A pharmaceutical composition for preventing and treating female cold coelom sterility and its preparation method and application

Abstract

The present application relates to a kind of pharmaceutical compositions for preventing and treating female palace cold infertility, and the pharmaceutical compositions contain jujube flesh 60-90 parts by weight, almond 1-10 parts, salt cake 1-10 parts, ginger 1-10 parts and camphor 1-10 parts.The cure rate of the pharmaceutical compositions of the present application for female palace cold infertility is more than 85%, and the pharmaceutical compositions have the advantages of safety and effectiveness, good patient compliance, etc.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, and specifically relates to a pharmaceutical composition for preventing and treating female infertility caused by cold uterus, its preparation method, and its application. Background Technology

[0002] Infertility refers to the inability of a couple to conceive or give birth successfully after more than one year of unprotected sex. Influenced by factors such as environmental pollution, excessive work stress, delayed childbearing age in women, physiological factors, psychological factors, and unhealthy lifestyle habits, the global incidence of infertility is showing an upward trend year by year, accounting for approximately 15% of the total population. The age of infertile patients is between 25 and 40 years old, and there is a trend towards younger ages. The global birth rate and population growth rate are showing a downward trend year by year, thus affecting the healthy development of the socio-economic system. Infertility is listed by the World Health Organization (WHO) as one of the three major diseases of the 21st century (after cancer and cardiovascular disease). The causes of infertility include female factors, male factors, and factors affecting both partners, and are classified into primary infertility, secondary infertility, and unexplained infertility.

[0003] The causes of infertility are highly complex. Women account for approximately 40-60% of infertility cases. Factors contributing to female infertility include fallopian tube blockage, polycystic ovary syndrome (PCOS), and endometriosis. Fallopian tube lesions and related conditions account for about 40%, ovulation disorders and related conditions for about 40%, uterine, cervical, and vaginal lesions for about 10%, and infertility due to cold uterus and other contributing factors. Infertility seriously impacts the healthy development of the global population and affects patient well-being (e.g., anxiety and depression, self-blame and guilt, social isolation, lack of social support), family harmony, social progress, and the full realization of the demographic dividend. Treatment methods for infertility include drug therapy, surgical treatment (such as in vitro fertilization, artificial insemination, embryo transfer, etc.), and assisted reproductive technologies. The specific treatment method needs to be selected based on the patient's individual circumstances, and all methods have drawbacks such as low effectiveness, high treatment costs, and poor patient compliance. Therefore, there is a need to develop safer and more effective drug combinations for the prevention and treatment of infertility to meet clinical needs. Summary of the Invention

[0004] The purpose of this invention is to provide a pharmaceutical composition for preventing and treating female infertility caused by cold uterus. By weight, the composition contains 70-90 parts of jujube pulp, 1-10 parts of almond, 1-10 parts of alum, 1-10 parts of ginger, and 1-10 parts of red lead.

[0005] In a preferred embodiment of the present invention, the composition contains, by weight, 75-85 parts of jujube pulp, 2-8 parts of almond, 2-8 parts of alum, 2-8 parts of ginger, and 2-8 parts of red lead.

[0006] In a preferred embodiment of the present invention, the composition contains, by weight, 90 parts of jujube pulp, 5 parts of almond, 2 parts of alum, 1 part of ginger, and 2 parts of red lead.

[0007] In a preferred embodiment of the present invention, the composition contains, by weight, 84 parts of jujube pulp, 6 parts of almond, 4 parts of alum, 2 parts of ginger, and 4 parts of red lead.

[0008] In a preferred embodiment of the present invention, the composition contains, by weight, 75 parts jujube pulp, 10 parts almonds, 5 parts alum, 2 parts ginger, and 8 parts red lead.

[0009] In a preferred embodiment of the present invention, the composition contains, by weight, 70 parts of jujube pulp, 10 parts of almond, 8 parts of alum, 4 parts of ginger, and 8 parts of red lead.

[0010] In a preferred embodiment of the present invention, the composition contains, by weight, 65 parts of jujube pulp, 10 parts of almond, 9 parts of alum, 8 parts of ginger, and 8 parts of red lead.

[0011] In a preferred embodiment of the present invention, the composition contains, by weight, 60 parts of jujube pulp, 10 parts of almond, 10 parts of alum, 10 parts of ginger, and 10 parts of red lead.

[0012] This invention employs a scientifically formulated pharmaceutical composition based on the principle of syndrome differentiation and treatment to prevent and treat female infertility caused by cold uterus. It utilizes alum, used to treat carbuncles, boils, vulvar ulcers, and other ailments; it also incorporates the detoxifying, tissue-regenerating, phlegm-reducing, and calming effects of litharge to regulate endocrine function, alleviate symptoms, and improve female reproductive health; it utilizes the spleen-tonifying, yin-nourishing, heart-calming, and drug-modifying effects of jujube pulp; and other components with effects such as promoting blood circulation, removing blood stasis, relaxing muscles and tendons, relieving pain, and promoting blood flow. The pharmaceutical composition of this invention possesses the effects of warming the meridians and dispelling cold, removing toxins and promoting tissue regeneration, killing parasites and relieving itching, stopping bleeding and removing putrefaction, draining pus and reducing swelling, dispelling wind and activating collaterals, promoting diuresis and reducing swelling, purging cold accumulation, opening the orifices, tonifying qi and blood, nourishing yin and blood, tonifying the spleen and stomach, replenishing qi and generating fluids, and regulating the body's defenses. Topical application significantly improves female infertility caused by cold uterus and has a good therapeutic effect.

[0013] Red dates, sweet and neutral in nature, grow in flat and moist areas. The *Shennong Bencao Jing* states that they treat evil qi in the heart and abdomen, soothe the spleen and stomach, assist the twelve meridians, regulate stomach qi, open the nine orifices, replenish qi and fluids, treat bodily deficiencies, fright, heaviness in the limbs, and harmonize with all medicines. This invention uses red dates to make date paste, which has the effects of tonifying the spleen and stomach, replenishing qi and blood, nourishing yin and blood, calming the mind and spirit, moderating the effects of other medicines, detoxifying and protecting the liver, and improving immunity. It is used to improve symptoms such as spleen qi deficiency, yin and blood deficiency, and visceral agitation in infertile individuals.

[0014] Almonds are bitter and slightly warm in nature; they enter the lung and large intestine meridians. The *Shennong Bencao Jing* states that almonds treat cough, shortness of breath, sore throat, promote qi circulation, aid lactation, treat sores, and relieve cold-induced abdominal pain. Almonds also have insecticidal and detoxifying effects, prevent and treat insect-induced sores and gynecological inflammations, and promote bowel movements.

[0015] Calcined alum (also known as white alum, obtained by calcining purified alum using the illumination calcination method (Appendix II D) until it becomes brittle) is sour, astringent, and cold in nature, and enters the lung, spleen, liver, and large intestine meridians. The *Shennong Bencao Jing* states that it "treats diarrhea with chills and fever, white discharge, vulvar erosion and malignant sores, eye pain, and strengthens bones and teeth." Externally, it has detoxifying, insecticidal, drying, and antipruritic effects, effectively preventing and treating gynecological inflammations.

[0016] Red lead (also known as Zhangdan or Qiandan) has a pungent, salty, and cold nature. It has the effects of detoxification, tissue regeneration, expectoration, and calming the nerves. It is used to regulate endocrine function and relieve symptoms, improve women's reproductive health, and is mainly used to treat carbuncles, ulcers, and bleeding wounds.

[0017] Ginger seeds (also known as ginger seeds, ginger mother, etc.) have the effects of warming the stomach and relieving nausea, dispelling cold and cold, and anti-inflammatory and antibacterial properties.

[0018] In a preferred embodiment of the present invention, the preparation of the pharmaceutical composition includes the following steps: weighing the required amount of jujube pulp and alum, stirring, mixing evenly, then adding the required amount of almonds and ginger, stirring, mixing evenly, rolling it into pills with a diameter of 0.6-0.8 cm, then placing the prepared pills in the required amount of camphor and kneading them into pills, drying them, and thus obtaining the product. In this embodiment, any one of the alum, almonds, ginger, and camphor is pulverized into fine powder with a particle size of 100-200 mesh before mixing.

[0019] In the preferred embodiment of the present invention, the preparation of jujube pulp (jujube paste) includes the following steps: weigh the required amount of jujubes, add water according to the mass-volume ratio of jujubes to water of 1:1-5, decoct or steam at 80-100℃ for 1-2 hours, filter, remove the jujube skin and pits, and dry to obtain the product.

[0020] In a preferred embodiment of the present invention, the pharmaceutical composition optionally contains a pharmaceutically acceptable carrier.

[0021] In a preferred embodiment of the present invention, the amount or type of the pharmaceutically acceptable carrier is determined based on factors such as the physicochemical properties and content of the active ingredient in the composition, the type of formulation, the dissolution and bioavailability of the formulation.

[0022] In a preferred embodiment of the present invention, the pharmaceutical composition is a topical preparation.

[0023] In a preferred embodiment of the present invention, the external preparation is selected from any one of pills, suppositories, gels, ointments, plasters, creams, ointments, liniments, lotions, smears, gels, ointments, aerosols, dry powder inhalers, sprays, and nebulizers.

[0024] In the preferred embodiment of the present invention, the pharmaceutically acceptable carrier is a commonly used excipient or additive in the art for preparing the desired formulation, including fillers (diluents), disintegrants, binders, lubricants (flow aids or anti-adhesion agents), dispersants, wetting agents, pH adjusters (acid-base adjusters), osmotic pressure adjusters, pore-forming agents, solubilizers, antioxidants, antibacterial agents (bactericides), analgesics (anesthetics), suspending agents, emulsifiers, co-emulsifiers, lyophilization protectants, flavoring agents, fragrances, etc.

[0025] In a preferred embodiment of the present invention, the filler is selected from any one or a combination of lactose, powdered sugar, dextrin, starch, sodium carboxymethyl starch, sodium starch glycolate, pregelatinized starch, modified starch, hydroxypropyl starch, potato starch, corn starch, cellulose, inorganic calcium salts, calcium chloride, calcium sulfate, calcium phosphate, calcium hydrogen phosphate, precipitated calcium carbonate, sorbitol, mannitol, microcrystalline cellulose, sodium carboxymethyl cellulose, ethyl cellulose, and hydroxypropyl methyl cellulose.

[0026] In a preferred embodiment of the present invention, the disintegrant is selected from any one or a combination of starch, sodium carboxymethyl starch, sodium starch glycolate, pregelatinized starch, modified starch, hydroxypropyl starch, potato starch, corn starch or its derivatives, croscarmellose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and croscarmellose sodium.

[0027] In a preferred embodiment of the present invention, the adhesive is selected from any one or a combination of syrup, gum arabic, gelatin, sorbitol, astragalus gum, cellulose, microcrystalline cellulose, sodium carboxymethyl cellulose, ethyl cellulose, methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, gelatin paste, starch paste, polyvinylpyrrolidone, sodium carboxymethyl starch, sodium starch glycolate, pregelatinized starch, modified starch, hydroxypropyl starch, potato starch, and corn starch.

[0028] In a preferred embodiment of the present invention, the wetting agent is selected from any one or a combination of sodium dodecyl sulfate, polysorbate (Tween), water, alcohol, ester.

[0029] In a preferred embodiment of the present invention, the antioxidant is selected from any one or a combination of sodium sulfite, sodium bisulfite, sodium metabisulfite, sodium thiosulfate, vitamin C, vitamin E, butylbenzoic acid, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), propyl gallate (PG), nicotinamide, acetylcysteine, and tert-butylhydroquinone (TBHQ).

[0030] In a preferred embodiment of the present invention, the antibacterial agent (bactericide) is selected from any one or a combination of phenol, cresol, chlorobutanol, and benzyl alcohol.

[0031] In a preferred embodiment of the present invention, the analgesic (anesthetic) is selected from any one or a combination of chlorobutanol, benzyl alcohol, lidocaine, and procaine.

[0032] In a preferred embodiment of the present invention, the suspending agent is selected from any one or a combination of microcrystalline cellulose, sodium carboxymethyl cellulose, ethyl cellulose, methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, syrup, glycerin, gelatin, gum arabic, tragacanth gum, sodium alginate, potassium alginate, and pectin.

[0033] In a preferred embodiment of the present invention, the acid-base adjuster (pH adjuster) is selected from any one or a combination of hydrochloric acid, sodium hydroxide, potassium hydroxide, citric acid, sodium citrate, potassium citrate, malic acid, sodium malate, potassium malate, sodium dihydrogen phosphate, disodium hydrogen phosphate, calcium hydroxide, calcium lactate, sodium lactate, sodium phosphate, potassium phosphate, dipotassium hydrogen phosphate, potassium dihydrogen phosphate, sodium bicarbonate, and sodium carbonate.

[0034] In a preferred embodiment of the present invention, the lubricant is selected from any one or a combination of micronized silica gel, magnesium stearate, talc, colloidal silica, aluminum hydroxide, boric acid, hydrogenated vegetable oil, polyethylene glycol, and sodium dodecyl sulfate.

[0035] In a preferred embodiment of the present invention, the osmotic pressure regulator is selected from any one of sodium chloride, potassium chloride, glucose, phosphate, and citrate.

[0036] In a preferred embodiment of the present invention, the emulsifier is selected from any one or a combination of sodium stearate, potassium stearate, triethanolamine stearate, magnesium stearate, calcium stearate, sodium dodecyl sulfate, sodium dodecylbenzene sulfonate, polysorbate (Tween), Span, Mize, benzyl sulfadiazine, polyvinyl alcohol, tragacanth gum, gum arabic, Pronic F-68, lecithin, and soybean lecithin.

[0037] In a preferred embodiment of the present invention, the co-emulsifier is selected from any one or a combination of n-butanol, ethylene glycol, ethanol, propylene glycol, glycerol, and polyglycerol ester.

[0038] In a preferred embodiment of the present invention, the freeze-drying protectant is selected from any one or a combination of sucrose, lactose, galactose, glucose, trehalose, mannitol, and sorbitol.

[0039] In a preferred embodiment of the present invention, the solubilizer is selected from any one or a combination of Tween-80, Prönnicke F-68, Mize, Benzylene, cholate, deoxycholate, glycerol, propylene glycol, and polyethylene glycol.

[0040] In a preferred embodiment of the present invention, the pharmaceutical composition of the present invention is combined with a pharmaceutically acceptable sustained-release or controlled-release formulation carrier and prepared according to the preparation methods of sustained-release or controlled-release formulations in the art, such as coating with an inhibitor or preparing a matrix formulation, to prepare a sustained-release or controlled-release formulation.

[0041] In a preferred embodiment of the present invention, the sustained-release formulation carrier or controlled-release formulation carrier is selected from any one or a combination of oily incorporators, hydrophilic colloids, water-insoluble blockers, enteric blockers, and biodegradable blockers.

[0042] In a preferred embodiment of the present invention, the oily admixture is selected from any one or a combination of glyceryl monostearate, hydrogenated castor oil, mineral oil, polysiloxane, and dimethylsiloxane.

[0043] In a preferred embodiment of the present invention, the hydrophilic colloid is selected from any one or a combination of methylcellulose (MC), sodium carboxymethylcellulose (CMC-Na), hydroxyethylcellulose (HEC), hydroxypropylcellulose (HPC), hydroxypropyl methylcellulose (HMPC), polyvinylpyrrolidone (PVP), gum arabic, tragacanth gum or carboplatin, polyvinyl alcohol (PVA), pectin, alginate, chitosan, xanthan gum, guar gum, carrageenan, gelatin, agar, and galactomannan.

[0044] In a preferred embodiment of the present invention, the water-insoluble inhibitor is selected from any one or a combination of ethyl cellulose (EC), cellulose acetate (CA), polyethylene, polypropylene, polysiloxane, ethylene vinyl acetate copolymer (EVA), and polymethyl methacrylate.

[0045] In a preferred embodiment of the present invention, the enteric inhibitor is selected from any one or a combination of cellulose acetate acetate (CAP), hydroxypropyl methylcellulose acetate (HMPCP), polyvinyl alcohol phthalate (PVAP), hydroxypropyl methylcellulose acetate succinate (HPMCAS), and acrylic resins.

[0046] In a preferred embodiment of the present invention, the biodegradable inhibitor is selected from any one or a combination of waxes, fatty acids, fatty acid esters, fatty alcohols, carnauba wax, stearic acid, glyceryl monostearate, stearyl alcohol, and cetyl alcohol.

[0047] In a preferred embodiment of the present invention, the pharmaceutical composition is administered vaginally.

[0048] The method of administration for the pharmaceutical composition of this invention is as follows: the user should begin vaginal administration on the third day after menstruation has ended. Before use, the vulva and vagina should be cleaned with warm water, and then one pill (weighing 3g per pill) should be inserted deep into the vagina using the applicator. Each pill should remain in the vagina for three nights before being removed, and the date of administration and replacement should be recorded. A course of treatment consists of 7 pills used consecutively.

[0049] The purpose of this invention is to provide a method for preparing a pharmaceutical composition for preventing and treating female infertility due to cold uterus. The composition contains, by weight, 60-90 parts of jujube pulp, 1-10 parts of apricot kernel, 1-10 parts of calcined alum, 1-10 parts of ginger, and 1-10 parts of red cinnabar. The method includes the following steps: weighing the required amount of jujube pulp and calcined alum, stirring and mixing evenly, then adding the required amount of apricot kernel and ginger, stirring and mixing evenly, rolling the mixture into pills with a diameter of 0.6-0.8 cm, then placing the pills in the required amount of red cinnabar and kneading them into pills, and drying them to obtain the final product. In this method, any one of the calcined alum, apricot kernel, ginger, and red cinnabar is pulverized into a fine powder with a particle size of 100-200 mesh before mixing.

[0050] In a preferred embodiment of the present invention, the preparation of jujube pulp includes the following steps: weigh the required amount of jujubes, add water according to the mass-volume ratio of jujubes to water of 1:1-5, decoct or steam at 80-100℃ for 1-2 hours, filter, remove the jujube skin and pits, and dry to obtain the pulp.

[0051] In a preferred embodiment of the present invention, the composition contains, by weight, 75-85 parts of jujube pulp, 2-8 parts of almond, 2-8 parts of alum, 2-8 parts of ginger, and 2-8 parts of red lead.

[0052] In a preferred embodiment of the present invention, the composition contains, by weight, 90 parts of jujube pulp, 5 parts of almond, 2 parts of alum, 1 part of ginger, and 2 parts of red lead.

[0053] In a preferred embodiment of the present invention, the composition contains, by weight, 84 parts of jujube pulp, 6 parts of almond, 4 parts of alum, 2 parts of ginger, and 4 parts of red lead.

[0054] In a preferred embodiment of the present invention, the composition contains, by weight, 75 parts jujube pulp, 10 parts almonds, 5 parts alum, 2 parts ginger, and 8 parts red lead.

[0055] In a preferred embodiment of the present invention, the composition contains, by weight, 70 parts of jujube pulp, 10 parts of almond, 8 parts of alum, 4 parts of ginger, and 8 parts of red lead.

[0056] In a preferred embodiment of the present invention, the composition contains, by weight, 65 parts of jujube pulp, 10 parts of almond, 9 parts of alum, 8 parts of ginger, and 8 parts of red lead.

[0057] In a preferred embodiment of the present invention, the composition contains, by weight, 60 parts of jujube pulp, 10 parts of almond, 10 parts of alum, 10 parts of ginger, and 10 parts of red lead.

[0058] Another object of the present invention is to use the pharmaceutical composition of the present invention in the preparation of a medicine for preventing and treating female infertility due to cold uterus.

[0059] In a preferred embodiment of the present invention, the cause of the infertility due to cold uterus is selected from any one or a combination of kidney deficiency, deficiency of body fluids and blood, phlegm and dampness obstruction, blood stasis, damp heat, and cold uterus.

[0060] In a preferred embodiment of the present invention, the infertility due to cold uterus is selected from any one or a combination of infertility due to cold uterus combined with dysmenorrhea, vulvar itching, vulvar burning, vulvar leukoplakia, vaginitis, adnexitis, ovarian cysts, pelvic cysts, cervicitis, abnormal vaginal discharge, pelvic inflammatory disease, ovarian cysts, and uterine fibroids.

[0061] In a preferred embodiment of the present invention, the pharmaceutical composition is administered vaginally.

[0062] The method of administration for the pharmaceutical composition of this invention is as follows: the user should begin vaginal administration on the third day after menstruation has ended. Before use, the vulva and vagina should be cleaned with warm water, and then one pill (weighing 3g per pill) should be inserted deep into the vagina using the applicator. Each pill should remain in the vagina for three nights before being removed, and the date of administration and replacement should be recorded. A course of treatment consists of seven pills. The duration of treatment for each patient is determined based on factors such as the patient's age, condition, and prior medication use.

[0063] Compared with the prior art, the present invention has the following beneficial effects:

[0064] 1. This invention is a pharmaceutical composition for the prevention and treatment of female infertility caused by cold uterus, formulated using the principle of syndrome differentiation and treatment. It uses alum to treat carbuncles, boils, vulvar ulcers, and other diseases; it works synergistically with the detoxifying, tissue-regenerating, phlegm-reducing, and calming effects of camphor to regulate endocrine function and relieve symptoms, thereby improving female reproductive health; it utilizes the spleen-tonifying, yin-nourishing, heart-calming, and drug-modifying effects of jujube pulp, as well as other components with the effects of promoting blood circulation, relieving muscle tension, relieving pain, and promoting blood circulation. The pharmaceutical composition of this invention has the effects of detoxification and tissue regeneration, insecticidal and antipruritic, hemostasis and debridement, pus drainage and swelling reduction; tonifying the spleen and stomach, replenishing qi and promoting body fluids, regulating the body's defenses, lowering qi and moistening the intestines to relieve constipation, eliminating stagnation, dispelling wind and activating collaterals, promoting diuresis and reducing swelling, purging cold accumulation, and opening the orifices; relieving exterior syndromes and dispersing cold. Topical application significantly improves female infertility due to uterine cold and has a good therapeutic effect, with a cure rate of over 85% for female infertility due to uterine cold. It also has the advantages of being safe and effective, having low adverse reactions, and good patient compliance.

[0065] 2. The preparation of the pharmaceutical composition of the present invention has the advantages of simple operation, green and environmentally friendly, lower cost, and suitability for industrial production. Detailed Implementation

[0066] The technical solution of the present invention will be further described below with reference to the embodiments.

[0067] Example 1 Preparation of the pharmaceutical composition of the present invention

[0068] Composition of the pharmaceutical composition:

[0069]

[0070]

[0071] The preparation of the pharmaceutical composition of the present invention includes the following steps: weigh the required amount of jujube pulp and alum powder, stir, mix evenly, then add the required amount of almond powder and ginger powder, stir, mix evenly, roll into pills with a diameter of 0.8 cm, then place the prepared pills in the required amount of camphor powder and knead into pills (3g / pill), dry, and the product is obtained.

[0072] Example 2 Preparation of the pharmaceutical composition of the present invention

[0073] The composition of the pharmaceutical composition of the present invention:

[0074] Date flesh 11250 Almonds (150 mesh) 1500 Dried vitriol (150 mesh) 750 Ginger (150 mesh) 300 Zhangdan (150 mesh) 1200

[0075] The preparation of the pharmaceutical composition of the present invention includes the following steps: weigh the required amount of jujube pulp and alum powder, stir, mix evenly, then add the required amount of almond powder and ginger powder, stir, mix evenly, roll into pills with a diameter of 0.6 cm, then place the prepared pills in the required amount of camphor powder and knead into pills (3g / pill), dry, and the product is obtained.

[0076] Example 3 Preparation of the pharmaceutical composition of the present invention

[0077] The composition of the pharmaceutical composition of the present invention:

[0078]

[0079]

[0080] The preparation of the pharmaceutical composition of the present invention includes the following steps: weigh the required amount of jujube pulp and alum powder, stir, mix evenly, then add the required amount of almond powder and ginger powder, stir, mix evenly, roll into pills with a diameter of 0.7 cm, then place the prepared pills in the required amount of camphor powder and knead into pills (3g / pill), dry, and the product is obtained.

[0081] Example 4 Preparation of the pharmaceutical composition of the present invention

[0082] The composition of the pharmaceutical composition of the present invention:

[0083] Date flesh 9750 Almonds (200 mesh) 1500 Dried vitriol (200 mesh) 1350 Ginger (200 mesh) 1200 Zhangdan (200 mesh) 1200

[0084] The preparation of the pharmaceutical composition of the present invention includes the following steps: weigh the required amount of jujube pulp and alum powder, stir, mix evenly, then add the required amount of almond powder and ginger powder, stir, mix evenly, roll into pills with a diameter of 0.8 cm, then place the prepared pills in the required amount of camphor powder and knead into pills (3g / pill), dry, and the product is obtained.

[0085] Example 5 Preparation of the pharmaceutical composition of the present invention

[0086] The composition of the pharmaceutical composition of the present invention:

[0087] Date flesh 9000 Almonds (200 mesh) 1500 Dried vitriol (200 mesh) 1500 Ginger (200 mesh) 1500 Zhangdan (200 mesh) 1500

[0088] The preparation of the pharmaceutical composition of the present invention includes the following steps: weighing the required amount of jujube pulp and alum powder, stirring, mixing evenly, then adding the required amount of almond powder and ginger powder, stirring, mixing evenly, rolling it into pills with a diameter of 0.75 cm, then placing the prepared pills in the required amount of camphor powder and kneading them into pills (3g / pill), drying, and thus obtaining the product.

[0089] Example 6 Preparation of the pharmaceutical composition of the present invention

[0090] The composition of the pharmaceutical composition of the present invention:

[0091] Date flesh 13500 Almonds (200 mesh) 750 Dried vitriol (200 mesh) 300 Ginger (200 mesh) 150 Zhangdan (200 mesh) 300

[0092] The preparation of the pharmaceutical composition of the present invention includes the following steps: weigh the required amount of jujube pulp and alum powder, stir, mix evenly, then add the required amount of almond powder and ginger powder, stir, mix evenly, roll into pills with a diameter of 0.85cm, then place the prepared pills in the required amount of camphor powder and knead into pills (3g / pill), dry, and the product is obtained.

[0093] Experimental Example 1 Activity study of the pharmaceutical composition of the present invention in the treatment of female infertility

[0094] Twenty-seven female volunteers with infertility due to cold uterus were selected as subjects. The subjects were aged between 22 and 36 years old, including 17 patients with infertility due to cold uterus combined with gynecological inflammation and 2 patients with infertility due to cold uterus combined with ovarian cysts.

[0095] Inclusion criteria: Voluntary participation in the trial; age between marriage and menopause, non-pregnant women with regular menstrual cycles; diagnosed with vaginitis, cervicitis, or pelvic inflammatory disease according to Western medicine diagnostic criteria; meeting the TCM diagnostic criteria for uterine cold syndrome; not having used other antifungal or broad-spectrum antibiotics in the past two weeks; participants must have signed an informed consent form and agree to abstain from sexual activity during the medication period.

[0096] Exclusion criteria: Individuals who have used large amounts of broad-spectrum antibiotics or corticosteroids within the past 2 weeks, or who have received treatment for other vulvovaginal diseases; individuals who have participated in other drug clinical trials within the past 3 months; individuals receiving estrogen replacement therapy; pregnant or planning to become pregnant women, or breastfeeding women; patients with severe cardiovascular or hematopoietic system diseases; patients with severe liver or kidney diseases, with liver function indicators ALT and AST exceeding twice the upper limit of normal, and kidney function indicators Cr and BUN exceeding the upper limit of normal; individuals allergic to the investigational drugs or components; patients with mental illness; and individuals with a suspected or confirmed history of alcohol or drug abuse.

[0097] This experiment used the pharmaceutical composition of Example 1 as an example. Subjects began vaginal administration on the 3rd day after their menstrual period ended. Before use, subjects cleaned their vulva and vagina with warm water. One pill (3g per pill) of the pharmaceutical composition of Example 1 was inserted deep into the vagina using a delivery device. Each pill was left in place for 3 days, and 7 pills were used consecutively for one course of treatment. Subjects continued treatment for 3 courses. The color, amount, and odor of vaginal discharge, as well as symptoms such as vulvar itching and burning, lumbosacral pain, and lower abdominal pain, were compared before and after treatment.

[0098] The results showed that 23 subjects achieved early intrauterine pregnancy, and the related symptoms of the 4 subjects who did not conceive were alleviated, reduced, or eliminated; the inflammation of 7 subjects with infertility due to cold uterus and gynecological inflammation was eliminated, and the cysts of 2 subjects with infertility due to cold uterus and ovarian cysts shrank or disappeared. Furthermore, no adverse reactions were observed in the subjects.

[0099] The above description of specific embodiments of the present invention does not limit the present invention. Those skilled in the art can make various changes or modifications based on the present invention, and as long as they do not depart from the spirit of the present invention, they should all fall within the scope of protection of the claims of the present invention.

Claims

1. A pharmaceutical composition for preventing and treating female infertility due to cold uterus, characterized in that: It is made by weight of 70-90 parts jujube pulp, 1-10 parts almonds, 1-10 parts alum, 1-10 parts ginger, and 1-10 parts red lead.

2. The pharmaceutical composition according to claim 1, characterized in that: It is made from 75-85 parts by weight of jujube pulp, 2-8 parts of almonds, 2-8 parts of alum, 2-8 parts of ginger, and 2-8 parts of red lead.

3. The pharmaceutical composition according to claim 1, characterized in that: It is made from 90 parts by weight of jujube pulp, 5 parts of almonds, 2 parts of alum, 1 part of ginger, and 2 parts of red lead.

4. The pharmaceutical composition according to claim 1, characterized in that: It is made from 84 parts by weight of jujube pulp, 6 parts of almonds, 4 parts of alum, 2 parts of ginger, and 4 parts of red lead.

5. The pharmaceutical composition according to claim 1, characterized in that: It is made from 75 parts by weight of jujube pulp, 10 parts of almonds, 5 parts of alum, 2 parts of ginger, and 8 parts of red lead.

6. The pharmaceutical composition according to claim 1, characterized in that: It is made from 70 parts by weight of jujube pulp, 10 parts of almonds, 8 parts of alum, 4 parts of ginger, and 8 parts of red lead.

7. The pharmaceutical composition according to any one of claims 1-6, characterized in that: The pharmaceutical composition is for intravaginal administration.

8. A method for preparing a pharmaceutical composition according to any one of claims 1-7, comprising the following steps: weighing the required amount of jujube pulp and alum, stirring, mixing evenly, then adding the required amount of almonds and ginger, stirring, mixing evenly, rolling it into pills with a diameter of 0.6-0.8 cm, then placing the prepared pills in the required amount of camphor and kneading them into pills and drying them, wherein any one of the alum, almonds, ginger, and camphor is pulverized into fine powder with a particle size of 100-200 mesh before mixing.

9. The method for preparing the pharmaceutical composition according to claim 8, wherein: The preparation of jujube pulp includes the following steps: weigh the required amount of jujubes, add water according to the mass-volume ratio of jujubes to water of 1:1-5, decoct or steam at 80-100℃ for 1-2 hours, filter, remove the jujube skin and pits, and dry to obtain the pulp.

10. The use of the pharmaceutical composition according to any one of claims 1-7 or the pharmaceutical composition prepared by the preparation method according to any one of claims 8-9 in the preparation of a medicament for preventing and treating female infertility due to cold uterus.

11. The application as described in claim 10, characterized in that: The method of administration of the drug composition is as follows: The user should start vaginal administration on the 3rd day after menstruation ends. Before use, the vulva and vagina should be cleaned with warm water, and then one pill should be inserted deep into the vagina using the applicator. Each pill should be left in the vagina for three nights and then removed. The date of administration and the date of replacement should be recorded. A course of treatment consists of 7 pills.

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