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Calcium hydrophenyl sulfonate capsule and its prepn process

A technology of calcium dobesilate and preparation process, which is applied in the directions of capsule delivery, anhydride/acid/halide active ingredients, metabolic diseases, etc., can solve problems such as normal production, sticky punching, uneven mixing of granules, etc., To achieve the effect of easy control of product quality, improved process steps, and improved compressibility

Active Publication Date: 2006-05-17
SHANGHAI ZHAOHUI PHARMA +1
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  • Abstract
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AI Technical Summary

Problems solved by technology

And it is easy to cause the sticking of the punch and calculation disc of the capsule filling machine, resulting in the failure of normal production
[0017] 2. Magnesium stearate is a lubricant in this formula, and it needs to be mixed for 50 rotations (15 minutes) to fully mix evenly during the total mixing, but the dissolution rate of the product does not meet the requirements of the standard under this process condition
If the mixing time is lower than this operation requirement, it will lead to uneven mixing of particles, differences in particle content, and sticking and punching will occur during the filling process, resulting in differences in loading capacity.
[0018] Due to the above-mentioned problems, the scale production of this process often causes certain difficulties, thus limiting the application

Method used

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  • Calcium hydrophenyl sulfonate capsule and its prepn process

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example 1-30

[0048] Calcium dobesilate capsule example

[0049]

[0050] Operation method:

[0051] 1. The raw and auxiliary materials are respectively crushed through a 100-mesh sieve.

[0052] 2. Calcium dobesilate-hydrate, sodium carboxymethyl starch, and glyceryl behenate in the prescription amount.

[0053] 3. Put the prescribed amount of calcium dobesilate-hydrate into a high-speed 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.

[0054] 4. Ventilate and dry at 60-65°C, and granulate with a 16-mesh sieve.

[0055] 5. Add the prescription amount of sodium carboxymethyl starch and glyceryl behenate, mix for 50 turns (15 minutes), and take samples to determine the content and moisture of the intermediate.

[0056] 6. According to the determination result of the intermediate content, the capsule loading is calculated as each capsule contains 0.5 g of calcium dobesilate.

[0057] 7. Fi...

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Abstract

The present invention provides calcium hydrophenyl sulfonate capsule and its preparation process. The present invention has new capsule recipe and new preparation process superior to available technological process. The technological process of the present invention is suitable for industrial production and has high product quality and high medicine leaching degree.

Description

Technical field: [0001] The invention belongs to the technical field of pharmaceutical preparations. It specifically relates to calcium dobesilate capsules and a preparation process. Background technique: [0002] Diabetes is a common and frequently-occurring disease, and its incidence is increasing year by year. At present, diabetes has become another chronic disease that threatens people's health after cardiovascular and cerebrovascular diseases, tumors, and hypertension. Diabetic retinopathy (DR) is a common microvascular complication of diabetes. Calcium dobesilate capsules can safely and effectively prevent and treat diabetic retinopathy, and greatly reduce the blindness of diabetics caused by DR. It is an ideal drug for preventing and treating DR. [0003] The preparation method of existing calcium dobesilate capsule is as follows: [0004] 1. Formula [0005] Raw material name dosage [0006] Calcium Dobesilate Hydrate 521.5g [0007] (equivalent...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/185A61K9/48A61P3/10
Inventor 熊洁包玉林蔡胜
Owner SHANGHAI ZHAOHUI PHARMA
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