CN114617837B - Gynecological traditional Chinese medicine lotion and preparation method thereof - Google Patents

Gynecological traditional Chinese medicine lotion and preparation method thereof Download PDF

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CN114617837B
CN114617837B CN202210103226.9A CN202210103226A CN114617837B CN 114617837 B CN114617837 B CN 114617837B CN 202210103226 A CN202210103226 A CN 202210103226A CN 114617837 B CN114617837 B CN 114617837B
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chinese medicine
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fructus
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CN114617837A (en
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向大位
佘艳艳
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Qianjin Pharmaceutical Co ltd
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Abstract

The invention discloses a gynecological traditional Chinese medicine lotion and a preparation method thereof. The method uses a composition for preparing gynecological traditional Chinese medicine lotion, wherein the composition contains fructus cnidii, cortex phellodendri, radix sophorae flavescentis, fructus kochiae, pepper, alum, radix stemonae, rhizoma curcumae and hydroxypropyl-beta-cyclodextrin. The invention relates to a gynaecologic traditional Chinese medicine lotion prepared according to the traditional Chinese medicine formula theory and the modern medicinal chemistry basic theory, which comprises effective plant volatile oil and aqueous extract aqueous solution. Meanwhile, the production technology avoids the problems that the traditional Chinese medicine lotion volatile oil and the water extraction solution cannot be dissolved together, the lotion is easy to delaminate after being stored for a long time, or the chemical solubilizer cannot be used, so that skin mucous membrane irritation occurs. The traditional Chinese medicine lotion prepared by the invention has the advantages of uniform oil-water mixing, no layering of the solution and synergistic effect of the antibacterial components of the components. The traditional Chinese medicine lotion prepared by the method provided by the invention has good antibacterial and antimicrobial effects, is mild, does not irritate, has stable quality, and can be stored and used for a long time.

Description

Gynecological traditional Chinese medicine lotion and preparation method thereof
Technical Field
The invention relates to the technical field of medicine manufacturing, in particular to a gynecological traditional Chinese medicine lotion and a preparation method thereof.
Background
Epidemic data show that gynecological inflammation, particularly colpitis and vulvitis, has become common diseases in women, and that more than 75% of adult women suffer from genital tract inflammatory infections with different degrees and multiple infections throughout life. Genital tract inflammation has been characterized by frequent and recurrent diseases, which seriously affect the quality of life and physical and mental health of females.
The traditional Chinese medicine considers that colpitis and vulvitis belong to the categories of leukorrhagia and pruritus vulvae, are mainly caused by downward flow of damp-heat, and have the symptoms of excessive leucorrhea, abnormal color, quality and smell, vulva, vaginal swelling and pain or pruritus or systemic symptoms, and white band specimens are taken for examination to see pathogen infection. Western medicine women believes that vaginitis and vulvitis are mainly caused by infection of one or more pathogens, including bacterial vaginosis, trichomonas vaginitis, mycotic vaginitis, nonspecific vaginitis and the like.
West Jin Wangshu and written "pulse meridian" describe: women's yin cold, middle energizer warming, sitting herbs and cnidium fruit powder. Cold in the yin is prone to generating dampness, and leucorrhea with white and thin color, pudendum itch and the like are usually seen. Grinding fructus Cnidii, mixing with rice flour, shaping like fructus Jujubae, wrapping with silk floss, and taking into yin. Fructus Cnidii, ben Jing (book of changes) records swelling and pain in yin of women, flaccidity, damp itching of yin of men, malignant sores and the like. It has warm nature and bitter and pungent taste, and can be used for treating yin-cold and cold-dampness leukorrhagia.
The "jin Kui Yao Lloyd" written by Zhang Jing Jiu is recorded: the women have adverse menstruation, abnormal leucorrhea and dry blood entrainment, and are mainly 'alum stone pills'; it is indicated for swelling, itching, scabies and other diseases by taking out the bitter cold, clearing heat and drying dampness to kill parasites. The traditional Chinese medicine treatment method of female genital tract inflammation is developed through medicine, and the external fumigation and washing hip bath method for treating colpitis is recommended by the diagnosis and treatment guide of gynecological common diseases-2012 of traditional Chinese medicine is adopted, and the decoction of fructus cnidii, pepper, alum, radix sophorae flavescentis, radix stemonae and the like is subjected to fumigation and then hip bath treatment.
At present, the traditional Chinese medicine lotion product has become an effective means and method for treating colpitis and vulvitis, and has become a main product for preventing and treating female genital tract inflammation. At present, according to the characteristics of active ingredients of traditional Chinese medicines, in the production and manufacturing process of the traditional Chinese medicine lotion, the active ingredients of the two water-soluble dissolution characteristics are mostly required to be respectively extracted by boiling and extracting the aromatic volatile oil, and in order to dissolve the aromatic volatile oil and the water-soluble ingredients mutually, the traditional Chinese medicine lotion is mostly added with a surfactant polysorbate-80 (solubilizer and foaming agent) component; or part of traditional Chinese medicine lotion products are not added with the solubilizer, so that the quality problems of layering, rancidity and the like of the lotion easily occur in the storage and use processes; or part of traditional Chinese medicine lotion products directly omit the extraction of aromatic volatile oil in the process of extracting the effective components, and only single water-soluble effective components are extracted by boiling.
The production and preparation methods of most traditional Chinese medicine lotion have the defects and shortcomings of different angles: (1) The traditional Chinese medicine lotion is added with the chemical surfactant polysorbate-80 as a solubilizer and a foaming agent, and the chemical components have obvious skin mucous membrane irritation and are easy to cause adverse reactions such as vaginal mucous membrane dryness, stinging and the like. Meanwhile, the chemical components have strong skin mucosa permeability, are easy to permeate into the skin mucosa and are accumulated for a long time. Especially, some patients with colpitis and vulvitis often have skin broken, and the surfactant has more irritation to mucous membrane and skin permeability. (2) The traditional Chinese medicine lotion is not added with chemical surfactant polysorbate-80, so that quality stability problems such as solution layering, rancidity and the like of lotion products are easy to occur during storage and use because of the difference of dissolution properties of aromatic volatile oil and water-soluble components extracted by water boiling. (3) In the extraction and preparation process of part of traditional Chinese medicine lotion, the extraction of aromatic volatile oil is omitted, the method does not accord with the theory of the traditional Chinese medicine formula, and meanwhile, the product curative effect of the traditional Chinese medicine lotion is greatly reduced.
In addition to the defects and inadequacies, most traditional Chinese medicine lotion has the quality problems of easy oxidation and deterioration, lost volatilization and the like when meeting heat and oxygen during storage and use because the aromatic volatile oil has stronger volatility and instability, thereby influencing the storage, the use and the curative effect of the traditional Chinese medicine lotion products.
Disclosure of Invention
The invention provides a gynecological traditional Chinese medicine lotion and a preparation method thereof, aiming at solving the problems of quality stability, effectiveness, irritation and the like of traditional Chinese medicine lotions.
The first object of the invention is to provide a composition for preparing gynecological traditional Chinese medicine lotion.
The second purpose of the invention is to provide a preparation method of gynecological traditional Chinese medicine lotion.
The third purpose of the invention is to provide the gynecological traditional Chinese medicine lotion prepared by the preparation method.
In order to achieve the above object, the present invention is realized by the following means:
the composition for preparing the gynecological traditional Chinese medicine lotion comprises the following components in parts by mass: 60-90 parts of fructus cnidii, 60-90 parts of amur corktree bark, 60-90 parts of lightyellow sophora root, 40-60 parts of belvedere fruit, 15-35 parts of Chinese prickly ash, 10-20 parts of alum, 45-75 parts of radix stemonae and 60-90 parts of zedoary.
Based on the traditional Chinese medicine theory and based on the recommended prescription of the diagnosis and treatment guide of the gynecopathy-2012 of the traditional Chinese medicine, the composition is added with three medicinal materials of cortex phellodendri, fructus kochiae and rhizoma zedoariae on the basis of the medicinal flavors of fructus cnidii, pepper, alum, radix sophorae flavescentis, radix stemonae and the like. Huang Baixing it is cold in nature and bitter in flavor, enters kidney meridian and bladder meridian, and is used for treating damp-heat diarrhea, jaundice and dark urine, itching of the lower extremities, stranguria due to heat, and pain due to stranguria. Kochiae fructus is pungent and bitter in taste, cold in nature, enters kidney and bladder meridians, and is used for relieving pain in urination, itching and leukorrhagia, rubella, eczema, skin itch and the like. The curcuma zedoary is pungent and bitter in taste and warm in nature, and enters liver and spleen meridians; the extracted volatile oil of Curcumae rhizoma has effects of promoting qi and blood circulation, resolving food stagnation and relieving pain, removing necrotic tissue and promoting granulation, and can relieve pain and promote healing of pathological tissue and wound surface for patients with colpitis and vulvitis accompanied with skin ulcer.
Preferably, the composition comprises the following components in parts by mass: 75 parts of fructus cnidii, 75 parts of amur corktree bark, 75 parts of lightyellow sophora root, 50 parts of belvedere fruit, 25 parts of Chinese prickly ash, 15 parts of alum, 60 parts of radix stemonae and 75 parts of rhizoma curcumae.
Preferably, the composition further comprises an inclusion agent.
More preferably, the inclusion agent is hydroxypropyl-beta-cyclodextrin.
A preparation method of gynecological traditional Chinese medicine lotion uses the composition.
Preferably, the preparation method comprises the following steps:
s1, adding water to fructus cnidii, pepper and rhizoma curcumae for distillation to obtain volatile oil and an aqueous extract;
s2, mixing the mixture of the fructus cnidii, the pepper, the curcuma zedoary and the water extract obtained in the step S1, and the mixture of the fructus cnidii, the pepper, the curcuma zedoary and the water extract, the cortex phellodendri, the radix sophorae flavescentis, the fructus kochiae and the radix stemonae, decocting, and filtering to obtain filtrate 1; mixing the filtrate 1 with Alumen, and filtering to obtain filtrate 2;
s3, uniformly mixing the volatile oil obtained in the step S1 with an aqueous solution of hydroxypropyl-beta-cyclodextrin to obtain a volatile oil clathrate compound;
s4, uniformly mixing the filtrate 2 obtained in the step S2 and the volatile oil inclusion compound obtained in the step S3.
Preferably, in the step S1, the mass of the distilled water is 6-8 times of the total mass of the fructus cnidii, the pepper and the rhizoma curcumae.
More preferably, in step S1, the mass of the distilled water is 7 times of the total mass of fructus cnidii, fructus zanthoxyli and rhizoma curcumae.
Preferably, in step S1, the distillation time is 4.5-6.5 h.
More preferably, in step S1, the distillation time is 5.5h.
Preferably, in step S2, the number of times of decoction is 2.
More preferably, in step S2, the method of decocting is: adding water to make up until the total mass of the liquid in the decoction system is 10 times of the mass of the medicinal materials, decocting for 2h, and filtering to obtain filtrate 1-1; adding water with the mass being 8 times of the mass of the medicinal materials, decocting for 1.5h, and filtering to obtain filtrate 1-2; mixing filtrate 1-1 and filtrate 1-2, and concentrating to obtain filtrate 1; the medicinal materials comprise fructus Cnidii, cortex Phellodendri, radix Sophorae Flavescentis, kochiae fructus, fructus Zanthoxyli, radix Stemonae and Curcumae rhizoma.
Preferably, in step S3, the preparation method of the aqueous solution of hydroxypropyl- β -cyclodextrin includes the following steps: and dissolving the hydroxypropyl-beta-cyclodextrin in purified water, and stirring while heating until the hydroxypropyl-beta-cyclodextrin is completely dissolved.
Preferably, in the step S3, the mass concentration of the hydroxypropyl- β -cyclodextrin in the aqueous solution of the hydroxypropyl- β -cyclodextrin is 35-45%.
More preferably, in step S3, the mass concentration of the hydroxypropyl- β -cyclodextrin in the aqueous solution of the hydroxypropyl- β -cyclodextrin is 40%.
Preferably, in step S3, the volatile oil obtained in step S1 is uniformly mixed with an aqueous solution of hydroxypropyl- β -cyclodextrin, and the method comprises the following steps: slowly adding the volatile oil obtained in the step (1) when the temperature of the aqueous solution of the hydroxypropyl-beta-cyclodextrin is reduced to 36 ℃, continuously stirring for 130min under the condition of 90r/min, and standing to obtain the volatile oil clathrate compound.
Preferably, in step S3, the mass of the hydroxypropyl- β -cyclodextrin is 4-12 times that of the volatile oil.
Further, in the step S3, the mass of the hydroxypropyl-beta-cyclodextrin is 8-12 times that of the volatile oil.
More preferably, in step S3, the mass of the hydroxypropyl- β -cyclodextrin is 8 times that of the volatile oil.
Preferably, in the step S4, after the filtrate 2 obtained in the step S2 and the volatile oil inclusion compound obtained in the step S3 are uniformly mixed, benzoic acid is added to adjust the pH to 4.3-6.5.
In step S4, the filtrate 2 obtained in step S2 and the volatile oil clathrate obtained in step S3 are mixed uniformly, and then benzoic acid is added to adjust the pH to 5.2.
More preferably, in step S4, the filtrate 2 obtained in step S2 and the volatile oil clathrate obtained in step S3 are mixed uniformly, and then benzoic acid is added to adjust the pH to 5.2, and then purified water is added, mixed uniformly and packaged.
Preferably, the total mass of the fructus cnidii, the amur corktree bark, the lightyellow sophora root, the belvedere fruit, the Chinese prickly ash, the alum, the radix stemonae and the curcuma zedoary in the composition is 440-460 g, and in the step S4, purified water is added to supplement to 450-550 mL.
More preferably, the total mass of fructus cnidii, cortex phellodendri, radix sophorae flavescentis, fructus kochiae, pepper, alum, radix stemonae and rhizoma curcumae in the composition is 450g, and purified water is added to make up 490-510 mL in the step S4.
Further, the total mass of fructus cnidii, cortex phellodendri, radix sophorae flavescentis, fructus kochiae, pepper, alum, radix stemonae and rhizoma curcumae in the composition is 450g, and in the step S4, purified water is added to supplement to 500mL.
The gynecological traditional Chinese medicine lotion prepared by the preparation method is also within the protection scope of the invention.
Compared with the prior art, the invention has the following beneficial effects:
according to the traditional Chinese medicine formula theory and the modern medicinal chemistry basic theory, the prepared gynecological traditional Chinese medicine lotion simultaneously comprises two kinds of medicinal effective components with solubility, and comprises effective plant volatile oil and aqueous extract aqueous solution. Meanwhile, the production technology avoids the problem that the traditional Chinese medicine lotion volatile oil and the water extraction solution cannot be dissolved together, the lotion is easy to delaminate after being stored for a long time, or the chemical solubilizer cannot be used, so that skin mucous membrane is stimulated. The traditional Chinese medicine lotion prepared by the invention has the advantages of uniform oil-water mixing, no layering of the solution and synergistic effect of the antibacterial components of the components. The traditional Chinese medicine lotion prepared by the method provided by the invention has good antibacterial and antimicrobial effects, is mild, does not irritate, has stable quality, and can be stored and used for a long time.
Detailed Description
The invention will be further illustrated in detail with reference to specific examples of the description, which are given solely for the purpose of illustration and are not intended to limit the scope of the invention. The test methods used in the following examples are conventional methods unless otherwise specified; the materials, reagents and the like used, unless otherwise specified, are those commercially available.
Example 1A method for preparing gynecological Chinese medicinal lotion
1. Chinese medicinal composition
The composition comprises the following components (450 g in total):
75 parts of fructus cnidii, 75 parts of amur corktree bark, 75 parts of lightyellow sophora root, 50 parts of belvedere fruit, 25 parts of Chinese prickly ash, 15 parts of alum, 60 parts of radix stemonae and 75 parts of rhizoma curcumae.
2. Preparation method of traditional Chinese medicine lotion
(1) Extracting the volatile oil of the cnidium fruit, the wild pepper and the curcuma zedoary by water distillation, wherein the mass of water is 7 times of the total mass of the cnidium fruit, the wild pepper and the curcuma zedoary, collecting the water extract and the volatile oil, and carrying out total distillation for 5.5h.
(2) Mixing the rest fructus Cnidii, fructus Zanthoxyli, curcumae rhizoma and water extract obtained in step (1) with the above cortex Phellodendri, radix Sophorae Flavescentis, kochiae fructus and radix Stemonae, and decocting in water twice. Adding water to supplement until the total mass of liquid in the decoction system is 10 times of the mass of the medicinal materials, decocting for 2h, and filtering to obtain filtrate 1-1; adding water with the mass being 8 times of the mass of the medicinal materials, decocting for 1.5h, and filtering to obtain filtrate 1-2; the medicinal materials comprise fructus Cnidii, cortex Phellodendri, radix Sophorae Flavescentis, kochiae fructus, fructus Zanthoxyli, radix Stemonae and Curcumae rhizoma. Mixing filtrate 1-1 and filtrate 1-2, and concentrating to obtain filtrate 1; adding the alum into the filtrate 1, stirring until the alum is completely dissolved, and filtering to obtain filtrate 2.
(3) And dissolving the hydroxypropyl-beta-cyclodextrin in purified water at 20-25 ℃, and stirring while heating until the hydroxypropyl-beta-cyclodextrin is completely dissolved to obtain an aqueous solution of the hydroxypropyl-beta-cyclodextrin with the mass concentration of 40%. Slowly adding the volatile oil obtained in the step (1) when the temperature of the aqueous solution of the hydroxypropyl-beta-cyclodextrin is reduced to 36 ℃, wherein the dosage mass ratio of the volatile oil to the hydroxypropyl-beta-cyclodextrin is (1): 8. stirring for 130min at 90r/min, and standing to obtain volatile oil clathrate.
(4) Adding the volatile oil inclusion compound obtained in the step (3) into the filtrate 2 of the step (2), stirring for 5min to uniformly mix the volatile oil inclusion compound and the filtrate 2 until the solution is uniformly black brown, adding a proper amount of benzoic acid to adjust the pH to 5.2, adding purified water to complement to 500mL, and subpackaging to obtain the gynecological traditional Chinese medicine lotion.
Example 2 preparation method of gynecological Chinese medicinal lotion
1. Chinese medicinal composition
The composition comprises the following components (450 g in total):
75 parts of fructus cnidii, 75 parts of amur corktree bark, 75 parts of lightyellow sophora root, 50 parts of belvedere fruit, 25 parts of Chinese prickly ash, 15 parts of alum, 60 parts of radix stemonae and 75 parts of rhizoma curcumae.
2. Preparation method of traditional Chinese medicine lotion
(1) Extracting the volatile oil of the cnidium fruit, the wild pepper and the curcuma zedoary by water distillation, wherein the mass of water is 7 times of the total mass of the cnidium fruit, the wild pepper and the curcuma zedoary, collecting the water extract and the volatile oil, and carrying out total distillation for 5.5h.
(2) Mixing the rest fructus Cnidii, fructus Zanthoxyli, curcumae rhizoma and water extract obtained in step (1) with the above cortex Phellodendri, radix Sophorae Flavescentis, kochiae fructus and radix Stemonae, and decocting in water twice. Adding water to supplement until the total mass of liquid in the decoction system is 10 times of the mass of the medicinal materials, decocting for 2h, and filtering to obtain filtrate 1-1; adding water with the mass being 8 times of the mass of the medicinal materials, decocting for 1.5h, and filtering to obtain filtrate 1-2; the medicinal materials comprise fructus Cnidii, cortex Phellodendri, radix Sophorae Flavescentis, kochiae fructus, fructus Zanthoxyli, radix Stemonae and Curcumae rhizoma. Mixing filtrate 1-1 and filtrate 1-2, and concentrating to obtain filtrate 1; adding the alum into the filtrate 1, stirring until the alum is completely dissolved, and filtering to obtain filtrate 2.
(3) And dissolving the hydroxypropyl-beta-cyclodextrin in purified water at 20-25 ℃, and stirring while heating until the hydroxypropyl-beta-cyclodextrin is completely dissolved to obtain an aqueous solution of the hydroxypropyl-beta-cyclodextrin with the mass concentration of 40%. Slowly adding the volatile oil obtained in the step (1) when the temperature of the aqueous solution of the hydroxypropyl-beta-cyclodextrin is reduced to 36 ℃, wherein the dosage mass ratio of the volatile oil to the hydroxypropyl-beta-cyclodextrin is (1): 4. stirring for 130min at 90r/min, and standing to obtain volatile oil clathrate.
(4) Adding the volatile oil inclusion compound obtained in the step (3) into the filtrate 2 of the step (2), stirring for 5min to uniformly mix the volatile oil inclusion compound and the filtrate 2 until the solution is uniformly black brown, adding a proper amount of benzoic acid to adjust the pH to 5.2, adding purified water to complement to 500mL, and subpackaging to obtain the gynecological traditional Chinese medicine lotion.
Example 3 preparation method of gynecological Chinese medicinal lotion
1. Chinese medicinal composition
The composition comprises the following components (450 g in total):
75 parts of fructus cnidii, 75 parts of amur corktree bark, 75 parts of lightyellow sophora root, 50 parts of belvedere fruit, 25 parts of Chinese prickly ash, 15 parts of alum, 60 parts of radix stemonae and 75 parts of rhizoma curcumae.
2. Preparation method of traditional Chinese medicine lotion
(1) Extracting the volatile oil of the cnidium fruit, the wild pepper and the curcuma zedoary by water distillation, wherein the mass of water is 7 times of the total mass of the cnidium fruit, the wild pepper and the curcuma zedoary, collecting the water extract and the volatile oil, and carrying out total distillation for 5.5h.
(2) Mixing the rest fructus Cnidii, fructus Zanthoxyli, curcumae rhizoma and water extract obtained in step (1) with the above cortex Phellodendri, radix Sophorae Flavescentis, kochiae fructus and radix Stemonae, and decocting in water twice. Adding water to supplement until the total mass of liquid in the decoction system is 10 times of the mass of the medicinal materials, decocting for 2h, and filtering to obtain filtrate 1-1; adding water with the mass being 8 times of the mass of the medicinal materials, decocting for 1.5h, and filtering to obtain filtrate 1-2; the medicinal materials comprise fructus Cnidii, cortex Phellodendri, radix Sophorae Flavescentis, kochiae fructus, fructus Zanthoxyli, radix Stemonae and Curcumae rhizoma. Mixing filtrate 1-1 and filtrate 1-2, and concentrating to obtain filtrate 1; adding the alum into the filtrate 1, stirring until the alum is completely dissolved, and filtering to obtain filtrate 2.
(3) And dissolving the hydroxypropyl-beta-cyclodextrin in purified water at 20-25 ℃, and stirring while heating until the hydroxypropyl-beta-cyclodextrin is completely dissolved to obtain an aqueous solution of the hydroxypropyl-beta-cyclodextrin with the mass concentration of 40%. Slowly adding the volatile oil obtained in the step (1) when the temperature of the aqueous solution of the hydroxypropyl-beta-cyclodextrin is reduced to 36 ℃, wherein the dosage mass ratio of the volatile oil to the hydroxypropyl-beta-cyclodextrin is (1): 12. stirring for 130min at 90r/min, and standing to obtain volatile oil clathrate.
(4) Adding the volatile oil inclusion compound obtained in the step (3) into the filtrate 2 of the step (2), stirring for 5min to uniformly mix the volatile oil inclusion compound and the filtrate 2 until the solution is uniformly black brown, adding a proper amount of benzoic acid to adjust the pH to 5.2, adding purified water to complement to 500mL, and subpackaging to obtain the gynecological traditional Chinese medicine lotion.
Example 4 preparation method of gynecological Chinese medicinal lotion
1. Chinese medicinal composition
The composition comprises the following components in parts by weight (460 g total):
60 parts of fructus cnidii, 90 parts of amur corktree bark, 90 parts of lightyellow sophora root, 40 parts of belvedere fruit, 35 parts of Chinese prickly ash, 10 parts of alum, 75 parts of radix stemonae and 60 parts of rhizoma curcumae.
2. Preparation method of traditional Chinese medicine lotion
(1) Extracting the volatile oil of the cnidium fruit, the wild pepper and the curcuma zedoary by water distillation, wherein the mass of water is 8 times of the total mass of the cnidium fruit, the wild pepper and the curcuma zedoary, collecting the water extract and the volatile oil, and carrying out total distillation for 6.5h.
(2) Mixing the rest fructus Cnidii, fructus Zanthoxyli, curcumae rhizoma and water extract obtained in step (1) with the above cortex Phellodendri, radix Sophorae Flavescentis, kochiae fructus and radix Stemonae, and decocting in water twice. Adding water to supplement until the total mass of liquid in the decoction system is 10 times of the mass of the medicinal materials, decocting for 2h, and filtering to obtain filtrate 1-1; adding water with the mass being 8 times of the mass of the medicinal materials, decocting for 1.5h, and filtering to obtain filtrate 1-2; the medicinal materials comprise fructus Cnidii, cortex Phellodendri, radix Sophorae Flavescentis, kochiae fructus, fructus Zanthoxyli, radix Stemonae and Curcumae rhizoma. Mixing filtrate 1-1 and filtrate 1-2, and concentrating to obtain filtrate 1; adding the alum into the filtrate 1, stirring until the alum is completely dissolved, and filtering to obtain filtrate 2.
(3) And dissolving the hydroxypropyl-beta-cyclodextrin in purified water at 20-25 ℃, and stirring while heating until the hydroxypropyl-beta-cyclodextrin is completely dissolved to obtain an aqueous solution of the hydroxypropyl-beta-cyclodextrin with the mass concentration of 40%. Slowly adding the volatile oil obtained in the step (1) when the temperature of the aqueous solution of the hydroxypropyl-beta-cyclodextrin is reduced to 36 ℃, wherein the dosage mass ratio of the volatile oil to the hydroxypropyl-beta-cyclodextrin is (1): 8. stirring for 130min at 90r/min, and standing to obtain volatile oil clathrate.
(4) Adding the volatile oil inclusion compound obtained in the step (3) into the filtrate 2 of the step (2), stirring for 5min to uniformly mix the volatile oil inclusion compound and the filtrate 2 until the solution is uniformly black brown, adding a proper amount of benzoic acid to adjust the pH to 5.2, adding purified water to complement to 500mL, and subpackaging to obtain the gynecological traditional Chinese medicine lotion.
Example 5 preparation method of gynecological Chinese medicinal lotion
1. Chinese medicinal composition
The composition comprises the following components in parts by weight (440 g in total):
90 parts of fructus cnidii, 60 parts of amur corktree bark, 60 parts of lightyellow sophora root, 60 parts of belvedere fruit, 15 parts of Chinese prickly ash, 20 parts of alum, 45 parts of radix stemonae and 90 parts of rhizoma curcumae.
2. Preparation method of traditional Chinese medicine lotion
(1) Extracting the volatile oil of the cnidium fruit, the wild pepper and the curcuma zedoary by water distillation, wherein the mass of water is 6 times of the total mass of the cnidium fruit, the wild pepper and the curcuma zedoary, collecting the water extract and the volatile oil, and carrying out total distillation for 4.5h.
(2) Mixing the rest fructus Cnidii, fructus Zanthoxyli, curcumae rhizoma and water extract obtained in step (1) with the above cortex Phellodendri, radix Sophorae Flavescentis, kochiae fructus and radix Stemonae, and decocting in water twice. Adding water to supplement until the total mass of liquid in the decoction system is 10 times of the mass of the medicinal materials, decocting for 2h, and filtering to obtain filtrate 1-1; adding water with the mass being 8 times of the mass of the medicinal materials, decocting for 1.5h, and filtering to obtain filtrate 1-2; the medicinal materials comprise fructus Cnidii, cortex Phellodendri, radix Sophorae Flavescentis, kochiae fructus, fructus Zanthoxyli, radix Stemonae and Curcumae rhizoma. Mixing filtrate 1-1 and filtrate 1-2, and concentrating to obtain filtrate 1; adding the alum into the filtrate 1, stirring until the alum is completely dissolved, and filtering to obtain filtrate 2.
(3) And dissolving the hydroxypropyl-beta-cyclodextrin in purified water at 20-25 ℃, and stirring while heating until the hydroxypropyl-beta-cyclodextrin is completely dissolved to obtain an aqueous solution of the hydroxypropyl-beta-cyclodextrin with the mass concentration of 40%. Slowly adding the volatile oil obtained in the step (1) when the temperature of the aqueous solution of the hydroxypropyl-beta-cyclodextrin is reduced to 36 ℃, wherein the dosage mass ratio of the volatile oil to the hydroxypropyl-beta-cyclodextrin is (1): 8. stirring for 130min at 90r/min, and standing to obtain volatile oil clathrate.
(4) Adding the volatile oil inclusion compound obtained in the step (3) into the filtrate 2 of the step (2), stirring for 5min to uniformly mix the volatile oil inclusion compound and the filtrate 2 until the solution is uniformly black brown, adding a proper amount of benzoic acid to adjust the pH to 5.2, adding purified water to complement to 500mL, and subpackaging to obtain the gynecological traditional Chinese medicine lotion. Comparative example 1A method for preparing gynecological Chinese medicinal lotion
1. Chinese medicinal composition
The composition comprises the following components (450 g in total):
75 parts of fructus cnidii, 75 parts of amur corktree bark, 75 parts of lightyellow sophora root, 50 parts of belvedere fruit, 25 parts of Chinese prickly ash, 15 parts of alum, 60 parts of radix stemonae and 75 parts of rhizoma curcumae.
2. Preparation method of traditional Chinese medicine lotion
(1) Extracting the volatile oil of the cnidium fruit, the wild pepper and the curcuma zedoary by water distillation, wherein the mass of water is 7 times of the total mass of the cnidium fruit, the wild pepper and the curcuma zedoary, collecting the water extract and the volatile oil, and carrying out total distillation for 5.5h.
(2) Mixing the rest fructus Cnidii, fructus Zanthoxyli, curcumae rhizoma and water extract obtained in step (1) with the above cortex Phellodendri, radix Sophorae Flavescentis, kochiae fructus and radix Stemonae, and decocting in water twice. Adding water to supplement until the total mass of liquid in the decoction system is 10 times of the mass of the medicinal materials, decocting for 2h, and filtering to obtain filtrate 1-1; adding water with the mass being 8 times of the mass of the medicinal materials, decocting for 1.5h, and filtering to obtain filtrate 1-2; the medicinal materials comprise fructus Cnidii, cortex Phellodendri, radix Sophorae Flavescentis, kochiae fructus, fructus Zanthoxyli, radix Stemonae and Curcumae rhizoma. Mixing filtrate 1-1 and filtrate 1-2, and concentrating to obtain filtrate 1; adding the alum into the filtrate 1, stirring until the alum is completely dissolved, and filtering to obtain filtrate 2.
(3) Adding the volatile oil obtained in the step (1) into the filtrate 2 of the step (2), slowly stirring and mixing uniformly, adding a proper amount of benzoic acid to adjust the pH to 5.2, adding purified water to complement to 500mL, and sub-packaging to obtain the gynecological traditional Chinese medicine lotion.
Comparative example 2 preparation method of gynecological traditional Chinese medicine lotion
1. Chinese medicinal composition
The composition comprises the following components (450 g in total):
75 parts of fructus cnidii, 75 parts of amur corktree bark, 75 parts of lightyellow sophora root, 50 parts of belvedere fruit, 25 parts of Chinese prickly ash, 15 parts of alum, 60 parts of radix stemonae and 75 parts of rhizoma curcumae.
2. Preparation method of traditional Chinese medicine lotion
(1) Decocting 7 kinds of materials including fructus Cnidii, cortex Phellodendri, radix Sophorae Flavescentis, kochiae fructus, fructus Zanthoxyli, radix Stemonae and Curcumae rhizoma in water twice. Adding water with the mass 10 times of the mass of the medicinal materials, decocting for 2 hours, and filtering to obtain filtrate 1-1; adding water with the mass being 8 times of the mass of the medicinal materials, and decocting for 1.5h to obtain filtrate 1-2; the medicinal materials comprise fructus Cnidii, cortex Phellodendri, radix Sophorae Flavescentis, kochiae fructus, fructus Zanthoxyli, radix Stemonae and Curcumae rhizoma. Mixing filtrate 1-1 and filtrate 1-2, and concentrating to obtain filtrate 1; adding the alum into the filtrate 1, stirring until the alum is completely dissolved, and filtering to obtain filtrate 2.
(2) And (3) adding a proper amount of benzoic acid into the filtrate 2 obtained in the step (1) to adjust the pH to 5.2, adding purified water to complement to 500mL, and subpackaging to obtain the gynecological traditional Chinese medicine lotion.
Comparative example 3 preparation method of gynecological traditional Chinese medicine lotion
1. Chinese medicinal composition
The composition comprises the following components (450 g in total):
75 parts of fructus cnidii, 75 parts of amur corktree bark, 75 parts of lightyellow sophora root, 50 parts of belvedere fruit, 25 parts of Chinese prickly ash, 15 parts of alum, 60 parts of radix stemonae and 75 parts of rhizoma curcumae.
2. Preparation method of traditional Chinese medicine lotion
(1) Extracting the volatile oil of the cnidium fruit, the wild pepper and the curcuma zedoary by water distillation, wherein the mass of water is 7 times of the total mass of the cnidium fruit, the wild pepper and the curcuma zedoary, collecting the water extract and the volatile oil, and carrying out total distillation for 5.5h.
(2) Mixing the rest fructus Cnidii, fructus Zanthoxyli, curcumae rhizoma and water solution obtained in step (1) with the above cortex Phellodendri, radix Sophorae Flavescentis, kochiae fructus and radix Stemonae, and decocting in water twice. Adding water to supplement until the total mass of liquid in the decoction system is 10 times of the mass of the medicinal materials, decocting for 2h, and filtering to obtain filtrate 1-1; adding water with the mass being 8 times of the mass of the medicinal materials, decocting for 1.5h, and filtering to obtain filtrate 1-2; the medicinal materials comprise fructus Cnidii, cortex Phellodendri, radix Sophorae Flavescentis, kochiae fructus, fructus Zanthoxyli, radix Stemonae and Curcumae rhizoma. Mixing filtrate 1-1 and filtrate 1-2, and concentrating to obtain filtrate 1; adding the alum into the filtrate 1, stirring until the alum is completely dissolved, and filtering to obtain filtrate 2.
(3) Adding the volatile oil obtained in the step (1) into the filtrate 2 in the step (2), adding polysorbate-80 (the adding amount of polysorbate-80 is 1.5%, m/v%), slowly and uniformly stirring until the volatile oil and the filtrate 2 are completely dissolved, adding a proper amount of benzoic acid to adjust the pH to 5.2, adding purified water to complement to 500mL, and sub-packaging to obtain the gynecological traditional Chinese medicine lotion.
Comparative example 4 preparation method of gynecological traditional Chinese medicine lotion
1. Chinese medicinal composition
The composition comprises the following components (450 g in total):
75 parts of fructus cnidii, 75 parts of amur corktree bark, 75 parts of lightyellow sophora root, 50 parts of belvedere fruit, 25 parts of Chinese prickly ash, 15 parts of alum, 60 parts of radix stemonae and 75 parts of rhizoma curcumae.
2. Preparation method of traditional Chinese medicine lotion
(1) Extracting the volatile oil of the cnidium fruit, the wild pepper and the curcuma zedoary by water distillation, wherein the mass of water is 7 times of the total mass of the cnidium fruit, the wild pepper and the curcuma zedoary, collecting the water extract and the volatile oil, and carrying out total distillation for 5.5h.
(2) Mixing the rest fructus Cnidii, fructus Zanthoxyli, curcumae rhizoma and water solution obtained in step (1) with the above cortex Phellodendri, radix Sophorae Flavescentis, kochiae fructus and radix Stemonae, and decocting in water twice. Adding water to supplement until the total mass of liquid in the decoction system is 10 times of the mass of the medicinal materials, decocting for 2h, and filtering to obtain filtrate 1-1; adding water with the mass being 8 times of the mass of the medicinal materials, decocting for 1.5h, and filtering to obtain filtrate 1-2; the medicinal materials comprise fructus Cnidii, cortex Phellodendri, radix Sophorae Flavescentis, kochiae fructus, fructus Zanthoxyli, radix Stemonae and Curcumae rhizoma. Mixing filtrate 1-1 and filtrate 1-2, and concentrating to obtain filtrate 1; adding the alum into the filtrate 1, stirring until the alum is completely dissolved, and filtering to obtain filtrate 2.
(3) Dissolving beta-cyclodextrin in purified water at 50 ℃, heating and stirring until the beta-cyclodextrin is completely dissolved, and obtaining an aqueous solution of the beta-cyclodextrin with the mass concentration of 4.8%. Slowly adding the volatile oil obtained in the step (1) when the temperature of the aqueous solution of the beta-cyclodextrin is reduced to 50 ℃, wherein the dosage mass ratio of the volatile oil to the beta-cyclodextrin is (1): 8. stirring at constant temperature of 50deg.C for 130min at 90r/min, and standing to obtain volatile oil clathrate.
(4) Adding the volatile oil inclusion compound obtained in the step (3) into the filtrate 2 of the step (2), stirring for 5min to uniformly mix the volatile oil inclusion compound and the filtrate 2 until the solution is uniformly black brown, adding a proper amount of benzoic acid to adjust the pH to 5.2, adding purified water to complement to 500mL, and subpackaging to obtain the gynecological traditional Chinese medicine lotion. Comparative example 5 preparation method of gynecological traditional Chinese medicine lotion
1. Chinese medicinal composition
The composition comprises the following components (175 g in total) in parts by weight:
75 parts of fructus cnidii, 25 parts of pepper and 75 parts of rhizoma curcumae.
2. Preparation method of traditional Chinese medicine lotion
(1) Extracting the volatile oil of the cnidium fruit, the wild pepper and the curcuma zedoary by water distillation, wherein the mass of water is 7 times of the total mass of the cnidium fruit, the wild pepper and the curcuma zedoary, collecting the volatile oil, and carrying out total distillation for 5.5 hours.
(2) And dissolving the hydroxypropyl-beta-cyclodextrin in purified water at 20-25 ℃, and stirring while heating until the hydroxypropyl-beta-cyclodextrin is completely dissolved to obtain an aqueous solution of the hydroxypropyl-beta-cyclodextrin with the mass concentration of 40%. Slowly adding the volatile oil obtained in the step (1) when the temperature of the aqueous solution of the hydroxypropyl-beta-cyclodextrin is reduced to 36 ℃, wherein the dosage mass ratio of the volatile oil to the hydroxypropyl-beta-cyclodextrin is (1): 8. stirring for 130min at 90r/min, and standing to obtain volatile oil clathrate.
(3) Adding the volatile oil inclusion compound obtained in the step (2) into purified water, stirring for 5min to uniformly mix the volatile oil inclusion compound and the purified water until the solution is in a uniform state, adding a proper amount of benzoic acid to adjust the pH to 5.2, adding purified water to complement to 195mL, and subpackaging to obtain the gynecological traditional Chinese medicine lotion.
Comparative example 6 preparation method of gynecological traditional Chinese medicine lotion
1. Chinese medicinal composition
The composition comprises the following components (450 g in total):
75 parts of fructus cnidii, 75 parts of amur corktree bark, 75 parts of lightyellow sophora root, 50 parts of belvedere fruit, 25 parts of Chinese prickly ash, 15 parts of alum, 60 parts of radix stemonae and 75 parts of rhizoma curcumae.
2. Preparation method of traditional Chinese medicine lotion
(1) Extracting the volatile oil of the cnidium fruit, the wild pepper and the curcuma zedoary by water distillation, wherein the mass of water is 7 times of the total mass of the cnidium fruit, the wild pepper and the curcuma zedoary, collecting the water extract and the volatile oil, and carrying out total distillation for 5.5h.
(2) Mixing the rest fructus Cnidii, fructus Zanthoxyli, curcumae rhizoma and water extract obtained in step (1) with the above cortex Phellodendri, radix Sophorae Flavescentis, kochiae fructus and radix Stemonae. Adding water to supplement until the total mass of liquid in the decoction system is 10 times of the mass of the medicinal materials, decocting for 2h, and filtering to obtain filtrate 1-1; adding water with the mass being 8 times of the mass of the medicinal materials, decocting for 1.5h, and filtering to obtain filtrate 1-2; the medicinal materials comprise fructus Cnidii, cortex Phellodendri, radix Sophorae Flavescentis, kochiae fructus, fructus Zanthoxyli, radix Stemonae and Curcumae rhizoma. Mixing filtrate 1-1 and filtrate 1-2, and concentrating to obtain filtrate 1; adding the alum into the filtrate 1, stirring until the alum is completely dissolved, and filtering to obtain filtrate 2.
(3) Dissolving methyl-beta-cyclodextrin in purified water at 20-25 deg.c while stirring until the methyl-beta-cyclodextrin is dissolved completely to obtain water solution with methyl-beta-cyclodextrin concentration of 4.8%. Slowly adding the volatile oil obtained in the step (1) when the temperature of the aqueous solution of the methyl-beta-cyclodextrin is reduced to 36 ℃, wherein the dosage mass ratio of the volatile oil to the methyl-beta-cyclodextrin is (1): 8. stirring for 130min at 90r/min, and standing to obtain volatile oil clathrate.
(4) Adding the volatile oil inclusion compound obtained in the step (3) into the filtrate 2 of the step (2), stirring for 5min to uniformly mix the volatile oil inclusion compound and the filtrate 2 until the solution is uniformly black brown, adding a proper amount of benzoic acid to adjust the pH to 5.2, adding purified water to complement to 500mL, and subpackaging to obtain the gynecological traditional Chinese medicine lotion. Application example 1 stability of gynecological Chinese medicinal lotion
1. Experimental method
(1) Long-term storage test
After the gynecological traditional Chinese medicine lotions of examples 1 to 5, comparative example 1, comparative example 4 and comparative example 6 are sealed, the traditional Chinese medicine lotions are placed for 36 months under the conditions of the temperature of 30+/-2 ℃ and the relative humidity of 60+/-5%, the state of the traditional Chinese medicine lotions is continuously observed, and the observation results are recorded periodically.
(2) Quality monitoring
The gynecological Chinese medicinal lotion of example 1 and comparative example 1 was placed at 30deg.C+ -2deg.C and relative humidity of 60% + -5% for 6 months, and sampled at the middle of the bottled lotion for 0, 1, 3, and 6 months, respectively, and the contents of matrine (water-soluble component) and cymene (main effective component of zedoary turmeric essential oil) were determined.
2. Experimental results
(1) Results of long-term storage experiments
The observation results of the gynecological Chinese medicinal washes of examples 1 to 5, comparative example 1, comparative example 4 and comparative example 6 are shown in Table 1.
Table 1 observations of long-term storage of gynecological Chinese medicinal washes of examples 1-5, comparative example 1, comparative example 4 and comparative example 6
As can be seen from table 1, the gynecological traditional Chinese medicine lotion of example 3 (i.e. the mass ratio of volatile oil to hydroxypropyl-beta-cyclodextrin=1:4) can meet the stability requirement of 24 months of storage, but at 36 months, a small amount of bubble foam is generated on the surface of the lotion. Whereas the gynecological traditional Chinese medicine lotion of examples 1-2 (i.e. the mass ratio of volatile oil to hydroxypropyl-beta-cyclodextrin=1:8 or 1:12) has equivalent mass stability for 36 months.
Therefore, when the mass of the hydroxypropyl-beta-cyclodextrin is 8-12 times of that of the volatile oil, the inclusion stability of the volatile oil is better. When the quality of the hydroxypropyl-beta-cyclodextrin is 12 times that of the volatile oil, the dosage of the hydroxypropyl-beta-cyclodextrin is higher when the quality of the product is not remarkably improved. Comprehensively considering that the quality of the hydroxypropyl-beta-cyclodextrin is 8 times of that of the volatile oil, the hydroxypropyl-beta-cyclodextrin is the optimal choice.
The gynecological Chinese medicinal washes of examples 4 to 5 were similar in observation results to those of examples 1 to 3.
The long-term storage observation result of the gynecological traditional Chinese medicine lotion of the comparative example 1 shows that the volatile oil and the water extraction solution are directly mixed, a small amount of foam exists on the surface of the solution after 0 month, and after storage, the volatile oil floats on the surface of the solution, and the stability of the lotion is obviously lower than that of the gynecological traditional Chinese medicine lotions of the examples 1-3. The long-term storage observation result of the gynecological traditional Chinese medicine lotion of the comparative example 4 shows that after the temperature of the lotion drops back to 30 ℃ in the storage condition, the beta-cyclodextrin loses the effective inclusion effect on the volatile oil because the solubility of the beta-cyclodextrin in the aqueous solution is reduced and the internal structure of the beta-cyclodextrin changes, and the volatile oil floats on the surface of the solution. Therefore, the stability of the gynecological traditional Chinese medicine lotion of comparative example 4 is also obviously lower than that of the gynecological traditional Chinese medicine lotions of examples 1 to 3.
Comparative example 6 the same quality stability effect of the traditional Chinese medicine lotions as in examples 1 to 3 was obtained by using water-soluble methyl-beta-cyclodextrin as an inclusion agent.
(2) Results of quality monitoring
The results of monitoring the contents of matrine (water-soluble component) and basket (essential component of zedoary turmeric essential oil) in the gynecological Chinese medicinal lotions of example 1 and comparative example 1 are shown in Table 2.
TABLE 2 quality monitoring results of gynecological Chinese medicinal washes of example 1 and comparative example 1
As can be seen from Table 2, the gynecological Chinese medicinal lotion of example 1 of the present invention was kept at a stable level in terms of the contents of the aromatic volatile oil and the water-soluble components extracted by boiling, although there were small fluctuations in the data of each measurement during the storage period of 6 months. When the gynecological traditional Chinese medicine lotion of the comparative example 1 is stored for only 1 month, the content of the volatile oil in the solution at the middle position of the bottled lotion is obviously reduced, after the bottled lotion is stored for 6 months, the solution at the middle position of the bottled lotion is basically free of the volatile oil, and the appearance surface is in a water-oil layered state.
Therefore, the quality stability of the traditional Chinese medicine lotion can be obviously improved by adding the hydroxypropyl-beta-cyclodextrin. The quality stability of the gynecological traditional Chinese medicine lotion added with the hydroxypropyl-beta-cyclodextrin is obviously superior to that of most traditional Chinese medicine lotion products which are used for simultaneously extracting volatile oil and water-soluble components by water boiling in the market, but are not added with chemical surfactant.
Application example 2 bacteriostatic effect of gynecological Chinese medicinal lotion
1. Experimental method
(1) Preparation of strains:
the nutrient agar medium was inoculated with staphylococcus aureus (bacteria), escherichia coli (bacteria), candida albicans (fungi) respectively using a sterile inoculating loop. Staphylococcus aureus and escherichia coli are cultured in a constant temperature incubator at 37 ℃ for 24 hours, and candida albicans is cultured in the constant temperature incubator at 37 ℃ for 48 hours. Single colonies of the three strains were picked up separately and diluted with sterile water to give strains at a concentration of about 1.5X10 8 CFU/mL of bacterial suspension.
(2) Determination of Minimum Inhibitory Concentration (MIC)
The gynecological traditional Chinese medicine washes of example 1, comparative example 2, comparative example 5 and comparative example 6 are respectively prepared into test liquid medicines with the mass concentration of 0.900g/mL, 0.450g/mL, 0.225g/mL, 0.112g/mL, 0.056g/mL, 0.028g/mL, 0.014g/mL, 0.007g/mL, 0.0035g/mL and 0.00176g/mL by a double dilution method, and 20 mu L of the bacterial suspension obtained in the step (1) is respectively added into each test liquid.
Placing into a 37 ℃ incubator, culturing staphylococcus aureus and escherichia coli for 24 hours, culturing candida albicans for 48 hours, observing the clarity of the test liquid in the example 1, the comparative example 2, the comparative example 5 and the comparative example 6, and recording the mass concentration of the medicinal materials corresponding to the clarified test liquid, namely the minimum antibacterial concentration of the traditional Chinese medicine lotion corresponding to gynecology.
(3) Determination of Minimum Bactericidal Concentration (MBC)
After the step (2) is completed, the inoculating loop is used for dipping the test liquid which is added with the bacterial suspension and clarified in the step (2), and the test liquid is streaked and inoculated in a nutrient agar culture dish.
Placing in a 37 ℃ incubator, culturing staphylococcus aureus and escherichia coli for 24 hours, and culturing candida albicans for 48 hours. And (3) observing whether strains grow on the culture dish, and recording the mass concentration of the medicinal materials corresponding to the test medicinal liquid without the strains, namely the minimum sterilization concentration of the corresponding gynecological traditional Chinese medicine lotion.
2. Experimental results
The minimum inhibitory concentrations of the gynecological Chinese medicinal lotions of example 1, comparative example 2, comparative example 5 and comparative example 6 are shown in Table 3, and the minimum inhibitory concentrations are shown in Table 4.
TABLE 3 minimum inhibitory concentration (medicinal mass concentration g/mL) of gynecological Chinese medicinal washes of example 1, comparative example 2, comparative example 5 and comparative example 6
Table 4 minimum sterilizing concentration (medicinal material mass concentration g/mL) of gynecological Chinese medicinal washes of example 1, comparative example 2, comparative example 5 and comparative example 6
From the results shown in tables 3 to 4, the gynecological Chinese medicinal lotion of the embodiment 1 of the invention has good antibacterial and antimicrobial effects on staphylococcus aureus, escherichia coli and candida albicans, and the minimum antibacterial concentration and the minimum bactericidal concentration of the gynecological Chinese medicinal lotion are superior to those of the gynecological Chinese medicinal lotions of the comparative examples 2 and 5.
Therefore, after the volatile oil is included by the hydroxypropyl-beta-cyclodextrin, the traditional Chinese medicine lotion containing the aromatic volatile oil and the water-soluble components extracted by boiling has better antibacterial and antibacterial effects, and the aromatic volatile oil and the water-soluble antibacterial components are synergistic with each other to exert better product curative effects.
The traditional Chinese medicine lotion of comparative example 6 uses methyl-beta-cyclodextrin as an inclusion material, so that the quality stability of the traditional Chinese medicine lotion is improved, and the irritation of skin mucous membrane can be reduced. However, the synergistic antibacterial and antibiotic effects of the aromatic volatile oil and the water-soluble antibacterial component in the lotion are obviously weaker than those of example 1, and the results show that the aromatic volatile oil inclusion and drug release performance of the hydroxypropyl-beta-cyclodextrin are better.
Application example 3 mucous membrane irritation of gynecological traditional Chinese medicine lotion
1. Experimental method
(1) Preparation of gynecological traditional Chinese medicine lotion diluent
The same volumes of the gynecological Chinese medicinal washes of example 1, comparative example 3 and comparative example 6 were respectively taken, and diluted 10 times with purified water to obtain the dilutions of example 1, comparative example 3 and comparative example 6.
(2) Animal experiment
9 healthy female rabbits were prepared, randomly divided into groups A, B and C, each group being 3, and each group being designated A-1, A-2, A-3, B-1, B-2, B-3, C-1, C-2, C-3, respectively.
The group A rabbits are fixed in a supine position, the vaginal orifice of the rabbits is exposed, the vaginal orifice of the rabbits is moistened and softened by the diluent of the embodiment 1, the rabbits are slowly inserted into the vagina of the rabbits by a syringe until the position 4-5 cm away from the vaginal orifice, 2mL of the diluent of the embodiment 1 is slowly injected, and the syringe is extracted. Group B rabbits were treated with the diluent of comparative example 3 and group C rabbits were treated with the diluent of comparative example 6 in the same manner.
Group a rabbits were treated with the diluent of example 1, group B rabbits were treated with the diluent of comparative example 3, and group C rabbits were treated with the diluent of comparative example 6 once a day for 7 consecutive days.
After 7 days, all rabbits were sacrificed, intact vagina was removed via laparotomy, longitudinal incision, and visual inspection for congestion, mucosal degeneration, edema, secretions, etc.
The vagina is fixed by formalin solution, three parts of the center and the two ends of the vagina are cut for tabletting, HE staining treatment and histopathological examination. And (3) observing the condition of the vaginal mucosa irritation lesion and the condition of microscopic histological change, recording the observation result in detail, and judging whether the irritation and the irritation degree exist or not based on the observation result.
2. Experimental results
The test results of the gynecological Chinese medicinal lotions of example 1, comparative example 3 and comparative example 6 on the irritation of rabbit mucous membrane are shown in Table 5.
Table 5 test results of gynecological Chinese medicinal lotions of example 1, comparative example 3 and comparative example 6 on irritation to mucous membrane
As can be seen from Table 5, the gynecological Chinese medicinal lotions of example 1 and comparative example 6 are substantially non-irritating to the vaginal mucosa of rabbits, and have good histocompatibility. In contrast, after the rabbits were treated with the gynecological Chinese medicinal lotion of comparative example 3 containing polysorbate-80 as a chemical surfactant for 7 days, the rabbits exhibited mild hyperemia symptoms, and the polysorbate-80 as a chemical surfactant had little penetration into the skin, causing mild inflammatory reaction in local tissues, and aggravated mucous membrane stimulating reaction if the treatment time was prolonged.
Therefore, compared with the traditional Chinese medicine lotion which is mostly added with chemical surfactant polysorbate-80 (solubilizer and foaming agent), the traditional Chinese medicine lotion has obvious biosafety advantage.
It should be noted that the above embodiments are merely for illustrating the technical solution of the present invention and not for limiting the scope of the present invention, and that other various changes and modifications can be made by one skilled in the art based on the above description and the idea, and it is not necessary or exhaustive to all embodiments. Any modification, equivalent replacement, improvement, etc. which come within the spirit and principles of the invention are desired to be protected by the following claims.

Claims (6)

1. The preparation method of the gynecological traditional Chinese medicine lotion is characterized by comprising the following steps of:
s1, adding water to fructus cnidii, pepper and rhizoma curcumae for distillation to obtain volatile oil and an aqueous extract;
s2, mixing the mixture of the fructus cnidii, the pepper, the curcuma zedoary and the water extract obtained in the step S1, and the mixture of the fructus cnidii, the pepper, the curcuma zedoary and the water extract, the cortex phellodendri, the radix sophorae flavescentis, the fructus kochiae and the radix stemonae, decocting, and filtering to obtain filtrate 1; mixing the filtrate 1 with Alumen, and filtering to obtain filtrate 2;
s3, uniformly mixing the volatile oil obtained in the step S1 with an aqueous solution of hydroxypropyl-beta-cyclodextrin to obtain a volatile oil clathrate compound; the mass of the hydroxypropyl-beta-cyclodextrin is 8 times of that of the volatile oil;
s4, uniformly mixing the filtrate 2 obtained in the step S2 and the volatile oil inclusion compound obtained in the step S3, and adding benzoic acid to adjust the pH to 5.2;
wherein, 60 to 90 parts of fructus cnidii, 60 to 90 parts of amur corktree bark, 60 to 90 parts of lightyellow sophora root, 40 to 60 parts of broom cypress fruit, 15 to 35 parts of Chinese prickly ash, 10 to 20 parts of alum, 45 to 75 parts of radix stemonae and 60 to 90 parts of zedoary.
2. The preparation method of claim 1, wherein the fructus cnidii is 75 parts, the cortex phellodendri is 75 parts, the radix sophorae flavescentis is 75 parts, the fructus kochiae is 50 parts, the fructus zanthoxyli is 25 parts, the alum is 15 parts, the radix stemonae is 60 parts and the rhizoma zedoariae is 75 parts.
3. The method according to claim 1, wherein in step S2, the number of times of the decoction is 2.
4. The preparation method according to claim 1, wherein in step S1, the mass of the distilled water is 6-8 times of the total mass of fructus cnidii, fructus Zanthoxyli and rhizoma Curcumae.
5. The method according to claim 4, wherein in step S1, the distilled water is 7 times of the total mass of fructus Cnidii, fructus Zanthoxyli and rhizoma Curcumae.
6. The gynecological Chinese medicinal lotion prepared by the preparation method of claims 1-5.
CN202210103226.9A 2022-01-27 2022-01-27 Gynecological traditional Chinese medicine lotion and preparation method thereof Active CN114617837B (en)

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* Cited by examiner, † Cited by third party
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