Chinese herbal medicine anhydrous fumigation expansion carrier and preparation method thereof

Abstract

The invention provides a Chinese herbal medicine anhydrous fumigation expansion carrier and a preparation method thereof, and relates to the technical field of gynecological medical instruments, the Chinese herbal medicine anhydrous fumigation expansion carrier comprises a vaginal expansion inner core, a traditional Chinese medicine composition, alkaline earth metal oxide and sodium dihydrogen phosphate, the vaginal dilation inner core is filled with the traditional Chinese medicine composition, the alkaline earth metal oxide and the sodium dihydrogen phosphate; the alkaline earth metal oxide and the sodium dihydrogen phosphate are respectively coated with a silicone oil emulsion layer or a polyvinyl alcohol film. The alkaline earth metal oxide reacts with moisture in menstrual blood to release heat, and the traditional Chinese medicine composition is fumigated under the condition of not additionally providing moisture, so that the release of active ingredients in the external traditional Chinese medicine composition is accelerated, the skin permeability is improved, the traditional Chinese medicine composition is fully released within 2-8 hours, and the medicine utilization rate is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of gynecological medical devices, in particular to a Chinese herbal medicine anhydrous fumigation expansion carrier and a preparation method thereof. BACKGROUND

[0002] Women are most susceptible to bacterial attack during menstruation. During this period, the elimination of menstrual blood changes the weak acidic environment in the vagina, creating conditions for bacterial growth and reproduction. During the use of sanitary plugs, bacteria are easily infected, and bacteria or other harmful substances in the excretory organ are easily transmitted to the reproductive organ, causing gynecological inflammation. At present, some sanitary plugs add Chinese medicine components to use the transdermal absorption principle of drugs for antibacterial or treatment of female gynecological diseases. However, the Chinese medicine components have the problems of poor skin permeability and low release efficiency as external drugs, and the replacement frequency of sanitary plug products is usually 2 to 8 hours, and the low release efficiency causes the drug components to be removed before being fully released, thereby causing low drug utilization. SUMMARY

[0003] The present application aims to solve the problems of poor skin permeability and low release efficiency of Chinese medicine when added to the vaginal tampon.

[0004] To solve the above problems, the present application provides a Chinese herbal medicine anhydrous fumigation expansion carrier and a preparation method thereof.

[0005] In a first aspect, the present application provides a Chinese herbal medicine anhydrous fumigation expansion carrier, which comprises a vaginal expansion inner core, a Chinese medicine composition, an alkaline earth metal oxide and sodium dihydrogen phosphate, the Chinese medicine composition, the alkaline earth metal oxide and the sodium dihydrogen phosphate are all filled in the vaginal expansion inner core; the alkaline earth metal oxide and the sodium dihydrogen phosphate are respectively coated with a silicone oil emulsion layer or a polyvinyl alcohol film; wherein the Chinese medicine composition comprises Sophora flavescens, Phellodendri Chinensis Cortex, Scutellaria baicalensis Georgi, Curcuma zedoary, Concha Mactrae, red lead, catechu, frankincense, myrrh, pig gall powder, borneol, ginseng, Cnidium, Astragalus, Herba Epimedii, Motherwort, Dipsacus, Saponaria, Cassia twig and licorice.

[0006] Optionally, the molar ratio of the alkaline earth metal oxide and the sodium dihydrogen phosphate is 1:1 to 1:2.

[0007] Optionally, the Chinese medicine composition comprises Sophora flavescens 10 to 15 parts, Phellodendri Chinensis Cortex 10 to 12 parts, Scutellaria baicalensis Georgi 9 to 12 parts, Curcuma zedoary 6 to 9 parts, Concha Mactrae 9 to 12 parts, red lead 1 to 2 parts, catechu 6 to 9 parts, frankincense 6 to 9 parts, myrrh 6 to 9 parts, pig gall powder 3 to 6 parts, borneol 1 to 3 parts, ginseng 5 to 7 parts, Cnidium 9 to 12 parts, Astragalus 12 to 18 parts, Herba Epimedii 9 to 12 parts, Motherwort 15 to 30 parts, Dipsacus 12 to 15 parts, Saponaria 3 to 6 parts, Cassia twig 6 to 9 parts, and licorice 5 to 7 parts by weight.

[0008] Optionally, the alkaline earth metal oxide is calcium oxide or light-burned magnesium oxide.

[0009] Optionally, the vaginal expansion inner core comprises, from outside to inside, an outer protective layer, an intermediate drug storage layer, and an inner fumigation layer, the traditional Chinese medicine composition is filled in the intermediate drug storage layer, and the alkaline earth metal oxide and sodium dihydrogen phosphate are filled in the inner fumigation layer.

[0010] Optionally, the outer protective layer comprises one or more of ethyl cellulose, hydrogenated vegetable oil, stearate, and povidone.

[0011] Optionally, the matrix of the intermediate drug storage layer comprises one or more of low-molecular-weight polyethylene glycol with a molecular weight less than PEG800 and glycerol gelatin.

[0012] Optionally, the matrix of the inner fumigation layer comprises one or more of sodium carboxymethyl cellulose, sodium alginate, and high-molecular-weight polyethylene glycol with a molecular weight not less than PEG4000.

[0013] Optionally, the inner fumigation layer further comprises a liquid-absorbing agent, and the liquid-absorbing agent comprises one or more of sodium polyacrylate, chitosan, carboxymethyl chitosan, and gelatin.

[0014] In a second aspect, the present application provides a preparation method of the Chinese herbal medicine anhydrous fumigation expansion carrier as described above, comprising the following steps: The alkaline earth metal oxide and sodium dihydrogen phosphate are respectively coated with a silicon oil emulsion layer or a polyvinyl alcohol film; The traditional Chinese medicine composition and the coated alkaline earth metal oxide and sodium dihydrogen phosphate are respectively added to a molten vaginal expansion inner core; The vaginal expansion inner core is formed by cooling at a temperature of 4 to 10℃; Ethylene oxide sterilization or cobalt-60 irradiation sterilization.

[0015] The Chinese herbal medicine anhydrous fumigation expansion carrier and the preparation method thereof have the following beneficial effects: the alkaline earth metal oxide reacts with water in the menstrual blood to release heat, the traditional Chinese medicine composition is fumigated without the need for additional water, the effective components of the externally used traditional Chinese medicine composition are accelerated to release and the skin permeability is improved, the traditional Chinese medicine composition is fully released within 2 to 8 hours, and the drug utilization rate is improved; the Chinese herbal medicine anhydrous fumigation expansion carrier can provide a warm and comfortable feeling, the skin pores are opened due to heat, the drug absorption capacity is enhanced, blood circulation is promoted, and good health care functions are achieved. The Chinese herbal medicine anhydrous fumigation expansion carrier further comprises sodium dihydrogen phosphate, after the alkaline earth metal oxide reacts with water to generate OH - , the sodium dihydrogen phosphate reacts with OH -The reaction, the inhibition system pH jump causes the alkaline earth metal oxide and water reaction to accelerate, and reduce the pH value of the system, so that the Chinese herbal medicine anhydrous fumigation swelling carrier remains neutral or slightly acidic, healthy skin is weakly acidic, the pH value is between 5.0-6.5, the slightly acidic environment is helpful to maintain the natural barrier function of the skin, inhibit the growth of harmful bacteria, and at the same time, it is beneficial to the existence of beneficial bacteria. The alkaline earth metal oxide and sodium dihydrogen phosphate are respectively coated with a silicone oil emulsion layer or a polyvinyl alcohol film, so that the alkaline earth metal oxide and sodium dihydrogen phosphate can be gradually dissolved and released, the reaction time is prolonged to 2 to 6 hours, the local overheating caused by the rapid reaction of the alkaline earth metal oxide with water is avoided, and the local pH jump is also avoided. Also can keep Chinese herbal medicine anhydrous fumigation swelling carrier continuously release heat during use. BRIEF DESCRIPTION OF DRAWINGS

[0016] Figure 1 The flow chart of the preparation method of the Chinese herbal medicine anhydrous fumigation swelling carrier of the embodiments of the present application. DETAILED DESCRIPTION

[0017] In order to make the above-mentioned objects, features and advantages of the present application more obvious and easy to understand, the specific embodiments of the present application will be described in detail below with reference to the drawings. Although some embodiments of the present application are shown in the drawings, it should be understood that the present application can be realized in various forms, and should not be interpreted as being limited to the embodiments described herein, on the contrary, these embodiments are provided to make the present application more thorough and complete. It should be understood that the drawings and embodiments of the present application are only for exemplary purposes, and are not intended to limit the scope of protection of the present application.

[0018] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present application belongs. The terms used in the specification of the present application are only for the purpose of describing the specific embodiments, and are not intended to limit the present application; The term "comprising" and its variants as used herein are open-ended, that is "including but not limited to"; the term "based on" is "at least partially based on"; the term "one embodiment" means "at least one embodiment"; the term "another embodiment" means "at least one additional embodiment"; the term "some embodiments" means "at least some embodiments"; the term "optionally" means "optional embodiments". Related definitions of other terms will be given in the following description. Therefore, the features limited by "first" and "second" can be explicitly or implicitly included. In the description of the present application, unless otherwise stated, the meaning of "a plurality of" is two or more.

[0019] In the related art, women are susceptible to bacterial attack during menstruation, and the removal of menstrual blood changes the weak acidic environment in the vagina, creating conditions for bacterial proliferation. The use of sanitary plugs is prone to bacterial infection, and the existing sanitary plugs have the problem of low transdermal absorption efficiency of the added traditional Chinese medicine components. The drug components are not fully released and are removed, resulting in insufficient drug utilization. In addition, the vaginal tampon products also have problems such as uneven distribution of drug components, easy inactivation of active ingredients, and poor use comfort, which are difficult to meet the clinical treatment needs. Although the traditional fumigation therapy has definite effect, it needs professional equipment and is inconvenient to operate, and cannot realize daily family care. These problems seriously restrict the application effect of traditional Chinese medicine in the field of gynecological external preparations.

[0020] In view of the problems in the above related art, the embodiments of the present application provide a Chinese herbal medicine anhydrous fumigation expansion carrier and a preparation method thereof.

[0021] The Chinese herbal medicine anhydrous fumigation expansion carrier provided by an embodiment of the present application comprises a vaginal expansion inner core, a traditional Chinese medicine composition, an alkaline earth metal oxide and sodium dihydrogen phosphate, and the traditional Chinese medicine composition, the alkaline earth metal oxide and the sodium dihydrogen phosphate are all filled in the vaginal expansion inner core. The alkaline earth metal oxide and the sodium dihydrogen phosphate are respectively coated with a silicone oil emulsion layer or a polyvinyl alcohol film. The traditional Chinese medicine composition comprises Sophora flavescens, Phellodendri Cortex, Scutellaria baicalensis, Curcuma zedoary, Concha Mactrae, red lead, catechu, frankincense, myrrh, pig gall powder, borneol, ginseng, Cnidium, Astragalus, Herba Epimedii, Motherwort, Dipsacus, Gleditsia sinensis, Cinnamomum cassia and licorice.

[0022] In the embodiment, the alkaline earth metal oxide reacts with water in the menstrual blood to release heat. Without the need for additional water, the traditional Chinese medicine composition is fumigated, so that the effective components of the external traditional Chinese medicine composition are accelerated and the skin permeability is improved. The traditional Chinese medicine composition is fully released in 2 to 8 hours, and the drug utilization rate is improved. The Chinese herbal medicine anhydrous fumigation expansion carrier can provide a warm and comfortable feeling. The skin pores open when the skin is heated, the drug absorption capacity is enhanced, and blood circulation is also promoted, which has good health care function. The Chinese herbal medicine anhydrous fumigation expansion carrier also comprises sodium dihydrogen phosphate. After the alkaline earth metal oxide reacts with water to generate OH - , the sodium dihydrogen phosphate reacts with OH -The reaction, the inhibition system pH jump caused by alkaline earth metal oxide and water reaction acceleration, and reduce the pH of the system, the Chinese herbal medicine anhydrous fumigation swelling carrier to keep neutral or slightly acidic, healthy skin is weak acid, pH between 5.0-6.5, slightly acidic environment helps to maintain the natural barrier function of the skin, inhibit the growth of harmful bacteria, while conducive to the existence of beneficial bacteria. Alkaline earth metal oxide and sodium dihydrogen phosphate are coated with silicone emulsion layer or polyvinyl alcohol film respectively, so that alkaline earth metal oxide and sodium dihydrogen phosphate can be gradually dissolved and released, the reaction time is prolonged to 2 to 6 hours, avoiding the rapid reaction of alkaline earth metal oxide with water, which can cause local overheating and scalding or local pH jump, and can also maintain the continuous release of heat of Chinese herbal medicine anhydrous fumigation swelling carrier during use.

[0023] The drug layer anhydrous fumigation vulva can promote blood circulation to remove blood stasis, remove dampness and relieve itching, clear heat and detoxify, dry dampness and kill insects, remove corruption and promote muscle regeneration, resolve blood stasis and relieve pain, relieve dysmenorrhea and female diseases, promote metabolism, improve blood circulation, relieve physiological pain, expel cold and damp, warm the uterus, resist cold, and inhibit the growth of bacteria during the physiological period.

[0024] By establishing a synergistic system of antibacterial ingredients, penetration enhancer and immunomodulator, the active ingredients are released in stages triggered by body temperature. Matrine first inhibits surface pathogens, Zedoary oil then carries Boswellia resin into tissue gaps, and ginsenosides finally activate the repair mechanism, forming a hierarchical treatment effect. The problem of low penetration efficiency caused by unreasonable component compatibility of traditional Chinese medicine suppositories is solved, and the directional release and efficient absorption of drug components are achieved in the special physiological environment during the menstrual period, while avoiding the waste of drugs caused by frequent replacement of sanitary suppositories.

[0025] Specifically, Sophora, Phellodendron, Scrophularia, and Cnidium are plant extracts with broad-spectrum antibacterial effects, which can be achieved by water extraction or alcohol extraction process, and can relieve gynecological inflammation by inhibiting the growth of pathogenic microorganisms. Zedoary, Frankincense, Myrrh, and Saponin are substances containing volatile oil and resin components, which can be achieved by mixing with other ingredients after being ground, and can promote drug penetration by improving local blood circulation. Borneol and pig gall powder are natural transdermal absorption enhancers, which can be achieved by micronization, and can improve the release efficiency of active ingredients by reducing the barrier effect of the stratum corneum. Ginseng, Astragalus, Epimedium, Motherwort, and Dipsacus are tonic herbs containing saponins and polysaccharides, which can be achieved by grinding the low-temperature dried powder, and can enhance the treatment effect by adjusting the local immune function. Shell powder, red lead, and catechu are astringent ingredients containing calcium salts and tannins, which can be achieved by sieving after calcination, and can adapt to the menstrual physiological environment by forming a protective film. Cassia twig, Fructus Aurantii, and Radix Glycyrrhizae are tonifying medicinal materials containing volatile components and flavonoids, which can be achieved by gradient extraction process, and can improve the comfort of use by reducing the mucosa irritation.

[0026] Matrine and baicalin form a complex, which has improved solubility in the weak alkaline environment of the vagina and synergistically inhibits the proliferation of Candida albicans and anaerobes. Olibanum resin and commiphoric acid soften at body temperature, encapsulating zedoary oil to form lipid microspheres that penetrate subcutaneous tissue through the hair follicle pathway. Borneol binds with bile acids in swine gall powder, changing the lipid arrangement structure of the cell membrane and promoting the transmembrane transport of oblate and astragaloside. Ginsenosides and icariin act on receptors on vaginal epithelial cells, upregulate the expression of defensins, and enhance local immune responses. Calcium carbonate in conchaespiralis powder forms a porous adsorption structure after contact with menstrual blood, loading iron oxide particles in red lead to achieve sustained hemostasis. Volatile oil of ramulus cinnamomi and citrus aurantium flavonoids are released slowly in a sodium carboxymethyl cellulose matrix, neutralizing the mucosal dryness caused by glycyrrhizic acid.

[0027] Specifically, the step of coating the alkaline earth metal oxide with the silicone oil emulsion layer is as follows: The surface of the alkaline earth metal oxide is pretreated with an ethanol solution of aminopropyl triethoxysilane (KH-550) to hydrophobize the surface of the alkaline earth metal oxide, and the alkaline earth metal oxide is ground to micron size after drying to prevent agglomeration of the alkaline earth metal oxide; Silicone oil emulsion is prepared by dissolving silicone oil (30% by mass) + Span-80 (2% by mass) in cyclohexane (oil phase), slowly adding an aqueous phase containing 1% (by mass) Tween-80, stirring at 50°C, and centrifugal homogenization emulsification (centrifugal force 10,000 rpm, speed 5 min) to form silicone oil emulsion; The hydrophobized alkaline earth metal oxide powder is added to the silicone oil emulsion, ultrasonically dispersed for 30 min, and the solvent is evaporated to obtain microparticles of the alkaline earth metal oxide coated with the silicone oil emulsion layer.

[0028] Specifically, the step of coating the sodium dihydrogen phosphate with the silicone oil emulsion layer is as follows: A 20% (by mass) aqueous solution of sodium dihydrogen phosphate is prepared and filtered to remove impurities; Silicone oil (10% by mass) + Tween-80 (3% by mass) is mixed and slowly added to an aqueous phase containing 0.5% (by mass) polyvinyl alcohol, and homogenization emulsification is performed at a high pressure of 15 MPa to form a silicone oil emulsion; The aqueous solution of sodium dihydrogen phosphate is blended with the silicone oil emulsion, and spray drying (inlet temperature 180°C) is performed to form microcapsules, obtaining microparticles of sodium dihydrogen phosphate coated with the silicone oil emulsion layer.

[0029] Specifically, the step of coating the alkaline earth metal oxide with the polyvinyl alcohol film is as follows: Polyvinyl alcohol (10 wt%) is dissolved in water at 80°C, glycerol is added as a plasticizer, and 1% (by mass) boric acid is added as a crosslinking agent to obtain a polyvinyl alcohol solution; The surface of the alkaline earth metal oxide nanoparticles is hydrophobized by treatment with an ethanol solution of aminopropyl triethoxysilane (KH-550); The hydrophobicized alkaline earth metal oxide nanoparticles were dispersed into the polyvinyl alcohol solution, and ultrasonic treatment was performed for 10 min to obtain a mixed solution; Film formation: The mixed solution was poured on a polytetrafluoroethylene plate, and dried at room temperature for 24 h to form an alkaline earth metal oxide uniformly coated polyvinyl alcohol film, and the thickness of the polyvinyl alcohol film was 50-100 μm.

[0030] Specifically, the step of coating the polyvinyl alcohol film with sodium dihydrogen phosphate was as follows: Polyvinyl alcohol (10 wt%) was dissolved in water at 80°C, and 1% (mass fraction) borax and 2% (volume fraction) glycerol were added as a crosslinking agent and a plasticizer, respectively, to obtain a polyvinyl alcohol solution; The surface of the sodium dihydrogen phosphate was hydrophobically treated with an ethanol solution of aminopropyltriethoxysilane (KH-550); The hydrophobically treated sodium dihydrogen phosphate (5-20 wt%) was dispersed into the polyvinyl alcohol solution, and ultrasonic homogenization was performed for 10 min; Pouring on a polytetrafluoroethylene plate, drying at 50°C for 24 h to form a sodium dihydrogen phosphate uniformly coated polyvinyl alcohol film, and the thickness of the polyvinyl alcohol film was 50-100 μm.

[0031] Specifically, the vaginal expansion inner core refers to a carrier structure with water absorption and expansion properties, which can be realized by using a multi-layer composite matrix material, for carrying drug components and physically expanding to contact the vaginal wall. The alkaline earth metal oxide refers to an inorganic compound that can react with water to generate alkaline substances, which can be realized by using calcium oxide or light-burned magnesium oxide, for reacting with body fluids to generate heat. The sodium dihydrogen phosphate refers to an acidic phosphate compound, which can be realized in a crystalline or powder state, for reacting with the alkaline earth metal oxide to generate carbon dioxide gas. The silicone oil emulsion layer refers to a hydrophobic coating film with silicone oil as the matrix, which can be formed by a spray coating process, for delaying the contact time of the reaction components with the body fluids. The polyvinyl alcohol film refers to a water-soluble polymer coating layer, which can be formed by a fluidized bed coating process, for controlling the release rate of the reaction components.

[0032] The water-absorbed and expanded vaginal expansion inner core is in close contact with the vaginal wall, ensuring that the drug components are fully delivered to the lesion site. The alkaline earth metal oxide and the sodium dihydrogen phosphate undergo acid-base neutralization reaction after the penetration of body fluids, generating heat and carbon dioxide gas. The heat promotes local blood circulation, enhancing the transdermal absorption efficiency of traditional Chinese medicine ingredients; the gas generation forms a micro-environment disturbance, accelerating the diffusion of drug molecules. The silicone oil emulsion layer delays the initial reaction of strong alkaline substances such as calcium oxide through hydrophobic properties, avoiding the premature consumption of effective ingredients; the polyvinyl alcohol film gradually dissolves after contacting the body fluids, controlling the release timing of sodium dihydrogen phosphate, so that the reaction continues until the drug is completely released.

[0033] The embodiment realizes reaction trigger phased control through differential coating materials, so that the drug release rate and action time are dynamically adapted. Efficient release and transdermal absorption of traditional Chinese medicine components in the vaginal environment are realized, the drug penetration efficiency is enhanced through fumigation effect, and the problem of low utilization rate caused by premature removal of the drug is avoided. The phased release control of the reaction components ensures that the drug action time matches the clinical treatment period, and the treatment effect is improved.

[0034] Optionally, the molar ratio of the alkaline earth metal oxide and sodium dihydrogen phosphate is 1:1 to 1:2.

[0035] In the optional embodiment, the molar ratio of the added alkaline earth metal oxide and sodium dihydrogen phosphate is 1:1 to 1:2. When the molar ratio of the alkaline earth metal oxide and sodium dihydrogen phosphate is 1:1, complete reaction can be achieved, so that the anhydrous fumigation layer remains neutral. When the molar ratio of the alkaline earth metal oxide and sodium dihydrogen phosphate is 1:2, part of the sodium dihydrogen phosphate is unreacted, so that the anhydrous fumigation layer is slightly acidic. The slightly acidic environment helps to maintain the natural barrier function of the skin.

[0036] Optionally, the traditional Chinese medicine composition includes Sophora flavescens 10 to 15 parts, Phellodendri Cortex 10 to 12 parts, Scutellaria baicalensis 9 to 12 parts, Curcuma zedoary 6 to 9 parts, Concha Mactra 9 to 12 parts, Red lead 1 to 2 parts, Uncaria 6 to 9 parts, Frankincense 6 to 9 parts, Myrrh 6 to 9 parts, Pig gall 3 to 6 parts, Borneol 1 to 3 parts, Ginseng 5 to 7 parts, Cnidium 9 to 12 parts, Astragalus 12 to 18 parts, Herba Epimedii 9 to 12 parts, Motherwort 15 to 30 parts, Dipsacus 12 to 15 parts, Gleditsia sinensis 3 to 6 parts, Cassia twig 6 to 9 parts, Citrus aurantium 6 to 9 parts, and Glycyrrhiza 5 to 7 parts.

[0037] In the optional embodiment, by limiting the accurate proportioning range of each component, a synergistic system of small molecule active ingredients, penetration enhancers and sustained-release matrix is formed, realizing the dual effects of rapid release and sustained penetration within a limited action time. The problem of insufficient drug utilization caused by poor transdermal absorption and low release efficiency of the traditional Chinese medicine composition in the expanded carrier is solved. The active ingredients form a rapid-release antibacterial and anti-inflammatory combination under optimized proportioning, and the sustained-release matrix prolongs the drug action time, so that the drug is fully released within the sanitary plug replacement cycle. Balanced proportioning of penetration components and astringent components reduces the risk of mucous membrane irritation, and the synergistic effect of blood-activating and stasis-removing components and qi-supplementing and tonifying components improves the local treatment effect.

[0038] Specifically, the proportions of Sophora flavescens, Phellodendron chinense, and Scutellaria baicalensis are set within a high-proportion range for the main antibacterial and anti-inflammatory components. For example, Sophora flavescens can be 10 to 15 parts, Phellodendron chinense 10 to 12 parts, and Scutellaria baicalensis 9 to 12 parts, ensuring basic antibacterial efficacy. The proportions of Curcuma zedoaria, Boswellia carterii, and Commiphora myrrha are set at 6 to 9 parts to enhance blood circulation and remove blood stasis. The proportion of red lead is set at 1 to 2 parts to exert an astringent effect and avoid toxicity risks through low dosage. The proportions of borneol and pig bile powder are set at 1 to 3 parts and 3 to 6 parts, respectively, to synergistically enhance drug permeability. The proportions of ginseng and Astragalus membranaceus are set at 5 to 7 parts and 12 to 18 parts, respectively, to tonify qi, strengthen the body, and balance the medicinal properties. The proportions of Leonurus japonicus and Dipsacus asper are set at 15 to 30 parts and 12 to 15 parts, respectively, to regulate uterine contraction function. The proportions of Gleditsia sinensis thorns, Cinnamomum cassia twigs, and Citrus aurantium are set at 3 to 6 parts, 6 to 9 parts, and 6 to 9 parts, respectively, to dredge the meridians and promote the flow of qi. The proportion of Glycyrrhiza uralensis is set at 5 to 7 parts, to harmonize the medicinal properties of each component.

[0039] Specifically, matrine and baicalin, as small-molecule active ingredients, form a high-concentration combination within the ratio range of matrine, phellodendron, and scutellaria. Through synergistic effects with borneol as a penetration enhancer, they can improve the drug's penetration efficiency in the vaginal mucosa. Astragalus polysaccharides and icariin, in a ratio of 12-18 parts astragalus and 9-12 parts icariin, form a sustained-release matrix, prolonging the duration of action of the active ingredients. Curcuma zedoaria, frankincense, and myrrh, in a range of 6-9 parts, release volatile oil components, promoting local blood circulation to enhance drug absorption. Red lead, at a low dose of 1-2 parts, forms an astringent film, avoiding mucosal irritation caused by excessive metal ions. Ginsenosides and astragalus polysaccharides, in ratios of 5-7 parts and 12-18 parts, regulate the immune microenvironment, reducing the risk of mucosal damage from antiviral drugs. At high doses of 15 to 30 parts, Leonurus japonicus alkaloids enhance uterine smooth muscle contraction and, when combined with Dipsacus asperoides at a ratio of 12 to 15 parts, synergistically regulate menstrual flow efficiency.

[0040] Optionally, the alkaline earth metal oxide is calcium oxide or lightly calcined magnesium oxide.

[0041] In this optional embodiment, both calcium oxide and light-burned magnesium oxide can react with water at room temperature to release heat. Calcium oxide controls the reaction interface through the coating layer, allowing the heat to be released in stages; light-burned magnesium oxide uses its porous structure to adsorb the reaction products, allowing the gas to be released uniformly. The combination of the two with sodium dihydrogen phosphate forms an acid-base system that can maintain a more stable reaction kinetics process compared to a single heat-generating agent. This achieves a gradient release of drug components: in the early stage, calcium oxide is used to quickly release volatile antibacterial components to kill pathogens; in the middle stage, light-burned magnesium oxide is used to continuously release drug components to maintain therapeutic concentrations; and in the later stage, the buffer system is used to extend the drug action time. The synergistic effect of heat and gas improves the transdermal absorption rate of the drug, and the drug concentration in the mucosal tissue can reach the effective treatment threshold of traditional methods within the same medication time.

[0042] Specifically, calcium oxide can be obtained by high-temperature calcination of limestone, while light-burned magnesium oxide is obtained by calcination of magnesite at 750 to 1100°C, and can also be obtained by calcination of brucite and magnesium hydroxide extracted from seawater or brine at a temperature of 700 to 1000°C.

[0043] When the anhydrous fumigation layer includes calcium oxide, vermiculite or diatomite (20% to 30% by weight of the anhydrous fumigation layer) can also be added to absorb excess heat and prevent local overheating.

[0044] The weight of the alkaline earth metal oxide is 0.2 to 0.5 g.

[0045] Specifically, calcium oxide refers to a compound that undergoes an exothermic reaction when contacted with water, and can be implemented using industrial-grade calcium oxide with a purity of not less than 95%. Its strong water absorption can promote heat generation and accelerate the diffusion of drug components. Light-burned magnesium oxide refers to a porous structure of magnesium oxide formed by low-temperature calcination, and can be implemented using light-burned magnesium oxide with a particle size of 100 to 200 mesh and a specific surface area of greater than 50 m 2 / g. Its porous structure can adsorb the gas generated by the reaction and slow down the release rate.

[0046] Calcium oxide or light-burned magnesium oxide undergoes a hydrolysis reaction when contacted with body fluids, releasing heat and carbon dioxide gas. The heat promotes the diffusion of volatile components in the traditional Chinese medicine composition, and the gas promotes the penetration of drug components into the surrounding tissue. The basic substances generated by the reaction form an acid-base buffer system with sodium dihydrogen phosphate, and the reaction rate is controlled to an increase of not more than 2°C per minute under the coating effect of the silicone oil emulsion layer or the polyvinyl alcohol film, avoiding local overheating damage to the mucosal tissue. The intense exothermic property of calcium oxide is suitable for scenarios that require rapid onset, while the sustained-release property of light-burned magnesium oxide is suitable for scenarios that require prolonged action time.

[0047] Optionally, the vaginal expansion inner core comprises, from outside to inside, an outer protective layer, an intermediate drug storage layer, and an inner fumigation layer, the traditional Chinese medicine composition is filled in the intermediate drug storage layer, and the alkali earth metal oxide and the sodium dihydrogen phosphate are filled in the inner fumigation layer.

[0048] In the optional embodiment, the drug and the reaction substance are physically isolated by the layered design, the release time sequence is controlled by the outer protective layer, the fumigation effect plays a role in the key stage of drug release, thereby prolonging the effective action time and improving the drug penetration efficiency. The phased release of the traditional Chinese medicine composition and the fumigation reaction substance is realized, the components are prevented from reacting prematurely and losing effectiveness, and the heat and gas expansion effect generated by the inner fumigation layer are used to accelerate the diffusion and penetration of the drug, thereby improving the drug utilization rate within the limited use time of the sanitary plug and solving the problem that the components of the drug are not fully released and are removed due to low release efficiency in the prior art.

[0049] Specifically, the outer protective layer refers to a barrier structure wrapped in the outermost layer of the expansion inner core, which can be implemented by one or more of ethyl cellulose, hydrogenated vegetable oil, stearate and povidone, and is used to delay the premature contact of the inner layer components with the body fluid and prevent the rapid loss of the drug. The intermediate drug storage layer refers to a drug carrying structure between the outer protective layer and the inner fumigation layer, which can be implemented by one or more of low molecular weight polyethylene glycol with a molecular weight less than PEG800 and glycerol gelatin as a matrix, and is used to centrally accommodate the traditional Chinese medicine composition and realize the gradual release thereof after contacting with the vaginal environment. The inner fumigation layer refers to a reaction layer structure in the innermost layer of the expansion inner core, which can be implemented by one or more of sodium carboxymethyl cellulose, sodium alginate and high molecular weight polyethylene glycol with a molecular weight not less than PEG4000 as a matrix, and is used to accommodate the alkali earth metal oxide and the sodium dihydrogen phosphate, generate heat and gas by the reaction of the two with the body fluid, and form a fumigation effect to promote the penetration of the drug.

[0050] The outer protective layer acts as a physical barrier in the initial stage, delays the direct contact of the intermediate drug storage layer and the inner fumigation layer with the vaginal fluid, and prevents the premature release of the drug components or the premature consumption of the reaction substances. The intermediate drug storage layer starts to release the active ingredients in the traditional Chinese medicine composition after the body fluid gradually penetrates, and controls the release rate through the dissolution characteristics of the matrix material. The inner fumigation layer triggers the exothermic reaction of the alkali earth metal oxide and the sodium dihydrogen phosphate when the body fluid completely penetrates to this layer, the generated heat can accelerate the diffusion of the drug in the intermediate drug storage layer, and the gas expansion pushes the drug components to penetrate into the vaginal tissue. Through the physical isolation and functional synergy of the three-layer structure, the traditional Chinese medicine composition and the fumigation reaction substance do not interfere with each other in the release process, which can not only avoid the premature mixing of the components and the loss of effectiveness, but also improve the drug release efficiency through the heat effect and gas expansion.

[0051] Optionally, the outer protective layer comprises one or more of ethyl cellulose, hydrogenated vegetable oil, stearate and povidone.

[0052] In this optional embodiment, by the composite system of ethyl cellulose and povidone, a directional release channel is established while ensuring structural stability, overcoming the defect that the dissolution rate of a single material does not match the drug release requirement. Gradual dissolution of the outer protective layer in the vaginal environment is achieved, allowing the traditional Chinese medicine composition to be continuously released during the use period of the vaginal suppository, while maintaining the integrity of the tampon form to avoid structural collapse. The material group matches the drug release rate with the 2 to 8 hour replacement period, ensuring that the active ingredients are fully released and absorbed.

[0053] Specifically, ethyl cellulose refers to a hydrophobic polymer material, which can be realized by hot melt forming process using ethyl cellulose powder. Its hydrophobic property can slow down the dissolution rate of the outer protective layer in the wet vaginal environment. Hydrogenated vegetable oil refers to vegetable oil treated by catalytic hydrogenation, which can be realized by hydrogenated palm oil or hydrogenated coconut oil. Its compatibility with stearate can adjust the flexibility and temperature sensitivity of the outer protective layer. Stearate refers to ester compounds formed by stearic acid and polyols, which can be realized by glyceryl monostearate or sorbitol stearate. Its melting point close to body temperature can trigger the gradual dissolution of the outer protective layer in the body. Povidone refers to water-soluble polymer of polyvinylpyrrolidone, which can be realized by K30 or K90 specification povidone. Its hydrophilic property can form microporous channels during the dissolution process to promote drug release.

[0054] Ethyl cellulose as a continuous phase forms a hydrophobic barrier, maintaining the structural integrity of the outer protective layer in the wet vaginal environment for at least 2 hours, avoiding premature drug release. Hydrogenated vegetable oil and stearate are mixed in a mass ratio of 3:1 to 5:1, and then softened by phase change under body temperature, causing the outer protective layer to gradually disintegrate. Povidone is dispersed in the above system at a proportion of 5% to 15%, and when it comes into contact with body fluid, it dissolves first to form a channel network with a pore size of 10 to 50 microns, allowing the traditional Chinese medicine composition in the intermediate drug storage layer to achieve gradient release. The material system realizes controllable dissolution of the outer protective layer while maintaining mechanical strength through the synergistic effect of hydrophobic and hydrophilic components.

[0055] Alternatively, the matrix of the intermediate drug storage layer includes one or more of low molecular weight polyethylene glycol with a molecular weight less than PEG800 and glycerol gelatin.

[0056] In this optional embodiment, low molecular weight polyethylene glycol accelerates the start of drug release by reducing the melting point and increasing the solubility, and glycerol gelatin controls the release time by swelling, and the synergistic effect of the two breaks through the contradiction between release efficiency and duration of single material. The balance of rapid release and sustained release of traditional Chinese medicine composition in the expanded carrier is achieved, and the problem of low drug utilization caused by insufficient release efficiency is solved. The drug component is rapidly released at an effective concentration after contacting with body fluid, and the blood drug concentration required for treatment is maintained through the gel network, avoiding drug waste caused by frequent replacement of sanitary plugs.

[0057] Specifically, low molecular weight polyethylene glycol with a molecular weight less than PEG800 refers to polyethylene glycol with a molecular weight ranging from 200 to 800, and PEG400 or PEG600 can be used to achieve it. Its water solubility increases with decreasing molecular weight, and the melting temperature decreases with decreasing molecular weight. Glycerol gelatin refers to a hydrophilic gel matrix formed by mixing glycerol and gelatin at a mass ratio of 1:1 to 3:1, which can be achieved by heating to 50-70°C, melting and then cooling to form. Its swelling property improves with increasing glycerol ratio.

[0058] Low molecular weight polyethylene glycol rapidly melts to form a drug release channel at body temperature, allowing the active ingredients in the traditional Chinese medicine composition to rapidly diffuse to the surface of the vaginal mucosa. Glycerol gelatin forms a gel network by absorbing tissue fluid to control the drug release rate and avoid burst release. The two matrices form a composite carrier by physical mixing, in which the solubility of polyethylene glycol dominates the initial drug release, and the swelling properties of gelatin gel maintain the subsequent sustained release process.

[0059] Alternatively, the matrix of the internal fumigation layer includes one or more of sodium carboxymethyl cellulose, sodium alginate, and high molecular weight polyethylene glycol with a molecular weight not less than PEG4000.

[0060] In this optional embodiment, by constructing a gel-solid composite matrix system, the water absorption and swelling properties and the phase change temperature differences of different materials are used to establish a controllable release kinetics model. Compared with the commonly used low molecular weight PEG or pure gelatin matrix, this composite system significantly prolongs the release duration of the active ingredients while maintaining the necessary water absorption capacity. It realizes the controllable sustained release of traditional Chinese medicine composition in the vaginal environment, and solves the problem of low drug release efficiency caused by the rapid dissolution of traditional sanitary plugs. The formation of the gel network effectively delays the start time of the fumigation reaction, and the solid barrier effect of high molecular weight polyethylene glycol maintains the stability of the matrix structure, and the synergistic effect of the two makes the drug release curve match the replacement cycle of the sanitary plug, ensuring that the active ingredients are fully released before removal.

[0061] Specifically, sodium carboxymethylcellulose refers to a water-soluble cellulose derivative, which can be implemented by using a type with a viscosity range of 1000 to 3000 mPa·s, and it delays the water penetration rate by forming a three-dimensional gel network. Sodium alginate refers to a natural polysaccharide extracted from brown algae, which can be implemented by using a variety with a degree of deacetylation greater than 80%, and it expands to form a physical barrier to control the contact speed of the reactants when it comes into contact with water. High molecular weight polyethylene glycol with a molecular weight not less than PEG4000 refers to a polyoxyethylene polymer with a degree of polymerization higher than 90, which can be implemented by using a solid form with a melting point of 50 to 60°C, and it maintains the structural integrity by increasing the melting viscosity of the matrix.

[0062] When the matrix contacts moisture in the vaginal environment, sodium carboxymethylcellulose and sodium alginate preferentially absorb water to swell and form a dense gel layer, which can delay the penetration rate of moisture to the internal fumigation reaction layer. High molecular weight polyethylene glycol remains solid at body temperature and forms a composite structure barrier with the gel layer, limiting the contact area of alkaline earth metal oxides and sodium dihydrogen phosphate. By regulating the swelling rate of the gel layer and the synergistic effect of the solid barrier, the gas and heat generated by the fumigation reaction are continuously released in a gradient form, which in turn drives the gradual diffusion of the components of the traditional Chinese medicine composition. This phased release mechanism avoids the sudden release of drugs caused by the rapid dissolution of traditional matrices, while ensuring the effective release of drug components within the hygiene plug replacement cycle.

[0063] Optionally, the internal fumigation layer further comprises a liquid absorbent, and the liquid absorbent comprises one or more of sodium polyacrylate, chitosan, carboxymethyl chitosan, and gelatin.

[0064] In this optional embodiment, by combining the use of liquid absorbents with different mechanisms of action, the liquid absorbents absorb excess liquid while forming a microenvironment that is not conducive to the survival of bacteria, and the swelling state of the drug release matrix is regulated to optimize the sustained release of active ingredients. This solves the problem of low drug release efficiency caused by the wet environment of the hygiene plug, reduces the risk of infection caused by bacterial growth during the menstrual period, and avoids the waste of drugs caused by frequent replacement of hygiene plugs.

[0065] Specifically, sodium polyacrylate refers to a high-molecular polymer with a three-dimensional network structure, which can be achieved by using cross-linked sodium polyacrylate, which quickly absorbs liquid and forms a gel state material through ion exchange. Chitosan refers to a natural polysaccharide obtained by deacetylation of chitin, which can be achieved by using chitosan powder with a degree of deacetylation greater than 85%, and the amino groups on the molecular chain can interact with the microbial cell membrane. Carboxymethyl chitosan refers to a derivative of chitosan modified by carboxymethylation, which can be achieved by using carboxymethyl chitosan with a degree of substitution of 0.6 to 1.2, which enhances water solubility and retains antibacterial activity. Gelatin refers to a water-soluble protein obtained by hydrolysis of collagen, which can be achieved by using type A gelatin with an isoelectric point of 4.8 to 5.2, which forms a three-dimensional water-absorbing network structure through hydrogen bonding.

[0066] Sodium polyacrylate swells after contact with body fluids to form a physical barrier, reducing the local environmental humidity; chitosan adsorbs negatively charged bacterial cell membranes through positive charges, destroying their integrity; carboxymethyl chitosan releases antibacterial components while absorbing liquid; the porous structure of gelatin can absorb water and slow down the diffusion rate of drugs. The four types of materials synergistically control the liquid content in the vagina through different mechanisms, maintaining the drug release environment in the appropriate humidity range, while inhibiting the proliferation of pathogenic microorganisms.

[0067] In some specific embodiments, sodium polyacrylate and carboxymethyl chitosan are mixed at a mass ratio of 3:1 and then dispersed in a gelatin matrix to form a composite film layer with gradient water absorption capacity. Chitosan powder can be processed into microspheres and uniformly distributed in the sodium carboxymethyl cellulose carrier of the inner fumigation layer.

[0068] The principle of sodium polyacrylate absorbing liquid: synthetic high-molecular material, containing a large number of hydrophilic groups (carboxyl, hydroxyl) in the molecular chain, quickly absorbing liquid through osmotic pressure, with a liquid absorption capacity of 100 to 500 times its own weight, forming a three-dimensional network gel that is insoluble in water.

[0069] The advantages of sodium polyacrylate: fast absorption speed, large capacity, can quickly lock blood and secretions, reducing outflow; strong gel stability, not easy to collapse; as a medical device grade material, it is suitable for the vaginal environment after low sensitization treatment.

[0070] The principle of chitosan or carboxymethyl chitosan absorbing liquid: natural cationic polysaccharide, containing amino groups (-NH2) and hydroxyl groups (-OH) in the molecule, which are easily protonated in weak acidic vaginal environment (pH 3.8-4.5), with strong water molecule binding capacity, with a liquid absorption capacity of about 6 to 12 times its own weight, forming a viscous colloid.

[0071] The advantages of chitosan or carboxymethyl chitosan: the colloid after absorbing liquid has viscosity, can adhere to the bleeding site, and reduces liquid leakage; at the same time, chitosan itself can activate the blood coagulation system (promote platelet aggregation), and the functions of absorbing liquid and hemostasis are superimposed; good biodegradability, no mucous membrane irritation.

[0072] The liquid absorption principle of gelatin: collagen hydrolysate, after cross-linking treatment (such as glutaraldehyde mild cross-linking), the water solubility is reduced but the liquid absorption is enhanced, after meeting water, slowly swells, the liquid absorption amount is about 3 to 8 times of its own weight, and an elastic gel is formed.

[0073] The advantages of gelatin: the gel after absorbing liquid is soft, has high affinity to the mucosa; can carry hemostatic components (such as thrombin), synchronous release during the liquid absorption process, and enhances the local hemostatic effect; natural source (animal collagen), good biocompatibility.

[0074] As shown in Figure 1 Another embodiment of the present application provides a preparation method of the Chinese herbal medicine anhydrous fumigation and expansion carrier as described above, comprising the following steps: The alkaline earth metal oxide and sodium dihydrogen phosphate are respectively coated with a silicone oil emulsion layer or a polyvinyl alcohol film; The traditional Chinese medicine composition and the coated alkaline earth metal oxide and sodium dihydrogen phosphate are respectively added into the molten vaginal expansion inner core; The vaginal expansion inner core is formed at a temperature of 4 to 10°C; Ethylene oxide sterilization or cobalt-60 irradiation sterilization.

[0075] In this embodiment, through low-temperature forming and double-coating layer design, the gas production reaction is delayed to start, and the drug release period is prolonged. Compared with the traditional hot pressing forming process, the low-temperature environment avoids the rupture of the coating film, and ensures the isolation effect of the reactants. The non-thermal source sterilization method is used instead of high-temperature treatment, which solves the problem of thermal sensitivity degradation of traditional Chinese medicine components.

[0076] Through the above technical solutions, the present application realizes the controllable slow release of traditional Chinese medicine components in the expansion carrier, so that the drug is fully released within the replacement period. The synergistic effect of the coating layer and low-temperature forming delays the contact time of the reactants, ensures the continuous generation of fumigation gas to promote drug transdermal absorption. The non-thermal source sterilization method maintains the bioavailability of the active ingredients of traditional Chinese medicine, and solves the problem of low drug utilization rate in the traditional process.

[0077] Specifically, the silicone oil emulsion layer refers to a silicone oil coating layer formed through an emulsification process. This can be achieved by mixing silicone oil with a surfactant to form a stable emulsion. This coating layer slows down the contact rate between the coated material and the external environment. The polyvinyl alcohol film refers to a separating film formed by drying a polyvinyl alcohol solution. This can be achieved by coating with a polyvinyl alcohol aqueous solution and then drying at low temperature. This film controls the release time of the coated material through physical barrier effects. The molten vaginal expansion core refers to a carrier formed by thermoplastic materials in a molten state. This can be achieved by heating polyethylene glycol or glycerin gelatin to a fluid state. The molten state facilitates the uniform dispersion of drug components. Cooling molding refers to solidifying the molten material through temperature control. This can be achieved by circulating cold air at 4 to 10°C or cooling with a low-temperature mold. This temperature range prevents the coating film from rupturing and maintains the integrity of the core structure.

[0078] Alkaline earth metal oxides and sodium dihydrogen phosphate are encapsulated in silicone oil or polyvinyl alcohol, respectively, forming a physical barrier within a molten carrier. When the filler comes into contact with body fluids, the encapsulation layer gradually dissolves, causing a reaction that generates gas, propelling the herbal components outward. A low-temperature molding process maintains the integrity of the encapsulation structure, preventing premature contact between reactants. The sterilization step employs a non-pyrogenic method to avoid high temperatures damaging the active pharmaceutical ingredients. By controlling the release of reactants and the rate of drug diffusion in stages, the continuous release of the herbal components is achieved.

[0079] The present invention will be further described below with reference to specific embodiments.

[0080] Example 1: Preparation of an anhydrous fumigation expansion carrier for traditional Chinese medicine.

[0081] Alkaline earth metal oxides and sodium dihydrogen phosphate are respectively coated with silicone oil emulsion layers; To prepare a traditional Chinese medicine composition, take 10mg of Sophora flavescens, 8mg of Phellodendron chinense, 8mg of Scutellaria baicalensis, 6mg of Curcuma zedoaria, 8mg of clam shell powder, 1.33mg of red lead, 6mg of catechu, 6mg of frankincense, 6mg of myrrh, 4mg of pig bile powder, 2mg of borneol, 4.66mg of ginseng, 8mg of Cnidium monnieri, 12mg of Astragalus membranaceus, 8mg of Epimedium brevicornu, 20mg of Leonurus japonicus, 10mg of Dipsacus asper, 4mg of Gleditsia sinensis thorns, 6mg of Cinnamomum cassia, 6mg of Citrus aurantium, and 4.66mg of Glycyrrhiza uralensis, mix and pulverize them, dissolve them in a glycerin gelatin matrix, and cool and solidify them at a temperature of 4 to 10℃ to form an intermediate drug storage layer. Take 0.5 g of lightly calcined magnesium oxide microparticles coated with silicone oil emulsion, 1.5 g of sodium dihydrogen phosphate microparticles coated with silicone oil emulsion, and 1 g of sodium polyacrylate, mix and pulverize them, dissolve them in sodium carboxymethyl cellulose matrix, and cool and mold them at a temperature of 4 to 10℃ to form an inner fumigation layer. Take an ethyl cellulose matrix and cool it at 4 to 10°C to form an outer protective layer. The outer protective layer, the intermediate drug storage layer and the inner fumigation layer are placed in a mold, and are slightly dissolved by heating to 40℃, and are formed by cooling at a temperature of 4 to 10℃, so that the outer protective layer, the intermediate drug storage layer and the inner fumigation layer are combined into an integrated structure; Ethylene oxide sterilization.

[0082] Example 2, preparation of Chinese herbal medicine anhydrous fumigation expansion carrier.

[0083] The alkaline earth metal oxide and the sodium dihydrogen phosphate are respectively coated with polyvinyl alcohol film; The Chinese medicine composition is prepared by taking Sophora flavescens 6.67 mg, Phellodendri Chinensis Cortex 6.67 mg, Scutellaria baicalensis Georgi 6 mg, Curcuma zedoary 4 mg, Concha Murex 6 mg, Red lead 0.67 mg, Uncaria 4 mg, Olibanum 4 mg, Myrrh 4 mg, Swine gall 2 mg, Borneolum Syntheticum 0.67 mg, Panax ginseng 3.34 mg, Cnidium 6 mg, Astragalus 8 mg, Herba Epimedii 6 mg, Motherwort 10 mg, Dipsacus 8 mg, Gleditsia sinensis 2 mg, Ramulus Cinnamomi 4 mg, Aurantii Fructus 4 mg and Glycyrrhiza 3.34 mg, uniformly mixing and crushing, dissolving in a low molecular weight polyethylene glycol matrix of molecular weight PEG600, and forming the intermediate drug storage layer by cooling at a temperature of 4 to 10℃. 0.2 g of polyvinyl alcohol film coated light burned magnesium oxide, 1 g of polyvinyl alcohol film coated sodium dihydrogen phosphate, 0.05 g of chitosan are uniformly mixed and crushed, dissolved in a sodium alginate matrix, and formed into the inner fumigation layer by cooling at a temperature of 4 to 10℃. A hydrogenated vegetable oil matrix is formed into the outer protective layer by cooling at a temperature of 4 to 10℃. The outer protective layer, the intermediate drug storage layer and the inner fumigation layer are placed in a mold, and are slightly dissolved by heating to 40℃, and are formed by cooling at a temperature of 4 to 10℃, so that the outer protective layer, the intermediate drug storage layer and the inner fumigation layer are combined into an integrated structure; Cobalt-60 irradiation sterilization, with a dose controlled at 20 kGy.

[0084] Although the present application is disclosed as above, the protection scope of the present application is not limited to this. Those skilled in the art can make various changes and modifications without departing from the spirit and scope of the present application, and these changes and modifications will fall within the protection scope of the present application.

Claims

1. A Chinese herbal anhydrous fumigating and expanding carrier, characterized in that, The vaginal dilatation inner core, traditional Chinese medicine composition, alkaline earth metal oxide and sodium dihydrogen phosphate are filled in the vaginal dilatation inner core; the alkaline earth metal oxide and the sodium dihydrogen phosphate are respectively coated with a silicon oil emulsion layer or a polyvinyl alcohol film; wherein the traditional Chinese medicine composition comprises Sophora flavescens, Phellodendri Chinensis Cortex, Scrophulariae Radix, Curcumae Radix, Concha Murex, Red lead, Uncaria, Olibanum, Myrrha, Swine gall powder, Borneolum Syntheticum, Radix Ginseng, Cnidii Fructus, Radix Paeoniae Alba, Herba Epimedii, Herba Leonuri, Radix Dipsaci, Gleditsiae Spina, Ramulus Cinnamomi, Fructus Aurantii and Glycyrrhiza.

2. The Chinese herb waterless fumigant expanding carrier according to claim 1, characterized in that, The molar ratio of the alkaline earth metal oxide and the sodium dihydrogen phosphate is 1:1 to 1:2 by weight.

3. The Chinese herb waterless fumigant expanding carrier according to claim 1, wherein, The traditional Chinese medicine composition comprises Sophora flavescens 10 to 15 parts, Phellodendri Chinensis Cortex 10 to 12 parts, Scrophulariae Radix 9 to 12 parts, Curcumae Radix 6 to 9 parts, Concha Murex 9 to 12 parts, Red lead 1 to 2 parts, Uncaria 6 to 9 parts, Olibanum 6 to 9 parts, Myrrha 6 to 9 parts, Swine gall powder 3 to 6 parts, Borneolum Syntheticum 1 to 3 parts, Radix Ginseng 5 to 7 parts, Cnidii Fructus 9 to 12 parts, Radix Paeoniae Alba 12 to 18 parts, Herba Epimedii 9 to 12 parts, Herba Leonuri 15 to 30 parts, Radix Dipsaci 12 to 15 parts, Gleditsiae Spina 3 to 6 parts, Ramulus Cinnamomi 6 to 9 parts, Fructus Aurantii 6 to 9 parts and Glycyrrhiza 5 to 7 parts by weight.

4. The Chinese herb waterless fumigant expanding carrier according to claim 1, wherein, The alkaline earth metal oxide is calcium oxide or light-burned magnesium oxide.

5. The Chinese herb waterless fumigant expanding carrier according to claim 1, wherein, The vaginal dilatation inner core comprises an outer protective layer, an intermediate drug storage layer and an inner fumigation layer from outside to inside, the traditional Chinese medicine composition is filled in the intermediate drug storage layer, and the alkaline earth metal oxide and the sodium dihydrogen phosphate are filled in the inner fumigation layer.

6. The Chinese herb waterless fumigant expanding carrier according to claim 5, wherein, The outer protective layer comprises one or more of ethyl cellulose, hydrogenated vegetable oil, stearate and povidone.

7. The Chinese herb waterless fumigant expanding carrier according to claim 5, wherein, The matrix of the intermediate drug storage layer comprises one or more of low molecular weight polyethylene glycol with a molecular weight less than PEG800 and glycerol gelatin.

8. The Chinese herb waterless fumigant expanding carrier according to claim 5, wherein, The matrix of the inner fumigation layer comprises one or more of sodium carboxymethyl cellulose, sodium alginate and high molecular weight polyethylene glycol with a molecular weight not less than PEG4000.

9. The Chinese herb anhydrous fumigating expansion carrier according to claim 1, characterized in that, The inner fumigation layer further comprises a liquid absorbent comprising one or more of sodium polyacrylate, chitosan, carboxymethyl chitosan and gelatin.

10. A method of preparing the Chinese herbal anhydrous fumigating expansion carrier according to any one of claims 1-9, characterized in that, The method comprises the following steps: The alkaline earth metal oxide and the sodium dihydrogen phosphate are respectively coated with a silicon oil emulsion layer or a polyvinyl alcohol film; The traditional Chinese medicine composition and the coated alkaline earth metal oxide and sodium dihydrogen phosphate are respectively added to a molten vaginal dilatation inner core; wherein the traditional Chinese medicine composition comprises Sophora flavescens, Phellodendri Chinensis Cortex, Scrophulariae Radix, Curcumae Radix, Concha Murex, Red lead, Uncaria, Olibanum, Myrrha, Swine gall powder, Borneolum Syntheticum, Radix Ginseng, Cnidii Fructus, Radix Paeoniae Alba, Herba Epimedii, Herba Leonuri, Radix Dipsaci, Gleditsiae Spina, Ramulus Cinnamomi, Fructus Aurantii and Glycyrrhiza; The vaginal dilatation inner core is formed by cooling at a temperature of 4 to 10℃; Ethylene oxide sterilization or cobalt-60 irradiation sterilization.

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