CN115590140A - Health-care functional food for regulating female endocrine balance and relieving climacteric syndrome and irregular menstruation - Google Patents
Health-care functional food for regulating female endocrine balance and relieving climacteric syndrome and irregular menstruation Download PDFInfo
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Abstract
The invention relates to the technical field of health-care functional food, in particular to health-care functional food for regulating female endocrine balance and relieving climacteric syndrome and irregular menstruation. The invention provides a health-care functional food, which comprises: chinese yam, cinnamon, tuckahoe, angelica, gordon euryale seed, turmeric, medlar, sealwort, liquorice, kudzu root, black bean, lily, lotus seed, oat, soybean and other raw materials. The raw materials are mainly taken from edible materials with homology of medicine and food and part of common nutritional edible materials, and are natural plant raw materials. The applicant deeply studies the characteristics of various raw materials, and finally determines the optimized variety composition, the most effective component proportion and the processing technology of the raw materials by screening and blending various food raw materials and repeated in-vitro and in-vivo experimental verification, so that the hormone balance of the adult female in the physiological period or the climacteric period can be effectively adjusted, the climacteric syndrome and the irregular menstruation can be obviously relieved, and the effect is better than that of a mature Chinese patent medicine in certain aspects. Meanwhile, the health-care functional food has no side effect and is suitable for long-term eating.
Description
Technical Field
The invention relates to the technical field of health-care functional food, in particular to health-care functional food for regulating female endocrine balance and relieving more annual syndrome and irregular menstruation.
Background
Women often face different physiological discomfort at different age stages. For example, women may experience menstruation slowly beginning at puberty and many women may experience irregular menstruation before and after menstruation. In the physiological period of women, the secretion of partial hormones in the body is rapidly reduced, the body temperature is lowered, and physiological bleeding causes physical consumption and nutrition loss, so that irregular menstruation with various symptoms such as lower abdominal pain, emotional excitement, insomnia, fatigue, edema and the like is easily caused.
For another example, most women aged 45-55 enter menopause, at which stage ovarian function declines until complete menopause. During the period, the female estrogen level is reduced, so that the female estrogen level is changed in psychological and physiological aspects, namely, the female estrogen level is subjected to multiple metabolic disorders, autonomic nervous disorder and the like, which are called climacteric syndromes, and the female estrogen level greatly affects the quality of life of the female.
On the other hand, the endocrine system is an important system for secreting various hormones and the nervous system to participate in the regulation of human metabolism and the maintenance of human physiological functions, and various hormones in the human body can be kept in balance, for example, the physiological balance of the hormones in the human body is broken due to various reasons, so that the content of the hormones in the human body is higher or lower, and a series of clinical symptoms of diseases occur, and the diseases become endocrine dysregulation. Modern medicine considers that the common symptoms of facial chloasma, breast lumps, irregular menstruation, dysmenorrheal, amenorrhea, infertility, hysteromyoma, immune system diseases, osteoporosis, hyperlipidemia, climacteric syndrome and the like in gynecology are all related to endocrine dyscrasia.
At present, the types of products capable of relieving the female irregular menstruation are few, western medicine treatment mainly takes pain relieving and hormone medicines, the effects are not ideal, and certain adverse reaction incidence rate is achieved. The medicine for relieving climacteric symptoms comprises kuntai capsule, lifumin and the like. Kuntai capsules are prepared from prepared rehmannia root, coptis root, white peony root, scutellaria root, donkey-hide gelatin and poria cocos, have the effect of promoting estradiol secretion, and thus relieve symptoms of climacteric syndromes (60 cases of treating female climacteric syndromes by a yin nourishing and heat clearing method in combination with psychological diversion, university of Shandong traditional Chinese medicine, 2008,32 (4): 314-315). The patent (CN 110367537A) discloses a health-care functional food for conditioning climacteric syndrome and a preparation method thereof, wherein kudzu root, soybean and liquorice are taken as raw materials, and are respectively prepared by carrying out alcohol extraction on the kudzu root and carrying out water extraction on the soybean and the liquorice, and the product has the advantages of complex process, higher cost and single effect. However, there is no medicine with good curative effect for the three diseases, and no matter western medicine or Chinese patent medicine, there are some side effects.
However, at present, a health-care functional food which can regulate female endocrine balance, relieve female climacteric symptoms and relieve irregular menstruation is still lacking.
Disclosure of Invention
The invention aims to overcome the technical problems in the prior art and provide a health-care functional food which can regulate the female endocrine balance and relieve climacteric syndrome and irregular menstruation and has no side effect, and the food is prepared from the following raw materials in parts by weight:
50-200 parts of Chinese yam, 30-60 parts of cinnamon, 50-150 parts of poria cocos, 10-50 parts of angelica sinensis, 20-100 parts of gordon euryale seed, 10-30 parts of turmeric, 20-100 parts of medlar, 20-100 parts of rhizoma polygonati, 10-30 parts of liquorice, 50-200 parts of radix puerariae, 50-100 parts of black bean, 30-100 parts of lily, 20-60 parts of lotus seed, 30-100 parts of oat and 50-100 parts of soybean. The health functional food can regulate female endocrine balance, and can relieve female climacteric symptom and menoxenia.
Preferably, the food also comprises 50-100 parts of maca and 20-50 parts of fructus amomi by weight.
Preferably, the food also comprises 40-100 parts of corn by weight.
The preparation method of the invention comprises the following steps:
sorting and cleaning the raw materials, cutting part of the raw materials into blocks, and drying the blocks at a low temperature (40-60 ℃) until the moisture content is below 15%;
curing the raw materials, weighing and mixing the raw materials in proportion;
and step three, crushing, sieving and bagging the mixed raw materials to obtain the product of the invention.
Preferably, in the second step of the preparation method, the curing process can be replaced by low-temperature microwave curing (80-120 ℃,10-30 minutes), low-temperature baking (60-120 ℃,10-30 minutes), frying (120-150 ℃,10-15 minutes) or extrusion puffing (150 ℃).
Preferably, the rhizoma polygonati in the raw materials is prepared by adopting a traditional nine-steaming nine-aeration or four-steaming four-aeration method. Steaming rhizoma Polygonati thoroughly, air drying until the outer skin is slightly dry, mixing with yellow wine and rhizoma Polygonati juice generated by steaming rhizoma Polygonati, steaming for the second time after yellow wine and rhizoma Polygonati juice are absorbed, and repeating the steaming, sun drying and moistening process for four times or nine times to obtain four times steaming and four times aeration or nine times steaming and nine times aeration. Other starting materials were prepared according to the above method steps one and two.
Preferably, the angelica sinensis in the raw materials is prepared by the following process: mixing clean radix Angelicae sinensis with appropriate amount of yellow wine, moistening, placing in a pan, heating with slow fire, parching to dry, and taking out and cooling when the aroma is strong and slight aroma of wine exists; other starting materials were prepared according to the above method steps one and two.
Preferably, the kudzu root and the tuckahoe in the raw materials are prepared by related processing and processing technologies of Chinese pharmacopoeia (2020 edition one); other starting materials were prepared according to the above method steps one and two.
Preferably, the raw material of the food of the present invention is wholly or partially a powdery extract.
The raw materials of the invention are mainly taken from food raw materials in the 'homology of medicine and food' catalogue and part of common food raw materials. The raw materials of the invention are all natural plant raw materials, and the raw materials are strictly controlled in quality, are purely natural and have no chemical addition, and the effective components of various foods are also retained to the greatest extent. Meanwhile, through research on the characteristics of the raw materials, screening and blending of various food raw materials and repeated in-vitro and in-vivo experimental verification, the raw materials, the proper component proportion and the processing technology are finally determined, so that the hormone balance of the adult female in the physiological period or the climacteric period can be effectively adjusted, the symptoms of climacteric syndrome and irregular menstruation can be remarkably relieved, and the effect is better than that of a mature Chinese patent medicine in some aspects. Meanwhile, the health-care food has no side effect and is suitable for long-term eating, so that the quality of life of adult females in the physiological period or in the climacteric period is greatly improved.
Drawings
Figure 1 organ coefficients and serum estradiol levels in various groups of animals after free feeding for 45 days, where a: animal weights for each group; b: uterine weight of each group of animals; c: uterine coefficients for each group of animals; d: estradiol levels in serum of each group of animals.
Fig. 2 organ coefficients and serum estradiol levels in various groups of animals after free feeding for 60 days, wherein a: animal weights for each group; b: uterine weight of each group of animals; c: uterine coefficients for each group of animals; d: estradiol levels in serum of each group of animals.
Fig. 3 the number of writhing and organ coefficients for each group of animals after free feeding for 30 days, where a: body weight of each group of animals; b: uterus weight of each group of animals; c: uterine coefficient of each group of animals; d: number of writhing for each group of animals.
Figure 4 serum hormone levels in animals of each group after 30 days of free feeding, where a: levels of 6-keto prostasin F1 α (6-keto-F1 α) in serum of each group of animals; b: levels of thromboxane B2 (TXB 2) in serum of each group of animals; c: the ratio of thromboxane B2 (TXB 2) to 6-keto prostaglandin F1 alpha (6-keto-F1 alpha) in the serum of each group of animals; d: levels of beta-endorphin (beta-EP) in serum of each group of animals.
Fig. 5 concentrations of PGF2 α, PGE2 in uterine tissue homogenate supernatants of groups of animals after 30 days of free feeding, wherein a: the concentration of prostaglandin F2 alpha (PGF 2 alpha) in the supernatant of the homogenate of the uterine tissue from each group of animals; b: the concentration of prostaglandin E2 (PGE 2) in the supernatant of the uterine tissue homogenates of each group of animals; c: the ratio of prostaglandin F2 alpha to prostaglandin E2 in the supernatant of the homogenate of the uterine tissue from each group of animals.
Fig. 6 graph of HE staining (x 100) of uterine tissue sections, wherein a: a normal group; b: a model group; c: dingkundan group; d: a group of Qianjin tablets; e: kunyikang group C; f: kunyikang group D.
Fig. 7 the number of writhing and organ coefficients for each group of animals after free feeding for 30 days, where a: body weight of each group of animals; b: uterine weight of each group of animals; c: uterine coefficients for each group of animals; d: number of writhing for each group of animals.
Fig. 8 the number of writhing and organ coefficients for each group of animals after free feeding for 30 days, where a: body weight of each group of animals; b: uterine weight of each group of animals; c: uterine coefficient of each group of animals; d: number of writhing for each group of animals.
Detailed Description
Example 1 functional food product for health
Preparation example (1)
Selecting raw materials of commercially available Chinese yam, cinnamon, poria cocos, gordon euryale seed, chinese angelica, turmeric, medlar, liquorice, kudzu root, lily, lotus seed and oat, cleaning, wherein the Chinese yam, the poria cocos, the Chinese angelica, the turmeric, the liquorice and the kudzu root are sliced or cut into pieces, and drying at low temperature (60 ℃) until the water content is below 15%.
Step two, curing the raw materials by low-temperature microwave (120 ℃ for 10 minutes) according to the following parts by weight: 150 parts of Chinese yam, 30 parts of cinnamon, 100 parts of tuckahoe, 100 parts of gordon euryale seed, 30 parts of angelica, 30 parts of turmeric, 100 parts of medlar, 30 parts of liquorice, 200 parts of kudzuvine root, 100 parts of lily, 50 parts of lotus seed and 80 parts of oat by weight.
And step three, crushing the mixed raw materials, sieving the crushed mixed raw materials by a 150-mesh sieve, and bagging the sieved mixed raw materials to obtain the product of the invention.
Preparation example (2)
Firstly, selecting commercially available raw materials of Chinese yam, cinnamon, poria, angelica sinensis, gordon euryale seed, turmeric, medlar, liquorice, kudzu root, black bean, lily, lotus seed, oat and soybean, cleaning, wherein the Chinese yam, the poria, the angelica sinensis, the turmeric, the liquorice and the kudzu root are sliced or cut into pieces, and drying at low temperature (60 ℃) until the water content is below 15%.
Step two, curing the raw materials by low-temperature microwave (120 ℃,10 minutes), and additionally purchasing commercially-available nine-process polygonatum (namely the polygonatum prepared by adopting the traditional nine-steaming nine-aeration method) according to the following parts by weight: 50 parts of Chinese yam, 60 parts of cinnamon, 100 parts of poria cocos, 30 parts of angelica sinensis, 100 parts of gordon euryale seed, 30 parts of turmeric, 100 parts of medlar, 20 parts of rhizoma polygonati, 30 parts of liquorice, 200 parts of radix puerariae, 100 parts of black bean, 50 parts of lily, 20 parts of lotus seed, 60 parts of oat and 50 parts of soybean are weighed and mixed.
And step three, crushing the mixed raw materials, sieving the crushed mixed raw materials by a 150-mesh sieve, and bagging the sieved mixed raw materials to obtain the product.
Preparation example (3)
And (3) replacing the low-temperature microwave curing process in the second step in the preparation example (2) with a low-temperature curing process (with the same effect, the low-temperature baking is carried out at 60 ℃,30 minutes or 120 ℃ and 10 minutes), wherein the rest preparation processes are the same as the preparation example (2).
Preparation example (4)
Selecting raw materials of commercially available Chinese yam, cinnamon, poria, angelica, gordon euryale seed, turmeric, medlar, rhizoma polygonati, liquorice, kudzu root, black bean, lily, lotus seed, oat and soybean, cleaning, wherein the Chinese yam, the poria, the angelica, the turmeric, the rhizoma polygonati, the liquorice and the kudzu root are sliced or cut into blocks, and drying at low temperature (60 ℃) until the water content is below 15%.
Step two, curing the raw materials by microwave (120 ℃,10 minutes) according to the following parts by weight: 150 parts of Chinese yam, 30 parts of cinnamon, 150 parts of poria cocos, 10 parts of angelica sinensis, 50 parts of gordon euryale seed, 10 parts of turmeric, 50 parts of medlar, 100 parts of rhizoma polygonati, 10 parts of liquorice, 100 parts of kudzuvine root, 50 parts of black bean, 100 parts of lily, 50 parts of lotus seed, 40 parts of oat and 100 parts of soybean are weighed and mixed.
And step three, crushing the mixed raw materials, sieving the crushed mixed raw materials by a 150-mesh sieve, and bagging the sieved mixed raw materials to obtain the product.
Preparation example (5)
The polygonatum and the angelica in the preparation example (4) are replaced by nine commercially available sealwort (namely sealwort prepared by adopting the traditional nine-steaming nine-aeration method) and wine-sold angelica (namely prepared by the following process that the clean angelica is taken and added with a proper amount of yellow wine for even stirring, slightly moistened, placed in a pot after the wine is completely absorbed, heated by slow fire, slightly fried to be dry, taken out when the fragrance is strong and the wine fragrance is slight, and cooled), and the mixture ratio of the other raw materials is the same as the processing process of the preparation example (4).
Preparation example (6)
Frying (frying at 120 ℃,15 minutes or 150 ℃,10 minutes and the same effect) is adopted to replace the medium-low temperature microwave curing process in the second step of the preparation example (4), and the rest of the preparation process is the same as the preparation example (4).
Preparation example (7)
Step one, purchasing commercially available Chinese yam, cinnamon, poria cocos, gordon euryale seed, turmeric, medlar, liquorice, kudzu root, black bean, lily, lotus seed, oat, soybean, maca, fructus amomi and raw materials, cleaning, wherein the Chinese yam, the cinnamon, the poria cocos, the turmeric, the liquorice, the kudzu root and the maca are sliced or cut into pieces, and drying at low temperature (40 ℃) until the water content is below 15%.
Step two, curing the raw materials by low-temperature microwave (100 ℃,20 minutes), purchasing nine-process sealwort sold in the market (namely the sealwort prepared by adopting the traditional nine-steaming nine-aeration method), and purchasing wine angelica sold in the market (namely, the wine is prepared by the following process that clean angelica is taken, an appropriate amount of yellow wine is added for stirring, the mixture is slightly moistened, after the wine is completely absorbed, the mixture is placed in a pot, heated by slow fire, slightly fried to be dry, and taken out for cooling when the fragrance is strong and has slight wine fragrance), and the wine is prepared according to the following weight parts: weighing and mixing 50 parts of Chinese yam, 60 parts of cinnamon, 90 parts of poria cocos, 50 parts of angelica sinensis, 80 parts of gordon euryale seed, 25 parts of turmeric, 80 parts of medlar, 20 parts of rhizoma polygonati, 25 parts of liquorice, 100 parts of kudzu root, 100 parts of black bean, 40 parts of lily, 20 parts of lotus seed, 60 parts of oat, 50 parts of soybean, 100 parts of maca and 50 parts of fructus amomi;
and step three, crushing the mixed raw materials, sieving the crushed mixed raw materials by a 150-mesh sieve, and bagging the sieved mixed raw materials to obtain the product of the invention.
Preparation example (8)
Step one, purchasing commercially available Chinese yam, cinnamon, poria cocos, chinese angelica, gordon euryale seed, turmeric, chinese wolfberry, liquorice, kudzu root, black bean, lily, lotus seed, oat, soybean, maca, fructus amomi and raw materials, cleaning, wherein the Chinese yam, the cinnamon, the poria cocos, the Chinese angelica, the turmeric, the liquorice, the kudzu root and the maca are sliced or cut into pieces, and drying at low temperature (40 ℃) until the water content is below 15%.
Step two, curing the raw materials by low-temperature baking (60 ℃,30 minutes or 120 ℃,10 minutes low-temperature baking with the same effect) and purchasing nine-process sealwort (namely sealwort prepared by adopting the traditional nine-steaming nine-aeration method) sold in the market according to the following parts by weight: 100 parts of Chinese yam, 30 parts of cinnamon, 70 parts of poria cocos, 30 parts of angelica sinensis, 50 parts of gordon euryale seed, 10 parts of turmeric, 50 parts of medlar, 100 parts of rhizoma polygonati, 30 parts of liquorice, 50 parts of kudzuvine root, 50 parts of black bean, 100 parts of lily, 60 parts of lotus seed, 100 parts of oat, 100 parts of soybean, 50 parts of maca and 20 parts of fructus amomi;
and step three, crushing the mixed raw materials, sieving the crushed mixed raw materials by a 150-mesh sieve, and bagging the sieved mixed raw materials to obtain the product.
Preparation example (9)
Step one, purchasing commercially available raw materials of Chinese yam, cinnamon, poria cocos, chinese angelica, gordon euryale seed, turmeric, chinese wolfberry, liquorice, kudzu root, black bean, lily, lotus seed, oat, soybean, maca, fructus amomi and corn, cleaning, slicing or cutting the Chinese yam, the cinnamon, the poria cocos, the Chinese angelica, the turmeric, the liquorice, the kudzu root and the maca, and drying at low temperature (40 ℃) until the water content is below 15%.
Step two, curing the raw materials by low-temperature microwave (100 ℃,20 minutes), and additionally purchasing nine-process sealwort (namely sealwort prepared by adopting a traditional nine-steaming nine-aeration method) sold in the market according to the following parts by weight: 200 parts of Chinese yam, 50 parts of cinnamon, 50 parts of poria cocos, 50 parts of angelica sinensis, 20 parts of gordon euryale seed, 30 parts of turmeric, 20 parts of medlar, 30 parts of polygonatum, 20 parts of liquorice, 120 parts of kudzuvine root, 50 parts of black bean, 60 parts of lily, 20 parts of lotus seed, 30 parts of oat, 50 parts of soybean, 80 parts of maca, 20 parts of fructus amomi and 100 parts of corn are weighed and mixed;
and step three, crushing the mixed raw materials, sieving the crushed mixed raw materials by a 150-mesh sieve, and bagging the sieved mixed raw materials to obtain the product of the invention.
Preparation example (10)
Step one, purchasing raw materials of commercially available Chinese yam, cinnamon, poria cocos, gordon euryale seed, turmeric, medlar, liquorice, kudzu root, black bean, lily, lotus seed, oat, soybean, maca, fructus amomi and corn, cleaning, wherein the Chinese yam, the cinnamon, the poria cocos, the turmeric, the liquorice, the kudzu root and the maca are sliced or cut into pieces, and drying at low temperature (40 ℃) until the water content is below 15%.
Step two, stir-frying the raw materials (stir-frying at 120 ℃,15 minutes or 150 ℃,10 minutes, the effect is the same) for curing, additionally purchasing nine-process sealwort (namely, sealwort prepared by adopting the traditional nine-steaming nine-aeration method) sold in the market, additionally purchasing wine angelica sold in the market (namely, manufacturing according to the following process, namely, taking pure angelica, adding a proper amount of yellow wine and evenly mixing, weighing and mixing according to the following weight parts of 50 parts of yam, 20 parts of cinnamon, 150 parts of tuckahoe, 20 parts of angelica, 50 parts of gordon euryale seed, 10 parts of turmeric, 60 parts of medlar, 100 parts of sealwort, 30 parts of liquorice, 50 parts of kudzuvine root, 100 parts of black bean, 30 parts of lily, 40 parts of lotus seed, 60 parts of oat, 100 parts of soybean, 50 parts of maca, 30 parts of amomum fruit and 50 parts of corn;
and step three, crushing the mixed raw materials, sieving the crushed mixed raw materials by a 150-mesh sieve, and bagging the sieved mixed raw materials to obtain the product.
Preparation example (11)
Step one, purchasing raw materials of commercially available Chinese yam, poria cocos, chinese angelica, gordon euryale seed, ginger, medlar, sealwort, liquorice, kudzu root, black bean, lily, lotus seed, oat, soybean, maca, fructus amomi and corn, cleaning, wherein the Chinese yam, the poria cocos, the Chinese angelica, the ginger, the sealwort, the liquorice, the kudzu root and the maca are sliced or cut into pieces, and drying at low temperature (40 ℃) until the water content is below 15%.
Step two, curing the raw materials by extrusion and expansion (at 150 ℃), wherein the raw materials comprise the following components in parts by weight: 150 parts of Chinese yam, 100 parts of tuckahoe, 50 parts of angelica, 25 parts of gordon euryale seed, 10 parts of ginger, 50 parts of medlar, 50 parts of rhizoma polygonati, 25 parts of liquorice, 100 parts of kudzu root, 75 parts of black bean, 50 parts of lily, 25 parts of lotus seed, 50 parts of oat, 75 parts of soybean, 100 parts of maca, 25 parts of fructus amomi and 40 parts of corn are weighed and mixed;
and step three, crushing the mixed raw materials, sieving the crushed mixed raw materials by a 150-mesh sieve, and bagging the sieved mixed raw materials to obtain the product of the invention.
Preparation example (12)
Firstly, selecting commercially available raw materials of Chinese yam, poria cocos, gordon euryale seed, ginger, wolfberry, sealwort, liquorice, kudzu root, black bean, lily, lotus seed, oat, soybean, maca, fructus amomi and corn, cleaning, wherein the Chinese yam, the poria cocos, the ginger, the sealwort, the liquorice, the kudzu root and the maca are sliced or cut into blocks, and drying at low temperature (60 ℃) until the water content is below 15%.
Step two, curing the raw materials by microwave (80 ℃,30 minutes) according to the following parts by weight: 50 parts of Chinese yam, 50 parts of tuckahoe, 30 parts of gordon euryale seed, 30 parts of ginger, 20 parts of medlar, 80 parts of rhizoma polygonati, 60 parts of liquorice, 50 parts of kudzu root, 120 parts of black bean, 30 parts of lily, 50 parts of lotus seed, 60 parts of oat, 120 parts of soybean, 100 parts of maca, 100 parts of fructus amomi and 50 parts of corn are weighed and mixed.
And step three, crushing the mixed raw materials, sieving the crushed mixed raw materials by a 150-mesh sieve, and bagging the sieved mixed raw materials to obtain the product.
Example 2 evaluation of drug efficacy in rat model of climacteric syndrome
Material sources are as follows:
health functional food (Kunyikang) TM ): prepared by the processes of preparation example 1 (namely Kunyikang A) and preparation example 7 (namely Kunyikang B).
Lifumin tablets: registration certificate number of imported drugs: z20130001, produced by natural pharmaceutical companies of xialinden, germany, as a positive drug in this experiment.
Experimental animals: SD rats were purchased from shanghai slaike laboratory animals ltd, animal specifications: SPF grade, female, 180-200g.
Basic feed: is selected from cooperative medical bioengineering limited company in Jiangsu province.
Feeding conditions and environment: animals were bred at the comparison medicine center of Zhonghong bioengineering pharmaceutical research institute, inc. of Jiangsu province (laboratory animal center of Qianhong pharmaceutical products, inc., of the mother company, with license number SYXK (Su) 2016-0036). Animals were housed in polycarbonate plastic boxes of length x width x height =545mm x 395mm x 200mm, no more than 5 animals per sex, housed in a barrier environment animal house, and had free access to food and water. The environmental conditions are controlled at the room temperature of 20-26 ℃, the relative humidity of 40-70 percent and the light and shade alternate when the lamp is illuminated for 12 hours.
The identification method of the experimental animal comprises the following steps: the experimental groups are distinguished by labels, and special codes, groups, grouping dates, animal numbers, dosage information and the like are written. The animals in the group were numbered on ear tags.
1. Rat model establishment and administration scheme for climacteric syndrome
SD rats weighing 180-260g were selected as experimental animals, and bilateral ovaries of the rats were removed. After being restored and raised for 2 weeks, the castrated rats were grouped according to weight and divided into 12 animals in each group, namely a model group, a Lifumin group, a Kunyikang A group and a Kunyikang B group. Gavage group is administrated by intragastric administration daily, the dose is 0.056g (0.2 tablet)/kg, kunyikang A and B groups are respectively administrated with the corresponding health-care functional food/basic feed =1/5 mixed feed of preparation example 1 and preparation example 7 according to the corresponding grouping number for free ingestion, and the model group is administrated with the basic feed for free ingestion.
Taking out the uterus of some animals killed by Anle 45 days and 60 days after administration, weighing the wet weight, calculating the uterus coefficient, and detecting the estradiol level in the serum by an ELISA kit.
2. Organ coefficient and serum hormone level of each group of animals after free feeding for 45 days
The animals of each group, 4 per group, in the above protocol were euthanized after 12h fasting. The uterus was removed and weighed to determine the wet weight, and the uterine coefficient was calculated and shown in Table 1, table 2 and FIG. 1.
TABLE 1 organ coefficients of groups of animals after free feeding for 45 days
| Group of | Body weight (g) | Uterine weight (g) | Coefficient of uterus |
| Model set | 356.00±23.45 | 0.201±0.01 | 0.567±0.051 |
| Lifumin group | 362.00±7.62 | 0.224±0.04 | 0.618±0.109 |
| Kunyikang group A | 336.75±27.22 | 0.204±0.03 | 0.611±0.105 |
| Kunyikang group B | 357.00±18.87 | 0.224±0.04 | 0.630±0.138 |
TABLE 2 estradiol in serum of animals of each group 45 days after free feeding
Compared to the model group, p <0.05, p <0.01.
3. Organ coefficient and serum hormone level of each group of animals 60 days after free feeding
Groups of 8 animals from the protocol were euthanized 12h after fasting. The uterus was removed and weighed to determine the wet weight, and the uterus coefficient was calculated and reported in tables 3 and 4, and fig. 2.
TABLE 3 organ coefficients of various groups of animals after free feeding for 60 days
| Group of | Body weight (g) | Uterine weight (g) | Coefficient of uterus |
| Model set | 377.38±17.73 | 0.12±0.02 | 0.33±0.06 |
| Lifumin group | 370.25±20.67 | 0.14±0.02 | 0.37±0.07 |
| Kunyikang group A | 359.00±10.94 | 0.12±0.02 | 0.34±0.06 |
| Kunyikang group B | 365.33±26.52 | 0.14±0.04 | 0.38±0.12 |
TABLE 4 estradiol in serum of various groups of animals 60 days after free feeding
Compared to the model group, p <0.05, p <0.01.
From the data, it can be seen that there was a rising trend of estradiol in Kun Yi kang group B compared to model group animals after 45 days of ad libitum feeding, but there was no statistical difference. After free feeding for 60 days, kunyikang group B can significantly increase the estradiol content in vivo, compared with the model group animals. And compared with the Kunyikang group B, the Kunyikang group A has no soybean, black bean and rhizoma polygonati, and the estradiol result has no significant difference with the model group.
The products obtained in preparation examples 3-10 of example 1 also showed similar results to Kunyikang group B.
The results suggest that Kunyikang B can better improve climacteric syndrome, effectively improve hormone balance and regulate endocrine balance compared with the positive drug Lifumin.
Example 3 evaluation of drug efficacy in rat model of dysmenorrhea
Material source:
health functional food (Kunyikang) TM ): prepared by the process of preparation example 8 (namely Kun Yi kang C) and preparation example 9 (namely Kun Yi kang D).
Qianjin tablets for gynecology: the Chinese medicine standard character Z43020027, purchased from Jingdong, is used as the positive medicine in this experiment.
Guanyu dingkunjian pill: the Chinese medicine standard Z20059003, purchased from Jingdong, was used as the positive drug in this experiment.
Experimental animals: SD rats were purchased from shanghai slaike laboratory animals ltd, and the animal specifications: SPF class, female, 180-200g.
Basic feed: is selected from cooperative medical bioengineering limited company in Jiangsu province.
Feeding conditions and environments: animals were bred at the comparison medicine center of Zhonghong bioengineering pharmaceutical research institute, inc. of Jiangsu province (laboratory animal center of Qianhong pharmaceutical products, inc., of the mother company, with license number SYXK (Su) 2016-0036). Animals were housed in polycarbonate plastic boxes of length x width x height =545mm x 395mm x 200mm, no more than 5 animals per sex, housed in a barrier environment animal house, and had free access to food and water. The environmental conditions are controlled at the room temperature of 20-26 ℃, the relative humidity of 40-70 percent and the light and shade alternate when the lamp is illuminated for 12 hours.
The identification method of the experimental animal comprises the following steps: the experimental groups are distinguished by labels, and special codes, groups, grouping dates, animal numbers, dosage information and the like are written. The animals in the group were numbered on ear tags.
1. Establishing and administration scheme of rat primary dysmenorrhea model
SD rats with the weight of 180-260g are selected as experimental animals, the rats are divided into a normal group, a model group, a Dingkudan group, a Qianjin group, a Kunyikang C group and a Kunyikang D group according to the weight, and each group comprises 12 animals. The positive medicine is administrated by gastric perfusion. D1-7: the administration dose of rats in the Dingkundan group is 1g/kg, the administration dose of rats in the Qianjin group is 1.65 tablets/kg, 7 times per week and 1 week continuously; d8-28: the dosage of the rats in the Dingkundan group is 1.4g/kg, and the dosage of the rats in the Qianjin group is 2.3 tablets/kg, 5 times per week and 3 weeks continuously. And the Kunyikang group C and D respectively give free feeding to the mixed feed with the corresponding health-care functional food/basic feed =1/5 in the preparation examples 8 and 9 according to the corresponding group numbers. All animals except the normal group were injected subcutaneously with 0.1mg/mL estradiol benzoate edible oil solution for molding, D21 and D30: the dosage is 0.3 mg/tube; d22-29: the dosage is 0.15 mg/tube. D31: except for the normal group, all animals were intraperitoneally injected with oxytocin (2U/mouse).
Measuring the times of writhing of animals within 30min of oxytocin injection; taking out the uterus after the animal euthanasia, weighing the wet weight of the uterus, and calculating the uterus coefficient; the ELISA kit detects the concentration of F1 alpha (6-keto-F1 alpha), TXB2/F1 alpha (6-keto-F1 alpha) and beta-EP in serum; the supernatant was assayed for PGF 2. Alpha. And PGE2 concentration after homogenization of uterine tissue.
2. Organ coefficient of each group of animals after 30 days of free feeding
The animals in each group, 12 per group, of the above protocol were euthanized after 12h fasting. The uterus was removed and weighed wet, and the coefficient of uterus was calculated and the data is shown in Table 5 and FIG. 3.
TABLE 5 statistics of body twisting times and organ coefficients
P <0.05, p <0.01 compared to model group.
From the data, it can be seen that the uterine weight of the animals in the normal group was lower than that in the model group and the uterine weight of the animals in the Kunyikang group D tended to decrease after the free feeding for 30 days, as compared with the animals in the model group. There was no significant difference in body weight between the groups of rats. In the aspect of uterine coefficient, compared with the model group animals, the uterine coefficient of the normal group animals is obviously reduced, and the positive medicine group and the Kunyikang group have no obvious difference. In torsion response, the torsion times of Kunyikang rats C and D are significantly reduced compared with those of the animals in the model group, wherein the torsion times of Kunyikang rats D are less.
2. After 30 days of free feeding, the serum of each group of animals has F1 alpha (6-keto-F1 alpha), TXB2 concentration, TXB2/F1 alpha (6-keto-F1 alpha) and beta-EP concentration.
The animals of the above protocol were bled from the eye socket after 12h fasting, and after centrifugation at 3000rpm for 10min, the supernatant was taken, and the serum concentrations of rat-6-keto prostaglandin F1 α (6-keto-F1 α), thromboxane B2 (TXB 2), and β -endorphin (β -EP) were measured by the kit, and TXB2/F1 α (6-keto-F1 α) was calculated. The data are shown in table 6 and fig. 4.
TABLE 6 serum F1 α (6-keto-F1 α), TXB2 concentration, TXB2/F1 α (6-keto-F1 α), β -EP concentration
Compared with the normal group, # p <0.05, # p <0.0001.
Compared to model groups, p <0.05, p <0.01, p <0.001, p <0.0001.
From the data, it is clear that 30 days after free ingestion. Compared with the normal group, the content of F1 alpha (6-keto-F1 alpha) in the serum of the rats in the model group is obviously reduced, TXB2 is not different, TXB2/6-keto-F1 alpha is obviously increased, and beta-endorphin is not different.
Compared with the model group, the 6-keto-F1 alpha water level in the serum of the rat of each administration group has no significant difference; the positive drugs of the Kunjin pellet and the Qianjin tablet can both obviously reduce the TXB2 level in serum, wherein the Qianjin tablet has better effect, kunjin C has a reduction trend on the TXB2 level in serum, and Kunjin D can obviously reduce the TXB2 level in serum; in the aspect of the ratio, the positive medicine and Kunyikang can both obviously reduce the ratio of TXB2/6-keto-F1 alpha in the serum of a rat, and the Qianjin tablet in the positive medicine has better effect and the Kunyikang D has better effect. The positive drug dingkundan can not obviously increase the level of beta-endorphin in serum; the Qianjin tablets have a rising trend to the level of beta-endorphin in serum; kun Yi kang C and D can obviously improve the level of beta-endorphin in serum, wherein Kun Yi kang D has better effect.
6-keto-F1 alpha is a metabolite of vasodilator PGI2, and PGI2 can inhibit platelet aggregation and relax blood vessels. TXB2 is a metabolite of TXA 2. TXA2 can significantly promote vasoconstriction and platelet aggregation. The beta-endorphin has the effects of endogenous analgesia and peripheral regulation, and the uterus is a target organ of the beta-endorphin and can participate in the regulation of the functions of the uterus, so that the level of the beta-endorphin in serum is increased, and the pain threshold of a patient can be increased to a certain extent. The experimental result shows that Kunyikang D can not increase the level of vasodilation factor PGI2 in a rat body, but changes the ratio of TXB2/6-keto-F1 alpha in a body by reducing the level of vasoconstriction factor TXB2, and simultaneously promotes the body to synthesize endogenous beta-endorphin, so that the effects of slowing down vasoconstriction, improving the pain threshold of a rat with dysmenorrhea and relieving the response of the dysmenorrhea are achieved.
3. After 30 days of free ingestion, the concentrations of PGF2 alpha and PGE2 in the supernatant are detected after the uterine tissue homogenate of each group of animals
The animals in each group, 12 per group, were euthanized after 12h fasting. The uterus was taken out, weighed, homogenized by adding PBS in a ratio of 1. The data are shown in table 7 and fig. 5.
TABLE 7 detection of PGF2 alpha, PGE2 concentration in supernatants following uterine tissue homogenization
P <0.05 compared to model group.
Compared with a model group, kunyikang C can obviously improve the level of the PGE2 in the uterus, kunyikang D and Qianjin tablets have a rising trend on the level of the PGE2 in the uterus, and Dingkudan has no influence on the level of the PGE2 in the uterus; there was no significant difference between PGF2 α and PGF2 α/PGE2 for each group.
PGE2 can promote vasodilation and smooth muscle development. PGF2 α has the effect of stimulating uterine contraction. The experimental result shows that: kunyikang C can improve the excessive contraction of the uterine smooth muscle during the dysmenorrhea to a certain extent, thereby playing a role in improving the symptoms of the dysmenorrhea.
4. Uterine tissue structure of rats in each group after free feeding for 30 days
The uterus of each group of rats in the scheme is placed in 10% neutral buffered formalin for fixation, after the fixation is completed, operations such as tissue dehydration, embedding, slicing, HE staining and the like are carried out, and after the staining is completed, the uterus tissue slices are subjected to microscopic examination, and the result is shown in figure 6.
From microscopic examination results, the endometrium of the uterine tissue of each group of rats is complete, the surface of the endometrium is in a wave shape, and the thickness of the endometrium is not obviously different; the glandular epithelium and the luminal epithelium of each group of rats are complete and cuboidal, are closely arranged, have no edema in the mesenchyme and have normal gland number.
The experimental results show that Kunyikang group C and group D can well relieve dysmenorrheal symptoms, improve irregular menstruation, effectively improve hormone balance and regulate endocrine balance, and the curative effect is superior to positive medicines such as Dingkundan and Qianjin tablets to a great extent. Meanwhile, the tissue section result shows that Kun Yi kang has no adverse effect on uterine tissues.
Example 4 evaluation of drug efficacy in rat model with dysmenorrhea
Material sources are as follows:
health functional food (Kunyikang) TM ): prepared by the processes of preparation example 10 (namely Kunyikang E) and preparation example 11 (namely Kunyikang F).
Experimental animals: SD rats were purchased from shanghai slaike laboratory animals ltd, and the animal specifications: SPF grade, female, 180-200g.
Basic feed: is selected from cooperative medical bioengineering limited company in Jiangsu province.
Feeding conditions and environment: animals were bred at the comparative medicine center of Zhonghong bioengineering pharmaceutical research institute, jiangsu, inc. (the experimental animal center of Qianhong pharmaceutical products, inc., changzhou, with license number SYXK (Su) 2016-0036). Animals were housed in polycarbonate plastic boxes of length x width x height =545mm x 395mm x 200mm in a cage of no more than 5 animals/sex, housed in a barrier environment animal room with free access to food and water. The environmental conditions are controlled at the room temperature of 20-26 ℃, the relative humidity of 40-70 percent and the light and shade alternation of 12 hours of illumination.
The identification method of the experimental animal comprises the following steps: the experimental groups are distinguished by labels, and special codes, groups, grouping dates, animal numbers, dosage information and the like are written. The animals in the group were numbered on ear tags.
1. Establishing and administration scheme of rat primary dysmenorrhea model
SD rats with the weight of 180-260g are selected as experimental animals, the rats are divided into a normal group, a model group, a Kunyikang E group and a Kunyikang F group according to the weight, and each group comprises 12 animals. And the Kunyikang group E and the Kunyikang group F respectively give the mixed feed with the health-care functional food/basic feed =1/5 corresponding to the preparation examples 10 and 11 according to the corresponding group numbers for free feeding. All animals except the normal group were molded by subcutaneous injection of 0.1mg/mL estradiol benzoate edible oil solution, D21 and D30: the dosage is 0.3 mg/mouse; d22-29: the dosage is 0.15 mg/mouse. D31: except for the normal group, all animals were injected intraperitoneally with oxytocin (2U/mouse).
Measuring the times of writhing of animals within 30min of oxytocin injection; the uterus of the animal is taken out after euthanasia, the wet weight of the animal is weighed, and the uterus coefficient is calculated.
2. Organ coefficient of each group of animals after 30 days of free feeding
The animals in each group, 12 per group, were euthanized after 12h fasting. The uterus was removed and weighed to determine the wet weight, and the uterus coefficient was calculated and shown in Table 8 and FIG. 7.
TABLE 8 statistics of number of torsions and organ coefficients
Compared to the model group, p <0.05, p <0.01, p <0.001.
As can be seen from the data, the uterine weight of the animals of the normal group was lower than that of the model group compared with the animals of the model group after the free feeding for 30 days. There was no significant difference in body weight between the groups of rats. In terms of uterine coefficient, the uterine coefficient was significantly reduced in the normal group animals compared with the model group animals, while there was no significant difference in the Kunyikang group. In the aspect of writhing response, the times of writhing of Kunyikang E and F rats are obviously reduced compared with the times of writhing of model animals, wherein the times of writhing of Kunyikang E rats are less.
The experimental results show that Kunyikang groups E and F can well relieve the symptoms of dysmenorrheal and improve the symptoms of irregular menstruation.
Example 5 evaluation of drug efficacy in rat model with dysmenorrhea
Material sources are as follows:
health functional food (Kunyikang) TM ): by usingPreparation example 12 (i.e. Kun Yi kang G).
Experimental animals: SD rats were purchased from shanghai slaike laboratory animals ltd, and the animal specifications: SPF grade, female, 180-200g.
Basic feed: is selected from cooperative medical bioengineering Co., ltd in Jiangsu province.
Feeding conditions and environment: animals were bred at the comparative medicine center of Zhonghong bioengineering pharmaceutical research institute, jiangsu, inc. (the experimental animal center of Qianhong pharmaceutical products, inc., changzhou, with license number SYXK (Su) 2016-0036). Animals were housed in polycarbonate plastic boxes of length x width x height =545mm x 395mm x 200mm, no more than 5 animals per sex, housed in a barrier environment animal house, and had free access to food and water. The environmental conditions are controlled at the room temperature of 20-26 ℃, the relative humidity of 40-70 percent and the light and shade alternate when the lamp is illuminated for 12 hours.
The identification method of the experimental animal comprises the following steps: the experimental groups are distinguished by labels, and special codes, groups, grouping dates, animal numbers, dosage information and the like are written. The animals in the group were numbered on an ear tag.
1. Establishing and administration scheme of rat primary dysmenorrhea model
SD rats with the weight of 180-260G are selected as experimental animals, the rats are divided into a model group and a Kunyikang G group according to the weight, and each group comprises 10 animals. And the Kunyikang G group freely eats the mixed feed with the health functional food/basic feed =1/5 corresponding to the preparation example 12 according to the corresponding group number. The animals of each group are injected with 0.1mg/mL estradiol benzoate edible oil solution for molding, D21 and D30: the dosage is 0.3 mg/mouse; d22-29: the dosage is 0.15 mg/tube. D31: each group of animals was injected intraperitoneally with oxytocin (2U/mouse).
Measuring the times of writhing of animals within 30min of oxytocin injection; the uterus of the animal is taken out after euthanasia, the wet weight of the animal is weighed, and the uterus coefficient is calculated.
2. Organ coefficient of each group of animals after 30 days of free feeding
The animals in each group, 10 per group, were euthanized after 12h fasting. The uterus was removed and weighed to determine the wet weight, and the uterine coefficient was calculated and shown in Table 9 and FIG. 8.
TABLE 9 statistics of number of wriggling and organ coefficients
Compared to the model group, p <0.05, p <0.01, p <0.001.
From the data, after freely eating for 30 days, compared with the animals in the model group, kun Yi kang G group has no significant difference in the times of writhing, the weight of uterus and the coefficient of uterus. And compared with other preparation example groups, the Kunyikang G group is not added with angelica sinensis, cinnamon and ginger, and the parts of liquorice and fructus amomi are different, so that the components cannot improve the related symptoms of the dysmenorrheal model rats after being changed.
Claims (7)
1. A health-care functional food for regulating female endocrine balance and relieving climacteric syndrome and irregular menstruation is prepared from the following raw materials in parts by weight:
50-200 parts of Chinese yam, 30-60 parts of cinnamon, 50-150 parts of poria cocos, 10-50 parts of angelica sinensis, 20-100 parts of gordon euryale seed, 10-30 parts of turmeric, 20-100 parts of medlar, 20-100 parts of rhizoma polygonati, 10-30 parts of liquorice, 50-200 parts of radix puerariae, 50-100 parts of black bean, 30-100 parts of lily, 20-60 parts of lotus seed, 30-100 parts of oat and 50-100 parts of soybean.
2. The functional health food according to claim 1, further comprising maca in an amount of 50 to 100 parts by weight and amomum villosum in an amount of 20 to 50 parts by weight.
3. The functional food for health care according to claim 1, further comprising corn in an amount of 40 to 100 parts by weight.
4. The health functional food according to any one of claims 1 to 3, which is prepared by the following method:
sorting and cleaning the raw materials, cutting part of the raw materials into blocks, and drying the blocks at a low temperature (40-60 ℃) until the moisture content is below 15%;
curing the raw materials, weighing and mixing the raw materials in proportion;
and step three, crushing, sieving and bagging the mixed raw materials to obtain the product of the invention.
5. The method of claim 4, wherein in the second step, the step of cooking is replaced by low temperature microwave cooking (80-120 deg.C, 10-30 min), low temperature baking (60-120 deg.C, 10-30 min), parching (120-150 deg.C, 10-15 min), or extrusion puffing (150 deg.C).
6. The preparation method according to claim 4, wherein the raw material rhizoma Polygonati is prepared by a traditional nine-steaming nine-aeration or four-steaming four-aeration method; other starting materials were prepared according to the above method steps one and two.
7. The preparation method according to claim 4, wherein the raw material angelica sinensis is prepared by the following process: mixing clean radix Angelicae sinensis with appropriate amount of yellow wine, slightly moistening, placing in a pan after the wine is completely absorbed, heating with slow fire, parching to dry, and taking out and cooling when the fragrance is strong and slight wine fragrance is obtained; other starting materials were prepared according to the above method steps one and two.
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| CN202110720336.5A CN115590140A (en) | 2021-06-28 | 2021-06-28 | Health-care functional food for regulating female endocrine balance and relieving climacteric syndrome and irregular menstruation |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102784295A (en) * | 2012-08-03 | 2012-11-21 | 天津红日药业股份有限公司 | Health-care preparation formula for improving female climacteric syndrome and preparation method of same |
| CN104606612A (en) * | 2015-01-05 | 2015-05-13 | 王元忠 | Alcohol-expelling kidney-tonifying tablet candy and preparation method thereof |
| CN110367537A (en) * | 2019-08-08 | 2019-10-25 | 哈福科技（武汉）集团有限公司 | A kind of functional food and preparation method thereof improving menopausal syndrome |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102784295A (en) * | 2012-08-03 | 2012-11-21 | 天津红日药业股份有限公司 | Health-care preparation formula for improving female climacteric syndrome and preparation method of same |
| CN104606612A (en) * | 2015-01-05 | 2015-05-13 | 王元忠 | Alcohol-expelling kidney-tonifying tablet candy and preparation method thereof |
| CN110367537A (en) * | 2019-08-08 | 2019-10-25 | 哈福科技（武汉）集团有限公司 | A kind of functional food and preparation method thereof improving menopausal syndrome |
Non-Patent Citations (1)
| Title |
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| 周祯祥主编: "《生命在于营养——营养忠告》", 中国中医药出版社, pages: 408 - 180 * |
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