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Kelimycin tablet and preparation method thereof

A karimycin tablet and karimycin technology are applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, and pill delivery, etc., which can solve the problems of slow disintegration of tablets, poor dissolution rate, and difficulty in sieving, etc. problem, to achieve the effect of rapid disintegration, suitable for mechanized production, and good dissolution rate

Active Publication Date: 2015-04-01
SHENYANG TONGLIAN GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, through further research by the inventors, it has been found that due to the strong cohesiveness and hygroscopicity of corimycin and the strong cohesiveness of starch, the soft material prepared by adopting this plain tablet prescription is not easy to sieve and granulate. Difficult, and the prepared tablet disintegrates slowly, and the dissolution rate is not good

Method used

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  • Kelimycin tablet and preparation method thereof
  • Kelimycin tablet and preparation method thereof
  • Kelimycin tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] Specification: 200mg / 350mg

[0076] Tablet prescription:

[0077]

[0078] Coating Solution Prescription:

[0079]

[0080] Preparation Process:

[0081] Preparation of the tablet core: the main drug and auxiliary materials are respectively passed through a 100-mesh sieve, and the prescription amount of carrimycin, microcrystalline cellulose and 1 / 2 of the prescription amount of carboxymethyl starch sodium are mixed evenly, and then 5% povidone K is added 30 The soft material made from aqueous solution is granulated with a 18 mesh sieve, and the wet granules are dried at 60°C under ventilated conditions for 2 hours; after drying, the granules are sieved with an 18 mesh sieve, and then add 1 / 2 of the prescription amount of sodium carboxymethyl starch and stearic acid After the magnesium was evenly mixed, the tablet was compressed with a shallow concave die with a diameter of 11 mm to obtain a drug-containing tablet core with a tablet weight of 350 mg and a hardne...

Embodiment 2

[0085] Specification: 150mg / 350mg

[0086] Tablet prescription:

[0087]

[0088]

[0089] Coating liquid prescription: with embodiment 1.

[0090] Preparation Process:

[0091] The preparation of the tablet core and the preparation of the coating solution are the same as in Example 1.

[0092] Preparation of film-coated tablets: Put the tablet cores in the coating pan, determine the coating conditions, the speed of the host machine is 25r / min, the inlet air temperature is 45°C, the outlet air temperature is 35°C, the spray pressure is 0.04Mpa, and the spray flow rate is 1.5 ml / min for coating, keep spraying for 2 hours after constant, until the surface of the tablets is smooth and the color is uniform, and it is qualified if it meets the film coating inspection standard. Coating weight gain about 5%.

Embodiment 3

[0094] Specification: 225mg / 350mg

[0095] Tablet prescription:

[0096]

[0097] Coating liquid prescription: with embodiment 1.

[0098] Preparation Process:

[0099] The preparation of the tablet core and the preparation of the coating solution are the same as in Example 1.

[0100] Preparation of film-coated tablets: Put the tablet cores in the coating pan, determine the coating conditions, the speed of the host machine is 22r / min, the inlet air temperature is 43°C, the outlet air temperature is 32°C, the spray pressure is 0.03Mpa, and the spray flow rate is 1.2 ml / min for coating, keep spraying for 1.8h after constant, until the surface of the tablets is smooth and uniform in color, meeting the film coating inspection standard is qualified. Coating weight gain about 5%.

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Abstract

The invention relates to a kelimycin tablet and a preparation method thereof. The kelimycin tablet comprises kelimycin and a tablet core comprising pharmaceutically acceptable adjuvants; and the pharmaceutically acceptable adjuvants include microcrystalline cellulose, carboxymethyl starch sodium, povidone K30 and magnesium stearate. The preparation method comprises the following step of: preparing the medicated tablet core, wherein an inside and outside addition method is adopted for the carboxymethyl starch sodium in the preparation of the medicated tablet core. The kelimycin tablet disclosed by the invention has the advantages of faster disintegration and better dissolution rate, and is easy to granulate. The preparation method of the kelimycin tablet has the advantages of simple process, large production quantity and low production cost, and easily realize hygienic standard and is suitable for large-scale mechanized production.

Description

technical field [0001] The invention belongs to the improvement of pharmaceutical dosage forms, and in particular relates to a carrimycin tablet and a preparation method thereof. Background technique [0002] Kelimycin, also known as Bitespiramycin and Shengjimycin, is produced by the Institute of Biotechnology of the Chinese Academy of Medical Sciences and the applicant through transgenic technology to produce carbamycin. The 4''-o-acyl-transferase group (4''-o-acyl-transferase) of the spiramycin was cloned into the spiramycin-producing bacteria, and the 4''-OH of the spiramycin was oriented, and the iso A new type of antibiotic with the 4'' isovaleryl spiramycin as the main component formed by the valeryl side chain. [0003] Corimycin is composed of a variety of spiramycin derivatives, the total content of the main active ingredient isovalerylspiramycin (I+II+III) is not less than 65%, and the total content of 4''acylated spiramycin Not less than 80%, it is a pharmaceut...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K9/36A61K31/7048A61K47/38A61P31/04
Inventor 姜洋杨生武赵小峰
Owner SHENYANG TONGLIAN GRP CO LTD