目的 应用超细粉羟丙基纤维素（HPC）作为包衣材料，通过新型静电干法包衣技术制备复方丹参防潮包衣片，探究包衣处方及工艺参数对包衣效率及包衣膜性能的影响，为复方丹参片等水敏性中药的防潮包衣提供新思路。方法 通过静电粉末沉积技术制备防潮游离包衣膜，考察增塑剂对其机械性质和透湿性的影响；采用静电干法包衣技术制备复方丹参防潮包衣片，评价防潮包衣片质量和防潮性能，并考察包衣处方和工艺参数对包衣效率及防潮包衣片质量性能的影响。结果 通过调节静电喷枪的充电电压和液态增塑剂的用量可以控制包衣效率；相比静态固化工艺，动态固化工艺制备的包衣膜性能更优，更有助于降低防潮包衣片的吸湿性；薄膜最佳工艺参数是增塑剂喷涂时间3 min、二氧化钛添加比例1%，当包衣增重为6.7%时，包衣膜具有良好的防潮性能。结论 以超细粉HPC为包衣成膜材料，利用新型静电干法包衣成功制备了复方丹参防潮片，为水敏性药物的干法包衣提供了新的思路。

Objective Using ultrafine hydroxypropyl cellulose (HPC) powders as coating material to prepare moisture barrier coating film for Compound Danshen Tablets by an innovative electrostatic powder coating technology. The effects of coating prescription and process parameters on coating efficiency and coating film properties were investigated, so as to provide new ideas for moistureproof coating of moisture sensitive traditional Chinese medicine such as Compound Danshen Tablets. Methods Free films were prepared by applying an electrostatic deposition process, and the effects of liquid plasticizer on the mechanical properties and the water vapor permeability were investigated. And the Compound Danshen Tablets were dry coated with ultrafine powders by the electrostatic coating technology. The effects of coating formulations and processing conditions on the moisture sorption behavior of the barrier film coated tablets were studied. Results The coating efficiency could be manipulated by adjusting the charging voltage of the electrostatic spray gun and the amount of the liquid plasticizer. Compared with static curing process, dynamic curing process was capable to produce a satisfactory film with an enhanced moisture barrier function for the herbal medicines. The best coating process parameters were plasticizer spraying time 3 min and titanium dioxide addition ratio 1%. The minimum hygroscopicity was achieved when the coating level was increased to 6.7%. Conclusion The moisture-protective effect by using a novel electrostatic coating technology with ultrafine powders was efficiently achieved, suggesting that it was a promising alternative for the protection for the moisture sensitive drugs.

R283.6

国家自然科学基金资助项目（21808206）；宁波市国际合作项目（2018D10011）；宁波市科技项目（2019C10080）