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Small-volume moxifloxacin hydrochloride injection and preparation method thereof

A technology of moxifloxacin hydrochloride and moxifloxacin, which is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, and drug delivery, can solve the problems of inability to use sodium chloride, unsuitable for clinical application, and large floor space, etc. Achieve the effect of good clarity, high sterilization guarantee value and low cost

Inactive Publication Date: 2013-08-14
北京赛盟医药科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The Moxifloxacin Hydrochloride Sodium Chloride Injection currently listed by Bayer is a large-capacity injection, which is inconvenient to transport and occupies a large area, which is not conducive to storage; on the other hand, the Sodium Chloride Injection has compatibility limitations, and some specific Sodium chloride injection cannot be used for patients with constitutional constitutions such as: heart failure patients, pulmonary edema patients, cerebral edema, increased intracranial pressure, pregnancy-induced hypertension syndrome, etc. In terms of economy, the market price of Baifule is relatively high
In order to broaden the scope of clinical application of moxifloxacin, some people have tried to develop moxifloxacin hydrochloride glucose injection, but when moxifloxacin and glucose coexist for a long time, the color will become darker and related substances will increase, which is not suitable for clinical application.

Method used

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  • Small-volume moxifloxacin hydrochloride injection and preparation method thereof
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  • Small-volume moxifloxacin hydrochloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Example 1 Preparation of small volume injection of moxifloxacin hydrochloride

[0043] Table 4 Moxifloxacin Hydrochloride Small Volume Injection Prescription

[0044] Moxifloxacin hydrochloride (calculated as moxifloxacin) 200g 0.5mol / L sodium hydroxide solution Appropriate amount Water for Injection Appropriate amount Full amount 10000ml

[0045] According to the above prescription, three batches of samples were continuously prepared, each batch was 2000ml, numbered 20110901, 20110902, 20110903, and the preparation method was as follows;

[0046] Preparation Process:

[0047] (1) Weigh the prescribed amount of moxifloxacin hydrochloride 200g and add it to 90% of the total volume of water for injection, stir at 60-80°C for 15 minutes to fully dissolve the main drug;

[0048] (2) Supplement an appropriate amount of water for injection to make up the volume to full volume;

[0049] (3) Then add an appropriate amount of 0.5mol / L sodi...

Embodiment 2

[0061] Example 2 Three batches of samples in Example 1 are detected

[0062] The finished product of each batch in the embodiment is checked, and sample is carried out the mensuration of pH, content, related substance, and observes its outward appearance, and the results are shown in the following table:

[0063] Table 8 Test results of three batches of small test samples

[0064]

[0065] The results show that all the indicators of the moxifloxacin hydrochloride injection of the present invention meet the quality standard requirements.

Embodiment 3

[0066] Example 3 investigates the solution stability prepared under normal light conditions

[0067] Since the color of the moxifloxacin hydrochloride raw material is darkened under the light conditions of the influencing factors, and the related substances and contents have no obvious changes, so the preparation of this product is investigated under normal light conditions, and the solution is placed under normal light conditions for 12 hours, measured 0 , 4, 8, 12h absorbance, content and related substances, the results are as follows:

[0068] The solution stability result prepared under the normal light condition of table 9

[0069]

[0070] It can be seen from the experimental results that the color, content and related substances of the moxifloxacin hydrochloride solution prepared under normal light conditions meet the requirements, and compared with 0h after being placed under normal light conditions for 12 hours, the absorbance, content and related substances hav...

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Abstract

The invention relates to a small-volume moxifloxacin hydrochloride injection and a preparation method thereof. The preparation method comprises the following steps of: regulating the PH value of 0.01-0.04 / ml of moxifloxacin hydrochloride water solution for injection to 4.2-4.7, adding activated carbon for absorption, treating by a filter membrane of 0.22mu m, filling nitrogen, encapsulating and sterilizing to prepare 10ml of small-volume injection. The injection product does not have sub-visible particles, is good in clarity and safe in medication, can be conveniently mixed with injections such as glucose, mannitol and the like, and is not restricted to a sodium chloride injection. The invention solves the problem that the sodium chloride injection can not be used for some patients having specific physiques.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a moxifloxacin hydrochloride small-volume injection preparation and a preparation method thereof. Background technique [0002] Moxifloxacin is a quinolone drug, an 8-methoxyfluoroquinolone antibacterial drug with broad-spectrum activity and bactericidal effect. Moxifloxacin has shown broad-spectrum antibacterial activity in vitro against Gram-positive, Gram-negative, anaerobic, acid-fast and atypical microorganisms such as Mycoplasma, Chlamydia and Legionella. [0003] The mechanism of bactericidal action is to interfere with topoisomerase Ⅱ and Ⅳ. Topoisomerases are enzymes that control DNA topology and are critical in DNA replication, repair and transcription. [0004] Moxifloxacin exhibited concentration-dependent bactericidal activity. The minimum bactericidal concentration and the minimum inhibitory concentration are basically the same. [0005] Mo...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4709A61P31/04
Inventor 关屹闫冬熊晓崴
Owner 北京赛盟医药科技发展有限公司
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