Medicament composition for eyes or nose, and uses thereof

A composition, ear and nose technology, applied in the directions of drug combination, drug delivery, antipyretic drugs, etc., can solve the problems of incomparability of chemical properties and physical properties, and the effect of levofloxacin and loteprednol etabonate cannot be inferred from this.

Active Publication Date: 2008-12-10
SHENZHEN REGOO LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, dexamethasone and loteprednol etabonate are not comparable in terms of chemical and physical properties, and it is not possible to infer the compatibility effect of levofloxacin and loteprednol etabonate

Method used

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  • Medicament composition for eyes or nose, and uses thereof
  • Medicament composition for eyes or nose, and uses thereof
  • Medicament composition for eyes or nose, and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Example 1 Pharmacodynamic prescription screening test of levofloxacin loteprednol etabonate series concentration eye drops in rabbits.

[0045] 1. The purpose of the experiment: by instilling different proportions of levofloxacin loteprednol etabonate eye drops into the eyelids of rabbits after simulated incision surgery, to observe the antibacterial and anti-inflammatory effects of different concentration ratios of the liquids to prevent postoperative infection, Compare the difference in efficacy between the designed dose and other doses.

[0046] 2. Experimental materials

[0047] 1) Experimental samples

[0048] Levofloxacin loteprednol etabonate eye drops (LZ01-09), batch number: 060701.

[0049] LZ01: Specification: 5ml: 20mg loteprednol etabonate + 15mg levofloxacin;

[0050] LZ02: Specification: 5ml: 20mg loteprednol etabonate + 25mg levofloxacin;

[0051] LZ03: Specification: 5ml: 20mg loteprednol etabonate + 35mg levofloxacin;

[0052] LZ04: Specification:...

Embodiment 2

[0115] Embodiment 2, preparation

[0116] Table 7. Prescription (unit g / 200ml)

[0117]

[0118] Feed according to the ratio stated in the above prescription

[0119] 2. The preparation process of the pharmaceutical composition of the present invention to make suspension eye drops is as follows:

[0120] (1) sterilize the bottle for subsequent use;

[0121] (2) Loteprednol etabonate is microcrystallized and pulverized through a 200-mesh sieve, and sterilized by radiation for subsequent use;

[0122] (3) Dissolve each auxiliary material except loteprednol etabonate and levofloxacin in 80% water for injection, and dissolve levofloxacin in it after forming a clear solution to form a light yellow-green solution;

[0123] (4) Filter the above solution through a microporous membrane, and sterilize it by circulating steam at 100° C. for 30 minutes before use;

[0124] (5) Disperse the sterilized loteprednol etabonate in the standby liquid in a class 100 clean area, and dispers...

Embodiment 3

[0132] Embodiment 3, the influence of levofloxacin loteprednol etabonate compound (expressed in LZ) on rabbit intraocular pressure

[0133] 20 healthy rabbits were randomly divided into 4 groups (respectively LZ-H high-dose group, LZ-M medium-dose group, LZ-L low-dose group, negative control group), 5 in each group. Both eyes were instilled with the LZ05 proportioning eye drops described in Example 1, LZ-H, LZ-M, and LZ-L were administered 4, 2, and 1 drops respectively, and the negative control group (control) was instilled with 2 drops of vehicle . At 0 min, 30 min, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min of administration, use YZ7A intraocular pressure meter to measure the intraocular pressure under tetracaine anesthesia. The above method reference can be found in the literature: Intraocular pressure, β-occlusion Action and dynamic changes of drug concentration in the intraocular fluid, Journal of ocular pharmacology, 1989, 5：271-279 . The data results are...

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Abstract

The present invention provides a combination of medicines for eyes or ears and nose, which comprises levofloxacin and loteprednol carbon ester; wherein, the weight ratio of the loteprednol carbon ester to the levofloxacin is between 1 to 0.2 and 1 to 5. The combination of medicine for eyes or ears and nose of the present invention is used for curing conjunctivitis, keratitis, blepharitis, dacryocystitis, hordeolum, corneal ulcer and eye infection with inflammation of eyes or even inflammation of tissue around eyes. The combination is also used for preventing bacterial infection risk after ophthalmology operation or eye injury and inflammation of the infected region, or the combination is used for curing or alleviating bacterial infection and tissue inflammation of the infected region after ophthalmology operation or eye injury, or cure tympanitis, otitis externa and infectious rhinitis.

Description

technical field [0001] The present invention relates to an ophthalmic or ear nasal pharmaceutical composition, more specifically, a pharmaceutical composition comprising levofloxacin or a pharmaceutically acceptable salt thereof and loteprednol etabonate. The invention also relates to the preparation and use of the composition. Background technique [0002] Eye infections are often accompanied by inflammation of the eye and even the surrounding tissues, and eye surgery or eye trauma often increases the risk of bacterial infection and inflames the tissues in the affected area. Therefore, a compound preparation in the form of a single preparation made of one or more antibiotics with anti-infection use and one or more steroidal or non-carrier anti-inflammatory drugs with anti-inflammatory effect is very desirable. [0003] The drug loteprednol etabonate tobramycin eye drops Zylet, which is listed in the United States, has active ingredients of loteprednol etabonate 5 mg (0.5%)...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/56A61K9/10A61K47/36A61P11/02A61P27/02A61P27/16A61P31/04A61K31/5383
CPCA61K9/0043A61K9/0046A61K9/0048A61K31/538A61K31/569A61P11/02A61P27/02A61P27/16A61P29/00A61P31/02A61P31/04
Inventor 张静肖高铿赵亮
Owner SHENZHEN REGOO LAB
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