咳特灵片生产工艺的研究.pdfVIP

目 录 摘要 Ⅰ- Ⅱ 1前言1 2仪器与药材2 2.1仪器2 2.2药材2 3方法与结果2 3.2生产操作过程及工艺条件2 3.3工艺流程图及生产区域洁净级别4 3.4产品质量标准5 3.5咳特灵片压片时颗粒大小和水分的选择5 3.6薄膜包衣法与传统的咳特灵糖衣片比较6 3.7小结8 4讨论8 4.1生产过程中常见问题及处理8 4.2咳特灵薄膜衣片和糖衣片比较10 5.结论11 参考文献12 致谢19 咳特灵片生产工艺的研究 摘要：目的 优化咳特灵片生产工艺，建立一个安全有效的咳特灵片的生产工艺规程。方法 以生产出的片剂片面完整、均匀、光洁、无粘片和麻面为指标，采用对比试验试验方法 ，进行对颗粒大小和水分含量、薄膜衣片和糖衣片的比较。结果 生产咳特灵片原料的颗粒大小和水分含量等条件的参数：颗粒大小为18目，水分含量 为5%，生产出以小叶榕高浸膏粉180g、马来酸氯苯那敏0.70g为主要原料，以糊精38.50 g、羧甲淀粉钠38.50g、乙醇适量、硬脂酸镁2.3g为辅料制成的咳特灵薄膜衣片，并且 安全有效。结论 此咳特灵片生产工艺规程能适用于所有药业生产咳特灵片，具有极高的经济效益。 关键词：咳特灵片；颗粒；水分；生产工艺 Study on the production technology of the Keteling tblets Abstract ：Objective Optimized Keteling tablets production process, the establishment of a safe and effective Keteling tablets production process planning.Methods To produce a tablet-sided complete, uniform, smooth, non-sticky tblets and pockmarked face as index by comparison test test methods were compared for particle size and moisture content, film-coated tablets and sugar-coated tablet.Results Specifications Production Keteling tblets material particle size and moisture content conditions: the particle size of 18 mesh, the moisture content of 5% in order to produce high Ficus extract powder 180g, chlorpheniramine maleate 0.70g of the main raw material, dextrin 38.50g, sodium carboxymethyl starch 38.50g, amount of ethanol, 2.3g of magnesium stearate as auxiliary materials Keteling film- coated tablets, and safe and effective. Conclusion This Keteling tblets production instructions can be applied to all pharmaceutical production Keteling tblets, with high economic efficiency. Keywords: Keteling tablets; granule; water; the production of process I 1前言 慢性支气管炎（chronic bronchitis）是由于感染或非感染因素引起气管、支气管粘膜及其周围组织的慢 [1] 性非特异性炎症。其病理特点是支气管腺体增生、粘液分泌增多 ，