Establishment of Quality Control Method in Production of Jinshuibao Capsules

Xue-ting ZHANG; Cheng-zan ZHONG; Ming YANG; Sha CHEN

doi:10.13422/j.cnki.syfjx.20191748

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Establishment of Quality Control Method in Production of Jinshuibao Capsules

Pharmacy and Processing | 更新时间：2021-02-09

- Establishment of Quality Control Method in Production of Jinshuibao Capsules
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 26, Issue 4, Pages: 139-144(2020)
- 作者机构：
  
  1.中国中医科学院　中药研究所　中药鉴定与安全性评估重点实验室，北京　 100700
  2.江西国药有限责任公司，南昌　 330052
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.20191748
  CLC： R22; R28; R94; O657.7
- Received：03 April 2019，
  
  Published Online：14 May 2019，
  
  Published：20 February 2020
- 稿件说明：
移动端阅览
Xue-ting ZHANG, Cheng-zan ZHONG, Ming YANG, et al. Establishment of Quality Control Method in Production of Jinshuibao Capsules[J]. Chinese journal of experimental traditional medical formulae, 2020, 26(4): 139-144.
DOI：

Xue-ting ZHANG, Cheng-zan ZHONG, Ming YANG, et al. Establishment of Quality Control Method in Production of Jinshuibao Capsules[J]. Chinese journal of experimental traditional medical formulae, 2020, 26(4): 139-144. DOI： 10.13422/j.cnki.syfjx.20191748.

摘要

目的：

完善金水宝胶囊生产过程中的质量控制体系，为该制剂的后续研究与应用提供实验依据。

方法：

采用高效液相色谱法(HPLC)，Ultimate AQ-C

色谱柱(4.6 mm×150 mm，5 μm)，腺苷、鸟苷、尿苷含量测定的色谱条件为流动相甲醇(A)-0.1%甲酸水溶液(B)梯度洗脱(0～14 min，100%～99%B；14～19 min，99%～89%B；19～39 min，89%～85%B)，流速0.4 mL·min

-1

，柱温30 ℃，进样量10 μL，检测波长260 nm。麦角甾醇含量测定的色谱条件为流动相甲醇-水(98∶2)，流速1 mL·min

-1

，柱温25 ℃，进样量10 μL，检测波长283 nm。

结果：

发酵虫草菌粉不同生产阶段样品的指纹图谱中主要色谱峰差异性较小。腺苷、鸟苷、尿苷的线性关系良好(

均

0.999)；三者的加样回收率分别为106.06%，101.25%，105.88%，RSD均

3.0%。于2016—2018年各抽取的20批样品中腺苷、麦角甾醇的含量均符合2015年版《中国药典》的要求，鸟苷、尿苷的质量分别为0.97～1.36，0.67～1.38 mg/粒。

结论：

市面所售金水宝胶囊质量较为稳定。建立的方法可用于检测金水宝胶囊的质量，且操作简便、稳定可靠，可为发酵虫草菌粉类产品的检测提供参考。

Abstract

Objective:

To improve the quality control system in the production of Jinshuibao capsules

and to provide experimental basis for the follow-up research and application of this preparation.

Method:

High performance liquid chromatography (HPLC) was employed

the analysis was performed on a Ultimate AQ-C

column (4.6 mm×150 mm

5 μm). The chromatographic conditions for the determination of adenosine

guanosine and uridine were as following: mobile phase of methanol-0.1%formic acid aqueous solution for gradient elution

the flow rate of 0.4 mL·min

-1

column temperature at 30 ℃

sample quantity of 10 μL

detection wavelength at 260 nm. The chromatographic conditions for the determination of ergosterol were as follows: mobile phase of methanol-water (98∶2)

the flow rate of 1 mL·min

-1

column temperature at 25 ℃

sample quantity of 10 μL

detection wavelength at 283 nm.

Result:

The main chromatographic peaks of fermented Cordyceps powder samples in different production stages showed little difference. The linear relationships of adenosine

guanosine and uridine were good (

0.999)

their recoveries were 106.06%

101.25%and 105.88%

respectively. The contents of adenosine and ergosterol in 20 batches of samples extracted from 2016 to 2018 were in line with the requirements in the 2015 edition of

Chinese Pharmacopoeia

the contents of guanosine and uridine were 0.97-1.36

0.67-1.38 mg/capsule

respectively.

Conclusion:

The quality of Jinshuibao capsules in the market is stable. This method can be used to detect the quality of Jinshuibao capsules

and it is simple

stable and reliable.

关键词

Keywords

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