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Recipe composition of dry turbid agent and its preparation process

A dry suspension and prescription technology, which is applied in the formulation and preparation of dry suspension, can solve the problems of uneven shape and particle size of dry suspension, long drying time of particles, low product yield, etc. Achieve the effect of shortening the preparation process time, good taste and fast melting

Active Publication Date: 2007-08-08
SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The dry suspension formulations disclosed in the above-mentioned patents all adopt wet granulation process, the shape and particle size of the prepared dry suspension are not uniform, and they are easy to be layered, resulting in large fluctuations in the volume of packaging; some particles are easily broken, and the powder More; some particles dissolve slowly, poor suspension
In addition, the above-mentioned process method is easy to agglomerate when granulating, and the drying time of the granules is long, and the product yield is low, and the production cost is high

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0032] The preparation method of the dry suspension of the present invention comprises the following steps: 1. Sieve the excipient with a particle size of 30 to 65 mesh, and dry it at 60°C in Chongqing Yongsheng Experimental Instrument Factory, model CS101-3E electric blast drying oven Two, emulsify the defoamer and surfactant of conventional dosage in Fluko, model FA25 emulsifying machine, make emulsion; %, disintegrating agent 0-12.0%, conventional doses of flavoring agents, coloring agents, and buffer salts are placed in an appropriate amount of water, and stirred with an EYELA, model Z-2100 electric mixer for 1-4 hours to obtain a suspending medium; 4. 1. Add 0.1% to 35.0% of the active ingredient of the drug and the emulsion into the suspending medium, and stir evenly with an EYELA, model Z-2100 electric mixer to obtain a drug suspension; 5. Mix the excipients by 29.0% to 99.3 % placed in Germany GLATT company, model GPCG1.1 fluidized bed, spray drug suspension on it, aft...

Embodiment 1

[0035] Example 1, preparing 200 bags of cefaclor dry suspension, specification: cefaclor 125mg / bag, the components are:

[0036] ingredient name

content

weight ratio

Cefaclor

28.2g

4.45％

sucrose

Excipient 575g, porogen

25g

Excipient 90.71%, porogen

3.94%

xanthan gum

1.6g

0.25％

Methylcellulose

0.5g

0.08％

Simethicone

1.2g

0.19％

Sodium dodecyl sulfate

0.3g

0.05％

Flavoring agent (strawberry powder flavor)

2.0g

0.32％

Colorant (Red No. 3)

0.11g

0.017％

Preparation

fluidized bed technology

Sedimentation Volume Ratio (Chinese Pharmacopoeia Oral Suspension Sedimentation Volume Ratio Inspection Method)

0.99

pH value (Chinese Pharmacopoeia Cefaclor dry suspension pH value determination method)

4.18

Solubility (Chinese Pharmacopoeia Soluble Granules Solubility Test Method)

35 seconds to melt

Tas...

Embodiment 2

[0062] Example 2, preparation of clarithromycin dry suspension, specification: clarithromycin 125mg / bag, the components are:

[0063] ingredient name

content

weight ratio

clarithromycin

125g

12.55％

sucrose

665g

66.79％

compressible starch

100g

10.04％

carbomer

5g

0.50％

Flavoring agent (sodium saccharin)

0.108g

0.01％

Flavoring agent (stevioside)

100g

10.04％

Flavoring agent (orange liquid flavor)

0.6g

0.06％

Preparation

fluidized bed technology

Sedimentation Volume Ratio (Chinese Pharmacopoeia Oral Suspension Sedimentation Volume Ratio Inspection Method)

0.95

Solubility (the method for checking the solubility of soluble granules in China Code)

60 seconds to melt

Taste (according to the taste of healthy volunteers)

sweet, good taste

[0064] Preparation process: 1. Sieve 40-60 mesh sucrose as excipient, a...

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PUM

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Abstract

The invention relates to a method for preparing dry mixture suspending agent, comprising 0.1-35.0% active components, 29.0-99.3% shaping agents, and 0.05-36.4% suspending agents. The preparation comprises that selecting the shaping agents, arranging the shaping agents, holing agents, and disintegration agent into the water to obtain suspending medium; adding active component into suspending medium to obtain the mixture suspending solution; arranging the shaping agent into fluid bed, atomizing drug mixed suspending solution, and drying. Compared with present technique, the invention contains suspending agent, without block and tacky contacted with water. The fluid bed can quickly dry material, with high efficiency and low cost.

Description

technical field [0001] The invention relates to a prescription composition of a pharmaceutical preparation and a preparation method thereof, in particular to a prescription composition of a dry suspension and a preparation method thereof. Background technique [0002] Dry suspension is a fine particle dosage form that has more advantages than solid dosage forms such as tablets. It has a large distribution area in the gastrointestinal tract, fast absorption, high bioavailability, and can avoid the disadvantages of tablets that are difficult to swallow. It not only changes the disadvantages of slow oral absorption of ordinary tablets, which is not conducive to taking by the elderly, children and those with dysphagia, but also enables the drug to exert its curative effect faster and better in the body through the characteristics of easy administration and instant dissolution. The dry suspension is stored in a solid form and is taken orally in the form of a suspension, so it is ...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/16A61K45/00A61K47/38A61K47/36A61K47/34A61K47/26A61K47/10A61K31/192A61K31/43A61K31/545A61K31/7048A61K47/32
Inventor 闫志刚曾环想陈芳晓王孟黄凯
Owner SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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