CN107773723A - 胆宁中成药固体口服制剂及其制备方法 - Google Patents

胆宁中成药固体口服制剂及其制备方法 Download PDF

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CN107773723A
CN107773723A CN201610728607.0A CN201610728607A CN107773723A CN 107773723 A CN107773723 A CN 107773723A CN 201610728607 A CN201610728607 A CN 201610728607A CN 107773723 A CN107773723 A CN 107773723A
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曾培安
张静
吴健民
贺莲
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Kamp Pharmaceuticals Co Ltd
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Abstract

本发明公开了胆宁中成药固体口服制剂及其制备方法，其特征在于，该口服制剂处方重量份数计为：大黄20‑30份，虎杖300‑400份，青皮100‑200份，陈皮100‑200份，郁金200‑300份，山楂200‑300份，白茅根180‑260份。该口服制剂为混悬颗粒剂、颗粒剂、片剂、胶囊剂。本发明制剂将原来的片剂更改为混悬型颗粒剂，具有吸收快，口感好，体积小的优点，方便儿童及老年患者使用，便于携带、贮存。本品用稠膏作为粘合剂可以节约成本。

Description

胆宁中成药固体口服制剂及其制备方法
技术领域
本发明属于医药制剂领域，具体涉及胆宁中成药固体口服制剂及其制备方法。
背景技术
随着人民生活水平的普遍提高，人们在饮食方面起了质的变化，因此肝胆疾病的发病率也随之提高。根据不完全统计，肝胆疾病占总患病率的18％左右，并且呈逐年上升趋势，已属常见病和多发病之一。中医认为肝胆互为表里，肝胆疾病往往互相影响。胆道系统最常见的疾病——胆石症就是由肝脏疾病而生。胆病常有肝脏病症，肝病及胆，胆病及肝，经常同时出现、互为因果。“胆病从肝论治”理论在中医临床证型上分为肝郁气滞型和肝阴不足型两类。目前临床治疗方法主要分为手术治疗和药物治疗。手术存在一定的局限性，且术后易复发。药物治疗是以祖国中医中药的“消、溶、排、防”的基本理论体系，无论单独运用还是与手术结合使用，都积累了丰富的经验，为此治疗肝胆疾病药物需要量也增大。
胆宁中成药固体口服制剂原剂型为片剂，虽然也是口服制剂，但在使用上有不方便的地方，如服用量为每日3次，每次5片，服用药片的数量较多，尤其对于老人和儿童患者，十分不便。颗粒剂是中成药常见剂型之一，不仅便于携带和服用，而且口感较好，尤其适合老人和儿童服用。
本制剂将原来的片剂更改为混悬型颗粒剂，具有吸收快，口感好，体积小的优点，方便儿童及老年患者使用，便于携带、贮存。我们将原处方中的每次用量由过去的5片更改为1袋，极大的方便了患者，达到了减少服用量，提高疗效的目的。
发明内容
本发明在将处方药材按原工艺进行提取、分离精制基础上制备胆宁中成药混悬型颗粒剂。
本发明胆宁中成药固体口服制剂及其制备方法，其特征在于，该口服制剂处方重量份数计为：大黄20-30份，虎杖300-400份，青皮100-200份，陈皮100-200份，郁金200-300份，山楂200-300份，白茅根180-260份。
本发明所述胆宁中成药固体口服制剂及其制备方法，该口服制剂处方重量份数计为：大黄24份，虎杖360份，青皮144份，陈皮144份，郁金216份，山楂260份，白茅根216份。
本发明所述胆宁中成药固体口服制剂及其制备方法，该口服制剂为混悬颗粒剂、颗粒剂、片剂、胶囊剂。
本发明所述胆宁中成药固体口服制剂及其制备方法，该口服制剂制备工艺为：以上七味，大黄粉碎成细粉，过五号筛备用，陈皮提取挥发油，其余虎杖等五味加6倍量和4倍量70%乙醇回流二次，每次1小时， 提取液浓缩成稠膏备用；取稠膏与药材细粉、陈皮提取挥发油及部分糖粉混匀，制成软材，制颗粒，6O℃以下干燥，整粒，分装即得。本发明所述胆宁中成药固体口服制剂及其制备方法，该口服制剂混悬颗粒剂制备工艺为：将处方中部分药材提取浓缩成稠膏，另部分药材粉碎成极细粉加入制成的颗粒剂，或是药材提取物加入不溶性赋形剂（如微晶纤维素）、加适量矫味剂（桔子香精）制成，用水冲后不能全部溶解，而成混悬性液体。
本发明优点：
本制剂将原来的片剂更改为混悬型颗粒剂，制备过程中将部分药材粉碎成极细粉加入，既是药物起治疗作用，又是赋形剂，节省其他的赋形剂，降低成本。
本发明混悬型颗粒剂具有吸收快，口感好，体积小的优点，方便儿童及老年患者使用，便于携带、贮存。
我们将原处方中的每次用量由过去的5片更改为1袋，极大的方便了患者，达到了减少服用量，提高疗效的目的。
具体实施方式
下面实施例只为进一步说明本发明，不以任何形式限制本发明范围。
实施例1
处方：
大黄24份，虎杖360份，青皮144份，陈皮144份，郁金216份，山楂260份，白茅根216份。
实施例2
处方：
大黄24份，虎杖350份，青皮144份，陈皮150份，郁金220份，山楂260份，白茅根216份。
实施例3
处方：
大黄20份，虎杖300份，青皮100份，陈皮100份，郁金200份，山楂200份，白茅根216份。
实施例4
处方：
大黄24份，虎杖400份，青皮200份，陈皮200份，郁金260份，山楂260份，白茅根216份。
实验例1：实施例1-4颗粒剂制备工艺：
以上七味，大黄粉碎成细粉，过五号筛备用，陈皮提取挥发油，其余虎杖等五味加6倍量和4倍量70%乙醇回流二次，每次1小时， 提取液浓缩成稠膏备用；取稠膏与药材细粉、陈皮提取挥发油及部分糖粉混匀，制成软材，制颗粒，6O℃以下干燥，整粒，分装即得。 实验例2：实施例1-4混悬型颗粒剂制备工艺：
将处方中部分药材提取浓缩成稠膏，另部分药材粉碎成极细粉加入制成的颗粒剂，或是药材提取物加入不溶性赋形剂（如微晶纤维素）、加适量矫味剂（桔子香精）制成，用水冲后不能全部溶解，而成混悬性液体。
根据实验例2的制备工艺生产三批实施例1-4处方混悬型颗粒剂可不进行溶化性检查，0个月质量检查及加速试验数据如下：

Claims (5)

1.胆宁中成药固体口服制剂及其制备方法，其特征在于，该口服制剂处方重量份数计为：大黄20-30份，虎杖300-400份，青皮100-200份，陈皮100-200份，郁金200-300份，山楂200-300份，白茅根180-260份。
2.根据权利要求1所述胆宁中成药固体口服制剂及其制备方法，其特征在于，该口服制剂处方重量份数计为：大黄24份，虎杖360份，青皮144份，陈皮144份，郁金216份，山楂260份，白茅根216份。
3.根据权利要求1所述胆宁中成药固体口服制剂及其制备方法，其特征在于，该口服制剂为混悬颗粒剂、颗粒剂、片剂、胶囊剂。
4.根据权利要求3所述胆宁中成药固体口服制剂及其制备方法，其特征在于，该口服制剂制备工艺为：以上七味，大黄粉碎成细粉，过五号筛备用，陈皮提取挥发油，其余虎杖等五味加6倍量和4倍量70%乙醇回流二次，每次1小时， 提取液浓缩成稠膏备用；取稠膏与药材细粉、陈皮提取挥发油及部分糖粉混匀，制成软材，制颗粒，6O℃以下干燥，整粒，分装即得。
5.根据权利要求3所述胆宁中成药固体口服制剂及其制备方法，其特征在于，该口服制剂混悬颗粒剂制备工艺为：将处方中部分药材提取浓缩成稠膏，另部分药材粉碎成极细粉加入制成的颗粒剂，或是药材提取物加入不溶性赋形剂（如微晶纤维素）、加适量矫味剂（桔子香精）制成，用水冲后不能全部溶解，而成混悬性液体。
CN201610728607.0A 2016-08-26 2016-08-26 胆宁中成药固体口服制剂及其制备方法 Pending CN107773723A (zh)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1557415A (zh) * 2004-02-03 2004-12-29 上海和黄药业有限公司 一种治疗肝胆疾病的药物制剂及其制备方法
CN101095896A (zh) * 2007-04-26 2008-01-02 上海和黄药业有限公司 一种治疗胆囊疾病的中药组合物及其指纹图谱分析方法
CN102085330A (zh) * 2009-12-02 2011-06-08 程兴顺 一种胆宁胶囊

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1557415A (zh) * 2004-02-03 2004-12-29 上海和黄药业有限公司 一种治疗肝胆疾病的药物制剂及其制备方法
CN101095896A (zh) * 2007-04-26 2008-01-02 上海和黄药业有限公司 一种治疗胆囊疾病的中药组合物及其指纹图谱分析方法
CN102085330A (zh) * 2009-12-02 2011-06-08 程兴顺 一种胆宁胶囊

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