目的 通過對(duì)養(yǎng)陰清肺丸114批樣品進(jìn)行標(biāo)準(zhǔn)檢驗(yàn)及7項(xiàng)探索性研究檢驗(yàn)，對(duì)該品種的質(zhì)量及標(biāo)準(zhǔn)狀況作出總體分析及評(píng)價(jià)。方法 標(biāo)準(zhǔn)檢驗(yàn)依據(jù)《中國藥典》2005年版增補(bǔ)本，其中包括顯微鑒別、TLC及HPLC檢驗(yàn)。探索性研究檢驗(yàn)采用灰分測(cè)定法測(cè)定成方制劑中總灰分；建立白芍的顯微鑒別方法以監(jiān)測(cè)白芍藥材未經(jīng)去皮、炮制不規(guī)范等質(zhì)量問題；增加了玄參的TLC鑒別；運(yùn)用GC-MS、GC法進(jìn)行薄荷等揮發(fā)性藥材的特征圖譜測(cè)定；建立HPLC法測(cè)定制劑中的芍藥苷以研究不同企業(yè)所用白芍原料的差異；采用HPLC法測(cè)定輔料蜂蜜中的有害成分5-羥甲基糠醛（5-HMF）；運(yùn)用加速試驗(yàn)考察藥包材的密閉性。結(jié)果 26.5%的樣品總灰分嚴(yán)重超標(biāo)；白芍的顯微鑒別結(jié)果表明20%的生產(chǎn)企業(yè)使用炮制不規(guī)范的白芍飲片；玄參的TLC都可以檢出，但斑點(diǎn)顏色深淺差別較大；近50%的樣品缺失薄荷藥材的特征峰；芍藥苷質(zhì)量分?jǐn)?shù)最高值約為最低值的4倍，說明不同企業(yè)所用藥材原料差異較大；由于沒有煉蜜的法定限量標(biāo)準(zhǔn)，導(dǎo)致各生產(chǎn)企業(yè)使用煉蜜的質(zhì)量差別極大，5-HMF嚴(yán)重超標(biāo)，最高達(dá)到6 mg/g，是未加工蜂蜜國家限量標(biāo)準(zhǔn)（0.04 mg/g）的150倍；加速試驗(yàn)結(jié)果表明“塑料球殼”與“鋁塑板”這兩種包裝材料的密封性較好。結(jié)論 各生產(chǎn)企業(yè)養(yǎng)陰清肺丸的質(zhì)量參差不齊，一些企業(yè)在原料、輔料、生產(chǎn)工藝及包裝材料方面存在著不同程度的問題。按現(xiàn)行質(zhì)量標(biāo)準(zhǔn)檢驗(yàn)合格率97.4%，依據(jù)探索性研究方法檢驗(yàn)合格率為45.6%，結(jié)果表明探索性研究增加了標(biāo)準(zhǔn)的專屬性、可控性及安全性，為進(jìn)一步修訂藥品標(biāo)準(zhǔn)、控制藥品質(zhì)量提供參考。

Objective There were 114 samples of Yangyin Qingfei Pills analyzed according to the quality standard, seven additional researches on the sample were carried out, and the global quality control and standard condition of this variety were analyzed and evaluated. Methods The standard inspection was based on Chinese Pharmacopoeia (2005), supplement edition, including microscopic identification, TLC, and HPLC methods. The exploratory research inspection was carried out by using the method of ash determination for analyzing the total ash of preparations. The microscopic identification on Paeoniae Radix Alba was developed for monitoring its quality problems with no-peeled or processed in a non-standard way. TLC identification with Scrophulariae Radix was carried out. The characteristic chromatograms of volatile herbs, such as Menthae Herba, were determined using GC-MS and GC methods. An HPLC method was estabilished for the quantitative determination of Paeonone Radix Alba in preparations to study the differences of raw materials used by different enterprises. The excessive content of a harmful composition in excipients honey, 5-hydroxyl methyl furfural (5-HMF), was determined by HPLC. Accelerated testing was applied for the impermeability examination of medicine packaging. Results The total ash of 26.5% in the samples exceeded the limited standard badly. Microscopic results of Paeoniae Radix Alba showed that 20% of the enterprises prepared the decoction pieces of Paeoniae Radix Alba by the non-standard processing. All the TLC of Scrophulariae Radix could be detected, while there were great differences in spot colourity among different samples. The samples in nearly 50% did not have the characteristic peak like Menthae Herba. The highest content of paeoniflorin was about four times as much as the lowest one, which suggested enterprises used materials in different qualities. Without statutory limit for refined honey, the enterprises used refined honey in various qualities. 5-HMF content exceeded seriously the limited standard up to a maximum of 6 mg/g, which was 150 times the amount of national limits (0.04 mg/g) for unrefined honey. Accelerated testing results showed that the packaging material “plastic spherical shell” and “alumimum-plastic plate” were good at sealing. Conclusion Experimental results show that the quality of this drug in each enterprise is uneven. For some enterprises, there have been different problems in raw materials, auxiliary materials, production process, and packing materials. Qualified sample rate is 97.4% according to the current standard of quality inspection. Qualified sample rate is 45.6% based on exploratory research testing method. The results of the test indicate that exploratory research could increase the specificity, controllability, and safety of the standard. It would provide the reference for further revising the drug standard and monitoring the drug quality.