摘要
目的:通过对干浸膏粉进行吸湿性研究,确定猴头菌-地龙(HD)生物转化物制剂成型工艺的相对湿度条件及对应相对湿度条件下制剂操作的最长时间。方法:配制不同湿度环境的溶液,测定HD生物转化物干浸膏粉样品在不同湿度环境溶液中的吸湿速度及计算HD干浸膏粉临界相对湿度(CRH)。建立吸湿速度的数学模型并绘制吸湿百分率随相对湿度变化的曲线,求吸湿速度参数和吸湿百分率达到5%时对应的相对湿度及时间,用解析几何及直线回归法计算CRH,从而确定生产、贮存过程中空气湿度的控制范围及操作条件。结果:在25℃,RH为66.0%、80.8%、88.2%、99.0%的条件下,HD干浸膏粉暴露空气中7.088,3.953,2.892,0.661 h吸湿百分率则达到5%;计算得吸湿百分率达到5%时对应的相对湿度是50.84%,最短时间是9.937 h。HD生物转化物干浸膏粉CRH为68.12%。结论:HD生物转化物干浸膏粉制剂环境的相对湿度控制在50.84%以下,操作时间不超过9.937 h;或相对湿度控制在68.12%以下,操作时间不超过6.810 h。该条件下才能保证HD干浸膏粉吸湿率控制在5%以下,不影响制剂的制备。
Objective： To confirm the relative humidity conditions of preparation of Hericium Erinaceus and Lumbricus （HD） bio- transformation and the longest operation time under the conditions through the study on hygroscopicity of dry extract powder. Methods： The solution was prepared respectively in the environment with various humidity, and the moisture absorption rate and critical relative humidity （CRH） of dry extract powder of HD biotransformation were measured, and then the mathematical model was built and the curves of moisture percentage vs relative humidity was drawn. The parameters of-moisture absorption rate, and the relative humidity and operation time with the moisture percentage up to 5% were calculated. The analytic geometry and linear regressionmethod were used to calculate CRH, so as to determine the air humidity control range and the conditions for the production and storage process. Results： The moisture absorption of HD dry extract powder could reach 5 % when exposed to the air respectively with the relative humidity of 66.0%, 80.8%, 88.2% and 99.0% for 7. 088, 3. 953, 2. 892 and 0.661 h. When the moisture percentage reached 5%, the rela- tive humidity and the shortest time was 50.84% and 9. 937 h, respectively. The CRH of the dry extract powder of HD biotransforma- tion was 68.12%. Conclusion： When the dry extract powder of HD biotransformation is under preparation, the relative humidity of en- vironment should be controlled below 50.84% with the operation time shorter than 9. 937 h, or the relative humidity is controlled below 68. !2% with the operation time shorter than 6. 810 h. Under the above conditions, the moisture absorption rate of HD dry extract pow- der can be controlled below 5%, which does not affect the preparation.
作者
刘园园
周代俊
何述金
陈光宇
李强
何群
Liu Yuanyuan Zhou Daijun He Shujin Chcn Guangyu Li Qiang He Qun(College of Pharmacy, Hunan University of Chi- nese Medicine, Key Disciplines of 12th Five-year Plan in Hunan Pharmacy, Changsha 410208, China Hunan Xinhui Pharmaceutical Co. Ltd.)
出处
《中国药师》
CAS
2017年第3期413-416,共4页
China Pharmacist
基金
湖南中医药大学校企合作科研项目(编号:kjc20150324)
关键词
猴头菌-地龙生物转化物干浸膏粉
吸湿性
吸湿速度
临界相对湿度
Dry powder of Hericium Erinaceus and Eathworn
Hygroscopicity
Rate of moisture adsorption
Critical relative humidity
