CN1026861C - 以普瑞维替丁作活性成分的药物组合物的稳定方法 - Google Patents
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Abstract
提供一种药物制剂,它具有良好稳定性,当它分散在水里时,pH值至少约为9,其中含有象普瑞维替丁的一类对低pH值环境敏感的药物,一种或多种填充剂(例如乳糖及/或微晶纤维素),一种或多种粘合剂[例如微晶纤维素(干粘合剂)或聚乙烯吡咯烷酮(湿粘合剂)]一种或多种崩解剂(例如交联羧甲基纤维素钠),一种或多种润滑剂(例如硬脂酸镁)和一种或多种碱化剂(例如氧化镁)。
Description
本发明涉及一类最好是片剂形式的药物制剂,它含有例如象普瑞维替丁(pravastatin)一类对低pH值环境敏感的药物,并且具有良好的稳定性。
含有在酸性环境中不稳定的药物的制剂需要一种碱性赋形剂来增加贮存时的稳定性。
Terahara等人的美国专利NO.4,346,227公开的具有如下分子式的普瑞维替丁(β-羟-β-甲基戊二酸单酰辅酶A还原酶抑制剂)对低pH值环境敏感并且会降解形成其内酯和各种异构体。
本发明提供的药物制剂,即使含有在低pH值环境可能降解的药物,也具有良好的贮存稳定性。本发明的药物制剂,最好作成片剂形式,可包含例如象普瑞维替丁的一类对低pH值环境敏感的药
物,一种或多种填充剂,例如乳糖及/或微晶纤维素,一种或多种粘合剂,例如微晶纤维素(干粘合剂)或聚乙烯吡咯烷酮(湿粘合剂),一种或多种崩解剂(例如交联羧甲基纤维素钠),一种或多种润滑剂(例如硬脂酸镁),一种或多种使制剂的水分散液pH值至少达到9左右的碱化剂(例如氧化镁)。
本发明特别适用于含普瑞维替丁的药物制剂。普瑞维替丁在制剂中的含量按重量计约在1-60%范围内,最好在3-50%之间。
为保证满意的稳定性,本发明的制剂要包含碱化剂,使制剂的水分散液的pH值至少提高到9左右,最好达到9.5左右。碱化剂的含量为制剂重量的1-75%范围内,最好在2-70%之间。在这里适用的碱化剂例如包括氧化镁、氧化铝、水合铝酸镁、碱金属氢氧化物(例如氢氧化钠、氢氧化钾或氢氧化锂)或碱土金属氢氧化物(例如氢氧化钙或氢氧化镁),最好是氧化镁,但并不局限于这些化合物。
本发明的制剂也包括一种或多种填充剂或赋形剂,其含量按重量计大约在5-90%范围内,最好在大约10-80%之间。例如乳糖、蔗糖、玉米淀粉、改良玉米淀粉、甘露糖醇、山梨糖醇、诸如碳酸钙之类的无机盐及/或纤维素衍生物(例如木纤维素和微晶纤维素)。
本发明的制剂中的一种或多种粘合剂可以作为填充剂的附加成分或替代填充剂,其含量按制剂的重量计约在5-35%范围内,最好在约10-30%之间。在这里适用的粘合剂例如包括聚乙烯吡咯烷酮(分子量范围约为5000至80,000,最好约40,000),乳糖,淀粉(例如玉米淀粉,改良玉米淀粉),蔗糖,阿拉伯树胶等,也可用细粉状(小于500微米)的蜡质粘合剂(例如巴西蜡棕树蜡,石蜡、鲸蜡、聚乙烯类或微晶石蜡)。
若要将制剂制成片剂形式,制剂中应含一种或多种片剂崩解剂,它的含量按制剂重量计约在0.5-10%范围内,最好约在2-8%之间,例如交联羧甲基纤维素钠、交联聚乙烯吡咯烷酮,淀粉甘醇酸钠、玉米淀粉或微晶纤维素,片剂中还包含一种或多种片剂润滑剂,它的含量按制剂重量计约在0.2-8%范围内,最好约在0.5-2%之间。例如硬脂酸镁、硬脂酸、棕榈酸、硬脂酸钙、滑石、巴西棕榈蜡等等。制剂中也可选用一些其它常规成分,诸如防腐剂、稳定剂、抗粘剂,硅流动性调节剂或助流剂(例如Syloid牌的二氧化硅)和FD&C着色剂。
本发明的片剂也可有包衣层,它的含量按片剂的重量计约在0-15%之间。用于片核的包衣层可以采用任意常规的包衣配方,并且可包含一种或多种成膜剂或粘合剂,诸如亲水性聚合物(例如羟基丙基甲基纤维素)和疏水性聚合物(例如乙基纤维素,醋酸纤维素、聚乙烯醇-马来酸酐共聚物、β-蒎烯聚合物、木树脂中的甘油酯类等等),也可包含一种或多种增塑剂,例如柠檬酸三乙酯、邻苯二甲酸二乙酯、丙二醇、甘油、邻苯二甲酸二丁酯和蓖麻油等,片核和包衣配料中都可用铝色淀染料着色。
使用成膜剂可采用含有一种或多种溶剂的溶剂系统,包括水,醇(如甲醇、乙醇、或异丙醇),酮(如丙酮或甲乙酮),氯代烃类(如二氯甲烷,二氯乙烷和1,1,1-三氯乙烷)。
如果采用着色剂,它要和成膜剂、增塑剂和溶剂等一起使用。
本发明的一个较好的片剂组成可包括(按重量计)约2-35%的普瑞维替丁,约2.5-70%的氧化镁,约10-80%的乳糖,约10-30%的微晶纤维素或聚乙烯吡咯烷酮,约2-8%的交联羧甲基纤
维素钠和约0.5-2%的硬脂酸镁。
本发明的药物制剂制备如下。将一种药物(普瑞维替丁)和碱化剂(最好是氧化镁)的混合物与一部分(少于50%)填充剂(例如乳糖),加或不加着色剂一起混合后通过12#到40#的筛网。再加入填充一粘合剂(例如微晶纤维素),崩解剂(例如交联羧甲基纤维素钠)以及余下的乳糖并混合。最后加润滑剂(例如硬脂酸镁),混合,直至得到均匀混合物。
可将所得的混合物再压成至多重1克的药片。
需要的时候,本发明的片剂可用湿粒法制成。把药物(普瑞维替丁)溶在粘合剂(聚乙烯吡咯烷酮)的温水溶液中。将所得到的溶液与填充剂(含水乳糖)、碱化剂(例如氧化镁)、填充一粘合剂(微晶纤维素)及一部分崩解剂(交联羧甲基纤维素钠)的混合物制成颗粒,制成颗粒的混合物通过4#到10#的筛网,然后放入盘架干燥箱干燥,干燥后的颗粒通过12#到20#的筛网。再加入剩余的崩解剂和润滑剂(例如硬脂酸镁),将得到的颗粒压成药片。
另一湿粒法制片技术是将药物(普瑞维替丁),碱化剂(最好是氧化镁),填充一粘合剂(例如微晶纤维素),一部分(少于50%)的填充剂(例如乳糖)及(或无)着色剂混合并通过12#至40#的筛网。加入一部分崩解剂(例如交联羧甲基纤维素钠)和余下的乳糖,并且混匀。把得到的混合物用粘合剂(例如聚乙烯吡咯烷酮)的水溶液制粒。所形成的湿混合物颗粒通过4#到20#筛网,再放入盘架干燥箱干燥。干颗粒通过12#到20#筛网,再将剩余的崩解剂和润滑剂(例如硬脂酸镁)加入得到的干颗粒中,并压成药片。
所有筛网的尺寸均为美国标准ASTME。
下面的实施例体现了本发明较好的具体方案。除非特意指出,所有的温度表示摄氏度,所有的筛网大小均为美国标准ASTME。
实施例1
一种制成片剂的有如下成分的普瑞维替丁制剂的制备方法如下所述。
组分 重量百分比
普瑞维替丁 6.7
乳糖 67
微晶纤维素 20
交联羧甲基纤维素钠 2
硬脂酸镁 1
氧化镁 3.3
将普瑞维替丁、氧化镁和一部分乳糖(30%)用适宜的混合器混合2到10分钟。所得混合物通过12#到40#的筛网。加入微晶纤维素,交联羧甲基纤维素钠和余下的乳糖,混合2到10分钟。然后加入硬脂酸镁,继续混合1到3分钟。
将所得到的均一的混合物压成药片,每片可含5mg,10mg,20或40mg的普瑞维替丁。
药片的水悬浮液的pH值大约为10。
用此法制成的药片在60℃、或40℃/75%相对湿度下放置2个月进行稳定性试验,结果表明含有普瑞维替丁的片剂相当稳定,未观察到有内酯生成。
实施例2
一个制成片剂、每片含5mg、10mg、20mg或40mg普瑞维
替丁的,有如下组成的普瑞维替丁制剂,除了把着色剂加入到含普瑞维替丁、氧化镁和一部分乳糖的粉末混合物中以外,制剂的制法与实施例1相同。
组分 重量百分比
普瑞维替丁 6.7
乳糖 66.8
微晶纤维素 20
交联羧甲基纤维素钠 2
硬脂酸镁 1
氧化镁 3.3
FD&C红3#色淀染料 0.2
药片的水悬浮液的pH值约为10。
用此法制成的药片在60℃、或40℃/75%相对湿度下放置2个月进行稳定性试验,结果表明含有普瑞维替丁的片剂相当稳定,未观察到有内酯生成。
实施例3
一种制成片剂的、每片含5mg、10mg、20mg、或40mg普瑞维替丁的、有如下组成的普瑞维替丁制剂的制备方法如下所述。
组分 重量百分比
普瑞维替丁 6.7
乳糖 71
微晶纤维素 15
交联羧甲基纤维素钠 2
组分 重量百分比
硬脂酸镁 1
氧化镁 3.3
聚乙烯吡咯烷酮 1
将普瑞维替丁溶解在聚乙烯吡咯烷酮的温水溶液中,溶液与乳糖、氧化镁、微晶纤维素和一部分交联羧甲基纤维素钠的混合物一起制粒。配好的混合物通过4#到10#的筛网,在盘架干燥箱中干燥成粒。干燥的颗粒再通过12#到20#的筛网。将余下的崩解剂加入干燥颗粒中,混合2到10分钟。然后加入硬脂酸镁,继续混合1到5分钟,所得颗粒压成药片。
药片的水分散体的pH值约为10。
用此法制成的药片在60℃或40℃/75%相对湿度下放置2个月进行稳定性试验,结果表明含有普瑞维替丁的片剂相当稳定,未观察到有内酯的生成。
实施例4
一种制成片剂、每片含5mg、10mg、20mg或40mg普瑞维替丁的、有如下组成的普瑞维替丁制剂,除了把着色剂加入到含乳糖、氧化镁、微晶纤维素和一部分交联羧甲基纤维素钠粉末混合物中外,此制剂的制法与实施例3相同。
组分 重量百分比
普瑞维替丁 6.7
乳糖 70.8
微晶纤维素 15
交联羧甲基纤维素钠 2
组分 重量百分比
硬脂酸镁 1
氧化镁 3.3
FD&C3#色淀染料 0.2
聚乙烯吡咯烷酮 1
药片的水分散体的pH值大约为10。
用此法制成的药片在60℃或40℃/75%相对湿度下放置2个月进行稳定性试验,结果表明含普瑞维替丁的片剂相当稳定,未观察到有内酯生成。
实施例5
按实施例3方法制备一种制成片剂、每片含10mg普瑞维替丁的、有如下组成的普瑞维替丁制剂。
组分 重量百分比
普瑞维替丁 6.7
乳糖 54.5
聚乙烯吡咯烷酮 0.5
交联羧甲基纤维素钠 4
硬脂酸镁 1
氧化镁 33.3
药片的水分散体的pH值大约为10。
用此法制成的片剂在40℃放置18个月进行稳定性试验,结果表明含普瑞维替丁的片剂相当稳定,未观察到有内酯生成。
实施例6
一种制成片剂、每片含5mg、10mg、20mg和40mg普瑞维替丁的、有如下组成的普瑞维替丁制剂的制备方法如下所述。
组分 重量百分比
普瑞维替丁 10
乳糖 66.7
微晶纤维素 15
交联羧甲基纤维素钠 2
硬脂酸镁 1
氧化镁 3.3
聚乙烯吡咯烷酮 2
将普瑞维替丁,氧化镁,微晶纤维素和一部分乳糖混合5到10分钟。所得的混合物通过12#到40#筛网。再加入一部分交联羧甲基纤维素钠和余下的乳糖,继续混合5-10分钟。所得混合物用聚乙烯吡咯烷酮水溶液制粒。成颗粒的湿混合物通过4#到20#的筛网,并且在盘架干燥箱中干燥。干燥的颗粒通过12#到20#的筛网。将余下的交联羧甲基纤维素钠加到颗粒中,并混合5-10分钟。再将硬脂酸镁加到所得的颗粒状混合物中,并继续混合1-5分钟,把所得药料压成药片。
此药片的水分散体的pH值大约为10。
用此法制成的药片在60℃或40℃/75%相对湿度下放置2个月进行稳定性试验,结果表明含普瑞维替丁的药片相当稳定,未观察到有内酯生成。
实施例7
一种制成片剂、每片含5mg、10mg、20mg和40mg普瑞维
替丁的、有如下组成的普瑞维替丁制剂,除了把FD&C红3#色淀染料加入到普瑞维替丁、氧化镁、微晶纤维素和乳糖混合物中外,此制剂的制法与实施例6相同。
组分 重量百分比
普瑞维替丁 10
乳糖 66.5
微晶纤维素 15
交联羧甲基纤维素钠 2
硬脂酸镁 1
氧化镁 3.3
FD&C红3#色淀染料 0.2
聚乙烯吡咯烷酮 2
此药片的水分散体的pH值大约为10。
用此法制成的药片在60℃或40℃/75%相对湿度下放置2个月进行稳定性试验,结果表明含普瑞维替丁的药片相当稳定,未观察到有内酯生成。
实施例8
一种制成片剂、每片含5mg、10mg、20mg和40mg普瑞维替丁的、有如下组成的普瑞维替丁制剂。除了将所有的交联羧甲基纤维素钠在加入硬脂酸镁之前与干燥颗粒混合外,制剂的制备方法与例6相同。
组分 重量百分比
普瑞维替丁 10
乳糖 64.7
微晶纤维素 15
组分 重量百分比
交联羧甲基纤维素钠 5
硬脂酸镁 1
氧化镁 3.3
聚乙烯吡咯烷酮 1
此药片的水分散体的pH值大约为10。
用此法制成的药片在60℃或40℃/75%相对湿度下放置2个月进行稳定性试验,结果表明含普瑞维替丁的药片相当稳定,未观察到有内酯生成。
实施例9
一种制成片剂、有如下组成的普瑞维替丁制剂,除了把FD&C红3#色淀染料与普瑞维替丁,氧化镁,微晶纤维素和乳糖混合外,此制剂的制法与例8相同。
组分 重量百分比
普瑞维替丁 10
含水乳糖 64.5
微晶纤维素 15
聚乙烯吡咯烷酮 1
交联羧甲基纤维素钠 5
硬脂酸镁 1
氧化镁 3.3
FD&C3#色淀染料 0.2
此药片的水分散体的pH值大约为10。
用此法制成的药片在40℃至60℃放置数月进行稳定性试验,结果
表明含普瑞维替丁的药片相当稳定,未观察到有内酯生成。
也可使用能把实施例1-9所示的本发明的制剂的水分散体的pH值升高至10左右的其它碱化剂。这些碱化剂的实例包括NaOH,KOH,Ca(OH)2,Mg(OH)2或NH4OH。
Claims (6)
1、一种以普端维替丁(Pravastatin)作活性成分的药物组合物的稳定方法,其特征是加碱化剂碱金属氢氧化物,碱土金属氢氧化物或氢氧化铵于含普端维替丁,一种或多种填充剂,一种或多种粘合剂,一种或多种崩解剂和一种或多种润滑剂的常规药物组合物中,使该组合物的水分散液的pH值至少为9。
2、根据权利要求1的方法,其中的碱化剂是MgO,Mg(OH)2,Ca(OH)2,NaOH,KOH,LiOH,NH4OH,Al(OH)3或水合铝酸镁。
3、根据权利要求1的方法,其中的填充剂是乳糖,蔗糖,玉米淀粉,改良玉米淀粉,甘露糖醇,山梨糖醇,木纤维素,微晶纤维素,碳酸钙或它们的混合物。
4、根据权利要求1的方法,其中的粘合剂是微晶纤维素,聚乙烯吡咯烷酮,乳糖,玉米淀粉,改良玉米淀粉,蔗糖,阿拉伯树胶,巴西棕榈树蜡,石蜡,鲸蜡,聚乙烯或微晶蜡。
5、根据权利要求1的方法,其中的崩解剂是交联羧甲基纤维素钠,交联聚乙烯吡咯烷酮,淀粉甘醇酸钠,玉米淀粉或微晶纤维素。
6、根据权利要求1的方法,制备有以下组成的制剂:
按重量计,普瑞维替丁3-50%,
氧化镁2-70%,使pH值至少达到9.5,
乳糖1-85%,
10-30%的微晶纤维素或聚乙烯吡咯烷酮,
2-8%的交联羧甲基纤维素钠,
0.5-2%的硬脂酸镁。
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US176,127 | 1988-03-31 | ||
US07/176,127 US5030447A (en) | 1988-03-31 | 1988-03-31 | Pharmaceutical compositions having good stability |
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EP3833667B1 (en) | 2018-08-07 | 2024-03-13 | Merck Sharp & Dohme LLC | Prmt5 inhibitors |
WO2021126731A1 (en) | 2019-12-17 | 2021-06-24 | Merck Sharp & Dohme Corp. | Prmt5 inhibitors |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3865935A (en) * | 1972-08-10 | 1975-02-11 | Abbott Lab | Tableting of erythromycin base |
US3891755A (en) * | 1973-07-11 | 1975-06-24 | Abbott Lab | Dosage formulation for erythromycin cetyl sulfate |
US4342767A (en) * | 1980-01-23 | 1982-08-03 | Merck & Co., Inc. | Hypocholesteremic fermentation products |
DK149080C (da) * | 1980-06-06 | 1986-07-28 | Sankyo Co | Fremgangsmaade til fremstilling af derivater af ml-236b-carboxylsyre |
US4609675A (en) * | 1984-08-17 | 1986-09-02 | The Upjohn Company | Stable, high dose, high bulk density ibuprofen granulations for tablet and capsule manufacturing |
US4681759A (en) * | 1985-05-08 | 1987-07-21 | Ortho Pharmaceutical Corporation | Rioprostil-PVP complex |
DE3524572A1 (de) * | 1985-07-10 | 1987-01-15 | Thomae Gmbh Dr K | Feste arzneimittelformen zur peroralen anwendung enthaltend 9-deoxo-11-deoxy-9,11-(imino(2-(2-methoxyethoxy)ethyliden)-oxy)-(9s)-erythromycin und verfahren zu ihrer herstellung |
GB2189699A (en) * | 1986-04-30 | 1987-11-04 | Haessle Ab | Coated acid-labile medicaments |
-
1988
- 1988-03-31 US US07/176,127 patent/US5030447A/en not_active Expired - Lifetime
-
1989
- 1989-02-16 CA CA000591236A patent/CA1323836C/en not_active Expired - Lifetime
- 1989-02-21 NZ NZ228076A patent/NZ228076A/en unknown
- 1989-02-23 ZA ZA891424A patent/ZA891424B/xx unknown
- 1989-02-23 AU AU30276/89A patent/AU624117B2/en not_active Expired
- 1989-03-23 IE IE92989A patent/IE62956B1/en not_active IP Right Cessation
- 1989-03-30 DK DK198901556A patent/DK173862B1/da not_active IP Right Cessation
- 1989-03-30 EP EP89105625A patent/EP0336298B1/en not_active Expired - Lifetime
- 1989-03-30 AT AT89105625T patent/ATE79030T1/de not_active IP Right Cessation
- 1989-03-30 DE DE8989105625T patent/DE68902344T2/de not_active Expired - Lifetime
- 1989-03-31 CN CN89101911A patent/CN1026861C/zh not_active Expired - Lifetime
-
1992
- 1992-10-14 SG SG1072/92A patent/SG107292G/en unknown
-
1993
- 1993-04-22 HK HK400/93A patent/HK40093A/xx not_active IP Right Cessation
- 1993-10-10 CY CY1675A patent/CY1675A/xx unknown
Also Published As
Publication number | Publication date |
---|---|
IE62956B1 (en) | 1995-03-08 |
CA1323836C (en) | 1993-11-02 |
US5030447A (en) | 1991-07-09 |
JPH026406A (ja) | 1990-01-10 |
DK173862B1 (da) | 2002-01-07 |
EP0336298A1 (en) | 1989-10-11 |
DE68902344T2 (de) | 1993-01-07 |
NZ228076A (en) | 1991-04-26 |
ATE79030T1 (de) | 1992-08-15 |
JP2935220B2 (ja) | 1999-08-16 |
HK40093A (en) | 1993-04-30 |
IE890929L (en) | 1989-09-30 |
EP0336298B1 (en) | 1992-08-05 |
AU624117B2 (en) | 1992-06-04 |
DK155689A (da) | 1989-10-01 |
SG107292G (en) | 1992-12-24 |
CN1036508A (zh) | 1989-10-25 |
DE68902344D1 (de) | 1992-09-10 |
CY1675A (en) | 1993-10-10 |
ZA891424B (en) | 1989-10-25 |
DK155689D0 (da) | 1989-03-30 |
AU3027689A (en) | 1989-10-05 |
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