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目的：考察影响药树脂体外溶出的因素，制备缓释盐酸苯丙醇胺（ＰＰＡ·ＨＣｌ）树脂。方法：以不同粘度规格的乙基纤维素（ＥＣ）为包衣膜材料制备缓释ＰＰＡ·ＨＣｌ树脂，以体外溶出试验，考察了树脂粒径、ＥＣ粘度、ＥＣ包衣增重百分率、ＥＣ分散介质（水或乙醇）以及体外释放介质的ｐＨ值和离子强度对上述缓释药树脂体外溶出的影响。结果：上述因素对药树脂的释药均有不同程度的影响，以ＥＣ２００Ｐａ·ｓ包衣增重达１５０ｇ·ｋｇ－１时，包衣药树脂在０．１ｍｏｌ·Ｌ－１ＨＣｌ中的释放符合美国药典２３版缓释ＰＰＡ·ＨＣｌ胶囊的要求。结论：用乙基纤维素为包衣膜材料，可以制备缓释ＰＰＡ·ＨＣｌ树脂。
OBJECTIVE: To investigate the factors influencing the dissolution of drug resin in vitro and prepare PPA · HCl (PPA · HCl) resin. Methods: The sustained-release PPA · HCl resin was prepared by using ethyl cellulose (EC) as coating film material with different viscosity. The dissolution test was conducted in vitro. The effects of resin particle size, EC viscosity, percentage of EC coating weight gain, EC dispersion The effect of medium (water or ethanol) and in vitro release medium pH and ionic strength on in vitro dissolution of the sustained release resin described above. Results: The above factors had different effects on the release of the medicinal resin. When the weight gain of EC200Pa · s was 150g · kg-1, the release of the coated drug in 0.1mol · L-1HCl was consistent with that of the United States Pharmacopoeia 23th Edition Release of PPA · HCl capsule requirements. Conclusion: The sustained release PPA · HCl resin can be prepared by using ethyl cellulose as coating film material.