Calcium dobesilate capsules and preparation method thereof

A technology for preparing calcium dobesilate and capsules, which is applied in the fields of capsule transportation, pharmaceutical formulations, anhydride/acid/halide active ingredients, etc. It can solve the problems of related substances not meeting the requirements, achieve great application value, and the method is simple and The effect of ensuring quality

Inactive Publication Date: 2012-04-18
SHANGHAI ZHAOHUI PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] Since calcium dobesilate capsules are included in the Chinese National Pharmacopoeia 2010 edition, inspection items for related substances have been added, and the related substances of the products produced by the existing process do not meet the requirements

Method used

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  • Calcium dobesilate capsules and preparation method thereof
  • Calcium dobesilate capsules and preparation method thereof
  • Calcium dobesilate capsules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0034] Example 1 prepares calcium dobesilate capsules:

[0035] serial number

ingredients

per 1000 capsules

1

Calcium dobesilate monohydrate

521.5g

2

Sodium carboxymethyl starch

5g

3

Magnesium stearate

1.4g

4

95% ethanol

20g

[0036] (1) Calcium dobesilate monohydrate is sieved with 80 mesh.

[0037] (2) Magnesium stearate is sieved with 100 mesh, and sodium starch glycolate is sieved with 100 mesh.

[0038] (3) Put the calcium dobesilate monohydrate sieved in step (1) into a wet granulator, stir at a low speed (120 rpm) for 1 min, add 95% ethanol to granulate, and stir at a low speed for 3 min.

[0039] (4) Oven drying the granules prepared in step (3) at 60-65°C for 1.0 hour.

[0040] (5) After drying, the granules are sized with a 18-mesh galvanized hard mesh with a swing machine.

[0041] (6) Add the granules obtained in step (5) into a mixer for mixing, and simultaneous...

example 2

[0044] Example 2 prepares calcium dobesilate capsules

[0045] serial number

ingredients

per 1000 capsules

1

Calcium dobesilate monohydrate

521.5g

2

Sodium carboxymethyl starch

4.0g

3

Magnesium stearate

1.0g

4

95% ethanol

30g

[0046] (1) Calcium dobesilate monohydrate is sieved with 60 mesh.

[0047] (2) Magnesium stearate is sieved with 100 mesh, and sodium starch glycolate is sieved with 100 mesh.

[0048] (3) Put the calcium dobesilate monohydrate sieved in step (1) into a wet granulator and stir at a low speed for 1 min, add 95% ethanol to granulate, and stir at a low speed (120 rpm) for 3 min.

[0049] (4) Oven drying the granules prepared in step (3) at 60-65°C for 1.5 hours.

[0050] (5) After drying, the granules are sized with a 18-mesh galvanized hard mesh with a swing machine.

[0051] (6) Add the granules obtained in step (5) into a three-dimensional mixer for m...

example 3

[0054] Example 3 prepares calcium dobesilate capsules

[0055] serial number

ingredients

per 1000 capsules

1

Calcium dobesilate monohydrate

521.5g

2

Sodium carboxymethyl starch

7.0g

3

Magnesium stearate

2.0g

4

95% ethanol

40g

[0056] (1) Calcium dobesilate monohydrate is sieved with 40 mesh.

[0057] (2) Magnesium stearate is sieved with 100 mesh, and sodium starch glycolate is sieved with 100 mesh.

[0058] (3) Put the calcium dobesilate monohydrate sieved in step (1) into a wet granulator and stir at a low speed for 1 min, add 95% ethanol to granulate, and stir at a low speed (120 rpm) for 3 min.

[0059] (4) drying the granules prepared in step (3) in an oven at 60-65° C. for 2 hours.

[0060] (5) After drying, the granules are sized with a 18-mesh galvanized hard mesh with a swing machine.

[0061] (6) Add the granules obtained in step (5) into a three-dimensional mixer...

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PUM

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Abstract

The invention provides calcium dobesilate capsules. The content of the calcium dobesilate capsules consists of the following components by weight: 521.5 grams of calcium dobesilate monohydrate, 4 to 7 grams of carboxymethyl starch sodium, 1 to 2 grams of magnesium stearate and 20 to 40 grams of 95-percent ethanol. The calcium dobesilate capsules are prepared by the steps of sieving, drying, granulating and mixing calcium dobesilate monohydrate, carboxymethyl starch sodium and magnesium stearate respectively, filling the mixture into capsules and the like. According the detection results, the calcium dobesilate capsules obtained by the preparation method of the invention meet the requirements of China Pharmacopeia 2010 on related matters, weight difference, dissolution degree and the like and that the quality of the calcium dobesilate capsules is guaranteed. The method of the invention is simple, avoids increasing cost, is suitable for large-scale production and has a high application value.

Description

Technical field: [0001] The invention relates to a pharmaceutical preparation, in particular to a medicine and a preparation method thereof, in particular to a calcium dobesilate capsule and a preparation method thereof. Background technique: [0002] Calcium dobesilate capsules are used to improve microcirculation. By regulating the physiological function of the microvascular wall, reducing resistance, reducing plasma viscosity and platelet aggregation, thereby preventing thrombosis. It can improve the flexibility of red blood cells, indirectly increase lymphatic drainage and reduce edema. In addition, it can also inhibit the hyperpermeability of microvessels caused by vasoactive substances (histamine, 5-hydroxytryptamine, bradykinin, hyaluronidase, prostaglandin), and improve the biosynthesis of basal collagen. This product is clinically involved in multiple therapeutic fields, and can be used to prevent and treat various diseases caused by microvascular circulation disor...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/185A61K47/36A61P9/10A61P9/14
Inventor 王燕包玉林
Owner SHANGHAI ZHAOHUI PHARMA
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