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Viscosity-stable eye drops containing polyalcohol-inorganic salt-xanthan gum ternary system and preparation method thereof

A ternary technology of inorganic salt and glue, applied in the field of medicine, can solve the problems of inability to filter and sterilize, and achieve the effect of increasing the conformational transition temperature, treating eye inflammation, and effectively eye inflammation

Inactive Publication Date: 2016-11-23
SHANGHAI HAOHAI BIOLOGICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since xanthan gum has a certain viscosity, it cannot be sterilized by filtration. The method of terminal sterilization at 121°C for 15 minutes can ensure that the product SAL≤10 -6 , but when xanthan gum is exposed to high temperature, a conformational transition process from order to disorder occurs

Method used

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  • Viscosity-stable eye drops containing polyalcohol-inorganic salt-xanthan gum ternary system and preparation method thereof
  • Viscosity-stable eye drops containing polyalcohol-inorganic salt-xanthan gum ternary system and preparation method thereof
  • Viscosity-stable eye drops containing polyalcohol-inorganic salt-xanthan gum ternary system and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

Add to 1000ml

[0057] Preparation method: The following materials are fed according to the prescription quantity

[0058] Step 1): Accurately weigh 5g of xanthan gum and 5g of sodium chloride and slowly place it in a container with 400ml of water for injection, stir at 400rpm for 30min to fully swell, pass through 5μm and 1μm secondary filter membranes to obtain clarification Continue filtrate, add the sorbitol of 1g, dissolve for subsequent use;

[0059] Step 2): Weigh 5g of moxifloxacin hydrochloride and place it in the remaining water for injection, stir, adjust the pH to 5.0 with a pH regulator, and stir evenly;

[0060] Step 3): The dissolved solution in step 1) and the homogenized solution in step 2) are respectively autoclaved and steam sterilized at 121° C. for 15 minutes, and cooled to room temperature;

[0061] Step 4): Mix the solution completed in step 3), add sterilized water for injection to 1000ml, stir evenly, and aseptically fill, the obtained solutio...

Embodiment 2

[0063]

[0064]

[0065] Preparation method: The following materials are fed according to the prescription quantity

[0066] Step 1): Accurately weigh 8g of xanthan gum and 9g of sodium chloride and slowly place them in a container containing 450ml of water for injection, stir at 400rpm for 40min to fully swell, pass through a 5μm and 1μm secondary filter membrane to obtain a clarified filtrate, add 10g sorbitol, dissolved for later use;

[0067] Step 2): Weigh 6g of moxifloxacin hydrochloride and place it in the remaining water for injection, stir, adjust the pH to 8.0 with a pH regulator, and stir evenly;

[0068] Step 3): The dissolved solution in step 1) and the homogenized solution in step 2) are respectively autoclaved and steam sterilized at 121° C. for 15 minutes, and cooled to room temperature;

[0069] Step 4): Mix the solution completed in step 3), add sterilized water for injection to 1000ml, stir evenly, and aseptically fill, the obtained solution is an eye...

Embodiment 3

Add to 1000ml

[0072] Preparation method: The following materials are fed according to the prescription quantity

[0073] Step 1): Accurately weigh 5g of xanthan gum and 3g of potassium chloride and slowly place them in a container containing 500ml of water for injection, stir at 400rpm for 35min to fully swell, pass through a 5μm and 1μm secondary filter membrane to obtain a clarified filtrate, add 1g Mannitol, dissolved for later use;

[0074] Step 2): Weigh 5 g of moxifloxacin hydrochloride, place it in the remaining water for injection, stir, adjust the pH to 5.0 with a pH regulator, and stir evenly;

[0075] Step 3): The dissolved solution in step 1) and the homogenized solution in step 2) are respectively autoclaved and steam sterilized at 121° C. for 15 minutes, and cooled to room temperature;

[0076] Step 4): Mix the solution completed in step 3), add sterilized water for injection to 1000ml, stir evenly, and aseptically fill, the obtained solution is an eye ...

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Abstract

The invention belongs to the technical field of medicine, and relates to an eye drop with stable viscosity comprising polyol-inorganic salt-xanthan gum ternary system and a preparation method thereof, comprising: moxifloxacin hydrochloride 0.5-0.6% w / v; xanthan glue 0.5-0.8% w / v; polyol compound 0.1-1% w / v; For the degradation problem of raw gum after sterilization, increase the ionic strength and add soluble alcohols as antioxidants to form a polyol-inorganic salt-xanthan gum ternary system, so that the viscosity does not decrease after sterilization and ensure that the eye drops are in the eyes The static viscosity of the part is 40-80pa s; it provides improved bioavailability for eye drops, which can more effectively treat ocular inflammation, and the contact angle of this product is small, which can increase the wetting effect of ocular tissue , There is no feeling of stickiness, which greatly improves the patient's compliance.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an eye drop with stable viscosity containing a polyol-inorganic salt-xanthan gum ternary system and a preparation method thereof. Background technique [0002] The ocular drug delivery system is a drug delivery system with the characteristics of local therapeutic effects. It is mainly used clinically for sterilization, anti-inflammation, mydriasis, anesthesia, treatment of glaucoma, and reduction of intraocular pressure. At present, the forms of ophthalmic medicine are mainly divided into eye drops, eye oils, eye ointment, gel, subconjunctival injection and intravitreal injection. Since the eyes have very effective protective mechanisms such as tearing and blinking reflex, the liquid medicine dripped into the eye can be quickly eliminated from the front of the cornea, and the viscosity of the eye ointment and gel makes the patient uncomfortable. To some extent, ther...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4709A61K47/36A61K47/10A61K47/02A61P31/04A61P29/00A61P27/02
CPCA61K9/0048A61K9/08A61K31/4709A61K47/02A61K47/10A61K47/36
Inventor 张真真廉云飞张军东吴剑英
Owner SHANGHAI HAOHAI BIOLOGICAL TECH
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