CN114712447A - Pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis and preparation method thereof - Google Patents

Pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis and preparation method thereof Download PDF

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CN114712447A
CN114712447A CN202210229975.6A CN202210229975A CN114712447A CN 114712447 A CN114712447 A CN 114712447A CN 202210229975 A CN202210229975 A CN 202210229975A CN 114712447 A CN114712447 A CN 114712447A
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pharmaceutical composition
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ovarian failure
premature ovarian
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何太洪
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Sichuan Huizhi Qichuang Technology Service Co ltd
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Sichuan Huizhi Qichuang Technology Service Co ltd
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Abstract

The invention discloses a pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis and a preparation method thereof, relates to the technical field of traditional Chinese medicine compositions, solves the technical problem that the aims of resisting failure and prolonging life cannot be fundamentally achieved by singly tonifying kidney or singly nourishing ovary in the treatment of premature ovarian failure and osteoporosis, and is prepared from the following raw materials: soybean isoflavone, herba Epimedii, fructus Ligustri Lucidi, radix Polygoni Multiflori Preparata, radix Angelicae sinensis, radix Paeoniae alba, fructus Lycii, Ginseng radix, Concha Ostreae, Carthami flos, flos Rosae Rugosae, fructus Jujubae, bran-parched Atractylodis rhizoma, fructus Psoraleae, and rhizoma Dioscoreae; the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis has the effects of tonifying kidney, regulating menstruation and nourishing ovary, and can regulate each link of cerebral cortex, hypothalamus-pituitary-adrenal gland and ovarian axis.

Description

Pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis and preparation method thereof
Technical Field
The invention relates to the technical field of traditional Chinese medicine compositions, in particular to a pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis and a preparation method thereof.
Background
Premature senility of women has become a focus of attention in the social and medical communities, and particularly, the phenomenon is more common in recent years; due to various reasons such as living pressure, fertility, abortion and the like, many women begin to have ovarian hypofunction just after the age of 40, the cells are aged and apoptotic to enter perimenopause, and the perimenopause is accompanied by various complications such as hot flashes, sweating, palpitation, dizziness, lassitude and hypodynamia; mental and nerve symptoms such as hypomnesis, dysphoria, irritability, insomnia, etc.; menstruation such as scanty menstruation, amenorrhea, etc.; other symptoms such as vaginal dryness, sexual life condition, senile vaginitis, etc., and even facial color spots, wrinkles, breast shrinkage, atrophy, relaxation, insomnia, dysphoria, heat, etc.; the symptoms are mainly caused by the decrease of estrogen, and at present, most gynecologists at home and abroad recommend that the beneficial effect of the post-menopausal hormone replacement therapy on the life quality of women is far beyond the potential harmful effect; as western medicines like estrogen have more or less side effects, the developed western countries now use the stilbestrol in synthetic estrogen, mainly natural preparations such as pregnant marestrone and 17B-estradiol.
Premature ovarian failure, irregular menstruation and scanty menstruation which are common diseases of the gynecology department are determined by women who are asynchronism before age 40; the traditional Chinese medicine considers that the deficiency of the kidney is the root cause of premature ovarian failure, irregular menstruation and scanty menstruation, and the cloud in Suzhou Shang Gu Zhen Lun: seven years old in women, kidney qi is exuberant, and teeth grow longer; the second seven pulse is usually associated with the ascending of the heaven and the descending of the ren channel, and the Taichong pulse is usually associated with the descending of the moon, so there are … … children with deficiency of the seven-ren channel, the Taichong pulse is weak, the heaven and the kidney are exhausted, and the channels are obstructed, so there are no children in the bad form. "and, as a result of research, about 45 years old women have an average number of oocytes in the ovary, which is more than ten thousand, and the mechanism of the cessation of menstruation is probably due to the failure of the remaining follicles in the ovary to mature normally and to ovulate.
At present, the research of the root cause and the safest and most effective treatment method of the premature senility of women is the most widely concerned subject of the current gynecology, the research of the invention considers that the kidney and the ovary play a decisive role in the aging change process of women, the kidney and the ovary are closely related and can not be used, the aim of resisting senility and prolonging life can not be achieved from the root by single kidney tonifying or single nutrition ovary, and only the way of really solving the premature senility of women is realized by simultaneously tonifying the kidney and nourishing the ovary.
Disclosure of Invention
The invention aims to: in order to solve the technical problems, the invention provides a pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis.
The invention specifically adopts the following technical scheme for realizing the purpose:
a pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis is prepared from the following raw materials in parts by weight: 40 to 50 parts of soybean isoflavone, 10 to 20 parts of herba epimedii, 8 to 12 parts of glossy privet fruit, 25 to 35 parts of prepared fleece flower root, 20 to 40 parts of Chinese angelica, 10 to 20 parts of white paeony root, 20 to 25 parts of medlar, 14 to 18 parts of ginseng, 12 to 16 parts of oyster, 6 to 14 parts of safflower, 22 to 28 parts of rose, 4 to 10 parts of Chinese date, 16 to 32 parts of bran-fried bighead atractylodes rhizome, 12 to 22 parts of fructus psoraleae and 14 to 24 parts of Chinese yam.
Further, the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis is prepared from the following raw materials in parts by weight: 42 to 48 parts of soybean isoflavone, 12 to 18 parts of herba epimedii, 9 to 11 parts of glossy privet fruit, 28 to 32 parts of prepared fleece flower root, 25 to 35 parts of angelica, 12 to 18 parts of white paeony root, 21 to 24 parts of medlar, 15 to 17 parts of ginseng, 13 to 15 parts of oyster, 8 to 12 parts of safflower, 24 to 26 parts of rose, 5 to 9 parts of Chinese date, 18 to 30 parts of bran-fried bighead atractylodes rhizome, 14 to 20 parts of fructus psoraleae and 16 to 22 parts of yam.
Further, the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis is prepared from the following raw materials in parts by weight: 45 parts of soybean isoflavone, 15 parts of herba epimedii, 10 parts of glossy privet fruit, 30 parts of radix polygoni multiflori preparata, 30 parts of angelica, 15 parts of white paeony root, 23 parts of medlar, 16 parts of ginseng, 14 parts of oyster, 10 parts of safflower, 25 parts of rose flower, 7 parts of Chinese date, 24 parts of bran-fried bighead atractylodes rhizome, 17 parts of fructus psoraleae and 19 parts of Chinese yam.
The pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis has the functions of tonifying kidney, adjusting yin-yang balance and recovering normal physiological functions of viscera, and simultaneously, according to the combination of disease identification and syndrome identification, the pharmaceutical composition is prepared from pure natural phytoestrogen extracted from defatted soybean meal and matched with traditional Chinese medicines such as herba epimedii, radix polygoni multiflori preparata, glossy privet fruit, fructus psoraleae, Chinese yam and the like.
Wherein, the soybean isoflavone is natural phytoestrogen extracted from defatted soybean meal, the soybean carried in the book of materia Medica can moisten spleen and dry, eliminate stagnation and dysentery, and the black soybean can moisten kidney and dry, prevent steatorrhea; therefore, the soybean isoflavone has the effects of tonifying kidney and spleen, and the kidney is the root of reinforcing thoroughfare and controlling, and the spleen tonifying is the source of benefiting blood, and the root of reinforcing congestion, yin balancing and yang balancing, and all syndromes are self-healed and are monarch drugs; the epimedium herb is sweet in taste and warm in nature, enters liver and kidney meridians, has the effects of warming kidney and tonifying yang, and replenishing vital essence and marrow, and the spleen of the book meridian plays a role in controlling impotence and stopping injury, namely tonifying qi and strengthening will assist monarch drugs in warming kidney and tonifying yang so as to tonify the deficiency of kidney yang; fructus Ligustri Lucidi, sweet and bitter in taste, cool in nature, enters liver and kidney meridians, and is good at nourishing yin of liver and kidney; the glossy privet fruit in the herbal preparation is 'liver and kidney benefiting, five internal organs calming, waist and knee strengthening, ear and eye brightening, beard and hair blackening, wind deficiency tonifying and all-disease removing', not only helps monarch drugs nourish kidney yin and tonify kidney yin, but also helps epimedium yin to tonify yang, and has the meaning of 'yang seeking in yin'; radix Polygoni Multiflori Preparata is sweet, astringent and slightly warm, and enters liver and kidney meridians; has the effects of tonifying essence and blood, reinforcing kidney and blackening beard; the compendium of materia medica says that the medicine has astringent taste, bitter taste and kidney tonifying, liver warming and astringency and can astringe essence and qi, thereby being a good nourishing medicine for nourishing blood, benefiting liver, securing essence and tonifying kidney, strengthening bones and muscles and blackening beard and hair; it is not cold and dry, and is superior to herbs of rehmannia and Tian Dong; the epimedium, the glossy privet fruit and the radix polygoni multiflori preparata are used as ministerial drugs; the angelica sinensis is sweet, warm and moist, and can enrich and activate blood and regulate menstruation; white peony root, bitter, sour, sweet, slightly cold; enter liver and spleen meridians and have the effects of nourishing blood and regulating menstruation; wolfberry fruit, sweet and neutral; it enters liver and kidney meridians, and has the actions of tonifying liver and kidney, and nourishing essence and blood; ginseng, sweet, slightly bitter and slightly warm; it enters heart, lung and spleen meridians; has the effects of invigorating primordial qi, promoting fluid production and tranquilizing; safflower, pungent and warm, enters heart and liver meridians; pungent, warm and unblocking, specially entering blood system, activating blood and dispelling stasis, unblocking and regulating meridians; rose, the text of the present herb: "Rose, clear but not turbid, and not fierce, liver softening and stomach awaking, activating qi-flowing and blood circulation, dredging and suffocating stagnation without the disadvantage of pungent, warm and hard dryness, among the divided herbs of pushing away qi, the most rapid and most tame, fragrant, almost without its match"; has effects in regulating qi, promoting blood circulation, and astringing, and can be used for treating menoxenia, traumatic injury, liver qi and stomach pain, breast swelling and pain, etc.; jujube, sweet in taste; the nature and the temperature; has the effects of invigorating spleen and stomach, replenishing qi and blood, tranquilizing, regulating ying and wei, and regulating drug properties; deficiency of spleen and stomach, deficiency of qi and blood, poor appetite, loose stool, asthenia, palpitation, insomnia, irritability of women, incoordination between nutrient and defensive qi; largehead atractylodes rhizome stir-baked with bran is used for treating incoordination between the spleen and the stomach, dysfunction of transportation and transformation, anorexia, fullness, tiredness, hypodynamia, exterior deficiency and spontaneous perspiration; psoralea fruit, bitter, pungent and warm; entering kidney and spleen meridians; invigorating kidney, supporting yang, arresting spontaneous emission, arresting polyuria, treating lumbago due to kidney deficiency, frequent micturition, infantile enuresis, renal leakage, warming spleen, relieving diarrhea, and relieving asthma; the yam is sweet, warm, mild and nontoxic; mainly treats the diseases of impairment, deficiency, cold and heat, pathogenic qi, middle warmer tonifying, strength benefiting, muscle growing and yin strengthening; the product can be taken for a long time, and has effects of improving hearing and eyesight, reducing weight, and prolonging life; the medicines are used together to achieve the effects of tonifying the kidney, nourishing blood, promoting blood circulation and nourishing ovaries, and are used as adjuvant medicines; oyster is salty and astringent in flavor and slightly cold in nature, enters kidney, liver and gallbladder meridians, has the actions of nourishing yin, suppressing yang, relieving convulsion and soothing the nerves, and is salty in flavor, heavy in flavor, entering kidney and heavy in weight, so that all the herbs can be introduced into kidney and directly reach the disease site as guiding drug. The medicines are combined to warm kidney yang, tonify kidney yin, nourish blood and harmonize blood, so that yang grows yin and grows, qi is congested and abundant, yin is flat and secret, the functions of viscera are recovered to be normal, and various symptoms in perimenopause disappear naturally .
Modern pharmacological studies suggest that: the chemical components of the epimedium plants are mainly flavonoid compounds, can enhance the secretion functions of endocrine systems such as hypothalamus-pituitary gland-gonad axis, adrenal cortex axis, thymus axis and the like, and has obvious curative effects on treating osteoporosis and preventing and treating premature senility; the fructus Ligustri Lucidi can enhance nonspecific immunity, and has bidirectional regulation effect on abnormal immunity; has effect in increasing leucopenia due to chemotherapy and radiotherapy; can reduce serum cholesterol, prevent and reduce atherosclerotic plaque and reduce plaque thickness, reduce coronary atherosclerotic disease variables and reduce the degree of obstruction; has effects in tonifying heart, promoting urination, lowering blood sugar, and protecting liver; and has certain anti-aging effect; the medlar has the function of promoting immunity and regulating immunity; can increase testosterone level in blood, and has strengthening effect; promoting hematopoietic function; has obvious function of increasing white blood cells for normal healthy people; also has antiaging, mutation resisting, antitumor, blood lipid reducing, liver protecting, fatty liver resisting, blood glucose reducing, and blood pressure lowering effects; the angelica water extract can obviously promote the generation of hemoglobin and red blood cells, the angelica neutral oil has obvious protective effect on ischemic myocardium, and the angelica and the sodium ferulate thereof have obvious antithrombotic effect; the white peony root has the functions of regulating immunity and resisting inflammation, and the main component paeoniflorin in the peony root has better spasmolytic and analgesic effects; the oyster contains calcium carbonate, calcium phosphate and calcium sulfate, and contains microelements such as copper, iron, zinc, manganese, strontium, chromium and the like and a plurality of amino acids; the Chinese yam is rich in various vitamins and mineral substances and has the effects of promoting the health of heart and brain, active ingredients such as glycoprotein, mannan and the like contained in fresh tubers can also effectively prevent blood fat from precipitating on vessel walls, so that the effect of preventing arteriosclerosis is achieved, and the decoction has the effects of nourishing and nourishing blood, maintaining beauty and keeping young; the psoralea fruit can improve the proportion of white blood cells in blood and reduce the percentage of neutral white blood cells, so that the immunologic function of a human body is obviously improved, and psoralen contained in the psoralea fruit has a high-efficiency killing effect on tumor cells and a certain anti-tumor effect; the white atractylodes rhizome has an antioxidation effect, can effectively inhibit lipid peroxidation, reduce the content of lipid peroxides in tissues, avoid the damage of harmful substances to the structure and the function of tissue cells, has the effect of delaying the senility of old people's kidneys, obviously improves the structure of old people's kidneys, can enhance the hematopoietic function of red blood cells by stir-frying the white atractylodes rhizome with bran, and enhances the capability of white blood cells to phagocytose staphylococcus aureus.
Further, the preparation of the soybean isoflavone comprises the following steps:
crushing defatted soybean meal into 60-80 meshes, mixing the defatted soybean meal with 60-70% ethanol solution in volume concentration, extracting for 4-6 hours at 45-65 ℃ to obtain ethanol extract of the defatted soybean meal, and removing ethanol from the ethanol extract of the defatted soybean meal by reduced pressure evaporation to obtain soybean isoflavone concentrated aqueous solution;
step two, standing the soybean isoflavone concentrated aqueous solution obtained in the step one for 2-4 hours, then performing ultrafiltration at the temperature of 35-45 ℃, and collecting ultrafiltrate, wherein the aperture of an ultrafiltration membrane is 6000-8000D, the ultrafiltration pressure is 300-600 kpa, and the flow rate of feed liquid is 7.0-9.0L/min;
drying the ultrafiltrate obtained in the step two for 2 to 4 hours under the water bath condition of the temperature of 105 to 110 ℃ to obtain a soybean isoflavone crude extract, performing reflux extraction on the soybean isoflavone crude extract by using an acetone solution with the volume concentration of 80 percent, and performing concentration crystallization to obtain a soybean isoflavone extract;
and step four, adding ethanol solution with volume concentration of 70-78% into the crude extract of the soybean isoflavone, stirring until the ethanol solution is completely dissolved to prepare mixed solution with concentration of 3-8 mg/mL, and then carrying out spray drying on the mixed solution to obtain the soybean isoflavone.
Furthermore, in the first step, the mass-to-volume ratio of the defatted soybean meal to the ethanol solution with the volume concentration of 60-70% is 1 kg: (3L-6L).
Furthermore, in the third step, the reflux extraction time is 2 to 4 hours.
Furthermore, in the fourth step, the temperature of spray drying is 110-120 ℃.
The invention also aims to provide a preparation method of the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis, which comprises the following steps:
s1, mixing the ginseng, the angelica, the fructus psoraleae and the medlar in parts by weight, adding water with the volume 4-6 times of that of the mixture, heating to 75-85 ℃, decocting for 20-30 min, adding the epimedium herb, the glossy privet fruit, the prepared fleece-flower root, the white paeony root, the oyster, the safflower, the bran-fried bighead atractylodes rhizome and the yam in parts by weight, continuously decocting for 10-15 min at the temperature of 75-85 ℃, heating to 90-95 ℃, adding the rose and the jujube in parts by weight, decocting for 15-20 min, and filtering to collect first filtrate and dregs;
s2, adding water with the volume 3-4 times of that of the medicine dregs collected in the S1, heating to 85-90 ℃, decocting for 30-35 min, filtering and collecting second filtrate, and discarding filter residues;
s3, uniformly mixing the first filtrate collected in the S1 and the second filtrate collected in the S2, adding the soybean isoflavone in parts by weight into the mixed solution, shearing and dispersing for 5-10 min, and concentrating to prepare the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis.
Further, in S2, the heating rate is 0.5 ℃/min to 2.0 ℃/min.
Further, in S3, before the soybean isoflavone is added to the mixed solution in the above weight part, the mixed solution is filtered through a 200-300 mesh sieve.
The invention has the following beneficial effects:
the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis has the effects of tonifying kidney, regulating menstruation and nourishing ovary, can regulate each link of cerebral cortex, hypothalamus-pituitary-adrenal gland and ovarian axis, particularly enables 'dying' follicles to recover through intra-ovarian regulation, delays the aging of ovaries, can effectively improve perimenopausal symptoms, and treats premature ovarian failure, irregular menstruation, scanty menstruation and other symptoms;
the invention relates to a pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis, wherein soybean isoflavone has antioxidant effect, can delay aging of organisms, recover functions of the organisms, and recover the lubrication, fineness and elasticity of skin, and also has obvious effects of reducing blood fat, reducing cholesterol and softening blood vessels, oxygen free radicals in human bodies cause oxidative stress damage of biomacromolecules of cells to cause mutation and canceration of the cells, the antioxidant effect of the soybean isoflavone can reduce or even eliminate the mutation and canceration of the cells, and the soybean isoflavone has bidirectional regulating and balancing function to the estrogen, when the estrogen in the body is low, can supplement estrogen, has anti-estrogen activity function when hormone in vivo is too high, has functions of nourishing ovary, regulating endocrine, supplementing female hormone level, and reducing blood lipid and cholesterol;
the invention relates to a pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis, which combines estrogen with a plurality of traditional Chinese medicines such as oyster, Chinese yam, fructus psoraleae, white atractylodes rhizome fried with bran and the like, so that the loss of bone mineral content can be prevented, osteoporosis and fracture can be effectively prevented, the proportion of white blood cells in blood can be increased, the percentage of neutral white blood cells is reduced, the immunologic function of a human body is obviously improved, lipid peroxidation can be effectively inhibited, the content of lipid peroxide in tissues is reduced, the damage of harmful substances to the structure and function of the tissue cells is avoided, the pharmaceutical composition has the effect of delaying the aging of the kidney of old people, and the structure of the kidney of old people is obviously improved.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below.
Example 1
A pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis is prepared from the following raw materials in parts by weight: 40g of soybean isoflavone, 10g of herba epimedii, 8g of glossy privet fruit, 25g of prepared fleece flower root, 20g of Chinese angelica, 10g of white paeony root, 20g of medlar, 14g of ginseng, 12g of oyster, 6g of safflower, 22g of rose, 4g of Chinese date, 16g of bran-fried rhizoma atractylodis macrocephalae, 12g of fructus psoraleae and 14g of Chinese yam.
Further, the preparation of the soybean isoflavone comprises the following steps:
crushing defatted soybean meal into 60 meshes, mixing the defatted soybean meal with an alcohol solution with the volume concentration of 60%, extracting for 4 hours at the temperature of 45 ℃ to obtain an ethanol extract of the defatted soybean meal, and removing ethanol from the ethanol extract of the defatted soybean meal by reduced pressure evaporation to obtain a soybean isoflavone concentrated aqueous solution; wherein the mass-volume ratio of the defatted soybean meal to the ethanol solution with the volume concentration of 60% is 1 kg: (3L);
step two, standing the soybean isoflavone concentrated aqueous solution obtained in the step one for 2 hours, then carrying out ultrafiltration at the temperature of 35 ℃, and collecting ultrafiltrate, wherein the aperture of an ultrafiltration membrane is 6000D, the ultrafiltration pressure is 300kpa, and the flow rate of feed liquid is 7.0L/min;
drying the ultrafiltrate obtained in the step two for 2 hours in a water bath condition at the temperature of 105 ℃ to obtain a soybean isoflavone crude extract, performing reflux extraction on the soybean isoflavone crude extract for 2 hours by using an acetone solution with the volume concentration of 80%, and performing concentration crystallization to obtain a soybean isoflavone extract;
and step four, adding an ethanol solution with the volume concentration of 70% into the crude extract of the soybean isoflavone, stirring until the ethanol solution is completely dissolved to prepare a mixed solution with the concentration of 3mg/mL, and then carrying out spray drying on the mixed solution at the temperature of 110 ℃ to obtain the soybean isoflavone.
The preparation method of the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis comprises the following steps:
s1, mixing the ginseng, the angelica, the fructus psoraleae and the medlar in parts by weight, adding water with the volume being 4 times of that of the mixture, heating to 75 ℃, decocting for 20min, adding the epimedium, the glossy privet fruit, the prepared fleece flower root, the white paeony root, the oyster, the safflower, the bran-fried bighead atractylodes rhizome and the Chinese yam in parts by weight, continuously decocting for 10min under the condition that the temperature is 75 ℃, heating to 90 ℃, adding the rose and the Chinese date in parts by weight, decocting for 15min, filtering and collecting a first filtrate and medicine residues;
s2, adding water with the volume 3 times of that of the decoction dregs collected in the step S1, heating to 85 ℃, decocting for 30min, filtering and collecting a second filtrate, and removing filter residues; wherein the heating rate is 0.5 ℃/min;
s3, mixing the first filtrate collected in S1 and the second filtrate collected in S2 uniformly, filtering by using a 200-mesh screen, adding the soybean isoflavone in parts by weight into the mixed solution, shearing and dispersing for 5min, and concentrating to prepare the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis.
Example 2
A pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis is prepared from the following raw materials in parts by weight: 50g of soybean isoflavone, 20g of herba epimedii, 12g of glossy privet fruit, 35g of radix polygoni multiflori preparata, 40g of Chinese angelica, 20g of white peony root, 25g of medlar, 18g of ginseng, 16g of oyster, 14g of safflower, 28g of rose, 10g of Chinese date, 32g of bran-fried bighead atractylodes rhizome, 22g of fructus psoraleae and 24g of Chinese yam.
Further, the preparation of the soybean isoflavone comprises the following steps:
crushing defatted soybean meal into 80 meshes, mixing the defatted soybean meal with an ethanol solution with the volume concentration of 70%, extracting for 6 hours at the temperature of 65 ℃ to obtain an ethanol extract of the defatted soybean meal, and removing ethanol from the ethanol extract of the defatted soybean meal by reduced pressure evaporation to obtain a soybean isoflavone concentrated aqueous solution; wherein the mass-volume ratio of the degreased soybean meal to the ethanol solution with the volume concentration of 70% is 1 kg: (6L);
step two, standing the soybean isoflavone concentrated aqueous solution obtained in the step one for 4 hours, then performing ultrafiltration at the temperature of 45 ℃, and collecting ultrafiltrate, wherein the aperture of an ultrafiltration membrane is 8000D, the ultrafiltration pressure is 600kpa, and the flow rate of feed liquid is 9.0L/min;
drying the ultrafiltrate obtained in the step two for 4 hours under the water bath condition of the temperature of 110 ℃ to obtain a soybean isoflavone crude extract, extracting the soybean isoflavone crude extract by refluxing for 4 hours by using an acetone solution with the volume concentration of 80 percent, and concentrating and crystallizing to obtain a soybean isoflavone extract;
and step four, adding an ethanol solution with the volume concentration of 78% into the crude extract of the soybean isoflavone, stirring until the ethanol solution is completely dissolved to prepare a mixed solution with the concentration of 8mg/mL, and then carrying out spray drying on the mixed solution at the temperature of 120 ℃ to obtain the soybean isoflavone.
The preparation method of the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis comprises the following steps:
s1, mixing the ginseng, the angelica sinensis, the fructus psoraleae and the medlar in parts by weight, adding water with the volume 6 times of that of the mixture, heating to 85 ℃, decocting for 30min, adding the herba epimedii, the glossy privet fruit, the radix polygoni multiflori preparata, the radix paeoniae alba, the oyster, the safflower, the bran-fried bighead atractylodes rhizome and the Chinese yam in parts by weight, continuously decocting for 15min under the condition that the temperature is 85 ℃, heating to 95 ℃, adding the rose and the Chinese date in parts by weight, decocting for 20min, filtering and collecting a first filtrate and medicine residues;
s2, adding water with the volume 4 times of that of the decoction dregs collected in the step S1, heating to 90 ℃, decocting for 35min, filtering and collecting a second filtrate, and removing filter residues; wherein the heating rate is 2.0 ℃/min;
s3, mixing the first filtrate collected in S1 and the second filtrate collected in S2 uniformly, filtering by using a 300-mesh screen, adding the soybean isoflavone in parts by weight into the mixed solution, shearing and dispersing for 10min, and concentrating to prepare the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis.
Example 3
A pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis is prepared from the following raw materials in parts by weight: 42g of soybean isoflavone, 12g of herba epimedii, 9g of glossy privet fruit, 28g of radix polygoni multiflori preparata, 25g of Chinese angelica, 12g of white paeony root, 21g of medlar, 15g of ginseng, 13g of oyster, 8g of safflower, 24g of rose, 5g of Chinese date, 18g of bran-fried rhizoma atractylodis macrocephalae, 14g of fructus psoraleae and 16g of Chinese yam.
Further, the preparation of the soybean isoflavone comprises the following steps:
crushing defatted soybean meal to 60 meshes, mixing the defatted soybean meal with an ethanol solution with the volume concentration of 60%, extracting for 4.5 hours at the temperature of 50 ℃ to obtain an ethanol extract of the defatted soybean meal, and performing reduced pressure evaporation on the ethanol extract of the defatted soybean meal to remove ethanol to obtain a soybean isoflavone concentrated aqueous solution; wherein the mass-volume ratio of the defatted soybean meal to the ethanol solution with the volume concentration of 60% is 1 kg: (4L);
step two, standing the soybean isoflavone concentrated aqueous solution obtained in the step one for 2.5 hours, then carrying out ultrafiltration at the temperature of 35 ℃, and collecting ultrafiltrate, wherein the aperture of an ultrafiltration membrane is 6000D, the ultrafiltration pressure is 400kpa, and the flow rate of feed liquid is 7.5L/min;
drying the ultrafiltrate obtained in the step two for 2.5 hours under the water bath condition of the temperature of 106 ℃ to obtain a soybean isoflavone crude extract, performing reflux extraction on the soybean isoflavone crude extract for 2.5 hours by using an acetone solution with the volume concentration of 80%, and performing concentration crystallization to obtain a soybean isoflavone extract;
and step four, adding an ethanol solution with the volume concentration of 70% into the crude extract of the soybean isoflavone, stirring until the ethanol solution is completely dissolved to prepare a mixed solution with the concentration of 4mg/mL, and then carrying out spray drying on the mixed solution at the temperature of 112 ℃ to obtain the soybean isoflavone.
The preparation method of the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis comprises the following steps:
s1, mixing the ginseng, the Chinese angelica, the fructus psoraleae and the Chinese wolfberry in parts by weight, adding water with the volume 4 times that of the mixture, heating to 75 ℃, decocting for 22min, adding the epimedium herb, the glossy privet fruit, the prepared fleece flower root, the white paeony root, the oyster, the safflower, the bran-fried bighead atractylodes rhizome and the Chinese yam in parts by weight, continuously decocting for 10min under the condition that the temperature is 75 ℃, heating to 90 ℃, adding the rose and the Chinese date in parts by weight, decocting for 15min, filtering and collecting a first filtrate and dregs;
s2, adding water with the volume 3-4 times of that of the medicine residues collected in S1, heating to 85 ℃, decocting for 30min, filtering and collecting second filtrate, and removing filter residues; wherein the heating rate is 1.0 ℃/min;
s3, mixing the first filtrate collected in S1 and the second filtrate collected in S2 uniformly, filtering by using a 200-mesh screen, adding the soybean isoflavone in parts by weight into the mixed solution, shearing and dispersing for 5min, and concentrating to prepare the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis.
Example 4
A pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis is prepared from the following raw materials in parts by weight: 48g of soybean isoflavone, 18g of herba epimedii, 11g of glossy privet fruit, 32g of radix polygoni multiflori preparata, 35g of Chinese angelica, 18g of white peony root, 24g of medlar, 17g of ginseng, 15g of oyster, 12g of safflower, 26g of rose, 9g of Chinese date, 30g of bran-fried bighead atractylodes rhizome, 20g of fructus psoraleae and 22g of Chinese yam.
Further, the preparation of the soybean isoflavone comprises the following steps:
crushing defatted soybean meal into 80 meshes, mixing the defatted soybean meal with an ethanol solution with the volume concentration of 70%, extracting for 5.5 hours at the temperature of 60 ℃ to obtain an ethanol extract of the defatted soybean meal, and performing reduced pressure evaporation on the ethanol extract of the defatted soybean meal to remove ethanol to obtain a soybean isoflavone concentrated aqueous solution; wherein the mass-volume ratio of the degreased soybean meal to the ethanol solution with the volume concentration of 70% is 1 kg: (5L);
step two, standing the soybean isoflavone concentrated aqueous solution obtained in the step one for 3.5 hours, then carrying out ultrafiltration at the temperature of 45 ℃, and collecting ultrafiltrate, wherein the aperture of an ultrafiltration membrane is 8000D, the ultrafiltration pressure is 500kpa, and the flow rate of feed liquid is 8.5L/min;
drying the ultrafiltrate obtained in the step two for 3.5 hours under the water bath condition of the temperature of 108 ℃ to obtain a soybean isoflavone crude extract, performing reflux extraction on the soybean isoflavone crude extract for 3.5 hours by using an acetone solution with the volume concentration of 80 percent, and performing concentration crystallization to obtain a soybean isoflavone extract;
and step four, adding an ethanol solution with the volume concentration of 78% into the crude extract of the soybean isoflavone, stirring until the ethanol solution is completely dissolved to prepare a mixed solution with the concentration of 7mg/mL, and then carrying out spray drying on the mixed solution at the temperature of 118 ℃ to obtain the soybean isoflavone.
The preparation method of the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis comprises the following steps:
s1, mixing the ginseng, the angelica sinensis, the fructus psoraleae and the medlar in parts by weight, adding water with the volume 6 times of that of the mixture, heating to 85 ℃, decocting for 30min, adding the herba epimedii, the glossy privet fruit, the radix polygoni multiflori preparata, the radix paeoniae alba, the oyster, the safflower, the bran-fried bighead atractylodes rhizome and the Chinese yam in parts by weight, continuously decocting for 15min under the condition that the temperature is 85 ℃, heating to 95 ℃, adding the rose and the Chinese date in parts by weight, decocting for 20min, filtering and collecting a first filtrate and medicine residues;
s2, adding water with the volume 4 times of that of the decoction dregs collected in the step S1, heating to 90 ℃, decocting for 35min, filtering and collecting a second filtrate, and removing filter residues; wherein the heating rate is 1.5 ℃/min;
s3, mixing the first filtrate collected in S1 and the second filtrate collected in S2 uniformly, filtering by using a 300-mesh screen, adding the soybean isoflavone in parts by weight into the mixed solution, shearing and dispersing for 10min, and concentrating to prepare the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis.
Example 5
A pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis is prepared from the following raw materials in parts by weight: 45g of soybean isoflavone, 15g of herba epimedii, 10g of glossy privet fruit, 30g of radix polygoni multiflori preparata, 30g of Chinese angelica, 15g of white peony root, 23g of medlar, 16g of ginseng, 14g of oyster, 10g of safflower, 25g of rose, 7g of Chinese date, 24g of bran-fried bighead atractylodes rhizome, 17g of fructus psoraleae and 19g of Chinese yam.
Further, the preparation of the soybean isoflavone comprises the following steps:
crushing defatted soybean meal to 70 meshes, mixing the defatted soybean meal with 65% ethanol solution in volume concentration, extracting for 5 hours at the temperature of 55 ℃ to obtain ethanol extract of the defatted soybean meal, and removing ethanol from the ethanol extract of the defatted soybean meal by reduced pressure evaporation to obtain soybean isoflavone concentrated aqueous solution; wherein the mass-volume ratio of the degreased soybean meal to the ethanol solution with the volume concentration of 65% is 1 kg: (4.5L);
step two, standing the soybean isoflavone concentrated aqueous solution obtained in the step one for 3 hours, then carrying out ultrafiltration at the temperature of 40 ℃, and collecting ultrafiltrate, wherein the aperture of the ultrafiltration membrane is 7000D, the ultrafiltration pressure is 450kpa, and the flow rate of the feed liquid is 8.0L/min;
drying the ultrafiltrate obtained in the step two for 3 hours under the water bath condition with the temperature of 107 ℃ to obtain a soybean isoflavone crude extract, extracting the soybean isoflavone crude extract by refluxing for 3 hours by using an acetone solution with the volume concentration of 80 percent, and concentrating and crystallizing to obtain a soybean isoflavone extract;
and step four, adding an ethanol solution with the volume concentration of 74% into the crude extract of the soybean isoflavone, stirring until the ethanol solution is completely dissolved to prepare a mixed solution with the concentration of 6mg/mL, and then carrying out spray drying on the mixed solution at the temperature of 115 ℃ to obtain the soybean isoflavone.
The preparation method of the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis comprises the following steps:
s1, mixing the ginseng, the angelica sinensis, the fructus psoraleae and the medlar in parts by weight, adding water with the volume 5 times of that of the mixture, heating to 80 ℃, decocting for 25min, adding the herba epimedii, the glossy privet fruit, the radix polygoni multiflori preparata, the radix paeoniae alba, the oyster, the safflower, the bran-fried bighead atractylodes rhizome and the Chinese yam in parts by weight, continuously decocting for 13min under the condition that the temperature is 80 ℃, heating to 93 ℃, adding the rose and the Chinese date in parts by weight, decocting for 18min, and filtering and collecting a first filtrate and medicine residues;
s2, adding water with the volume 3-4 times of that of the medicine dregs collected in the S1, heating to 88 ℃, decocting for 33min, filtering and collecting second filtrate, and removing filter residues; wherein the heating rate is 1.0 ℃/min;
s3, mixing the first filtrate collected in S1 and the second filtrate collected in S2 uniformly, filtering by using a 300-mesh screen, adding the soybean isoflavone in parts by weight into the mixed solution, shearing and dispersing for 8min, and concentrating to prepare the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis.
Examples of the experiments
In order to further prove the step-by-step performance of the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis, the following experiments are carried out:
60 perimenopausal syndrome patients are treated in a traditional Chinese medicine gynecological outpatient service in the hospital, wherein the age is 59 years maximum, 43 years minimum and 43-59 (48.8 +/-10.6) years; the shortest disease course is 3 months, and the longest disease course is 8 years; the patients are all primary; the group of patients are orally administered with the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis prepared in the embodiment 5 of the invention, 2 times a day with 5g each time, and 3 months is a treatment course; HRT treatment with hyperacidin was not performed prior to treatment.
Observation index
(1) According to clinical symptoms, judging the effect before and after treatment according to an improved Kuppermann grading method (63 points in total, grading is mild: 15-20 points, moderate 21-35 points, and severe is more than or equal to 36 points);
(2) follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and estradiol (E2) assays;
(3) routine examination of blood and urine, and liver and kidney function examination.
Criteria for efficacy assessment
And (3) healing: the total score is reduced by more than or equal to 90 percent after treatment, clinical symptoms disappear, and no relapse occurs after 3 months of drug withdrawal; the effect is shown: after treatment, the total score is reduced by 70-89%, the main symptoms are obviously improved, and the observation is not repeated for 3 months after the medicine is stopped; the method has the following advantages: after treatment, the total score is reduced by 30-69 percent, the main symptoms are controlled, the degree is reduced, and after the medicine is stopped, part of symptoms are easy to relapse but are reduced compared with before treatment; and (4) invalidation: the total score is reduced by less than or equal to 29 percent after treatment, the clinical symptoms are not improved or slightly relieved, and the symptoms are recovered before treatment after the medicine is stopped.
Results of the experiment
After one course of clinical treatment, 30 cases are cured, 15 cases with obvious effect account for 25%, 10 cases with effective effect account for 16.66%, and 5 cases with ineffective effect account for 8.33%. The Kuppermann values of perimenopausal syndrome patients before and after treatment are changed, the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis, which is prepared in the embodiment 5, is obvious in improvement of perimenopausal syndrome clinical symptoms, the Kuppermann value of 60 patients is 30 patients with normal symptoms, the value is reduced by 10 patients with the value of 1/2 patients, and 15 patients with the value of 1/3 patients with the value of 15 patients with the value of each type is reduced to different degrees, and especially the value of the patient with severe disease is reduced more obviously. See table 1 for details.
TABLE 1 comparison of Kuppermann values before and after treatment
Figure BDA0003534844160000141
Time Mild (n ═ 30) Moderate (n ═ 20) Severe (n is 10)
Before treatment 17.32±4.73 31.26±5.97 42.28±11.53
After treatment 10.95±3.83 24.45±5.82 28.79±10.26
Note: p <0.05 compared to post-treatment.
The FSH, LH and E2 sex hormone levels are changed before and after treatment, the sex hormone level is improved to different degrees, and especially FSH reduction is more obvious. See table 2.
TABLE 2 comparison of FSH, LH, E2 content before and after treatment
Figure BDA0003534844160000142
Time FSH/(IU/L) LH/(IU/L) E2/(ng/L)
Before treatment 45.92±8.57 56.83±11.41 21.25±5.56
After treatment 23.98±4.61 37.28±8.41 20.78±5.12
Note: p <0.05 compared to post-treatment.

Claims (10)

1. The pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis is characterized by being prepared from the following raw materials in parts by weight: 40 to 50 parts of soybean isoflavone, 10 to 20 parts of herba epimedii, 8 to 12 parts of glossy privet fruit, 25 to 35 parts of prepared fleece flower root, 20 to 40 parts of Chinese angelica, 10 to 20 parts of white paeony root, 20 to 25 parts of medlar, 14 to 18 parts of ginseng, 12 to 16 parts of oyster, 6 to 14 parts of safflower, 22 to 28 parts of rose, 4 to 10 parts of Chinese date, 16 to 32 parts of bran-fried bighead atractylodes rhizome, 12 to 22 parts of fructus psoraleae and 14 to 24 parts of Chinese yam.
2. The pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis as claimed in claim 1, wherein the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis is prepared from the following raw materials in parts by weight: 42 to 48 parts of soybean isoflavone, 12 to 18 parts of herba epimedii, 9 to 11 parts of glossy privet fruit, 28 to 32 parts of prepared fleece flower root, 25 to 35 parts of angelica, 12 to 18 parts of white paeony root, 21 to 24 parts of medlar, 15 to 17 parts of ginseng, 13 to 15 parts of oyster, 8 to 12 parts of safflower, 24 to 26 parts of rose, 5 to 9 parts of Chinese date, 18 to 30 parts of bran-fried bighead atractylodes rhizome, 14 to 20 parts of fructus psoraleae and 16 to 22 parts of Chinese yam.
3. The pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis of claim 1, wherein the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis is prepared from the following raw materials in parts by weight: 45 parts of soybean isoflavone, 15 parts of herba epimedii, 10 parts of glossy privet fruit, 30 parts of radix polygoni multiflori preparata, 30 parts of Chinese angelica, 15 parts of white paeony root, 23 parts of medlar, 16 parts of ginseng, 14 parts of oyster, 10 parts of safflower, 25 parts of rose, 7 parts of Chinese date, 24 parts of bran-fried bighead atractylodes rhizome, 17 parts of fructus psoraleae and 19 parts of Chinese yam.
4. The pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis as claimed in claim 1, wherein the preparation of the soybean isoflavone comprises the following steps:
step one, crushing defatted soybean meal into 60-80 meshes, mixing the defatted soybean meal with an ethanol solution with the volume concentration of 60-70%, extracting for 4-6 hours at the temperature of 45-65 ℃ to obtain an ethanol extract of the defatted soybean meal, and removing ethanol from the ethanol extract of the defatted soybean meal by reduced pressure evaporation to obtain a soybean isoflavone concentrated aqueous solution;
step two, standing the soybean isoflavone concentrated aqueous solution obtained in the step one for 2 to 4 hours, then performing ultrafiltration at the temperature of between 35 and 45 ℃, and collecting ultrafiltrate, wherein the aperture of an ultrafiltration membrane is 6000 to 8000D, the ultrafiltration pressure is 300 to 600kpa, and the flow rate of feed liquid is 7.0L/min to 9.0L/min;
drying the ultrafiltrate obtained in the step two for 2 to 4 hours under the water bath condition of the temperature of 105 to 110 ℃ to obtain a soybean isoflavone crude extract, performing reflux extraction on the soybean isoflavone crude extract by using an acetone solution with the volume concentration of 80 percent, and performing concentration crystallization to obtain a soybean isoflavone extract;
and step four, adding ethanol solution with volume concentration of 70-78% into the crude extract of the soybean isoflavone, stirring until the ethanol solution is completely dissolved to prepare mixed solution with concentration of 3-8 mg/mL, and then carrying out spray drying on the mixed solution to obtain the soybean isoflavone.
5. The pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis of claim 4, wherein in the first step, the mass-to-volume ratio of the defatted soybean meal to the ethanol solution with the volume concentration of 60-70% is 1 kg: (3L-6L).
6. The pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis of claim 4, wherein in the third step, the reflux extraction time is 2-4 hours.
7. The pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis of claim 4, wherein in the fourth step, the spray drying temperature is 110-120 ℃.
8. The preparation method of the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis as claimed in any one of claims 1 to 7, comprising the following steps:
s1, mixing the ginseng, the angelica, the fructus psoraleae and the medlar in parts by weight, adding water with the volume 4-6 times of the mixed volume, heating to 75-85 ℃, decocting for 20-30 min, adding the epimedium herb, the glossy privet fruit, the prepared fleece flower root, the white paeony root, the oyster, the safflower, the bran-fried bighead atractylodes rhizome and the yam in parts by weight, continuously decocting for 10-15 min at the temperature of 75-85 ℃, heating to 90-95 ℃, adding the rose and the jujube in parts by weight, decocting for 15-20 min, filtering and collecting a first filtrate and dregs of a decoction;
s2, adding water with the volume 3-4 times of that of the medicine dregs collected in the S1, heating to 85-90 ℃, decocting for 30-35 min, filtering and collecting second filtrate, and discarding filter residues;
s3, uniformly mixing the first filtrate collected in the S1 and the second filtrate collected in the S2, adding the soybean isoflavone in parts by weight into the mixed solution, shearing and dispersing for 5-10 min, and concentrating to prepare the pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis.
9. The method according to claim 8, wherein the temperature increase rate in S2 is 0.5 ℃/min to 2.0 ℃/min.
10. The method according to claim 8, wherein in S3, the mixture is filtered through a 200-300 mesh screen before the soy isoflavones are added to the mixture in parts by weight.
CN202210229975.6A 2022-03-07 2022-03-07 Pharmaceutical composition for preventing and treating premature ovarian failure and improving osteoporosis and preparation method thereof Pending CN114712447A (en)

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CN106420970A (en) * 2016-03-10 2017-02-22 青岛辰达生物科技有限公司 Pharmaceutical composition for curing premature ovarian failure
CN106963845A (en) * 2017-06-02 2017-07-21 四川和济健康管理有限公司 It is a kind of to be used to protect female to prolong the Chinese medicine composition in spring and preparation method thereof

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Publication number Priority date Publication date Assignee Title
CN106420970A (en) * 2016-03-10 2017-02-22 青岛辰达生物科技有限公司 Pharmaceutical composition for curing premature ovarian failure
CN106963845A (en) * 2017-06-02 2017-07-21 四川和济健康管理有限公司 It is a kind of to be used to protect female to prolong the Chinese medicine composition in spring and preparation method thereof

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