CN112138126A - Composition for effectively relieving dysmenorrhea and preparation method thereof - Google Patents
Composition for effectively relieving dysmenorrhea and preparation method thereof Download PDFInfo
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Abstract
The invention provides a composition for effectively relieving dysmenorrhea and a preparation method thereof, wherein the composition comprises the following raw materials in parts by weight: 53-57 parts of wolfberry fruit, 48-52 parts of kudzu root, 16-20 parts of peach kernel, 16-20 parts of Chinese date, 14-18 parts of dried ginger, 7-11 parts of longan aril, 3-7 parts of peanut coat, 2-6 parts of double-petal red rose and 48-52 parts of maltodextrin. The formula is scientific in compatibility, green and safe (food grade), and can effectively relieve dysmenorrhea. The traditional Chinese medicine composition is scientific and precise in formula, no preservative is added in the preparation process, the pertinence of the population is clear, the uncomfortable symptoms such as abdominal spasm pain, nausea and vomiting of a patient can be quickly and mildly relieved, the blood vessels are relieved, and the qi and blood are smooth. And the ingredients are selected from medicinal and edible raw materials, so that the composition has no toxicity, side effects and dependence after long-term administration. Meanwhile, through animal efficacy tests and crowd trial verification, the product prepared by the invention has the effect of obviously relieving various discomfort in menstrual period, ensures safety and effectiveness, and has the advantages of simultaneous treatment of principal and subordinate symptoms, quick response and short treatment course.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, and particularly relates to a composition for effectively relieving dysmenorrhea and a preparation method thereof.
Background
Primary dysmenorrhea (Primary Dysmenorrhal) is one of common gynecological diseases, accounts for more than 90% of dysmenorrhea population, mainly refers to the symptoms of difficult abdominal pain of patients in and around menstrual period, soreness and weakness of waist, usually accompanied with symptoms of unsmooth menstruation, reduction of menstrual flow, breast distending pain and the like, and can cause nausea, dizziness and even syncope in severe cases and periodic attacks. According to the survey results of a college and universities in tibet in 2018, 88.61% of girl students in the universities have different degrees of dysmenorrheal troubles, wherein 357 (68.12%) mild dysmenorrheal, 111 (21.18%) moderate dysmenorrheal and 56 (10.69%) severe dysmenorrheal. In 2015 white paper for physiological health of female in China, it is shown that nearly 80% of women in China are accompanied by mild or more dysmenorrhea, and more than 14% of women have influence on normal life. Therefore, dysmenorrhea is common in female diseases and is highly harmful.
Normal female menses are regulated by the thalamic-pituitary-ovarian axis and are cross-affected by a number of factors. For the etiology and pathogenesis of primary dysmenorrhea, modern western medicine considers that the pathogenesis is numerous, and the first few herbs belong to endocrine factors, other peptides, autonomic nervous system, uterine factors, psychological factors and the like. The modern medicine mainly adopts hormone drugs, antipyretic analgesics, non-steroidal anti-inflammatory drugs and oral contraceptives, such as compound norethisterone, compound megestrol, progesterone, ibuprofen, and juesheetrol cyproterone, etc., and achieves the effect of rapidly relieving pain by inhibiting the activity of prostaglandin synthetase, reducing the synthesis of prostaglandin, inhibiting uterine contraction and improving the local blood supply condition of uterus. The medicine can quickly relieve menstrual pain, but only temporarily relieve pain after being taken, patients suffer from dysmenorrhea for a long time and repeatedly, hormone medicines can influence the fertility function of women of normal childbearing age with high probability, non-steroidal anti-inflammatory medicines can induce gastrointestinal ulcer bleeding of patients, asthma is caused, and side effects are high.
From the perspective of traditional Chinese medicine, primary dysmenorrhea is classified into 6 types of syndromes of congealing cold with blood stasis, qi stagnation and blood stasis, accumulation of damp-heat, yang deficiency and internal cold, qi and blood deficiency and liver and kidney deficiency, blood stasis caused by qi and blood imbalance is considered as the key cause of primary dysmenorrhea, and the congealing cold and blood stasis type is the most common type clinically. The primary dysmenorrhea is located in uterus, Chong and ren meridians, and its pathogenesis is manifested as "pain due to obstruction" or "pain due to poor appetite". Compared with western medicines, the traditional Chinese medicine for treating primary dysmenorrhea has the advantages of natural raw materials, mild action, less side effects, treatment of both symptoms and root causes, lasting curative effect and the like, and has wide prospects in the aspect of developing products for treating dysmenorrhea.
At present, the traditional Chinese medicine products for treating dysmenorrhea in the market are various and can be classified into two categories of oral administration and external application. The oral conditioning products are commonly seen as lower abdomen stasis-removing granules, dysmenorrheal pills, black-bone chicken and white phoenix pills, Fukang tablets, woman-and-woman-killing pills and the like, and the traditional Chinese medicine compound products contain more than ten kinds of traditional Chinese medicine raw materials and have complex prescription. Wherein, the dysmenorrhea pill is taken 6-18 g daily during menstruation, contains about 10-32 g of crude drugs and has large dosage. Moreover, the traditional Chinese medicine products have drug interaction and are more prohibited to take, for example, the black-bone chicken and white phoenix pills contain ginseng and white paeony root and are prohibited to be used together with the drug containing veratrum nigrum. In addition, most products fall behind in the whole process, lack systematic quality standard, have certain difficulty to guarantee the process stability and product efficiency. For example, CN101829298A A Chinese medicinal composition for treating primary dysmenorrhea and its preparation method, the prepared composition has effects of activating qi-flowing, promoting blood circulation, removing blood stasis and relieving pain, and has definite therapeutic effect, but most of its ingredients are qi and blood, which easily causes insecurity of Chong and ren meridians and uterus, so that the body is not always metrorrhagia, and the heart heat is easily dry, and corydalis tuber has trace toxicity, which requires strict control of product process and quality, however, the related quality standards of the composition are not mentioned in the invention. For another example, CN106309506A a probiotic composition with menstruation regulating function, which comprises a plurality of probiotic combinations and a series of medicinal and edible traditional Chinese medicine combinations of radix glycyrrhizae preparata, fructus lycii, fructus jujubae, pericarpium citri reticulatae, rhizoma zingiberis, and longan, in the invention, the efficacy of the composition is verified by using a primary dysmenorrhea mouse model, but the writhing inhibition rate of the optimal combination ratio is only 42.42%.
Most of external use soothing products are uterus warming patches, massage essential oils and the like, the products can relieve dysmenorrhea to a certain extent, have no side effect, can only temporarily relieve pain, hardly achieve the effect of treating both symptoms and root causes, are inconvenient to carry during traveling, and some essential oils are easy to cause allergy and menstrual blood volume increase, even have the phenomena of metrorrhagia and endocrine dyscrasia in the using process and cause menstrual cycle disorder due to the physique of patients. For example, CN209500042U an essential oil physiotherapy chinese mugwort uterus warming patch is a novel physiotherapy product, which is provided with a sticking layer, a chinese mugwort layer, a heating layer, etc., and can be injected with essential oil according to the needs of patients, but the essential oil physiotherapy chinese mugwort uterus warming patch is not suitable for fast-paced urban women at present due to not light and portable carrying, not easy to use, and too long use time.
Disclosure of Invention
In view of the above, the present invention aims to provide a composition for effectively relieving dysmenorrhea and a preparation method thereof, and aims to effectively relieve dysmenorrhea and simultaneously have the effects of endocrine regulation and menstrual discomfort relief.
Based on the above purpose, the invention provides a composition for effectively relieving dysmenorrhea, which comprises the following raw materials in parts by weight:
53-57 parts of wolfberry fruit, 48-52 parts of kudzu root, 16-20 parts of peach kernel, 16-20 parts of Chinese date, 14-18 parts of dried ginger, 7-11 parts of longan aril, 3-7 parts of peanut coat, 2-6 parts of double-petal red rose and 48-52 parts of maltodextrin.
Preferably, the composition for effectively relieving dysmenorrhea comprises the following raw materials in parts by weight:
55.88 parts of medlar, 50.29 parts of kudzu root, 18.63 parts of peach kernel, 18.63 parts of Chinese date, 16.75 parts of dried ginger, 9.31 parts of longan aril, 5.59 parts of peanut coat, 4.47 parts of double-petal red rose and 50.09 parts of maltodextrin.
The invention also provides a preparation method of the composition for effectively relieving dysmenorrhea, which comprises the steps of crushing and sieving the kudzu root, the rose with double petals and the peanut coat according to the formula amount, adding water into the medlar, the peach kernel, the Chinese date and the longan pulp, crushing and sieving, and then carrying out primary extraction, centrifugation, secondary extraction, secondary centrifugation, concentration, filtration, drying and granulation on the crushed and sieved raw materials.
Preferably, the preparation method of the composition for effectively relieving dysmenorrhea comprises the following steps:
(1) raw material treatment: weighing radix Puerariae and peanut coat according to formula ratio, and pulverizing in a pulverizer to obtain a first mixed sieved substance; weighing barbary wolfberry fruit, peach kernel, Chinese date and longan pulp, adding 6-8 times of purified water, and crushing to obtain a second mixed filtrate; weighing and crushing the double-petal red rose to obtain double-petal red rose powder; weighing dried ginger, crushing and sieving to obtain dried ginger powder;
(2) primary extraction: mixing the first mixed sieved substance and the second mixed sieved substance, and adding 16-18 times of water to obtain fructus Lycii and radix Puerariae extractive solution; adding 16-18 times of water into the double-petal red rose powder to obtain a double-petal red rose extracting solution; adding 9-11 times of 70% ethanol into the dried ginger powder, and performing hot reflux extraction to obtain a dried ginger extract;
(3) centrifuging and filtering: centrifuging the extractive solution to obtain primary centrifugate and residue; centrifuging the extract to obtain primary centrifugate and residue; sieving the dried ginger extract by a screen mesh to obtain dried ginger filtrate and dried ginger filter residue;
(4) secondary extraction and centrifugation: adding 13-15 times of water into the wolfberry fruit and kudzuvine root centrifugation residue for extraction, and centrifuging to obtain wolfberry fruit and kudzuvine root secondary centrifugation liquid; adding 13-15 times of water into the centrifugal residue of the double-petal red rose, extracting with water, and centrifuging to obtain secondary centrifugal liquid of the double-petal red rose;
(5) concentration and sterilization: mixing the primary centrifugate and the secondary centrifugate, microfiltering, concentrating, and filtering to obtain concentrated steam; mixing the primary centrifugate and the secondary centrifugate, microfiltering, concentrating, and sterilizing to obtain concentrated solution; vacuum concentrating the filtrate of Zingiberis rhizoma, and sterilizing to obtain concentrated solution;
(6) and (3) drying: adding adjuvants into the concentrated decoction of fructus Lycii and radix Puerariae, the concentrated decoction of flos Rosae Rugosae and the concentrated decoction of rhizoma Zingiberis, and drying to obtain dried powder of fructus Lycii and radix Puerariae, dried powder of flos Rosae Rugosae and dried powder of rhizoma Zingiberis HE;
(7) and (3) granulating: adding adhesive into the dried powder of the medlar and the kudzuvine root, the dried powder of the double red rose and the dried powder of the dried ginger HE for granulation, wherein the granulation process is wet granulation, dry granulation or spray granulation.
Preferably, the raw materials in the step (1) are all sieved after being crushed, and the aperture of the sieved materials is 0.6-3 mm.
Extracting the wolfberry fruit and kudzuvine root extracting solution and the double-petal red rose extracting solution in the step (2) by adopting high-pressure-difference low-temperature continuous extraction equipment, or carrying out hot reflux extraction, dipping extraction, ultrasonic extraction or wall breaking extraction.
Preferably, the centrifugation in the step (3) sequentially passes through low-speed centrifugation and high-speed centrifugation, wherein the rotation speed of the low-speed centrifugation is 3500-15000 r/min, and the rotation speed of the high-speed centrifugation is 6500-15000 r/min. By adopting the centrifugal mode, the finally obtained composition has good curative effect and relatively better taste.
Preferably, the pore size of the microfiltration in the step (5) is 300-600 nm.
Preferably, in the step (5), membrane concentration or vacuum concentration is adopted in both the concentration of the wolfberry fruit-radix puerariae concentrated solution and the concentration of the double-petal red rose concentrated solution.
Preferably, the sterilization in the step (5) is performed by ceramic membrane or plate-and-frame filtration sterilization or instantaneous high-temperature sterilization, and the temperature of the instantaneous high-temperature sterilization is 130-140 ℃. More preferably, the ceramic membrane has a pore size of 200nm and the plate-frame filtration has a pore size of 220 nm.
Preferably, the auxiliary material in the step (6) is maltodextrin/fructo-oligosaccharide; the addition amount of the auxiliary materials is 30-50% of the total amount.
The main components and effects of the raw materials of the invention are as follows:
fructus Lycii, dried mature fruit of Lycium barbarum (Lycium barbarum) of Solanaceae, has mild nature and taste, and has effects of nourishing liver and kidney, replenishing vital essence, improving eyesight, and treating asthenia essence deficiency, blood deficiency chlorosis, soreness of waist and knees, etc., and its effective active components are Lycium barbarum polysaccharide, polyphenol and carotenoid. Research shows that the medlar has the effects of promoting hematopoiesis and relieving fatigue, can enhance the immunoregulation function, improve the health condition of the organism, indirectly relieve the problems of soreness and weakness of waist and knees, fatigue, hypodynamia and the like, and is one of the preferred Chinese medicinal materials for the development of the product for relieving the menstrual pain.
Kudzu root, a dry root of Pueraria lobata (Willd.) Ohwi) of Leguminosae, is sweet, pungent and neutral in flavor, and has effects of expelling pathogenic factors from muscles, relieving fever, promoting fluid production to quench thirst, invigorating yang and relieving diarrhea. Research shows that the kudzuvine root can promote sexual function, produce sperms to help breeding, strengthen sperms to replenish qi, improve the quality of the sperms, enhance the activity of the sperms and have certain curative effect on enhancing the renal function. In addition, the kudzuvine root can regulate endocrine, the high-activity isoflavone rich in the kudzuvine root can effectively regulate the endocrine, and chloasma is reduced and disappears after the kudzuvine root powder is eaten independently; the ovulation period is normal; regression of whelk and other manifestations. Meanwhile, the kudzuvine root can expand blood vessels and effectively improve the local blood supply condition of the uterus in the aspect of treating dysmenorrhea.
Peach kernel, which is a dried mature seed of Prunus persica (L.) Batsch) or Prunus davidiana (P.davidiana (Carr.) Franch.) belonging to Rosaceae. It is neutral in nature and bitter and sweet in taste, enters heart, liver and large intestine channels, can activate blood circulation to dissipate blood stasis, moisten intestines to relieve constipation, relieve cough and asthma, and is mainly used for amenorrhea, dysmenorrhea, abdominal mass and lump, traumatic injury, intestinal dryness and constipation. Researches show that peach kernel can achieve the effect of activating blood and dissolving stasis by improving hemodynamics, so that the peach kernel also attracts more and more attention in clinical treatment of menstrual pain and has obvious curative effect.
Arillus longan is the aril of longan (Dimocarpus longan Long, Lour.) belonging to Sapindaceae, and has sweet taste, mild nature, and enters heart and spleen meridians. Has the main effects of invigorating heart and spleen, nourishing blood and tranquillizing, and treating deficiency of qi and blood, palpitation, amnesia and insomnia, and can be used for treating menstrual period pain, blood deficiency and sallow complexion, and puerperal asthenia. Research shows that the ethanol extract of the arillus longan can obviously reduce the content of prolactin in the serum of female rats, can obviously increase the content of progesterone and follicle stimulating hormone, and directly influences endocrine.
Fructus Jujubae, the mature fruit of Zizyphi fructus (Zizp Husjujuba Miil) of Rhamnaceae, is sweet in taste and neutral in nature, is a common medicine and food homologous Chinese medicine, and has effects of invigorating qi and spleen, nourishing heart and tranquilizing mind. The Chinese date is rich in iron, calcium and flavonoid substances, wherein the iron element is an essential element for synthesizing hemoglobin, and is suitable for people with weak constitution, anemia and female menstruation; the calcium and the flavonoid substances can sooth liver, relieve depression, nourish blood, tranquilize mind, have obvious effects of tranquilizing and hypnotizing and reducing blood pressure, and relieve and regulate symptoms of dysphoria, restlessness or poor sleep.
Peanut coat (Arachis Hypogaea Linn), also known as peanut coat, is a traditional Chinese medicine, has sweet, astringent and flat nature and taste, enters lung, spleen and liver channels, and has the functions of strengthening spleen and stomach, nourishing blood and stopping bleeding, and removing blood stasis and reducing swelling. The traditional Chinese medicine composition is mainly used for treating primary or secondary thrombocytopenic purpura, hemophilia, liver disease bleeding and the like clinically, and can also be used for treating postoperative bleeding, lung bleeding, stomach bleeding, intestinal bleeding and the like. Modern pharmacological studies show that peanut coat can resist the dissolution of fibrin, promote the hematopoietic function of bone marrow, shorten the blood coagulation time and improve the content of blood platelets in blood.
The flos Rosae Rugosae with multiple petals can enter liver and spleen channels, and has effects of activating qi-flowing, resolving stagnation, promoting blood circulation, removing blood stasis, relieving pain, and relieving chest distress, depression, gastrointestinal discomfort, breast pain, abnormal leucorrhea, etc. caused by stagnation of liver-qi. And has effects of astringing and removing blood stasis, and can be used for caring skin, preventing wrinkle, healing wound, and treating carbuncle, sore and pain. Modern researches find that roses contain abundant vitamins and tannic acid and can improve the problem of endocrine dyscrasia.
Dried ginger, dried rhizome of Zingiber officinale Rosc of Zingiberaceae, is pungent and hot in flavor, and has effects of warming spleen and stomach, invigorating kidney, heart and lung channels, dispelling cold, restoring yang, dredging collaterals, warming lung, and resolving fluid retention. The rhizoma zingiberis contains volatile oil, diphenyl heptane, gingerol and other chemical components, has various pharmacological effects of relieving fever and inflammation and improving local blood circulation, and has a certain effect of treating female menstrual pain.
The invention has the beneficial effects that:
1. the formula is scientific in compatibility, green and safe (food grade), and can effectively relieve dysmenorrhea. The traditional Chinese medicine composition is scientific and precise in formula, no preservative is added in the preparation process, the pertinence of the population is clear, the uncomfortable symptoms such as abdominal spasm pain, nausea and vomiting of a patient can be quickly and mildly relieved, the blood vessels are relieved, and the qi and blood are smooth. And the ingredients are selected from raw materials which can be used as both medicine and food, and the composition has no toxic or side effect and no addiction after long-term administration. Meanwhile, clinical trial proves that the product prepared by the invention has the effect of obviously relieving various discomforts in menstrual period, ensures safety and effectiveness, treats both symptoms and root causes, and has quick response and short treatment course.
2. Most of the existing products for treating dysmenorrhea basically adopt an extraction mode of hot water extraction and high-temperature decoction, which has high energy consumption and low efficiency, the process is complicated, and the destructiveness to functional components is large.
3. The membrane filtration sterilization is used in the extraction and concentration process, and the terminal process is implemented in a universal clean area, so that the microbial qualification of the product can be fully ensured, the product preparation process is further simplified, and other sterilization processes do not need to be developed. And for the convenience of women, the finished product is independently packaged in design, and the product has good dissolubility and is convenient and easy to carry.
4. The product prepared by the invention has pure taste, is instant and clear when meeting water, and is not added with food additives such as preservatives, flavoring agents and the like.
5. The composition obtained by the combined processes of extraction, filtration, concentration, drying, granulation and the like has good taste and pure smell, effectively removes heavy metal and pesticide residues, and is green and harmless.
Detailed Description
To make the objects, technical solutions and advantages of the present disclosure more apparent, the present disclosure is further described in detail below with reference to specific embodiments.
It should be noted that technical terms or scientific terms used in the embodiments of the present specification should have a general meaning as understood by those having ordinary skill in the art to which the present disclosure belongs, unless otherwise defined.
Example 1
Composition for effectively relieving dysmenorrhea
The formula is as follows: 55.88 parts of wolfberry fruit, 50.29 parts of kudzu vine root, 18.63 parts of peach kernel, 18.63 parts of Chinese date, 16.75 parts of dried ginger, 9.31 parts of longan aril, 5.59 parts of peanut coat, 4.47 parts of double-petal red rose and 50.09 parts of maltodextrin.
The preparation method of the composition for effectively relieving dysmenorrhea comprises the following steps:
(1) crushing: pulverizing radix Puerariae and peanut coat in the raw materials weighed according to the formula ratio in a universal pulverizer, and sieving by 1.2 mm; adding 7 times of purified water into fructus Lycii, semen Persicae, fructus Jujubae, and arillus longan, pulverizing, and sieving by 1.2 mm; pulverizing Zingiberis rhizoma and flos Rosae Rugosae in universal pulverizer, and sieving by 1.2 mm;
(2) primary extraction: mixing the pulverized materials except Zingiberis rhizoma and flos Rosae Rugosae of (1), and extracting with 17 times of extraction medium at 20-30 deg.C under 30Mpa by high-efficiency high-pressure difference low-temperature continuous extraction equipment (HHLSE) with water to obtain fructus Lycii and radix Puerariae extractive solution; extracting double-petal red rose with high-efficiency high pressure difference low-temperature continuous extraction equipment (HHLSE) at 17 times with 35Mpa as extraction medium of water at 20-30 deg.C to obtain double-petal red rose extractive solution; and (3) adding 10 times of 70% ethanol into the dried ginger powder obtained in the step (1) for hot reflux extraction to obtain a dried ginger extracting solution.
(3) Centrifuging and filtering: (2) centrifuging the extractive solution at 4500r/min, and centrifuging at 10000r/min to obtain primary centrifugate and centrifugate residue; (2) centrifuging the medium-petal red rose extract at 4200r/min, and centrifuging at 10000r/min to obtain heavy-petal red rose centrifugate and heavy-petal red rose centrifugate; (2) filtering the medium-dry ginger extract by a 200-mesh screen to obtain a dried ginger filtrate and dried ginger filter residue;
(4) secondary extraction and centrifugation: (3) adding 14 times of purified water into the Chinese wolfberry fruit and kudzuvine root centrifugation residues for extraction, and centrifuging to obtain a Chinese wolfberry fruit and kudzuvine root secondary centrifugation liquid; (3) adding 14 times of purified water into the medium-heavy-petal red rose centrifugal slag for extraction, and centrifuging to obtain heavy-petal red rose centrifugal liquid;
(5) concentration and sterilization: mixing the centrifugates of fructus Lycii and radix Puerariae obtained in (3) and (4), mixing the centrifugates of double-petal red rose, separating, performing ceramic membrane microfiltration (500nm), vacuum concentration (less than or equal to 65 deg.C), and plate-frame filtration (sterilization) to obtain fructus Lycii and radix Puerariae concentrated solution and double-petal red rose concentrated solution; vacuum concentrating (at most 65 ℃) the dried ginger filtrate obtained in the step (3) to obtain a dried ginger concentrated solution;
(6) and (3) drying: (5) allowing the medium-concentration steamed liquid to enter a universal clean area, and respectively adding maltodextrin to the wolfberry fruit and radix puerariae concentrated steamed liquid, the double-petal red rose concentrated steamed liquid and the dried ginger concentrated steamed liquid to perform spray drying to obtain wolfberry fruit and radix puerariae dried powder, double-petal red rose dried powder and dried ginger HE dried powder; wherein, the amount of maltodextrin added in the wolfberry fruit and kudzuvine root concentrated steaming solution, the double-petal red rose concentrated steaming solution and the dried ginger concentrated steaming solution is respectively 50 percent, 35 percent and 60 percent of the corresponding total amount;
(7) and (3) granulating: (6) and adding maltodextrin with the total content of 5% into the three dry powders obtained in the step (a), and granulating, wherein the granulating process is spray granulation.
Example 2
Composition for effectively relieving dysmenorrhea
The formula is as follows: 53 parts of wolfberry fruit, 52 parts of kudzu root, 20 parts of peach seed, 16 parts of Chinese date, 15 parts of dried ginger, 11 parts of longan aril, 4 parts of peanut coat, 2 parts of double-petal red rose and 48 parts of maltodextrin.
The preparation method of the composition for relieving dysmenorrhea comprises the following steps:
(1) crushing: pulverizing radix Puerariae and peanut coat in the raw materials weighed according to the formula ratio in a universal pulverizer, and sieving by 1.2 mm; adding 8 times of purified water into fructus Lycii, semen Persicae, fructus Jujubae, and arillus longan, pulverizing, and sieving by 1.2 mm; pulverizing Zingiberis rhizoma and flos Rosae Rugosae in universal pulverizer, and sieving by 1.2 mm;
(2) primary extraction: mixing the pulverized materials except Zingiberis rhizoma and flos Rosae Rugosae of (1), and extracting with 17 times of extraction medium at 20-30 deg.C under 25Mpa by high-efficiency high-pressure difference low-temperature continuous extraction equipment (HHLSE) with water to obtain fructus Lycii and radix Puerariae extractive solution; extracting double-petal red rose with high-efficiency high pressure difference low-temperature continuous extraction equipment (HHLSE) at 17 times with 25Mpa as extraction medium of water at 20-30 deg.C to obtain double-petal red rose extractive solution; and (3) adding 10 times of 70% ethanol into the dried ginger powder obtained in the step (1) for hot reflux extraction to obtain a dried ginger extracting solution.
(3) Centrifuging and filtering: (2) centrifuging the Chinese wolfberry fruit and radix puerariae extracting solution at 3500r/min, and then centrifuging at 6500r/min to obtain a primary wolfberry fruit and radix puerariae centrifugate and a wolfberry fruit and radix puerariae centrifugate residue; (2) centrifuging the medium-heavy-petal red rose extracting solution at 3500r/min to obtain heavy-petal red rose centrifugal liquid and heavy-petal red rose centrifugal slag; (2) filtering the medium-dry ginger extract by a 200-mesh screen to obtain a dried ginger filtrate and dried ginger filter residue;
(4) secondary extraction and centrifugation: (3) adding 14 times of purified water into the Chinese wolfberry fruit and kudzuvine root centrifugation residues for extraction, and centrifuging to obtain a Chinese wolfberry fruit and kudzuvine root secondary centrifugation liquid; (3) adding 14 times of purified water into the medium-heavy-petal red rose centrifugal slag for extraction, and centrifuging to obtain heavy-petal red rose centrifugal liquid;
(5) concentration and sterilization: combining the wolfberry fruit and kudzuvine root centrifugates obtained in the steps (3) and (4), combining and separating the double red rose centrifugates, and respectively carrying out a series of working procedures of ceramic membrane microfiltration (300nm), reverse osmosis membrane concentration and plate-and-frame filtration (sterilization) to obtain wolfberry fruit and kudzuvine root concentrated steam and double red rose concentrated steam; vacuum concentrating (at most 65 ℃) the dried ginger filtrate obtained in the step (3) to obtain a dried ginger concentrated solution;
(6) and (3) drying: (5) allowing the medium-concentration steamed liquid to enter a universal clean area, and respectively adding maltodextrin to the wolfberry fruit and radix puerariae concentrated steamed liquid, the double-petal red rose concentrated steamed liquid and the dried ginger concentrated steamed liquid to perform spray drying to obtain wolfberry fruit and radix puerariae dried powder, double-petal red rose dried powder and dried ginger HE dried powder; wherein, the amount of maltodextrin added in the wolfberry fruit and kudzuvine root concentrated steaming solution, the double-petal red rose concentrated steaming solution and the dried ginger concentrated steaming solution is respectively 50 percent, 35 percent and 60 percent of the corresponding total amount;
(7) and (3) granulating: (6) adding Arabic gum with the total content of 5% into the three dry powders to granulate, wherein the granulating process is spray granulation.
Example 3
Composition for effectively relieving dysmenorrhea
The formula is as follows: 57 parts of medlar, 48 parts of kudzu root, 17 parts of peach kernel, 16 parts of Chinese date, 18 parts of dried ginger, 7 parts of longan aril, 7 parts of peanut coat, 6 parts of double-petal red rose and 52 parts of maltodextrin.
The preparation method of the composition for relieving dysmenorrhea comprises the following steps:
(1) crushing: pulverizing radix Puerariae and peanut coat in the raw materials weighed according to the formula ratio in a universal pulverizer, and sieving by 1.2 mm; adding 6 times of purified water into fructus Lycii, semen Persicae, fructus Jujubae, and arillus longan, pulverizing, and sieving by 1.2 mm; pulverizing Zingiberis rhizoma and flos Rosae Rugosae in universal pulverizer, and sieving by 1.2 mm;
(2) primary extraction: mixing the pulverized materials except Zingiberis rhizoma and flos Rosae Rugosae of (1), and extracting with 17 times of extraction medium at 20-30 deg.C under 45Mpa by high-efficiency high-pressure difference low-temperature continuous extraction equipment (HHLSE) with water to obtain fructus Lycii and radix Puerariae extractive solution; extracting double-petal red rose with high-efficiency high pressure difference low-temperature continuous extraction equipment (HHLSE) at 17 times with 45Mpa as extraction medium of water at 20-30 deg.C to obtain double-petal red rose extractive solution; and (3) adding 10 times of 70% ethanol into the dried ginger powder obtained in the step (1) for hot reflux extraction to obtain a dried ginger extracting solution.
(3) Centrifuging and filtering: (2) centrifuging the Chinese wolfberry fruit and radix puerariae extracting solution at 5000r/min, and then centrifuging at 15000r/min to obtain a primary wolfberry fruit and radix puerariae centrifugate and wolfberry fruit and radix puerariae centrifugate residues; (2) centrifuging the medium-heavy-petal red rose extract at 5000r/min to obtain heavy-petal red rose centrifugate and heavy-petal red rose centrifugate residue; (2) filtering the medium-dry ginger extract by a 200-mesh screen to obtain a dried ginger filtrate and dried ginger filter residue;
(4) secondary extraction and centrifugation: (3) adding 14 times of purified water into the Chinese wolfberry fruit and kudzuvine root centrifugation residues for extraction, and centrifuging to obtain a Chinese wolfberry fruit and kudzuvine root secondary centrifugation liquid; (3) adding 14 times of purified water into the medium-heavy-petal red rose centrifugal slag for extraction, and centrifuging to obtain heavy-petal red rose centrifugal liquid;
(5) concentration and sterilization: mixing the centrifugates of fructus Lycii and radix Puerariae obtained in (3) and (4), mixing the centrifugates of double-petal red rose, separating, and performing microfiltration (600nm), vacuum concentration (less than or equal to 65 deg.C), and ceramic membrane (pore diameter of 200nm) filtration to obtain fructus Lycii and radix Puerariae concentrated solution and double-petal red rose concentrated solution; vacuum concentrating (at most 65 ℃) the dried ginger filtrate obtained in the step (3) to obtain a dried ginger concentrated solution;
(6) and (3) drying: (5) allowing the medium-concentration steamed liquid to enter a universal clean area, and respectively adding maltodextrin to the wolfberry fruit and radix puerariae concentrated steamed liquid, the double-petal red rose concentrated steamed liquid and the dried ginger concentrated steamed liquid to perform spray drying to obtain wolfberry fruit and radix puerariae dried powder, double-petal red rose dried powder and dried ginger HE dried powder; wherein, the amount of maltodextrin added in the wolfberry fruit and kudzuvine root concentrated steaming solution, the double-petal red rose concentrated steaming solution and the dried ginger concentrated steaming solution is respectively 50 percent, 35 percent and 60 percent of the corresponding total amount;
(7) and (3) granulating: (6) and adding maltodextrin with the total content of 5% into the three dry powders obtained in the step (a), and granulating, wherein the granulating process is spray granulation.
Comparative example 1
The formula is as follows: in the formulation of example 1, two kinds of raw materials, i.e., jujube and ginger, were removed.
The procedure was as in example 1.
Comparative example 2
The formula is the same as that of the embodiment 1, and the difference is that when the raw materials are processed, the kudzuvine root, the double-petal red rose and the peanut coat are weighed according to the formula amount and are crushed in a crusher and then sieved; weighing barbary wolfberry fruit, peach kernel, Chinese date and longan pulp, adding 6-8 times of purified water, crushing and sieving, wherein the sieved aperture is 1.2 mm; then mixing and then sequentially carrying out the subsequent steps.
Product test verification with effect of treating dysmenorrhea
1. Experimental study of primary dysmenorrhea mouse model
(1) Experimental animals: female ICR mice, SPF-grade Kunming mice, 20 + -2 g, purchased from Guangdong province medical laboratory animal center. The temperature of the room is 20-23 ℃, the relative humidity is 45-60%, and food and water are freely obtained; fasting was performed for 12h before the experiment, and water was freely drunk.
(2) Modeling, experimental grouping and administration: after the adaptive feeding was completed, the mice were randomly divided into a blank control group, a model group, an aspirin group, a low dose group of example 1, a high dose group of example 1, a low dose group of comparative example 1, and a high dose group of comparative example 1, and 12 mice per group. After random grouping, the experimental mice were weighed to ensure that the differences in body weight between groups of mice were not statistically significant. The primary dysmenorrhea model was established by combining estrogen with oxytocin without any stimulation except for the blank control group, and the estradiol benzoate injection was administered by subcutaneous injection 0.1mg/kg 1 time daily for 12 days to assimilate the uterus and increase the sensitivity of the uterus to oxytocin, and the blank group was injected with normal saline of the same volume. Starting from 8 days of molding, the aspirin group starts to gaze according to 0.2g/kg/d, the dosage groups of example 1 and comparative example 1 start to gaze corresponding samples respectively, wherein the low dosage groups start to gaze 0.1g/10g each day, the high dosage groups start to gaze 0.4g/10g each day, and the blank control group and the model group start to gaze distilled water (1ml/100g/d) for 5 days continuously. Oxytocin 0.1U/10g is injected into the abdominal cavity after administration for 1 hour on day 12 to induce writhing reaction, and the same amount of normal saline is injected into the abdominal cavity of a blank control group. The writhing latency before and after administration of each group of mice and the writhing frequency of each group within 15min after intraperitoneal injection of oxytocin were observed. (writhing reaction, which shows that the abdomen of the mouse contracts inwards, the abdominal wall is tightly attached to the bottom of the cage, the trunk and the hind limb stretch, one side of the limb rotates inwards, and writhing latency period, which is the time from the beginning of intraperitoneal injection of oxytocin to the 1 st writhing reaction of the mouse.)
The torsion incidence rate is equal to the total number of torsion generating animals in each group/experimental animals in each group multiplied by 100 percent
(3) Analysis of Experimental results
In the experiment, the general condition of each group of mice is good, no obvious toxic or side effect is detected, and no mice die; as shown in Table 1, compared with the blank control group, the model group has significant differences in the mouse writhing latency and the writhing frequency, and the differences have statistical significance (P is less than 0.05), which indicates that the primary dysmenorrhea modeling of the mouse is successful.
From the comparison of the writhing rate, it was found that the writhing reaction occurred in each group of mice except the blank control group. Compared with the blank group, the torsion incidence rate of the model group is 100%, and the torsion times are obviously increased, which indicates that the primary dysmenorrhea modeling of the mice is successful. Compared with the model group, the writhing latency of the aspirin group, the example 1 low-dose group, the example 1 high-dose group, the comparative example 1 low-dose group and the comparative example 1 high-dose group is prolonged, wherein the differences of the aspirin group, the example 1 low-dose group and the example 1 high-dose group have extremely significant statistical significance (P is less than 0.01); compared with the model group, the writhing times of the aspirin group, the example 1 low-dose group, the example 1 high-dose group, the comparative example 1 low-dose group and the comparative example 1 high-dose group are obviously reduced, wherein the aspirin group, the example 1 low-dose group and the example 1 high-dose group have significant difference (P is less than 0.01). The results show that the composition prepared by the invention has obvious effect of relieving the menstrual pain.
Table 1 influence of sanchun fever on writhing response of primary dysmenorrhea model mice (X ± s, n ═ 12)
2. Clinical experiments
(1) Test subjects: 120 cases of dysmenorrhea patients were selected as the study subjects for the effect of treating dysmenorrhea in the examples and comparative examples of the present invention, and the ages were 18-40 years, the mean age (26 + -2) years and the mean course (4.12 + -1.52) years. The patients were randomized into 5 groups.
(2) Diagnostic criteria: referring to "gynaecology obstetrics", it is clinically manifested as the symptoms of falling pain in the lower abdomen, soreness and distending pain in the waist, diarrhea, nausea, vomiting, fatigue, etc., before or after menstruation, and syncope of severe symptom, and it can be diagnosed by monitoring B-ultrasonic to eliminate the organic change of genitals.
(3) Exclusion criteria: combined with other gynecological diseases, such as hysteromyoma, acute and chronic pelvic inflammatory disease, etc.; the patients with possible pregnancy in the treatment period can be treated by taking contraceptive drugs or hormone drugs for a long time; combined with tumors, cardiopulmonary insufficiency, mental diseases, etc., may interfere with the observation results.
(4) The taking method comprises the following steps: the administration method of the products of example 1, comparative example 1 and comparative example 2 comprises the following steps: the menstrual period is 3 times per day, 1 bag (3g) each time, and 2 months is a treatment course.
(5) Efficacy evaluation criteria: after the trial, the subjects evaluate and score according to the evaluation standard shown in the table 1, and then count the corresponding number of people.
TABLE 2 subject scores according to criteria
TABLE 3 comparison of trial clinical efficacy of Subjects
| Group of | Number of examples | Cure/example | Improvement/example | Non-healing/example |
| Example 1 | 40 | 36 | 4 | 0 |
| Comparative example 1 | 40 | 0 | 5 | 35 |
| Comparative example 2 | 40 | 30 | 10 | 0 |
In summary, example 1 cures patients (no abdominal pain, cramp, colic, normal activity, normal appetite, no nausea, vomiting, cold hands and feet, significantly increased menstrual blood volume, no blood clots, normal color, and no recurrence after 2 consecutive months of menstrual cycle) 90%, improved patients (improved abdominal pain, increased appetite, relieved nausea and vomiting, reduced menstrual blood clots, normal color, but not maintained for more than 2 months) 10%, and invalid patients (intolerable abdominal pain, tenderness, nausea, vomiting, low menstrual blood volume, blood clots, dark red and black color) 0%. Comparative example 1 (group with date and dried ginger removed) cured 0% of patients, improved 12.5% and ineffective 87.5%. Comparative example 2 (preparation method different from example 1) cured 75% of patients, improved 25% and failed 0%.
The above examples show that the composition of the invention has reasonable proportioning, scientific compatibility, synergistic effect of ingredients, reasonable auxiliary materials matching, and can be prepared into granules, powder and the like with obvious effect of relieving dysmenorrhea and no side effect.
Those of ordinary skill in the art will understand that: the discussion of any embodiment above is meant to be exemplary only, and is not intended to intimate that the scope of the disclosure, including the claims, is limited to these examples; within the idea of the present disclosure, also technical features in the above embodiments or in different embodiments may be combined, steps may be implemented in any order, and there are many other variations of the different aspects of the embodiments of the present description as described above, which are not provided in detail for the sake of brevity.
The embodiments of the present description are intended to embrace all such alternatives, modifications and variances that fall within the broad scope of the appended claims. Therefore, any omissions, modifications, equivalents, improvements, and the like that may be made within the spirit and principles of the embodiments described herein are intended to be included within the scope of the disclosure.
Claims (9)
1. The composition for effectively relieving dysmenorrhea is characterized by comprising the following raw materials in parts by weight:
53-57 parts of wolfberry fruit, 48-52 parts of kudzu root, 16-20 parts of peach kernel, 16-20 parts of Chinese date, 14-18 parts of dried ginger, 7-11 parts of longan aril, 3-7 parts of peanut coat, 2-6 parts of double-petal red rose and 48-52 parts of maltodextrin.
2. The composition for effectively relieving dysmenorrhea according to claim 1, which is characterized by comprising the following raw materials in parts by weight:
55.88 parts of medlar, 50.29 parts of kudzu root, 18.63 parts of peach kernel, 18.63 parts of Chinese date, 16.75 parts of dried ginger, 9.31 parts of longan aril, 5.59 parts of peanut coat, 4.47 parts of double-petal red rose and 50.09 parts of maltodextrin.
3. The method for preparing the composition for effectively relieving dysmenorrhea according to claim 1 or 2, wherein the preparation method comprises the steps of firstly, crushing and sieving the kudzuvine root, the rose with the double-petal red and the peanut coat according to the formula, crushing and sieving the medlar, the peach kernel, the Chinese date and the longan aril by adding water, and then, carrying out primary extraction, centrifugation, secondary extraction, secondary centrifugation, concentration, filtration, drying and granulation on the crushed and sieved raw materials.
4. A method for preparing a composition effective in relieving dysmenorrhea according to claim 3, comprising the steps of:
(1) raw material treatment: weighing radix Puerariae and peanut coat according to formula ratio, and pulverizing in a pulverizer to obtain a first mixed sieved substance; weighing barbary wolfberry fruit, peach kernel, Chinese date and longan pulp, adding 6-8 times of purified water, and crushing to obtain a second mixed filtrate; weighing and crushing the double-petal red rose to obtain double-petal red rose powder; weighing and crushing the dried ginger to obtain dried ginger powder;
(2) primary extraction: mixing the first mixed sieved substance and the second mixed sieved substance, and adding 16-18 times of water to obtain fructus Lycii and radix Puerariae extractive solution; adding 16-18 times of water into the double-petal red rose powder to obtain a double-petal red rose extracting solution; adding 9-11 times of 70% ethanol into the dried ginger powder, and performing hot reflux extraction to obtain a dried ginger extract;
(3) centrifuging and filtering: centrifuging the extractive solution to obtain primary centrifugate and residue; centrifuging the extract to obtain primary centrifugate and residue; sieving the dried ginger extract by a screen mesh to obtain dried ginger filtrate and dried ginger filter residue;
(4) secondary extraction and centrifugation: adding 13-15 times of water into the wolfberry fruit and kudzuvine root centrifugation residue for extraction, and centrifuging to obtain wolfberry fruit and kudzuvine root secondary centrifugation liquid; adding 13-15 times of water into the centrifugal residue of the double-petal red rose, extracting with water, and centrifuging to obtain secondary centrifugal liquid of the double-petal red rose;
(5) concentration and sterilization: mixing the primary centrifugate and the secondary centrifugate, microfiltering, concentrating, and filtering to obtain concentrated steam; mixing the primary centrifugate and the secondary centrifugate, microfiltering, concentrating, and sterilizing to obtain concentrated solution; vacuum concentrating the filtrate of Zingiberis rhizoma, and sterilizing to obtain concentrated solution;
(6) and (3) drying: adding adjuvants into the concentrated decoction of fructus Lycii and radix Puerariae, the concentrated decoction of flos Rosae Rugosae and the concentrated decoction of rhizoma Zingiberis, and drying to obtain dried powder of fructus Lycii and radix Puerariae, dried powder of flos Rosae Rugosae and dried powder of rhizoma Zingiberis HE;
(7) and (3) granulating: adding adhesive into the dried powder of the medlar and the kudzuvine root, the dried powder of the double red rose and the dried powder of the dried ginger HE for granulation, wherein the granulation process is wet granulation, dry granulation or spray granulation.
5. The method for preparing a composition for effectively relieving dysmenorrhea according to claim 4, wherein the wolfberry fruit-radix puerariae extract and the rose bengal extract extracted in the step (2) are extracted by high-pressure-difference low-temperature continuous extraction equipment, or are subjected to hot reflux extraction, or are subjected to dipping extraction, or are subjected to ultrasonic extraction, or are subjected to wall breaking extraction.
6. The method for preparing a composition for alleviating dysmenorrhea according to claim 4, wherein the centrifugation in step (3) is sequentially performed by low-speed centrifugation at 3500-5000r/min and high-speed centrifugation at 6500-15000 r/min.
7. The method for preparing a composition for effectively relieving dysmenorrhea according to claim 4, wherein the pore size of the microfiltration in (5) is 300-600 nm.
8. The method for preparing a composition for relieving dysmenorrhea according to claim 4, wherein the concentration of the wolfberry fruit-pueraria lobata concentrated solution and the concentrated double petal red rose concentrated solution in step (5) are membrane concentration or vacuum concentration.
9. The method for preparing a composition for effectively relieving dysmenorrhea according to claim 4, wherein the sterilization in step (5) is performed by filtration sterilization with ceramic membrane or plate frame or instantaneous high temperature sterilization at 130-140 ℃.
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