不同企业生产的解痉镇痛酊中橙皮苷的薄层色谱法鉴别实验及其可行性分析

Identification Experiment and Feasibility Analysis of Hesperidin in Spasmolytic Analgesia Tincture by Thin Layer Chromatography

目的:分析基本药物解痉镇痛酊中橙皮苷的薄层色谱法鉴别的可行性和不同企业的成品质量。方法:采用硅胶G薄层板展开,以乙酸乙酯-甲醇-水(10∶1.7∶1.3)、甲苯-乙酸乙酯-甲醇-水(2:1:0.5:0.5)为展开剂展开;将展开后分离出的橙皮苷,采用薄层色谱法与对照品比较其斑点颜色、分离位置的相同点。结果:抽取医药公司、零售药店、医院的解痉镇痛酊50批次中,涉及生产企业4家(A、B、C、D);产品分布在江苏省11个城市中;与对照品比较均具有相同的荧光斑点,但颜色不一致,反映出生产企业工艺的不同和原药材质量的差异。结论:不同企业生产的解痉镇痛酊,其成品质量受原药材质量的影响存在一定的差异;药品监管部门应加强对生产企业原药材质量的监控,以确保患者用药的有效性。

Objective:To analyze the feasibility of identification of hesperidin in Spasmolytic analgesia tincture(SAT)by thin layer chromatography(TLC)and the quality of finished products made in different enterprises.Methods:Silica gel G thin laminate was used to unfold;and ethyl acetate-methanol-water(10:1.7:1.3)and toluene-ethyl acetatemethanol-water(2:1:0.5:0.5)were used as developing agents.The spot color and separation position of hesperidin were compared by TLC with the control substance.Results:Among the 50 batches of SAT extracted from pharmaceutical companies,retail pharmacies and hospitals,4 manufacturing enterprises were involved(A,B,C and D).The products are distributed in 11 cities in Jiangsu Province.Compared with the control substance,they all have the same fluorescent spots,but the color is not the same,which reflects the different technology of production enterprises and the difference of the quality of the original medicinal materials.Conclusion:The quality of the finished products of SAT produced by different enterprises is affected by the quality of the original medicinal materials.Pharmaceutical supervisory and administrative departments should strengthen the quality control of the original medicinal materials in the production enterprises to ensure the effectiveness of drug use.