CN1650859A - 一种马来酸依那普利分散片及其制备工艺 - Google Patents
一种马来酸依那普利分散片及其制备工艺 Download PDFInfo
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- CN1650859A CN1650859A CN 200410002674 CN200410002674A CN1650859A CN 1650859 A CN1650859 A CN 1650859A CN 200410002674 CN200410002674 CN 200410002674 CN 200410002674 A CN200410002674 A CN 200410002674A CN 1650859 A CN1650859 A CN 1650859A
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- enalapril maleate
- dispersible tablet
- preparation technology
- starch
- magnesium stearate
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- 238000002360 preparation method Methods 0.000 title claims description 6
- 239000006185 dispersion Substances 0.000 title 1
- VZCYOOQTPOCHFL-UPHRSURJSA-N maleic acid Chemical compound OC(=O)\C=C/C(O)=O VZCYOOQTPOCHFL-UPHRSURJSA-N 0.000 title 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 title 1
- 108010061435 Enalapril Proteins 0.000 claims abstract description 26
- 229960000309 enalapril maleate Drugs 0.000 claims abstract description 26
- OYFJQPXVCSSHAI-QFPUQLAESA-N enalapril maleate Chemical compound OC(=O)\C=C/C(O)=O.C([C@@H](C(=O)OCC)N[C@@H](C)C(=O)N1[C@@H](CCC1)C(O)=O)CC1=CC=CC=C1 OYFJQPXVCSSHAI-QFPUQLAESA-N 0.000 claims abstract description 26
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 22
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 21
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims abstract description 12
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 12
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 12
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 12
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 12
- 229920002472 Starch Polymers 0.000 claims abstract description 11
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 11
- 235000019698 starch Nutrition 0.000 claims abstract description 11
- 238000001035 drying Methods 0.000 claims abstract description 6
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims abstract description 6
- 239000007919 dispersible tablet Substances 0.000 claims description 15
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims description 10
- 239000000203 mixture Substances 0.000 claims description 10
- 239000008107 starch Substances 0.000 claims description 10
- 239000008187 granular material Substances 0.000 claims description 6
- 229950005770 hyprolose Drugs 0.000 claims description 6
- 206010013786 Dry skin Diseases 0.000 claims description 5
- 239000007779 soft material Substances 0.000 claims description 5
- 238000012856 packing Methods 0.000 claims description 4
- 206010020772 Hypertension Diseases 0.000 claims description 2
- 201000010099 disease Diseases 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 239000001341 hydroxy propyl starch Substances 0.000 abstract 1
- 239000000843 powder Substances 0.000 abstract 1
- 238000007873 sieving Methods 0.000 abstract 1
- 239000003814 drug Substances 0.000 description 5
- 239000003826 tablet Substances 0.000 description 4
- 230000008901 benefit Effects 0.000 description 3
- 238000004090 dissolution Methods 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 229940079593 drug Drugs 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 239000005541 ACE inhibitor Substances 0.000 description 1
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 1
- 101710129690 Angiotensin-converting enzyme inhibitor Proteins 0.000 description 1
- 101710086378 Bradykinin-potentiating and C-type natriuretic peptides Proteins 0.000 description 1
- 108010066671 Enalaprilat Proteins 0.000 description 1
- 229940044094 angiotensin-converting-enzyme inhibitor Drugs 0.000 description 1
- 230000003276 anti-hypertensive effect Effects 0.000 description 1
- 229960000830 captopril Drugs 0.000 description 1
- FAKRSMQSSFJEIM-RQJHMYQMSA-N captopril Chemical compound SC[C@@H](C)C(=O)N1CCC[C@H]1C(O)=O FAKRSMQSSFJEIM-RQJHMYQMSA-N 0.000 description 1
- 229960002680 enalaprilat Drugs 0.000 description 1
- LZFZMUMEGBBDTC-QEJZJMRPSA-N enalaprilat (anhydrous) Chemical compound C([C@H](N[C@@H](C)C(=O)N1[C@@H](CCC1)C(O)=O)C(O)=O)CC1=CC=CC=C1 LZFZMUMEGBBDTC-QEJZJMRPSA-N 0.000 description 1
- 230000003203 everyday effect Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 230000002045 lasting effect Effects 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 230000003389 potentiating effect Effects 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
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Abstract
本发明涉及一种主要用于治疗高血压病的化学药品。特别是马来酸依那普利分散片及其制备工艺。其特征是以马来酸依那普利为原料,经科学工艺制成的一种化学药制剂。选用马来酸依那普利及微晶纤维素、L-羟丙纤维素、淀粉,分别过80目筛,混合均匀,用50%乙醇制成适宜软材,过24目筛制粒,40℃通风干燥,加入硬脂酸镁和滑石粉混合均匀,压片,分装,即得马来酸依那普利分散片。采用先进技术工艺制成的携带、服用方便,起效快、生物利用度高化学药制剂。
Description
本发明涉及一种主要用于治疗高血压病的化学药品。特别是马来酸依那普利分散片及其制备工艺。其特征是以马来酸依那普利为原料,经科学工艺制成的一种化学药制剂。
马来酸依那普利是抗高血压药,是不含巯基的强效血管紧张素转换酶抑制剂。它在体内水解为依那普利拉而发挥作用,其强度比卡托普利强10倍。作用持久。目前为治疗高压药的常用药。我们将其制成分散片。马来酸依那普利为难溶性药物,原普通片口服后一小时见效。分散片具有快速崩解,迅速吸收,提高生物利用度的优点。马来酸依那普利普通片的溶出度规定30分钟时的溶出限度为标示量的75%;美国药典23版规定30分钟时的溶出限度为标示量的80%,我们所制备的分散片,规定5分钟时的溶出限度为标示量的80%。说明马来酸依那普利分散片溶出度远高于普通片。
本发明的目的:为了使片剂快速崩解,迅速吸收,溶出速率快,提高生物利用度,我们采用了全新工艺,将其制成分散片,使其服用方便,在临床应用上发挥更好的效果,以期取得更好的社会效益。
本发明是这样实现的:
选用
马来酸依那普利 5g
微晶纤维素 50g
L-羟丙纤维素 20g
淀 粉 10g
硬脂酸镁 0.25g
滑 石 粉 1g
50%乙醇 适量
制 成 1000片
将马来酸依那普利及微晶纤维素、L-羟丙纤维素、淀粉,分别过80目筛,混合均匀,用50%乙醇制成适宜软材,过24目筛制粒,40℃通风干燥,加入硬脂酸镁和滑石粉混合均匀,压片。
本发明的优点:由于本发明为分散片,携带、服用方便,可口服或允服。每次1片,每日2次。与原马来酸依那普利片一日服用量相同。另外,由于添加了微晶纤维素、L-羟丙基纤维素,使其在3分钟以内崩解并能通过2号筛,起效快,生物利用度高。
附图:是根据本发明提出的工艺流程。
实施例1:选用马来酸依那普利5g、微晶纤维素50g、L-羟丙基纤维素20g、淀粉10g、滑石粉1g、硬脂酸镁0.25g、50%乙醇适量。将马来酸依那普利及微晶纤维素、L-羟丙纤维素、淀粉,分别过80目筛,混合均匀,用50%乙醇制成适宜软材,过24目筛制粒,40℃通风干燥,加入硬脂酸镁和滑石粉混合均匀,压片。得1000片,分装,即得马来酸依那普利分散片。
实施例2:选用马来酸依那普利50g、微晶纤维素500g、L-羟丙基纤维素200g、淀粉100g、滑石粉10g、硬脂酸镁2.5g、50%乙醇适量。将马来酸依那普利及微晶纤维素、L-羟丙纤维素、淀粉,分别过80目筛,混合均匀,用50%乙醇制成适宜软材,过24目筛制粒,40℃通风干燥,加入硬脂酸镁和滑石粉混合均匀,压片。得10000片,分装,即得马来酸依那普利分散片。
实施例3:选用马来酸依那普利500g、微晶纤维素5000g、L-羟丙基纤维素2000g、淀粉1000g、滑石粉100g、硬脂酸镁25g、50%乙醇适量。将马来酸依那普利及微晶纤维素、L-羟丙纤维素、淀粉,分别过80目筛,混合均匀,用50%乙醇制成适宜软材,过24目筛制粒,40℃通风干燥,加入硬脂酸镁和滑石粉混合均匀,压片。得100000片,分装,即得马来酸依那普利分散片。
Claims (2)
1、马来酸依那普利分散片及其制备工艺,其特征在于:选用马来酸依那普利5g、微晶纤维素50g、L-羟丙基纤维素20g、淀粉10g、滑石粉1g、硬脂酸镁0.25g、50%乙醇适量。进行制粒、干燥、压片,成为分散片,用于高血压等疾病。
2、根据权利要求书1所述马来酸依那普利分散片的制备工艺,其特征在于将马来酸依那普利及微晶纤维素、L-羟丙纤维素、淀粉,分别过80目筛,混合均匀,用50%乙醇制成适宜软材,过24目筛制粒,40℃通风干燥,加入硬脂酸镁和滑石粉混合均匀,压片。分装,即得马来酸依那普利分散片。
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