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A kind of preparation method of low viscosity sertaconazole nitrate cream and prepared product thereof

A technology of sertaconazole nitrate and low viscosity, which is applied in the directions of non-active ingredient medical preparations, medical preparations containing active ingredients, and ointment delivery, etc. reduced effect

Active Publication Date: 2022-07-29
HAINAN HAISHEN TONGZHOU PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Not easy to fill
This seriously affects the generation efficiency

Method used

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  • A kind of preparation method of low viscosity sertaconazole nitrate cream and prepared product thereof
  • A kind of preparation method of low viscosity sertaconazole nitrate cream and prepared product thereof
  • A kind of preparation method of low viscosity sertaconazole nitrate cream and prepared product thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Optimization of the recipe of Example 1

[0027] In order to improve the viscosity of sertaconazole nitrate cream and facilitate filling in the workshop, the matrix ratio was further screened with reference to the prescription before the change. Design 5 prescriptions. See Table 1 for a prescription.

[0028] Adopt the prescription in table 1 respectively, prepare sertaconazole nitrate cream according to the following steps:

[0029] (1) prepare oil phase: mix the light liquid paraffin, mono-, bis-stearate glyceride, stearyl alcohol and ethyl paraben of recipe quantity and heat to about 80 ℃, keep warm for later use;

[0030] (2) prepare water phase: mix the polysorbate 80 of recipe quantity, purified water and the propylene glycol of 80% recipe quantity and heat to about 85 ℃, keep warm for later use;

[0031] (3) preparation of main drug dispersion: sertaconazole nitrate is dispersed and ground with remaining propylene glycol to obtain main drug dispersion;

[003...

Embodiment 2

[0039] Embodiment 2 is to the performance investigation of sertaconazole nitrate cream prescription

[0040] The appearance properties and viscosity of the sertaconazole nitrate cream prepared according to various prescriptions were investigated.

[0041] Inspection method

[0042] Appearance inspection: human eye observation

[0043] Viscosity detection: According to the third method of viscosity determination in the 2015 edition of the Chinese Pharmacopoeia, take an appropriate amount of the sample, put it into a 250ml beaker, drain the air, and measure the paste after equilibrating in a 25°C water bath for 1-2 hours.

[0044] Inspection results See Table 2 below.

[0045] Table 2 Prescription performance test results

[0046]

[0047] It can be seen from the above table that the appearance properties of prescriptions 1 to 6 are all fine and soft, and the viscosity value of prescription 5 is the smallest. The prescription 6 is the prescription before the change. C...

Embodiment 3

[0052] Embodiment 3 Stability investigation

[0053] The stability of these 6 formulations was further screened. The resistance of the preparation to high temperature, low temperature and centrifugation was mainly investigated.

[0054] experiment method

[0055] Heat resistance test: Put the prepared cream samples into test tubes with plugs and place them at a constant temperature of 60°C for 24 hours to observe whether there is liquefaction, stratification and discoloration.

[0056] Cold resistance test: Put each cream sample into a test tube with a stopper and place it at a constant temperature of -15°C for 24 hours to observe whether there is liquefaction, stratification and discoloration.

[0057] Centrifugation test: put each cream sample into a 10cm centrifuge tube, centrifuge for 5h, and observe whether there is any separation phenomenon.

[0058] test results See Table 3

[0059] Table 3 Heat resistance, cold resistance, centrifugal test results

[0060] ...

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Abstract

The invention discloses a preparation method of low-viscosity sertaconazole nitrate cream. Alcohol and ethyl hydroxybenzoate are mixed and heated, and heat preservation is for subsequent use; (2) water phase is prepared: the polysorbate 80 of recipe quantity, purified water and the propylene glycol of part of recipe quantity are mixed and heated, and heat preservation is for standby use; (3) main drug is prepared Dispersion: dispersing and grinding sertaconazole nitrate with the remaining propylene glycol to obtain the main drug dispersion; (4) emulsification: the oil phase prepared in step (1), the water phase prepared in step (2) and the water phase prepared in step (3) ) The prepared main drug dispersion liquid is mixed and stirred to emulsify to obtain a low-viscosity sertaconazole nitrate cream. Through testing, the viscosity of the sertaconazole nitrate cream provided by the present invention is less than 20,000 mPa·s, and compared with the known formulation, the viscosity is significantly reduced.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation method of a low-viscosity sertaconazole nitrate cream and a prepared product thereof. Background technique [0002] Sertaconazole nitrate is a novel, broad-spectrum, and highly effective topical antifungal agent, developed by Spain's Ferrer Company. It has broad antibacterial activity against pathogens causing skin and mucous membrane infections, pathogenic yeasts, dermatophytes, opportunistic pathogens, filamentous fungi, Gram-positive bacteria and Trichomonas spp. Mycosis, Candida, and Pityriasis versicolor are treated quickly and efficiently, and include fungi resistant to other therapeutic antifungals, such as rubrum, Microsporum canis, Epidermophyton floccosum, sores beard, tinea versicolor Compared with other clinical imidazole antibacterial agents, it has a wider and complete range. [0003] The company developed a kind of sertaconazole nitrate cr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/06A61K31/4178A61K47/06A61K47/10A61K47/14A61K47/26A61P31/10A61P31/02
CPCA61K31/4178A61K9/06A61K47/14A61K47/06A61K47/10A61K47/26A61K9/0014A61P31/10A61P31/02
Inventor 戴金林王汕桃
Owner HAINAN HAISHEN TONGZHOU PHARM CO LTD
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