CN1236812C - 戒毒中药及其制备工艺 - Google Patents
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Abstract
本发明公开了一种戒毒中草药及其制备工艺，它是取木香，沉香，白术，干姜提取挥发油；红参渗漉，漉液回收乙醇；以上药渣与黄芪、白芍、诃子、甘草加水煎煮，合并煎液及蒸馏水液；附片、延胡索、青风藤、洋金花、姜半夏、黄柏提取，合并滤液，回收乙醇，上述煎液、漉液、回流提取液分别浓缩，合并浓缩液，喷雾干燥成浸膏；全蝎浸润，干燥、粉碎、过筛，所得细粉与上述浸膏、挥发油与糊精、蔗糖适量混匀，用乙醇润湿制粒，干燥整粒即得。本发明具有质量稳定、服用方便、吸收快、生物利用度高、无毒副作用等优点。并具有益气温阳、解痉止痛、清解烟毒、醒脑安神之功效。
Description
技术领域：
本发明涉及一种戒毒中草药及其制备工艺。
技术背景：
目前由于毒品泛滥，各种戒毒的药物和方法很多，但大多数药物都含有有毒成分，毒副作用大，安全系数小，服用后万分痛苦，神志不清；有的疗程过长，费用高，特别是复吸率高居不下，不能解除患者的痛苦。
发明内容：
本发明的目的在于：提供一种用纯中草药制备的戒毒药，它疗效好，服用方便，无毒副作用，以解决上述问题。
本发明是这样实现的：以制取1000g计，各原料的用量为：红参120～180g，黄芪240～360g，附片160～240g，延胡索320～480g，青风藤360～540g，洋金花8～12g，白芍240～360g，黄柏120～180g，木香40～60g，沉香40～60g，姜半夏180～270g，全蝎120～180g，白术120～180g，诃子200～300g，干姜40～60g，甘草100～150g。
其制备工艺为：取木香，沉香，白术，干姜提取挥发油，挥发油以6倍量的β-环糊精包结，蒸馏后的水液另器收集；红参切片，用乙醇浸泡24小时后渗漉，漉液回收乙醇；以上药渣与黄芪、白芍、诃子、甘草加水煎煮2次，合并煎液及蒸馏水液；附片、延胡索、青风藤、洋金花、姜半夏、黄柏用乙醇回流提取2次，合并滤液，回收乙醇，上述煎液、漉液、回流提取液分别浓缩至相对密度为1.10～1.12，合并以上3种浓缩液，喷雾干燥成浸膏；全蝎用乙醇浸润4小时，干燥、粉碎、过筛，所得细粉与上述浸膏、挥发油β-环糊精包结物与糊精、蔗糖适量混匀，用乙醇润湿制粒，干燥整粒即得。
本发明与现有技术相比，具有质量稳定、服用方便、吸收快、生物利用度高、无毒副作用等优点。并具有益气温阳、解痉止痛、清解烟毒、醒脑安神之功效。具体临床试验小结如下：
本发明用于海洛因依赖者脱毒治疗临床试验
1.试验设计：
多中心随机双盲双模拟对照试验及开放试验。
2.一般情况：
421例受试者全部为海洛因依赖，男性334例，女性87例，年龄最小17岁，最大45岁，体重最轻36公斤，最重73公斤。其中对照试验219例，含本发明组110例，阳性对照药凯尔丁组79例(其中因不良反应中途停药2例)，阴性对照药安慰剂组30例，本发明开放性试验202例，全部试验本发明组无因不良反应停药退出试验者。
3.试验药：本发明颗粒，每包10g；
阳性对照药：盐酸洛非西定片，每片0.2mg，湖北正大药业
有限公司生产
阴性对照药：安慰剂
4.给药方法
试验组：第1日：本发明颗粒2包，1包，1包，1包。
第2-3日，本发明颗粒2包，2包，2包。
第4-6日，本发明颗粒2包，1包，1包。
第7-8日，本发明颗粒1包，1包，1包。
第9日，本发明颗粒1包，1包。
第10日，本发明颗粒1包。
阳性对照组：第1日，凯尔丁2片，日2次。
第2-4日，凯尔丁3片，日3次。
第5-7日，凯尔丁2片，日3次。
第8日，凯尔丁1片，日3次。
第9日，凯尔丁1片，日2次。
第10日，凯尔丁1片，日1次。
阴性对照组：与试验组(药物外观包装与试验药相同)服药方法完全一样。
5.观察评分记录
记录内容包括：
简要病历记录表；
戒断症状评定量表：于治疗前及治疗期间每天上午服药后1小时进行评分。临床症状分5级，严重程度分4度，即0度(无表现)；I度(轻度)经询问有症状；II度(中度)主动诉有症状但可忍受；III度(严重)症状不能忍受；
Hamilton焦虑量表(HAMA)：测定三次，于试验前发瘾时，治疗中第5天，治疗结束时各评分一次。出现特殊心理障碍时，在备注栏内另加文字说明。
6.不良反应监测：于用药前及用药后每日记录受试者体温、血压、呼吸、脉搏及各种临床可能出现的不良反应，并按其严重程度(轻、中、重)和与受试药物的相关性(即无关、可能有关、很可能有关，肯定有关)及时判定。
7.资料总结：对所有记录各类数据统一进行统计处理，计量资料用t检验，计数资料用x2检验。
8.结果表明：用药1-10日内，本发明组的逐日戒断效果，逐日减分率、戒断症状总分逐日评分情况、主要戒断症状分值变化及焦虑量表三次评价结果均明显优于安慰剂组，各项指标均存在显著性差异(P＜0.001)，与安慰剂对照有效，表现出本品的脱毒疗效肯定。本发明与凯尔丁比较，上述各项评价指标的对比结果基本一致。但在某些评价指标方面显示出本发明优于凯尔丁的趋势，如对用药1-10日戒断效果的评定，前者优于后者。特别是用药第3-4日被戒断者前者明显优于后者，分别为42.5％和16.5％，P＜0.001，具有统计学差异。另外，本发明对戒断症状失眠的控制效果，也优于凯尔丁(P＜0.05或P＜0.01)。显示出本发明有一定优势。
结果表明，本发明为纯中药制剂，药效温和，未见严重不良反应，少数受试者有头晕、眼花、视物模糊、口干、步态不稳等，减量或停药后很快恢复正常。该药对呼吸系统、循环系统、消化系统等无明显影响，对心、肝、肾功能亦无明显影响。
具体实施方式：
本发明的实施例：以制取1000g为例，取木香50g，沉香50g，白术150g，干姜50g提取挥发油，挥发油以6倍量的β-环糊精包结，蒸馏后的水液另器收集；红参150g切片，用75％乙醇浸泡24小时后渗漉，漉液回收乙醇；以上药渣与黄芪300g、白芍300g、诃子250g、甘草125g加水煎煮2次，合并煎液及蒸馏水液；附片200g、延胡索400g、青风藤450g、洋金花10g、姜半夏225g、黄柏150g用70％乙醇回流提取2次，合并滤液，回收乙醇；上述煎液(含水液)、漉液、回流提取液分别浓缩至相对密度为1.10～1.12，合并以上3种浓缩液，喷雾干燥成浸膏；全蝎用75％乙醇浸润4小时，60～70℃干燥、粉碎、过筛，所得细粉与上述浸膏、挥发油β-环糊精包结物与糊精、蔗糖适量混匀，用80％乙醇润湿制粒，干燥整粒，制成1000g即得。
Claims (2)
1、一种戒毒中药，其特征在于：以制取1000g计，各原料的用量为：红参120～180g，黄芪240～360g，附片160～240g，延胡索320～480g，青风藤360～540g，洋金花8～12g，白芍240～360g，黄柏120～180g，木香40～60g，沉香40～60g，姜半夏180～270g，全蝎120～180g，白术120～180g，诃子200～300g，干姜40～60g，甘草100～150g。
2、一种如权利要求1所述的戒毒中药的制备工艺，其特征在于：取木香，沉香，白术，干姜提取挥发油，挥发油以6倍量的β-环糊精包结，蒸馏后的水液另器收集；红参切片，用乙醇浸泡24小时后渗漉，漉液回收乙醇；以上药渣与黄芪、白芍、诃子、甘草加水煎煮2次，合并煎液及蒸馏水液；附片、延胡索、青风藤、洋金花、姜半夏、黄柏用乙醇回流提取2次，合并滤液，回收乙醇，上述煎液、漉液、回流提取液分别浓缩至相对密度为1.10～1.12，合并以上3种浓缩液，喷雾干燥成浸膏；全蝎用乙醇浸润4小时，干燥、粉碎、过筛，所得细粉与上述浸膏、挥发油β-环糊精包结物与糊精、蔗糖适量混匀，用乙醇润湿制粒，干燥整粒即得。
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