分光光度法测定颠胃酸口服液胃蛋白酶的效价

Valence Determination of Pepsin in Dianweisuan Oral Liquid by Spectrophotometry

目的:建立颠胃酸口服液效价的测定方法,考察低温和室温储存条件下的有效期。方法:以酪氨酸为对照品,牛血红蛋白为底物,水浴温度(37±0.5)℃,紫外分光光度法测定胃蛋白酶的效价,测定波长275 nm;考察2～10℃低温储存和室温储存的有效期。结果:测得颠胃酸口服液胃蛋白酶的平均效价为39.1 u/mL,低温储存有效期为6个月,室温储存有效期为3个月。结论:该方法用于颠胃酸口服液胃蛋白酶的效价测定,操作便利、条件稳定,结果重现性好,适用于制剂的质量控制。颠胃酸口服液在低温环境中储存比室温储存有效期延长3个月。

Objective： To develop a method for the determination of pepsin valence in Dianweisuan oral liquid and detect the validity duration at low temperature and room temperature. Methods： Tyrosine was the control sample. Bovine hemoglobin was used as the substrate. Bathing temperature was at （37±0.5） ℃. The determining wavelength was at 275 nm by spectrophotometry. The validity duration at low temperature （2 -10℃ ） and room temperature were determined respectively. Results： The mean valence of pepsin in Dianweisuan oral liquids was 39.1 u/mL. The periods of validity were 6 months at low temperature and 3 months at room temperature.Conclusions： This method was simple and convenient. The accurate result and reappearing feature will be regarded as conventional quality control method in hospital. The period of validity can be prQlonged to 6 months at low temperature.