Oxybutynin chloride externally-applied preparation and preparation method thereof

An external preparation, oxybutynin technology, applied in the field of pharmaceutical preparations, can solve problems such as poor stability

Inactive Publication Date: 2013-11-13
HANGZHOU SHARPLY PHARM R&D INSTIT +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the transdermal gel has poor stabili...

Method used

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  • Oxybutynin chloride externally-applied preparation and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Embodiment 1: the preparation of oxybutynin granule intermediate adopts following prescription:

[0036] Oxybutynin 5g

[0037] Medium Chain Fatty Acid Ester 95g

[0038] Lecithin 20g

[0039] Tween 80 10g

[0040] water 370g

[0041] Prepared fat milk 500g

[0042] Hypromellose 200g

[0043] Sucrose 50g

[0044] Prepared into granules 380g

[0045] Preparation Process:

[0046] 1. Raw and auxiliary materials are pretreated, oxybutynin is crushed to 300 mesh, and other solid auxiliary materials are crushed to 200 mesh;

[0047] 2. Disperse oxybutynin in the medium-chain fatty acid ester, heat and melt, keep the temperature at 70°C, and form the oil phase;

[0048] 3. Weigh lecithin and Tween-80 in water at 75°C, stir and disperse evenly, forming the water phase;

[0049] 4. Slowly add the oil phase into the water phase under low-speed stirring, emulsify until there are no oil droplets on the surface, and then get colostrum;

[0050] 5. High-speed shearing of...

Embodiment 2

[0055] Embodiment 2: the preparation of oxybutynin granule intermediate adopts following prescription:

[0056] Oxybutynin 5g

[0057] soybean oil 55g

[0058] Span 80 10g

[0059] Tween 80 10g

[0060] water 220g

[0061] Made into fat milk 300g

[0062] Sucrose 60g

[0063] Mannitol 60g

[0064] Makes 110g

[0065] Preparation Process:

[0066] 1. Raw and auxiliary materials are pretreated, oxybutynin is crushed to 300 mesh, and other solid auxiliary materials are crushed to 200 mesh;

[0067] 2. Disperse oxybutynin in soybean oil and Span 80, heat and melt, keep the temperature at 80°C, and form the oil phase;

[0068] 3. Weigh Tween-80 and dissolve it in water at 85°C to form the water phase;

[0069] 4. Slowly add the oil phase into the water phase under low-speed stirring, emulsify until there are no oil droplets on the surface, and then get colostrum;

[0070] 5. High-speed shearing of colostrum in a high-pressure homogenizer to obtain fat emulsion;

[...

Embodiment 3

[0075] Embodiment 3: Preparation of dry milk type oxybutynin granules

[0076] The oxybutynin granule intermediate 380g of embodiment 1 gained

[0077] Povidone 180g

[0078] Sodium carboxymethyl starch 395g

[0079] Fragrance 20g

[0080] Make 1000 bags

[0081] Preparation Process:

[0082] 1. Pretreatment of auxiliary materials, passing through a 200-mesh sieve;

[0083] 2. The oxybutynin granule intermediate obtained in Example 1 is mixed homogeneously with other auxiliary materials;

[0084] 3. Test and package.

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Abstract

The invention relates to an oxybutynin chloride externally-applied preparation for treating overactive bladder, and a preparation method thereof. The oxybutynin chloride externally-applied preparation is prepared by an oxybutynin chloride particle intermediate and pharmaceutical preparation adjuvants, wherein the oxybutynin chloride particle intermediate comprises 0.1%-10% of oxybutynin, 10%-50% of an oil phase, 1%-20% of a surface-active agent and 20%-70% of a propping agent. The oxybutynin chloride externally-applied preparation can greatly increase stability of the preparation, is beneficial to long-term storage of the drug, prevents the situations of applying a lot of the surface-active agent for increasing the solubility and stability of a liquid emulsion, and is beneficial to reduce stimulation of the preparation to skins. Beside, for a single dose dry emulsion, water-adding proportions can be adjusted by a patient in a certain range, and proper viscosity and thickness can be obtained, thereby facilitating increasing compliance of the patient.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an external preparation of oxybutynin for treating overactive bladder and a preparation method thereof. Background technique [0002] Overactive bladder (OAB) refers to a group of frequent urination, urgency and urgency caused by the unstable contraction of the detrusor muscle caused by non-neurogenic factors and the hyperreflexia of the detrusor muscle caused by neurogenic factors. Urinary incontinence syndrome is a common chronic disease that seriously affects people's quality of life. [0003] OAB affects an estimated 33 million people in the United States and approximately 22 million people in Europe. Oxybutynin hydrochloride and tolterodine are currently clinically used to treat overactive bladder, and they are administered orally and intravesically. There are few adverse reactions, but the way of medication is inconvenient, so it is only suitable for patients w...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/16A61K9/20A61K9/46A61K31/216A61P13/10
Inventor 范敏华孙军刘华
Owner HANGZHOU SHARPLY PHARM R&D INSTIT
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