CN113318084A - 一种醋酸泼尼松片及其体外溶出曲线的检测方法 - Google Patents
一种醋酸泼尼松片及其体外溶出曲线的检测方法 Download PDFInfo
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Abstract
本发明公开了一种醋酸泼尼松片及其体外溶出曲线的检测方法。所述的醋酸泼尼松片含5质量份的醋酸泼尼松、35质量份的玉米淀粉、35质量份的蔗糖、4质量份的糊精、0.3质量份的硬脂酸镁；在制备醋酸泼尼松片过程中乙醇和纯化水作为润湿剂，最后干燥除去。所述的醋酸泼尼松片体外溶出曲线的检测方法为：将醋酸泼尼松片分别置于水、pH值为1.0或1.2的盐酸溶液、pH值为4.5的醋酸盐缓冲液、pH值为6.8的磷酸盐缓冲液四种介质中进行溶出测试；采用紫外‑可见分光光度法检测，检测波长为243nm。本发明解决了现有工艺中存在的醋酸泼尼松不易被人体快速吸收的问题，同时提供了一种有效的体外溶出曲线的评价方式。
Description
技术领域
本发明属于药物制剂技术领域，特别涉及一种醋酸泼尼松片及其体外溶出曲线的检测方法。
背景技术
醋酸泼尼松是肾上腺皮质激素类药适用于结缔组织病，系统性红斑狼疮，重症多肌炎，严重的支气管哮喘，皮肌炎，血管炎等过敏性疾病，其能抑制结缔组织的增生，降低毛细管比和细胞膜的通透性，减少炎性渗出。主要用于过敏性及炎症性疾病。
但是醋酸泼尼松不溶于水，由于其在水中的溶解性较差，作为活性成分，直接被人体服用时，只有能快速的溶于水中才能在人体中得到良好的吸收。通常情况下，醋酸泼尼松与淀粉混合，压片成型后被服用，但是其药物的有效性大打折扣。通过调整处方组成及比例可有效控制其在体内的溶出速度。
由于醋酸泼尼松为难溶性药物，体外溶出曲线的检测通常采用加入一定量的表面活性剂(如十二烷基硫酸钠)来加快其在介质中的溶出速度，但是表面活性剂的加入，使其溶出速度过快，测得的溶出曲线无区分力，不能准确反映制剂批间与批内的真实情况，无法有效控制制剂批间批内质量的一致性。且大部分的片剂通常采用浆法的搅拌方式，但是本品溶出过程为溶蚀过程，无崩解现象，溶出过程中药片附着在溶出杯底，有堆积现象，容易造成RSD偏大的假象。
发明内容
针对现有工艺及检测方法的不足，本发明提供一种醋酸泼尼松片及其体外溶出曲线的检测方法。
所述的醋酸泼尼松片含5质量份的醋酸泼尼松、35质量份的玉米淀粉、35质量份的蔗糖、4质量份的糊精、0.3质量份的硬脂酸镁；在制备醋酸泼尼松片过程中乙醇和纯化水作为润湿剂，最后干燥除去。
所述的醋酸泼尼松片体外溶出曲线的检测方法为：将醋酸泼尼松片分别置于水、pH值为1.0或1.2的盐酸溶液、pH值为4.5的醋酸盐缓冲液、pH值为6.8的磷酸盐缓冲液四种介质中进行溶出测试；转速为每分钟75转；采用紫外-可见分光光度法检测，检测波长为243nm。
本发明解决了现有工艺中存在的醋酸泼尼松不易被人体快速吸收的问题，同时提供了一种有效的体外溶出曲线的评价方式。
具体实施方式
下面结合具体实施方式对本发明进行进一步的详细描述，给出的实施例仅为了阐述本发明，而不是为了限制本发明的范围。
实施例1：
本实施例制备的醋酸泼尼松片，包括以下质量组成：醋酸泼尼松20kg、玉米淀粉140kg、蔗糖140kg、糊精16kg、硬脂酸镁1.2kg。适量的乙醇和纯化水作为润湿剂，最后干燥除去。
醋酸泼尼松片的参数为：含量101.0％(由于在压片过程中醋酸泼尼松片总质量存在一定误差，导致醋酸泼尼松片中的有效成分也会存在偏差)、脆碎度≤0.5％、溶出度≥70％、干燥失重≤5.0％。
溶出曲线检测方法：
溶出方法：按照溶出度与释放度测定法(中国药典2020年版四部通则0931第二法)测定，分别以水、pH1.2盐酸溶液、pH4.5醋酸盐缓冲液、pH6.8磷酸盐缓冲液600ml为溶出介质，转速为每分钟75转，依法操作，经5、10、15、20、30、45、60、90分钟时取样检测。
检测方法：紫外分光光度法，检测波长243nm。
溶出曲线检测结果：
表1：实施例1的醋酸泼尼松片在4条介质中溶出曲线的检测结果
实施例2：
本实施例制备的醋酸泼尼松片，包括以下质量组成：醋酸泼尼松30kg、玉米淀粉210kg、蔗糖210kg、糊精24kg、硬脂酸镁1.8kg。适量的乙醇和纯化水作为润湿剂，最后干燥除去。
醋酸泼尼松片的参数为：含量100.1％(由于在压片过程中醋酸泼尼松片总质量存在一定误差，导致醋酸泼尼松片中的有效成分也会存在偏差)、脆碎度≤0.5％、溶出度≥70％、干燥失重≤5.0％。
溶出曲线检测方法：
溶出方法：按照溶出度与释放度测定法(中国药典2020年版四部通则0931第二法)测定，分别以水、pH1.0盐酸溶液、pH4.5醋酸盐缓冲液、pH6.8磷酸盐缓冲液600ml为溶出介质，转速为每分钟75转，依法操作，经5、10、15、20、30、45、60、90分钟时取样检测。
检测方法：紫外分光光度法，检测波长243nm。
溶出曲线检测结果：
表2：实施例2的醋酸泼尼松片在4条介质中溶出曲线的检测结果
从表1-2中累计溶出度结果可以看出：采用该处方制备的醋酸泼尼松片，可以在模拟的人体内环境条件下有效的溶出，并且采用该方法检测本品的溶出过程缓慢，在采用篮法75rpm条件下，样品从篮中逐渐溶出，分散在介质中，且在该条件下本品在4种介质(水、pH1.0盐酸溶液、pH4.5醋酸盐缓冲液、pH6.8磷酸盐缓冲液中)中溶出均匀缓慢，分别于45-60min累积溶出量达到85％以上，可准确评价产品批间批内的均一性，从而有效控制工艺生产的稳定性，保证产品质量。
以上仅是本发明的优选实施方式，应当指出，对于本领域的研究人员来说，在不脱离本发明创造构思的前提下，还可以做出若干变形和改变，这些都属于本发明的保护范围。
Claims (2)
1.一种醋酸泼尼松片，其特征在于，所述的醋酸泼尼松片含5质量份的醋酸泼尼松、35质量份的玉米淀粉、35质量份的蔗糖、4质量份的糊精、0.3质量份的硬脂酸镁；在制备醋酸泼尼松片过程中乙醇和纯化水作为润湿剂，最后干燥除去。
2.根据权利要求1所述的醋酸泼尼松片体外溶出曲线的检测方法，其特征在于，所述的检测方法为：将醋酸泼尼松片分别置于水、pH值为1.0或1.2的盐酸溶液、pH值为4.5的醋酸盐缓冲液、pH值为6.8的磷酸盐缓冲液四种介质中进行溶出测试；转速为每分钟75转；采用紫外-可见分光光度法检测，检测波长为243nm。
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| CN114209666A (zh) * | 2021-12-07 | 2022-03-22 | 濮阳市汇元药业有限公司 | 一种醋酸泼尼松片及其制备方法 |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB792656A (en) * | 1956-08-31 | 1958-04-02 | Upjohn Co | Improvements in or relating to therapeutic compositions |
| CN104721160A (zh) * | 2015-03-27 | 2015-06-24 | 贾红瑞 | 一种醋酸泼尼松片剂及其制备方法 |
| CN108236605A (zh) * | 2016-12-23 | 2018-07-03 | 天津金耀集团有限公司 | 一种醋酸泼尼松片的药物组合物 |
| CN110840854A (zh) * | 2019-11-28 | 2020-02-28 | 安徽金太阳生化药业有限公司 | 一种醋酸泼尼松片及其制备方法 |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB792656A (en) * | 1956-08-31 | 1958-04-02 | Upjohn Co | Improvements in or relating to therapeutic compositions |
| CN104721160A (zh) * | 2015-03-27 | 2015-06-24 | 贾红瑞 | 一种醋酸泼尼松片剂及其制备方法 |
| CN108236605A (zh) * | 2016-12-23 | 2018-07-03 | 天津金耀集团有限公司 | 一种醋酸泼尼松片的药物组合物 |
| CN110840854A (zh) * | 2019-11-28 | 2020-02-28 | 安徽金太阳生化药业有限公司 | 一种醋酸泼尼松片及其制备方法 |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114209666A (zh) * | 2021-12-07 | 2022-03-22 | 濮阳市汇元药业有限公司 | 一种醋酸泼尼松片及其制备方法 |
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Application publication date: 20210831 |