A traditional Chinese medicine drug composition for treating female damp-heat downward transmission and a preparation method thereof

Abstract

The present application relates to a kind of traditional Chinese medicine drug composition for treating gynecological damp-heat down injection, and its pharmaceutical active ingredient is composed of zedoary, ginseng, fishy grass, comfrey, dandelion, purple flower dindin, amethyst, corydalis, groundcherry, or by traditional Chinese medicine extract of the above-mentioned drugs, has significant curative effect on gynecological damp-heat down injection, according to the disease degree of patient and application condition is different, can select internal and external use or only internal use or only external use.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, specifically to a traditional Chinese medicine composition for treating damp-heat accumulation in women and its preparation method. Background Technology

[0002] Damp-heat descending to the lower abdomen refers to damp-heat flowing into the lower jiao (lower burner). The main manifestations include scanty, dark urine, heaviness and fatigue, a yellow, greasy tongue coating, and a soft, rapid pulse. Symptoms include painful, dark urine, lower abdominal distension, perineal distending pain, leukorrhea at the urethral opening, a yellow, greasy tongue coating, and a slippery, rapid pulse. Clinically, it is often seen in damp-heat dysentery, damp-heat diarrhea, urinary tract infections, urinary retention, vulvar itching, leukorrhea, lower limb joint swelling and pain, and athlete's foot. Western medicine diagnoses commonly include vaginal itching, cervical erosion, trichomonal vaginitis, HPV infection, and bacterial vaginosis; in severe cases, it can lead to cervical cancer.

[0003] For damp-heat syndrome, current treatments mainly target various pathogens, using targeted drugs to inhibit or eliminate them; or employing traditional Chinese medicine. While these methods have some efficacy, there is still a lack of a simple, effective, and low-toxicity treatment that can be used both internally and externally. Further research and development of such drugs is needed. Summary of the Invention

[0004] The purpose of this invention is to overcome the shortcomings of the prior art and provide a therapeutic drug that is easy to use, relatively universally effective, has few toxic side effects, and can be used both internally and externally to treat damp-heat syndrome in women.

[0005] This invention provides a traditional Chinese medicine composition whose active pharmaceutical ingredients are composed of the following herbs: Curcuma zedoaria, ginseng, Houttuynia cordata, Lithospermum erythrorhizon, dandelion, Viola yedoensis, amethyst, Cnidium monnieri, and Kochia scoparia.

[0006] Furthermore, the present invention also provides a traditional Chinese medicine composition, wherein the active pharmaceutical ingredient is made from the following parts by weight of the following herbs: Curcuma zedoaria 24-36 parts, ginseng 12-15 parts, Houttuynia cordata 12-18 parts, Lithospermum erythrorhizon 24-36 parts, Taraxacum mongolicum 15-24 parts, Viola yedoensis 30-35 parts, amethyst 9-12 parts, Cnidium monnieri 12-18 parts, and Kochia scoparia 10-15 parts.

[0007] Furthermore, the present invention also provides a traditional Chinese medicine composition, according to the traditional Chinese medicine composition described above, wherein the active pharmaceutical ingredient is made from the following parts by weight of the following herbs: 30 parts of Curcuma zedoaria, 12 parts of ginseng, 15 parts of Houttuynia cordata, 30 parts of Lithospermum erythrorhizon, 15 parts of Taraxacum mongolicum, 30 parts of Viola yedoensis, 12 parts of amethyst, 12 parts of Cnidium monnieri, and 12 parts of Kochia scoparia.

[0008] Furthermore, the present invention also provides a traditional Chinese medicine composition, wherein the active pharmaceutical ingredient is made from the following parts by weight of the following herbs: 30 parts of Curcuma zedoaria, 12 parts of ginseng, 12 parts of Houttuynia cordata, 27 parts of Lithospermum erythrorhizon, 18 parts of Taraxacum mongolicum, 27 parts of Viola yedoensis, 12 parts of amethyst, 15 parts of Cnidium monnieri, and 15 parts of Kochia scoparia.

[0009] Furthermore, the present invention also provides a traditional Chinese medicine composition, according to any of the preceding claims, which further includes a non-pharmaceutical active ingredient, said non-pharmaceutical active ingredient including water and excipients.

[0010] Furthermore, the present invention also provides a traditional Chinese medicine composition, wherein the herbs Curcuma zedoaria, ginseng, Houttuynia cordata, Lithospermum erythrorhizon, dandelion, Viola yedoensis, amethyst, Cnidium monnieri, and Kochia scoparia are each water extracts.

[0011] Furthermore, the present invention also provides a traditional Chinese medicine composition, which is a granule, ointment, powder, oral liquid preparation, gel, suppository, or tablet as described above.

[0012] Furthermore, the present invention also provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicine for treating damp-heat accumulation in women.

[0013] Furthermore, the present invention also provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicine for treating female vaginal itching, cervical erosion, trichomonal vaginitis, HPV infection, and bacterial vaginitis.

[0014] In some aspects, the present invention also provides a method for preparing a traditional Chinese medicine composition, comprising weighing the traditional Chinese medicine composition as described above, soaking it in water for 30 minutes, decocting it twice, each time for 1.5 hours, combining the decoctions at 80°C, filtering, concentrating the filtrate to a clear extract with a relative density of 1.20-1.25, cooling it to 40°C, adding ethanol to make the alcohol content reach 75%, stirring thoroughly, letting it stand for 12 hours, taking the supernatant, adding an appropriate amount of 75% ethanol to the residue, stirring well, letting it stand for 12 hours, filtering, combining the two filtrates, recovering the ethanol until there is no alcohol odor, adding an appropriate amount of white dextrin and purified water to adjust the relative density to about 1.1, spray drying, adding an appropriate amount of microcrystalline cellulose and sodium carboxymethyl starch to the spray-dried fine powder, mixing well, making granules, and drying to obtain granules; or adding magnesium stearate to the granules, mixing well, compressing into tablets, coating with a film to obtain tablets.

[0015] In some aspects, as described above in the preparation method of the traditional Chinese medicine composition, the ointment prepared during the preparation process is made into a suppository or gel.

[0016] Compared with existing technologies, this invention has the advantages of simultaneous internal and external use, fewer toxic side effects, significant efficacy, and a relatively wider range of applications. It can be applied to gynecological damp-heat syndrome and is effective for bacterial, trichomonal, and viral vaginitis diagnosed by Western medicine. Depending on the severity of the patient's disease and the application conditions, it can be used internally or externally, or only internally or only externally. Its production process is simple, the production cost is low, it is highly implementable, and it is easy to carry out large-scale industrial production. Detailed Implementation

[0017] The present invention will now be described in further detail.

[0018] This invention relates to a traditional Chinese medicine composition for treating damp-heat accumulation in women.

[0019] As those skilled in the art know, the active ingredients that exert therapeutic effects in traditional Chinese medicine drug compositions are derived from traditional Chinese medicine drug components, such as water, excipients, diluents, lubricants, binders, disintegrants, sweeteners, stabilizers, preservatives, etc., and do not directly exert disease therapeutic effects, and are not active drug ingredients.

[0020] As those skilled in the art know, what actually works in a drug are the chemical components contained in these traditional Chinese medicine ingredients. Therefore, the raw materials mentioned above can also be extracts of these components, including water extracts and / or organic solvent extracts. Considering the needs of drug safety and ease of preparation, water extracts are preferred.

[0021] The traditional Chinese medicine composition of the present invention can be used alone. For ease of administration and to improve the flavor and taste of the medicine, it is preferably a pharmaceutical preparation comprising the traditional Chinese medicine composition of the present invention and a pharmaceutically acceptable carrier. Simultaneously, the traditional Chinese medicine composition of the present invention can also be prepared into gels or suppositories for external use in the female vagina. For example, the traditional Chinese medicine composition can be prepared into a raw herb for use using the following method.

[0022] According to the stated weight proportions, each raw material is extracted using appropriate water or organic solvent, preferably water. Then, the extracts from each raw material are mixed, dried, and pulverized until homogeneous.

[0023] As described above, in this invention, the traditional Chinese medicine composition is usually prepared into a pharmaceutical preparation. The pharmaceutically acceptable carrier is a commonly used excipient for preparing pharmaceutical preparations, including but not limited to one or more of diluents, lubricants, binders, disintegrants, sweeteners, stabilizers, and preservatives. It is obvious to those skilled in the art that different carriers are selected as excipients for different types of preparations.

[0024] The dosage, usage, and types of the aforementioned carriers have been fully disclosed in pharmaceutical science. For example, the diluents include, but are not limited to, lactose, starch, microcrystalline cellulose, and mannitol; the lubricants include, but are not limited to, magnesium stearate and talc; the binders include, but are not limited to, polyvinylpyrrolidone and hydroxypropyl cellulose; the disintegrants include, but are not limited to, carboxymethyl cellulose, sodium carboxymethyl starch acetate, and crospovidone; the sweeteners include, but are not limited to, sucrose, fructose, and sorbitol; the stabilizers include, but are not limited to, sodium carboxymethyl cellulose, cyclodextrin, and xanthan gum; and the preservatives include, but are not limited to, potassium sorbate and parabens.

[0025] The present invention is prepared according to the following steps: Step 1, weigh the components of the traditional Chinese medicine composition according to the specified weight proportions.

[0026] Step 2: Add enough water and decoct twice, the first time for 0.5 to 2 hours and the second time for 1 to 3 hours. Combine the decoctions, filter, and form a filtrate.

[0027] Step 3: After filtration and concentration with organic solvent, the organic solvent is recovered, and the mixture is concentrated into a thick paste. This paste is then dried under reduced pressure and pulverized. Volatile oil excipients and excipients, including mannitol, are added. The mixture is thoroughly mixed and granulated, then dried, granulated, and packaged sequentially to form a traditional Chinese medicine composition preparation. This traditional Chinese medicine composition preparation contains one or more of the following: diluents, lubricants, binders, disintegrants, sweeteners, stabilizers, and preservatives.

[0028] The concentration and drying methods used are any methods available in the art, such as vacuum concentration or room temperature reduced pressure concentration, or spray drying or freeze drying.

[0029] The method for separating the filtrate from the residue can be any method available in the art, such as filtration or centrifugation.

[0030] The organic solvent used is ethanol. The conditions for filtration and concentration with the organic solvent are: concentration to a relative density of 1.08–1.28, followed by the addition of ethanol to bring the alcohol content to 50–70%.

[0031] The traditional Chinese medicine composition preparations are tablets, granules, gels, or suppositories.

[0032] By using the above methods and preparation conditions, the extraction effect and product stability are most effectively guaranteed, and the production process is simplified, reducing production costs.

[0033] Furthermore, the above-mentioned drug combination can be prepared into a gel or suppository suitable for female reproductive tract infections. The drug extract is prepared using the same method as for preparing granules. For the gel or suppository, the combined filtrate is concentrated to 1 / 3 of the original volume, and then excipients are added. The extract volume is concentrated to 1 / 3 of the original volume, and then excipients are added for preparation and packaging.

[0034] The excipients are water, glycerol or propylene glycol and cellulose derivatives, carbomer and alginate, tragacanth gum, gelatin, starch; or are composed of liquid paraffin and polyethylene or fatty oil and colloidal silica or aluminum soap, zinc soap, preferably glycerol.

[0035] The dosage and administration of the tablets, granules, and other oral preparations of this invention are as follows: dissolve in boiling water and take 10-20 grams (1-3 packets) at a time, 1-3 times daily, for a course of treatment of 1-3 months. Adjustments can be made according to the specific circumstances of different cases.

[0036] The dosage and administration of the suppositories or gels of this invention are as follows: 5 grams once daily for a course of treatment of 1 to 3 months. Adjustments may be made according to the specific circumstances of different cases.

[0037] Clinical trials have shown that this invention has the effects of clearing heat and detoxifying. It has a significant therapeutic effect in preventing and treating gynecological damp-heat syndrome.

[0038] The medicinal properties and pharmacological characteristics of the drugs selected in this invention are as follows:

[0039] Ginseng, in terms of its properties and channels: sweet, slightly bitter, and slightly warm. It enters the spleen and lung channels. Its functions and indications include: greatly replenishing vital energy, tonifying the spleen and lungs, promoting body fluid production and quenching thirst, calming the mind and enhancing intelligence.

[0040] Kochia scoparia fruit, its properties and channels: pungent, bitter, cold. It enters the kidney and bladder channels. Functions and indications: clears heat and promotes diuresis, relieves itching.

[0041] Purple gromwell root, its properties and channels: sweet, salty, cold. It enters the heart and liver channels. Functions and indications: cools the blood, invigorates blood circulation, detoxifies and promotes rash eruption. Used for blood heat and toxicity, purplish-black rashes, incomplete measles eruption, sores, eczema, and burns.

[0042] Dandelion, properties and channels: bitter, sweet, cold. It enters the liver and stomach channels. Functions and indications: clears heat and detoxifies, promotes diuresis and relieves strangury. Used for carbuncles and sores; mastitis; intestinal abscess; sore throat; red and swollen eyes; damp-heat jaundice; and strangury due to heat.

[0043] Viola yedoensis, properties and channels: bitter, pungent, cold. It enters the heart and liver channels. Functions and indications: clears heat and detoxifies, cools the blood and reduces swelling. Used for boils, carbuncles, erysipelas, and snake bites.

[0044] Houttuynia cordata, properties and channels: pungent, slightly cold. It enters the Lung channel. Functions and indications: clears heat and detoxifies, drains pus, promotes urination and relieves strangury. Used for lung abscess; carbuncles; and painful urination due to heat.

[0045] Amethyst, its properties and channels: sweet, warm. It enters the heart, lung, and kidney channels. Functions and indications: calms the mind and soothes the nerves, warms the lungs, and warms the uterus. Used for insomnia with excessive dreaming, palpitations and easy startling, cough and asthma due to lung deficiency, and infertility due to cold uterus.

[0046] Cnidium monnieri, properties and channels: pungent, bitter, warm; slightly toxic. It enters the kidney channel. Functions and indications: warms the kidneys and strengthens yang, dries dampness, dispels wind, and kills parasites. Used for impotence, cold uterus, leukorrhea due to cold and dampness, and lower back pain due to dampness; externally used for vulvar eczema, vulvar pruritus in women; and trichomonal vaginitis.

[0047] Curcuma zedoaria, properties and channels: pungent, bitter, warm. Enters the liver and spleen channels. Functions and indications: promotes qi circulation and breaks up blood stasis, eliminates stagnation and relieves pain. Used for abdominal masses, amenorrhea due to blood stasis, abdominal distension and pain due to food stagnation; early-stage cervical cancer.

[0048] Drug preparation:

[0049] The present invention can be prepared according to the following steps: Step 1, weigh out the following ingredients according to the weight proportions: Curcuma zedoaria, ginseng, Houttuynia cordata, Lithospermum erythrorhizon, dandelion, Viola yedoensis, amethyst, Cnidium monnieri, and Kochia scoparia.

[0050] Step 2: Add enough water and decoct twice, the first time for 0.5 to 2 hours and the second time for 1 to 3 hours. Combine the decoctions, filter, and form a filtrate.

[0051] Step 3: After filtration and concentration with organic solvent, the organic solvent is recovered, and the mixture is concentrated into a thick paste. This paste is then dried under reduced pressure and pulverized. Volatile oil excipients and excipients, including mannitol, are added. The mixture is thoroughly mixed and granulated, then dried, granulated, and packaged sequentially to form a traditional Chinese medicine composition preparation. This traditional Chinese medicine composition preparation contains one or more of the following: diluents, lubricants, binders, disintegrants, sweeteners, stabilizers, and preservatives.

[0052] In addition, the extracts of the above-mentioned traditional Chinese medicine drug compositions can be concentrated and prepared into tablets, granules, gels or suppositories according to conventional methods in the art.

[0053] The preparation method of the above-mentioned Chinese herbal medicine composition extract should not be construed as a limitation on the composition of the Chinese herbal medicine composition of the present invention. The active pharmaceutical ingredients prepared by conventional extraction and decoction methods in the art based on the components of the Chinese herbal medicine composition disclosed in the present invention have the same or similar effects, based on the knowledge of those skilled in the art.

[0054] Tablet preparation method:

[0055] Composition 1 (30 parts Curcuma zedoaria, 12 parts Ginseng, 15 parts Houttuynia cordata, 30 parts Lithospermum erythrorhizon, 15 parts Taraxacum mongolicum, 30 parts Viola yedoensis, 12 parts Amethyst, 12 parts Cnidium monnieri, 12 parts Kochia scoparia) consists of nine herbs. After soaking in water for 30 minutes, the herbs are decocted twice, each time for 1.5 hours. The decoctions are combined at 80°C, filtered, and the filtrate is concentrated to a clear extract with a relative density of 1.20-1.25. The extract is cooled to 40°C, and ethanol is added to adjust the alcohol content to [a certain level]. 75%, stir thoroughly, let stand for 12 hours, take the supernatant, add an appropriate amount of 75% ethanol to the residue, stir well, let stand for 12 hours, filter, combine the secondary filtrates, recover the ethanol until there is no alcohol odor, add an appropriate amount of white dextrin and purified water to adjust to a relative density of about 1.1, spray dry, add an appropriate amount of microcrystalline cellulose and sodium carboxymethyl starch to the spray-dried fine powder, mix well, make into granules, dry, add magnesium stearate, mix well, compress into tablets, coat with film, and the product is obtained.

[0056] Suppository Preparation Method:

[0057] The ointment prepared using the above-mentioned tablet preparation process is then used to prepare a suppository using conventional methods.

[0058] Preparation method of granules II:

[0059] Weigh out the above-mentioned composition two (30 parts of Curcuma zedoaria, 12 parts of ginseng, 12 parts of Houttuynia cordata, 27 parts of Lithospermum erythrorhizon, 18 parts of Taraxacum mongolicum, 27 parts of Viola yedoensis, 12 parts of amethyst, 15 parts of Cnidium monnieri, and 15 parts of Kochia scoparia), prepare it into granules using the above-mentioned tablet preparation method one, and dry them to obtain the final product.

[0060] Treatment of typical case 1:

[0061] Ms. Cai, female, 38 years old, married. Chief complaint: Itching in the genital area, painful urination. Western medicine diagnosis: Vaginal itching. Treatment: Symptoms disappeared after taking the medication of this invention for 14 days.

[0062] Treatment of typical case 2:

[0063] Ms. Lü, female, 35 years old, married. Chief complaint: Itching in the genital area, increased and foul-smelling vaginal discharge, fatigue, poor concentration, nighttime itching, and difficulty falling asleep. Western medicine diagnosis: Trichomonal vaginitis. Treatment: Using the suppositories and oral granules of this invention, the foul odor disappeared after 14 days; the itching lessened after 28 days; and after two months of treatment with added or subtracted sedative medication, she recovered completely.

[0064] Treatment of typical case 3:

[0065] Ms. Chen, female, 43 years old, married. Chief complaint: Itching in the genital area, increased, thick, yellowish discharge, and irritability. Western medicine diagnosis: HPV infection. Treatment: External application of the suppositories of this invention. After 28 days, HPV turned negative, itching subsided, and discharge returned to normal.

[0066] A retrospective analysis was conducted on 23 female patients with damp-heat syndrome from March 2018 to August 2021. The patients ranged in age from 26 to 55 years, with a mean age of 42 years. The duration of illness ranged from 2 weeks to 10 months, and the patients weighed 47 to 80 kilograms. Three patients had a history of smoking. All patients had sexual experience. Among them, 15 patients had vaginal itching, 2 patients had trichomonal vaginitis, 2 patients had bacterial vaginosis, and 4 patients had HPV infection.

[0067] Table 1. Patient Medication Use Status

[0068]

[0069] Table 1 shows the medications used by patients. Granules were taken twice daily after meals for at least 14 consecutive days; tablets were taken three times daily after meals for at least 14 consecutive days; and suppositories were taken once daily for at least 21 consecutive days, until the observation period was completed. One course of treatment lasted three months, and generally two courses were administered.

[0070] Diagnostic criteria for therapeutic effect:

[0071] Cure: Itching is eliminated, trichomoniasis or bacterial vaginosis is eliminated, or HPV becomes negative, odor disappears, or if accompanied by urinary frequency and urgency, the above symptoms disappear.

[0072] Significant effects: Itching is significantly reduced, foul odor is significantly reduced, and symptoms of frequent and urgent urination are significantly improved.

[0073] Effective: Reduces itching, reduces foul odor, and alleviates symptoms of frequent and urgent urination.

[0074] Ineffective: Symptoms did not improve upon consultation.

[0075] The treatment results are detailed in the table below.

[0076] n cure Effective efficient invalid Overall efficiency 23 12（52.2%） 5（21.7%） 5（21.7%） 1（4.3%） 22（95.7%）

[0077] In summary, the tablets, suppositories, and granules prepared from Composition 1 and Composition 2 are all effective for treating gynecological damp-heat syndrome. Depending on clinical needs, they can be prepared into different dosage forms for both internal and external use. Furthermore, the fewer medicinal ingredients allow for a more concentrated therapeutic effect, while still maintaining high efficacy.

[0078] The specific embodiments of the present invention are not intended to limit the technical solutions of the present invention. Those skilled in the art can make improvements and modifications based on conventional knowledge and skills, all of which are within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition, wherein the active pharmaceutical ingredient is made from the following ingredients in parts by weight: Curcuma zedoaria 24-36 parts, ginseng 12-15 parts, Houttuynia cordata 12-18 parts, Lithospermum erythrorhizon 24-36 parts, Taraxacum mongolicum 15-24 parts, Viola yedoensis 30-35 parts, amethyst 9-12 parts, Cnidium monnieri 12-18 parts, and Kochia scoparia 10-15 parts, wherein the traditional Chinese medicine composition is in the form of granules, ointment, powder, oral liquid preparation, gel, suppository, or tablet.

2. The traditional Chinese medicine composition according to claim 1, wherein the active pharmaceutical ingredient is made from the following parts by weight: 30 parts of Curcuma zedoaria, 12 parts of ginseng, 15 parts of Houttuynia cordata, 30 parts of Lithospermum erythrorhizon, 15 parts of Taraxacum mongolicum, 30 parts of Viola yedoensis, 12 parts of amethyst, 12 parts of Cnidium monnieri, and 12 parts of Kochia scoparia.

3. The traditional Chinese medicine composition according to claim 1, wherein the active pharmaceutical ingredient is made from the following parts by weight: 30 parts of Curcuma zedoaria, 12 parts of ginseng, 12 parts of Houttuynia cordata, 27 parts of Lithospermum erythrorhizon, 18 parts of Taraxacum mongolicum, 27 parts of Viola yedoensis, 12 parts of amethyst, 15 parts of Cnidium monnieri, and 15 parts of Kochia scoparia.

4. The traditional Chinese medicine composition according to any one of claims 1-3, further comprising a non-pharmaceutical active ingredient.

5. The traditional Chinese medicine composition according to claim 4, wherein the herbs Curcuma zedoaria, ginseng, Houttuynia cordata, Lithospermum erythrorhizon, dandelion, Viola yedoensis, amethyst, Cnidium monnieri, and Kochia scoparia are their respective water extracts.

6. The use of the traditional Chinese medicine composition according to any one of claims 1-5 in the preparation of a medicine for treating female vaginal itching, trichomonal vaginitis, HPV infection, and bacterial vaginitis.

7. A method for preparing a traditional Chinese medicine composition, comprising: weighing the traditional Chinese medicine composition as described in any one of claims 1-5, soaking it in water for 30 minutes, decocting it twice for 1.5 hours each time, combining the decoctions at 80°C, filtering, concentrating the filtrate to a clear extract with a relative density of 1.20-1.25, cooling it to 40°C, adding ethanol to make the alcohol content reach 75%, stirring thoroughly, letting it stand for 12 hours, taking the supernatant, adding an appropriate amount of 75% ethanol to the residue, stirring well, letting it stand for 12 hours, filtering, combining the two filtrates, recovering the ethanol until there is no alcohol odor, adding an appropriate amount of white dextrin and purified water to adjust the relative density to about 1.1, spray drying, adding an appropriate amount of microcrystalline cellulose and sodium carboxymethyl starch to the spray-dried fine powder, mixing well, making granules, and drying to obtain granules; or adding magnesium stearate to the granules, mixing well, compressing into tablets, coating with a film to obtain tablets.

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