CN111374957A - 奥美沙坦酯制剂的制造方法 - Google Patents
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Abstract
本发明属于药物制剂领域,具体涉及一种奥美沙坦酯片剂的制备方法,该方法采用干法制粒工艺制备奥美沙坦酯片,操作简单,影响因素少,可控性强。
Description
技术领域
本发明属于药物制剂领域,具体涉及一种奥美沙坦酯制剂的制备方法。
背景技术
奥美沙坦酯(olmesartan medoxomil, 1) 是一种前体药物,口服后通过胃肠道吸收可迅速完全脱酯成为活性代谢物奥美沙坦。1 为一种较理想的抗高血压药,是选择性血管紧张素Ⅱ(AngⅡ)1 型受体(AT1)阻滞剂,通过选择性地阻断AngⅡ与AT1的作用,抑制AngⅡ的缩血管作用,使血管平滑肌松弛,从而降低血压(1对AT1受体的亲和力比AT2强12500倍)。现有公开的资料或文献中提到的制备方法多为湿法工艺,但湿法制粒工艺程序繁琐,影响产品质量的因素多,可控性差。
发明内容
本发明的目的是提供一种奥美沙坦酯制剂的制备方法,其采用干法制粒工艺制备奥美沙坦酯片。
本发明所述的奥美沙坦酯片剂为按重量百分含量,包含以下成分:5%~10%的奥美沙坦酯、50%~70%的填充剂、1%~5 %的黏合剂、10%~20%的崩解剂、0.5 %~2 %的润滑剂,0.5~5%的包衣。
其中,所述的奥美沙坦酯原料药粒度D(0.9)≤400μm。
本发明中,所述的填充剂选自微晶纤维素、乳糖或甘露醇中的一种或两种以上组合,优选微晶纤维素和乳糖组合。
本发明中,所述的黏合剂选自羟丙基纤维素、聚维酮 K30、羟丙基甲基纤维素或羧甲基纤维素钠中的一种或几种。
本发明中,所述的崩解剂选自低取代羟丙基纤维素、交联羧甲基纤维素钠或羧甲基淀粉钠中一种或几种,优选低取代羟丙基纤维素。
本发明中,所述的润滑剂选自硬脂酸镁、滑石粉或硬酯富马酸钠中的一种或几种。
本发明中,所述包衣组成为羟丙甲纤维素、滑石粉、二氧化钛、氧化铁或聚乙二醇中的一种或几种。
一种奥美沙坦酯片剂的制备方法,包括如下步骤:
(1)取奥美沙坦酯原料药及常规药用辅料,采用干法制粒工艺,制备压片前总混中间体;
(2)将总混中间体压片制得片芯;
(3)将所得片芯进行包衣,制得所述奥美沙坦酯片剂。
上述步骤具体为:将奥美沙坦酯与填充剂、黏合剂、崩解剂和润滑剂混合均匀,得到压片前总混中间体;将步骤1所得总混中间体压片得片芯;将步骤2所得片芯进行包衣,得所述奥美沙坦酯片剂。
本发明的制造方法操作简单,重复性好,且与原研溶出曲线相似,20mg规格在pH6.8中30min溶出度大于80%,40mg规格在pH6.8中30min溶出度大于70%。
具体实施方式
通过以下的具体实施例,可以更加具体地说明本发明,但本发明不局限以下实施例。
实施例1
制备奥美沙坦酯片剂6000片,规格20mg,片重219mg ,批号为181203-1,具体配料如表1所示:
表1
奥美沙坦酯片剂的制备方法,包括如下步骤:
(1)按处方量称取奥美沙坦酯、微晶纤维素、一水乳糖、低取代羟纤维素钠,羟丙基纤维素,硬脂酸镁并混合均匀;
(2)干法制粒,制得的粒子压片得片芯;
(3)所得片芯进行包衣,包衣增重4.29%。
制备奥美沙坦酯片剂3000片,规格40mg,片重434mg ,批号为181203-2,具体配料如表2所示:
奥美沙坦酯片剂的制备方法,包括如下步骤:
(1)按处方量称取奥美沙坦酯、微晶纤维素、一水乳糖、低取代羟纤维素钠,羟丙基纤维素,硬脂酸镁并混合均匀;
(2)干法制粒,制得的粒子压片得片芯;
(3)所得片芯进行包衣,包衣增重3.33%。
实施例2
制备奥美沙坦酯片剂6000片,规格20mg,片重219mg ,批号为181204-1,具体配料如表3所示:
表3
奥美沙坦酯片剂的制备方法,包括如下步骤:
(1)按处方量称取奥美沙坦酯、微晶纤维素、一水乳糖、交联羧甲基纤维素钠,羟丙基纤维素,硬脂酸镁并混合均匀;
(2)干法制粒,制得的粒子压片得片芯;
(3)所得片芯进行包衣,包衣增重4.29%。
制备奥美沙坦酯片剂3000片,规格40mg,片重434mg ,批号为181204-2,具体配料如表4所示:
奥美沙坦酯片剂的制备方法,包括如下步骤:
(1)按处方量称取奥美沙坦酯、微晶纤维素、一水乳糖、交联羧甲基纤维素钠,羟丙基纤维素,硬脂酸镁并混合均匀;
(2)干法制粒,制得的粒子压片得片芯;
(3)所得片芯进行包衣,包衣增重3.33%。
实施例3
制备奥美沙坦酯片剂6000片,规格20mg,片重219mg ,批号为181205-1,具体配料如表5所示:
表5
奥美沙坦酯片剂的制备方法,包括如下步骤:
(1)按处方量称取奥美沙坦酯、微晶纤维素、一水乳糖、羧甲基淀粉钠,羟丙基纤维素,硬脂酸镁并混合均匀;
(2)干法制粒,制得的粒子压片得片芯;
(3)所得片芯进行包衣,包衣增重4.29%。
制备奥美沙坦酯片剂3000片,规格40mg,片重434mg ,批号为181205-2,具体配料如表6所示:
表6
奥美沙坦酯片剂的制备方法,包括如下步骤:
(1)按处方量称取奥美沙坦酯、微晶纤维素、一水乳糖、羧甲基淀粉钠,羟丙基纤维素,硬脂酸镁并混合均匀;
(2)干法制粒,制得的粒子压片得片芯;
(3)所得片芯进行包衣,包衣增重3.33%。
实施例4
对上述实施例制得的奥美沙坦酯片各项指标进行检测,检测结果见表7、表8。
表7(规格20mg)
表8(规格40mg)
实施例5
将上述实施例制得的奥美沙坦酯片与原研厂家进行累积百分溶出度比较,检测结果见表9、表10。
表9 规格20mg 原研厂家为第一三共制药(上海)有限公司 原研批号为ST015YA
表10 规格40mg 原研厂家为Daiichi Sankyo 原研批号为6386034
从表9,表10可以看出上述实施例制得的奥美沙坦酯片20mg规格和40mg规格溶出曲线相似。
实施例6
将上述实施例制得的奥美沙坦酯片进行含量检测,检测结果见表11、表12。
表11
表12
从表11,表12可以看出由上述实施例制得的20 mg和40 mg规格的奥美沙坦酯含量符合规定要求。
Claims (10)
1.奥美沙坦酯片剂,按重量百分含量,包含以下成分:5%~10%的奥美沙坦酯、50%~70%的填充剂、1%~5 %的黏合剂、10%~20%的崩解剂、0.5 %~2 %的润滑剂,0.5~5%的包衣。
2.如权利要求1所述的奥美沙坦酯片剂,所述的奥美沙坦酯原料药粒度D(0.9)≤400μm。
3.如权利要求1所述的奥美沙坦酯片剂,所述的填充剂选自微晶纤维素、乳糖或甘露醇中的一种或两种以上组合。
4. 如权利要求1所述的奥美沙坦酯片剂,所述的黏合剂选自羟丙基纤维素、聚维酮K30、羟丙基甲基纤维素或羧甲基纤维素钠中的一种或几种。
5.如权利要求1所述的奥美沙坦酯片剂,所述的崩解剂选自低取代羟丙基纤维素、交联羧甲基纤维素钠或羧甲基淀粉钠中一种或几种。
6.如权利要求5所述的奥美沙坦酯片剂,所述的崩解剂优选低取代羟丙基纤维素。
7.如权利要求1所述的奥美沙坦酯片剂,所述的润滑剂选自硬脂酸镁、滑石粉或硬酯富马酸钠中的一种或几种。
8.如权利要求1所述的奥美沙坦酯片剂,所述包衣组成为羟丙甲纤维素、滑石粉、二氧化钛、氧化铁或聚乙二醇中的一种或几种。
9.一种奥美沙坦酯片剂的制备方法,包括如下步骤:
(1)取奥美沙坦酯原料药及常规药用辅料,采用干法制粒工艺,制备压片前总混中间体;
(2)将总混中间体压片制得片芯;
(3)将所得片芯进行包衣,制得所述奥美沙坦酯片剂。
10.如权利要求9所述的制备方法,具体步骤为:步骤(1)将奥美沙坦酯与填充剂、黏合剂、崩解剂和润滑剂混合均匀,得到压片前总混中间体;步骤(2):将步骤(1)所得总混中间体压片得片芯;将步骤(2)所得片芯进行包衣,得所述奥美沙坦酯片剂。
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CN113893226A (zh) * | 2021-11-16 | 2022-01-07 | 烟台万润药业有限公司 | 一种奥美沙坦酯片剂及其制备方法 |
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