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.PDFVIP

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 ＊ 姜建国 ，张西如，宋更申，赫晓军（河北省食品药品检验院，石家庄 050011） + 中图分类号 R927.11；R974.2 文献标志码 A 文章编号 1001-0408（2013）17-1593-03 DOI 10.6039/j.issn. 1001-0408.2013.17.21 摘 要 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Agilent C18，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/ml（r ＝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。 关键词 枸橼酸喷托维林；溶出度；高效液相色谱法；片剂；滴丸 Establishment of the Method for Dissolution Test of Pentoxyverine Citrate Preparations and Sample Inspec- tion from 42Manufactures JIANG Jian-guo ，ZHANG Xi-ru ，SONG Geng-shen ，HE Xiao-jun （Hebei Provincial Institute for Food and Drug Control ，Shijiazhuang 050011，China ） ABSTRACT OBJECTIVE ：To establish a method for the dissolution test of Pentoxyverine citrate preparations ，and to investigate the dissolution rate of 220batches of Pentoxyverine citrate preparations. METHODS ：Basket method was used to determine dissolu- tion rate using 900ml 0.1mol/L HCl as medium. HPLC method was adopted. Agilent C18 column was used with mobile phase con- sisted 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 220batches of samples. CON- CLUSIONS ：The dissolution test method is accurate ，highly precise. The method can effectively control the quality of product. It is suggeste