目的 研究抗癌平分散片的制备工艺与处方。方法 采用正交实验设计优化中药材水提工艺、提取物的喷雾干燥工艺和分散片处方。结果 确立最优水提工艺参数为8倍加水量,提取2次,每次煎煮时间60 min;提取物喷雾干燥最优工艺参数为药液密度1.20 g·mL-1,进风温度为180 ℃,出风温度为80 ℃;最优处方比例为微晶纤维素加入量37%,交联羧甲基纤维素钠与交联聚乙烯吡咯烷酮加入量之比为5∶1,硬脂酸镁0.15%。结论 采用正交实验设计优化的工艺处方可以用于制备抗癌平分散片。
Abstract
OBJECTIVE To study preparation process and formula of Kang′aiping dispersible tablets.METHODS Orthogonal designs were used to optimize water extraction process of traditional Chinese herbs from Kang′aiping pills, spray drying process of extracts and formulas of Kang′aiping dispersible tablets.RESULTS The optimal water-extraction process is established by adding eight times water of raw materials, boiling for 60 min and extracting for two times. The optimal spray drying process parameters are that the density of the liquid extracts is 1.20 g·mL-1, inlet air temperature is 180 ℃ and outlet air temperature is 80 ℃. And the optimal formula consists of 37% microcrystalline cellulose, 5∶1 of the ratio of croscarmellose sodium and PVPP, and 0.15% magnesium stearate. CONCLUSION Formula and process optimized by using orthogonal experimental design is suitable for preparation of Kang′aiping dispersible tablets.
关键词
抗癌平分散片 /
正交实验设计 /
优化 /
水提法 /
喷雾干燥
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Key words
Kang′aiping dispersible tablets /
orthogonal experimental design /
optimization /
water extraction /
spray drying
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中图分类号:
R944
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参考文献
[1] CHEN F M, LUO J, DUN M F. The effect of anti-cancer and combination of trastuzumab and chemotherapy on the short-term and long-term effect of combination of trastuzumab and chemotherapy on the patients with advanced gastric cancer [J]. Pract J Cancer(实用癌症杂志), 2019, 34(2):264-266.
[2] FANG Q, XU H G, SHAO C F. Clinical study of Kangaipin Wan on postoperative patients with colorectal cancer treated with FOLFOX chemotherapy [J]. Chin J Biochem Pharm (中国生化药物杂志), 2017, 37(2):93-96.
[3] DAI Y L, PU J X, LIAO R. Comparison of oral preparations of Chinese medicine dispersible tablets and traditional Chinese medicine [J]. Chin J Ethnomed Ethnopharm (中国民族民间医药杂志), 2017, 26(8):63-65.
[4] JING J, HUANG G H. Research progress of traditional Chinese medicine dispersible tablet [J]. Guide China Med(中国医药指南), 2013, 11(8):73-75.
[5] Ch.P(2015). Vol 4(中国药典2015年版.四部)[S]. 2015:118.
[6] ZHAO K, WU Q D, LIU Z T. Factors affecting disintegration degree of traditional Chinese medicine tablets and solution [J]. Chin J Pharm Econ (中国药物经济学), 2014(S1):78-79.
[7] YIN M Y, LIU S X, ZHANG T J. Overview of extraction technology of compound Chinese medicine [J]. Chin Herb Med (中草药), 2015, 46(21):3279-3283.
[8] ZHAN Z Y. Research progress on new technology of extraction and separation of traditional Chinese medicine[J]. Dietary Health(饮食保健), 2017, 4(3):297.
[9] ZHANG Y Q, ZHU H X, GUO L W. Study on extraction technology of compound Yuetongping capsule [J]. Lishizhen Med Mat Med Res (时珍国医国药), 2008, 19(3):594-596.
[10] LIU K, LI X, CHEN F. Determination of isofraxidin content in sarcandrae diskets by RP-HPLC [J]. Pharm J Chin PLA (解放军药学学报), 2018(2):140-143.
[11] ZHANG J B, GE Y R. Determination of isofraxidine content in whole plant of sarcandra glabra compound prescription by HPLC method [J]. Chin Cont Med Educ (中国继续医学教育), 2017, 9(11):186-189.
[12] LI C L, XIONG W J, YU X X. Simultaneous determination of eight constituents in Kangaiping Pills by HPLC [J]. Chin Tradit Pat Med(中成药), 2018, 40(8):90-93.
[13] WANG J. Application of orthogonal design method in spray drying process of traditional Chinese medicine [J]. South Agricul Mach(南方农机), 2017, 3(2):20-21.
[14] ZHENG J, ZHANG G J. Research progress of spray drying technology in pharmaceutical process [C]. Academic Conference on Chinese Traditional Chinese Medicine and Symposium on Teaching Reform and Textbook Constructio n of Traditional Chinese Medicine Identification Discipline, 2015.
[15] CHEN J, YANG Z Q, ZHANG K. The characteristics of the nano spray drying technology and its application in the pharmaceutics fields [J]. Chin J New Drug (中国新药杂志), 2017 (5):43-48.
[16] WANG Y R, LI H, ZHANG B X. Application of new accessories in traditional Chinese medicine dispersible tablets [J]. Chin J Exp Tradit Med Form(中国实验方剂学杂志), 2010, 16(10):207-209.
[17] HAN L, ZHANG D K, QIN C F. The determination of micromeritics parameters of dispersible tablet's common excipients and the effects of SiO2 on TCM dispersible tablet′s disintegrating properties [J]. Chin J Hosp Pharm (中国医院药学杂志), 2013, 33(11):844-849.
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脚注
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