盐酸丙卡特罗舌下滴丸的研制及其稳定性考察

Study on Procaterol Hydrochloride Sublingual Dropping Pill and Stability

关键词:  盐酸丙卡特罗舌下滴丸  正交试验  处方工艺  稳定性

Key words:  procaterol hydrochloride sublingual dropping pill  orthogonal experiment  prescription and technology  stability

摘要:

目的 优化盐酸丙卡特罗舌下滴丸的处方和工艺，确定最佳处方与工艺，并进行稳定性试验研究。方法 以滴丸的成型效果、丸重差异、溶散时限为指标，采用正交试验筛选滴丸基质及用量，确定最佳处方；采用正交试验优化滴丸滴制工艺，包括冷却剂甲基硅油温度、料温、滴头到液面的距离等；取3批试样，模拟上市包装，按中国药典的要求，考察稳定性。结果 最佳处方为盐酸丙卡特罗0.007 g，PEG4000 5 g，PEG6000 15 g和泊洛沙姆F68 15 g；最佳工艺为冷却剂甲基硅油温度8 ℃，料温65 ℃，滴头到液面的距离5 cm。经加速试验6个月及长期试验12个月考察，性状、含量、有关物质、溶散时限等项指标均未见明显变化，说明该制剂较稳定。结论 盐酸丙卡特罗舌下滴丸处方工艺简单，稳定性较好。

Abstract:

OBJECTIVE To optimize the formulation technology of procaterol hydrochloride sublingual dropping pill and study the stablity. METHODS The optimal preparation technology was selected by the orthogonal experiment, using the forming effect, weight variation and dissolution time as evalution indexs. And the stability of three batches of samples simulated market packaging was also studied according to Ch.P(2005). RESULTS The optimal condition of procaterol hydrochloride sublingual dropping pill was procaterol hydrochloride 0.007 g, PEG4000 5 g, PEG6000 15 g and poloxamer F68 15 g, the coolant temperature was 8 ℃, the dropping temperature was 65 ℃, and the distance between dropping head and coolant surface was 5 cm. The characteristics, content, related substances, dissolution time of procaterol hydrochloride sublingual dropping pill were no significant changes through the six months accelerated test and 12 months long-term test. CONCLUSION The optimized preparation technology of procaterol hydrochloride sublingual dropping pill is easy, and the stability is good.