CN201727758U - 普伐他汀钠肠溶片 - Google Patents
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Abstract
本实用新型涉及一种普伐他汀钠肠溶片。该普伐他汀钠肠溶片包括普伐他汀钠药品制剂及其表面包被的肠溶衣。本实用新型克服了普伐他汀在胃酸环境下生物利用度较低，长期服用产生恶心、呕吐等不良反应。本剂型普伐他汀钠肠溶片在小肠碱性环境中生物利用度明显优于胃酸环境，且大大降低副作用。
Description
技术领域
本实用新型涉及一种普伐他汀钠肠溶片。
背景技术
普伐他汀钠为3-羟基3-甲基戊二酰辅酶A还原酶(HMG-COA还原梅)的竞争性抑制剂，HMG-COA还原酶是胆固醇生物合成初期阶段的限速酶。普伐他汀钠可逆性地抑制HMG-COA还原酶，从而抑制胆固醇的生物合成，具有疗效显著、不良反应小、耐受性好的特点，是一类新型降血脂药物。临床用于饮食限制仍不能控制的原发性高胆固醇血症或合并有高甘油三酯血症患者。
目前市售的普伐他汀钠的口服制剂主要是胃溶片剂。实验证明，pH值对普伐他汀的稳定性影响显著。普伐他汀在模拟胃中的酸性条件下不稳定，易发生转化，尤其在模拟空腹时的胃液中转化迅速，其初期的转化行为符合一级动力学。3’α-异普伐他汀为普伐他汀的一个主要转化产物，其生物活性只有母体药的1/40～1/10。普伐他汀在模拟肠道pH条件下较稳定，不发生明显转化。可见，普伐他汀钠胃溶片在患者体内的转化速率高，降低其生物利用度，长期服用可对胃黏膜产生强烈刺激，引起恶心、呕吐等不良反。
发明内容
本实用新型所要解决的技术问题是提供一种生物利用度高、治疗效果好的普伐他汀钠肠溶片。
本实用新型解决上述技术问题所采用的技术方案是通过对普伐他汀钠片进行包肠溶衣，所述肠溶包衣层为糖衣层或薄膜衣层。
具体地，本实用新型普伐他汀钠肠溶片是由普伐他汀钠和辅料压成片剂后，用肠溶包衣材料如虫胶、聚乙烯醇乙酸苯二甲酸醋(PVAP)、丙烯酸树脂类(肠溶型I号树脂、肠溶型II号树脂、肠溶型III号树脂、三元丙烯酸共聚物)、纤维素及其衍生物(邻苯二甲酸乙酸纤维素、1，2，4-苯三甲酸乙酸纤维素、邻苯二甲酸羟丙基甲基纤维素、1，2，4-苯三甲酸羟丙基甲基纤维素等)中一种或几种配制成包衣液，对普伐他汀钠片进行包衣，制得普伐他汀钠肠溶片。主要用于饮食限制仍不能控制的原发性高胆固醇血症或合并有高甘油三酯血症治疗。经过实验证实，与普通的普伐他汀钠片相比，普伐他汀钠肠溶片避免受胃酸的破坏，提高生物利用度，延长治疗时间，而且肠溶片提供延迟释放作用，无普通片剂的明显的降谷现象，避免了普伐他汀钠片的突释效应，降低了副作用。
本实用新型的优势在于普伐他汀钠肠溶片克服了普伐他汀钠在胃酸环境下生物利用度低，避免了长期服用产生恶心、呕吐等不良反应。本实用新型在小肠碱性环境中的生物利用度明显优于胃酸环境，且提供延迟释放作用，能保持稳定的血药浓度并延长治疗时间，降低副作用。
附图说明
图1是本实用新型的结构示意图
图2是本实用新型的结构示意图
具体实施方式
如图1、图2所示，普伐他汀钠肠溶片包括普伐他汀钠药品制剂1和包被在普伐他汀钠药品制剂1表面的肠溶包衣2。具体地，所述肠溶包衣层为糖衣层或薄膜衣层，普伐他汀钠肠溶片形状可以制作成如图1和图2所示的形状或其他需要的形状。
普伐他汀钠肠溶片的具体制备方法：
(1)将10g普伐他汀钠原料药和一定量的MCC、甘露醇、PVP K30以及20g氧化镁加入湿法混合颗粒机中混合均匀，再加入5g CMS-Na作为崩解剂和2g硬脂酸镁作为润滑剂，混合均匀后直接压片，每片含普伐他汀钠10mg。
(2)将适量聚丙烯酸树脂II号、III号溶解于95％乙醇中，溶解后加人少量蓖麻油、苯二甲酸二乙醋、滑石粉、肤白粉、食用色素，配成肠溶包衣液对普伐他汀钠片进行包衣，制的普伐他汀钠肠溶片。每日1次，每次10～20mg。
本实用新型普伐他汀钠肠溶片和现有的普伐他汀钠片的对比试验及相关数据如下：
(1)试验药物：由沈阳亿灵医药科技有限公司自制的普伐他汀钠肠溶片(规格10mg/片)；参比药物：购买华北制药有限公司生产的普伐他汀钠片(规格10mg/片)
(2)选择10名健康男性志愿者，年龄(23±3)岁，体重(63±4)kg，试验前进行病史询问和体格检查，心电图、胸透、肝功、肾功、血常规、尿常规检查等均正常。受试者试验前2周及试验期间未服用其他任何药物，试验期间禁烟酒及含咖啡因的饮料。将10名健康受试者随机分为2组，分别2周期单剂量交叉口服普伐他汀钠参比药和受试药物40mg，用高效液相色谱法测定血清中的普伐他汀的药物浓度，用3P97软件计算药代动力学参数。根据文献中有关普伐他汀钠的药理、毒理、临床及相关不良反应报道，确定单次给药剂量为40mg。
本实验采用2周期自身交叉服用受试制剂或参比制剂，清洗期为1周。受试者于试验前12h吃清淡晚餐后禁食，试验当日清晨8时空腹口服受试制剂或参比制剂，剂量均为40mg，用200ml温开水送服。间隔一周后交换服用另一种普伐他汀钠药物。
5名健康受试者口服普伐他汀钠片后，经3P97程序处理，符合权重为1的一室模型；体内有明显的吸收，5名受试者tmax为0.98±0.16h，Cmax为69.41±38.63ng/ml，普通片代谢较快，t1/2为2.01±0.46h。
5名健康受试者口服普伐他汀钠肠溶片后，经3P97程序处理，符合权重为1的一室模型；体内有吸收，5名受试者tmax为2.56±0.48h，Cmax为53.24±31.47ng/ml，与普通片相比血药浓度偏低但半衰期延长，t1/2为3.81±0.78h。肠溶片与普通片相比，相对生物利用度是129.98±20.03％。受试者服用受试制剂和参比制剂，均未见不良反应。
本预试验结果表明，受试者口服普伐他汀钠肠溶片和普通片后，肠溶片表现出缓释特征：tmax延长，Cmax降低，MRT延长，与口服普通片相比，生物利用度较普通片高。
Claims (2)
1.普伐他汀钠肠溶片其特征在于，包括普伐他汀钠药品制剂，所述普伐他汀钠药品制剂表面包有肠溶衣。
2.根据权利要求1所述的普伐他汀钠肠溶片，其特征在于所述肠溶包衣为糖衣层或薄膜衣层。
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| CN2010202695271U CN201727758U (zh) | 2010-07-19 | 2010-07-19 | 普伐他汀钠肠溶片 |
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| CN2010202695271U CN201727758U (zh) | 2010-07-19 | 2010-07-19 | 普伐他汀钠肠溶片 |
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| CN201727758U true CN201727758U (zh) | 2011-02-02 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111803462A (zh) * | 2020-07-15 | 2020-10-23 | 浙江诺得药业有限公司 | 一种普伐他汀钠肠溶片及其制备方法 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111803462A (zh) * | 2020-07-15 | 2020-10-23 | 浙江诺得药业有限公司 | 一种普伐他汀钠肠溶片及其制备方法 |
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