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Levofloxacin hydrochloride dropping pill and preparation method thereof

A technology of levofloxacin hydrochloride and dripping pills, which is applied in the fields of pill delivery, pharmaceutical formulations, and medical preparations of non-active ingredients. It can solve the problems of slow release of capsules and tablets, poor compliance of injections, and high production costs, and achieve absorption Fast, strong market competitiveness, low cost effect

Pending Publication Date: 2019-08-23
扬子江药业集团江苏紫龙药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] A preparation method of levofloxacin hydrochloride dripping pills proposed by the present invention solves the problems of poor compliance, low safety, and high cost of injections; capsules and tablets have slow drug release, slow onset of effect, and relatively high production costs.

Method used

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  • Levofloxacin hydrochloride dropping pill and preparation method thereof

Examples

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Effect test

preparation example Construction

[0041]Preparation of reference substance solution: Take an appropriate amount of levofloxacin hydrochloride reference substance, accurately weigh it, add 0.1mol / L hydrochloric acid solution to make a mixed solution containing 0.1mg of levofloxacin hydrochloride reference substance per 1mL, and get ready.

[0042] The preparation of need testing solution: get 30 balls of this product, grind finely, take by weighing the fine powder amount (about 1.0g that is equivalent to levofloxacin by C 20 times of average ball weight) 18 h 20 FN 3 o 4 (about 0.2g), put it in a 100mL measuring bottle, add 0.1mol / L hydrochloric acid solution to dissolve and dilute to the mark, shake well, filter through a 0.45μm filter membrane, accurately measure 5mL of the subsequent filtrate, put it in a 100mL measuring bottle, Dilute to the mark with 0.1mol / L hydrochloric acid solution, shake well, as the test solution.

[0043] Measure the absorbance at a wavelength of 294nm according to the ultraviole...

Embodiment 2

[0045] According to the mass ratio of PEG-4000, PEG-6000, and levofloxacin hydrochloride fine powder 0.6︰0.6︰0.3, each raw material was accurately weighed, totaling 10g. Prepare as follows:

[0046] (1) Melting of the matrix: Weigh the prescription quantities of PEG-4000 and PEG-6000, put them in an evaporating dish according to a certain proportion, heat and melt them in a water bath at 80-90°C, and stir evenly.

[0047] (2) Dispersion of the medicine: get the prescribed amount of levofloxacin hydrochloride fine powder (through a 100-mesh nylon sieve), add it to the above-mentioned molten matrix, stir evenly, so that the medicine is uniformly dispersed or / and dissolved.

[0048] (3) Dropping: Move the obtained molten liquid to the heat-insulated liquid reservoir. The temperature in the liquid reservoir needs to be kept at 80-85°C. Adjust the distance between the dripper and the cooling liquid, and drop the molten liquid containing medicine into the cooling liquid. Liquid par...

Embodiment 3

[0060] According to the mass ratio of PEG-4000, PEG-6000, and levofloxacin hydrochloride fine powder 0.8︰0.8︰0.4, each raw material was accurately weighed, totaling 10g. Prepare as follows:

[0061] (1) Melting of the matrix: Weigh the prescription quantities of PEG-4000 and PEG-6000, put them in an evaporating dish according to a certain proportion, heat and melt them in a water bath at 80-90°C, and stir evenly.

[0062] (2) Dispersion of the medicine: get the prescribed amount of levofloxacin hydrochloride fine powder (through a 100-mesh nylon sieve), add it to the above-mentioned molten matrix, stir evenly, so that the medicine is uniformly dispersed or / and dissolved.

[0063] (3) Dropping: Move the obtained molten liquid to the heat-insulated liquid reservoir. The temperature in the liquid reservoir needs to be kept at 80-85°C. Adjust the distance between the dripper and the cooling liquid, and drop the molten liquid containing medicine into the cooling liquid. Liquid par...

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Abstract

The invention relates to the technical field of biological medicine, in particular to a preparation method of a levofloxacin hydrochloride dropping pill. The dropping pill contains the following pharmaceutical grade components of PEG-4000, PEG-6000 and levofloxacin hydrochloride fine powder, wherein the mass ratio of the materials in the prescription is (0.4-0.8) : (0.4-0.8) : (0.2-0.4) in sequence. According to a new dosage form of levofloxacin hydrochloride, except that acute infectious diseases need intravenous injection of a levofloxacin hydrochloride injection, the anti-infective therapyof other adaptation diseases all can select the levofloxacin hydrochloride dropping pill with quicker effects.

Description

technical field [0001] The invention relates to the technical field of levofloxacin hydrochloride preparations, in particular to a levofloxacin hydrochloride dripping pill. Background technique [0002] Levofloxacin hydrochloride is the levorotatory isomer of ofloxacin hydrochloride, a quinolone drug, which has a broad-spectrum antibacterial effect. Strong antibacterial activity. It also has certain inhibitory activity against Gram-positive bacteria such as Staphylococcus aureus, Streptococcus pyogenes, and Streptococcus pneumoniae, as well as Mycoplasma pneumoniae and Chlamydia, but its effect on anaerobic bacteria and enterococci is poor. It is suitable for urinary system, respiratory system, digestive system, skin and soft tissue infection caused by sensitive bacteria. [0003] The antibacterial activity of levofloxacin hydrochloride is about twice that of the racemate of ofloxacin hydrochloride, and its adverse reactions are less than that of the racemate. It is one of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/10A61K31/5383A61P31/04
CPCA61K9/2031A61K31/5383A61P31/04
Inventor 宋人杰史彦斌王少华景佳佳
Owner 扬子江药业集团江苏紫龙药业有限公司
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