目的：解决复方丹参薄膜衣片中主要活性成份丹参提取液，使用乙醇回收浓缩器不易清洁且有残留，不符合GMP规范要求的问题。改进方法：采用球型浓缩器，加装真空缓冲罐，以每片含量丹参酮ⅡA、丹酚酸B作为主要含量测定指标，对丹参提取液浓缩工艺进行技术改进。结果：丹参酮ⅡA、丹酚酸B含量符合质量标准，球型浓缩罐不残留浸膏、易收膏、易清洁，符合GMP要求。结论：技术改进后，浓缩设备不残留浸膏、易收膏、易清洁，生产中杜绝了污染和交叉污染风险的发生，生产过程符合GMP要求。同时相应提高了浸膏收率，丹参酮ⅡA、丹酚酸B含量在复方丹参薄膜衣片检测项中亦符合质量标准，增加了该产品的经济效益，可用于实际生产。%Objective: to solve the problem that in obtaining salvia miltiorrhiza extraction, recovery condenser is dififcult to be cleaned and ethanol may be remained, which is not consistent with the requirements in GMP standard. Improving method:to use spherical condenser and add vacuum buffer tank, with the contents of tanshinone II A and Dan Phenolic acid B in each tablet as measuring index, salvia miltiorrhiza extraction condensing process was technically reformed. Result:tanshinone II A and Dan Phenolic acid B conform to the quality standard. In spherical tank, there is no remained extracts. Liquid is easy be condensed and the equipment is easy be cleaned. Thus, GMP requirements are reached. Conclusion:with technical improvement, there is no remained extracts, the liquid is easy be condensed and the equipment is easy be cleaned. The occurrences of contamination and cross contamination have been avoided. GMP requirements are met in the process of production. At the same time, extract yield increases, the contents of tanshinone II A and Dan Phenolic acid B inspected in salvia miltiorrhiza tablet are also consistent with quality standard. Thus the economic proift is increased and this process can be used in practical production.
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