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日本医蛭冻干粉的质量标准研究
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| 篇名： | 日本医蛭冻干粉的质量标准研究 |
| TITLE： | |
| 摘要： | 目的：建立日本医蛭（水蛭）冻干粉（简称“冻干粉”）的质量标准，为控制其质量提供参考。方法：取3批冻干粉，按照2015年版《中国药典》（一部）（简称“药典”）水蛭项下要求对冻干粉进行鉴别、检查和抗凝血霉素活性分析；通过最大耐受量（MTD）实验来考察其毒性；通过设计温度、湿度和强光照射试验来考察其稳定性。结果：供试品薄层色谱中，在与对照药材色谱的相应位置显相同的紫红色斑点，紫外光灯（365 nm波长）下显相同的橙红色荧光斑点。3批样品的平均水分含量为2.61％、总灰分含量为2.83％、酸不溶性灰分含量为0.38％、pH为6.92、黄曲霉毒素总量为0.28 μg/kg、抗凝血酶活性为257.0 U/g，除汞元素含量略高于药典水蛭项下限量外，铅、镉、砷、铜元素含量均符合药典规定。MTD实验结果显示，给予以生药量计26.4 g/kg的冻干粉后小鼠未出现死亡及不良反应，此剂量为药典规定最大用量的58倍。在20、40 ℃和强光[（4 500±500） Lx]照射条件下，冻干粉的抗凝血酶活性随着贮藏时间的延长均明显下降，在4 ℃条件下保存6个月其抗凝血酶活性仍符合药典要求；在高湿（相对湿度为90％、75％）条件下，冻干粉的吸湿性极强。结论：本研究按照药典标准对日本水蛭冻干粉建立了一套系统的质量评价标准，可用于其质量控制。 |
| ABSTRACT： | OBJECTIVE： To establish the quality standard of Hirudo nipponica freeze-dried powder （called “freeze-dried powder” for short）， and to provide reference for controlling its quality. METHODS： A total of 3 batches of freeze-dried powder were collected， identified and tested according to the requirements of H. nipponica stated in 2015 edition of Chinese Pharmacopoeia （part Ⅰ） （shorted for pharmacopoeia）； the antithrombin activity was also analyzed. The maximum tolerated dose （MTD） was used to investigate the toxicity. The stability was determined by designing temperature， humidity and strong light exposure tests. RESULTS： In the TLC of test sample， the same red spots were found in the corresponding location of the control drug chromatogram， and the same orange-red fluorescence spots were shown under the UV light （365 nm）. Average content of moisture in 3 batches of samples was 2.61％， and the levels of total ash， acid-insoluble ash， pH aflatoxin and antithrombin activity were 2.83％， 0.38％， 6.92， 0.28 μg/kg and 257.0 U/g， respectively. The content of Pb， Cd， As and Cu were in line with the requirements of pharmacopoeia except that the content of Hg was slightly higher than lower limit of H. nipponica in pharmacopoeia. Results of MTD showed that no death and ADR was found in mice after giving 26.4 g/kg freeze-dried powder by the amount of crude drug， which was 58 times as large as the maximum dosage that the pharmacopoeia described. Under the condition of 20， 40 ℃ and strong light exposure [（4 500±500） Lx]， the anticoagulase activity of freeze-dried powder decreased significantly over time， while the anticoagulase activity of freeze-dried powder stored at 40 ℃ for 6 months was in line with the requirements of pharmacopoeia. Under the condition of high humidity （relative humidity were 90％， 75％）， freeze-dried powder showed a strong hygroscopicity. CONCLUSIONS： Established quality evaluation standard for freeze-dried powder according to pharmacopoeia standard could be used to control its quality. |
| 期刊： | 2018年第29卷第9期 |
| 作者： | 丁钊，肖凌，龚元，陈科力 |
| AUTHORS： | DING Zhao，XIAO Ling，GONG Yuan，CHEN Keli |
| 关键字： | 日本医蛭；冻干粉；质量标准；最大耐受量实验；稳定性试验 |
| KEYWORDS： | Hirudo nipponica； Freeze-dried powder； Quality standard； Maximum tolerated dose； Stability test |
| 阅读数： | 622 次 |
| 本月下载数： | 6 次 |
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