双黄连微乳质量评价研究

Quality evaluation of Shuanghuanglian microemulsion

目的:探讨双黄连微乳的质量评价方法与指标的合理性与适用性。方法:以自制"双黄连微乳"为样品,观察和测定制剂的外观性状、pH值、粒径和粒径分布、电导率、黏度等指标,采用HPLC方法测定制剂中黄芩苷、绿原酸和连翘苷的含量,进行3个月的初步稳定性实验,并与普通双黄连口服液作比较。结果:外观性状、pH值、相对密度、粒径和有效成分的含量测定可作为双黄连微乳口服液的质量评价指标。其中粒径的测定是微乳的重要指标。结论:双黄连微乳的质量评价指标应以物理指标与化学成分(或有效成分)相结合比较合理。

Objective：To explore the quality evaluation of Shuanghuanglian microemulsion. Methods：The Shuanghuanglian microemulsion was prepared. Particle size and distribution were investigated by dynamic light scatter. The concentrations and stability of baicalin,chlorogenic acid and phillyrin in Shuanghuanglian microemulsion were determined by HPLC,and were compared with Shuanghuanglian oral solution. Besides, the properties of appearance,pH,conductivity, viscosity of Shuanghuanglian microemulsion were studied. Results： The properties of appearance, pH, particle size, concentration of baicalin, chlorogenic acid and phillyrin were suitable for quality evaluation of Shuanghuanglian microemulsion. The particle size of Shuanghuanglian microemulsion was different from Shuanghuanglian oral solution. Conclusion：Physical and chemical evaluation is suitable for oral microemulsion preparation of traditional Chinese medicine.