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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 study the hygroscopicity of dry extract powders to determine the relative humidity conditions of the molding process of Hericium erinaceus - earthworm (HD) biotransformation preparations and the longest time of preparation operation under the corresponding relative humidity conditions. Methods: The solution of different humidity environment was prepared. The moisture absorption rate of HD biotransformation dry extract powder in different humidity environment solution and the critical relative humidity (CRH) of HD dry extract powder were calculated. The mathematical model of moisture absorption rate was established and the curve of moisture absorption percentage with relative humidity was plotted. The corresponding relative humidity and time when the moisture absorption rate reached 5% and the moisture absorption rate were calculated, and the CRH was calculated by analytic geometry and linear regression to determine the production and storage Control of air humidity in the process of control and operating conditions. Results: Under the condition of RH = 66.0%, 80.8%, 88.2% and 99.0% at 25 ℃, the moisture absorption percentage of HD dry powder extract in 7.088, 3.953, 2.892 and 0.661 h in air was 5% When it reaches 5%, the corresponding relative humidity is 50.84%, the shortest time is 9.937 h. HD Biotransformation dry extract powder CRH was 68.12%. CONCLUSION: The relative humidity of HD biotransformation dry extract powder preparation is controlled below 50.84%, operating time not exceeding 9.937 h, relative humidity below 68.12% and operating time not exceeding 6.810 h. Under this condition, the moisture absorption rate of HD dry extract powder can be controlled under 5% without affecting the preparation of the preparation.