Levo-cetirizine hydrochloride orally disintegrating tablets and preparation method thereof

A technology of levocetirizine hydrochloride and orally disintegrating tablets, applied in the field of levocetirizine hydrochloride orally disintegrating tablets and its preparation, can solve the problems of slow drug onset, low drug bioavailability, and hard appearance

Inactive Publication Date: 2008-11-26
海南高升医药科技开发股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Traditional tablets and capsules not only have long disintegration time and slow drug onset, which lead to low bioavailability of drugs and cann...

Method used

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  • Levo-cetirizine hydrochloride orally disintegrating tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Main drug: Levocetirizine hydrochloride 5g

[0016] Filler: Microcrystalline Cellulose 50g

[0017] Mannitol 45g

[0018] Flavoring: Sucralose 1.5g

[0019] Disintegrant: cross-linked polyvinylpyrrolidone 20g

[0020] Lubricant: Magnesium Stearate 0.2%

[0021] A total of 1000 pieces were made.

[0022] Preparation:

[0023] (1) pulverizing levocetirizine hydrochloride and auxiliary materials, passing levocetirizine hydrochloride through a 200 mesh sieve, and auxiliary materials passing through a 100 mesh sieve respectively, for subsequent use;

[0024] (2) Take by weighing the levocetirizine hydrochloride and microcrystalline cellulose, mannitol, cross-linked polyvinylpyrrolidone, sucralose etc. of prescription quantity, earlier levocetirizine hydrochloride and microcrystalline cellulose Incremental method to mix evenly, then fully mix with mannitol, then add the remaining excipients and mix evenly;

[0025] (3) wet granulation with water;

[0026] (4) ...

Embodiment 2

[0033] Main drug: Levocetirizine hydrochloride 5g

[0034] Filler: Microcrystalline Cellulose 70g

[0035] Mannitol 30g

[0036] Flavoring agent: Aspartame 1.0g

[0037] Sweet orange essence 0.7g

[0038] Disintegrant: low-substituted hydroxypropyl cellulose 25g

[0039] Lubricant: Magnesium Stearate 0.2%

[0040] A total of 1000 pieces were made.

[0041] Preparation:

[0042] (1) pulverizing levocetirizine hydrochloride and auxiliary materials, passing levocetirizine hydrochloride through a 200 mesh sieve, and auxiliary materials passing through a 100 mesh sieve respectively, for subsequent use;

[0043] (2) Take by weighing the levocetirizine hydrochloride and microcrystalline cellulose, mannitol, low-substituted hydroxypropyl cellulose, aspartame, sweet orange essence etc. of prescription quantity, levocetirizine hydrochloride and The microcrystalline cellulose is mixed evenly by the method of equal increment, and then fully mixed with mannitol, and ...

Embodiment 3

[0052] Main drug: Levocetirizine hydrochloride 5g

[0053] Filler: Microcrystalline Cellulose 60g

[0054] Lactose 20g

[0055] Flavoring agent: Stevia 1.0g

[0056] Disintegrant: croscarmellose sodium 25g

[0057] Lubricant: Magnesium Stearate 0.2%

[0058] A total of 1000 pieces were made.

[0059] Preparation:

[0060] (1) pulverizing levocetirizine hydrochloride and auxiliary materials, passing levocetirizine hydrochloride through a 200 mesh sieve, and auxiliary materials passing through a 100 mesh sieve respectively, for subsequent use;

[0061] (2) Take by weighing prescription amount of levocetirizine hydrochloride and microcrystalline cellulose, lactose, croscarmellose sodium, stevioside, etc., first levocetirizine hydrochloride and microcrystalline cellulose, etc. Incremental volume method to mix evenly, then fully mix with lactose, then add the remaining excipients and mix evenly;

[0062] (3) carry out wet granulation with 50% ethanol solution;

[00...

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Abstract

The invention relates to a hydrochloric acid levocetirizine orally disintegrating tablet and a preparation method thereof. The hydrochloric acid levocetirizine orally disintegrating tablet is obtained by directly pressing principal medicine and accessories. The tablet of the invention can be dissolved fast in a mouth cavity and has no grit feeling and high biological availability, which takes effect fast and can have curative effect faster.

Description

technical field [0001] The invention provides a levocetirizine hydrochloride orally disintegrating tablet and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Levocetirizine non-sedating antihistamine, in 2001, levocetirizine hydrochloride tablets have been listed in Germany and the United Kingdom. Levocetirizine hydrochloride is mainly used for the treatment of seasonal and perennial allergic rhinitis, itchy eyes and skin, and chronic idiopathic urticaria caused by histamine. The affinity of the R-isomer of cetirizine hydrochloride to the H1-receptor (K1=3.2nmol / L) is twice that of cetirizine (K1=6.3nmol / L), which is a highly selective peripheral H1-receptor Body antagonist, is a drug with dual anti-allergic effects, its anti-allergic effect is stronger than other second-generation antihistamines, levocetirizine is one of the optical isomers of cetirizine hydrochloride (L-body ), is the active ing...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/495A61K47/26A61K47/10A61K47/38A61K47/40A61K47/36A61K47/34A61K47/12A61K47/42A61P37/08A61P11/02A61P17/04
Inventor 王小树文万江肖文礼
Owner 海南高升医药科技开发股份有限公司
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