筋骨痛消丸质量标准的提高  

Improvement of Quality Control Standard for Jingu Tongxiao Pills

作　　者：赵新杰 孙实 李小倩 吴晓龙 Zhao Xinjie;Sun Shi;Li Xiaoqian;Wu Xiaolong(Henan Luozheng Pharmaceutical Co.Ltd.,Henan Luoyang 471013,China)

机构地区：[1]河南省洛正药业有限责任公司,河南洛阳471013

出　　处：《中国药师》2022年第12期2246-2250,共5页China Pharmacist

基　　金：河南省科技攻关(编号:202102310193);河南省中医药科学研究专项课题(编号:2017ZY1001、2021ZY2241)。

摘　　要：目的:修订并提高筋骨痛消丸的质量标准。方法:增加了甘草的薄层鉴别,改进了香附、桂枝、白芍、川牛膝和秦艽的TLC鉴别,并用HPLC法同时测定了隐丹参酮、丹参酮Ⅰ、丹参酮ⅡA的含量。色谱条件:采用COSMOSIL 5C18-MS-Ⅱ(250 mm×4.6 mm, 5μm)色谱柱,以乙腈-0.02%磷酸溶液为流动相梯度洗脱,流速为1 ml·min^(-1),检测波长为270 nm,柱温为20℃,进样量为10μl。结果:薄层色谱图斑点清晰,阴性无干扰;隐丹参酮、丹参酮Ⅰ、丹参酮ⅡA在2~20μg·ml^(-1)范围内,与峰面积呈良好的线性关系,回收率分别为97.32%,100.22%,102.08%,RSD分别为3.05%,2.22%,1.55%(n=9)。结论:该质量标准可更好地控制产品质量。Objective: To revise and improve the quality standard for Jingu Tongxiao pills. Methods: The TLC identification of Glycyrrhizae Radix et Rhizoma was added, and the TLC identification of Cyperi Rhizoma, Cinnamomi Ramulus, Paeoniae Radix Alba, Cyathulae Radix and Gentianae Macrophyllae Radix were improved. The contents of cryptotanshinone, tanshinone Ⅰ and tanshinone ⅡAwere determined simultaneously by HPLC. The chromatographic conditions were as follows: a COSMOSIL 5 C18-MS-Ⅱ(250 mm×4.6 mm, 5 μm) chromatographic column was used with acetonitrile-0.02% phosphoric acid solution as the mobile phase in a gradient elution mode at the flow rate of 1.0 ml·min^(-1), the detection wavelength was 270 nm, the column temperature was set at 20 ℃, and the injection volume was 10 μl. Results: The spots of TLC were clear without any negative interference. There was a good linear relationship with the peak area within the range of(2-20) μg·ml^(-1)for cryptotanshinone, tanshinone Ⅰ and tanshinone ⅡA. The recoveries were 97.32%, 100.22% and 102.08%, and the RSDs were 3.05%, 2.22% and 1.55%, respectively. Conclusion: The product quality can be better controlled by the revised quality standard.

关 键 词：筋骨痛消丸 质量标准 薄层色谱法 高效液相色谱法 隐丹参酮 丹参酮Ⅰ 丹参酮ⅡA 

分 类 号：TQ460.72[医药卫生—药物分析学]