2020年版《中国药典》关于金水宝胶囊中核苷酸含量测定项修订的研究

Study on the Revision of Nucleotide Determination Items in Jinshuibao Capsules in the Chinese Pharmacopoeia(2020 Edition)

金水宝胶囊是一种发酵虫草菌丝体制剂,具有补肾保肺、固精益气等功效,临床应用广泛,核苷酸是其中一类主要有效成份。本文通过使用高效液相色谱(HPLC)方法同时测定该制剂中尿苷、鸟苷和腺苷的含量。采用Shiseido Capcell C18 AQ色谱柱(4.6 mm×250 mm,5μm),以甲醇(A)-0.05 mol/L KH_(2)PO_(4)水溶液(B)为流动相,梯度洗脱,检测波长260 nm。结果表明,尿苷、鸟苷和腺苷在各自范围内线性关系良好(r=1.0000),平均加样回收率分别为99.29%、98.86%和99.10%,同时该方法对色谱柱耐用性良好。样品测定结果显示,金水宝胶囊中3种核苷酸的总含量为2.31~2.70mg/粒。在上述研究基础上2020年版《中国药典》中对金水宝胶囊的质量标准进行修订,解决了原标准中核苷酸含量测定项指标成份单一、方法复杂等问题,具有重要应用价值。

Jinshuibao Capsule is a fermented Cordyceps mycelium preparation,which has the functions of invigorating the kidney and lungs,and replenishing essence,and has a wide range of clinical applications.Nucleotide is one of the main active ingredients in this preparation.In this paper,an HPLC method was established to simultaneously determine the contents of uridine,guanosine and adenosine in Jinshuibao Capsule.Chromatographic separation was performed on a Shiseido Capcell C18 AQ column(4.6 mm×250 mm,5μm).Methanol(A)–0.05 mol/L KH_(2)PO_(4) aqueous solution(B)were adopted as mobile phase with a gradient elution.The detection wavelength was set at 260 nm.The results indicated that uridine,guanosine,and adenosine showed good linearity(r=1.0000)within their test ranges,and the average recoveries were 99.17%,98.75%and 99.07%,respectively.The method also showed good ruggedness to the chromatographic column.Quantitative data showed that the total content of three nucleotides was 2.31~2.70 mg per capsule.On the basis of the above study,the specifications for Jinshubao Capsule was revised in the 2020 edition of Chinese Pharmacopoeia,which solved the problems of having only one marker component and over-complicated method for the determination of nucleotides content in the original standard,and had significant practical value.