Levofloxacin hydrochloride capsule and preparation method thereof

A technology of levofloxacin hydrochloride and capsules, which is applied in directions such as capsule delivery and antibacterial drugs, can solve the problems of complicated operation, high production cost, unfavorable industrialized large-scale production and the like, and achieves the effect of simple preparation process

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

[0007] The above-mentioned patented production methods are all cumbersome to operate, and the production cost is high, which is not conducive to industrialized large-scale production

Method used

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  • Levofloxacin hydrochloride capsule and preparation method thereof
  • Levofloxacin hydrochloride capsule and preparation method thereof
  • Levofloxacin hydrochloride capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Prescription: (by weight percentage)

[0033] Levofloxacin hydrochloride 54%, starch 36%, micronized silica gel 9%, magnesium stearate 1%.

[0034] Preparation:

[0035] 1) The raw and auxiliary materials are passed through a 100-mesh sieve for later use;

[0036] 2) The raw and auxiliary materials are dry mixed evenly, and the mixing time is not less than 0.5 hours;

[0037] 3) Calculate the loading amount after the content detection, and fill the capsules.

Embodiment 2

[0039] Prescription: (by weight percentage)

[0040] Levofloxacin hydrochloride 60%, starch 20%, sodium carboxymethyl starch 9%, micronized silica gel 9%, magnesium stearate 2%.

[0041] Preparation:

[0042] 1) The raw and auxiliary materials are passed through a 100-mesh sieve for later use;

[0043] 2) The raw and auxiliary materials are dry mixed evenly, and the mixing time is not less than 0.5 hours;

[0044] 3) Calculate the loading amount after the content detection, and fill the capsules.

[0045] Taking Zhuhai United Laboratories Levofloxacin Hydrochloride Capsules (0.1g) as the reference preparation, the sample of Levofloxacin Hydrochloride Capsules in Example 1 was used for relative bioavailability test to determine whether it is bioequivalent to the reference preparation with the same dosage. Methods: A two-period randomized cross-over experimental design was used. Eighteen healthy male volunteers were randomly divided into two groups. After the volunteers to...

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PUM

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Abstract

The invention provides a levofloxacin hydrochloride capsule and a preparation method thereof. The levofloxacin hydrochloride capsule is characterized by being prepared from the following ingredients in percentage by the medicine composition recipe weight: 20 to 70 percent of levofloxacin hydrochloride, 20 to 65 percent of filling agents and disintegrating agents and 1 to 15 percent of lubricating agents. The levofloxacin hydrochloride capsule and the preparation method have the advantages that the recipe matching is reasonable; the preparation method is simple; the operation is easy; the production requirements can be met by conventional equipment; and the levofloxacin hydrochloride capsule and the preparation method are suitable for industrial mass production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a levofloxacin hydrochloride capsule and a preparation method thereof. Background technique [0002] Levofloxacin is the levoisomer of ofloxacin, a fluoroquinolone. It was first successfully developed by Japan's Daiichi Pharmaceutical Co., Ltd. in 1994 and launched in Japan, and was allowed to enter China in 1995. [0003] Levofloxacin appears to be the levorotatory optical isomer of ofloxacin, which is a racemic mixture of the levorotatory and dextrorotatory isomers. Since the antibacterial activity of the left-handed isomer is 8-128 times stronger than that of the right-handed isomer, the antibacterial activity of levofloxacin is 2 times stronger than that of ofloxacin, and the clinical dosage is 1 / 2 of ofloxacin. Levofloxacin not only has strong antibacterial activity against Gram-positive and Gram-negative clinical common pathogens, but also has strong...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/5383A61P31/04
Inventor 曾培安张静吴健民
Owner KAMP PHARMA
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