液经分子蒸馏浓缩至浸膏的相对密度为1.16~1.21(55~60℃热测)为止;
(4)向步骤(3)的浸膏中加入步骤(1)所选用的薄荷脑、冰片、樟脑、水杨酸甲酯,搅拌后用均质机进行处理,得到混合物;
(5)向步骤(4)中得到的混合物中加入3.7~4倍重量的由橡胶、松香等辅料组成的基质,制成涂料,进行涂膏,切段,盖衬,切成小块,即得伤湿祛痛膏。
2.根据权利要求1所述的一种中药贴膏剂伤湿祛痛膏的制备方法,其特征在于:所述的步骤(2)中,提取溶剂为70~80%的乙醇溶液,料液比为1∶5~8(m/v),提取温度为45~50℃,提取时间为50~60min,电场强度为11~15kv/cm,脉冲数为13~20,提取2遍。
3.根据权利要求1所述的一种中药贴膏剂伤湿祛痛膏的制备方法,其特征在于:所述的步骤(3)中,分子蒸馏的压力为20~30Pa,蒸发温度为30~35℃,冷凝温度0~10℃。
4.根据权利要求1所述的一种中药贴膏剂伤湿祛痛膏的制备方法,其特征在于:所述的步骤(4)中,搅拌后的物料倒入均质机中,先在6~15MPa条件下均质3~5次,再在20~30MPa条件下均质2-4次。
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