CAJ | 학술논문

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。
목적：해결복방단삼박막의편중주요활성성빈단삼제취액，사용을순회수농축기불역청길차유잔류，불부합GMP규범요구적문제。개진방법：채용구형농축기，가장진공완충관，이매편함량단삼동ⅡA、단분산B작위주요함량측정지표，대단삼제취액농축공예진행기술개진。결과：단삼동ⅡA、단분산B함량부합질량표준，구형농축관불잔류침고、역수고、역청길，부합GMP요구。결론：기술개진후，농축설비불잔류침고、역수고、역청길，생산중두절료오염화교차오염풍험적발생，생산과정부합GMP요구。동시상응제고료침고수솔，단삼동ⅡA、단분산B함량재복방단삼박막의편검측항중역부합질량표준，증가료해산품적경제효익，가용우실제생산。
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.