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硫酸阿託品片的测定,一般系采用酸硷滴定法,测定时費时間,检品需量較多,在提取过程中因賦型剂的量太多,难以提净,不易得到恒定的結果。硫酸阿託品片此色測定法文献記載的有Vitali’s比色法,操作比較复杂,条件要求較严,难以控制;改良Vitali’s法,比色时需在丙酮中显色后1分钟时比色,不易掌握。另外N-萘基乙烯二胺此色法,溴甲酚紫比色法等也不理想。Tomasck等报道,古柯硷和普魯卡因,硫酸阿託品酯类結构药物与經胺氯化鉄有呈色反应,利用此反应可进行此色测定,但在比色过程中需加乙醚做溶剂,此色液在測定时需通过氯化鈉,而且乙醚的揮发性較大,所以呈色不稳定,操作时比較复杂,难以控制。本文在比基础上对硫酸阿託品与盐酸涇胺三氯化铁呈色反应的条件进行試驗,拟定了一个硫酸阿託品片此色测定的簡单方法,制剂試驗回收結果良好,检品用量甚少,操作比較簡单。
Determination of atropine sulfate tablets, the general use of acid titration method, the determination of the time-consuming, seizure demand more, because the amount of excipients in the extraction process is too large, it is difficult to mention net, not easy to get constant result. Atropine sulfate tablets colorimetric assay literature Vitali’s colorimetric method, the operation is more complex, the conditions require more stringent, difficult to control; modified Vitali’s method, the colorimetric need acetone in 1 minute after colorimetric, Not easy to grasp. In addition N-naphthalene ethylenediamine color method, bromocresol purple color method is not ideal. Tomasck et al reported that cocaine and procaine, atropine sulfate structural drugs with amine chloride by a color reaction, the reaction can be used for color determination, but in the colorimetric process need to add ethyl ether Solvent, the color liquid through the determination of sodium chloride, and the larger the volatility of ether, so the color instability, the operation is more complex and difficult to control. In this paper, based on the conditions of atropine sulfate and hydrochlorothiazide ferric chloride ferric chloride test conditions, developed a simple determination of the color of atropine sulfate tablets, the test results of the preparation of good results, seized goods Little amount, the operation is relatively simple.