Investigation of Systematic Stability of Danshen Capsules

Li-hong ZHOU; Feng-lian ZHANG; Shun-nan ZHANG; Zheng-liang YE; Tao WANG

doi:10.13422/j.cnki.syfjx.20190301

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Investigation of Systematic Stability of Danshen Capsules

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

- Investigation of Systematic Stability of Danshen Capsules
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 25, Issue 13, Pages: 119-125(2019)
- 作者机构：
  
  1.天津中医药大学　中药学院，天津　 300193；
  2.天士力医药集团股份有限公司　中药先进制造技术国家地方联合工程实验室，天津　 300410
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.20190301
  CLC： R22; R94; R28; C37
- Received：04 June 2018，
  
  Published Online：16 November 2018，
  
  Published：05 July 2019
- 稿件说明：
移动端阅览
Li-hong ZHOU, Feng-lian ZHANG, Shun-nan ZHANG, et al. Investigation of Systematic Stability of Danshen Capsules[J]. Chinese journal of experimental traditional medical formulae, 2019, 25(13): 119-125.
DOI：

Li-hong ZHOU, Feng-lian ZHANG, Shun-nan ZHANG, et al. Investigation of Systematic Stability of Danshen Capsules[J]. Chinese journal of experimental traditional medical formulae, 2019, 25(13): 119-125. DOI： 10.13422/j.cnki.syfjx.20190301.

摘要

目的：

制备丹参提取物和丹参胶囊，研究二者在高湿、高温和光照条件下的稳定性，并考察丹参胶囊及相关物料的吸湿特性。

方法：

采用UPLC测定丹参素、迷迭香酸、紫草酸和丹酚酸B的含量，流动相0.05%磷酸水溶液(A)-乙腈(B)梯度洗脱(0～2 min，93%～79.2%A；2～6 min，79.2%～75%A；6～9 min，75%～65%A；9～10.5 min，65%～10%A；10.5～11 min，10%～93%A)，流速0.4 mL·min

－1

，检测波长280 nm。通过测定丹参胶囊及相关物料的吸湿增重，绘制吸湿等温曲线，测算临界相对湿度(CRH)。

结果：

丹参提取物和丹参胶囊分别在温度40 ℃，相对湿度75%和92.5%，光照强度(4 500±500) Lx条件下放置10 d后，4个酚酸成分含量波动均在±10%以内，无明显变化趋势；高温60 ℃条件，二者中的丹参素变化率分别为47.45%和32.24%，丹酚酸B变化率分别为－6.39%和－9.64%。吸湿性考察显示，淀粉基丸CRH＝58.5%，丹参提取物CRH＝72.34%，包衣丸CRH＝72.85%，丹参胶囊CRH＝73.55%。

结论：

高温环境会影响丹参提取物和丹参胶囊中酚酸类指标成分的稳定性，为确保丹参提取物及丹参胶囊质量稳定，应避免高温环境。为防止丹参胶囊及其相关物料过度吸湿，淀粉基丸、丹参提取物、丹参包衣丸和丹参胶囊的生产、贮存环境中相对湿度应控制在相应CRH以下。

Abstract

Objective:

To prepare Danshen extract and Danshen capsules

and study on its stability under high humidity

high temperature and light conditions.To determine the hygroscopicity of Danshen capsules and its intermediates.

Method:

The contents of danshensu

rosmarinic acid

lithospermic acid and salvianolic acid B in Danshen extract and Danshen capsules were determined by UPLC

the detection wavelength was 280 nm and the mobile phase was 0.05%phosphoric acid aqueous solution(A)-acetonitrile(B)for gradient elution(0-2 min

93%-79.2%A; 2-6 min

79.2%-75%A; 6-9 min

75%-65%A; 9-10.5 min

65%-10%A; 10.5-11 min

10%-93%A). The critical relative humidity(CRH) was calculated and hygroscopic isothermal curve was drawn by determining the moisture absorption and weight gain of Danshen capsules and its intermediates.

Result:

The fluctuation of contents of these four phenolic acids in Danshen extract and Danshen capsules was within±10%and no significant change trend after placing at temperature of 40 ℃

relative humidity of 75%and 92.5%

light intensity of (4 500±500) Lx for 10 days.The change rates of danshensu in Danshen extract and Danshen capsules under 60 ℃ were 47.45%and 32.24%

and change rates of salvianolic acid B were -6.39%and -9.64%

respectively.The hygroscopic investigation showed that CRH of starch-based pellets was 58.5%

CRH of Danshen extract was 72.34%

CRH of coated pills was 72.85%

and CRH of Danshen capsules was 73.55%.

Conclusion:

High temperature has effect on stability of phenolic acids in Danshen extract and Danshen capsules

in order to ensure the quality of them

high temperature environment should be avoided.In order to prevent excessive moisture absorption of Danshen capsules and its intermediates

the relative humidity in the production and storage environment should be controlled below the corresponding CRH.

关键词

Keywords

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