CN113520993B - Preparation method of low-viscosity sertaconazole nitrate cream and product prepared by same - Google Patents
Preparation method of low-viscosity sertaconazole nitrate cream and product prepared by same Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4178—1,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/02—Local antiseptics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/10—Antimycotics
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Abstract
The invention discloses a preparation method of low-viscosity sertaconazole nitrate cream, which comprises the following steps: (1) preparing an oil phase: mixing light liquid paraffin, glyceryl monostearate, glyceryl distearate, stearyl alcohol and ethylparaben according to the prescription amount, heating, and keeping the temperature for later use; (2) preparing an aqueous phase: mixing and heating polysorbate 80, purified water and a part of propylene glycol according to the prescription amount, and keeping the temperature for later use; (3) preparing a main drug dispersion liquid: dispersing and grinding sertaconazole nitrate with the rest propylene glycol to obtain a main drug dispersion liquid; (4) emulsification: and (3) mixing the oil phase prepared in the step (1), the water phase prepared in the step (2) and the main drug dispersion liquid prepared in the step (3), and stirring and emulsifying to obtain the sertaconazole nitrate cream with low viscosity. Through tests, the viscosity of the sertaconazole nitrate cream provided by the invention is less than 20000mPa s, and the viscosity is obviously reduced compared with the known prescription.
Description
Technical Field
The invention relates to the field of pharmaceutical preparations, in particular to a preparation method of low-viscosity sertaconazole nitrate cream and a product prepared by the same.
Background
Sertaconazole nitrate is a novel, broad-spectrum and efficient local antifungal agent, is developed and developed by Ferrer Spanish company, is firstly marketed in Spain in 1992, and is annotated in China in 2003 to be marketed as an ointment preparation. The antifungal composition has wide antibacterial activity on pathogenic bacteria, pathogenic yeasts, dermatophytes, opportunistic pathogens, filamentous fungi, gram-positive bacteria and trichomonas causing skin and mucosa infection, can quickly and efficiently treat the dermatophytosis, candida and pityriasis versicolor, and has wider complete range compared with other clinical imidazole antibacterial agents for treating other fungi with antifungal drug resistance, such as red ringworm, dog microsporum, floccosum epidermophyton, sycosis, trichophyton and the like.
The company develops sertaconazole nitrate cream in the early stage, and the formula of the sertaconazole nitrate cream comprises: 2% sertaconazole nitrate, 12% mono-and diglycerides, 5% octadecanol, 5% light paraffin wax, 15% propylene glycol, 3% polysorbate 80, 0.1% ethylparaben, and the balance water.
In the actual production process, the sertaconazole nitrate cream of the formula is found to be excessively viscous, and the viscosity is more than 20000 mPa-s. Is not easy to fill. This seriously affects the production efficiency. In view of the above, it is an urgent technical problem to be solved to develop a low-viscosity sertaconazole nitrate cream by adjusting the preparation process of the sertaconazole nitrate cream.
Disclosure of Invention
In order to solve the technical problems, the invention provides a preparation method of a low-viscosity sertaconazole nitrate cream and a product prepared by the same. The specific technical scheme is as follows:
the invention firstly provides a preparation method of low-viscosity sertaconazole nitrate cream, which comprises the following steps:
(1) preparing an oil phase: mixing light liquid paraffin, glyceryl monostearate, glyceryl distearate, stearyl alcohol and ethylparaben according to the prescription amount, heating, and keeping the temperature for later use;
(2) preparing an aqueous phase: mixing and heating polysorbate 80, purified water and a part of propylene glycol according to the prescription amount, and keeping the temperature for later use;
(3) preparing a main drug dispersion liquid: dispersing and grinding sertaconazole nitrate with the rest propylene glycol to obtain a main drug dispersion liquid;
(4) emulsification: mixing the oil phase prepared in the step (1), the water phase prepared in the step (2) and the main drug dispersion liquid prepared in the step (3), and stirring and emulsifying to obtain the low-viscosity sertaconazole nitrate cream;
the prescription of the low-viscosity sertaconazole nitrate cream comprises, by mass, 2% of sertaconazole nitrate, 10% of glyceryl monostearate, 5% of octadecanol, 3% of light liquid paraffin, 15% of propylene glycol, 7% of polysorbate 80, 0.1% of ethylparaben and the balance of water.
In some embodiments of the invention, the materials are mixed and heated to 80-85 ℃ in step (1).
In some embodiments of the invention, the amount of propylene glycol used in step (2) is 80% of the prescribed amount.
In some embodiments of the invention, the materials are mixed and heated to 80-85 ℃ in step (2).
In some embodiments of the invention, step (4) specifically comprises:
mixing part of the water phase with the main drug dispersion liquid to obtain a first water phase;
mixing the oil phase and the first water phase under stirring and emulsifying to obtain a first mixed phase;
mixing and emulsifying the first mixed phase with the remaining aqueous phase under stirring to obtain the low viscosity sertaconazole nitrate cream.
The invention also provides a product prepared by the preparation method.
In some embodiments of the invention, the viscosity of the prepared product is less than 20000 mPa-s.
In some embodiments of the invention, the viscosity of the prepared product is less than 14000-16000 mPas.
Advantageous effects
The invention prepares the low-viscosity sertaconazole nitrate cream by optimizing and adjusting the dosage of auxiliary materials on the basis of the existing prescription of the sertaconazole nitrate cream, and tests show that the viscosity of the sertaconazole nitrate cream is less than 20000mPa & s, and compared with the known prescription, the viscosity is reduced by 40%.
Detailed Description
The following description of the embodiments of the present invention is provided for the purpose of making the objects, technical solutions and advantages of the present invention more apparent, and the technical solutions of the present invention will be described in detail and fully with reference to the following embodiments.
In the following examples, those not indicated with specific conditions were performed according to conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available commercially.
EXAMPLE 1 optimization of the recipe
In order to improve the viscosity of the sertaconazole nitrate cream and facilitate filling in a workshop, the proportion of the matrix is further screened by referring to the prescription before change. 5 prescriptions were designed. See table 1 for prescription.
The sertaconazole nitrate cream was prepared as follows, using the formulations in table 1, respectively:
(1) preparing an oil phase: mixing the light liquid paraffin, the glyceryl monostearate, the glyceryl distearate, the octadecanol and the ethylparaben according to the prescription amount, heating to about 80 ℃, and preserving heat for later use;
(2) preparing an aqueous phase: mixing polysorbate 80, purified water and 80% of propylene glycol according to the prescription amount, heating to about 85 ℃, and keeping the temperature for later use;
(3) preparing a main drug dispersion liquid: dispersing and grinding sertaconazole nitrate with the rest propylene glycol to obtain a main drug dispersion liquid;
(4) a, emulsification: mixing half of the water phase with the main drug dispersion liquid to obtain a first water phase;
b. mixing the oil phase and the first water phase under stirring and emulsifying to obtain a first mixed phase;
c. the first mixed phase was mixed with the remaining aqueous phase and emulsified for 30 minutes under stirring to give a low viscosity sertaconazole nitrate cream.
Table 1 prescription table
Note: the units in table 1 are parts by weight.
Example 2 Performance examination of Sertaconazole nitrate cream formulations
The appearance and the viscosity of the sertaconazole nitrate cream prepared according to the above formula are examined.
Examination method
And (3) appearance detection: observation by human eye
And (3) viscosity detection: according to a third method of viscosity measurement in Chinese pharmacopoeia of 2015 edition, a proper amount of samples are taken, air in a 250ml beaker is exhausted, and the ointment is balanced in a water bath at 25 ℃ for 1-2 h and then measured.
Examination resultsSee table 2 below.
Table 2 prescription Performance test results
From the above table, it can be seen that: the appearance properties of the prescriptions 1-6 are fine and soft, and the viscosity value of the prescription 5 is the minimum. Prescription 6 is the prescription before the change. Compared with the prescription 6 before changing, the prescription 5 only reduces the amount of monoglyceride and diglyceride by 2 percent, reduces the amount of light liquid paraffin by 2 percent and increases polysorbate 80 by 4 percent, so that the viscosity value is obviously reduced, and the reduction range is close to 40 percent.
Prescription 4 differs from prescription 5 only in that prescription 4 has a 9% polysorbate 80 content, while prescription 5 has a 7% content, and prescription 4 has a significantly higher viscosity than prescription 5.
However, prescription 3 differs from prescription 2 only in that prescription 3 has a polysorbate 80 content of 9%, whereas prescription 2 has a polysorbate 80 content of 7%, and prescription 2 has a significantly higher viscosity than prescription 3.
Formula 2 differs from formula 5 only in that formula 2 has a smaller amount of mono-and diglycerides, but formula 2 has a greater viscosity.
Thus, from the analyses of tables 1 and 2, it was concluded that optimization of the entire recipe, rather than changes in the amount of individual excipients, resulted in such a large reduction in the viscosity value of recipe 5.
Example 3 stability study
The 6 prescriptions were further screened for stability. The tolerance of the preparation to high temperature, low temperature and centrifugation is mainly considered.
Test method
Heat resistance test: the prepared cream samples are respectively put into test tubes with plugs and placed for 24 hours at the constant temperature of 60 ℃, and whether liquefaction, delamination and discoloration phenomena exist or not is observed.
Cold resistance test: placing each cream sample into a test tube with a plug respectively, standing at-15 deg.C for 24 hr, and observing whether liquefaction, delamination and discoloration occur.
And (3) centrifugal test: and (3) respectively putting each cream sample into a 10cm centrifuge tube, centrifuging for 5h at the rotating speed of 3750 rpm, and observing whether the separation phenomenon exists or not.
Test resultsSee Table 3
TABLE 3 Heat, Cold, centrifuge test results
As can be seen from Table 3 above, formula 5 is more stable.
And (4) conclusion:
through the appearance observation of samples prepared by each formula and the tests, in the cream formulas 1 to 6, the formula 5 has uniform and consistent appearance and luster, fineness, no coarse feeling, no layering phenomenon and relatively low viscosity. Therefore, the invention takes the prescription 5 as a final prescription to prepare the low-viscosity sertaconazole nitrate cream.
Example 4 influencing factor test
According to the preparation method of example 1 and the formula 5, a batch of cream (batch number: 0801) samples were prepared and placed under the conditions of strong light (4500 +/-500 lx), high temperature 40 ℃ and high humidity 75% for 10 days, samples were taken for 5 days and 10 days respectively, and the appearance, particle size, uniformity, related substances, delamination phenomenon and content change conditions of the cream were examined, and the examination results are shown in the following table 4.
TABLE 4 influence factor test results
The influence factor test can obtain that: the sample is placed for 10 days under the conditions of high temperature of 40 ℃, high humidity of 75 percent and strong light (the illumination intensity is 4500 +/-500 lx), the preparation properties are not obviously changed, and the uniformity, the granularity, the layering phenomenon and related substances all accord with the regulations. Under the high temperature and high humidity condition, the content is not changed greatly, but under the high light condition, the content is reduced. Reference (the second appendix I F of the 2010 version of the chinese pharmacopoeia) to the sixth term: the cream should be sealed in shade, and should be stored at below 25 deg.C without freezing. Therefore, it should be stored under sealed condition in cool and dark place (not higher than 20 ℃ in dark place).
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is specific and detailed, but not to be understood as limiting the scope of the present invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention.
Claims (8)
1. A preparation method of low-viscosity sertaconazole nitrate cream is characterized by comprising the following steps:
(1) preparing an oil phase: mixing light liquid paraffin, glyceryl monostearate, glyceryl distearate, stearyl alcohol and ethylparaben according to the prescription amount, heating, and keeping the temperature for later use;
(2) preparing an aqueous phase: mixing and heating polysorbate 80, purified water and part of propylene glycol according to the prescription amount, and keeping the temperature for later use;
(3) preparing a main drug dispersion liquid: dispersing and grinding sertaconazole nitrate with the rest propylene glycol to obtain a main drug dispersion liquid;
(4) emulsification: mixing the oil phase prepared in the step (1), the water phase prepared in the step (2) and the main drug dispersion liquid prepared in the step (3), and stirring and emulsifying to obtain the low-viscosity sertaconazole nitrate cream;
the prescription of the low-viscosity sertaconazole nitrate cream comprises, by mass, 2% of sertaconazole nitrate, 10% of glycerol mono-stearate, 5% of octadecanol, 3% of light liquid paraffin, 15% of propylene glycol, 7% of polysorbate 80, 0.1% of ethylparaben and the balance of water.
2. The method according to claim 1, wherein in the step (1), the materials are mixed and heated to 80 to 85 ℃.
3. The method according to claim 1, wherein the amount of propylene glycol used in step (2) is 80% of the prescribed amount.
4. The method according to claim 1, wherein in the step (2), the materials are mixed and heated to 80 to 85 ℃.
5. The method according to any one of claims 1 to 4, wherein step (4) specifically comprises:
mixing part of the water phase with the main drug dispersion liquid to obtain a first water phase;
mixing the oil phase and the first water phase under stirring and emulsifying to obtain a first mixed phase;
mixing and emulsifying the first mixed phase with the remaining aqueous phase under stirring to obtain the low viscosity sertaconazole nitrate cream.
6. A product produced by the production method according to any one of claims 1 to 5.
7. The product according to claim 6, characterized in that the viscosity is less than 20000 mPa-s.
8. The product of claim 7, characterized by a viscosity of 14000-.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110875049.1A CN113520993B (en) | 2021-07-30 | 2021-07-30 | Preparation method of low-viscosity sertaconazole nitrate cream and product prepared by same |
| PCT/CN2021/119263 WO2023004963A1 (en) | 2021-07-30 | 2021-09-18 | Preparation method for low-viscosity sertaconazole nitrate cream and product prepared thereby |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110875049.1A CN113520993B (en) | 2021-07-30 | 2021-07-30 | Preparation method of low-viscosity sertaconazole nitrate cream and product prepared by same |
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| Publication Number | Publication Date |
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| CN113520993A CN113520993A (en) | 2021-10-22 |
| CN113520993B true CN113520993B (en) | 2022-07-29 |
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| CN202110875049.1A Active CN113520993B (en) | 2021-07-30 | 2021-07-30 | Preparation method of low-viscosity sertaconazole nitrate cream and product prepared by same |
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| WO (1) | WO2023004963A1 (en) |
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| TR201512960A1 (en) * | 2015-10-19 | 2017-05-22 | Karaağaç Bülent | TOPICAL FORMULATIONS |
| US20170290810A1 (en) * | 2016-04-08 | 2017-10-12 | Imprimis Pharmaceuticals, Inc. | Anti-fungal compositions for treating nails and methods for fabricating and using thereof |
| EP3709969B1 (en) * | 2017-11-14 | 2023-08-23 | ProFem GmbH | Emulsions for the topical treatment of dermal and mucosal infections |
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2021
- 2021-07-30 CN CN202110875049.1A patent/CN113520993B/en active Active
- 2021-09-18 WO PCT/CN2021/119263 patent/WO2023004963A1/en unknown
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| CN113520993A (en) | 2021-10-22 |
| WO2023004963A1 (en) | 2023-02-02 |
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