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异丙肾上腺素气雾剂剂型有两种:一种是溶液型,主药及抗氧剂溶于潜溶剂酒精中再充入抛射剂制成。它制造工艺简单,但容易变色,有效期短;另一种是混悬型,主药及附加剂先处理成超细粉末,配伍表面活性剂等,再充入抛射剂制成。本型主药不易变色、质量稳定、有效期长,但制造工艺要求高。从药品稳定性角度考虑应以生产混悬型为好。但目前国内生产的多是溶液型而国外都为混悬型。有关混悬剂型的制造工艺尚未见有完整的资料报道。本文就异丙肾上腺素盐酸盐混悬型气雾剂的处方、工艺、稳定性及质量标准作一探讨。
Isoprenaline aerosol dosage forms are two: one is the solution type, the main drug and antioxidant dissolved in latent solvent alcohol and then filled with propellant. Its manufacturing process is simple, but easily discolored, the short period of validity; the other is the suspension type, the main drug and the additive first processed into ultrafine powder, compatible surfactants, and then filled with propellant. This type of main drug is not easy to change color, quality and long validity, but the manufacturing process requires high. From the point of view of drug stability should be based on the production of suspension type as well. At present, however, most of the domestic products are solution-based and foreign ones are suspended. No complete information has been reported on the manufacturing process for the suspension formulations. In this paper, isoprenaline hydrochloride aerosol suspension formulations, process, stability and quality standards for a discussion.