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Improvement of quality standard of Xiaojin capsules

Published on Dec. 28, 2023Total Views: 1114 times Total Downloads: 417 times Download Mobile

Author: Shuang LIU 1 Mao-Quan LIN 1 Jing JIN 2 Zhi-Jun HUANG 3 Yang XIANG 3 Gang ZHAO 3 Kai-Li MING 3

Affiliation: 1. Center For Food and Drug Inspection, National Medical Products Administration, Beijing 100044, China 2. Evaluation and Certification Center, Hubei Medical Products Administration, Wuhan 430071, China 3. Jianmin Pharmaceutical Group Co. Ltd., Wuhan 430052, China

Keywords: Xiaojin capsules Quality standard Acetyl-11-keto-β-boswellic acid High performance liquid chromatography Gas chromatography fingerprint

DOI: 10.12173/j.issn.1008-049X.202305058

Reference: Shuang LIU, Mao-Quan LIN, Jing JIN, Zhi-Jun HUANG, Yang XIANG, Gang ZHAO, Kai-Li MING.Improvement of quality standard of Xiaojin capsules[J].Zhongguo Yaoshi Zazhi,2023, 26(11):332-338.DOI: 10.12173/j.issn.1008-049X.202305058.[Article in Chinese]

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Abstract

Objective  To improve the quality standard of Xiaojin capsules.

Methods The agents content of acetyl-11-keto-β-boswellic acid in Vinegar frankincense was determined by HPLC. According to GC detection patterns of 15 batches of samples, the similarity evaluation was conducted by using the “similarity evaluation system for chromatographic fingerprint of TCM (2012 edition)” of National Pharmacopoeia Committee to confirm common peaks. According to the Chinese Pharmacopoeia method, the contents of Pb, Cd, Cu, As and Hg in samples were detected.

Results  The linear range of acetyl-11-keto-β-boswellic acid was 13.346-166.824 μg·ml-1 (r=0.999 8). The method which possesses high accuracy, and strong specificity, repeatability is good, and the average recovery was 100.76% with an RSD of 1.52% (n=6). The GC fingerprint detection method of Xiaojin capsules was established, and 11 common peaks were identified. The similarity of 15 batches of samples was greater than 0.870, indicating a good similarity. The contents of Pb, Cd, Cu, As and Hg in 15 batches of samples are in accordance with the reference limits in Chinese Pharmacopoeia.

Conclusion  The GC fingerprint detection method and the HPLC method for the determination of 11-carbonyl-β-acetylboswellic acid, as well as the examination of heavy metals, it can be used as a quality control item for the enhancement of the quality control standards of Xiaojin capsules.

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References

1.明凯利, 向阳, 杨艳霞, 等. 小金胶囊的HPLC指纹图谱建立及主成分分析[J].中国药房, 2019, 30(2): 188-192. [Ming KL, Xiang Y, Yang YX, et al. Establishment of HPLC fingerprint and principal component analysis of Xiaojin capsules[J]. China Pharmacy, 2019, 30(2): 188-192.] DOI: 10.6039/j.issn.1001-0408.2019.02.09.

2.黄志军, 梁鹏, 余黎, 等. 小金胶囊药材组分过敏性研究[J].世界中医药, 2016, 11(11): 2393-2395. [Huang ZJ, Liang P, Yu L, et al. Hypersusceptibility study of Chinese materia medica Xiaojin capsules[J]. World Chinese Medicine, 2016, 11(11): 2393-2395.] DOI: 10.3969/j.issn.1673-7202.2016.11.049.

3.中国药典2020版. 一部[S]. 2020: 88, 108, 139, 315, 598.

4.夏纯, 赵刚, 徐胜, 等. 小金胶囊疽证理论探析[J]. 世界中医药, 2016, 11(12): 2580-2583. [Xia C, Zhao G, Xu S, et al. Theoretical analysis of Ju syndrome of Xiaojin capsules[J]. World Chinese Medicine, 2016, 11(12): 2580-2583.] DOI: 10.3969/j.issn.1673-7202.2016.12.015.

5.杨艳霞, 朱尔刚, 裴学军, 等. 小金胶囊的疽证临床应用[J]. 世界中医药, 2016, 11(11): 2483-2485. [Yang YX, Zhu RG, Pei XJ, et al. Clinical application of Xiaojin capsules in carbuncle syndrome[J]. World Chinese Medicine, 2016, 11(11): 2483-2485.] DOI: 10.3969/j.issn.1673-7202.2016.11.072.

6.张琪, 李思佳, 唐晓龙, 等. 小金胶囊联合达那唑治疗子宫肌瘤的临床研究[J].现代药物与临床, 2022, 37(10): 2344-2348. [Zhang Q, Li SJ, Tang XL, et al. Clinical study on Xiaojin capsules combined with danazol in treatment of  uterine fibroids[J]. Drugs & Clinic, 2022, 37(10): 2344-2348.] DOI: 10.7501/j.issn.1674-5515. 2022.10.032.

7.张霞, 高友兵, 朱勇. 小金胶囊联合中医情志疗法在乳腺增生症中应用价值及对血脂、性激素水平的影响[J].世界中医药, 2016, 17(6): 820-826. [Zhang X,  Gao YB, Zhu Y. Application value of Xiaojin capsules combined with TCM emotion therapy in hyperplasia of mammary glands and influence on blood lipid and sex hormone levels[J]. World Chinese Medicine, 2016, 17(6): 820-826.] DOI: 10.3969/j.issn.1673-7202.2022.06.012.

8.刘萍, 张宸宇, 夏长军, 等. 小金胶囊治疗甲状腺结节疗效与安全性的系统评价[J].云南中医中药杂志, 2021, 42(10): 45-51. [Liu P, Zhang CY, Xia CJ, et al. A systematic evaluation of the efficacy and safety of Xiaojin capsules in the treatment of thyroid nodules[J]. Yunnan Journal of Traditional Chinese Medicine, 2021, 42(10): 45-51. ] DOI: 10.16254/j.cnki.53-1120/r.2021.10.013.

9.亓小坡.小金胶囊的化学成分及指纹图谱研究[D].福州: 福建中医药大学, 2019.

10.中国药典2020版. 四部[S]. 2020: 234.

11.巩晓宇, 陆燕萍, 严俊珍, 等. 地龙和水蛭脂质成分的比较分析[J].中国药师, 2022, 25(8): 1486-1489.[Gong XY, Lu YP, Yan JZ, et al. Comparative analysis of lipid components between earthworm and leech[J]. China Pharmacist, 2022, 25(8): 1486-1489.] DOI: 10.19962/j.cnki.issn1008-049X.2022.08.37.

12.易腾达, 秦梦琳, 刘丽宁, 等. 五灵脂的本草及配伍规律考证[J]. 中医学报, 2021, 36(12): 2693-2700. [Yi TD, Qin ML, Liu LN, et al. Textual research on herbal medicine and matching regularity of Wulingzhi (Faeces togopteri)[J]. Acta Chinese Medicine, 2021, 36(12): 2693-2700.] DOI: 10.16368/j.issn.1674-8999.2021.12.555.

13.李沐森, 郭文场, 刘佳贺. 复齿鼯鼠的分布、形态及五灵脂的采收方法和药理作用[J]. 特种经济动植物, 2017, 20(2): 4-7. [Li MS, Guo WC, Liu JH. Distribution and morphology of Trogopterus xanthipes, and the harvesting methods and  pharmacological action of  Faeces Trogopterori[J]. Special Economic Animal and Plant, 2017, 20(2): 4-7.] DOI: 10.3969/j.issn.1001-4713.2017.02.002.

14.韩舒, 包丽媛, 韩喜桃, 等.基于均匀设计的诃子制草乌特征性成分对H9c2心肌细胞毒性的影响[J].中国药师, 2022, 25(1): 27-33. [Han S, Bao LY, Han XT, et al. Effects of characteristic components in Aconitii kusnezoffii Radicx processed with Chebulae fructus on the cytotoxicity of H9c2 cardiomyocytes based on uniform design experiment[J]. China Pharmacist, 2022, 25(1): 27-33.] DOI: 10.19962/j.cnki.issn1008-049X.2022.01.005.

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