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目的:针对经宁颗粒制备过程中收率低、易吸潮,服用过程中溶化性差进而影响临床疗效等问题,进行成型工艺的改进。方法:采取浸膏直接与乳糖、糊精混匀后干燥、制粒的新工艺,与原工艺所得颗粒从外观、溶化性、吸湿性、颗粒成型率(即粒度)等方面进行比较,并考察临界相对湿度的差异。结果:新工艺制得颗粒外观、溶化性、颗粒成型率等均较原工艺为优,吸湿率降低,临界相对湿度提升至70%(25℃),增强了颗粒稳定性。结论:采取新的成型工艺后,颗粒剂成型率、得到改善,有效解决了易吸潮、溶化性差的问题,提高了该颗粒剂质量。
OBJECTIVE: To improve the molding process for the problems of low yield, easy absorption of moisture in the process of preparation of Ningning granule, poor solubility in taking process and influence of clinical curative effect. Methods: The new technology of mixing the extract directly with lactose and dextrin, drying and granulating was compared with that of the original process in terms of appearance, solubility, hygroscopicity and granular forming rate Differences in critical relative humidity. Results: The particle appearance, dissolvability and particle formation rate of the new process were superior to those of the original process. The moisture absorption rate decreased and the critical relative humidity increased to 70% (25 ℃), which enhanced the particle stability. Conclusion: After the new forming process is adopted, the forming rate of granule is improved, the problems of easy to absorb moisture and poor dissolvability are effectively solved, and the quality of granule is improved.