CN115364043A - 盐酸克林霉素凝胶及其制备方法 - Google Patents
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Abstract
本发明提供了一种盐酸克林霉素凝胶及其制备方法，该处方中含有活性成分，表面活性剂，胶凝剂，吸湿剂。本发明的盐酸克林霉素凝胶处方简单，制备工艺过程简单，易于操作，且性能稳定。
Description
技术领域
本发明涉及一种盐酸克林霉素凝胶及其制备方法。
背景技术
克林霉素用于宠物治疗有很长的历史，主要用于革兰氏阴信菌的感染，如口腔感染和皮肤感染，常用的制剂有片剂、胶囊、溶液剂。但是溶液剂和片剂在给药方面具有一定的缺陷，因此开发新的给药方式，克林霉素凝胶。
CN103405383 B公开了一种克林霉素磷酸酯凝胶剂及其制备方法，该制剂处方组成为克林霉素磷酸酯，羟丙纤维素，卵磷脂。卵磷脂用来保护克林霉素复合物，避免活性成分的水解。
CN105395473 A公开了一种盐酸克林霉素乳膏及其制备方法，该制剂处方组成为盐酸克林霉素，十六醇，轻质液状石蜡，白凡士林，丙二醇，司盘60，山梨酸钾，羟苯乙酯，2,6-二叔丁基对甲酚，香精，用磷酸溶液或枸橼酸水溶液调节pH值。采用油相基质对活性成分盐酸克林霉素进行包合，以及通过对乳膏成品的pH范围的控制，避免原料的水解。加入香精可避免使用过程中的难闻性气味。
克林霉素在制备凝胶的过程中添加许多添加剂，导致克林霉素的长期稳定性变化，但根据本发明的实施方案，凝胶在长期实验中稳定。
根据本发明的实施方案，在治疗宠物牙齿和皮肤疾病上可以将凝胶直接涂于患病部位，对于牙齿感染可以直接给药，对于皮肤感染可以保护皮肤不受外界的第二次损伤。同时凝胶剂可以作为新的给药图经，将凝胶混于食品中或涂抹在宠物玩具上，用于全身或局部尤其是牙齿感染治疗上具有良好的效果。
为了达到这个目标，对凝胶的粘度选择进行了研究，实验证明凝胶的粘度在5000—20000mPa·s的范围内，能够用于贴合与动物的牙齿及皮肤上。
发明内容
本发明提供了一种盐酸克林霉素凝胶，其中处方由活性成分，表面活性剂，胶凝剂，吸湿剂组成。
本发明凝胶中，所述的活性成分为盐酸克林霉素。
本发明凝胶中，所述的凝胶基质为羟丙甲纤维素。
本发明凝胶中，所述的吸湿剂为丙二醇。
本发明凝胶中，所述的表面活性剂为十二烷基硫酸钠。
本发明凝胶中，所述的pH调节剂为氢氧化钠溶液。
本发明凝胶中，按组合物的重量计，所述凝胶含有0.1—2.7%(w/w)的盐酸克林霉素，4—9%(w/w)的羟丙甲纤维素，1-2.5%(w/w)的十二烷基硫酸钠，5-50%(w/w)的丙二醇，其余为pH调节剂和水。
所述的盐酸克林霉素凝胶的制备方法，包含以下步骤：
（1）将水加热至80-90℃，缓慢搅拌下将羟丙甲纤维素加入；缓慢搅拌下冷却至室温，形成凝胶；
（2）将丙二醇、十二烷基硫酸钠、盐酸克林霉素加入凝胶中，搅拌均匀；
（3）取氢氧化钠溶液调节pH值至中性。
本发明的优势为简化了盐酸克林霉素凝胶的处方及制备工艺，并对稳定性进行了研究，质量稳定。
具体实施方式
实施例1
本发明提供的盐酸克林霉素凝胶，含有2.7%(w/w)的盐酸克林霉素，9%(w/w)的羟丙甲纤维素，1%(w/w)的十二烷基硫酸钠，30%(w/w)的丙二醇，其余为pH调节剂和水。
所述的盐酸克林霉素凝胶制备工艺为：
（1）将十二烷基硫酸钠和适量纯化水搅拌溶解，混合均匀加热至80-90℃，缓慢加入羟丙纤维素搅拌均匀，取出缓慢搅拌冷却至室温形成凝胶体系；
（2）加入丙二醇，盐酸克林霉素，搅拌溶解；
（3）氢氧化钠溶液调节pH至6.0-6.5之间。
按上述步骤（2）制备的盐酸克林霉素凝胶粘度已超出设备粘度范围（最大为100000mPa·s），按步骤（3）调节凝胶pH值，粘度降为26000mPa·s。
按上述步骤（3）制得的盐酸克林霉素凝胶性状为无色透明凝胶，密封放置24小时后盐酸克林霉素凝胶性状为淡黄色透明凝胶，粘度无变化。
实施例2
本发明提供的盐酸克林霉素凝胶，含有2.7%(w/w)的盐酸克林霉素，8%(w/w)的羟丙甲纤维素，1%(w/w)的十二烷基硫酸钠，30%(w/w)的丙二醇，其余为pH调节剂和水。
所述的盐酸克林霉素凝胶制备工艺为：
（1）将适量纯化水加热至80-90℃，缓慢加入羟丙纤维素搅拌均匀，取出缓慢搅拌冷却至室温形成凝胶体系；
（2）加入丙二醇，十二烷基硫酸钠，盐酸克林霉素，搅拌溶解；
（3）氢氧化钠溶液调节pH至6.0-6.5之间。
按上述步骤（3）调节凝胶pH值，粘度降为70000mPa·s。
按上述步骤（3）制得的盐酸克林霉素凝胶性状为无色透明凝胶，密封放置24小时后盐酸克林霉素凝胶性状为无色透明凝胶，粘度无变化。
实施例3
本发明提供的盐酸克林霉素凝胶，含有2.7%(w/w)的盐酸克林霉素，6%(w/w)的羟丙甲纤维素，1%(w/w)的十二烷基硫酸钠，30%(w/w)的丙二醇，其余为pH调节剂和水。
所述的盐酸克林霉素凝胶制备工艺为：
（1）将适量纯化水加热至80-90℃，缓慢加入羟丙纤维素搅拌均匀，取出缓慢搅拌冷却至室温形成凝胶体系；
（2）加入丙二醇，十二烷基硫酸钠，盐酸克林霉素，搅拌溶解；
（3）氢氧化钠溶液调节pH至6.0-6.5之间。
按上述步骤（3）制备的盐酸克林霉素凝胶粘度为27000mPa·s。
实施例4
本发明提供的盐酸克林霉素凝胶，含有2.7%(w/w)的盐酸克林霉素，4%(w/w)的羟丙甲纤维素，1%(w/w)的十二烷基硫酸钠，30%(w/w)的丙二醇，其余为pH调节剂和水。
所述的盐酸克林霉素凝胶制备工艺为：
（1）将适量纯化水加热至80-90℃，缓慢加入羟丙纤维素搅拌均匀，取出缓慢搅拌冷却至室温形成凝胶体系；
（2）加入丙二醇，十二烷基硫酸钠，盐酸克林霉素，搅拌溶解；
（3）氢氧化钠溶液调节pH至6.0-6.5之间。
按上述步骤（3）制备的盐酸克林霉素凝胶粘度为5000mPa·s。
检验试验例1
该检验试验例1涉及按本发明的实施例2所制备的盐酸克林霉素凝胶样品。
检验方法
性状：目视检测，应为无色透明凝胶。
鉴别：采用HPLC法检验，供试品溶液主峰的保留时间应与对照品溶液主峰的保留时间一致。
含量：采用HPLC法检验，含盐酸克林霉素按克林霉素计算应为标示量的90.0%~110.0%。
有关物质含量：采用HPLC法检验，杂质总和不得大于6.0%。
检验结果
按本发明实施例2所制备的盐酸克林霉素凝胶的检验结果汇总表如下所示：
结果表明，经放置，制备的盐酸克林霉素凝胶性状、含量、有关物质、粘度均稳定。
Claims (7)
1.一种盐酸克林霉素凝胶，其中处方由活性成分，表面活性剂，胶凝剂，吸湿剂组成；其特征在于，所述的活性成分为盐酸克林霉素，凝胶基质为羟丙甲纤维素，吸湿剂为丙二醇，表面活性剂为十二烷基硫酸钠。
2.根据权利要求1所述的盐酸克林霉素凝胶，其特征在于，pH调节剂为氢氧化钠溶液。
3.根据权利要求1-2所述的盐酸克林霉素凝胶，其特征在于，按组合物的重量计，所述凝胶含有0.1—2.7%(w/w)的盐酸克林霉素，4—9%(w/w)的羟丙甲纤维素，1-2.5%(w/w)的十二烷基硫酸钠，5-50%(w/w)的丙二醇，其余为pH调节剂和水。
4.根据权利要求1-3所述的盐酸克林霉素凝胶的制备方法，其特征在于，包含以下步骤：
（1）将水加热至80-90℃，缓慢搅拌下将羟丙甲纤维素加入；缓慢搅拌下冷却至室温，形成凝胶；
（2）将丙二醇、十二烷基硫酸钠、盐酸克林霉素加入凝胶中，搅拌均匀；
（3）取氢氧化钠溶液调节pH值至中性。
5.根据权利要求4所描述的盐酸克林霉素凝胶的制备方法，pH调节剂氢氧化钠溶液的加入可改变凝胶产品的粘度。
6.根据权利要求书所述的制备的盐酸克林霉素凝胶，其特征在于，所述的盐酸克林霉素凝胶用于治疗宠物。
7.根据权利要求书所述的制备的盐酸克林霉素凝胶，其特征在于，所述的盐酸克林霉素凝胶用于治疗宠物皮肤及牙齿部位的发炎和感染。
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS6251619A (ja) * | 1985-08-30 | 1987-03-06 | Wako Pure Chem Ind Ltd | 外用ゲル製剤 |
| US6117843A (en) * | 1992-02-18 | 2000-09-12 | Lloyd J. Baroody | Compositions for the treatment of acne containing clindamycin and benzoyl peroxide |
| CN109646392A (zh) * | 2017-10-11 | 2019-04-19 | 多多药业有限公司 | 一种含克林霉素磷酸酯的凝胶剂及其制备工艺 |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS6251619A (ja) * | 1985-08-30 | 1987-03-06 | Wako Pure Chem Ind Ltd | 外用ゲル製剤 |
| US6117843A (en) * | 1992-02-18 | 2000-09-12 | Lloyd J. Baroody | Compositions for the treatment of acne containing clindamycin and benzoyl peroxide |
| CN109646392A (zh) * | 2017-10-11 | 2019-04-19 | 多多药业有限公司 | 一种含克林霉素磷酸酯的凝胶剂及其制备工艺 |
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