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Nebivolol hydrochloride soft capsule preparation and preparation process thereof

A technology for nebivolol hydrochloride and soft capsule preparations, applied in the field of nebivolol hydrochloride soft capsule preparations and its preparation technology, to achieve the effects of improving cumulative dissolution rate, good stability, and improving dissolution efficiency

Inactive Publication Date: 2018-04-13
FOSHAN TENGRUI MEDICINE TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

What deserves special attention is that no orthostatic hypotension has been reported after using this product

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] Nebivolol Hydrochloride Soft Capsules Contents Prescription:

[0060] Nebivolol hydrochloride raw material 0.5g; caprylic capric macrogol glyceride 220g;

[0061] Polyglycerol oleate 45g; medium chain triglyceride 75g;

[0062] 0.035 g of 2,6-di-tert-butyl-p-cresol.

[0063] Softgel prescription:

[0064] Gelatin 160mg; Glycerin 80mg;

[0065] Yellow iron oxide 0.29mg; titanium dioxide 2mg.

[0066] Preparation:

[0067] (1) Prepare the contents: take the prescription amount of caprylic capric acid macrogolglyceride, polyglycerol oleate and medium chain triglyceride and stir evenly, add the prescription amount of nebivolol hydrochloride after heating up to 40°C Crude drug and 2,6-di-tert-butyl-p-cresol, continue to stir for 1 hour until uniform, then cool down to room temperature to obtain the content;

[0068] (2) Preparation of soft capsules: Take the prescribed amount of glycerin, add water, put it in a plastic tank, stir and mix evenly, then add titanium dioxi...

Embodiment 2

[0071] Nebivolol Hydrochloride Soft Capsules Contents Prescription:

[0072] Nebivolol hydrochloride raw material 1g; caprylic capric acid macrogol glyceride 225g;

[0073] Polyglycerol oleate 50g; medium chain triglyceride 72g;

[0074] 0.038g of 2,6-di-tert-butyl-p-cresol.

[0075] Softgel prescription:

[0076] Gelatin 160mg; Glycerin 80mg;

[0077] Yellow iron oxide 0.25mg; titanium dioxide 2.2mg.

[0078] Preparation:

[0079] (1) Prepare the contents: take the prescription amount of caprylic capric acid macrogolglyceride, polyglycerol oleate and medium chain triglyceride and stir evenly, add the prescription amount of nebivolol hydrochloride after heating up to 40°C Crude drug and 2,6-di-tert-butyl-p-cresol, continue to stir for 1 hour until uniform, then cool down to room temperature to obtain the content;

[0080] (2) Preparation of soft capsules: Take the prescribed amount of glycerin, add water, put it in a plastic tank, stir and mix evenly, then add titanium dio...

Embodiment 3

[0083] Nebivolol Hydrochloride Soft Capsules Contents Prescription:

[0084] Nebivolol hydrochloride raw material 0.1g; caprylic capric acid macrogol glyceride 220g;

[0085] Polyglycerol oleate 45g; medium chain triglyceride 75g;

[0086] Softgel prescription:

[0087] Gelatin 161mg; Glycerin 85mg;

[0088] Yellow iron oxide 0.27mg; titanium dioxide 2mg.

[0089] Preparation:

[0090] (1) Prepare the contents: take the prescription amount of caprylic capric acid macrogolglyceride, polyglycerol oleate and medium chain triglyceride and stir evenly, add the prescription amount of nebivolol hydrochloride after heating up to 40°C Continue to stir the raw material for 1 hour until it is uniform, and then lower it to room temperature to obtain the content;

[0091] (2) Preparation of soft capsules: Take the prescribed amount of glycerin, add water, put it in a plastic tank, stir and mix evenly, then add titanium dioxide and yellow iron oxide passed through an 80-mesh sieve and ...

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PUM

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Abstract

The invention discloses a nebivolol hydrochloride soft capsule preparation which comprises a soft capsule and a content, wherein the content consists of the following components: 0.1-1.0g of a nebivolol hydrochloride raw material, 200-250g of octanoic acid capric acid polyethylene glycol glyceride, 30-60g of polyglycerin oleate, 50-100g of mid-chain triglyceride fatty acid and 0.02-0.05g of 2,6-di-tertiary butyl p-cresol. By adopting the nebivolol hydrochloride soft capsule preparation disclosed by the invention, the accumulation dissolution degree can be remarkably increased within five minutes of dissolution, the dissolution efficiency of a main medicine within a front time quantum is improved, and the preparation is good in stability and good in product appearance quality.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a nebivolol hydrochloride soft capsule preparation and a preparation process thereof. Background technique [0002] Nebivolol hydrochloride is a selective β-blocker with vasodilator effect, mainly used in the treatment of essential hypertension and chronic heart failure. It has the advantages of significant curative effect, convenient medication, and less adverse reactions. It is a new promising antihypertensive drug. It was approved for marketing in Germany for the first time in 1997 for the treatment of essential hypertension. Because this product, nebivolol hydrochloride, has the advantages of both cardioprotection and vasodilation, it is predicted to be one of the "ten blockbusters" with good market prospects in the future. [0003] Features of this product: [0004] (1) Nebivolol hydrochloride lacks endogenous reverse sympathetic and membrane stabilizin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/42A61K47/02A61K47/14A61K47/10A61K31/353A61P9/12A61P9/04
CPCA61K9/4808A61K9/4825A61K9/4858A61K9/4866A61K31/353
Inventor 欧泽桂
Owner FOSHAN TENGRUI MEDICINE TECH CO LTD
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