Disperse tablet contg. klinemycin hydrochloride palmitate, and its prepn. method

A technology of clindamycin hydrochloride and palmitate, which is applied in the direction of medical preparations containing active ingredients, pharmaceutical formulas, organic active ingredients, etc., can solve the problem of single dosage form, and achieve the advantages of convenient portability, simple process and low cost Effect

Inactive Publication Date: 2005-01-05
重庆凯林制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In order to solve the shortcoming of the single oral dosage form of clindamycin in the prior art, the invention provides a clindamycin hydrochloride palmitate dispersible tablet and a preparation method thereof

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] The prescription composition of clindamycin hydrochloride palmitate dispersible tablets of 37.5mg specification is as follows: based on 1000 tablets, it contains

[0053] Clindamycin Palmitate Hydrochloride 61.8g

[0054] Hypromellose 50-100g

[0055] Lactose 50-80g

[0056] Sodium carboxymethyl starch 30-60g

[0057] Crospovidone 10-20g

[0058] Co-solvent amount

[0059] Appropriate amount of sweetener

[0060] Appropriate amount of talcum powder

[0061] Magnesium Stearate Appropriate amount

[0062] Flavor Appropriate amount

[0063] Pure water 20-40g

[0064] The blank dry granulation method granulation method of clindamycin palmitate hydrochloride dispersible tablet is as follows:

[0065] First pass the auxiliary materials through a 60-120 mesh sieve, and the main ingredient through a 40-80 mesh sieve; weigh hypromellose, lactose, saccharin, sodium carboxymethyl starch, and crospovidone and mix them in a mixer for 10- After 30 minutes until uniform, the...

Embodiment 2

[0069] The proportioning of raw and auxiliary materials of 37.5 mg of clindamycin hydrochloride palmitate dispersible tablets is the same as in Example 1.

[0070] The wet granulation method of clindamycin palmitate hydrochloride dispersible tablet is:

[0071] First pass the auxiliary materials through a 60-120 mesh sieve, and the main ingredient through a 40-80 mesh sieve; weigh clindamycin hydrochloride palmitate, hypromellose, lactose, sodium carboxymethyl starch, crospovidone, Put the sweetener and co-solvent in the mixer and mix them for 10-30 minutes until they are uniform. The mixture is made into a soft material with pure water as the wetting agent, and wet granules are made. The wet granules are 20 mesh. Ventilate and dry at -80°C to obtain granules; then add magnesium stearate, talcum powder, essence, etc., mix for 5-30 minutes until uniform, and compress into tablets to obtain 1,000 tablets.

Embodiment 3

[0073] The prescription composition of the clindamycin hydrochloride palmitate dispersible tablet of 75mg specification is as follows: in 1000 tablets, it contains

[0074] Clindamycin Palmitate Hydrochloride 123.5g

[0075] Microcrystalline Cellulose 50-100g

[0076] Lactose 50-100g

[0077] Sodium carboxymethyl starch 50-100g

[0078] Croscarmellose Sodium 10-30g

[0079] Co-solvent amount

[0080] Appropriate amount of sweetener

[0081] Appropriate amount of talcum powder

[0082] Magnesium Stearate Appropriate amount

[0083] Flavor Appropriate amount

[0084] Pure water 40-60g

[0085] The granulation method of the blank dry granulation method of the clindamycin palmitate hydrochloride dispersible tablet is the same as in Example 1.

[0086] Sampling, detection of content and solubility, and disintegration time limit all meet the corresponding drug quality standards.

[0087] batch number

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Abstract

A dispersing tablet of clindamycin hydrochloride palmitate and its preparing process are disclosed.

Description

technical field [0001] The invention relates to a clindamycin hydrochloride palmitate dispersible tablet and a preparation method thereof. Background technique [0002] Clindamycin palmitate hydrochloride is a prodrug of clindamycin. Clindamycin has a higher antibacterial effect, which is 2-8 times that of lincomycin. Clindamycin mainly has a strong antibacterial effect on Gram-positive bacteria and various anaerobic bacteria. Its pharmacological research shows that free clindamycin is quickly hydrolyzed, and it is completely absorbed orally and has high bioavailability. It is suitable for a wide range of patients. Because this product has high oral bioavailability and is not affected by food, it is often made into an oral dosage form. However, so far, the oral dosage form at home and abroad is single, only granules, which cannot meet the needs of patients of all ages. Moreover, granules are easy to absorb moisture and deteriorate easily. Contents of the invention [0...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/7056A61P31/02
Inventor 李振亚李锋兰志银
Owner 重庆凯林制药有限公司
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