复方链霉素滴鼻液的制备及质量控制

目的:改善复方链霉素滴鼻液的稳定性,建立其质量控制方法.方法:采用复合乳化剂改制成乳浊液.用氯仿去除鱼肝油后,利用链霉素的特征反应-麦芽酚反应生成麦芽酚,与Fe3 形成红色络合物,在550 nm处测定A值,求其含量.结果:成品在室温下贮存一年未见分层.链霉素的含量测定研究:空白试验A仅为0.001～0.003,3种不同浓度的回收率平均值(三次)分别为98.3%,98.0%,101.5%(RSD2.39%,0.50%,0.87%).样品测定两批,每批测定3次,RSD分别为0.50%和0.45%.结论:复方链霉素滴鼻液稳定,含量测定方法简便可靠.

Preparation and Quality Control of Compound Streptomycin Nasal Drops

ABSTRACT Objective: To improve the stability of compound streptomycin nasal drops and to establish a method for its quality control. Method: An emulsion was prepared with a compound emulgent. A red chelated compound was formed with Matol ( a production of character reaction of Streptomycin) and Fe3+ after Cod liver oil was extracted with Chloroform. The absorption value (A) was determinate in 550 nm of the wavelength. Result: No stratification was found to the production in storage of one year in room temperature. The A value of the blank test of the analysis were 0. 001-0. 003 , the average recoveries for 3 concentration of samples were 78. 8% ( RSD 1. 96% ) ,98.0% (RSD 0. 50% ) ,and 121.7% ( RSD 1.01%),respectively. The RSD of analysis for 2 batches samples were 0. 50% and 0. 45%. Conclusion: This product was stable. The method of analysis is simple and reliable.