Fu Ke, Song Yinglian, Zhang Dewei, Xu Min, Wu Ruixia, Xiong Xueqing, Liu Xianwu, Wu Lei, Guo Ya, Zhou You, Li Xiaoli, Wang Zhang
College of Pharmacy, Chengdu University of Traditional Chinese Medicine, Chengdu 611137, China.
Wanzhou Institute for Drug and Food Control, Chongqing 404000, China.
Evid Based Complement Alternat Med. 2022 Jan 13;2022:8548378. doi: 10.1155/2022/8548378. eCollection 2022.
Qishiwei Zhenzhu pills (QSW) was first recorded in the Tibetan medicine classic and has been used to treat "Baimai" disease, stroke, paralysis, hemiplegia, cerebral hemorrhage, and other diseases till today. This prescription contains more than 70 medicines including myrobalan, pearl, agate, opal, bezoar, coral, musk, gold, silver, and a mineral mixture Zuotai. As a result, QSW contains a large amount of mercury, copper, lead, and other trace elements. The aim of this study was to determine the 18 trace elements (lithium, beryllium, scandium, vanadium, chromium, manganese, cobalt, nickel, copper, arsenic, strontium, argentum, cadmium, cesium, barium, lead, aurum, and mercury) in 10 batches of QSW produced by 5 pharmaceutical companies (Ganlu Tibetan Medicine Co., Ltd. has 6 different batches) by direct inductively coupled plasma-mass spectrometry (ICP-MS). ICP-MS is a rapid, sensitive, accurate methodology allowing the determination of 18 elements simultaneously. The results showed that each element had an excellent linear relationship in the corresponding mass concentration range. The results showed that the rank order of the elements in QSW was copper > mercury > lead from high to low, with the mass fraction higher than 6000 g/kg; the mass fractions of argentum, arsenic, manganese, aurum, strontium, barium, chromium, and nickel were in the range of 33-1034 g/kg; and the mass fractions of vanadium, cobalt, lithium, beryllium, cadmium, scandium, and cesium were lower than 10 g/kg. The reproducibility from the same manufacturer (Tibet Ganlu Tibetan Medicine Co., Ltd.) was relatively high; however, the element amounts among 5 manufacturers were different, which could affect the efficacy and toxicity of QSW. All in all, ICP-MS can be used as an effective tool for the analysis of trace elements in QSW and standard quality control needs to be enforced across different manufactures.
七十味珍珠丸(QSW)最早记载于藏药典籍,至今一直用于治疗“白脉”病、中风、瘫痪、偏瘫、脑出血等疾病。该方剂包含70多种药材,如诃子、珍珠、玛瑙、蛋白石、牛黄、珊瑚、麝香、金、银以及一种矿物混合物佐太。因此,七十味珍珠丸含有大量汞、铜、铅等微量元素。本研究旨在通过直接电感耦合等离子体质谱法(ICP-MS)测定5家制药公司生产的10批次七十味珍珠丸(甘露藏药股份有限公司有6个不同批次)中的18种微量元素(锂、铍、钪、钒、铬、锰、钴、镍、铜、砷、锶、银、镉、铯、钡、铅、金和汞)。ICP-MS是一种快速、灵敏、准确的方法,可同时测定18种元素。结果表明,各元素在相应质量浓度范围内具有良好的线性关系。结果显示,七十味珍珠丸中元素含量从高到低依次为铜>汞>铅,质量分数高于6000 g/kg;银、砷、锰、金、锶、钡、铬和镍的质量分数在33 - 1034 g/kg范围内;钒、钴、锂、铍、镉、钪和铯的质量分数低于10 g/kg。同一厂家(西藏甘露藏药股份有限公司)的重现性相对较高;然而,5家厂家之间的元素含量存在差异,这可能会影响七十味珍珠丸的疗效和毒性。总而言之,ICP-MS可作为分析七十味珍珠丸中微量元素的有效工具,不同厂家需要加强标准质量控制。