CN1261097C - Nisoldipine capsule composition - Google Patents

Nisoldipine capsule composition Download PDF

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Publication number
CN1261097C
CN1261097C CN 02104211 CN02104211A CN1261097C CN 1261097 C CN1261097 C CN 1261097C CN 02104211 CN02104211 CN 02104211 CN 02104211 A CN02104211 A CN 02104211A CN 1261097 C CN1261097 C CN 1261097C
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CN
China
Prior art keywords
nisoldipine
soft capsule
preparation
glycerol
capsule preparation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CN 02104211
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Chinese (zh)
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CN1436535A (en
Inventor
陈云芳
万忠新
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
ZHEJIANG WANLIAN PHARMACEUTICAL INDUSTRY Co Ltd
Original Assignee
ZHEJIANG WANLIAN PHARMACEUTICAL INDUSTRY Co Ltd
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Application filed by ZHEJIANG WANLIAN PHARMACEUTICAL INDUSTRY Co Ltd filed Critical ZHEJIANG WANLIAN PHARMACEUTICAL INDUSTRY Co Ltd
Priority to CN 02104211 priority Critical patent/CN1261097C/en
Publication of CN1436535A publication Critical patent/CN1436535A/en
Application granted granted Critical
Publication of CN1261097C publication Critical patent/CN1261097C/en
Anticipated expiration legal-status Critical
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  • Medicinal Preparation (AREA)

Abstract

The present invention relates to a nisoldipine soft capsule composition which is liquid content suitable for being prepared into soft capsules. The nisoldipine soft capsule composition contains nisoldipine serving as the active component, glycerol serving as the cosurfactant, solvent components and surfactants. The present invention also relates to a soft capsule preparation containing the liquid content, wherein nisoldipine in the preparation is dissolved in the solvent, so that small dosage of nisoldipine has better dispersing uniformity and is quicker to take effect than tablets, and the disadvantage of lower bioavailability existing in conventional tablets is overcome. Simultaneously, the product as a novel dosage form can provide a newer and better dosage form selection for both doctors and patients.

Description

Nisoldipine capsule composition
The present invention relates to contain the stable liquid capsule composition of the soft capsule that is suitable for preparing nisoldipine.More particularly, the present invention relates to a kind of liquid content that is suitable for being mixed with soft capsule, it contains nisoldipine is active component, and glycerol also relates to the soft capsule preparation that contains described solution shape content as cosurfactant, solvent composition and surfactant.
Nisoldipine is a second filial generation dihydropyridine calcium ion antagonist, its chemical constitution and nifedipine are similar, to photaesthesia, compare with other dihydropyridine calcium ion antagonists, the effect of being characterized in is stronger, and biological half-life is longer, compares blood lipid metabolism and blood sugar level that nisoldipine can not influence the patient with beta-blocker, compare with nifedipine, nisoldipine is because littler to the high selectivity thereby the negative inotropic action of blood vessel.It can reduce myocardial oxygen consumption and total peripheral resistance, also can increase the CC circulation, and coronary flow is increased.Nisoldipine is a German Bayer drugmaker initiative, and principal indication is hypertension and angina pectoris.China's Ministry of Public Health had been ratified nisoldipine raw material and tablet (specification: 5mg), produced by Shandong Province Pharmacy stock Co., Ltd of Xinhua and pharmaceutical factory of Shandong Province's industrial research institute thereof in 1998.The present invention is a nisoldipine capsule, does not see the report of the patent of relevant nisoldipine capsule and related preparations thereof so far as yet.
The present invention is a nisoldipine capsule, and wherein nisoldipine is dissolved in the solvent in the preparation, makes low dose of nisoldipine dispersed homogeneous degree better than tablet, and rapid-action, has overcome the lower shortcoming of conventional tablet bioavailability; Simultaneously, this product can provide the possibility of a kind of renewal, better dosage form selection for doctor and patient as a kind of novel form.
The object of the present invention is to provide a kind of nisoldipine novel formulation, said preparation is guaranteeing under the suitable prerequisite of principal agent dosage, by selecting adjuvant and formulation method for use, nisoldipine is made solution to be wrapped in and to make soft capsule in the rubber, help oral, the absorption of medicine, reach high bioavailability.Simultaneously, also be clinical a kind of renewal, the better dosage form selection of providing.
Be detailed description of the present invention below:
Nisoldipine capsule preparation of the present invention is made up of soft capsule rubber and the pharmaceutical composition that is wrapped in the rubber, and described pharmaceutical composition mainly contains following material and weight ratio:
Nisoldipine 1
Glycerol 1~4
Vegetable oil and/or Polyethylene Glycol 50~100
Surfactant 0.5~3.
Above-mentioned soft capsule preparation, wherein the weight ratio of each material is preferably:
Nisoldipine 1
Glycerol 1.2~3
Vegetable oil and/or Polyethylene Glycol 50~80
Surfactant 0.8~2.
Above-mentioned soft capsule preparation wherein preferably contains 5.0 milligrams of nisoldipines in every soft capsule.
Above-mentioned soft capsule preparation, wherein vegetable oil is preferably soybean oil.
Above-mentioned soft capsule preparation, wherein Polyethylene Glycol is preferably PEG400.
Above-mentioned soft capsule preparation, surfactant can add and can not add, and preferably add surfactant, and surfactant is preferably non-ionic surface active agent.
Above-mentioned non-ionic surface active agent is preferably Tween 80 or polysorbate60.
In the above-mentioned soft capsule, can also comprise other pharmaceutic adjuvant, as excipient etc.
Be described more specifically the present invention by the following example.But these embodiment should not be construed as the restriction to any aspect of the present invention.
The specific embodiment
Embodiment 1
The poly-ethanol 400 (60 ℃ of water temperatures) in water-bath that takes by weighing 180g is heated, add the 5.0g nisoldipine, constantly stir and make medicine dissolution, add 6.3g glycerol again, stir, add the 95.7g PEG400 at last, stir to put and be chilled to room temperature, make the pale yellow solution that contains principal agent 17.4mg among every 1g, after measuring content, medicinal liquid is incorporated in the machine of preparation soft capsule, regulates this machine and make the medicinal liquid that injects 0.287g in each soft capsule, preparation contains the soft capsule of nisoldipine pale yellow solution in gelatin shell.
Embodiment 2
Preparing the soft capsule with following composition according to same steps as among the embodiment 1, is the consumption difference as the glycerol of cosurfactant.
2--A constituent content (mg/ grain)
Nisoldipine 5.0
Glycerol 4.3
PEG400 275.7
Amount to 285mg
2-B constituent content (mg/ grain)
Nisoldipine 5.0
Glycerol 10.3
PEG400 275.7
Amount to 291mg
Embodiment 3
Prepare soft capsule according to embodiment 1 identical step, just increase the composition of surfactant with following composition.
3A constituent content (mg/ grain)
Nisoldipine 5.0
Glycerol 6.3
Tween 80 10
PEG400 275.7
Amount to 297mg
3-B constituent content (mg/ grain)
Nisoldipine 5.0
Glycerol 4.3
Polysorbate60 10
PEG400 275.7
Amount to 297mg
Embodiment 4
Same steps as preparation according to embodiment 1 has following soft capsule, just the composition of solvent and its changes of contents.
4--A constituent content (mg/ grain)
Nisoldipine 5.0
Glycerol 4.3
PEG400 220.7
Amount to 230mg
4--B constituent content (mg/ grain)
Nisoldipine 5.0
Glycerol 4.3
PEG400 350.7
Amount to 360mg
4C constituent content (mg/ grain)
Nisoldipine 5.0
Sweet Shan 8.0
Soybean oil 250
Amount to 262mg
4--D constituent content (mg/ grain)
Nisoldipine 5.0
Glycerol 6.0
Soybean oil 300
Amount to 310mg

Claims (7)

1, the soft capsule preparation of nisoldipine is made up of soft capsule rubber and the pharmaceutical composition that is wrapped in the rubber, it is characterized in that described pharmaceutical composition mainly contains following material and weight ratio:
Nisoldipine 1
Glycerol 1~4
Vegetable oil and/or Polyethylene Glycol 50~100
Surfactant 0.5~3.
2, the soft capsule preparation of claim 1, wherein the weight ratio of each material is:
Nisoldipine 1
Glycerol 1.2~3
Vegetable oil and/or Polyethylene Glycol 50~80
Surfactant 0.8~2.
3, claim 1 or 2 soft capsule preparation wherein contain 5.0 milligrams of nisoldipines in each soft capsule.
4, claim 1 or 2 soft capsule preparation, wherein vegetable oil is a soybean oil.
5, claim 1 or 2 soft capsule preparation, wherein Polyethylene Glycol is a PEG400.
6, claim 1 or 2 soft capsule preparation, wherein surfactant is a non-ionic surface active agent.
7, the soft capsule preparation of claim 6, wherein non-ionic surface active agent is Tween 80 or polysorbate60.
CN 02104211 2002-02-09 2002-02-09 Nisoldipine capsule composition Expired - Fee Related CN1261097C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN 02104211 CN1261097C (en) 2002-02-09 2002-02-09 Nisoldipine capsule composition

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN 02104211 CN1261097C (en) 2002-02-09 2002-02-09 Nisoldipine capsule composition

Publications (2)

Publication Number Publication Date
CN1436535A CN1436535A (en) 2003-08-20
CN1261097C true CN1261097C (en) 2006-06-28

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CN 02104211 Expired - Fee Related CN1261097C (en) 2002-02-09 2002-02-09 Nisoldipine capsule composition

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CN (1) CN1261097C (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1771949B (en) * 2005-11-06 2011-04-20 沈阳药科大学 Soft nimodipine capsule and its preparation
CN102247598A (en) * 2011-06-13 2011-11-23 浙江爱生药业有限公司 Oil-soluble drug composition
CN106511294B (en) * 2016-12-09 2019-05-07 汤臣倍健股份有限公司 A kind of soft capsule and preparation method thereof

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CN1436535A (en) 2003-08-20

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