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Preparation method of bepotastine besilate pharmaceutical composition

A technology of bepotastine bepotastine and its composition, which is applied in the field of preparation of bepotastine bepotastine pharmaceutical composition, can solve the problems of complex operation, high production line cost, and large quality difference, and achieve uniform dispersion and prolonged solidification Good time and stability

Active Publication Date: 2018-03-06
BEIJING XINLINGXIAN MEDICAL TECH DEV CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] There are few patents related to the prescription composition and preparation process of Bepotastine Bepotastine Tablets. The original patent JP2007003909998 describes the composition and preparation method of Bepotastine Bepotastine Tablets. The preparation process is a melt granulation wet granulator , for melt granulation. This patent uses special equipment. There is no mature production line for this special equipment in China, and it is necessary to build a special production line at a high cost.
In addition, the relevant domestic preparation patents are CN201610683980.9, which describes the composition and preparation method of bepotastine bepotastine tablets. The preparation process adopts oven heating, melting and granulation, which has many problems: the uneven distribution of polyethylene glycol 6000 The difference is large, and it is easy to produce huge hard lumps, which is not conducive to granulation, and the operation is complicated, which is not conducive to industrial production

Method used

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  • Preparation method of bepotastine besilate pharmaceutical composition
  • Preparation method of bepotastine besilate pharmaceutical composition
  • Preparation method of bepotastine besilate pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1: The mass ratio of polyethylene glycol 6000 to water is 2:1

[0029]

[0030] Preparation Process:

[0031] 1) Pretreatment: Mechanically pulverize the raw materials through an 80-mesh sieve for subsequent use; pass the auxiliary materials through an 80-mesh sieve for subsequent use;

[0032] 2) Adhesive preparation: Prescribed amount of polyethylene glycol 6000 and appropriate amount of water were placed in a water bath and heated at 85°C;

[0033] 3) Granulation steps: 1. Put the raw material drug and corresponding auxiliary materials in a wet granulator and mix them evenly; 2. Disperse the melted polyethylene glycol 6000 and water evenly according to the ratio of 2:1. (60s) Add to the wet granulator to make PEG6000 evenly dispersed; 3. Add 50g of water to prepare soft material, stir and shear at low speed (60s); granulate, dry, and granulate;

[0034] 4) Blending step: specifically, uniformly mixing the granules obtained in step 3) with additional auxi...

Embodiment 2

[0036] Example 2: The mass ratio of polyethylene glycol 6000 to water is 20:1

[0037]

[0038] Preparation Process:

[0039] 1) Pretreatment: Mechanically pulverize the raw materials through an 80-mesh sieve for subsequent use; pass the auxiliary materials through an 80-mesh sieve for subsequent use;

[0040] 2) Adhesive preparation: Prescribed amount of polyethylene glycol 6000 and appropriate amount of water were placed in a water bath and heated at 70°C;

[0041] 3) Granulation steps: 1. Put the raw material drug and corresponding auxiliary materials in a wet granulator and mix them evenly; 2. Disperse the melted polyethylene glycol 6000 and water according to the ratio of 20:1. (60s) into the wet granulator, so that polyethylene glycol 6000 is evenly dispersed; 3. Add 20g of water to prepare soft materials, stir and shear at low speed (30s); granulate, dry, and granulate;

[0042] 4) Blending step: specifically, uniformly mixing the granules obtained in step 3) with ...

Embodiment 3

[0044] Example 3: The mass ratio of polyethylene glycol 6000 to water is 5:1

[0045]

[0046] Preparation Process:

[0047] 1) Pretreatment: Mechanically pulverize the raw materials through an 80-mesh sieve for subsequent use; pass the auxiliary materials through an 80-mesh sieve for subsequent use;

[0048] 2) Adhesive preparation: put the prescribed amount of PEG6000 and appropriate amount of water in a water bath and heat at 80°C;

[0049] 3) Granulation steps: 1. Mix the raw materials and corresponding excipients in a wet granulator; 2. Disperse the melted PEG6000 and water at a ratio of 5:1, and add In the wet granulator, PEG6000 is dispersed evenly; 3. Add 10g of water to prepare soft material, stir and shear at low speed (20s); granulate, dry, and granulate;

[0050] 4) Blending step: specifically, uniformly mixing the granules obtained in step 3) with additional auxiliary materials to obtain blended granules;

[0051] 5) Tablet compression and coating, specifica...

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Abstract

The invention belongs to the technical field of medicines, and relates to a preparation method of a bepotastine besilate pharmaceutical composition. Wet process granulation is carried out by adoptingconventional wet process granulation equipment; polyethyleneglycol 6000 and water are mixed according to a mass ratio of (2 to 1) to (20 to 1) and are heated to obtain a mixture; the mixture is addedinto a material containing bepotastine besilate and an excipient and then granulation is carried out so as to prepare the bepotastine besilate pharmaceutical composition. Compared with an original triturate, the preparation method disclosed by the invention has the advantages that requirements on equipment and processes are lower, the preparation method has a mature production line in China and issuitable for industrial production; prepared bepotastine besilate tablets are good in stability, and a stripping curve is consistent with a reference formulation.

Description

technical field [0001] The invention relates to a method for preparing a pharmaceutical composition of bepotastine besilate, and the pharmaceutical composition particularly relates to a tablet of bepotastine besilate. The preparation process of this method is simple to operate, adopts conventional wet granulator to carry out wet granulation, has lower requirement than reference preparation equipment (melt wet granulator), has mature production line in China, is suitable for industrialized production, and the prepared besulphate The stastatin tablet has good stability, and its dissolution profile is consistent with that of the reference preparation (bepotastine besilate tablet, trade name Tanliang). Background technique [0002] Allergic rhinitis is allergic rhinitis, which refers to the release of mediators (mainly histamine) mediated by IgE after atopic individuals are exposed to allergens, and a variety of immune active cells and cytokines are involved. Noninfectious infl...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/10A61K31/4545A61P11/02A61P37/08
CPCA61K9/2031A61K31/4545
Inventor 邓超张龙杰张文君赵德千
Owner BEIJING XINLINGXIAN MEDICAL TECH DEV CO LTD
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