妇阴康洗剂生产工艺改进探究

Study on the Improvement of Fuyinkang Lotion Production Process

采用pH值5.7的纯化水替代pH值7.3的饮用水提取妇阴康洗剂处方中的中药材,研究并对比两种不同pH溶媒中秦皮乙素的含量,并通过测定0,6和12个月制剂样品中秦皮乙素含量,研究其在制剂中的稳定性.结果发现用pH值5.7的纯化水替代pH值7.3的饮用水,在中药有效成分提取浓缩设备、中药材、工艺参数不变的情况下,提取浓缩液中的秦皮乙素转化率可以提高30%以上,提取浓缩液pH值相对工艺用水有不同程度下降.选用两种不同工艺提取浓缩液各制备1批市售样品,分别进行0,6和12个月稳定性检测分析,结果优化工艺的样品含量稳定性有较大提高,pH基本无变化.因此用pH值较低的纯化水替代pH值较高的饮用水提取妇阴康洗剂处方中的中药材,可提高秦皮乙素的转化率,并能提高产品收率,也能保证药品质量稳定性.

The traditional Chinese medicine from Fuyinkang lotion was extracted with purified water with a pH value of 5.7 instead of drinking water with a pH value of 7.3.The extracted content of esculin in two different pH solvents was studied,and the stability of esculin in preparation samples was determined at 0 months,six months and 12 months,respectively.The results showed that when the purified water with a pH value of 5.7 instead of drinking water with a pH value of 7.3.the conversion rate of acanthine in the concentrated solution could be increased by more than 30%under the condition of the same extraction and concentration equipment of active ingredients,traditional Chinese medicine and process parameters,and the pH value of the concentrated solution decreased to some extent compared with the water used in the process.Two different processes prepared one batch of commercial samples,and the stability of the samples was analyzed for 0 months,six months and 12 months,respectively.The results showed that the content stability of the samples under the optimized process was greatly improved compared with that before optimization,and there was no change in pH.Therefore,using purified water with lower pH instead of drinking water with higher pH to extract Chinese herbal medicines from Fuyinkang lotion prescription can increase the conversion rate of esculetin,increase the yield of the product,and ensure the stability of drug quality.