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Pharmaceutical composition containing besifloxacin hydrochloride and preparation method thereof

A technology of besifloxacin hydrochloride and its composition, which is applied in the field of pharmaceutical preparations, can solve the problems of decreased stability, poor stability of besifloxacin hydrochloride, unfavorable antibacterial effect of besifloxacin hydrochloride, etc., achieve good stability, improve curative effect, prolong The effect of action time

Active Publication Date: 2018-11-16
JIANGSU YABANG AIPUSEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Although besifloxacin hydrochloride has strong bactericidal effect and wide antibacterial spectrum, if besifloxacin hydrochloride is prepared into common solution eye drops, there are some problems as follows: (1) The stability of besifloxacin hydrochloride is relatively poor, and the (2) The solubility of besifloxacin hydrochloride is not good, and it is not easy to prepare solution ophthalmic preparations; It is easy to be lost during the process, which is not conducive to the antibacterial effect of besifloxacin hydrochloride in the eye

Method used

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  • Pharmaceutical composition containing besifloxacin hydrochloride and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment 1: the preparation of besifloxacin hydrochloride eye drops

[0025] The composition of the prescription is as follows:

[0026] Besifloxacin Hydrochloride 6.56g

[0027] Polyethylene glycol-phosphatidylethanolamine 39.36g

[0028] Polycarbophil 3.28g

[0029] Edetate Disodium 0.03g

[0030] Benzalkonium Chloride 0.03g

[0031] Mannitol 6.56g

[0032] Sodium chloride 3.28g

[0033] 10% sodium hydroxide solution appropriate amount

[0034] Add water for injection to 1000mL

[0035] Preparation:

[0036] (1) Weigh the prescribed amount of polycarbophil, edetate disodium, and mannitol, add them to an appropriate amount of water for injection, stir and swell at room temperature for 10-12 hours, and prepare solution 1;

[0037] (2) Weigh the prescribed amount of benzalkonium chloride and sodium chloride, add an appropriate amount of water to dissolve, add to solution 1, and stir evenly to obtain solution 2;

[0038] (3) Dissolve the prescribed amount of p...

Embodiment 2

[0039] Embodiment 2: the preparation of besifloxacin hydrochloride eye drops

[0040] The composition of the prescription is as follows:

[0041] Besifloxacin Hydrochloride 6.56g

[0042] Polyethylene glycol-phosphatidylethanolamine 52.26g

[0043] Polycarbophil 4.20g

[0044] Edetate Disodium 0.10g

[0045] Benzalkonium Chloride 0.10g

[0046] Mannitol 22.00g

[0047] Sodium chloride 4.50g

[0048] 10% sodium hydroxide solution appropriate amount

[0049] Add water for injection to 1000mL

[0050] Preparation:

[0051] (1) Weigh the prescribed amount of polycarbophil, edetate disodium, and mannitol, add them to an appropriate amount of water for injection, stir and swell at room temperature for 10-12 hours, and prepare solution 1;

[0052] (2) Weigh the prescribed amount of benzalkonium chloride and sodium chloride, add an appropriate amount of water to dissolve, add to solution 1, and stir evenly to obtain solution 2;

[0053] (3) Dissolve the prescribed amount of po...

Embodiment 3

[0054] Embodiment 3: the preparation of besifloxacin hydrochloride eye drops

[0055] The composition of the prescription is as follows:

[0056] Besifloxacin Hydrochloride 6.56g

[0057] Polyethylene glycol-phosphatidylethanolamine 65.60g

[0058] Polycarbophil 4.20g

[0059] Edetate Disodium 0.10g

[0060] Benzalkonium Chloride 0.10g

[0061] Mannitol 22.00g

[0062] Sodium chloride 4.50g

[0063] 10% sodium hydroxide solution appropriate amount

[0064] Add water for injection to 1000mL

[0065] Preparation:

[0066] (1) Weigh the prescribed amount of polycarbophil, edetate disodium, and mannitol, add them to an appropriate amount of water for injection, stir and swell at room temperature for 10-12 hours, and prepare solution 1;

[0067] (2) Weigh the prescribed amount of benzalkonium chloride and sodium chloride, add an appropriate amount of water to dissolve, add to solution 1, and stir evenly to obtain solution 2;

[0068] (3) Dissolve the prescribed amount of ...

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PUM

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Abstract

The invention discloses a pharmaceutical composition containing besifloxacin hydrochloride and a preparation method thereof. The pharmaceutical composition comprises the following components by mass percentage: 5-10% of besifloxacin hydrochloride, 5-65% of an amphiphilic block polymer carrier, 0.01-2% of a bacterial depressant, 0.01-20% of a thickening agent, 0.01-40% of an osmotic pressure conditioning agent, 0.01-10% of a pH conditioning agent, 0.01-2% of a metal ion chelating agent and injection water. The stability of the prepared besifloxacin hydrochloride eye drop is good, the effect time of besifloxacin hydrochloride in eyes can be obviously prolonged, and the curative effect is increased.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing besifloxacin hydrochloride and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Liposomes are a kind of drug carrier, which was first discovered by Professor Bangham in 1965. Its raw materials are lipid compounds, such as phospholipids and cholesterol. Because phospholipids and cholesterol have amphiphilicity, that is, one end is a hydrophobic group and the other end is a hydrophilic group. At the same time, the hydrophilic and hydrophobic interactions between molecules can spontaneously form closed vesicles of phospholipid bilayers. Drugs can Encapsulated in vesicles, using the physiological characteristics of liposomes, it can specifically deliver drugs to diseased tissues and release drugs, so as to achieve the therapeutic effect of reducing toxicity, improving curative effect and reducing side effects. Liposome technol...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K47/24A61K31/55A61P31/04A61P27/02
CPCA61K47/24A61P27/02A61P31/04A61K9/0048A61K9/1075A61K31/55
Inventor 陈再新徐丽洁葛育红王淑娟朱峰王勇军于水涛
Owner JIANGSU YABANG AIPUSEN PHARMA