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Formulation composition and preparation method of pranoprofen-containing suspension

A suspension and prescription technology, which is applied in the field of composition and preparation of suspension containing pranoprofen, can solve problems such as poor stability and complicated preparation process, and achieve the effect of improving stability

Active Publication Date: 2016-08-17
WUHAN LEADPHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The timely problem to be solved by the present invention is: the stability of the pranoprofen suspension in the prior art is poor, and the preparation process is complicated

Method used

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  • Formulation composition and preparation method of pranoprofen-containing suspension
  • Formulation composition and preparation method of pranoprofen-containing suspension
  • Formulation composition and preparation method of pranoprofen-containing suspension

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1: The formulation of the pranoprofen-containing suspension of this example is as follows:

[0037] ingredient

Dosage (g)

Percentage content (%)

Pranoprofen

15.0

1.50%

Microcrystalline Cellulose-Sodium Carboxymethyl Cellulose (RC-591NF)

5.0

0.50%

Hypromellose

0.5

0.05%

Sucrose Fatty Acid Ester

1.0

0.10%

Polyvinyl alcohol

10.0

1.00%

purified water

Right amount

――

[0038] Make 1000mL

[0039] The preparation process steps of the formulation composition of the pranoprofen-containing suspension composed of the above formula are as follows:

[0040] (1) Mix the prescription amount of polyvinyl alcohol and water, and stir evenly.

[0041] (2) Add the prescribed amount of pranoprofen to the solution obtained in step (1) and stir to form an aqueous suspension containing pranoprofen.

[0042] (3) Add the prescribed amount of microcrystalline cellulose-sodium carboxymethyl cellulose and the rest of the ingredients into the solution obtained in step (2), and st...

Embodiment 2

[0056] Example 2: The formulation of the pranoprofen-containing suspension of this example is as follows:

[0057] ingredient

Dosage (g)

Percentage content (%)

Pranoprofen

15.0

1.50%

Microcrystalline Cellulose-Sodium Carboxymethyl Cellulose (RC-591NF)

6.0

0.60%

Hypromellose

0.5

0.05%

Sucrose Fatty Acid Ester

1.0

0.10%

Polyvinyl alcohol

9.0

0.90%

purified water

Right amount

――

[0058] Make 1000mL

[0059] The preparation method is the same as in Example 1:

[0060] Results: The particle size distribution diagram of the formulation composition of the pranoprofen-containing suspension prepared in Example 2 is shown in figure 2 , The particle size distribution diagram is shown in Table 3 below, and the stability evaluation results are shown in Table 4 below.

[0061] Table 3: The particle size distribution table of the formulation composition of the suspension containing Pranoprofen obtained in Example 2

[0062] percentage(%)

d（0.1）

d（0.5）

d（0.9）

Particle size (μm...

Embodiment 3

[0065] Example 3: The formulation of the pranoprofen-containing suspension of this example is as follows:

[0066] ingredient

Dosage (g)

Percentage content (%)

Pranoprofen

15.0

1.50%

Microcrystalline Cellulose-Sodium Carboxymethyl Cellulose (RC-591NF)

7.5

0.75%

Hypromellose

0.5

0.05%

Sucrose Fatty Acid Ester

1.0

0.10%

Polyvinyl alcohol

7.5

0.75%

purified water

Right amount

――

[0067] Make 1000mL

[0068] The preparation method is the same as in Example 1:

[0069] Results: The particle size distribution diagram of the formulation composition of the pranoprofen-containing suspension prepared in Example 3 is shown in image 3 , The particle size distribution table is shown in Table 5 below; the stability evaluation results are shown in Table 6 below.

[0070] Table 5: The particle size distribution table of the formulation composition of the suspension containing Pranoprofen obtained in Example 3

[0071] percentage(%)

d（0.1）

d（0.5）

d（0.9）

Particle size (μm)

0.68...

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PUM

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Abstract

The invention discloses a formulation composition and a preparation method of a pranoprofen-containing suspension. The formulation composition of the pranoprofen-containing suspension comprises the following components: pranoprofen, polyvinyl alcohol, sodium microcrystalline cellulose-carboxymethyl cellulose and water, wherein polyvinyl alcohol accounts for 0.5%-2.5% by mass of the formulation composition of pranoprofen-containing suspension; sodium microcrystalline cellulose-carboxymethyl cellulose accounts for 0.5%-1% by mass of the formulation composition of pranoprofen-containing suspension. According to the invention, polyvinyl alcohol and sodium microcrystalline cellulose-carboxymethyl cellulose are conventionally mixed to achieve excellent suspension effect, while the formulation composition significantly improves the stability of products during storage.

Description

Technical field [0001] The invention relates to the technical field of pharmacy, in particular to a prescription composition of a suspension containing pranoprofen and a preparation method thereof. Background technique [0002] Pranoprofen (Pranoprofen, Cas NO: 52549-17-4) is an anti-inflammatory drug developed by Welfide (formerly Jifu Pharmaceutical Co., Ltd.) (now Mitsubishi Pharmaceuticals). Pranoprofen can inhibit the arachidonic acid cascade. The cyclooxygenase activity, thereby inhibiting the synthesis of prostaglandins. This product inhibits the synthesis of prostaglandin E2 through the body temperature regulation center of the hypothalamus, thereby playing an antipyretic effect. Its eye drops were marketed in Japan and Belgium under the trade name Pranox in 1988; it was imported and marketed in China under the trade name pranopulin (Chinese name: 普南扑灵) in 1999; the oral suspension solution for children was launched in December 1995 , Are produced by Japan Tongjin Pharm...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K47/38A61K47/32A61K31/436A61P29/00
CPCA61K9/10A61K31/436A61K47/32A61K47/38
Inventor 谢树伟严汉军徐旻明陈蔚江
Owner WUHAN LEADPHARM TECH CO LTD
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