阅读说明：本技术 用于***的紧致抑菌组合物、用于***的紧致抑菌药物及制备方法和应用 (Tightening antibacterial composition for vagina, tightening antibacterial medicine for vagina, preparation method and application ) 是由 胡晓娟 刘洪生 张荣培 盛三辈 于 2019-12-06 设计创作，主要内容包括：本发明提供了一种用于阴道的紧致抑菌组合物、用于阴道的紧致抑菌药物及制备方法和应用,涉及妇科药物技术领域,本发明提供的用于阴道的紧致抑菌组合物,按照各组分含量之和是100份包括五倍子0.1-2份、金银花0.1-2份、苦参0.1-2份、蛇床子0.1-2份、乌梅0.1-2份、黄连0.1-2份、当归0.1-2份、芽孢杆菌发酵产物0.1-2份和余量的助剂。上述各组分在特定的配比下配伍使用,能够有效治疗细菌性阴道病,起到一定的抑菌抗炎、提高机体免疫、修复紧致阴道的作用,并且,各组分均为天然产品,对阴道黏膜无刺激性,避免了化药对机体的危害,能够有效提高患者的生理健康和生活质量。(The invention provides a tightening antibacterial composition for vagina, a tightening antibacterial medicine for vagina, a preparation method and an application, and relates to the technical field of gynecological medicines, wherein the tightening antibacterial composition for vagina comprises, by 100 parts of the sum of the contents of all components, 0.1-2 parts of gallnut, 0.1-2 parts of honeysuckle, 0.1-2 parts of radix sophorae flavescentis, 0.1-2 parts of fructus cnidii, 0.1-2 parts of dark plum, 0.1-2 parts of coptis chinensis, 0.1-2 parts of angelica sinensis, 0.1-2 parts of a bacillus fermentation product and the balance of an auxiliary agent. The components are used in a compatible manner in a specific ratio, so that bacterial vaginosis can be effectively treated, certain effects of inhibiting bacteria, resisting inflammation, improving organism immunity and repairing and tightening vagina are achieved, and the components are natural products, have no irritation to vaginal mucosa, avoid harm of chemical drugs to organisms, and can effectively improve physiological health and life quality of patients.)

1. The tightening antibacterial composition for the vagina is characterized by comprising the following components in parts by weight, wherein the sum of the contents of the components is 100:

0.1-2 parts of gallnut, 0.1-2 parts of honeysuckle, 0.1-2 parts of lightyellow sophora root, 0.1-2 parts of common cnidium fruit, 0.1-2 parts of dark plum fruit, 0.1-2 parts of coptis root, 0.1-2 parts of Chinese angelica, 0.1-2 parts of bacillus fermentation product and the balance of auxiliary agent.

2. The tightening bacteriostatic composition according to claim 1, which comprises the following components in parts by weight, based on the total content of 100 parts:

0.2-1.5 parts of gallnut, 0.2-1.5 parts of honeysuckle, 0.2-1.5 parts of radix sophorae flavescentis, 0.2-1.5 parts of fructus cnidii, 0.2-1.5 parts of dark plum fruit, 0.2-1.5 parts of coptis chinensis, 0.2-1.5 parts of angelica sinensis, 0.2-1.5 parts of bacillus fermentation product and the balance of auxiliary agent;

preferably, the tightening antibacterial composition comprises the following components in parts by weight according to the sum of the content of each component being 100 parts:

0.2-1 part of nutgall, 0.2-1 part of honeysuckle, 0.2-1 part of radix sophorae flavescentis, 0.2-1 part of fructus cnidii, 0.2-1 part of dark plum fruit, 0.2-1 part of coptis chinensis, 0.2-1 part of angelica sinensis, 0.2-1 part of bacillus fermentation product and the balance of auxiliary agents.

3. The tightening bacteriostatic composition according to claim 1 or 2, wherein said adjuvant comprises at least one of dispersing agent, suspending agent, antioxidant and perfume, preferably comprises dispersing agent, suspending agent, antioxidant and perfume.

4. The tightening bacteriostatic composition according to claim 3, wherein said dispersing agent comprises soybean oil;

the suspending agent comprises propolis;

preferably, the antioxidant comprises vitamin E or 2, 6-di-tert-butyl-4-methylphenol;

preferably, the essence comprises yulan magnolia oil, lily oil and perilla herb oil, and the mass ratio of the yulan magnolia oil, the lily oil and the perilla herb oil is preferably 1:1: 1.

5. The tightening bacteriostatic composition as claimed in claim 3, wherein the weight ratio of the total weight of Galla chinensis, flos Lonicerae, radix Sophorae Flavescentis, fructus Cnidii, mume fructus, Coptidis rhizoma, radix Angelicae sinensis and Bacillus fermentation product to the total weight of dispersant and suspending agent is 1-2: 10;

preferably, the dispersing agent and the suspending agent are used in an amount of 55-60% w/w, preferably 57% w/w of the tightening and bacteriostasis composition; wherein the dosage ratio of the suspending agent to the dispersing agent is preferably 1:10-15, more preferably 1: 13;

preferably, the antioxidant is used in an amount of 0.1% -1% w/w, preferably 0.5% w/w of the tightening bacteriostatic composition;

preferably, the amount of the essence is 1% -2% w/w, preferably 1.5% w/w of the tightening bacteriostatic composition.

6. The preparation method of the tightening antibacterial composition as claimed in any one of claims 1 to 5, wherein the tightening antibacterial composition is prepared by taking the components in the formula amount, stirring uniformly, emulsifying and removing air bubbles.

7. The tightening bacteriostatic drug for the vagina, which comprises the tightening bacteriostatic composition of any one of claims 1-5, preferably, the tightening bacteriostatic soft capsule.

8. The method for preparing the compact bacteriostatic soft capsule as claimed in claim 7, wherein the method comprises the following steps:

providing a soft capsule shell and the compact antibacterial composition of any one of claims 1-5, filling the compact antibacterial composition into the soft capsule shell, and forming to obtain the compact antibacterial soft capsule.

9. The method of claim 8, wherein the soft capsule shell is prepared from a gelatin solution, preferably the gelatin solution is mainly prepared from glycerol, water and gelatin;

preferably, gelatin is added into the mixture of glycerol and water at 70-80 ℃ under the stirring state, and bubbles are removed in a vacuum mode after the gelatin is dissolved to prepare a glue solution;

preferably, the weight ratio of the glycerol to the gelatin to the water is 0.3-0.5:0.8-1.2:0.5-1.5, preferably 0.4:1: 1;

preferably, the vacuum satisfies at least one of the following conditions:

the vacuum time is 2-2.5 hours, the vacuum degree is 0.06-0.09MPa, and the vacuum temperature is 58-62 ℃;

preferably, press forming is adopted, and the press forming satisfies at least one of the following conditions:

the pressing temperature is 20-30 ℃, and the humidity of the pressed air is below 60%;

preferably, the method further comprises the steps of shaping and shaping after the pressing, and then the compact antibacterial soft capsule is obtained;

preferably, the air is blown to shape at the temperature of 18-26 ℃;

preferably, shaping is carried out 3 to 6 hours after setting;

preferably, the method further comprises a step of cleaning after shaping and shaping, and then the compact antibacterial soft capsule is obtained;

preferably, the soft capsules are washed using an ethanol solution as a washing solution;

preferably, a drying step is further included after cleaning, and then the compact antibacterial soft capsule is obtained.

10. Use of the tightening bacteriostatic composition of any one of claims 1 to 5 or the tightening bacteriostatic medicament of claim 7 for the preparation of a product for treating bacterial vaginosis and/or tightening the vagina.

Technical Field

The invention relates to the technical field of gynecological medicines, in particular to a tightening antibacterial composition for vagina, a tightening antibacterial medicine for vagina, a preparation method and application.

Background

Bacterial vaginosis is one of the most common vaginal infectious diseases of women of childbearing age, and seriously affects the physiological health and the quality of life of patients due to bacterial mixed infection. Staphylococcus aureus, Escherichia coli and Candida albicans are pathogenic bacteria of three gynecological diseases, and the imbalance of microorganism balance in the vagina of a patient caused by abnormal proliferation of the three pathogenic bacteria is the main cause of bacterial vaginosis. The existing clinical examples treat the disease by combining antibacterial drugs with antibiotics. Although the antibacterial effect can be good, the harm of chemical drugs to the body is a concern which cannot be ignored, and the large-scale use of antibiotics can cause endogenous infection and double infection and the generation of bacterial drug-resistant strains. Only from the bacteriostatic point of view, the regeneration of the body function is not considered.

Therefore, the problem to be solved by people is urgent to find an antibacterial drug which is natural and can improve the body immunity, astringe the existing wound surface and promote the regeneration and repair of vaginal tissue.

In view of the above, the present invention is particularly proposed.

Disclosure of Invention

A first object of the present invention is to provide a firming and bacteriostatic composition for vagina, which at least alleviates one of the technical problems of the prior art.

The second purpose of the invention is to provide a preparation method of the compact antibacterial composition.

The third purpose of the invention is to provide a compact bacteriostatic medicine for vagina.

The fourth purpose of the invention is to provide a preparation method of the compact antibacterial soft capsule for vagina.

The fifth purpose of the invention is to provide application of the compact antibacterial composition or the compact antibacterial soft capsule in preparation of products for treating bacterial vaginosis and/or compact vagina.

The invention provides a tightening antibacterial composition for vagina, which comprises the following components in parts by weight according to the total content of 100 parts:

0.1-2 parts of gallnut, 0.1-2 parts of honeysuckle, 0.1-2 parts of lightyellow sophora root, 0.1-2 parts of common cnidium fruit, 0.1-2 parts of dark plum fruit, 0.1-2 parts of coptis root, 0.1-2 parts of Chinese angelica, 0.1-2 parts of bacillus fermentation product and the balance of auxiliary agent.

Further, according to the condition that the sum of the contents of all the components is 100 parts, the tightening antibacterial composition comprises the following components in parts by weight:

0.2-1.5 parts of gallnut, 0.2-1.5 parts of honeysuckle, 0.2-1.5 parts of radix sophorae flavescentis, 0.2-1.5 parts of fructus cnidii, 0.2-1.5 parts of dark plum fruit, 0.2-1.5 parts of coptis chinensis, 0.2-1.5 parts of angelica sinensis, 0.2-1.5 parts of bacillus fermentation product and the balance of auxiliary agent;

preferably, the tightening antibacterial composition comprises the following components in parts by weight according to the sum of the content of each component being 100 parts:

0.2-1 part of nutgall, 0.2-1 part of honeysuckle, 0.2-1 part of radix sophorae flavescentis, 0.2-1 part of fructus cnidii, 0.2-1 part of dark plum fruit, 0.2-1 part of coptis chinensis, 0.2-1 part of angelica sinensis, 0.2-1 part of bacillus fermentation product and the balance of auxiliary agents.

Further, the auxiliary agent comprises at least one of a dispersing agent, a suspending agent, an antioxidant and an essence, and preferably comprises the dispersing agent, the suspending agent, the antioxidant and the essence.

Further, the dispersant comprises soybean oil;

the suspending agent comprises propolis;

preferably, the antioxidant comprises vitamin E or 2, 6-di-tert-butyl-4-methylphenol;

preferably, the essence comprises yulan magnolia oil, lily oil and perilla herb oil, and the mass ratio of the yulan magnolia oil, the lily oil and the perilla herb oil is preferably 1:1: 1.

Further, the weight ratio of the total weight of the gallnut, the honeysuckle, the lightyellow sophora root, the common cnidium fruit, the dark plum fruit, the coptis root, the Chinese angelica and the bacillus fermentation product to the total weight of the dispersing agent and the suspending agent is 1-2: 10;

preferably, the dispersing agent and the suspending agent are used in an amount of 55-60% w/w, preferably 57% w/w of the tightening and bacteriostasis composition; wherein the dosage ratio of the suspending agent to the dispersing agent is preferably 1:10-15, more preferably 1: 13;

preferably, the antioxidant is used in an amount of 0.1% -1% w/w, preferably 0.5% w/w of the tightening bacteriostatic composition;

preferably, the amount of the essence is 1% -2% w/w, preferably 1.5% w/w of the tightening bacteriostatic composition.

The invention also provides a preparation method of the compact antibacterial composition, which comprises the steps of uniformly stirring the components according to the formula amount, emulsifying, and removing bubbles to prepare the compact antibacterial composition.

The invention also provides a tightening antibacterial drug for vagina, which comprises the tightening antibacterial composition, and preferably, the tightening antibacterial drug is a soft capsule.

The invention also provides a preparation method of the compact antibacterial soft capsule, which comprises the following steps:

providing a soft capsule shell and the compact antibacterial composition, filling the compact antibacterial composition into the soft capsule shell, and forming to obtain the compact antibacterial soft capsule.

Further, preferably, the soft capsule shell is prepared from a glue solution, and preferably, the glue solution is mainly prepared from glycerol, water and gelatin;

preferably, gelatin is added into the mixture of glycerol and water at 70-80 ℃ under the stirring state, and bubbles are removed in a vacuum mode after the gelatin is dissolved to prepare a glue solution;

preferably, the mass ratio of the glycerol to the gelatin to the water is 0.3-0.5:0.8-1.2:0.5-1.5, preferably 0.4:1: 1;

preferably, the vacuum satisfies at least one of the following conditions:

the vacuum time is 2-2.5 hours, the vacuum degree is 0.06-0.09MPa, and the vacuum temperature is 58-6260 ℃;

preferably, press forming is adopted, and the press forming satisfies at least one of the following conditions:

the pressing temperature is 20-30 deg.C, and the air humidity is below 60%.

Further, the steps of shaping and shaping are also included after the pressing, and then the compact antibacterial soft capsule is obtained;

preferably, the air is blown to shape at the temperature of 18-26 ℃;

preferably, shaping is carried out 3 to 6 hours after setting;

preferably, the method further comprises a step of cleaning after shaping and shaping, and then the compact antibacterial soft capsule is obtained;

preferably, the soft capsules are washed using an ethanol solution as a washing solution;

preferably, a drying step is further included after cleaning, and then the compact antibacterial soft capsule is obtained.

In addition, the invention also provides application of the compact antibacterial composition or the compact antibacterial medicine in preparation of products for treating bacterial vaginosis and/or compact vagina.

The tightening and antibacterial composition for vagina provided by the invention comprises, by 100 parts of the sum of the content of each component, 0.1-2 parts of gallnut, 0.1-2 parts of honeysuckle, 0.1-2 parts of radix sophorae flavescentis, 0.1-2 parts of fructus cnidii, 0.1-2 parts of dark plum fruit, 0.1-2 parts of coptis chinensis, 0.1-2 parts of angelica sinensis, 0.1-2 parts of bacillus fermentation product and the balance of auxiliary agent. Galla chinensis, honeysuckle, radix sophorae flavescentis, fructus cnidii, dark plum fruit, coptis chinensis, angelica sinensis and bacillus fermentation products are used as active ingredients, wherein the honeysuckle, the coptis chinensis, the radix sophorae flavescentis and the gallnut have good anti-inflammatory and antibacterial effects and can improve the immune function of an organism; the dark plum, the angelica and the common cnidium fruit have the functions of killing parasites, relieving itching, eliminating dampness, astringing and promoting granulation; the bacillus fermentation product can effectively inhibit the growth of staphylococcus aureus and reduce the pathogenic rate of the staphylococcus aureus, and has the advantages of environmental protection, no toxic or side effect and the like; the auxiliary agent can improve the compatibility of each component, improve the effective utilization rate of the medicine and prolong the storage period of the product. The components are used in a compatible manner in a specific ratio, so that bacterial vaginosis can be effectively treated, certain effects of inhibiting bacteria, resisting inflammation, improving organism immunity and repairing and tightening vagina are achieved, and the components are natural products, have no irritation to vaginal mucosa, avoid harm of chemical drugs to organisms, and can effectively improve physiological health and life quality of patients.

The preparation method of the compact antibacterial soft capsule comprises the steps of filling the compact antibacterial composition into a soft capsule shell, and pressing to obtain the compact antibacterial soft capsule. The method has simple process and convenient operation, and is suitable for large-scale production and application.

Detailed Description

The technical solutions of the present invention will be described clearly and completely with reference to the following embodiments, and it should be understood that the described embodiments are some, but not all, embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

According to one aspect of the invention, the tightening antibacterial composition for the vagina is provided, and comprises the following components in parts by weight, wherein the sum of the contents of the components is 100:

0.1-2 parts of gallnut, 0.1-2 parts of honeysuckle, 0.1-2 parts of lightyellow sophora root, 0.1-2 parts of common cnidium fruit, 0.1-2 parts of dark plum fruit, 0.1-2 parts of coptis root, 0.1-2 parts of Chinese angelica, 0.1-2 parts of bacillus fermentation product and the balance of auxiliary agent.

Wherein, the gallnut (Galla Chinensis), also known as Meretrix meretrix, Baichong and Wood aconite, is insect gall formed by Chinese gall aphid parasitizing on the leaves of Rhus Chinensis, Populus deltoidea or Populus deltoidea of Anacardiaceae, and has obvious bacteriostasis and sterilization effects on Escherichia coli, Staphylococcus aureus, Diplococcus pneumoniae, streptococcus, typhoid bacillus, Shigella dysenteriae, diphtheria bacillus, Bacillus anthracis, Pseudomonas aeruginosa and the like. The amount may be, for example, but is not limited to, 0.1 part, 0.2 part, 0.5 part, 0.8 part, 1 part, 1.2 parts, 1.5 parts, 1.8 parts, or 2 parts.

The honeysuckle has the efficacy of clearing away heat and toxic materials. It can be used for treating fever due to affection of exogenous wind-heat or epidemic febrile disease, heatstroke, toxic heat, dysentery, carbuncle, furuncle, pharyngitis, and various infectious diseases. The amount may be, for example, but is not limited to, 0.1 part, 0.2 part, 0.5 part, 0.8 part, 1 part, 1.2 parts, 1.5 parts, 1.8 parts, or 2 parts.

Kuh-seng has the functions of clearing heat and drying dampness, killing parasites and promoting urination. Can be used for treating dysentery with heat, hematochezia, jaundice, anuria, leucorrhea with red and white discharge, pudendal swelling, pudendal pruritus, eczema, skin pruritus, scabies, tinea, leprosy, and trichomonas vaginitis. The amount may be, for example, but is not limited to, 0.1 part, 0.2 part, 0.5 part, 0.8 part, 1 part, 1.2 parts, 1.5 parts, 1.8 parts, or 2 parts.

Fructus Cnidii has effects of eliminating dampness, dispelling pathogenic wind, killing parasites, relieving itching, warming kidney and tonifying yang. It is commonly used for pruritus vulvae, leukorrhagia, eczema, pruritus, lumbago due to damp arthralgia, impotence due to kidney deficiency, and infertility due to cold womb. The amount may be, for example, but is not limited to, 0.1 part, 0.2 part, 0.5 part, 0.8 part, 1 part, 1.2 parts, 1.5 parts, 1.8 parts, or 2 parts.

The dark plum has the effects of astringing lung, astringing intestine, promoting fluid production and calming ascaris. It is commonly indicated for chronic cough due to lung deficiency, chronic diarrhea and dysentery, diabetes due to deficiency heat, vomiting and abdominal pain due to ascariasis. The amount may be, for example, but is not limited to, 0.1 part, 0.2 part, 0.5 part, 0.8 part, 1 part, 1.2 parts, 1.5 parts, 1.8 parts, or 2 parts.

Coptis root has the effects of clearing heat, drying dampness, purging fire and removing toxicity. Mainly treats damp-heat fullness, vomiting and acid regurgitation, diarrhea, jaundice, high fever and coma, hyperactivity of heart-fire, vexation and insomnia, palpitation and restlessness, blood heat and hematemesis and epistaxis, conjunctival congestion, toothache, diabetes, carbuncle and swelling and sore; it is used externally to treat eczema, eczema and purulent ear canal. The amount may be, for example, but is not limited to, 0.1 part, 0.2 part, 0.5 part, 0.8 part, 1 part, 1.2 parts, 1.5 parts, 1.8 parts, or 2 parts.

The angelica has the effects of enriching blood and activating blood, regulating menstruation and relieving pain, and relaxing bowel. It is commonly used for blood deficiency and sallow complexion, vertigo and palpitation, irregular menstruation, amenorrhea and dysmenorrhea, deficiency cold and abdominal pain, rheumatic arthralgia, traumatic injury, superficial infection, pyocutaneous disease, intestinal dryness and constipation. The wine angelica sinensis can activate blood and promote menstruation. Can be used for treating amenorrhea, dysmenorrhea, rheumatalgia, and traumatic injury. The amount may be, for example, but is not limited to, 0.1 part, 0.2 part, 0.5 part, 0.8 part, 1 part, 1.2 parts, 1.5 parts, 1.8 parts, or 2 parts.

Bacillus fermentation products refer to probiotic bacteria that are capable of inhibiting fungi (e.g., Candida albicans, etc.). The bacillus fermentation product can effectively inhibit the growth of staphylococcus aureus, reduce the pathogenic rate of staphylococcus aureus, and has the advantages of environmental protection, no toxic or side effect and the like. The amount may be, for example, but is not limited to, 0.1 part, 0.2 part, 0.5 part, 0.8 part, 1 part, 1.2 parts, 1.5 parts, 1.8 parts, or 2 parts.

The components of the compact antibacterial composition for vagina provided by the invention are compatible for use in a specific proportion, so that bacterial vaginosis can be effectively treated, a certain antibacterial and anti-inflammatory effect is achieved, the immunity of an organism is improved, and the compact vagina is repaired; honeysuckle, coptis and angelica are compounded in a ratio of 2:1:2, so that the immunity of the organism can be enhanced; the fructus Cnidii and radix Sophorae Flavescentis have antibacterial effect, and have synergistic effect of 1:1 for enhancing antibacterial effect. Moreover, all the components are natural products, so that the vaginal mucosa is not stimulated, the harm of chemicals to organisms is avoided, and the physiological health and the life quality of patients can be effectively improved.

It is understood that the "balance" in the present invention means that the content of the fermented product of gallnut, honeysuckle, sophora flavescens, cnidium fruit, dark plum, coptis, angelica and bacillus is removed, and the remaining amount is the amount of the auxiliary agent, according to the sum of the content of each component being 100 parts.

In some preferred embodiments, the tightening antibacterial composition comprises the following components in parts by weight, with the sum of the content of each component being 100 parts:

0.2-1.5 parts of gallnut, 0.2-1.5 parts of honeysuckle, 0.2-1.5 parts of radix sophorae flavescentis, 0.2-1.5 parts of fructus cnidii, 0.2-1.5 parts of dark plum fruit, 0.2-1.5 parts of coptis chinensis, 0.2-1.5 parts of angelica sinensis, 0.2-1.5 parts of bacillus fermentation product and the balance of auxiliary agent;

preferably, the tightening antibacterial composition comprises the following components in parts by weight according to the sum of the content of each component being 100 parts:

0.2-1 part of nutgall, 0.2-1 part of honeysuckle, 0.2-1 part of radix sophorae flavescentis, 0.2-1 part of fructus cnidii, 0.2-1 part of dark plum fruit, 0.2-1 part of coptis chinensis, 0.2-1 part of angelica sinensis, 0.2-1 part of bacillus fermentation product and the balance of auxiliary agents.

Through further adjustment and optimization of the proportion of each component in the compact antibacterial composition, bacterial vaginosis can be treated more effectively, colleagues play a role in repairing compact vagina, and the physiological health and the life quality of patients are improved more effectively.

In some preferred embodiments, the adjuvant comprises at least one of a dispersing agent, a suspending agent, an antioxidant, and a fragrance, and may be, for example, a dispersing agent, a suspending agent, or an antioxidant, or a fragrance, and may also be a dispersing agent and a fragrance, or a suspending agent, an antioxidant, and a fragrance. Preferably including dispersing agents, suspending agents, antioxidants and perfumes. Wherein, the components can be uniformly dispersed in the whole system of the tightening bacteriostatic composition through the dispersing agent and the suspending agent. The antioxidant can prevent the adverse effect of oxygen, and the stability and the storage period of the compact antibacterial composition can be effectively prolonged by adding the antioxidant. The essence can generate pleasant smell, so that the use experience of the firming and antibacterial composition is improved.

Preferably, the dispersing agent comprises soybean oil and the suspending agent comprises propolis. Propolis and soybean oil are all pure natural products, and can effectively avoid the harm of chemical substances to the body on the basis of playing a good role in suspending and dispersing.

Preferably, the antioxidant comprises vitamin E or 2, 6-di-tert-butyl-4-methylphenol. The vitamin E andor the 2, 6-di-tert-butyl-4-methylphenol have stronger antioxidation, can keep stable under the acid and heat conditions, and is suitable for being used in the vaginal environment.

Preferably, the essence comprises yulan magnolia oil, lily oil and perilla oil. Three essential oils of yulan magnolia oil, perilla herb oil and lily oil belong to natural perfume components, and a large number of research works prove that the essential oils also have the in vitro antibacterial and antioxidant effects.

The mass ratio of the magnolia oil, the lily oil and the perilla herb oil is preferably 1:1: 1. When the components in the essence are within the mass ratio range, the effect is optimal.

In some preferred embodiments, the weight ratio of the sum of the weights of the gallnut, honeysuckle, sophora flavescens, cnidium fruit, smoked plum, coptis chinensis, angelica sinensis and bacillus fermentation product to the sum of the weights of the dispersing agent and the suspending agent is 1-2:10, such as may be, but not limited to, 1:10, 1.2:10, 1.5:10, 1.8:10 or 2: 10;

preferably, the dispersing agent and the suspending agent are used in an amount of 55% to 60% w/w of the firming and bacteriostatic composition, and may be, for example, but not limited to, 55% w/w, 56% w/w, 57% w/w, 58% w/w, 59% w/w or 60% w/w, preferably 57% w/w; the ratio of the suspending agent to the dispersing agent is preferably 1:10-15, and can be, for example, but not limited to, 1:10, 1:11, 1:12, 1:13, 1:14 or 1:15, and more preferably 1: 13.

Preferably, the antioxidant is used in an amount of 0.1% to 1% w/w of the tightening and bacteriostatic composition, and may be, for example, but not limited to, 0.1% w/w, 0.2% w/w, 0.3% w/w, 0.4% w/w, 0.5% w/w, 0.6% w/w, 0.7% w/w, 0.8% w/w, 0.9% w/w or 1% w/w, preferably 0.5% w/w. When the amount of the antioxidant is within the above range, the cost can be effectively saved on the basis of ensuring the antioxidant effect.

Preferably, the perfume is used in an amount of 1% -2% w/w of the tightening and bacteriostatic composition, for example, but not limited to, 1% w/w, 1.1% w/w, 1.2% w/w, 1.3% w/w, 1.4% w/w, 1.5% w/w, 1.6% w/w, 1.7% w/w, 1.8% w/w, 1.9% w/w or 2% w/w, preferably 1.5% w/w.

According to the second aspect of the invention, the preparation method of the firming and antibacterial composition is further provided, wherein the firming and antibacterial composition is prepared by uniformly stirring the components according to the formula amount, emulsifying and removing bubbles.

According to the third aspect of the invention, the tightening bacteriostatic drug for the vagina is also provided, and comprises the tightening bacteriostatic composition, preferably, the tightening bacteriostatic drug is in a soft capsule form.

Compared with common gel, antibacterial granules and tightening suppositories in the market, the tightening antibacterial soft capsule for the vagina provided by the invention has the advantages of convenience in carrying and simplicity in use, is used for local application, has a direct effect, is good in mucosa absorption and has a more remarkable curative effect.

According to a fourth aspect of the present invention, there is provided a preparation method of the compact antibacterial soft capsule, the method includes:

providing a soft capsule shell and a compact antibacterial composition, filling the compact antibacterial composition into the soft capsule shell, and forming to obtain the compact antibacterial soft capsule. The method has simple process and convenient operation, and is suitable for large-scale production and application.

The soft capsule shell refers to an outer soft capsule material for coating in the compact antibacterial soft capsule, and the material of the soft capsule shell is not limited, and the soft capsule shell can be made of gelatin, glycerin or other appropriate pharmaceutical excipients alone or in a mixed manner.

The specific operation mode of filling the compact antibacterial composition into the soft capsule shell is not limited, and the compact antibacterial composition can be manually filled or mechanically filled.

In some preferred embodiments, the soft capsule shell is prepared from a gelatin solution, preferably, the gelatin solution is mainly prepared from glycerol, water and gelatin;

preferably, gelatin is added into the mixture of glycerol and water at 70-80 ℃ under the stirring state, and bubbles are removed in a vacuum mode after the gelatin is dissolved to prepare a glue solution;

the temperature is controlled at 70-80 deg.C, which can ensure rapid dissolution of gelatin without adverse effect on the quality of gelatin solution, and the temperature can be, but is not limited to, 70 deg.C, 72 deg.C, 75 deg.C, 78 deg.C or 80 deg.C, preferably 78 deg.C. Gelatin is added under the stirring state, so that the gelatin can be dissolved more quickly, and the homogeneity of the gelatin solution is ensured.

Preferably, the weight ratio of the glycerol to the gelatin to the water is 0.3-0.5:0.8-1.2:0.5-1.5, preferably 0.4:1: 1;

preferably, the vacuum satisfies at least one of the following conditions:

the time of the vacuum is 2-2.5 hours, for example, but not limited to, 2 hours, 2.1 hours, 2.2 hours, 2.3 hours, 2.4 hours, or 2.5 hours; the degree of vacuum is 0.06 to 0.09MPa, and may be, for example, but not limited to, 0.06MPa, 0.07MPa, 0.08MPa or 0.09 MPa; the temperature of the vacuum is 58-62 ℃, for example, but not limited to, 58 ℃, 59 ℃, 60 ℃, 61 ℃ or 62 ℃; the gel is easily formed at a low temperature, and the quality of the glue solution is affected.

Wherein the vacuum condition can be that the vacuum time is 2-2.5 hours, or the vacuum degree is 0.06-0.09MPa, or the vacuum temperature is 58-62 ℃, or the vacuum time is 2-2.5 hours and the vacuum degree is 0.06-0.09MPa, or the vacuum degree is 0.06-0.09MPa and the vacuum temperature is 58-62 ℃, or the vacuum time is 2-2.5 hours, the vacuum degree is more than 0.06-0.09MPa and the vacuum temperature is 58-62 ℃.

Preferably, press forming is adopted, and the press forming satisfies at least one of the following conditions:

the pressing temperature is 20-30 deg.C, and the air humidity is below 60%.

The soft capsules are pressed under the optimal conditions of the invention, which is beneficial to the shaping of the soft capsules, otherwise, the temperature and humidity are too high, and the pressed soft capsules are easy to be adhered together, thereby causing deformation and leakage.

Wherein, the condition of the compression molding can be that the compression temperature is 20-30 ℃, or the air humidity of the compression is below 60%, or the compression temperature is 20-30 ℃ and the air humidity of the compression is below 60%.

In a specific embodiment, the preparation method of the compact antibacterial soft capsule comprises the following steps:

(a) preparing a liquid medicine: weighing raw and auxiliary materials according to the formula dosage, stirring to fully mix the raw and auxiliary materials, placing the mixture into a colloid mill, grinding, pumping into a liquid preparation tank, and removing bubbles in vacuum;

(b) sol: adding glycerol and purified water into a sol tank, heating the temperature in the sol tank to 78 ℃, starting stirring for 25 r/m, and adding the gelatin with the formula amount into the sol tank at a constant speed under the stirring state. After the gelatin is basically dissolved, the opening of the tank is sealed, and a vacuum pump is started, wherein the vacuum degree is 0.06-0.09 MPa. Observing the complete elimination of bubbles in the glue solution, and stopping vacuum. The glue solution is placed at the temperature of 55 ℃;

(c) pressing: making the above-mentioned glue solution into qualified glue sheet, then making the content medicinal liquor into soft capsule by means of automatic rotary capsule-making machine. Adjusting the loading amount to 0.5 g/granule;

(d) shaping and reshaping: blowing the pressed soft capsule in a net machine at 20 ℃ for shaping, and shaping after shaping for 4 hours;

(e) washing and rubbing pills: washing off the oil layer on the surface of the capsule in a pill washing and wiping machine by using an ethanol solution, and drying the washing liquid;

(f) drying and pill drying: drying the prepared capsule in a drying chamber or a rotating cage until the hardness is qualified, and collecting the capsule;

(g) picking: placing the capsule on a picking table, and picking out unqualified products such as leakage pill, abnormal pill, and shrivelled pill;

(h) packaging: and selecting a proper packaging material for packaging according to requirements.

According to a fourth aspect of the invention, the application of the compact antibacterial composition or the compact antibacterial medicament in preparing a product for treating bacterial vaginosis and/or compact vagina is also provided.

It is understood that the above "and/or" means "and" or ", that is, the above tightening antibacterial composition or tightening antibacterial drug can be applied in the preparation of products for treating bacterial vaginosis, can also be applied in the preparation of products for tightening vagina, and can also be applied in the preparation of products for treating bacterial vaginosis and tightening vagina simultaneously.

The invention is further illustrated by the following specific examples, which, however, are to be construed as merely illustrative, and not limitative of the remainder of the disclosure in any way whatsoever.