Pharmaceutical composition for treating gynecological diseases as well as preparation method and application thereof

Abstract

The invention discloses a pharmaceutical composition for treating gynecological diseases, which is characterized by comprising the following components in percentage by mass: 7.6 to 44 percent of total alkaloids of sophora flavescens, 13 to 60 percent of sea buckthron oil, 1.8 to 18 percent of zedoary turmeric oil and 18 to 69 percent of astragalus membranaceus, and the sum of the mass percentages of the components is 100 percent. The invention also discloses a preparation method and application of the pharmaceutical composition for treating gynecological diseases. The composition disclosed by the invention has the characteristics of stable active ingredients and quick effect, and meanwhile, the preparation method disclosed by the invention solves the problem of low extraction rate of the active ingredients in the existing method.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and specifically relates to a pharmaceutical composition for treating gynecological diseases. The present invention also relates to a preparation method and application of the pharmaceutical composition for treating gynecological diseases. Background Art

[0002] The female vagina, an open cavity, is a crucial microecological zone within the human body. It is susceptible to changes in response to endogenous and exogenous factors, leading to the development of disease. Once the vaginal microecological system becomes unbalanced, endogenous and exogenous microorganisms in the vagina lose control, rapidly growing and causing recurrent infections, leading to a variety of gynecological conditions, including various forms of vaginitis, fallopian tube infections, chronic pelvic inflammatory disease, and ovarian cysts.

[0003] Currently, antibiotics are often used clinically to treat gynecological conditions. However, these drugs can disrupt the vaginal environment, resulting in suboptimal treatment outcomes. Some traditional Chinese medicines (TCMs) are also being marketed as combined with antibiotics. However, due to complex formulations, inappropriate extraction and preparation processes, and inappropriate dosing methods, these formulas can lead to significant loss of active ingredients and slow efficacy. Summary of the Invention

[0004] The first object of the present invention is to provide a pharmaceutical composition for treating gynecological diseases, which has the characteristics of stable active ingredients and rapid onset of effect.

[0005] The second object of the present invention is to provide a method for preparing the above-mentioned pharmaceutical composition for treating gynecological diseases, which solves the problem of low extraction rate of active ingredients in existing methods.

[0006] The third object of the present invention is to provide the use of the above-mentioned pharmaceutical composition for treating gynecological diseases.

[0007] The first technical solution adopted by the present invention is a pharmaceutical composition for treating gynecological diseases, which is composed of the following components in mass percentage: 7.6%-44% total sophora flavescens alkaloids, 13%-60% sea buckthorn oil, 1.8%-18% zedoary oil, and 18%-69% astragalus. The sum of the mass percentages of the above components is 100%.

[0008] The first technical solution adopted by the present invention is also characterized in that: Furthermore, the pharmaceutical composition for treating gynecological diseases is composed of the following components in mass percentage: 13%-32% of total sophora flavescens alkaloids, 20%-46% of sea buckthorn oil, 2.1%-6.7% of zedoary oil, and 29%-57% of astragalus. The sum of the mass percentages of the above components is 100%.

[0009] Furthermore, the pharmaceutical composition for treating gynecological diseases is composed of the following components by mass percentage: 21% total sophora flavescens alkaloids, 31.6% sea buckthorn oil, 5.3% zedoary oil, and 42.1% astragalus.

[0010] The second technical solution adopted by the present invention is a method for preparing the above-mentioned pharmaceutical composition for treating gynecological diseases, which is specifically implemented according to the following steps: Step 1, Astragalus Extraction: Weigh the Astragalus slices and extract them with ethanol, filter the extract and set aside; extract the residue with purified water, filter and combine the filtrate, recover the ethanol, concentrate under reduced pressure to a paste, dry and crush it and set aside; Step 2, sea buckthorn oil extraction: crush the dried sea buckthorn fruit, extract with supercritical CO2, let it stand, separate and mix to obtain sea buckthorn oil; Step 3: Weigh seabuckthorn oil, zedoary turmeric oil, and total sophora flavescens alkaloids according to the prescribed amount; mix the seabuckthorn oil and zedoary turmeric oil evenly, then add total sophora flavescens alkaloids and astragalus mixed powder, and stir evenly to obtain a pharmaceutical composition for treating gynecological diseases.

[0011] The second technical solution adopted by the present invention is also characterized in that: Furthermore, step 1 is as follows: Step 1.1, weigh the Astragalus membranaceus slices and prepare them for use; Step 1.2, first add 10-12 times the amount of ethanol to the Astragalus slices, stir evenly, extract and filter for later use; second add 8-10 times the amount of ethanol to the Astragalus slices, stir evenly, extract and filter, and combine the two filtrates; Step 1.3: Recover ethanol from the filtrate of step 1.2 until there is no alcohol smell, then concentrate under reduced pressure to a paste, dry the paste, and grind it into fine powder for later use; Step 1.4, add appropriate amount of purified water to extract the residue 2-4 times, filter and combine the filtrates; concentrate the filtrate under reduced pressure to a paste, dry the paste and grind it into fine powder for later use; Step 1.5: Mix the powders obtained from the two extractions to obtain Astragalus powder.

[0012] Furthermore, the paste in steps 1.4 and 1.5 is specifically: a clear paste with a relative density of 1.1-1.2 at 60°C.

[0013] Furthermore, the reduced pressure concentration conditions in step 1.3 are: -0.06~-0.08Mpa, temperature 50℃~60℃, drying temperature 55℃~65℃, and passing through an 80-mesh sieve. The reduced pressure concentration conditions in step 1.4 are: -0.06~-0.08Mpa, temperature 50℃~60℃, drying temperature 50℃~60℃, and passing through an 80-mesh sieve.

[0014] Furthermore, step 2 is as follows: The dried sea buckthorn fruit is crushed and extracted for 4.5-5.5 hours at a pressure of 270-290 bar, a temperature of 52°C-55°C, and a CO2 flow rate of 2750-2850 kg / h. After extraction, the primary separation is carried out at a pressure of 100-110 bar and a temperature of 45°C-50°C, and then the secondary separation is carried out at a pressure of 50-55 bar and a temperature of 30-35°C. The sea buckthorn oil is obtained after standing at 40-45°C for 4-6 hours and mixing evenly.

[0015] The third technical solution adopted by the present invention is: Application of the above-mentioned pharmaceutical composition for treating gynecological diseases in the preparation of gynecological drugs.

[0016] The third technical solution adopted by the present invention is also characterized in that: The composition is prepared into a gynecological medicine in the form of suppository, lotion or gel.

[0017] The beneficial effects of the present invention are: The invention provides a pharmaceutical composition for treating gynecological diseases. The pharmaceutical composition uses total alkaloids of sophora flavescens as a main drug, and is compounded with three medicinal materials: seabuckthorn oil, zedoary turmeric oil, and astragalus. The bitter and cold nature of the total alkaloids of sophora flavescens can easily damage yin, while the moistening and drying nature of the seabuckthorn oil can neutralize its dryness; the zedoary turmeric has a strong blood-breaking effect, while the qi-invigorating and protective nature of the astragalus can prevent its excessive attack; the whole formula combines cold and hot properties, so that the medicinal properties are mild, and the composition is suitable for long-term or repeated local use in the vagina, reducing irritation or discomfort.

[0018] The pharmaceutical composition of the present invention directly selects total alkaloids of sophora flavescens, sea buckthorn oil, and zedoary turmeric oil with high purity, thereby avoiding the loss and consumption of active ingredients during the extraction process, effectively increasing the proportion of active ingredients, and better exerting the medicinal effects; the astragalus in the prescription adopts the alcohol-water double extraction method, while taking into account the water-soluble components and fat-soluble components, reducing the decomposition or loss of active ingredients, and better retaining the original medicinal effects of the medicinal materials.

[0019] The pharmaceutical composition of the present invention avoids the limitations of a single ingredient and works through multiple pathways, including antibacterial, anti-inflammatory, repair, and immune regulation, rapidly eliminating pathogens while simultaneously repairing damaged tissue and enhancing the body's defenses. This formulation can be used to prepare suppositories, lotions, gels, and other dosage forms. The raw materials are readily available, the active ingredients are stable, the preparation method is simple, and the efficacy is significant. It can effectively regulate the vaginal microecological environment and achieve enhanced therapeutic effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 is a flow chart of the astragalus extraction method of the present invention; Figure 2 The present invention is a flow chart of the sea buckthorn oil extraction method. DETAILED DESCRIPTION

[0021] The present invention is described in detail below through specific embodiments.

[0022] The present invention provides a pharmaceutical composition for treating gynecological diseases. The pharmaceutical composition is composed of the following components in percentage by mass: 7.6%-44% of total sophora flavescens alkaloids, 13%-60% of seabuckthorn oil, 1.8%-18% of zedoary turmeric oil, and 18%-69% of astragalus root, wherein the sum of the percentages by mass of the above components is 100%.

[0023] Preferably, the above-mentioned pharmaceutical composition is composed of the following components in terms of mass percentage: 13%-32% of total sophora flavescens alkaloids, 20%-46% of sea buckthorn oil, 2.1%-6.7% of zedoary oil, and 29%-57% of astragalus. The sum of the mass percentages of the above-mentioned components is 100%.

[0024] Preferably, the above-mentioned pharmaceutical composition is composed of the following components by mass percentage: 21% total sophora flavescens alkaloids, 31.6% sea buckthorn oil, 5.3% zedoary oil, and 42.1% astragalus.

[0025] Total Sophora flavescens alkaloids are a mixture of alkaloids extracted from the roots, plants, and fruits of the leguminous plant Sophora flavescens. They primarily include matrine, oxymatrine, and sophocarpine, with the first two comprising the highest proportions. As the core active ingredient in Sophora flavescens, total sophora flavescens alkaloids possess broad-spectrum antibacterial, antifungal, and insecticidal properties, directly inhibiting and killing common vaginal pathogens such as Escherichia coli, Candida albicans, and Trichomonas. They also clear heat and dampness, relieving symptoms of damp-heat syndromes such as vaginal itching, burning, and increased discharge, making them the core therapeutic ingredient in this formula.

[0026] Seabuckthorn oil is a precious natural oil extracted from the fruit of the seabuckthorn plant. It is rich in vitamins, amino acids, sugars, and other nutrients. It has antioxidant properties and can scavenge free radicals in the body. It repairs damaged skin and promotes skin healing. It also has the effect of enhancing immunity and regulating the body's immune function. Seabuckthorn oil is the auxiliary medicine in the prescription.

[0027] Curcuma oil is a volatile oil extracted through steam distillation from the dried rhizome of the ginger plant Curcuma zedoaria (Zingiber officinale). It contains various components, including curcumene, germacrone, curdione, neocurdione, and curcumol. It has antiviral, anti-inflammatory, anti-tumor, and antibacterial properties and is primarily used to treat respiratory and digestive ailments, cancer, cardiovascular and cerebrovascular diseases, reproductive system disorders, and skin diseases. Curcuma oil has antibacterial and anti-inflammatory properties, inhibiting various pathogens; it can improve local blood circulation and promote the absorption of inflammation; it also has anti-tumor activity, inhibiting certain tumor cells; and in gynecological settings, it has a significant therapeutic effect on conditions such as cervical erosion.

[0028] Astragalus is the root of Astragalus mongolica or Astragalus membranaceus, a plant of the genus Astragalus in the Leguminosae family. It has the effects of strengthening the spleen and replenishing the middle, elevating yang and lifting the sunken, strengthening the defensive system and consolidating the exterior, promoting diuresis, and expelling toxins and promoting tissue regeneration. It is primarily used to treat spleen qi deficiency, lung qi deficiency, spontaneous sweating due to qi deficiency, qi and blood deficiency, and ulcers that are difficult to heal or that persist for a long time. Modern pharmacology suggests that it can replenish qi and blood, enhance immunity, improve antioxidant capacity, regulate blood sugar, lower blood pressure, and promote metabolism. The vagina is the gateway to the lower abdomen of the human body, and its normal function depends on immune support. Astragalus, as an adjuvant, can regulate local vaginal immune function, activate immune cell activity, and enhance the body's defenses against pathogens. By strengthening local immune defenses, it reduces the risk of recurrent inflammation, consolidates therapeutic effects, and maintains vaginal microecological balance. It also directs the actions of other herbs to the lower abdomen, harmonizing the cold and heat of the entire prescription.

[0029] The pharmaceutical composition for treating gynecological diseases and its preparation method of the present invention are prepared by specifically following the steps below: Step 1: Astragalus Extraction like Figure 1 As shown, weigh the prescribed amount of Astragalus slices for preparation.

[0030] Add appropriate amount of ethanol, stir evenly and extract twice. The first time, add 10-12 times the amount of ethanol of the Astragalus slices, and the second time, add 8-10 times the amount of ethanol of the Astragalus slices. After filtering, combine the filtrate.

[0031] The filtrate is concentrated under reduced pressure to a clear paste with a relative density of 1.1-1.2 (measured at 60°C) after recovering ethanol until there is no alcohol smell. The clear paste is dried and crushed into fine powder for later use. The conditions for vacuum concentration are: -0.06~-0.08Mpa, temperature 50℃~60℃, drying temperature 55℃~65℃, and sieve through 80 mesh. Add appropriate amount of purified water to the medicinal residue and extract twice. After filtering, combine the filtrates and concentrate the filtrates under reduced pressure to a clear paste with a relative density of 1.1-1.2 (measured at 60°C). The conditions for reduced pressure concentration are: -0.06~-0.08Mpa, temperature 50°C~60°C, drying temperature 50°C~60°C, pass through an 80-mesh sieve, place the clear paste in a constant temperature drying oven, dry it, and grind it into fine powder for later use.

[0032] The medicinal powders extracted twice are mixed to obtain mixed medicinal powder.

[0033] Step 2: Sea buckthorn oil extraction like Figure 2As shown, an appropriate amount of sea buckthorn dried fruit is weighed and crushed, and extracted for 4.5-5.5 hours at a pressure of 270-290 bar, a temperature of 52-55°C, and a CO2 flow rate of 2750-2850 kg / h. After extraction, a primary separation is performed at a pressure of 100-110 bar and a temperature of 45-50°C, and a secondary separation is performed at a pressure of 50-55 bar and a temperature of 30-35°C. The product is allowed to stand at 40-45°C for 4-6 hours and mixed evenly to obtain sea buckthorn oil.

[0034] Step 3: Mix Weigh seabuckthorn oil, zedoary turmeric oil, and total sophora flavescens alkaloids according to the prescribed amount; mix the seabuckthorn oil and zedoary turmeric oil evenly, then add total sophora flavescens alkaloids and astragalus mixed powder and stir evenly.

[0035] The present invention also provides the use of the above-mentioned pharmaceutical composition for treating gynecological diseases in the preparation of gynecological drugs; specifically, the above-mentioned composition is prepared into gynecological drugs in the form of suppositories, lotions or gels.

[0036] The present invention will be further described in detail below with reference to the embodiments, but the protection scope of the present invention is not limited to these embodiments.

[0037] Example 1 A traditional Chinese medicine suppository for treating gynecological diseases comprises the following components by mass percentage: 7.6% total sophora flavescens alkaloids, 47% seabuckthorn oil, 5.8% zedoary turmeric oil, 39.6% astragalus, an appropriate amount of base, an appropriate amount of polysorbate 80, an appropriate amount of sodium benzoate, and an appropriate amount of β-cyclodextrin.

[0038] The preparation method is as follows: Step 1. Weigh the prescribed amount of Astragalus slices, add appropriate amount of ethanol, stir evenly and extract twice, filter and combine the filtrate; recover the ethanol until there is no alcohol taste, and then concentrate under reduced pressure to a clear paste with a relative density of 1.1-1.2 (measured at 60°C). Dry the clear paste and grind it into fine powder for later use. The reduced pressure concentration conditions are: -0.06Mpa, temperature 50°C, drying temperature 55°C, and pass through an 80-mesh sieve.

[0039] The medicinal residue was extracted twice with an appropriate amount of purified water, and the filtrates were combined after filtration. The filtrates were concentrated under reduced pressure to a clear paste with a relative density of 1.1-1.2 (measured at 60°C). The clear paste was placed in a constant temperature drying oven, dried, and then crushed into fine powder for later use. The pressure concentration conditions were: -0.06Mpa, temperature 50°C, drying temperature 50°C, and passed through an 80-mesh sieve. The medicinal powders extracted twice are mixed to obtain mixed medicinal powder.

[0040] Step 2: Weigh an appropriate amount of sea buckthorn dried fruit, crush the sea buckthorn dried fruit, and extract it for 4.5 hours at a pressure of 270 bar, a temperature of 52°C, and a CO2 flow rate of 2750 kg / h. After extraction, perform primary separation at a pressure of 100 bar and a temperature of 45°C, and then perform secondary separation at a pressure of 50 bar and a temperature of 30°C; let it stand at 40°C for 4 hours, and mix it evenly to obtain sea buckthorn oil.

[0041] Step 3: Weigh seabuckthorn oil and zedoary turmeric oil according to the prescribed amount and mix them evenly; prepare a saturated aqueous solution of β-cyclodextrin, slowly add the mixed volatile oil under constant temperature stirring, stir evenly, refrigerate overnight, filter, dry, and sieve to obtain volatile oil inclusion compound powder.

[0042] Step 4: Heat and melt an appropriate amount of glycerol gelatin matrix, stirring constantly to ensure even heating and complete melting. Add an appropriate amount of polysorbate 80 to the melted matrix after it is completely dissolved. Slowly add the mixed powder, total alkaloids of sophora flavescens, and cyclodextrin inclusion compound powder, stirring rapidly to mix thoroughly. Dissolve the sodium benzoate and add it to the mixture.

[0043] The mixed liquid medicine is quickly poured into a suppository mold coated with a small amount of liquid paraffin, until a little overflows from the edge of the mold to ensure the correct weight of the suppository. The mold is placed in a refrigerator to accelerate cooling. After the suppository is completely solidified, it is carefully demolded to obtain the prepared suppository.

[0044] Example 2 A traditional Chinese medicine suppository for treating gynecological diseases comprises the following raw materials in parts by weight: 21% total sophora flavescens alkaloids, 32% seabuckthorn oil, 5.2% zedoary turmeric oil, 41.8% astragalus, an appropriate amount of matrix, an appropriate amount of polysorbate 80, an appropriate amount of sodium benzoate, and an appropriate amount of β-cyclodextrin.

[0045] The preparation method is as follows: Step 1. Weigh the prescribed amount of Astragalus slices, add appropriate amount of ethanol, stir evenly and extract twice, filter and combine the filtrate; recover the ethanol until there is no alcohol taste, and then concentrate under reduced pressure to a clear paste with a relative density of 1.1-1.2 (measured at 60°C). Dry the clear paste and grind it into fine powder for later use. The reduced pressure concentration conditions are: -0.07Mpa, temperature 55°C, drying temperature 60°C, and pass through an 80-mesh sieve.

[0046] The medicinal residue was extracted twice with an appropriate amount of purified water, and the filtrates were combined after filtration. The filtrates were concentrated under reduced pressure to a clear paste with a relative density of 1.1-1.2 (measured at 60°C). The clear paste was placed in a constant temperature drying oven, dried, and then crushed into fine powder for later use. The pressure concentration conditions were: -0.07 MPa, temperature 55°C, drying temperature 55°C, and passed through an 80-mesh sieve. The medicinal powders extracted twice are mixed to obtain mixed medicinal powder.

[0047] Step 2: Weigh an appropriate amount of sea buckthorn dried fruit, crush it, and extract it at a pressure of 290 bar, a temperature of 55°C, and a CO2 flow rate of 2850 kg / h for 5.5 hours. After extraction, perform primary separation at a pressure of 110 bar and a temperature of 50°C, and then perform secondary separation at a pressure of 55 bar and a temperature of 35°C; let it stand at 45°C for 6 hours, and mix it evenly to obtain sea buckthorn oil.

[0048] Step 3: Weigh seabuckthorn oil, zedoary turmeric oil, and total alkaloids of sophora flavescens according to the prescribed amount; prepare a saturated aqueous solution of β-cyclodextrin, slowly add the mixed volatile oils under constant temperature stirring, stir evenly, refrigerate overnight, filter, dry, and sieve to obtain volatile oil inclusion compound powder.

[0049] Step 4: Heat and melt an appropriate amount of glycerol gelatin matrix, stirring constantly to ensure even heating and complete melting. Add an appropriate amount of polysorbate 80 to the melted matrix after it is completely dissolved. Slowly add the mixed powder, total alkaloids of sophora flavescens, and cyclodextrin inclusion compound powder, stirring rapidly to mix thoroughly. Dissolve the sodium benzoate and add it to the mixture.

[0050] The mixed liquid medicine is quickly poured into a suppository mold coated with a small amount of liquid paraffin, until a little overflows from the edge of the mold to ensure the correct weight of the suppository. The mold is placed in a refrigerator to accelerate cooling. After the suppository is completely solidified, it is carefully demolded to obtain the prepared suppository.

[0051] Example 3 A traditional Chinese medicine lotion for treating gynecological diseases comprises the following raw materials in parts by weight: 44% total sophora flavescens alkaloids, 20% seabuckthorn oil, 18% zedoary turmeric oil, 18% astragalus, appropriate amounts of butylated tert-butyl 4-cresol, appropriate amounts of polysorbate 80, and appropriate amounts of sodium benzoate.

[0052] The preparation method is as follows: Step 1. Weigh the prescribed amount of Astragalus slices, add appropriate amount of ethanol, stir evenly and extract twice, filter and combine the filtrate; recover the ethanol until there is no alcohol taste, and then concentrate under reduced pressure to a clear paste with a relative density of 1.1-1.2 (measured at 60°C). Dry the clear paste and grind it into fine powder for later use. The reduced pressure concentration conditions are: -0.08Mpa, temperature 60°C, drying temperature 65°C, and pass through an 80-mesh sieve.

[0053] The medicinal residue was extracted twice with an appropriate amount of purified water, and the filtrates were combined after filtration. The filtrates were concentrated under reduced pressure to a clear paste with a relative density of 1.1-1.2 (measured at 60°C). The clear paste was placed in a constant temperature drying oven, dried, and then crushed into fine powder for later use. The pressure concentration conditions were: -0.08Mpa, temperature 60°C, drying temperature 60°C, and passed through an 80-mesh sieve. The medicinal powders extracted twice are mixed to obtain mixed medicinal powder.

[0054] Step 2: Weigh an appropriate amount of sea buckthorn dried fruit, crush the sea buckthorn dried fruit, and extract it for 5 hours at a pressure of 280 bar, a temperature of 535°C, and a CO2 flow rate of 2800 kg / h. After extraction, perform primary separation at a pressure of 105 bar and a temperature of 47°C, and then perform secondary separation at a pressure of 54 bar and a temperature of 32°C; let it stand at 42°C for 5 hours, and mix it evenly to obtain sea buckthorn oil.

[0055] Step 3: Weigh seabuckthorn oil, zedoary turmeric oil, and butylated cresol according to the prescribed amount and stir to mix evenly, then add the prescribed amount of polysorbate 80 to completely dissolve it.

[0056] Step 4: Add mixed Astragalus powder and total alkaloids of Sophora flavescens to purified water in sequence and stir quickly to mix evenly; dissolve sodium benzoate and add it to the above mixture.

[0057] Step 5: Slowly add the mixed solution obtained in step 3 to the above mixed solution, stir continuously, and add purified water to make up to the amount to obtain the Chinese medicine lotion.

[0058] Example 4 A traditional Chinese medicine lotion for treating gynecological diseases comprises the following raw materials in parts by weight: 16.2% total sophora flavescens alkaloids, 13% seabuckthorn oil, 1.8% zedoary turmeric oil, 69% astragalus, an appropriate amount of di-tert-butyl-p-cresol, an appropriate amount of polysorbate 80, and an appropriate amount of sodium benzoate.

[0059] The preparation method is as follows: Step 1. Weigh the prescribed amount of Astragalus slices, add appropriate amount of ethanol, stir evenly and extract twice, filter and combine the filtrate; recover the ethanol until there is no alcohol taste, and then concentrate under reduced pressure to a clear paste with a relative density of 1.1-1.2 (measured at 60°C). Dry the clear paste and grind it into fine powder for later use. The reduced pressure concentration conditions are: -0.06Mpa, temperature 50°C, drying temperature 55°C, and pass through an 80-mesh sieve.

[0060] The medicinal residue was extracted twice with an appropriate amount of purified water, and the filtrates were combined after filtration. The filtrates were concentrated under reduced pressure to a clear paste with a relative density of 1.1-1.2 (measured at 60°C). The clear paste was placed in a constant temperature drying oven, dried, and then crushed into fine powder for later use. The pressure concentration conditions were: -0.06Mpa, temperature 50°C, drying temperature 50°C, and passed through an 80-mesh sieve. The medicinal powders extracted twice are mixed to obtain mixed medicinal powder.

[0061] Step 2: Weigh an appropriate amount of sea buckthorn dried fruit, crush it, and extract it at a pressure of 290 bar, a temperature of 55°C, and a CO2 flow rate of 2850 kg / h for 5.5 hours. After extraction, perform primary separation at a pressure of 110 bar and a temperature of 50°C, and then perform secondary separation at a pressure of 55 bar and a temperature of 35°C; let it stand at 45°C for 6 hours, and mix it evenly to obtain sea buckthorn oil.

[0062] Step 3: Weigh seabuckthorn oil, zedoary turmeric oil, and butylated cresol according to the prescribed amount and stir to mix evenly, then add the prescribed amount of polysorbate 80 to completely dissolve it.

[0063] Step 4: Add mixed Astragalus powder and total alkaloids of Sophora flavescens to purified water in sequence and stir quickly to mix evenly; dissolve sodium benzoate and add it to the above mixture.

[0064] Step 5: Slowly add the mixed solution obtained in step 3 to the above mixed solution, stir continuously, and add purified water to make up to the amount to obtain the Chinese medicine lotion.

[0065] Example 5 A traditional Chinese medicine gel for treating gynecological diseases comprises the following raw materials in parts by weight: 12% total sophora flavescens alkaloids, 60% seabuckthorn oil, 3% zedoary turmeric oil, 25% astragalus, an appropriate amount of glycerin, an appropriate amount of vitamin E, an appropriate amount of polysorbate 80, and an appropriate amount of sodium benzoate.

[0066] The specific preparation method is as follows: Step 1. Weigh the prescribed amount of Astragalus slices, add appropriate amount of ethanol, stir evenly and extract twice, filter and combine the filtrate; recover the ethanol until there is no alcohol taste, and then concentrate under reduced pressure to a clear paste with a relative density of 1.1-1.2 (measured at 60°C). Dry the clear paste and grind it into fine powder for later use. The reduced pressure concentration conditions are: -0.06Mpa, temperature 50°C, drying temperature 55°C, and pass through an 80-mesh sieve.

[0067] The medicinal residue was extracted twice with an appropriate amount of purified water, and the filtrates were combined after filtration. The filtrates were concentrated under reduced pressure to a clear paste with a relative density of 1.1-1.2 (measured at 60°C). The clear paste was placed in a constant temperature drying oven, dried, and then crushed into fine powder for later use. The pressure concentration conditions were: -0.06Mpa, temperature 50°C, drying temperature 50°C, and passed through an 80-mesh sieve. The medicinal powders extracted twice are mixed to obtain mixed medicinal powder.

[0068] Step 2: Weigh an appropriate amount of sea buckthorn dried fruit, crush the sea buckthorn dried fruit, and extract it for 4.5 hours at a pressure of 270 bar, a temperature of 52°C, and a CO2 flow rate of 2750 kg / h. After extraction, perform primary separation at a pressure of 100 bar and a temperature of 45°C, and then perform secondary separation at a pressure of 55 bar and a temperature of 30°C; let it stand at 45°C for 4 hours and mix evenly to obtain sea buckthorn oil.

[0069] Step 3: Weigh seabuckthorn oil and zedoary turmeric oil according to the prescribed amount, add the prescribed amount of vitamin E and mix evenly, slowly add the prescribed amount of polysorbate 80 and stir continuously.

[0070] Step 4: Weigh the prescribed amount of matrix and add purified water to completely swell it, then add the astragalus mixed powder, the prescribed amount of total sophora flavescens alkaloids, glycerol, and sodium benzoate in sequence and stir until uniform; Step 5: Slowly add the mixture obtained in step 3 and stir continuously until a uniform and fine Chinese medicine gel is obtained.

[0071] Example 6 A traditional Chinese medicine gel for treating gynecological diseases comprises the following raw materials in parts by weight: 18% total sophora flavescens alkaloids, 25% seabuckthorn oil, 6% zedoary turmeric oil, 51% astragalus, an appropriate amount of glycerin, an appropriate amount of vitamin E, an appropriate amount of polysorbate 80, and an appropriate amount of sodium benzoate.

[0072] The specific preparation method is as follows: Step 1. Weigh the prescribed amount of Astragalus slices, add appropriate amount of ethanol, stir evenly and extract twice, filter and combine the filtrate; recover the ethanol until there is no alcohol taste, and then concentrate under reduced pressure to a clear paste with a relative density of 1.1-1.2 (measured at 60°C). Dry the clear paste and grind it into fine powder for later use. The reduced pressure concentration conditions are: -0.06Mpa, temperature 50°C, drying temperature 55°C, and pass through an 80-mesh sieve.

[0073] The medicinal residue was extracted twice with an appropriate amount of purified water, and the filtrates were combined after filtration. The filtrates were concentrated under reduced pressure to a clear paste with a relative density of 1.1-1.2 (measured at 60°C). The clear paste was placed in a constant temperature drying oven, dried, and then crushed into fine powder for later use. The pressure concentration conditions were: -0.06Mpa, temperature 50°C, drying temperature 50°C, and passed through an 80-mesh sieve. The medicinal powders extracted twice are mixed to obtain mixed medicinal powder.

[0074] Step 2: Weigh an appropriate amount of sea buckthorn dried fruit, crush the sea buckthorn dried fruit, and extract it for 5.5 hours at a pressure of 270 bar, a temperature of 55°C, and a CO2 flow rate of 2850 kg / h. After extraction, perform primary separation at a pressure of 100 bar and a temperature of 45°C, and then perform secondary separation at a pressure of 50 bar and a temperature of 35°C; let it stand at 45°C for 6 hours, and mix it evenly to obtain sea buckthorn oil.

[0075] Step 3: Weigh seabuckthorn oil and zedoary turmeric oil according to the prescribed amount, add the prescribed amount of vitamin E and mix evenly, slowly add the prescribed amount of polysorbate 80 and stir continuously.

[0076] Step 4: Weigh the prescribed amount of matrix and add purified water to completely swell it, then add the astragalus mixed powder, the prescribed amount of total sophora flavescens alkaloids, glycerol, and sodium benzoate in sequence and stir until uniform; Step 5: Slowly add the mixture obtained in step 3 and stir continuously until a uniform and fine Chinese medicine gel is obtained.

Claims

1. A pharmaceutical composition for treating gynecological diseases, characterized in that: According to mass percentage, it is composed of the following components: total sophora flavescens alkaloids 7.6%-44%, sea buckthorn oil 13%-60%, zedoary oil 1.8%-18%, and astragalus 18%-69%. The sum of the mass percentages of the above components is 100%.

2. The pharmaceutical composition for treating gynecological diseases according to claim 1, characterized in that According to mass percentage, it is composed of the following components: 13%-32% of total sophora flavescens alkaloids, 20%-46% of sea buckthorn oil, 2.1%-6.7% of zedoary oil, and 29%-57% of astragalus. The sum of the mass percentages of the above components is 100%.

3. The pharmaceutical composition for treating gynecological diseases according to claim 1, characterized in that By mass percentage, it is composed of the following components: 21% total alkaloids from Sophora flavescens, 31.6% from sea buckthorn oil, 5.3% from Curcuma zedoaria oil, and 42.1% from Astragalus membranaceus.

4. The method for preparing the pharmaceutical composition for treating gynecological diseases according to any one of claims 1 to 3, characterized in that: Please follow the steps below to implement: Step 1, Astragalus Extraction: Weigh the Astragalus slices and extract them with ethanol, filter the extract and set aside; extract the residue with purified water, filter and combine the filtrate, recover the ethanol, concentrate under reduced pressure to a paste, dry and crush it and set aside; Step 2, sea buckthorn oil extraction: crush the dried sea buckthorn fruit, extract with supercritical CO2, let it stand, separate and mix to obtain sea buckthorn oil; Step 3, weighing seabuckthorn oil, zedoary turmeric oil, and total sophora flavescens alkaloids according to the prescribed amount; mixing the seabuckthorn oil and zedoary turmeric oil evenly, adding total sophora flavescens alkaloids and astragalus mixed powder, and stirring evenly to obtain the pharmaceutical composition for treating gynecological diseases.

5. The method for preparing the pharmaceutical composition for treating gynecological diseases according to claim 4, characterized in that: The step 1 is specifically as follows: Step 1.1, weigh the Astragalus membranaceus slices and prepare them for use; Step 1.2, first add 10-12 times the amount of ethanol to the Astragalus slices, stir evenly, extract and filter for later use; second add 8-10 times the amount of ethanol to the Astragalus slices, stir evenly, extract and filter, and combine the two filtrates; Step 1.3: Recover ethanol from the filtrate of step 1.2 until there is no alcohol smell, then concentrate under reduced pressure to a paste, dry the paste, and grind it into fine powder for later use; Step 1.4, add appropriate amount of purified water to extract the residue 2-4 times, filter and combine the filtrates; concentrate the filtrate under reduced pressure to a paste, dry the paste and grind it into fine powder for later use; Step 1.5: Mix the powders obtained from the two extractions to obtain Astragalus powder.

6. The method for preparing the pharmaceutical composition for treating gynecological diseases according to claim 5, characterized in that: The paste in steps 1.4 and 1.5 is specifically a clear paste with a relative density of 1.1-1.2 at 60°C.

7. The method for preparing the pharmaceutical composition for treating gynecological diseases according to claim 5, characterized in that: The reduced pressure concentration conditions in step 1.3 are: -0.06~-0.08Mpa, temperature 50℃~60℃, drying temperature 55℃~65℃, and passing through an 80-mesh sieve. The reduced pressure concentration conditions in step 1.4 are: -0.06~-0.08Mpa, temperature 50℃~60℃, drying temperature 50℃~60℃, and passing through an 80-mesh sieve.

8. The method for preparing the pharmaceutical composition for treating gynecological diseases according to claim 5, characterized in that: The step 2 is specifically as follows: The dried sea buckthorn fruit is crushed and extracted for 4.5-5.5 hours at a pressure of 270-290 bar, a temperature of 52°C-55°C, and a CO2 flow rate of 2750-2850 kg / h. After extraction, the primary separation is carried out at a pressure of 100-110 bar and a temperature of 45°C-50°C, and then the secondary separation is carried out at a pressure of 50-55 bar and a temperature of 30-35°C. The sea buckthorn oil is obtained after standing at 40-45°C for 4-6 hours and mixing evenly.

9. Use of the pharmaceutical composition for treating gynecological diseases according to any one of claims 1 to 3 in the preparation of gynecological drugs.

10. Use of the pharmaceutical composition for treating gynecological diseases according to claim 9 in the preparation of gynecological drugs, characterized in that: The composition is prepared into a gynecological medicine in the form of suppository, lotion or gel.

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