中药半浸膏片压片工艺定量化控制研究  

Studies on Quantitative Control of Compression Technology for Semi-Extract Tablets

作　　者：张源[1] 周琴妹[1] 

机构地区：[1]江苏省中医院制剂部,南京210029

出　　处：《中国药房》2013年第19期1763-1765,共3页China Pharmacy

基　　金：江苏省中医药科技项目立项计划资助(No.LZ09055)

摘　　要：目的:对中药半浸膏片压片工艺进行定量化控制,为素片进行薄膜包衣提供参考。方法:以甲花片为模型,以润滑剂用量、颗粒含水量、粒度分布、颗粒强度、压片力、压片机转速为考察因素,以抗张强度、重量差异、脆碎度、崩解时限的综合评分为指标,采用正交试验优选压片工艺。结果:颗粒含水量、压片力是影响片剂质量的主要因素,粒度分布、颗粒强度和润滑剂用量为次要因素,压片机转速对片剂质量影响很小。最佳压片工艺为润滑剂用量3%,颗粒含水量6%～7.5%,粒度分布18～60目间的颗粒占90%以上,颗粒强度98%,压片机指针在0.4～0.5刻度(片厚3.75mm左右)之间,压片机转速18～19r/min。结论:通过对压片工艺的主要影响因素进行定量化控制,可制备出质量较好的中药半浸膏片。OBJECTIVE： To control the compression technology for semi-extract tablets quantitatively, and to provide reference for the film coating of plain film. METHODS： Using Jiahua pills as model, the compression technology was optimized by orthogonal test with the amount of lubricant, moisture content of particle, distribution of particle size, intensity of paticle, strength and rotation rate of pressure machine as index using comprehensive score of tensile strength, tablet weight variation, friability and disintegration as factors. RESULTS： The moisture content and strength were the leading factors which affect tablet quality. The distribution of particel size, granules strength and amount of lubricant were the secondary factors. The rotation rate of pressure machine had little effect on tablet quality. Optimal compression technology was as follows： amount of lubricant 3%, moisture content of 6%-7.5%, 90% particel size of 18-60 mesh, intensity of paticle 98%, strength of 0.4-0.5 （tablet thickness of about 3.75 mm）, rotation rate of 18-19 r/min. CONCLUSIONS： Qualified semi-extract tablets can be prepared by control the main influential factors of compression technology quantitatively.

关 键 词：中药半浸膏片 压片工艺 正交试验 多指标评分法 

分 类 号：R283[医药卫生—中药学] R284[医药卫生—中医学]