| 引用本文: | 陈光宇,易军如,肖海英,瞿昊宇,何群,谢梦洲.新五汁饮颗粒剂处方优选及吸湿性研究[J].中国现代应用药学,2021,38(2):173-178. |
| CHEN Guangyu,YI Junru,XIAO Haiying,QU Haoyu,HE Qun,XIE Mengzhou.Research on Formulation Optimization and Hygroscopicity of New Five-juice Decoction Granules[J].Chin J Mod Appl Pharm(中国现代应用药学),2021,38(2):173-178. |
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| 新五汁饮颗粒剂处方优选及吸湿性研究 |
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陈光宇1,2,3,4, 易军如5, 肖海英5, 瞿昊宇1,2,3,4, 何群2, 谢梦洲1,2,3,4
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1.湖南中医药大学, 中医学院, 长沙 410208;2.湖南中医药大学, 湖南省药食同源功能性食品工程技术研究中心, 长沙 410208;3.湖南中医药大学, 中医诊断学湖南省重点实验室, 长沙 410208;4.湖南中医药大学, 中医心肺病证辩证与药膳食疗重点研究室, 长沙 410208;5.长沙固本生物科技有限公司, 长沙 410221
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| 摘要: |
| 目的 优选新五汁饮颗粒剂制剂处方配比，考察新五汁饮颗粒剂吸湿性，为将其开发成药膳普通食品提供依据。方法 以外观、澄明度、溶化性、色泽、口感等为评价指标，采用等级一致性检验法优选新五汁饮颗粒剂制剂处方中稀释剂、润湿剂、矫味剂等辅料及其用量；以颗粒收率、休止角（流动性）为评价指标，验证制剂处方优化结果，通过吸湿性试验确定临界相对湿度等参数。结果 新五汁饮颗粒剂最优制剂处方：新五汁饮干浸膏粉1.0份，乳糖1.0份，赤鲜醇1.0份； 95%乙醇制软材，湿法制粒，50℃减压干燥4 h；在不同湿度下吸湿速度动力学方程皆满足幂函数数学模型，吸湿百分率为5%时对应时间（Y）与环境相对湿度（X）最接近的数学表达式为Y=146.7-1.455 00X（R2=0.917 6，F=22.27，P=0.042 1）。结论 生产中环境相对湿度应控制在<65%，暴露在空气中操作的最长时间≤48 h，可保证新五汁饮颗粒剂吸水量<5%。 |
| 关键词: 新五汁饮颗粒剂 制剂处方 吸湿性 药膳普通食品 临界相对湿度 环境相对湿度 |
| DOI：10.13748/j.cnki.issn1007-7693.2021.02.008 |
| 分类号:R283.6 |
| 基金项目:湖南省教育厅科学研究基金（18B237，19K070） |
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| Research on Formulation Optimization and Hygroscopicity of New Five-juice Decoction Granules |
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CHEN Guangyu1,2,3,4, YI Junru5, XIAO Haiying5, QU Haoyu1,2,3,4, HE Qun2, XIE Mengzhou1,2,3,4
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1.HunanUniversity of Chinese Medicine, College of Traditional Chinese Medicine, Changsha 410208, China;2.HunanUniversity of Chinese Medicine, Hunan Engineering Technology Research Centerfor Medicinal and Functional Food, Changsha 410208, China;3.HunanUniversity of Chinese Medicine, Provincial Key Laboratory of TCM Oiagnostics of Hunan, Changsha 410208, China;4.HunanUniversity of Chinese Medicine, The Key Laboratory ofCardiopulmonary Disease Syndrome Differentiation and Medicinal Diet Therapy in Chinese Medicine, Changsha 410208, China;5.Changsha Strengthening Bioscience Technology Co. , Ltd. , Changsha 410221, China
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| Abstract: |
| OBJECTIVE To optimize the formulation and investigate the hygroscopicity of New Five-juice Decotion granules, so as to provide a basis for developing new five-juice decoction granules into herbal cuisine plain food. METHODS Appearance, clarity, melting, color, mouthfeel, etc were used as evaluation indexes. The amount or ratio of excipients in formulation of New Five-juice Decoction granules like the diluent, wetting agent, flavoring agent, etc were optimized by grade-consistency-test-method. Particle yield and angle of repose(fluidity) were used as evaluation indexes, optimal results of the formulation was validated. Parameters like critical relative humidity was determined by hygroscopicity test. RESULTS The best formulation of New Five-juice Decoction granules was:1.0 parts of dry extract powder, 1.0 parts of lactose and 1.0 parts of paclitaxel; soft material was made by 95% ethanol, wet granulation, drying under reduced pressure at 50℃ for 4 h. The kinetic equation of humidity absorption speed at different humidity meet the requirement of power function. The mathematical expression between time(Y) and environment relative humidity(X) at humidity absorption rate of 5% was Y=146.7-1.455 00X (R2=0.917 6, F=22.27, P=0.042 1). CONCLUSION Environment relative humidity should be controlled < 65% in production, the operating time when is exposed to the air should be controlled ≤ 48 h, in this condition the humidity absorption amount of New Five-juice Decoction granules can be controlled < 5%. |
| Key words: New Five-juice Decoction granules formulation hygroscopicity herbal cuisine plain food critical relative humidity environment relative humidity |
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