CN109419777A - 一种恩诺沙星微丸片 - Google Patents
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Abstract
本发明涉及医药领域，是一种恩诺沙星微丸片，包括以下组分及各组分重量份数为：恩诺沙星100‑300份，崩解剂10‑40份，粘合剂20‑60份，稀释剂300‑1000份；制备时将原料混合后制成微丸颗粒，在微丸颗粒表面包覆有隔离层，在隔离层外又包覆有缓释层；本发明产品服用后能够迅速、均匀分布在胃肠道，在胃肠道分布面积大，而且作为多单元释药系统，具有生物利用度高，释药速率均匀，重现性好，较少或消除药物对胃肠道的刺激等特点。
Description
技术领域
本发明涉及医药领域，具体是一种恩诺沙星微丸片。
背景技术
恩诺沙星又称恩氟沙星，是动物专用的氟喹诺酮类药物，为广谱抗生素类药物，可用于治疗细菌及支原体引起的呼吸道、消化道、泌尿生殖道感染，以及化脓性皮肤病。该药的作用机理为选择性的作用于原核生物的 DNA 回旋酶，从而使 mRNA 和蛋白质的合成失控，阻断细菌 DNA 的复制，导致细菌死亡。恩诺沙星在动物体内给药后吸收迅速，达到稳态后组织中的药物浓度要高于血浆中的药物浓度，因此恩诺沙星可以作为全身性治疗药物用于全身性治疗给药。目前的恩诺沙星制剂有注射液、恩诺沙星片以及微囊等，因为动物细菌性感染疾病的治疗过程较长，而恩诺沙星注射液在宠物临床上不方便宠物主人的自行给药治疗，因此具有一定的使用局限性；现在普遍使用的恩诺沙星片多因给药次数频繁造成血药浓度波动太大影响治疗效果，而且因为频繁给药增加被宠物咬伤的风险。因此本发明提供了恩诺沙星缓释片，可以将原来一天两次的给药方式减少到一天一次，提高了临床治疗效果，并降低了受到伤害的风险。
专利 (CN101190194A，2008 年 6 月 4 日公开 ) 提供一种犬猫用恩诺沙星咀嚼片，主要由恩诺沙星、阿斯巴甜、口服葡萄糖、脱脂奶粉、硬脂酸镁、淀粉、糊精等组成，主要优点是增强了恩诺沙星的适口性，方便了临床给药，但是给药频繁易造成血药浓度波动过大，对临床治疗时的治疗效果影响较大。专利 (CN1177300A，1998 年 3 月 25 日公开 )提供了一种恩氟沙星注射液或输液的制备方法，主要由恩诺沙星和多羟基羧酸组成，该专利具有易注射、稳定的优点，但是其不能解决临床中给药困难的问题。专利（CN 102949365A，2013年3月6日公开）提供一种宠物用恩诺沙星缓释片及其制备方法，解决了恩诺沙星给药频繁易造成血药浓度波动过大的问题，但是普通的缓释片生物利用度、疗效和安全性能都有待提高。
发明内容
本发明的目的就是要解决现有的恩诺沙星片给药频繁造成血药浓度波动过大和疗效不稳定的问题，提供一种给药方便，作用持久，疗效稳定的恩诺沙星微丸片。
本发明的一种恩诺沙星微丸片包括以下组分及各组分重量份数为：恩诺沙星100-300份，崩解剂10-40份，粘合剂20-60份，稀释剂300-1000份；制备时将原料混合后制成微丸颗粒，在微丸颗粒表面包覆有隔离层，在隔离层外又包覆有缓释层。
本发明中所述崩解剂为低取代羟丙甲基纤维素，羧甲基纤维素钠，羧甲基淀粉钠中的任意一种或多种。
本发明中所述粘合剂为水，乙醇，聚乙烯吡咯烷酮，淀粉浆中的任意一种或多种。
本发明中所述稀释剂为微晶纤维素，淀粉，甘露醇，糊精，蔗糖中的任意一种或多种。
本发明中所述隔离层由粘合剂20-60份，抗粘剂10-30份构成；其中所述粘合剂为低粘度羟丙甲基纤维素；所述抗粘剂为滑石粉和二氧化硅中的任意一种。
本发明中所述缓释层由缓释材料100-300份，塑化剂20-80份，包衣层助剂10-40份和致孔剂5-30份组成；所述缓释材料包括甲基丙烯酸树脂共聚物，聚丙烯酸树脂，乙基纤维素和醋酸纤维素中的一种或几种；所述塑化剂包括柠檬酸三乙酯；所述包衣层助剂为二氧化钛；所述致孔剂为聚乙二醇。
本发明有益效果为：1、本发明具有特定的缓释结构，服用后能够广泛，均匀地分布在胃肠道；2、本发明具有疗效好、安全性高的特点；3、本发明具有给药方便，作用持久，疗效稳定的优点。
具体实施方式
实施例1
本实施例处方制备步骤：
1、称取恩诺沙星200mg，羧甲基淀粉纳40mg，微晶纤维素80mg，混合均匀备用；
2、取适量聚乙烯吡咯烷酮溶解于75%乙醇溶液中，使聚乙烯吡咯烷酮的质量分数为10%，溶解完好后作为粘合剂备用；
3、取羟丙甲基纤维素12mg，滑石粉4mg均匀分散到100mg的10%乙醇溶液中，作为隔离层包衣液备用；
4、取乙基纤维素52mg，柠檬酸三乙酯4mg，二氧化钛4mg，4mg聚乙醇6000均匀分散到10%乙醇溶液中，作为缓释包衣液备用；
5、取适量步骤2中的粘合剂加入到步骤1中，制粒；
6、取适量步骤3的隔离层包衣液包衣；
7、取适量步骤4的缓释包衣液包衣。即得缓释丸芯，备用；
8、取80mg缓释丸芯，34mg交联聚乙烯吡咯烷酮，6mg硬脂酸镁和80mg微晶纤维素，混合均匀，用适量的水作为粘合剂，压片即得。
实施例2
本实施例处方制备步骤：
1、称取恩诺沙星100mg，羧甲基淀粉纳60mg，微晶纤维素160mg，混合均匀备用；
2、取适量聚乙烯吡咯烷酮溶解于75%乙醇溶液中，使聚乙烯吡咯烷酮的质量分数为10%，溶解完好后作为粘合剂备用；
3、取羟丙甲基纤维素12mg，滑石粉4mg均匀分散到100mg的10%乙醇溶液中，作为隔离层包衣液备用；
4、取乙基纤维素52mg，柠檬酸三乙酯4mg，二氧化钛4mg，4mg聚乙醇6000均匀分散到10%乙醇溶液中，作为缓释包衣液备用；
5、取适量步骤2中的粘合剂加入到步骤1中，制粒；
6、取适量步骤3的隔离层包衣液包衣；
7、取适量步骤4的缓释包衣液包衣。即得缓释丸芯，备用；
8、取80mg缓释丸芯，34mg交联聚乙烯吡咯烷酮，6mg硬脂酸镁和80mg微晶纤维素，混合均匀，用适量的水作为粘合剂，压片即得。
Claims (6)
1.一种恩诺沙星微丸片，其特征在于包括以下组分及各组分重量份数为：恩诺沙星100-300份，崩解剂10-40份，粘合剂20-60份，稀释剂300-1000份；制备时将原料混合后制成微丸颗粒，在微丸颗粒表面包覆有隔离层，在隔离层外又包覆有缓释层。
2.根据权利要求1所述的一种恩诺沙星微丸片，其特征是：所述崩解剂为低取代羟丙甲基纤维素，羧甲基纤维素钠，羧甲基淀粉钠中的任意一种或多种。
3.根据权利要求1所述的一种恩诺沙星微丸片，其特征是：所述粘合剂为水，乙醇，聚乙烯吡咯烷酮，淀粉浆中的任意一种或多种。
4.根据权利要求1所述的一种恩诺沙星微丸片，其特征是：所述稀释剂为微晶纤维素，淀粉，甘露醇，糊精，蔗糖中的任意一种或多种。
5.根据权利要求1所述的一种恩诺沙星微丸片，其特征是：所述隔离层由粘合剂20-60份，抗粘剂10-30份构成；其中所述粘合剂为低粘度羟丙甲基纤维素；所述抗粘剂为滑石粉和二氧化硅中的任意一种。
6.根据权利要求1所述的一种恩诺沙星微丸片，其特征是：所述缓释层由缓释材料100-300份，塑化剂20-80份，包衣层助剂10-40份和致孔剂5-30份组成；所述缓释材料包括甲基丙烯酸树脂共聚物，聚丙烯酸树脂，乙基纤维素和醋酸纤维素中的一种或几种；所述塑化剂包括柠檬酸三乙酯；所述包衣层助剂为二氧化钛；所述致孔剂为聚乙二醇。
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| CN110075082A (zh) * | 2019-04-12 | 2019-08-02 | 瑞普（天津）生物药业有限公司 | 一种恩诺沙星速释微丸及其制备方法 |
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| CN110075082A (zh) * | 2019-04-12 | 2019-08-02 | 瑞普（天津）生物药业有限公司 | 一种恩诺沙星速释微丸及其制备方法 |
| CN110075082B (zh) * | 2019-04-12 | 2021-05-18 | 瑞普（天津）生物药业有限公司 | 一种恩诺沙星速释微丸及其制备方法 |
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Application publication date: 20190305 |