CN109985063B - Efficient antibacterial pharmaceutical composition and preparation method and application thereof - Google Patents

Efficient antibacterial pharmaceutical composition and preparation method and application thereof Download PDF

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CN109985063B
CN109985063B CN201910386463.9A CN201910386463A CN109985063B CN 109985063 B CN109985063 B CN 109985063B CN 201910386463 A CN201910386463 A CN 201910386463A CN 109985063 B CN109985063 B CN 109985063B
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mixing
emulsifier
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CN109985063A (en
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王若研
田德海
张军
史跃满
黄炎
冯雪
陈晓彤
李建
石佳
袁一鸣
何爱琳
王翼超
刘爽
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Cspc Yuanda Dalian Pharmaceutical Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/155Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic 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
    • A61K31/41641,3-Diazoles
    • A61K31/41661,3-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. phenytoin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/04Sulfur, selenium or tellurium; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/10Anti-acne agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10Antimycotics
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The invention provides a high-efficiency bacteriostatic medicinal composition, wherein 3 components of chlorhexidine acetate, sulfur and allantoin are selected as active ingredients of the composition, and the composition can effectively inhibit pathogenic bacteria parasitized on the surface of skin through mutual synergistic action, particularly has obvious inhibition effect on staphylococcus aureus, escherichia coli and candida albicans, and meanwhile, the composition effectively ensures the activity of the medicament by strictly controlling the process temperature in the preparation process, plays the synergistic action among the components and enhances the bacteriostatic effect.

Description

Efficient antibacterial pharmaceutical composition and preparation method and application thereof
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a high-efficiency antibacterial composition, and a preparation method and application thereof.
Background
The skin, as the largest organ of the human body, plays an important role in the processes of sensing external stimulation, regulating the body temperature, regulating and controlling the water evaporation loss, protecting various tissues and organs in the body from physical and chemical damages, resisting the invasion of pathogenic microorganisms and the like. The skin participates in the metabolism process of the human body, and has important significance for keeping the stability of the internal environment of the human body and maintaining the normal physiological function of the organism. An adult skin area of about 1.8m2A large number of microorganisms, up to 10, live on the skin7Per cm-2. These microbial flora are closely related to human skin and human health. However, in recent years, with the increasing environmental pollution and the increasing severe weather such as haze, high-concentration fine particulate matters and chemical pollutants in the air can destroy the microecological balance of the skin, resulting in skin disease bacteria including staphylococcus epidermidis, candida albicans, escherichia coli and the like; the bacteria and the skin diseases are closely related, the bacteria and the toxins thereof can respectively cause infectious diseases (such as furuncle), toxic diseases (such as staphylococcus scald-like skin syndrome), immune-mediated diseases (such as superantigen induction or aggravation of atopic dermatitis and psoriasis) and the like, the health of people is seriously affected, and even certain social panic can be caused by the infectious skin diseases.
Currently, the treatment for various skin diseases is mainly an external medicine, but if the external medicine is selected improperly or used improperly, the external medicine is often ineffective, and even the disease condition is aggravated. Common external skin preparations comprise dermatan, the main components of which are dexamethasone acetate, menthol, camphor and the like, and are used for localized pruritus, neurodermatitis, contact dermatitis, seborrheic dermatitis and chronic eczema; a yellow skin Chinese medicinal cream comprises cortex pseudolaricis, radix Sophorae Flavescentis, fructus Cnidii, Kochiae fructus, etc., has strong inhibiting and killing effects on Staphylococcus, Candida, Escherichia coli, etc., which cause dermatitis, eczema, tinea manus and pedis, tinea cruris, tinea versicolor, psoriasis, balanitis, pudendum itch, hemorrhoid, scabies, mosquito bite, acne, blister, pityriasis alba, urticaria, etc., and can prevent skin infection. However, the conventional skin bacteriostatic cream has relatively complicated components and relatively limited inhibitory effect on bacteria causing skin disorders.
Chlorhexidine is a broad-spectrum bactericide, has antibacterial effect on gram-positive and gram-negative bacteria, and can be combined with salivary glycoprotein to reduce adsorption of protein on tooth surface and interfere formation of bacterial plaque. In addition, chlorhexidine can be combined with bacterial extracellular polysaccharide to prevent bacteria from being adsorbed on the obtained membrane, thereby preventing and reducing periodontal diseases and dental caries. As can be seen, chlorhexidine is commonly used for the treatment of oral diseases, and currently, chlorhexidine is used in combination with other components to form a bactericide on the skin surface, for example, patent application CN106336973A discloses a bactericidal soap, which is made of the following raw materials in parts by weight: 50-100 parts of soap base, 5-8 parts of turpentine, 4-5 parts of aloe, 8-15 parts of chlorhexidine hydrochloride, 1-3 parts of alkyl polyglycoside, 1-3 parts of alcohol, 3-5 parts of glycerol, 2-5 parts of sulfur and 2-3 parts of lactein; CN105419998A also discloses a mite-killing toilet soap which comprises the following raw materials: 9-14 parts of sodium cocoate, 7-11 parts of sodium palmitate, 6-8 parts of alkyl polyglycoside, 7-10 parts of sodium lauroyl glutamate, 4-7 parts of safflower, 6-9 parts of gardenia, 7-8 parts of sulfur, 9-12 parts of natural oil, 11-14 parts of chlorhexidine hydrochloride and 6-10 parts of aloe powder. However, in the above patents, chlorhexidine is used in the preparation of toilet soap for preventing bacterial infection, and the use of chlorhexidine in medicine for preparing a medicine capable of treating skin diseases caused by bacterial infection has not been found yet.
Disclosure of Invention
Based on the defects of the prior art, the invention provides the efficient antibacterial pharmaceutical composition, which adopts chlorhexidine, sulfur and allantoin as active ingredients of the composition, can effectively inhibit pathogenic bacteria parasitized on the surface of skin, has an inhibiting effect on staphylococcus aureus, escherichia coli and candida albicans, and is used for treating whelk and the like.
The invention provides a high-efficiency antibacterial pharmaceutical composition, which comprises the active ingredients of chlorhexidine acetate (namely chlorhexidine acetate), sulfur and allantoin.
Furthermore, the antibacterial pharmaceutical composition comprises, by weight, 4-8 parts of chlorhexidine acetate, 70-100 parts of sulfur and 4-8 parts of allantoin as active ingredients.
Further, the antibacterial pharmaceutical composition also comprises pharmaceutically acceptable auxiliary materials, and the antibacterial pharmaceutical composition comprises the following auxiliary materials in parts by weight: 150-180 parts of 15# white oil, 50-70 parts of 340B-emulsifier, 50-70 parts of A165 emulsifier, 50-70 parts of 16-18 alcohol, 80-120 parts of glycerol, 190-220 parts of propylene glycol, 1-3 parts of methyl paraben, 0.5-2 parts of propyl paraben, 70-100 parts of isopropyl myristate, 30-50 parts of stearic acid, 10-30 parts of silicone oil, 10-30 parts of azone and 1000-1500 parts of purified water.
Furthermore, the antibacterial pharmaceutical composition comprises the following components in parts by weight: 6 parts of chlorhexidine acetate, 80 parts of sulfur, 6 parts of allantoin, 160 parts of No. 15 white oil, 60 parts of 340B-emulsifier, 60 parts of A165 emulsifier, 60 parts of 16-18 alcohol, 100 parts of glycerol, 200 parts of propylene glycol, 2 parts of methyl paraben, 1 part of propyl paraben, 80 parts of isopropyl myristate, 40 parts of stearic acid, 20 parts of silicone oil, 20 parts of azone and 1200 parts of purified water.
The invention also provides a preparation method of the antibacterial pharmaceutical composition, which comprises the following steps:
(1) preparing an aqueous phase: mixing glycerol, allantoin and purified water, and stirring to obtain water phase;
(2) preparing an oil phase: mixing 340B-emulsifier, 16-18 alcohol, methyl paraben, propyl paraben, A165 emulsifier, stearic acid, 15# white oil, azone, silicone oil and isopropyl myristate, and stirring to obtain oil phase;
(3) mixing the water phase and the oil phase, and homogenizing to obtain a mixture 1;
(4) dissolving chlorhexidine acetate in water, mixing with the mixture 1, homogenizing, adding sulfur, and grinding.
Further, the temperature is increased to 60-80 ℃ in the step (1) and the step (2) during mixing and stirring.
Further, in the step (3), the water phase and the oil phase are mixed in a vacuum material sucking and mixing mode, homogenization is carried out for 1-3min at the speed of 20-30r/min, and then the temperature is reduced to 50-70 ℃.
Further, in the step (4), the chlorhexidine acetate and the propylene glycol are heated in water bath to 50-70 ℃ to be dissolved, then mixed with the mixture 1, homogenized for 1-3min at 20-30r/min, then cooled to 30-50 ℃, and sulfur is added.
Further, the grinding mode in the step (4) is colloid mill grinding.
The invention further provides application of the antibacterial pharmaceutical composition in preparation of a medicine for treating skin inflammation.
The invention has the beneficial effects that:
(1) the invention adopts the combined application of the chlorhexidine acetate, sulfur and 3 active components of allantoin, wherein the chlorhexidine acetate is a broad-spectrum antibacterial agent, the sulfur has the functions of sterilization and skin softening, the allantoin has the functions of moisturizing, softening keratin and making the skin glossy and soft, and the 3 components cooperate with each other to inhibit bacteria, thereby effectively inhibiting pathogenic bacteria parasitized on the surface of the skin.
(2) The preparation method of the antibacterial pharmaceutical composition is optimized, the temperature change in the technological process is strictly controlled, the activity of the effective components is ensured, the curative effect of the medicine is improved, the antibacterial pharmaceutical composition has a remarkable inhibiting effect on staphylococcus aureus, escherichia coli and candida albicans, and can be used for treating whelk.
Drawings
FIG. 1 is a flow chart of the preparation of the pharmaceutical composition of the present invention
Detailed Description
EXAMPLE 1 bacteriostatic pharmaceutical compositions and preparation thereof
The composition comprises the following components: 6 parts of chlorhexidine acetate, 80 parts of sulfur, 6 parts of allantoin, 160 parts of No. 15 white oil, 60 parts of 340B-emulsifier, 60 parts of A165 emulsifier, 60 parts of 16-18 alcohol, 100 glycerol, 200 parts of propylene glycol, 2 parts of methyl paraben, 1 part of propyl paraben, 80 parts of isopropyl myristate, 40 parts of stearic acid, 20 parts of silicone oil, 20 parts of azone and 1200 parts of purified water.
The preparation method comprises the following steps:
(1) preparing an aqueous phase: mixing glycerol, allantoin and purified water, stirring, and heating to 70 deg.C to obtain water phase;
(2) preparing an oil phase: mixing 340B-emulsifier, 16-18 alcohol, methyl paraben, propyl paraben, A165 emulsifier, stearic acid, 15# white oil, azone, silicone oil and isopropyl myristate, stirring, and heating to 70 deg.C to obtain oil phase;
(3) mixing the water phase and the oil phase by vacuum suction, homogenizing for 2min at 25r/min, and cooling to 60 ℃ to obtain a mixture 1;
(4) heating chlorhexidine acetate and propylene glycol in water bath to 60 deg.C for dissolving, mixing with mixture 1, homogenizing at 25r/min for 2min, cooling to 40 deg.C, adding sulfur, grinding with colloid mill, bottling, and packaging to obtain the final product.
EXAMPLE 2 bacteriostatic pharmaceutical compositions and their preparation
The composition comprises the following components: 4 parts of chlorhexidine acetate, 70 parts of sulfur, 4 parts of allantoin, 150 parts of No. 15 white oil, 50 parts of 340B-emulsifier, 50 parts of A165 emulsifier, 50 parts of 16-18 alcohol, 80 glycerol, 190 parts of propylene glycol, 1 part of methyl paraben, 0.5 part of propyl paraben, 70 parts of isopropyl myristate, 30 parts of stearic acid, 10 parts of silicone oil, 10 parts of azone and 1000 parts of purified water.
The preparation method comprises the following steps:
(1) preparing an aqueous phase: mixing glycerol, allantoin and purified water, stirring, and heating to 60 deg.C to obtain water phase;
(2) preparing an oil phase: mixing 340B-emulsifier, 16-18 alcohol, methyl paraben, propyl paraben, A165 emulsifier, stearic acid, 15# white oil, azone, silicone oil and isopropyl myristate, stirring, and heating to 60 deg.C to obtain oil phase;
(3) mixing the water phase and the oil phase by vacuum suction, homogenizing for 3min at 20r/min, and cooling to 50 ℃ to obtain a mixture 1;
(4) heating chlorhexidine acetate and propylene glycol in water bath to 50 deg.C for dissolving, mixing with mixture 1, homogenizing at 20r/min for 3min, cooling to 30 deg.C, adding sulfur, grinding with colloid mill, bottling, and packaging to obtain the final product.
EXAMPLE 3 bacteriostatic pharmaceutical compositions and preparation thereof
The composition comprises the following components: 8 parts of chlorhexidine acetate, 100 parts of sulfur, 8 parts of allantoin, 180 parts of No. 15 white oil, 70 parts of 340B-emulsifier, 70 parts of A165 emulsifier, 70 parts of 16-18 alcohol, 120 glycerol, 220 parts of propylene glycol, 3 parts of methyl paraben, 3 parts of propyl paraben, 100 parts of isopropyl myristate, 50 parts of stearic acid, 30 parts of silicone oil, 30 parts of azone and 1500 parts of purified water.
The preparation method comprises the following steps:
(1) preparing an aqueous phase: mixing glycerol, allantoin and purified water, stirring, and heating to 80 deg.C to obtain water phase;
(2) preparing an oil phase: mixing 340B-emulsifier, 16-18 alcohol, methyl paraben, propyl paraben, A165 emulsifier, stearic acid, 15# white oil, azone, silicone oil and isopropyl myristate, stirring, and heating to 80 deg.C to obtain oil phase;
(3) mixing the water phase and the oil phase by vacuum suction, homogenizing for 1min at 30r/min, and cooling to 70 ℃ to obtain a mixture 1;
(4) heating chlorhexidine acetate and propylene glycol in water bath to 70 deg.C for dissolving, mixing with mixture 1, homogenizing at 30r/min for 1min, cooling to 50 deg.C, adding sulfur, grinding with colloid mill, bottling, and packaging to obtain the final product.
Comparative example 1 antibacterial pharmaceutical composition prepared by substituting chlorhexidine acetate with triclosan and preparation thereof
Example 1 was followed except that triclosan was used in place of chlorhexidine acetate.
Comparative example 2 antibacterial pharmaceutical composition prepared from povidone iodine sulfur and preparation thereof
The procedure of example 1 was followed except that povidone-iodine was used instead of sulfur.
Comparative example 3 preparation Process temperature not controlled
The composition was the same as in example 1.
The preparation method comprises the following steps:
(1) preparing an aqueous phase: mixing glycerol, allantoin and purified water, stirring, and heating to 70 deg.C to obtain water phase;
(2) preparing an oil phase: mixing 340B-emulsifier, 16-18 alcohol, methyl paraben, propyl paraben, A165 emulsifier, stearic acid, 15# white oil, azone, silicone oil and isopropyl myristate, stirring, and heating to 70 deg.C to obtain oil phase;
(3) mixing the water phase and the oil phase by vacuum suction, homogenizing for 2min at 25r/min, and cooling to 60 ℃ to obtain a mixture 1;
(4) heating chlorhexidine acetate and propylene glycol to 100 deg.C for dissolving, mixing with the mixture 1, homogenizing at 25r/min for 2min, adding sulfur, grinding with colloid mill, bottling, and packaging to obtain the final product.
Experimental examples each bacteriostatic composition bacteriostatic test research
1. Equipment
Test strains: escherichia coli (ATCC 25922), Staphylococcus aureus (ATCC 6538), Candida albicans (ATCC 10231), the generation numbers of which are 3-5, and a bacterial suspension containing 0.03mol/L PBS was prepared.
Test samples: examples 1-3, comparative examples 1-3
2. Test method
The 24h slant culture of the test bacteria was washed with PBS to prepare a bacterial suspension (the required concentration was 100. mu.l of the test bacteria was dropped on a control sample or 5ml of the sample, and the number of recovered bacteria was 1 × 104cfu/tablet or ml-9 × 104cfu/tablet or ml).
A test sample (2.0cm × 3.0.0 cm) or sample solution (5ml) and a control sample (the same material as the sample, the same size, but containing no antibacterial material, and sterilized) were taken, 4 pieces each (placed in a sterilized plate) or 4 tubes were taken.
Taking the bacterial suspension, respectively dripping 100 mu l of the bacterial suspension on or in each sample piece or sample liquid to be tested and each reference sample piece or sample liquid, uniformly coating/mixing, starting timing, acting for 2min,5min,10min and 20min, respectively putting the sample pieces or sample liquids (0.5ml) into test tubes containing 5ml of PBS by using sterile forceps, fully and uniformly mixing, properly diluting, then taking 2-3 dilutions, respectively sucking 0.5ml, putting into 2 plates, pouring by using nutrient agar medium (escherichia coli and staphylococcus aureus) or 15ml of Sabouraud's agar medium (candida albicans) cooled to 40-45 ℃, rotating the plates to fully and uniformly, turning the plates after agar solidification, culturing for 48h (escherichia coli and staphylococcus aureus) or 72h (candida albicans) at 35 +/-2 ℃ and counting viable bacteria colonies.
The experiment was repeated 3 times and the inhibition was calculated as follows:
Figure BDA0002055009020000051
in the formula: x is the bacteriostasis rate,%; n is a radical ofCMean colony number, cfu/plate, for control samples; n is a radical ofSThe average colony count of the samples to be tested, cfu/plate.
If the bacteriostatic rate is 80-95%, the product has bacteriostatic action, the bacteriostatic rate is more than or equal to 95%, and the product has strong bacteriostatic action.
The antibacterial tests of the pharmaceutical compositions of examples 1-3 and comparative examples 1-3 were carried out according to the above method, with the action times of 2min,5min,10min and 20min, and the tests were repeated 3 times.
3. Results of the experiment
TABLE 1 results of bacteriostatic experiments on different pharmaceutical compositions
Figure BDA0002055009020000061
4. Conclusion
The pharmaceutical composition prepared in the embodiment of the application acts for 2min,5min,10min and 20min, has strong inhibition effect on escherichia coli, staphylococcus aureus and candida albicans, and has the bacteriostasis rate of more than 90%. But the bacteriostatic effects of comparative examples 1 to 3 were relatively poor.
The above detailed description is specific to one possible embodiment of the present invention, and the embodiment is not intended to limit the scope of the present invention, and all equivalent implementations or modifications without departing from the scope of the present invention should be included in the technical scope of the present invention.

Claims (6)

1. An external bacteriostatic medicinal composition is characterized by being prepared from an active ingredient and pharmaceutically acceptable auxiliary materials;
the active ingredients comprise, by weight, 4-8 parts of chlorhexidine acetate, 70-100 parts of sulfur and 4-8 parts of allantoin;
the pharmaceutically acceptable auxiliary materials comprise the following auxiliary materials in parts by weight: 150-180 parts of 15# white oil, 50-70 parts of 340B-emulsifier, 50-70 parts of A165 emulsifier, 50-70 parts of 16-18 alcohol, 80-120 parts of glycerol, 190-220 parts of propylene glycol, 1-3 parts of methyl paraben, 0.5-2 parts of propyl paraben, 70-100 parts of isopropyl myristate, 30-50 parts of stearic acid, 10-30 parts of silicone oil, 10-30 parts of azone and 1000-1500 parts of purified water;
the preparation method of the antibacterial pharmaceutical composition comprises the following steps:
(1) preparing an aqueous phase: mixing glycerol, allantoin and purified water, and stirring to obtain water phase;
(2) preparing an oil phase: mixing 340B-emulsifier, 16-18 alcohol, methyl paraben, propyl paraben, A165 emulsifier, stearic acid, 15# white oil, azone, silicone oil and isopropyl myristate, and stirring to obtain oil phase;
(3) mixing the water phase and the oil phase, and homogenizing to obtain a mixture 1;
(4) dissolving chlorhexidine acetate in propylene glycol, mixing with the mixture 1, homogenizing, adding sulfur, and grinding to obtain the final product;
in the step (4), the chlorhexidine acetate and the propylene glycol are heated to 50-70 ℃ to be dissolved, then mixed with the mixture 1, homogenized for 1-3min at 20-30r/min, then cooled to 30-50 ℃, and sulfur is added.
2. The bacteriostatic pharmaceutical composition according to claim 1, which is prepared from the following components in parts by weight: 6 parts of chlorhexidine acetate, 80 parts of sulfur, 6 parts of allantoin, 160 parts of No. 15 white oil, 60 parts of 340B-emulsifier, 60 parts of A165 emulsifier, 60 parts of 16-18 alcohol, 100 parts of glycerol, 200 parts of propylene glycol, 2 parts of methyl paraben, 1 part of propyl paraben, 80 parts of isopropyl myristate, 40 parts of stearic acid, 20 parts of silicone oil, 20 parts of azone and 1200 parts of purified water.
3. A method for preparing a bacteriostatic pharmaceutical composition according to any one of claims 1-2, which comprises the following steps:
(1) preparing an aqueous phase: mixing glycerol, allantoin and purified water, and stirring to obtain water phase;
(2) preparing an oil phase: mixing 340B-emulsifier, 16-18 alcohol, methyl paraben, propyl paraben, A165 emulsifier, stearic acid, 15# white oil, azone, silicone oil and isopropyl myristate, and stirring to obtain oil phase;
(3) mixing the water phase and the oil phase, and homogenizing to obtain a mixture 1;
(4) dissolving chlorhexidine acetate and propylene glycol, mixing with the mixture 1, homogenizing, adding sulfur, and grinding.
4. The method according to claim 3, wherein the temperature is raised to 60 to 80 ℃ in both the step (1) and the step (2) while mixing and stirring.
5. The preparation method according to claim 3, wherein the mixing of the water phase and the oil phase in the step (3) adopts a vacuum suction mixing mode, the homogenization is carried out for 1-3min at the speed of 20-30r/min, and then the temperature is reduced to 50-70 ℃.
6. The method according to claim 3, wherein the grinding in step (4) is colloid mill grinding.
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