Objective: To establish an in vitro dissolution test method in order to control the quality of compound licorice tablets, and further evaluate its production process. Methods: The dissolution conditions were the paddle method, the speed was 50 r·min-1, the dissolution medium was water, the detection method was the HPLC method, and the self-control method was used to calculate the dissolution. The established dissolution method was used to investigate the release of morphine, codeine phosphate and glycyrrhizic acid in compound licorice tablets from 3 companies. The Weibull model was used to fit the dissolution data. Results: The products from each company were evaluated by comparing the fitting parameters. There were significant differences between the Weibull fitting parameters of different manufacturers, indicating that there were a big difference in the preparation process of each manufacturer. Through the comparison of batch uniformity, it was found that the production process of manufacturer A was relatively stable, but there were certain differences in the samples produced in different years. Conclusion: An dissolution test method is established, and the method was used to evaluate the similarity of the dissolution curves of samples from different manufacturers, which provids a reference for the quality research of compound licorice tablets.
ZHOU Xiao-li, ZENG Yue-lin, YIN Li-hui, CHEN Hua
. Establishment of dissolution method and similarity evaluation of dissolution culves of compound licorice tablets[J]. Chinese Journal of Pharmaceutical Analysis, 2023
, 43(2)
: 280
-288
.
DOI: 10.16155/j.0254-1793.2023.02.11
[1] 闫慧, 孙万阳, 孙国祥, 等. 复方甘草片工艺变革和分析方法进展及一致性评价流程研究[J].中南药学, 2018, 16(1): 14
YAN H, SUN WY, SUN GX, et al. Progress in the preparation process and analytical methods and the consistency evaluation of compound licorice tablets[J].Cent South Pharm, 2018, 16(1): 14
[2] 中华人民共和国药典1963年版.二部[S]:1963:570
ChP 1963. Vol Ⅱ [S]. 1963: 570
[3] 中华人民共和国药典2005年版.二部[S]: 2005:421
ChP 2005. Vol Ⅱ [S]. 2005: 421
[4] 中华人民共和国药典2020年版.二部[S]:2020:960
ChP 2020. Vol Ⅱ [S]. 2020:960
[5] 韦广辉. 常用中药固体制剂溶出度的研究概况[J].中国现代药物应用, 2011, 5(3): 228
WEI GH. Overview of the research on the dissolution of commonly used traditional Chinese solid preparation[J].Chin J Mod Drug Appl, 2011, 5 (3): 228
[6] 翁水旺. 溶出度在中药制剂中的应用进展[J].中药新药与临床药理, 2003, 14(4): 289
WENG SW. Application progress of dissolution rate in traditional Chinese medicine preparations[J].Tradit Chin Drug Res Clin Pharmacol, 2003, 14(4): 289
[7] 姜雄平. 中成药固体制剂溶出度测定的探讨[J].中国药品标准, 2005, 6(3): 66
JIANG XP. Discussion about dissolution or srug release test of solid preparations of traditional Chinese medicine[J].Drug Stand China, 2005, 6(3): 66
[8] 刘晓晴, 周益芬. 中西药复方制剂——谷参肠安胶囊溶出度测定方法研究[J].药物分析杂志, 1995, 15(A01): 206
LIU XQ, ZHOU YF. Study on the dissolution determination method of Chinese and Western medicine compound preparation- Gushen Chang’an capsules[J].Chin J Pharm Anal, 1995, 15(A01): 206
[9] 李霞, 徐升兵. 中西药复方制剂再评价的有关问题探讨[J].药物评价研究, 2017, 40(5): 577
LI X, XU SB. Discussion about re-evaluation of compound preparation of Chinese-Western medicine on post-marketing drug[J].Drug Eval Res, 2017, 40(5): 577
[10] 严婷, 黄方威, 王金钱, 等. 不同厂家复方丹参片物质组溶出度研究[J].药物评价研究, 2013, 36(6): 442
YAN T, HUANG FW, WANG JQ, et al. Study on dissolution of multi-components in compound Danshen tablets from different manufacturers[J].Drug Eval Res, 2013, 36(6): 442
[11] 程丹红, 赵艳玲, 杨宏博, 等. 左金丸及类方的体外溶出行为研究[J].中成药, 2010, 32(11): 1895
CHENG DH, ZHAO YL, YANG HB, et al. Comparative study on exoteric dissolution of Zuojin pill and its similar prescriptions[J].Chin Tradit Pat Med, 2010, 32(11): 1895
[12] 范吕林, 黄雪梅, 杨青. 功劳去火片的体外溶出度考察[J].海峡药学, 2001, 13(2):26
FAN LL, HUANG XM, YANG Q. Study on dissolution rate of Gonglaoquhuo tablets[J].Strait Pharm J, 2001, 13(2):26
[13] 国家食品药品监督管理局.普通口服固体制剂溶出度试验技术指导原则[EB/OL]. [2015-02-05]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20150205120001100.htmll
National Medical Products Administration. Technical guidelines for dissolution testing of common oral solid dosage forms [EB/OL]. [2015-02-05]https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20150205120001100.htmll
[14] 陈幼亭. 威布尔分布函数处理溶出数据应注意的问题[J].中国医院药学杂志, 1998, 18(9): 419
CHEN YT. Problems to the processing of dissolution data by Weibull distribution function[J].Chin J Hosp Pharm, 1998, 18(9): 419
[15] 彭永富, 董慧. 药物溶出度Weibull分布的计算机求解[J].中国药学杂志, 1996, 31(10): 606
PENG YF, DONG H. The resolution with computer analysing for Weibull’s distribution of drug dissolution rate[J].Chin Pharm J, 1996, 31(10): 606
[16] 翟聪杰, 陈华, 南楠. 艾司唑仑片溶出数据的Weibull分布[J].药物分析杂志, 2016, 36(6): 1089
ZHAI CJ, CHEN H, NAN N. Weibull distribution of dissolution data of estazolam tablets[J].Chin J Pharm Anal, 2016, 36 (6):1089
[17] LANGENBUCHER F. Linearization of dissolution rate curves by the Weibull distribution.[J].J Pharm Pharmacol, 1973, 24(12): 979
[18] 中华人民共和国药典2020年版. 一部[S]: 2020:603
ChP 2020. Vol Ⅰ [S]. 2020: 603
[19] 中华人民共和国药典2020年版. 四部[S]: 2020:129
ChP 2020. Vol Ⅳ [S]. 2020: 129
