| 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 |
| 葡萄糖酸钙片脆碎度与产品质量的相关性 |
| Correlation between Friability and Quality of Calcium Gluconate Tablets |
| 投稿时间：2017-10-02 修订日期：2018-04-16 |
| DOI： |
| 中文关键词: 葡萄糖酸钙片 脆碎度 质量 |
| 英文关键词: Calcium Gluconate Tablets Friability Quality |
| 基金项目: |
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| 摘要点击次数: 488 |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| 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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