Amphotericin B cream and preparation method thereof

A technology for amphotericin and cream, which is applied in the field of amphotericin B cream and its preparation, can solve problems such as unstable quality, limited popularization and application, and increased cost, and achieve reduction of toxic and side effects, simple preparation process, and compliance Good results

Inactive Publication Date: 2011-10-12
上海医药科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, amphotericin B for injection has obvious nephrotoxicity, hepatotoxicity and infusion-related toxicity (such as fever, chills, nausea, etc.), which limits its popularization and application.
After amphotericin B is made into liposome preparations, its toxic and side effects are significantly reduced, but the cost increases and the quality is unstable
Amphotericin B vaginal effervescent tablets are used to treat infections caused by sensitive fungi such as Cryptococcus neoformans, Blastomyces dermatitidis, Histoplasma, Coccidioides, Candida, etc. vaginal fungal infection

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] formula:

[0034] Amphotericin B 30g, glyceryl monostearate 35g, stearic acid 50g, cetostearyl alcohol 40g, sodium lauryl sulfate 8g, ethylparaben 1g, propylene glycol 100g, azone 10g, 25g of methyl silicone oil, an appropriate amount of purified water to a total weight of 1000g.

[0035] Preparation:

[0036] ①Take the prescribed amount of glyceryl monostearate, stearic acid, and cetostearyl alcohol, heat and melt in a water bath, the temperature of the water bath is 80°C, add simethicone and azone after melting, stir well, and make oil phase;

[0037] ② Take sodium lauryl sulfate, ethylparaben, and propylene glycol, add appropriate amount of purified water, place in 80°C water bath, stir to fully dissolve, then add amphotericin B raw material, stir to make it fully dispersed in the water phase middle;

[0038] ③Under stirring, mix the water phase and the oil phase, add purified water to the full amount, stir and emulsify, leave it at room temperature, detect the c...

Embodiment 2

[0040] prescription:

[0041] Amphotericin B 30g, Glyceryl Monostearate 30g, Stearic Acid 30g, Cetearyl Alcohol 45g, Sodium Lauryl Sulfate 8g, Propylparaben 2g, Glycerol 100g, Azone 10g , 400ml of 0.16% sodium hydroxide solution, and an appropriate amount of purified water to a total weight of 1000g.

[0042] Preparation:

[0043] ①Take the prescribed amount of glyceryl monostearate, stearic acid, and cetostearyl alcohol, heat and melt in a water bath, the temperature of the water bath is 70°C, add azone after melting, stir evenly, and make an oil phase;

[0044] ②Add sodium lauryl sulfate, propylparaben, and glycerin to an appropriate amount of purified water, place in a water bath at 70°C, stir to fully dissolve, and obtain an aqueous phase;

[0045] ③Take the amphotericin B bulk drug, add 400ml of 0.16% sodium hydroxide solution, place it in a 40°C water bath and stir to dissolve it;

[0046] ④In the state of stirring, add the water phase to the oil phase, stir and mix, ...

Embodiment 3

[0048] prescription:

[0049] Amphotericin B 30g, Glyceryl Monostearate 50g, Cetostearyl Alcohol 70g, Sodium Lauryl Sulfate 10g, Benzyl Alcohol 2g, Propylene Glycol 100g, Azone 10g, Dimethyl Sulfoxide 100g, 0.16% 300ml of sodium hydroxide solution, and an appropriate amount of purified water until the total weight is 1000g.

[0050] Preparation:

[0051] ① Take the prescribed amount of glyceryl monostearate and cetostearyl alcohol, heat and melt in a water bath, the temperature of the water bath is 80°C, add azone after melting, stir evenly, and make an oil phase;

[0052] ② Add sodium lauryl sulfate, benzyl alcohol, and propylene glycol to an appropriate amount of purified water, place in a water bath at 70°C, stir to fully dissolve, and obtain an aqueous phase;

[0053] ③Take the amphotericin B bulk drug, add dimethyl sulfoxide and 0.16% sodium hydroxide solution, place it in a 45°C water bath and stir to dissolve it;

[0054] ④In the state of stirring, add the water phas...

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PUM

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Abstract

The invention discloses an amphotericin B cream and a preparation method thereof; the technical scheme is as follows: the cream is composed of an amphotericin B, a solvent or cosolvent, an oil phase matrix, a transdermal enhancer, an emulsifier, a preservative, a humectant, a defoamer and the like. The preparation process comprises the following steps: 1, mixing the oil phase matrix, an oil-soluble emulsifier and the defoamer, heating and melting in water bath to prepare an oil phase; 2, putting a water-soluble emulsifier, the preservative and the humectant into a proper amount of purified water, putting into the water bath, stirring to uniformly dissolve the water-soluble emulsifier, the preservative and the humectant to prepare a water phase; 3, taking the solvent or the cosolvent, adding the amphotericin B bulk drug, stirring to uniformly dissolve the amphotericin B bulk drug; 4, mixing the water phase with the oil phase while stirring, adding an amphotericin B liquid, supplementing the purified water to the total; stirring for emulsifying, standing at room temperature, detecting the content of the amphotericin B, computing, filling, and packaging to obtain the finished product. The bad water-solubility of the amphotericin B is overcome by using the preparation method which is simple in process and good in compliance. The serious toxic side effect in injection of the amphotericin B is overcome by the externally applying the amphotericin B cream; a safe, effective and stable preparation is provided for a patient.

Description

technical field [0001] The invention relates to pharmaceutical preparations, in particular to an amphotericin B cream and a preparation method thereof. Background technique [0002] Fungal skin diseases are caused by pathogenic fungal infections, which can be divided into two categories: superficial fungi and deep fungi. More than 90% of fungal diseases in China belong to superficial mycoses, and fungi only invade the surface, cuticle, hair and deck. Violations of subcutaneous tissue and internal organs are called deep mycoses. Fungal dermatosis is a common and frequently-occurring disease in dermatology. There are many kinds of fungi and they are widely distributed, but only a small number of fungi are pathogenic to humans. In recent years, due to the widespread use of antibiotics, glucocorticoids, immunosuppressants, organ transplantation, radiotherapy, chemotherapy and other reasons, the incidence of fungal skin diseases has also been on the rise; on the other hand, du...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/7048A61P17/00A61P31/10
Inventor 黄君勤袁晖张晓航商鼎
Owner 上海医药科技发展有限公司
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