Kleinberg M L, Duafala M E, Nacov C, Flora K P, Hines J, Davis K, McDaniel A, Scott D
University of California San Diego Medical Center.
Am J Hosp Pharm. 1990 Feb;47(2):377-81.
The stability of heroin hydrochloride in various drug-administration devices was studied. Heroin hydrochloride was supplied as the bulk powder by the National Institute on Drug Abuse and in the formulated dosage form by Evans Medical, Ltd. Stability was determined at concentrations of 1 and 20 mg/mL at room temperature (23-25 degrees C) and at 4 degrees C in a polyvinyl chloride (PVC) bag, a disposable glass syringe, and two disposable infusion devices. Studies at both concentrations also were conducted at 31 degrees C in the disposable infusion devices. All experiments were conducted in triplicate. A validated, stability-indicating, high-performance liquid chromatography assay was used. Heroin hydrochloride remained stable for a minimum of 15 days in the PVC bag and the Infusor infusion device at the tested temperatures and concentrations. In the glass syringe, heroin hydrochloride was shown to be stable for a minimum of 15 days at both 1 mg/mL and 20 mg/mL if refrigerated at 4 degrees C, whereas at room temperature it was stable for a minimum of 7 days at 1 mg/mL and for 12 days at 20 mg/mL. In the Intermate 200 infusion device, heroin hydrochloride was stable for a minimum of 15 days at both concentrations and all temperatures except for the 1 mg/mL concentration at 31 degrees C. In the latter case, stability was for a minimum of two days. No substantial changes in physical appearance or pH were observed in any of the containers under the conditions studied. Heroin hydrochloride can be repackaged in the disposable glass syringe, PVC bag, and each of the disposable infusion devices for routine clinical use.
研究了盐酸海洛因在各种给药装置中的稳定性。盐酸海洛因由美国国家药物滥用研究所提供散装粉末，并由伊文斯医疗有限公司提供制成的剂型。在室温（23 - 25摄氏度）和4摄氏度下，于聚氯乙烯（PVC）袋、一次性玻璃注射器和两种一次性输液装置中，测定1毫克/毫升和20毫克/毫升浓度的盐酸海洛因的稳定性。在一次性输液装置中，也在31摄氏度下对两种浓度进行了研究。所有实验均重复进行三次。使用了经过验证的、稳定性指示的高效液相色谱法。在测试的温度和浓度下，盐酸海洛因在PVC袋和输液器输液装置中至少稳定15天。在玻璃注射器中，如果在4摄氏度冷藏，1毫克/毫升和20毫克/毫升的盐酸海洛因至少稳定15天，而在室温下，1毫克/毫升时至少稳定7天，20毫克/毫升时至少稳定12天。在Intermate 200输液装置中，除了在31摄氏度下1毫克/毫升的浓度外，盐酸海洛因在所有浓度和温度下至少稳定15天。在后一种情况下，稳定性至少为两天。在所研究的条件下，任何容器中的外观或pH值均未观察到实质性变化。盐酸海洛因可重新包装在一次性玻璃注射器、PVC袋和每种一次性输液装置中用于常规临床使用。
