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Clindamycin palmitate hydrochloride chewing tablet andi its preparing method

A technology of clindamycin hydrochloride and palmitate, which is applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, pill delivery, etc., can solve the problem of single dosage form, achieve good compliance, simple process, and bioavailability high effect

Inactive Publication Date: 2007-06-13
张文静
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In order to solve the shortcoming of single oral dosage form of clindamycin hydrochloride palmitate in the prior art; improve its bioavailability; allow patients to have more options for dosage forms; reduce the toxic and side effects of medicines. Purpose of Chewable Tablets

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] 1. The prescription composition of clindamycin hydrochloride palmitate chewable tablets is as follows: (37.5mg specification is calculated as 1000 tablets), which contains:

[0017] Clindamycin palmitate hydrochloride 37.5g (calculated as clindamycin)

[0018] Mannitol 250g

[0019] 50g powdered sugar

[0020] Poloxamer 10g

[0021] Stevia 5g

[0022] Talc powder 10g

[0023] Magnesium Stearate 15g

[0024] Fragrance 20ml

[0025] 2. The preparation method of clindamycin hydrochloride palmitate chewable tablets is as follows:

[0026] (a) the clindamycin palmitate hydrochloride is passed through a 40-60 mesh sieve, and the auxiliary materials used are passed through a 60-80 mesh sieve for subsequent use; (b) taking by weighing the clindamycin palmitate hydrochloride and the auxiliary materials of the prescribed amount; (c ) Put clindamycin hydrochloride palmitate, mannitol, powdered sugar, solubilizer, flavoring agent, talcum powder, etc. in a mixer and mix until...

Embodiment 2

[0029] 1. The prescription composition of clindamycin hydrochloride palmitate chewable tablets is as follows: (1000 tablets of 75mg specification), which contains:

[0030] Clindamycin palmitate hydrochloride 75g (calculated as clindamycin)

[0031] Mannitol 200g

[0032] 40g powdered sugar

[0033] Poloxamer 15g

[0034] Stevia 5g

[0035] Talc powder 10g

[0036] Magnesium Stearate 15g

[0037] Fragrance 25ml

[0038] 2. Preparation methods 1 and 2 of clindamycin palmitate hydrochloride chewable tablets are the same as in Example 1.

Embodiment 3

[0040] 1. The prescription composition of clindamycin palmitate hydrochloride chewable tablets is as follows: (150mg size is calculated as 1000 tablets), which contains:

[0041] Clindamycin palmitate hydrochloride 150g (calculated as clindamycin)

[0042] Mannitol 160g

[0043] 40g powdered sugar

[0044] Poloxamer 30g

[0045] Stevia 6g

[0046] Talc powder 10g

[0047] Magnesium Stearate 15g

[0048] Essence 30ml

[0049] 2. Preparation methods 1 and 2 of clindamycin palmitate hydrochloride chewable tablets are the same as in Example 1.

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PUM

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Abstract

The present invention relates to a clindamicin palmitate masticatory tablet and its preparation method. It is characterized by that it adopts dry granulation process so as to maximally retain the activity of clindamicin palmitate, it is easy to implement industrial production and its preparation process is simple.

Description

technical field [0001] The invention relates to a clindamycin hydrochloride palmitate chewable tablet and a preparation method thereof for treating various infectious diseases caused by aerobic G+ bacteria, anaerobic bacteria, chlamydia, protozoa and the like. Background technique [0002] Clindamycin palmitate hydrochloride is a kind of antibacterial drug successfully developed by Upjohn (Upjohn) company, and the trade name is Cleocin Pediatric ®, and the foreign oral dosage form is mainly dry syrup. The granules of this product were developed in China in the 1990s, and the dispersible tablet form of this product was developed in the early 20th century. [0003] Clindamycin Hydrochloride Palmitate Chewable Tablets is the prodrug of clindamycin, which is rapidly absorbed after oral administration and hydrolyzed into the active parent in the body to exert its curative effect. Clindamycin palmitate hydrochloride has a unique chemical structure and is not affected by β-lactama...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7056A61K9/20A61P31/04
Inventor 张文静
Owner 张文静
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