CN115518053A - 一种维参锌胶囊及其制备方法 - Google Patents
一种维参锌胶囊及其制备方法 Download PDFInfo
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- CN115518053A CN115518053A CN202211324334.5A CN202211324334A CN115518053A CN 115518053 A CN115518053 A CN 115518053A CN 202211324334 A CN202211324334 A CN 202211324334A CN 115518053 A CN115518053 A CN 115518053A
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- ginseng
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- 239000011701 zinc Substances 0.000 title claims abstract description 68
- 229910052725 zinc Inorganic materials 0.000 title claims abstract description 67
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 title claims abstract description 64
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- 235000005035 Panax pseudoginseng ssp. pseudoginseng Nutrition 0.000 title claims abstract description 55
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- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims abstract description 70
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- WIGCFUFOHFEKBI-UHFFFAOYSA-N gamma-tocopherol Natural products CC(C)CCCC(C)CCCC(C)CCCC1CCC2C(C)C(O)C(C)C(C)C2O1 WIGCFUFOHFEKBI-UHFFFAOYSA-N 0.000 claims abstract description 35
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Abstract
本申请涉及药物制剂领域,具体公开了一种维参锌胶囊及其制备方法。一种维参锌胶囊,包括胶囊外壳和内容物,所述内容物包括速释颗粒和缓释颗粒;速释颗粒包括以下组分:维生素E、人参、硫酸锌、花粉素、水溶性载体、崩解剂;缓释颗粒包括以下重量份的组分:8.33‑16.67份维生素E、41.67‑83.33份人参、0.28‑0.57份硫酸锌、8.33‑16.67份花粉素、30‑60份聚乙烯醇、40‑80份聚乳酸和50‑100份包衣材料。本申请的维参锌胶囊具有血药浓度平稳,药物释放时间长,以防短时间内药物释放浓度较快,引起脾胃虚弱食用者肠胃不适的优点。
Description
技术领域
本申请涉及药物制剂技术领域,更具体地说,它涉及一种维参锌胶囊及其制备方法。
背景技术
维参锌胶囊是一种复方制剂,主要由人参、维生素E、花粉和硫酸锌等制成,用于治疗老年人男性性功能、双眼视敏度、听力、心脏功能自我调节能力、肺功能衰退症。该复方制剂根据有效成分而命名为“维参锌”。
现有维参锌制剂为硬胶囊剂,胶囊内容物的粒度为80目,主要市售规格为每粒含人参125mg、维生素E25mg、花粉25mg、硫酸锌0.85mg。其中人参中单体成分人参皂苷Rg3水溶性差,口服吸收慢,血药浓度和生物利用度低,而且维生素E为脂溶性物质,水溶性不佳,吸收速度较慢。
现有技术中,申请号为CN2011103045566的中国发明专利申请文件公开了一种维参锌包衣片,其中各组分的重量配比为:人参∶维生素E∶花粉素∶硫酸锌∶稀释剂∶崩解剂∶润滑剂∶粘合剂∶水溶性薄膜衣材料=(140-150)∶(25-40)∶(25-40)∶1∶(110-130)∶(170-190)∶(20-30)∶(5-15)∶(15-25),该相关技术中记载花粉素和硫酸锌在50min时的溶出度最高分别达到97.2%和99.2%。
针对上述中的相关技术,发明人发现维参锌中各组分的溶出度在短时间内达到95%以上,若肠胃虚弱患者食用,短时间内在肠胃内释放较多易刺激肠胃的硫酸锌、花粉等物质,极易导致肠胃副反应的发生,对肠胃的黏膜造成刺激,表现出胃部疼痛;因此亟待研制一种有效成分释放速度平缓,且能持久释放的维参锌胶囊。
发明内容
为了使维参锌胶囊中有效成分的释放速度平稳,延长释放时间,降低刺激成分在短时间内释放较快对肠胃的影响,本申请提供一种维参锌胶囊及其制备方法。
第一方面,本申请提供一种维参锌胶囊,采用如下的技术方案:
一种一种维参锌胶囊,包括胶囊外壳和内容物,所述内容物包括速释颗粒和缓释颗粒;
所述速释颗粒包括以下重量份的组分:8.33-16.67份维生素E、41.67-83.33份人参、0.28-0.57份硫酸锌、8.33-16.67份花粉素、60-100份水溶性载体、0.5-1份崩解剂;
所述缓释颗粒包括以下重量份的组分:8.33-16.67份维生素E、41.67-83.33份人参、0.28-0.57份硫酸锌、8.33-16.67份花粉素、30-60份聚乙烯醇、40-80份聚乳酸和50-100份包衣材料。
通过采用上述技术方案,使用速释颗粒和缓释颗粒混合作为内容物,维参锌胶囊口服后,速释颗粒能使维生素E、花粉素、人参和硫酸锌快速溶出,实现快速起效的作用,缓释颗粒则可以缓慢释放活性药物成分,使用后能实现血药浓度维持性高的效果和有效性,降低短时间内药物的血液浓度,防止短时间内释放较多有效成分导致肠胃虚弱患者肠胃不适。
速释颗粒使用水溶性载体包覆有效成分,使维生素E、花粉素、人参和硫酸锌制成速释颗粒,使活性药物分子以无定形的形态分散于水溶性载体中,实现有效的提高药物的溶出速度和生物利用度的作用,改善维参锌药物溶出度差、起效时间长的问题;缓释颗粒由包衣材料包覆制成,通过包衣技术对维生素E、花粉素、人参和硫酸锌进行包衣能够起到缓释作用,实现活性药物成分的持续释放,维持药物的血药浓度,增加药物的作用时间;缓释颗粒中聚乙烯醇分子链结构对称规整,含有大量的极性基团羟基,具有良好的成膜性、粘结性和乳化性,作为活性药物成分的载体,在一定的释药环境中,随着亲水性聚乙烯醇与水的相互作用,药物活性成分缓慢扩散、释放,从而优化释药速度;聚乳酸是以乳酸为主要原料聚合得到的高分子聚合物,在人体内降解,最终代谢产物是无毒的二氧化碳和水,其中间代谢产物乳酸也是人体正常代谢产物,不会在体内积累,因此聚乳酸对于人体无毒副作用,随着聚乳酸的降解,活性药物成分被释放、扩散,延长了药物释放时间,使血药浓度较为平稳,降低维参锌胶囊对肠胃的刺激性。
可选的,所述速释颗粒与缓释颗粒的质量比为1:0.5-2。
通过采用上述技术方案,速释颗粒与缓释颗粒的用量比为1:0.5-2,既能获得适合的初始浓度,又能延长药物的持续时间,使血药浓度平稳。
可选的,所述包衣材料包括5.4-7.6份肠溶性聚合物、0.5-1.5份增塑剂、0.9-1份致孔剂、1-2.5份抗粘剂。
通过采用上述技术方案,肠溶性聚合物需要在进入肠道内才能溶解,从而起到缓释作用,实现药物的持续释放时间,增加药物的有效作用时间,致孔剂能在肠溶性聚合物形成的包衣层上形成孔隙,使药物活性成分能进入人体就得到初始释放,增塑剂能改善肠溶性聚合物的韧性,提高包覆均匀性和紧密性,抗粘剂能防止肠溶性聚合物粘附在药物活性成分上,难以溶解分离。
可选的,所述肠溶性聚合物选自乙基纤维素、醋酸纤维素、甲基丙烯酸甲酯共聚物中的一种或几种。
通过采用上述技术方案,乙基纤维素、醋酸纤维素和甲基丙烯酸甲酯共聚物均为水不溶性物质,具有优秀的成膜性,能保护药物活性成分不被快速溶解,延缓药物的作用时间,增加药物的疗效。
可选的,所述增塑剂为甘油,致孔剂为羟丙基纤维素,抗粘剂为二氧化硅微粉。
通过采用上述技术方案,甘油增塑的膜表面结构被软化,增加了分子链的流动性,甘油能与肠溶性聚合物形成网络,刚性结构被软化,能改善肠溶性聚合物成膜后的柔软度和弹性,使药物活性成分被包裹紧密;羟丙基纤维素不仅具有致孔剂的作用,还能作为增塑剂使用,能改善包衣材料的柔韧性。
可选的,所述水溶性载体选自PEG4000、PEG6000、泊洛沙姆188中的一种或几种。
通过采用上述技术方案,PEG4000、PEG6000、泊洛沙姆188具有良好的水溶性和分散性,能快速溶解,释放有效成分,从而在短时间内使血液浓度升高。
第二方面,本申请提供一种维参锌胶囊的制备方法,采用如下的技术方案:
一种维参锌胶囊的制备方法,包括以下步骤:
将速释颗粒和缓释颗粒按照1:0.5-2的质量比混合均匀,装入胶囊外壳中,制得维参锌胶囊。
通过采用上述技术方案,缓释颗粒和速释颗粒按照比例混合后装入胶囊外壳中,简单方便,易于操作。
可选的,所述缓释颗粒由以下方法制成:
将维生素E、人参、硫酸锌和花粉素混合均匀,制成混合药粉;
将壳聚糖与浓度为1-4wt%的醋酸溶液混合,制成浓度为3-5%wt的壳聚糖溶液,加入所述混合药粉,造粒,制得维参锌丸;
将聚乙烯醇与水混合,升温至溶解,制成质量浓度为5-8%的粘合液,冷却,向粘合液中加入所述维参锌丸,搅拌均匀后,晾干,制成预处理维参锌丸;
将聚乳酸和预处理维参锌丸混合均匀,熔融挤出,室温固化,粉碎,制成包衣维参锌丸;将肠溶性聚合物、增塑剂、致孔剂和抗粘剂与浓度为65-80wt%的乙醇溶液混合,制成包衣溶液;
将包衣溶液均匀喷涂在所述包衣维参锌丸上,干燥后制得缓释颗粒。
通过采用上述技术方案,在制备缓释颗粒时,先用壳聚糖溶液作为粘结剂,将混合药粉进行粘结,制成维参锌丸,维参锌中壳聚糖溶液干燥后形成粘结膜,将药物活性成分进行包裹,然后用聚乙烯醇作为粘合液,在维参锌丸的表面形成一层水溶性膜,增加一层缓释层,接着将预处理维参锌丸与聚乳酸共混挤出,聚乳酸在预处理维参锌丸上继续包覆一层缓释层,最后喷涂包衣材料,当缓释颗粒在体内缓释时,要经过四层分解:首先是包衣材料的溶解,然后是聚乳酸的降解,接着是聚乙烯醇的溶解,最后的壳聚糖的溶解,从而延长药物的作用时间。
可选的,所述熔融挤出温度为170-180℃,螺杆转速为40-45r/min。
通过采用上述技术方案,在此温度和转速下,聚乳酸能与预处理维参锌丸充分混合,使聚乳酸均匀包覆预处理维参锌丸。
可选的,所述速释颗粒由以下方法制成:
将水溶性载体与水混合,制成喷涂溶液后,均匀喷涂在维生素E、人参、硫酸锌、花粉素和崩解剂的混合物上,干燥,制成了速释颗粒。
通过采用上述技术方案,水溶性载体溶于水,喷涂在混合物上以后,干燥形成速释膜,当进入人体后,遇水溶解,在崩解剂的作用下,药物活性成分快速扩散,在短时间内增加血药浓度。
综上所述,本申请具有以下有益效果:
1、由于本申请采用速释颗粒和缓释颗粒配合使用,速释颗粒能实现提高维参锌的溶出度,具有溶出速度快,实现提高起效时间的作用,缓释颗粒药物能够保持平稳的血药浓度,达到长效,增加疗效的目的,也能维持同等药效时降低短时间内的给药量,减少服用硫酸锌或花粉素对脾胃虚弱患者带来的副作用。
2、本申请优选采用壳聚糖、聚乙烯醇、聚乳酸和包衣材料依次对药物活性成分进行包覆,当缓释颗粒进入人体缓释时,至少要经过四层分解,使药物的释放时间延长,改善血药浓度的平稳性。
具体实施方式
实施例
实施例1:一种维参锌胶囊,包括胶囊外壳和内容物,以1000颗胶囊为例,内容物中维生素E总重25g、人参总重125g、硫酸锌总重0.85g、花粉素总重25g,内容物由质量比为1:0.5的速释颗粒和缓释颗粒组成,速释颗粒和缓释颗粒的原料用量如表1所示,速释颗粒中,水溶性载体为PET4000,崩解剂为微晶纤维素,缓释颗粒中,包衣材料包括5.4g肠溶性聚合物、1.5g增塑剂、1g致孔剂、2.5g抗粘剂,肠溶性聚合物为乙基纤维素,增塑剂为甘油,致孔剂为羟丙基纤维素,抗粘剂为二氧化硅微粉。
维参锌胶囊的制备方法,包括以下步骤:
S1、缓释颗粒的制备:(1)将维生素E、人参、硫酸锌和花粉素混合均匀,制成混合药粉;
(2)将壳聚糖与浓度为1wt%的醋酸溶液混合,制成浓度为5%wt的壳聚糖溶液,加入混合药粉,造粒,制得维参锌丸,壳聚糖和混合药粉的质量比为0.5:1;
(3)将聚乙烯醇与水混合,升温至溶解,制成质量浓度为5%的粘合液,冷却,向粘合液中加入维参锌丸,搅拌均匀后,晾干,制成预处理维参锌丸;
(4)将聚乳酸和预处理维参锌丸混合均匀,升温至170℃熔融,螺杆以45r/min的转速挤出,室温固化,粉碎,制成包衣维参锌丸;
(5)将肠溶性聚合物、增塑剂、致孔剂和抗粘剂与浓度为65wt%的乙醇溶液混合,制成包衣溶液;
(6)将包衣溶液均匀喷涂在所述包衣维参锌丸上,干燥后制得缓释颗粒。
S2、速释颗粒的制备:将水溶性载体与水混合,制成质量浓度为15%的喷涂溶液后,均匀喷涂在维生素E、人参、硫酸锌、花粉素和崩解剂的混合物上,干燥,制成了缓释颗粒。
S3、胶囊的制备:将速释颗粒和缓释颗粒按比例混合均匀,装入胶囊外壳中,制得维参锌胶囊。
表1实施例1-2中维参锌胶囊的原料用量
实施例2:一种维参锌胶囊,与实施例1的区别在于,以1000颗胶囊为例,速释颗粒与缓释颗粒的质量比为1:2,原料用量如表1所示。
对比例3:一种维参锌胶囊,与实施例1的区别在于,缓释颗粒制备时,使用等量水替代壳聚糖溶液。
对比例
对比例1:一种维参锌胶囊,与实施例1的区别在于,未添加聚乙烯醇,将维参锌丸与聚乳酸共混进行熔融挤出。
对比例2:一种维参锌胶囊,与实施例1的区别在于,未添加聚乳酸,将包衣溶液喷涂在预处理维参锌丸上。
对比例3:一种维参锌胶囊,与实施例1的区别在于,未喷涂包衣溶液。
对比例4:一种维参锌胶囊,与实施例1的区别在于,使用等量速释颗粒替代缓释颗粒。
对比例5:一种维参锌薄膜包衣片,包括125g人参、25g花粉素、25g维生素E、0.85g硫酸锌、100g预胶化淀粉、交联聚维酮XL-10 100g、低取代羟丙纤维素50g、硬脂酸镁20g、聚乙烯吡咯烷酮10g、欧巴代II15g,
制备方法:将人参、花粉素、硫酸锌混合后用微粉机粉碎,得到微粉化混合物,其中约90%的颗粒粒径小于100μm。然后在该混合物中加入稀释剂、崩解剂混匀,再与维生素E、15%的粘合剂水溶液搅拌混合制成软材,用18~24目筛制粒,然后放入干燥箱60℃干燥,最后加入润滑剂混匀,压片。制得的片芯投入包衣锅中,滚动预热,用喷雾的方式将水溶性包衣液(固含量为0.02%)均匀地撒在片芯表面,再经锅床干燥(转速30转/分,风温75℃左右),如此反复操作,直至形成薄膜衣。
对比例6:选择市售维参锌胶囊(青岛格瑞药液有限公司生产,批号11080403)。
性能检测试验
一、花粉素和硫酸锌的释放率检测:根据《中华人民共和国药典》2015年版四部通则中“缓释、控释和迟释制剂指导原则”,以0.25%十二烷基硫酸钠为释放介质,分别精密称取实施例1-3和对比例1-6所制得的维参锌胶囊适量(约100mg),按照《中华人民共和国药典》2015年版四部通则溶出度与释放度测定法测定,用HPLC法测定峰面积,计算花粉素和硫酸锌的累积释放百分率。
表2维参锌胶囊中花粉素的累积释放率
表3维参锌胶囊中硫酸锌的累积释放率
释放率/% | 2h | 4h | 6h | 12h | 18h | 24h |
实施例1 | 43.2 | 55.1 | 68.7 | 82.3 | 91.8 | 100 |
实施例2 | 45.1 | 54.2 | 69.1 | 85.1 | 93.2 | 100 |
实施例3 | 43.1 | 72.8 | 89.4 | 100 | / | / |
对比例1 | 43.0 | 74.6 | 90.2 | 100 | / | / |
对比例2 | 44.5 | 76.5 | 91.6 | 100 | / | / |
对比例3 | 50.8 | 78.5 | 92.8 | 100 | / | / |
对比例4 | 91.8 | 100 | / | / | / | / |
对比例5 | 97.5 | 100 | / | / | / | / |
对比例6 | 98.2 | 100 | / | / | / | / |
由表2中数据可以看出,实施例1中速释颗粒和缓释颗粒的质量比为1:0.5,实施例1制成的维参锌胶囊中花粉素在2h内的累积释放率达到56.5%,且花粉素持续释放,在24h时达到100%;同样速释颗粒和缓释颗粒的质量比为1:2的实施例2制成的维参锌胶囊在4h前的花粉素不及实施例1,但在6h时就反超实施例1,说明缓释颗粒起到持续释放的作用。同样实施例1和实施例2制成的维参锌胶囊内硫酸锌的释放速度平稳,释放时间长。
实施例3与实施例1的区别在于,使用等量水替代壳聚糖,虽然花粉素虽然在4h内的释放率不及实施例1,但在4h往后的释放率选择增大,说明使用壳聚糖作为粘合剂,能减缓维参锌胶囊中有效成分的释放速度。
对比例1与实施例1的区别在于,未使用聚乙烯醇,表2和表3内显示,维参锌胶囊中硫酸锌和花粉素在18h达到100%释放,且在3h时释放速度显著增大。
对比例2中未使用聚乳酸进行熔融挤出,对比例3与实施例1的区别在于,未喷涂包衣溶液,对比例2和对比例3制成的维参锌胶囊经测试可知,有效成分释放速度较快,易造成脾胃虚弱的食用者肠胃不适。
对比例4与实施例1的区别在于,未添加缓释颗粒,全部使用速释颗粒,对比例4中有效成分释放速度很快,2h内完成全部释放。
对比例5为现有技术制备的一种维参锌薄膜包衣片,在2h内就差不多完成了接近100%的释放率;对比例6为市售的维参锌胶囊,其在2h左右释放率就达到了91%左右,在2h时完成了百分之百的释放率。
二、对肠胃刺激性检测:对实施例1和对比例6中的维参锌胶囊进行食用检测,检测是否对肠胃产生刺激,检测方法如下:
(1)受试动物:30只选自复旦大学实验动物中心的小鼠,体重为18-22g,均为雄性,平均分为3组,每组10只;
(2)小鼠脾虚模型制造:采用大黄水煎液灌服方式,每只小鼠每日灌服37.5g/kg,连续灌服8天,造成脾胃虚弱模型;
(3)食用方法:每只小鼠早晨服用维参锌胶囊,每只每日食用2粒,每粒0.38g,给药30min后,记录30min内小鼠扭体反应次数,扭体次数越多,说明刺激越大,将检测结果记录于表4中,检测结果取每组平均值。
表4维参锌胶囊对肠胃的影响
项目 | 扭体反应次数/次 |
实施例1 | 1.35 |
对比例5 | 12.34 |
对比例6 | 11.21 |
表4内数据可以看出,实施例1制成的维参锌胶囊,由脾胃虚弱的食用者食用后,不易引起肠胃不适,而对比例5和对比例6中维参锌胶囊食用后,短时间内快速释放的活性成分会造成脾胃虚弱的食用者肠胃不适。
本具体实施例仅仅是对本申请的解释,其并不是对本申请的限制,本领域技术人员在阅读完本说明书后可以根据需要对本实施例做出没有创造性贡献的修改,但只要在本申请的权利要求范围内都受到专利法的保护。
Claims (10)
1.一种维参锌胶囊,其特征在于,包括胶囊外壳和内容物,所述内容物包括速释颗粒和缓释颗粒;
所述速释颗粒包括以下重量份的组分:8.33-16.67份维生素E、41.67-83.33份人参、0.28-0.57份硫酸锌、8.33-16.67份花粉素、60-100份水溶性载体、0.5-1份崩解剂;
所述缓释颗粒包括以下重量份的组分:8.33-16.67份维生素E、41.67-83.33份人参、0.28-0.57份硫酸锌、8.33-16.67份花粉素、30-60份聚乙烯醇、40-80份聚乳酸和50-100份包衣材料。
2.根据权利要求1所述的维参锌胶囊,其特征在于,所述速释颗粒与缓释颗粒的质量比为1:0.5-2。
3.根据权利要求1所述的维参锌胶囊,其特征在于,所述包衣材料包括5.4-7.6份肠溶性聚合物、0.5-1.5份增塑剂、0.9-1份致孔剂、1-2.5份抗粘剂。
4.根据权利要求3所述的维参锌胶囊,其特征在于,所述肠溶性聚合物选自乙基纤维素、醋酸纤维素、甲基丙烯酸甲酯共聚物中的一种或几种。
5.根据权利要求3所述的维参锌胶囊,其特征在于,所述增塑剂为甘油,致孔剂为羟丙基纤维素,抗粘剂为二氧化硅微粉。
6.根据权利要求1所述的维参锌胶囊,其特征在于,所述水溶性载体选自PEG4000、PEG6000、泊洛沙姆188中的一种或几种。
7.权利要求1-6任一项所述的维参锌胶囊的制备方法,其特征在于,包括以下步骤:
将速释颗粒和缓释颗粒按照1:0.5-2的质量比混合均匀,装入胶囊外壳中,制得维参锌胶囊。
8.根据权利要求7所述的维参锌胶囊的制备方法,其特征在于,所述缓释颗粒由以下方法制成:
将维生素E、人参、硫酸锌和花粉素混合均匀,制成混合药粉;
将壳聚糖与浓度为1-4wt%的醋酸溶液混合,制成浓度为3-5%wt的壳聚糖溶液,加入所述混合药粉,造粒,制得维参锌丸;
将聚乙烯醇与水混合,升温至溶解,制成质量浓度为5-8%的粘合液,冷却,向粘合液中加入所述维参锌丸,搅拌均匀后,晾干,制成预处理维参锌丸;
将聚乳酸和预处理维参锌丸混合均匀,熔融挤出,室温固化,粉碎,制成包衣维参锌丸;
将肠溶性聚合物、增塑剂、致孔剂和抗粘剂与浓度为65-80wt%的乙醇溶液混合,制成包衣溶液;
将包衣溶液均匀喷涂在所述包衣维参锌丸上,干燥后制得缓释颗粒。
9.根据权利要求8所述的维参锌胶囊的制备方法,其特征在于,所述熔融挤出温度为170-180℃,螺杆转速为40-45r/min。
10.根据权利要求7所述的维参锌胶囊的制备方法,其特征在于,所述速释颗粒由以下方法制成:
将水溶性载体与水混合,制成喷涂溶液后,均匀喷涂在维生素E、人参、硫酸锌、花粉素和崩解剂的混合物上,干燥,制成了速释颗粒。
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Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
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CN1939301A (zh) * | 2005-09-28 | 2007-04-04 | 中国人民解放军军事医学科学院毒物药物研究所 | 含有维生素e烟酸酯的缓释制剂及其制备方法 |
CN101023961A (zh) * | 2006-02-23 | 2007-08-29 | 山东省生物药物研究院 | 一种含透明质酸钠和锌盐的药物组合物 |
CN101623311A (zh) * | 2009-07-03 | 2010-01-13 | 青岛格瑞药业有限公司 | 微粉化维参锌及其药物组合物 |
CN102885810A (zh) * | 2012-10-30 | 2013-01-23 | 台州职业技术学院 | 一种坎地沙坦酯双释胶囊及其制备方法 |
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Publication number | Priority date | Publication date | Assignee | Title |
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CN1939301A (zh) * | 2005-09-28 | 2007-04-04 | 中国人民解放军军事医学科学院毒物药物研究所 | 含有维生素e烟酸酯的缓释制剂及其制备方法 |
CN101023961A (zh) * | 2006-02-23 | 2007-08-29 | 山东省生物药物研究院 | 一种含透明质酸钠和锌盐的药物组合物 |
CN101623311A (zh) * | 2009-07-03 | 2010-01-13 | 青岛格瑞药业有限公司 | 微粉化维参锌及其药物组合物 |
CN102885810A (zh) * | 2012-10-30 | 2013-01-23 | 台州职业技术学院 | 一种坎地沙坦酯双释胶囊及其制备方法 |
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