| 葡萄糖酸钙片脆碎度与产品质量的相关性 |
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| 引用本文： | 祝莉莎,杨鹏飞,陶虹,艾则孜·莫合买提.葡萄糖酸钙片脆碎度与产品质量的相关性[J].中国药品标准,2018,19(2):95-98. |
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| 作者姓名： | 祝莉莎 杨鹏飞 陶虹 艾则孜·莫合买提 |
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| 作者单位： | 新疆维吾尔自治区食品药品检验所,武警新疆总队医院,新疆维吾尔自治区食品药品检验所,新疆维吾尔自治区食品药品检验所 |
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| 摘 要： | 目的：考察葡萄糖酸钙片的脆碎度情况。方法：采用《中国药典》2015年版四部片剂脆碎度检查法,对2017年国家药品评价品种葡萄糖酸钙片抽样样品进行测定并判定。结果：涉及16家生产企业的306批样品中,不合格8批,不合格率2.6% ,不合格涉及4家企业。结论：脆碎度可反映非包衣片的质量,建议将其纳入到各论项下作为检查项目。
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| 关 键 词： | 葡萄糖酸钙片 脆碎度 质量 |
| 收稿时间： | 2017/10/2 0:00:00 |
| 修稿时间： | 2018/4/16 0:00:00 |
Correlation between Friability and Quality of Calcium Gluconate Tablets |
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| Abstract: | ABSTRACT: Objective To observe the Friability of Calcium Gluconate Tablets. Methods The Friability of Calcium Gluconate Tablets which was the program of national drug quality assessment programs in 2017 was inspected by the method according to the Chinese Pharmacopoeia 2015 edition. Results 8 batches samples failed the friability test in 306 batches from 16 pharmaceutical manufactures,the failure rate was 2.6% involving 4 manufactures. Conclusion Friability had correlation with quality of uncoated tablets ,it is suggested that friability should be specified in momographs. |
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| Keywords: | Calcium Gluconate Tablets Friability Quality |
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