枸橼酸喷托维林制剂溶出度试验方法的建立及42厂家样品考察

Establishment of the Method for Dissolution Test of Pentoxyverine Citrate Preparations and Sample Inspection from 42 Manufactures

目的:建立枸橼酸喷托维林制剂溶出度试验方法,考察220批枸橼酸喷托维林制剂的溶出度。方法:溶出试验方法采用篮法,以0.1mol/L盐酸溶液900ml为溶出介质;溶出液含量测定采用高效液相色谱法,色谱柱为AgilentC18,流动相为水(含三乙胺,pH值3.0)-甲醇(45∶55),检测波长为215nm。考察42个厂家218批枸橼酸喷托维林片剂和2批滴丸剂的溶出情况。结果:枸橼酸喷托维林检测质量浓度线性范围为5.608～56.08μg/m(lr=0.9999),平均回收率为100.32%～101.29%,RSD<0.76%(n=3);220批样品中有55.5%批次的溶出度结果在标准限度以下。结论:建立的溶出度试验方法准确、精密度好,可有效控制产品质量;同时建议在该制剂的现行国家标准中增加溶出度检查项目。

OBJECTIVE： To establish a method for the dissolution test of Pentoxyverine citrate preparations, and to investigate the dissolution rate of 220 batches of Pentoxyverine citrate preparations. METHODS ： Basket method was used to determine dissolution rate using 900 ml 0.1 mol/L HCl as medium. HPLC method was adopted. Agilent C18 column was used with mobile phase consisted of water （containing ethylamine, pH adjusted to 3.0）-methanol （45 ： 55）. The detection wavelength was set at 215 nm. The dissolution of 218 batches of Pentoxyverine citrate tablets and 2 batches of dripping pills from 42 manufacturers were investigated. RESULTS： The linear range of pentoxyverine citrate was 5.608-56.08 μg/ml （r=0.999 9） with average recoveries of 100.32%- 101.29% （RSD〈0.76%, n=3）; the dissolution rates of 55.5% of batches were below limit among 220 batches of samples. CONCLUSIONS： The dissolution test method is accurate, highly precise. The method can effectively control the quality of product. It is suggested to add dissolution test into present national standard for the preparation.