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Hydrochloric clindamycinum palmitate capsule and method for preparing the same

A technology of clindamycin hydrochloride and palmitate, which is applied in capsule delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problem of single dosage form, and achieve stable drug efficacy, good safety and compliance Good results

Inactive Publication Date: 2008-04-02
重庆智上医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In order to solve the shortcoming of the single dosage form of this variety, the object of the present invention is to provide a kind of clindamycin hydrochloride palmitate capsule and its preparation method, so that more dosage form options are given to patients

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] 1. Prescription: The prescription composition of Clindamycin Palmitate Hydrochloride Capsules is as follows: (37.5mg size is calculated as 1000 tablets), which contains:

[0035] Clindamycin palmitate hydrochloride 37.5g (calculated as clindamycin)

[0036] Lactose 100g

[0037] Sodium carboxymethyl starch 10g

[0038] Poloxamer 10g

[0039] Opadry AMB 2.5% (by particle weight)

[0040] 2. The preparation method of clindamycin palmitate hydrochloride capsules is as follows:

[0041] (a) take by weighing the clindamycin hydrochloride palmitate and adjuvant of recipe quantity, Opadry AMB is made into the Opadry AMB solution containing 2.5% with pure water dispersion stirring for subsequent use;

[0042] (b) Put clindamycin hydrochloride palmitate, lactose, and poloxamer in a mixer and mix evenly, use a dry granulation mechanism to granulate, sieve out 20-50 mesh granules, and continue granulating the rest of the materials. The preparation process Control the relative...

Embodiment 2

[0046] 1. Prescription: The prescription composition of clindamycin palmitate hydrochloride capsules is as follows: (1000 tablets for 75 mg), which contains:

[0047] Clindamycin palmitate hydrochloride 75g (calculated as clindamycin)

[0048] Lactose 70g

[0049] Sodium carboxymethyl starch 12g

[0050] Poloxamer 10g

[0051] Opadry AMB 2.5% (by particle weight)

[0052] 2. Preparation method: The preparation method of clindamycin palmitate hydrochloride capsules is the same as in Example 1.

Embodiment 3

[0054] 1. Prescription: The prescription composition of clindamycin palmitate hydrochloride capsules is as follows: (150mg size is calculated as 1000 tablets), which contains:

[0055] Clindamycin palmitate hydrochloride 150g (calculated as clindamycin)

[0056] Lactose 50g

[0057] Sodium carboxymethyl starch 15g

[0058] Poloxamer 10g

[0059]Opadry AMB 3.0% (by particle weight)

[0060] 2. Preparation method: The preparation method of clindamycin palmitate hydrochloride capsules is the same as in Example 1.

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Abstract

The invention discloses a clindamycin hydrochloride palmitate capsule and the preparation method. Each capsule contains clindamycin hydrochloride palmitate with a content equal to 35 to 300 milligram of clindamycin hydrochloride. The capsule also contains pharmaceutical excipients such as diluent, disintegrant, solubilizer and seed coating agents. The invention produces granules by dry granulating method, wraps the granules with moisture proof agricultural film, and performs the process of capsule loading. The invention solves the problems of easy moisture absorbing, caking and breaking of capsule shell caused by moisture absorbing. The invention also solves the problems with the product that the formulation is unitary and only granules and dispersible tables are provided, enriches the formulation of the capsule, offers patients with more choices of formulation and the compliance is good. Due to the addition of solubilizer, the clindamycin hydrochloride palmitate is stripped more rapidly and the bioavailability of the invention is enhanced. And the invention adopts the process of moisture proof agricultural film wrapping after dry granulating method, so the activity of the clindamycin hydrochloride palmitate is preserved better, the effect of the drug is better and the drug is much safer; thereby the invention is fit for industrial production.

Description

technical field [0001] The invention relates to a clindamycin hydrochloride palmitate capsule for treating infectious diseases and a preparation method thereof. Background technique [0002] Clindamycin palmitate hydrochloride is an antibacterial drug successfully developed by Upjohn Company, and its oral dosage form abroad is mainly dry syrup. Its granules and dispersible tablets have also been successfully developed in China since the 1990s. [0003] Clindamycin palmitate hydrochloride is the prodrug of clindamycin, which has no antibacterial activity in vitro, and can be hydrolyzed by esterase to form clindamycin in vivo to exert antibacterial activity. After oral administration of clindamycin palmitate hydrochloride , its absorption is complete. Clindamycin has a higher antibacterial effect, which is 2-8 times that of lincomycin. Clindamycin is antibacterial against many Gram-positive aerobic bacteria (excluding enterococci), streptococci (including pneumococci), baci...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/7056A61K47/34A61P31/04A61K47/10
Inventor 丁鹏
Owner 重庆智上医药科技有限公司
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