Hydrochloride epinastine dispersing tablets and their production

A technology for epinastine hydrochloride and dispersible tablets, which is applied in the fields of active ingredients of heterocyclic compounds, pill delivery, respiratory diseases, etc. It can solve the problems of single oral dosage form of epinastine hydrochloride, and achieve easy industrial production and simple process , high bioavailability

Inactive Publication Date: 2010-03-24
张文静
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to solve the single shortcoming of prior art epinastine hydrochloride oral dosage forms, improve the bitter taste of epinastine hydrochloride, and make the compliance of epinastine hydrochloride dispersible tablets good is the purpose of the present invention

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] 1. Prescription: The prescription composition of Epinastine Hydrochloride Dispersible Tablets is as follows: (2.5mg specification is calculated as 1000 tablets), which contains:

[0037] Epinastine Hydrochloride 2.5g

[0038] Cyclodextrin 5g

[0039] Starch lactose 100g

[0040] Microcrystalline Cellulose 60g

[0041] Calcium hydrogen phosphate 20g

[0042] Carboxymethyl Starch Sodium 25g

[0043] Stevia 25g

[0044] Magnesium Stearate 5g

[0045] Micronized silica gel 10g

[0046] Solid essence 15g

[0047] Pure water 8ml

[0048] 2. Method 1: The preparation method of Epinastine Hydrochloride Dispersible Tablets is as follows:

[0049] (a) the epinastine hydrochloride is passed through a 100-mesh sieve, and the auxiliary materials used are passed through a 80-mesh sieve for subsequent use; (b) the epinastine hydrochloride is dissolved with a small amount of pure water for subsequent use. Take the cyclodextrin of prescription quantity, add pure water, grind e...

Embodiment 2

[0055] 1. Prescription: The prescription composition of Epinastine Hydrochloride Dispersible Tablets is as follows: (1000 tablets of 5mg specification), which contains:

[0056] Epinastine Hydrochloride 5g

[0057] Cyclodextrin 10g

[0058] Starch lactose 100g

[0059] Microcrystalline Cellulose 60g

[0060] Calcium hydrogen phosphate 20g

[0061] Carboxymethyl Starch Sodium 25g

[0062] Stevia 25g

[0063] Magnesium Stearate 5g

[0064] Micronized silica gel 10g

[0065] Solid essence 15g

[0066] Pure water 10ml

[0067] 2, preparation method: the preparation method of epinastine hydrochloride dispersible tablet is the same as embodiment 1.

Embodiment 3

[0069] 1. Prescription: The prescription composition of Epinastine Hydrochloride Dispersible Tablets is as follows: (1000 tablets for 10 mg), which contains:

[0070] Epinastine Hydrochloride 10g

[0071] Cyclodextrin 15g

[0072] Starch lactose 90g

[0073] Microcrystalline Cellulose 60g

[0074] Calcium hydrogen phosphate 20g

[0075] Carboxymethyl Starch Sodium 25g

[0076] Stevia 25g

[0077] Magnesium Stearate 5g

[0078] Micronized silica gel 10g

[0079] Solid essence 15g

[0080] Pure water 15ml

[0081] 2, preparation method: the preparation method of epinastine hydrochloride dispersible tablet is the same as embodiment 1.

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PUM

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Abstract

A dispersing tablet of epinastine hydrochloride is prepared proportionally from epinastine hydrochloride, filler, disintegrant, sweetening agent, flavouring and lubricant. Its preparing process is also disclosed.

Description

technical field [0001] The present invention relates to histamine H 1 Epinastine hydrochloride dispersible tablet of receptor antagonist and preparation method thereof. Background technique [0002] Epinastine hydrochloride was developed by Boehringer Ingelheim of Germany. It was launched in Japan in 1991, and has been listed in South America and many Asian countries one after another. Now Boehringer Ingelheim and Allergan are cooperating to apply for listing in U.S. and E.U. The Ministry of Health of my country has approved the import of this product Tablets of existing epinastine hydrochloride capsules and epinastine hydrochloride tablets are on the market in China. [0003] Since the first antihistamine was developed in 1937, there have been more than 50 kinds of H 1 Receptor antagonists for clinical use. Antihistamines before the 1980s were the first generation, and the first generation of antihistamines had a central inhibitory effect and H 1 Two disadvantages of poo...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/55A61K9/20A61P37/08A61P11/02A61P17/00
Inventor 张文静
Owner 张文静
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