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Levocetirizine dihydrochloride granule and preparation and detection methods thereof

A technology of levocetirizine hydrochloride and detection method, which is applied in the direction of pharmaceutical formula, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as poor adhesion, incomplete absorption, and inconvenience for children to take. question

Active Publication Date: 2010-03-17
HAINAN HONZ PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the listed formulations of levocetirizine hydrochloride have defects such as incomplete absorption, poor fluidity, poor adhesion, and inconvenience for children to take.

Method used

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  • Levocetirizine dihydrochloride granule and preparation and detection methods thereof
  • Levocetirizine dihydrochloride granule and preparation and detection methods thereof
  • Levocetirizine dihydrochloride granule and preparation and detection methods thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0170] Embodiment 1: Levocetirizine hydrochloride granules

[0171] Each bag contains 2.5 mg of levocetirizine hydrochloride, and the raw material composition of 1000 bags of levocetirizine hydrochloride granules is:

[0172] Levocetirizine Hydrochloride 2.5g

[0173] Lactose 1000g

[0174] Aspartame 2.0g

[0175] Povidone K30 20g

[0176] a, pulverize levocetirizine hydrochloride through an 80-mesh sieve for subsequent use; lactose and aspartame are respectively passed through an 80-mesh sieve for subsequent use; povidone K30 is made into a 10% aqueous solution for subsequent use;

[0177] b. Weigh the lactose, aspartame, levocetirizine hydrochloride of prescription amount, after aspartame, levocetirizine hydrochloride mix uniformly, then mix homogeneously with lactose according to the principle of increasing in equal quantity to obtain the mixture ;

[0178] c, transfer the mixture to the blender, use 10% povidone K30 aqueous solution as a binder to make a soft material...

Embodiment 2

[0182] Embodiment 2: Levocetirizine hydrochloride granule

[0183] Each bag contains 2.5 mg of levocetirizine hydrochloride, and the raw material composition of 1000 bags of levocetirizine hydrochloride granules is:

[0184] Levocetirizine Hydrochloride 2.5g

[0185] Lactose 600g

[0186] Aspartame 1.0g

[0187] Povidone K30 12g

[0188] a, pulverize levocetirizine hydrochloride through a 100-mesh sieve for subsequent use; lactose and aspartame are respectively passed through a 100-mesh sieve for subsequent use; povidone K30 is made into a 15% aqueous solution for subsequent use;

[0189] b. Weigh the lactose, aspartame, levocetirizine hydrochloride of prescription amount, after aspartame, levocetirizine hydrochloride mix uniformly, then mix homogeneously with lactose according to the principle of increasing in equal quantity to obtain the mixture ;

[0190] c, transfer the mixture to the blender, use 15% povidone K30 aqueous solution as a binder to make a soft material, ...

Embodiment 3

[0194] Embodiment 3: Levocetirizine hydrochloride granule

[0195] Each bag contains 2.5 mg of levocetirizine hydrochloride, and the raw material composition of 1000 bags of levocetirizine hydrochloride granules is:

[0196] Levocetirizine Hydrochloride 2.5g

[0197] Lactose 1400g

[0198] Aspartame 2.8g

[0199] Povidone K30 28g

[0200] a. Grinding levocetirizine hydrochloride through a 60-mesh sieve for subsequent use; lactose and aspartame were respectively passed through a 60-mesh sieve for subsequent use; Povidone K30 was made into a 7% aqueous solution for subsequent use;

[0201] b. Weigh the lactose, aspartame, levocetirizine hydrochloride of prescription amount, after aspartame, levocetirizine hydrochloride mix uniformly, then mix homogeneously with lactose according to the principle of increasing in equal quantity to obtain the mixture ;

[0202] c, transfer the mixture to the blender, use 7% povidone K30 aqueous solution as a binder to make a soft material, an...

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Abstract

The invention discloses a levocetirizine dihydrochloride granule and preparation and detection methods thereof. The specification of the levocetirizine dihydrochloride particle is 2.5 mg, and milk sugar is used as filling agent. The levocetirizine dihydrochloride granule dispenses with the process of disintegration of tablets and capsules in a human body, the degree of dispersion in the human bodyis superior to the tablets and the capsules, and the absorption is faster than the tablets, the capsules and dispersible tablets; and the flowability, the dispersibility and the adhesiveness are better than the dispersible tablets, the granule is convenient to take, the mouthfeel is easier to adjust, and the curative effect of the medicine can be guaranteed to be better played.

Description

technical field [0001] The invention relates to a granule, in particular to a levocetirizine hydrochloride granule and a preparation method and a detection method thereof. Background technique [0002] Levocetirizine hydrochloride is a new generation of high-efficiency non-sedating antihistamines, which is the R-isomer of cetirizine hydrochloride. 1 The receptor affinity is twice that of cetirizine, which is highly selective for peripheral H 1 receptor antagonists. In January 2001, levocetirizine hydrochloride tablets were first listed in Germany, and then in the UK, for the treatment of seasonal and perennial allergic rhinitis caused by histamine, itchy eyes and skin, and chronic idiopathic urticaria. measles. At present, the solid preparations on the domestic market include levocetirizine hydrochloride tablets, levocetirizine hydrochloride capsules and levocetirizine hydrochloride dispersible tablets, with a specification of 5 mg. However, the listed formulations of le...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/495A61K47/38A61K47/36A61K47/32A61P37/08A61P11/02A61P17/04A61P17/00
Inventor 洪江游洪丽萍
Owner HAINAN HONZ PHARMA
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