肿节风三清颗粒成型工艺与中试生产研究

doi:10.16431/j.cnki.1671-7236.2020.04.030

中国畜牧兽医 ›› 2020, Vol. 47 ›› Issue (4): 1233-1240.doi: 10.16431/j.cnki.1671-7236.2020.04.030

肿节风三清颗粒成型工艺与中试生产研究

邓锐涵¹, 彭健波², 吴文健², 唐廷崇^1,2, 陶卿², 廖晓光¹, 王春元³, 郝智慧⁴, 杨善忠², 何家康^1,2

1. 广西大学动物科学技术学院, 南宁 530005;
2. 广西兽药制剂工程技术研究中心, 南宁 530003;
3. 青岛农业大学化学与药学院, 青岛 266109;
4. 中国农业大学动物医学院, 北京 100193

收稿日期:2019-09-02 出版日期:2020-04-20 发布日期:2020-04-17
通讯作者: 杨善忠, 何家康 E-mail:870589775@qq.com;32148859@qq.com
作者简介:邓锐涵(1994-),男,山东淄博人,硕士生,研究方向:中兽医药,E-mail:77375366@qq.com
基金资助:
广西创新驱动发展专项资金项目（桂科AA17204057）；广西自然科学基金项目（2017GXNSFAA198351）；广西大学大学生创新创业训练计划项目（201810593294）

Study on Forming Process and Scale-up of Zhongjiefeng Sanqing Granule

DENG Ruihan¹, PENG Jianbo², WU Wenjian², TANG Tingchong^1,2, TAO Qing², LIAO Xiaoguang¹, WANG Chunyuan³, HAO Zhihui⁴, YANG Shanzhong², HE Jiakang^1,2

1. College of Animal Science and Technology, Guangxi University, Guangxi Nanning 530005, China;
2. Engineering Research Center for Veterinary Medicine Preparations in Guangxi, Nanning 530003, China;
3. College of Chemistry and Pharmaceutical Sciences, Qingdao Agricultural University, Qingdao 266109, China;
4. College of Veterinary Medicine, China Agricultural University, Beijing 100193, China

Received:2019-09-02 Online:2020-04-20 Published:2020-04-17

摘要/Abstract

摘要： 为了优选肿节风三清颗粒的最佳成型工艺并考察中试生产的合理性，进行颗粒成型工艺和中试工艺放大研究，颗粒成型工艺试验以成型率、溶化率、吸湿率为考察指标，以浸膏粉与辅料的配比、蔗糖与糊精的配比、乙醇浓度为考察因素，采用正交试验优化成型工艺；中试生产以浸膏得率、成品率、有效成分含量为指标，考察中试工艺放大的可行性。结果显示，优选的肿节风三清颗粒最佳成型工艺为蔗糖∶糊精为3∶2、乙醇浓度为65%、浸膏粉∶辅料为1∶6；颗粒临界相对湿度为73.49%。三批肿节风三清浸膏（中间体）的浸膏得率分别为8.58%、8.58%和8.63%，三批肿节风三清颗粒（成品）的成品率分别为93.40%、92.13%和93.53%，中间体和成品中有效成分异嗪皮啶、迷迭香酸的含量均稳定可控。表明肿节风三清颗粒成型工艺合理，中试生产稳定可控，适合批量生产。

关键词: 浸膏; 颗粒; 成型工艺; 中试生产; 浸膏得率; 成品率

Abstract: In order to optimize the forming process and to examine the rationality of the scale up effect of Zhongjiefeng Sanqing granule,the forming process and scale-up process were performed.In the optimal forming process,orthogonal design was used to optimize three factors,namely the ratio of extract powder to auxiliary materials,the ratio of sucrose to dextrin and the concentration of ethanol,which the molding rate,melting rate and moisture absorption rate were used as the indexes of the process parameters.For the scale up design,the extraction yield,product yield and the content of active ingredient as the indexes to investigate the feasibility of the scale up process.The results showed that the preferred Zhongjiefeng Sanqing granule optimal molding process was that the ratio of sucrose to dextrin was 3∶2,the ethanol concentration was 65%,and the ratio of extract powder to excipient was 1∶6,the critical relative humidity of the granule was 73.49%.The extraction yields of the three batches of Zhongjiefeng Sanqing extract (intermediate) were 8.58%,8.58% and 8.63%,respectively,and the product yields of the three batches of Zhongjiefeng Sanqing granule (finished products) were 93.40%,92.13% and 93.53%,respectively.The content of the active ingredients,namely isoxazidine and rosmarinic acid in the intermediates and finished products,were stable and controllable.It was shown that the molding process of Zhongjiefeng Sanqing granule was reasonable,and the scale up production was stable and controllable,which was suitable for mass production.

Key words: extract; granule; forming process; scale-up; extract yield; product yield

中图分类号:

S853.7

邓锐涵, 彭健波, 吴文健, 唐廷崇, 陶卿, 廖晓光, 王春元, 郝智慧, 杨善忠, 何家康. 肿节风三清颗粒成型工艺与中试生产研究[J]. 中国畜牧兽医, 2020, 47(4): 1233-1240.

DENG Ruihan, PENG Jianbo, WU Wenjian, TANG Tingchong, TAO Qing, LIAO Xiaoguang, WANG Chunyuan, HAO Zhihui, YANG Shanzhong, HE Jiakang. Study on Forming Process and Scale-up of Zhongjiefeng Sanqing Granule[J]. China Animal Husbandry and Veterinary Medicine, 2020, 47(4): 1233-1240.

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肿节风三清颗粒成型工艺与中试生产研究

Study on Forming Process and Scale-up of Zhongjiefeng Sanqing Granule

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