CN111214435A - 一种复方甲硝唑凝胶剂的制备方法 - Google Patents

一种复方甲硝唑凝胶剂的制备方法 Download PDF

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CN111214435A
CN111214435A CN201811413257.4A CN201811413257A CN111214435A CN 111214435 A CN111214435 A CN 111214435A CN 201811413257 A CN201811413257 A CN 201811413257A CN 111214435 A CN111214435 A CN 111214435A
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Qidong Mau Wood Industry Co Ltd
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Abstract

本发明公开了一种复方甲硝唑凝胶剂的制备方法，步骤如下：将卡波姆940溶于质量分数为25%的丙二醇水溶液，让其充分溶胀4‑6h；将甲硝唑和小檗碱溶于丙二醇和乙醇的混合溶液中，将溶解后药物加入溶胀好的卡波姆中，混匀，氢氧化钠调节pH值至6.8‑7.2，继续加入聚山梨酯‑80、甘油和乙醇，搅拌均匀即得。该方法简便、快捷、易操作，制备的复方甲硝唑凝胶剂稳定性好，释放速率高，可大规模制备。

Description

一种复方甲硝唑凝胶剂的制备方法
技术领域
本发明涉及一种复方甲硝唑凝胶剂的制备方法。
背景技术
甲硝唑是硝基咪唑类合成药物，临床使用广泛，疗效显著，具有广谱抗厌氧菌感染的作用。临床上，甲硝唑一般用于治疗细菌性阴道炎等妇科疾病、口腔炎症及由毛囊虫引起的诸如痤疮、酒糟鼻之类的皮肤感染性疾病。甲硝唑的羟化代谢物可消除厌氧环境起到抑菌作用。目前市面上甲硝唑的凝胶制剂不仅减少了甲硝唑的不良反应，提高了安全性，并且使用方便。但是甲硝唑的耐药性使得其使用受到限制并影响治疗效果。小檗碱（berberine）又名黄连素，是毛茛科植物黄连的有效成分。小檗碱对金黄色葡萄球菌、大肠杆菌、白色念珠菌等革兰阳性、阴性菌有较强的抑菌作用。据文献报道小檗碱和甲硝唑联用有较好的效果，故选择甲硝唑和小檗碱作为复方凝胶剂的主药。
发明内容
本发明的目的在于提供一种复方甲硝唑凝胶剂的制备方法。
本发明通过下面技术方案实现：
一种复方甲硝唑凝胶剂的制备方法，包括如下步骤：将20-30份卡波姆940溶于55-65份质量分数为25%的丙二醇水溶液，让其充分溶胀4-6h；将10-20份甲硝唑和7-9份小檗碱溶于25-35份丙二醇和40-50份乙醇的混合溶液中，将溶解后药物加入溶胀好的卡波姆中，混匀，氢氧化钠调节pH值至6.8-7.2，继续加入15-25份聚山梨酯-80、7-13份甘油和2-4份乙醇，搅拌均匀即得；各原料均为重量份。
优选地，所述的制备方法中，让其充分溶胀5h。
优选地，所述的制备方法中，氢氧化钠调节pH值至7.0。
本发明技术效果：
该方法简便、快捷、易操作，制备的复方甲硝唑凝胶剂稳定性好，释放速率高，可大规模制备。
具体实施方式
下面结合实施例具体介绍本发明的实质性内容。
实施例1
一种复方甲硝唑凝胶剂的制备方法，包括如下步骤：将25份卡波姆940溶于60份质量分数为25%的丙二醇水溶液，让其充分溶胀5h；将15份甲硝唑和8份小檗碱溶于30份丙二醇和45份乙醇的混合溶液中，将溶解后药物加入溶胀好的卡波姆中，混匀，氢氧化钠调节pH值至7.0，继续加入20份聚山梨酯-80、10份甘油和3份乙醇，搅拌均匀即得；各原料均为重量份。
实施例2
一种复方甲硝唑凝胶剂的制备方法，包括如下步骤：将20份卡波姆940溶于55份质量分数为25%的丙二醇水溶液，让其充分溶胀4h；将10份甲硝唑和7份小檗碱溶于25份丙二醇和40份乙醇的混合溶液中，将溶解后药物加入溶胀好的卡波姆中，混匀，氢氧化钠调节pH值至6.8，继续加入15份聚山梨酯-80、7份甘油和2份乙醇，搅拌均匀即得；各原料均为重量份。
实施例3
一种复方甲硝唑凝胶剂的制备方法，包括如下步骤：将30份卡波姆940溶于65份质量分数为25%的丙二醇水溶液，让其充分溶胀6h；将20份甲硝唑和9份小檗碱溶于35份丙二醇和50份乙醇的混合溶液中，将溶解后药物加入溶胀好的卡波姆中，混匀，氢氧化钠调节pH值至7.2，继续加入25份聚山梨酯-80、13份甘油和4份乙醇，搅拌均匀即得；各原料均为重量份。
该方法简便、快捷、易操作，制备的复方甲硝唑凝胶剂稳定性好，释放速率高，可大规模制备。

Claims (3)

1.一种复方甲硝唑凝胶剂的制备方法，其特征在于包括如下步骤：将20-30份卡波姆940溶于55-65份质量分数为25%的丙二醇水溶液，让其充分溶胀4-6h；将10-20份甲硝唑和7-9份小檗碱溶于25-35份丙二醇和40-50份乙醇的混合溶液中，将溶解后药物加入溶胀好的卡波姆中，混匀，氢氧化钠调节pH值至6.8-7.2，继续加入15-25份聚山梨酯-80、7-13份甘油和2-4份乙醇，搅拌均匀即得；各原料均为重量份。
2.根据权利要求1所述的制备方法，其特征在于：让其充分溶胀5h。
3.根据权利要求1所述的制备方法，其特征在于：氢氧化钠调节pH值至7.0。
CN201811413257.4A 2018-11-26 2018-11-26 一种复方甲硝唑凝胶剂的制备方法 Pending CN111214435A (zh)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113476397A (zh) * 2021-07-12 2021-10-08 海南海神同洲制药有限公司 一种甲硝唑凝胶及其制备方法

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113476397A (zh) * 2021-07-12 2021-10-08 海南海神同洲制药有限公司 一种甲硝唑凝胶及其制备方法

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