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Levofloxacin hydrochloride medicinal composition for injection and preparation method thereof

A technology for levofloxacin hydrochloride and injection, which is applied in drug delivery, pharmaceutical formulations, antibacterial drugs, etc. It can solve the problems of production process and production cost, and achieve the effects of avoiding the reduction of main drug content, mature technology and simple operation

Inactive Publication Date: 2011-04-06
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In the prior art, industrial production often adopts light-shielding technology to manufacture this variety. In the middle and middle stages of this variety’s market packaging, brown glass bottles or light-shielding materials are often used for packaging. To a certain extent On the one hand, it causes troubles to the production process and production cost

Method used

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  • Levofloxacin hydrochloride medicinal composition for injection and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Levofloxacin hydrochloride injection prescription

[0028] Ingredient Weight

[0029] Levofloxacin Hydrochloride 200mg

[0030] Cysteine ​​Hydrochloride 20mg

[0031] Edetate Calcium Sodium 2mg

[0032] Add water for injection to 2ml

[0033] Preparation process of levofloxacin hydrochloride injection

[0034] 1) Heat 70% of the water for injection to 50°C, add the prescribed amount of cysteine ​​hydrochloride and calcium sodium edetate and stir until completely dissolved, cool down to 50°C, add the prescribed amount of levofloxacin hydrochloride, stir until completely dissolved, spare;

[0035] 2) Add 0.1% medicinal charcoal to 1), stir well and let stand for 30 minutes;

[0036] 3) Filter and adjust the pH value to 3.0-5.0 with 10% hydrochloric acid solution or 4% sodium hydroxide solution;

[0037] 4) After fine filtration until the visible foreign matter is qualified, potting;

[0038] 5) Sterilize at 121°C for 15 minutes, ready to serve.

Embodiment 2

[0039] Embodiment 2 (comparative embodiment)

[0040] Levofloxacin hydrochloride injection prescription

[0041] Ingredient Weight

[0042] Levofloxacin Hydrochloride 200mg

[0043] Add water for injection to 2ml

[0044] Preparation process of levofloxacin hydrochloride injection

[0045] 1) Heat 70% water for injection to 50°C, add the prescribed amount of cysteine ​​hydrochloride and calcium sodium edetate and stir until completely dissolved, cool down to 50°C, add the prescribed amount of levofloxacin hydrochloride, stir until completely dissolved, spare;

[0046] 2) Add 0.1% medicinal charcoal to 1), stir well and let stand for 30 minutes;

[0047] 3) Filter and adjust the pH value to 3.0-5.0 with 10% hydrochloric acid solution or 4% sodium hydroxide solution;

[0048] 4) After fine filtration until the visible foreign matter is qualified, potting;

[0049] 5) Sterilize at 121°C for 15 minutes, ready to serve.

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PUM

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Abstract

The invention relates to a levofloxacin hydrochloride medicinal composition for injection and a preparation method thereof. The levofloxacin hydrochloride medicinal composition for injection comprises levofloxacin hydrochloride with curative dose and calcium disodium edetate and cysteine hydrochloride which can inhibit photolysis. The levofloxacin hydrochloride medicinal composition for injection adopts a special process and selects the calcium disodium edetate and the cysteine hydrochloride as a combinational antioxidant, so the stability of products is improved greatly. The invention also discloses the preparation method of the medicinal composition.

Description

technical field [0001] The invention relates to a pharmaceutical composition of levofloxacin hydrochloride injection and a preparation method thereof. Background technique [0002] The natural growth of the population and the aging of the population structure are the main factors driving the continuous growth of the pharmaceutical market. From the perspective of population size and structural evolution, the elderly population over 65 years old accounts for 7% of the total population in my country, nearly 100 million people. Therefore, the continuous increase of my country's aging population will increase the market demand for anti-infective drugs, which is the basis for the enhancement of the vitality of the pharmaceutical market. [0003] Fluoxinolone antibiotics are a new class of anti-infective drugs developed in the early 1970s. At present, the global market size of fluoroquinolones has reached about 5 billion US dollars per year, second only to cephalosporins and peni...

Claims

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Application Information

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IPC IPC(8): A61K31/5383A61K47/18A61K47/20A61K9/08A61P31/04
Inventor 黄欣严洁
Owner TIANJIN HANKANG PHARMA BIOTECH
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