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Clindamycin hydrochloride medicine composition and preparation method thereof

A technology of clindamycin hydrochloride and composition, which is applied in the direction of medical formula, antibacterial drug, medical preparation containing active ingredients, etc., to achieve the effects of reasonable composition, simple preparation process and safe taking

Inactive Publication Date: 2016-06-22
KAMP PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The active substance of tiopronin is added to this prescription, the pharmacological and toxicological mechanism, and the toxic and side effects need to be further confirmed and studied

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Prescription: (by weight percentage)

[0030] Clindamycin hydrochloride 58%, starch 35%, micronized silica gel 7%.

[0031] Preparation:

[0032] 1) The raw and auxiliary materials are passed through a 100-mesh sieve for later use;

[0033] 2) The raw and auxiliary materials are dry mixed evenly, and the dry mixing time is not less than 15 minutes;

[0034] 3) Calculate the theoretical loading according to the content of the intermediate, and fill the capsules to obtain the capsules of this product.

Embodiment 2

[0036] Prescription: (by weight percentage)

[0037] Clindamycin Hydrochloride 60%, Lactose 20%, Microcrystalline Cellulose 10%, Carboxymethyl Starch Sodium 8%, Magnesium Stearate 2%.

[0038] Preparation:

[0039] 1) The raw and auxiliary materials are passed through a 100-mesh sieve for later use;

[0040] 2) Dry mix the raw and auxiliary materials (except magnesium stearate) evenly (stir for 5 minutes), add 30% of the prescription amount of raw and auxiliary materials and 70% alcohol and stir to make soft materials;

[0041] 3) The soft material is granulated through a 16-mesh sieve, dried, and granulated with an 18-mesh sieve to obtain dry granules;

[0042] 4) Add the prescribed amount of magnesium stearate to the above dry granules, and mix well (mixing time is 35 minutes);

[0043] 5) Calculate the theoretical tablet weight according to the content of the intermediate, and press the tablet to get the tablet of this product.

Embodiment 3

[0045] Prescription: (by weight percentage)

[0046] Clindamycin hydrochloride 58%, starch 25%, hydroxypropyl cellulose 4%, pregelatinized starch 12%, magnesium stearate 1%.

[0047] Preparation:

[0048] 1) The raw and auxiliary materials are passed through a 100-mesh sieve for later use;

[0049] 2) Dry mix the raw and auxiliary materials (except magnesium stearate) evenly (stir for 5 minutes), add 30% of the prescription amount of raw and auxiliary materials and 70% alcohol and stir to make soft materials;

[0050] 3) The soft material is granulated through a 16-mesh sieve, dried, and granulated with an 18-mesh sieve to obtain dry granules;

[0051] 4) Add the prescribed amount of magnesium stearate to the above dry granules and mix well (mixing time is 30 minutes);

[0052] 5) Calculate the theoretical loading according to the content of the intermediate, and pack in separate bags to obtain the granules of this product.

[0053] The above-mentioned different dosage for...

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PUM

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Abstract

The invention provides a clindamycin hydrochloride medicine composition and a preparation method thereof. The clindamycin hydrochloride medicine composition is characterized by being prepared from the following ingredients in percentage by the medicine composition recipe weight: 20 to 70 percent of clindamycin hydrochloride, 20 to 70 percent of filling agents and disintegrating agents, a proper amount of bonding agents (removal in the drying process) and 1 to 10 percent of lubricating agents. The clindamycin hydrochloride medicine composition and the preparation method have the advantages that the recipe is reasonable; the preparation is simple; the operation is easy; and the production requirements can be met by conventional equipment.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a clindamycin hydrochloride pharmaceutical composition and a preparation method thereof. Background technique [0002] Clindamycin, also known as clindamycin, is a derivative obtained by substituting the hydroxyl group at the 7-position of lincomycin. Clindamycin was first synthesized by Magerlein et al. in 1966. Upjohn Company of the United States first successfully developed it and obtained a US patent in 1969. It was first launched in Switzerland in 1968 under the trade name Dalacin, and later in Germany, in 1970 in the United States and the United Kingdom, and then in many countries in the world. At present, clindamycin has been included in the pharmacopoeias of the United States, the United Kingdom, Japan, and China. [0003] Clindamycin is a bacterial protein synthesis inhibitor with strong antibacterial activity. The antibacterial spectrum is simil...

Claims

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Application Information

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IPC IPC(8): A61K31/7056A61P31/04
Inventor 张静吴健民
Owner KAMP PHARMA
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