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盐酸丁卡因注射液制备时,加适量的枸橼酸或盐酸对制剂的pH进行控制有利于稳定。文献报道,本品在20℃时最稳定,pH为3.45。[Schmid H W: Pharm Acta Helv 36:423,1961]美国药典19版规定本品的pH为3.5～6.0。我们将pH因素对本品稳定性方面的影响,进行了实验观察和作了处方设计。一、1%盐酸丁卡因实验液的配制取盐酸丁卡因(北京制药厂产品,批号790527)加注射用水溶解后,分别在酸度计控
Preparation of tetracaine hydrochloride injection, add the appropriate amount of citric acid or hydrochloric acid on the preparation of the pH control is conducive to stability. Reported in the literature, this product is the most stable at 20 ℃, pH 3.45. [Schmid H W: Pharm Acta Helv 36: 423, 1961] The U.S. Pharmacopeia version 19 states that the pH of this product is 3.5 to 6.0. We will pH factors on the stability of this product, the experimental observation and made a prescription design. First, the preparation of 1% tetracaine hydrochloride test solution Tetracaine hydrochloride (Beijing Pharmaceutical Factory, batch number 790527) plus water for injection dissolved, respectively, in the acidity meter control