CN101269067B - 抗菌的妇科外用药物组合物 - Google Patents
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Abstract
本发明公开了一种妇科外用药物组合物，其含有活性成分硝酸布康唑及其它药学上可接受的药物载体。此组合物的存在形式可以为栓剂、阴道片和阴道泡腾片，用于治疗念珠菌属引起的外阴道的霉菌感染。
Description
技术领域
本发明涉及一种抗菌的妇科外用药物组合物，属于医药技术领域。
背景技术
真菌性阴道炎是女性的三大阴道常见疾病之一(其余两个为细菌性阴道病和滴虫性阴道炎)，其发病率高，根治困难。硝酸布康唑是咪唑类抗真菌药，它对白色念珠菌的抑菌作用等同或优于其它咪唑类衍生物如克霉唑、咪康唑及制霉素类。其临床用药3天和8天治愈率为80％和95％，明显优于克霉唑。其使用的疗程短，副作用小，耐受良好。
目前，美国KV Pharmaceutical公司已有硝酸布康唑的乳膏上市，商品名为
。乳膏多次使用管口的药物容易污染，且使用时药物的剂量难以掌握。因此，将其制成能单剂量使用的栓剂、泡腾片或阴道片使用更方便，使用量的控制更容易。
CN200510045031公开了一种硝酸布康唑的复方制剂，以奥硝唑、硝酸布康唑和聚甲酚磺醛为活性成分治疗妇科炎症。CN200510045030公开了一种治疗妇科炎症的复方制剂，由硝酸布康唑与莪术油为活性成分治疗阴道感染等症。复方制剂虽然扩展了抗菌谱，但成分多可能会导致稳定性问题。另外，高酸性阴道炎与真菌性阴道炎关系密切，很多真菌性阴道炎都合并有高酸性阴道炎，这也是单纯用抗真菌药物难以根治反复发作的原因。因此，单纯扩展抗菌谱，采用多种活性成分联合使用也达不到良好的治疗效果。
发明内容
本发明采用硝酸布康唑一种药物，通过调节药物的酸性，控制高酸性阴道炎的发生，从而达到根治真菌引起的阴道炎的作用。此妇科外用抗菌药物组合物稳定性佳，抗菌效果好，对难以根治的阴道炎有良好的治疗效果。
本发明中的妇科外用抗菌药物组合物，由活性成分硝酸布康唑、酸度调节剂及其它药学上可接受的药物载体组成。
本发明的妇科外用抗菌药物组合物可以以栓剂、阴道片和阴道泡腾片的形式存在。
本发明的妇科外用药物组合物中，活性成分硝酸布康唑的量为20-200mg。
本发明的妇科外用药物组合物中还应用酸度调节剂调节pH值至中性到弱碱性范围内，具体选用碳酸氢钠、枸橼酸钠、乳酸钠中的一种或几种，调节pH值为6.5-8.5。
本发明的妇科外用药用组合物以阴道栓的形式存在时，选用载体基质500—2000mg，具体为甘油明胶、聚乙二醇类、聚氧乙烯(40)单硬脂酸酯类和泊洛沙姆中的一种或几种。
本发明的妇科外用药用组合物以阴道片的形式存在时，选用载体为填充剂、崩解剂、助流剂和润滑剂。其中的崩解剂用量为20-200mg，具体选用微晶纤维素、羧甲基淀粉钠、低取代羟丙纤维素、交联聚维酮和交联羧甲纤维素钠中的一种或几种。
本发明的妇科外用药用组合物以阴道泡腾片的形式存在时，选用的药学上可接受的载体是填充剂、泡腾崩解剂、助流剂和润滑剂。此泡腾崩解剂由有机酸和碱组成，具体为枸橼酸、酒石酸、富马酸中的一种或几种与碳酸钠或碳酸氢钠组合而成。
具体实施例
下面结合实施例对本发明作进一步的详细说明，但并不局限于下述的实施例。其中“％”是指“重量％”。
实施例1
此实施例的存在形式为栓剂。
制备方法：称取处方量的PEG-4000、PEG-6000、甘油和水至水浴上加热熔化；称取处方量的硝酸布康唑和乳酸钠加入熔融的基质中，混合均匀；趁热倾入模具中；放冷，待完全凝固后开模取出即可。
实施例2
此实施例的存在形式为阴道片。
制备方法：
称取处方量的硝酸布康唑、乳酸钠、微晶纤维素、甘露醇和一部分交联聚维酮混合均匀；向混合物中加入聚维酮的水溶液，制粒。50℃鼓风干燥，整粒。将两组干颗粒混合，加入剩余部分的交联聚维酮和硬脂酸镁，混匀。检测颗粒含量，压片，即可。
实施例3此实施例的存在形式为阴道泡腾片。
制备方法：
称取处方量的硝酸布康唑、甘露醇和碳酸氢钠混合均匀得混合物1；称取处方量的微晶纤维素和枸橼酸混合均匀得混合物2；向混合物1和2中分别加入聚维酮的水溶液，制粒。50℃鼓风干燥，整粒。将两组干颗粒混合，加入硬脂酸镁，混匀。检测颗粒含量，压片，即可。
Claims (1)
1.一种抗菌的妇科外用药物组合物，其特征在于，由以下组分及重量百分比组成：硝酸布康唑6.67％，微晶纤维素33.33％，甘露醇24.5％，枸橼酸10％，碳酸氢钠20％，聚维酮5％，硬脂酸镁0.5％，所述的药物组合物通过以下步骤进行制备：(1)称取处方量的硝酸布康唑、甘露醇和碳酸氢钠混合均匀得混合物1；(2)称取处方量的微晶纤维素和枸橼酸混合均匀得混合物2；(3)向步骤(1)和步骤(2)制得的混合物1和混合物2中分别加入聚维酮的水溶液，制粒，50℃鼓风干燥，整粒；(4)将两组干颗粒混合，加入硬脂酸镁，混匀，检测颗粒含量，压片，即可。
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| CN109330983A (zh) * | 2018-07-27 | 2019-02-15 | 江苏中天药业有限公司 | 一种阴道泡腾片及其制备方法 |
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