CN102038749B - Traditional Chinese medicinal composite used for improving or preventing perimenopause syndrome - Google Patents
Traditional Chinese medicinal composite used for improving or preventing perimenopause syndrome Download PDFInfo
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- CN102038749B CN102038749B CN 200910192931 CN200910192931A CN102038749B CN 102038749 B CN102038749 B CN 102038749B CN 200910192931 CN200910192931 CN 200910192931 CN 200910192931 A CN200910192931 A CN 200910192931A CN 102038749 B CN102038749 B CN 102038749B
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Abstract
The invention relates to a traditional Chinese medicinal composite used for improving or preventing perimenopause syndrome. The composite consists of the traditional Chinese medicines comprising black pepper and sophora flower bud, or black pepper extract and sophora flower bud extract; and the traditional Chinese medicinal composite can be jointly used with one or more of medicines such as glossy privet fruit or glossy privet fruit extract, Kudzuvine root or Kudzuvine root extract, angelica or angelica extract, the root of rehmannia or the extract of root extract of rehmannia and Chinese wolfberry or Chinese wolfberry extract used for preventing or curing perimenopause syndrome, and can be prepared into any formulation of common oral drugs.
Description
Technical field:
The present invention relates to a kind of Chinese medicine composition that improves or prevent perimenopausal syndrome, belong to the field of Chinese medicines.
Technical background:
The women gets into menopause, because endocrine alteration causes the autonomic nervous system dysfunction, a systemic symptom can occur, as: vasomotor symptoms: comprise flushing, hectic fever, perspiration, cardiopalmus, headache etc.Neural mental symptom: skin pruritus, numbness or the sense of ant row, emotion are emotional, irritable, depressed, suspicious, insomnia, absent minded etc.General symptom: blood fat rising, osteoporosis acceleration, neural blood vessel functional disorder, dysbolism, obesity, arthralgia, myalgia, genitourinary system state etc.
Perimenopausal syndrome betides before and after natural menopause, drug-induced menopause and the operation menopause usually.
When natural menopause is every female old aged people must through the aging of ovary nature physiological cause.The syndrome that occurs before and after the natural menopause is also referred to as climacteric syndrome.According to statistics, the women of China more than 45 years old accounts for 12.72% of national population, and 1,600,000,000 people are arranged approximately, and wherein perimenopausal women has 0.83 hundred million people approximately.Wherein, perimenopausal syndrome can appear in the women of 60-75%.
Drug-induced menopause possibly occur in because of gynecological cancer, as: breast carcinoma, carcinoma of endometrium, cervical cancer, ovarian cancer, cancer of vagina etc. or any must blocking-up estrogen or progesterone secretion and drug application stops the gynaecopathia of disease progression.
The menopause that operation is brought out is meant because of multiple gynaecopathia thereby carries out the uterus or the caused menopause of oophorectomize.These causes of disease comprise pain in insufferable menstrual period, the muscular tumor of uterus, cervix uteri or ovary, inner membrance dystopy, prolapsus and malignant change or precancerous lesion etc.
The method of treatment perimenopausal syndrome mainly contains general treatment, Chinese medicine and gonadotherapy at present.
General treatment mainly comprises psychotherapy, exercise therapy and general Drug therapy.The patient is carried out psychology support and dredge, the patient's that listens to sb. patiently heartfelt wishes are understood fully and are concerned about their unhealthy emotion reaction expression, are that patient's unhealthy emotion is led off, reduce the generation of mental illness.Help their physiological change, improve health care consciousness, association's self regulation with the attitude understanding self of science; Encourage it to participate in the physical training and the recreational activities of appropriateness; Suggestion increases the Exposure to Sunlight time, and takes in the food that contains protein and rich calcium, as: milk, bean product etc. reach elimination or alleviate the symptom of enclosing exhausted menopausal syndrome, the purpose of improving the quality of living.In addition, can give the Drug therapy that some regulate the vegetative nerve function effect according to patient's symptom, like oryzanol, vitamin B
1, B
6And the medicine of sedation etc.
Theory of Chinese medical science is thought; Perimenopausal syndrome is that the body that causes owing to the spleen nephrasthenia is regulated a series of symptoms that the miopragia of equilibrium between yin and yang shows, and is main to suffer from a deficiency of the kidney, because of deficiency of the kidney yin; Or insufficiency of kidney-YANG; Or kidney insufficiency and influence the conscience spleen and cause multiple pathological change, so the Chinese medicine perimenopausal syndrome primarily is determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, is guiding principle with kidney yin, kidney yang dysequilibrium mainly.Medicines such as clinical LIUWEI DIHUANG WAN commonly used, female precious ball, Radix Aconiti Lateralis Preparata lizhong decoction.
Gonadotherapy is the more definite therapy of present curative effect, but its side effect is also very big.It is serious to be mainly used in the symptom price, adopts general treatement and all irremediable patient of Chinese medicine therapy.Its administration time is longer, and life-time service can increase suffer from breast cancer, the generation of carcinoma of endometrium, rectal cancer, colon cancer etc.
Though gonadotherapy method curative effect is clear and definite but its side effect is bigger, the patient lighter for symptom generally will not adopt.The Chinese medicine therapy is occupied certain advantage in the perimenopausal syndrome treatment.Not only can alleviate its clinical symptoms, also can be used as the gonadotherapy auxiliary treatment, reduce the consumption of gonadal hormone.
Chinese invention patent publication number CN1313114A discloses " a kind of medicine of treating female dimacteric syndrome and preparation method thereof " and has selected Chinese medicines such as Fructus Ligustri Lucidi, Herba Epimedii, Radix Salviae Miltiorrhizae, succinum, Rhizoma Cyperi (processed with vinegar), Semen Ziziphi Spinosae (parched) for use; Be prepared from, be used to treat female dimacteric syndrome; Chinese invention patent publication number CN101293063A discloses " composition and method of making the same and method of quality control of treatment climacteric syndrome " and has selected for use Fructus Ligustri Lucidi, Fructus Rubi, Semen Cuscutae, Radix Polygoni Multiflori, Cortex Lycii, Radix Adenophorae, Radix Ophiopogonis etc. to add processed with honey to become honeyed pill, be used to treat climacteric syndrome; Chinese invention patent publication number CN101394892A discloses " composition and use thereof of treatment or prevention hectic fever " and has selected Radix Bupleuri, Radix Curcumae, Cortex Moutan, Radix Arnebiae (Radix Lithospermi), the Radix Paeoniae Alba and Fructus Schisandrae Chinensis for use; Or their extract, preparation is used to treat the symptom of climacteric hectic fever.
Summary of the invention:
The purpose of this invention is to provide a kind of the improvement or the Chinese medicine composition of prevention perimenopausal syndrome or the compositions of its extract, improve or the clinical symptoms of prevention perimenopausal syndrome (comprising: flushing, hectic fever, perspiration, cardiopalmus, headache, emotion are emotional, irritable, depressed, suspicious, insomnia, obesity, arthralgia, myalgia etc.) in purposes.
Another one purpose of the present invention provides the proportioning of this Chinese medicine composition or the proportioning of its extract combination.
Theory of Chinese medical science thinks that the generation of perimenopausal syndrome is relevant with " empty towards conception vessel, exhaustion of kidney-essence with promoting reproductive function, asthenia of renal qi ".Someone proposes " deficiency of kidney-YIN, hyperactivity of hesrt-fire and liver-fire are primary disease because of "; " deficiency of kidney-essence, towards conception vessel empty for morbidity this ", " battalion defend become estranged maybe maybe be relevant with neuroendocrine disturbance, cause perimenopausal syndrome ".The present invention adopts Fructus Piperis or its extract and the Flos Sophorae Immaturus or its extract to make up, and has to improve or the effect of prevention perimenopausal syndrome clinical symptoms.The Flos Sophorae Immaturus is the dry flower and alabastrum of leguminous plant Chinese scholartree Sophora japonica L., flavor: hardship, be slightly cold, and have cooling blood for hemostasis, the effect of purging liver-fire.Also have a large amount of flavones ingredients to have estrogen action in the Flos Sophorae Immaturus, can replenish human body estrogen, and can not cause side effect.Fructus Piperis is dry near maturation or the mature fruit of Piperaceae plant Fructus Piperis Piper nigrum L., and acrid in the mouth, heat have warming spleen and stomach for dispelling cold, the therapeutic method to keep the adverse QI flowing downwards, the effect of expectorant.Modern study shows that piperic extract piperine has effects such as tranquillizing and allaying excitement, anti-inflammatory analgetic, blood fat reducing.Two medicines share, and can prevent or alleviate the clinical symptoms of perimenopausal syndrome.
In addition; Chinese medicine composition of the present invention can also have one or more Combined application in the medicine that prevents or treat perimenopausal syndrome with other, as: Fructus Ligustri Lucidi or its extract, Radix Puerariae or its extract, Radix Angelicae Sinensis or its extract, the Radix Rehmanniae or its extract, Fructus Lycii or its extract etc.
Each component raw material consumption of preparation the present invention is: Fructus Piperis 20-80 part, Flos Sophorae Immaturus 10-90 part.Adopt any method for distilling effective component extracting to process preparation.
Each component raw material preferable amount of preparation the present invention is: Fructus Piperis 30-70 part, Flos Sophorae Immaturus 20-80 part.Adopt any method for distilling effective component extracting to process preparation.
The optimum consumption of each component raw material of preparation the present invention is: Fructus Piperis 40-60 part, Flos Sophorae Immaturus 35-65 part.Adopt any method for distilling effective component extracting to process preparation.
Each component raw material consumption of preparation the present invention is: Fructus Piperis extract 10-30 part, Flos Sophorae Immaturus extract 5-35 part.
Each component raw material preferable amount of preparation the present invention is: Fructus Piperis extract 15-25 part, Flos Sophorae Immaturus extract 10-30 part.
The optimum consumption of each component raw material of preparation the present invention is: Fructus Piperis extract 18-22 part, Flos Sophorae Immaturus extract 15-25 part.
Chinese medicine composition of the present invention can be prepared into and be fit to oral any dosage form, like tablet, capsule, granule, oral liquid, chewable tablet, pill etc.
The specific embodiment:
Below in conjunction with embodiment the present invention is done further elaboration, but be not limited to this.
Embodiment 1 granule preparation of the present invention
Take by weighing 20 parts in Fructus Piperis, 50 parts of the Flos Sophorae Immaturus, subsequent use.
The Fructus Piperis of above-mentioned weight proportion, the Flos Sophorae Immaturus mix, and add 10 times of water gagings and soak 0.5 hour, and heating decocted 1 hour, filtered; Filtering residue adds 8 times of water gagings, and heating decoction 0.5 hour is filtered, and filtrating merges, and puts high speed centrifuge and separates solid content, gets supernatant.Supernatant concentration to relative density is 1.10 o'clock, advances spray dryer, 135 ℃ of EAT controls, and 105 ℃ of leaving air temps, 75 rev/mins of nebulizer rotating speeds, charging rate is 5ml/ minute, gets spray drying powder.Pulverize spray drying powder and become fine powder, add adjuvant and process granule, promptly get.
Embodiment 2 preparation tablets of the present invention
Take by weighing 80 parts in Fructus Piperis, 40 parts of the Flos Sophorae Immaturus, subsequent use.
The Fructus Piperis of above-mentioned weight proportion, the Flos Sophorae Immaturus mix, and add 8 times of amount 60% ethanol, and reflux, extract, 1 hour is filtered; Filtering residue adds 6 times of amount 60% ethanol, and heating decocted 0.5 hour, filtered, and filtrating merges.Put high speed centrifuge and separate solid content, get supernatant.The supernatant concentrating under reduced pressure becomes the thick paste shape, and drying is pulverized, and gets fine powder after sieving, and fine powder adds adjuvant, and tabletting is processed tablet.
Embodiment 3 capsule preparations of the present invention
Take by weighing 60 parts in Fructus Piperis, 50 parts of the Flos Sophorae Immaturus, 40 parts of Fructus Ligustri Lucidi, 30 parts of Radix Puerariaes, subsequent use.
The Fructus Piperis of above-mentioned weight proportion, the Flos Sophorae Immaturus, Fructus Ligustri Lucidi, Radix Puerariae add 10 times of water gagings, and supersound extraction 40 minutes is filtered; Medicinal residues add 8 times of water gagings, and supersound extraction 20 minutes is filtered; Medicinal residues add 6 times of water gagings again, and supersound extraction 10 minutes is filtered; Merge filtrating three times.Put high speed centrifuge and separate solid content, get supernatant.The supernatant concentrating under reduced pressure becomes the thick paste shape, and drying is pulverized, and gets fine powder after sieving, and fine powder adds adjuvant, incapsulates to process capsule.
Embodiment 4 granule preparations of the present invention
Take by weighing 30 parts of Fructus Piperis extracts, 5 parts of Flos Sophorae Immaturus extracts, drying is pulverized, and gets fine powder after sieving, and fine powder adds adjuvant and processes granule, promptly gets.
Embodiment 5 preparation tablets of the present invention
Take by weighing 20 parts of Fructus Piperis extracts, 20 parts of Flos Sophorae Immaturus extracts, drying is pulverized, and gets fine powder after sieving, and fine powder adds adjuvant, and tabletting is processed tablet.
Embodiment 6 capsule preparations of the present invention
Take by weighing 25 parts of Fructus Piperis extracts, 25 parts of Flos Sophorae Immaturus extracts, 10 parts of Radix Angelicae Sinensis extracts, 10 parts of Radix Rehmanniae extracts, 10 parts of wolfberry fruit extracts, drying is pulverized, and gets fine powder after sieving, and fine powder adds adjuvant, incapsulates to process capsule.
The experiment of experimental example 1 tranquilizing soporific drug effect
Medication preparation: by weight 50 parts in Fructus Piperis, 50 parts of the Flos Sophorae Immaturus.Add 10 times of water gagings, microwave extraction 60 minutes is filtered; Medicinal residues add 8 times of water gagings, and microwave extraction 30 minutes is filtered; Merge filtrating twice.Put high speed centrifuge and separate solid content, get supernatant.The supernatant concentrating under reduced pressure, subsequent use.
Method: 15 the monthly age 40 of Kunming kind white mice, be divided into 4 groups at random, 10 every group, be respectively: matched group, high dose group of the present invention, middle dose groups and low dose group.Wherein, high dose group of the present invention, middle dose groups and low dose group mice are irritated stomach respectively and give medicine 12g of the present invention (crude drug)/kg body weight, 9g (crude drug)/kg body weight, 6g (crude drug)/kg body weight, and matched group is irritated stomach and given isodose normal saline.1 time/day, successive administration 15 days.After the last administration 30 minutes, mice is put in the autonomic activities appearance, let it adapt to 5 minutes, write down the movable number of times in every mice 5 minutes again.With the mice that finishes autonomic activities, press 50mg/kg body weight ip0.5% pentobarbital sodium respectively, write down from giving the time that pentobarbital sodium to righting reflex loss to righting reflex recovers, once as the length of one's sleep with stopwatch.Compare between organizing.
The result: medicine of the present invention can obviously reduce the number of times of mice autonomic activities, shortens time for falling asleep and prolongs the insomnia time, has significance meaning (P＜0.01,0.05) with the matched group comparing difference, explains that drug regimen of the present invention has certain sedative-hypnotic effect.The result sees the following form.
Table is respectively organized the effect of tranquilizing soporific drug effect relatively
* compare with matched group, P＜0.05, * * and matched group compare, P＜0.01
The pharmacodynamic experiment of 2 pairs of castrated rats sweat gland secretion influences of experimental example
Medication preparation: by weight taking by weighing 15 parts of Fructus Piperis extracts, 25 parts of Flos Sophorae Immaturus extracts are pulverized, and are prepared into the solution for standby of suitable dosage.
Method: 50 SD rats are divided into 5 groups at random, 10 every group, are respectively normal control group, model group, medicine high dose group of the present invention, middle dose groups and low dose group.Except that the normal control group, all the other respectively organize all first surgical removal of ovaries of rat.High dose group of the present invention, middle dose groups and low dose group rat began to irritate respectively stomach on the 2nd day in the operation back and give medicine 0.4g/kg body weight of the present invention, 0.2g/kg body weight, 0.1g/kg body weight, and normal control group and model group are irritated stomach and given isodose normal saline.1 time/day, successive administration 30 days.After the last administration 2 hours, with 70% ethanol the rat toes are cleaned out, put into big rat holder, and with outside the rat two rear solid end holders, let rat holder endoadaptation 10 minutes; With dry cotton ball the antiperspirant that goes out because of struggle on each rat toes is dried, each organizes rat by 35mg/0.1ml/100g body weight difference ip3.5% pilocarpine, utilizes the excited m receptor of pilocarpine, impels sweat gland secretion.After 30 minutes, use magnifier in the injection pilocarpine, naked eyes examine, and calculate rat toes portion perspiration point.Compare between organizing.
The result: model group with compare the point of perspiring and significantly increase, difference has statistical significance (P＜0.01), explain that modeling is successfully.The present composition can obviously reduce modeling rat toes perspiration point, relatively perspires with model group and a little significantly reduces (P＜0.01), explains that medicine of the present invention has certain inhibitory action to the castrated rats sweat gland secretion.The result sees the following form.
Table is respectively organized the sweat gland secretion influence relatively
## and normal control group compare, P＜0.01; * and model group compare, P＜0.01.
The pharmacodynamic experiment of 3 pairs of castrated rats estrogen level influences of experimental example
Medication preparation: by weight taking by weighing 18 parts of Fructus Piperis extracts, 20 parts of Flos Sophorae Immaturus extracts, 10 parts of Fructus Ligustri Lucidi extracts, 10 parts of Radix Puerariae extracts, pulverize, be prepared into the solution for standby of suitable dosage.
Method: 60 SD rats, randomly draw 10 as the normal control group, all the other 120 rats underwent bilateral oophorectomies, subsequent use.Postoperative is got capable ovarian resection after 3 months rat is divided into 5 groups at random, 10 every group, is respectively normal control group, model group, positive controls, high dose group of the present invention, middle dose groups and low dose group.Positive controls is irritated stomach in the back of dividing into groups and is given diethylstilbestrol 0.02mg/kg+ cod-liver oil 450 μ l/kg+ calcium oxide 0.5g/kg mixed liquors; High dose group of the present invention, middle dose groups and low dose group are irritated stomach respectively at the back of dividing into groups and are given medicine 0.8g/kg body weight of the present invention, 0.4g/kg body weight, 0.2g/kg body weight, and normal control group and model group are irritated stomach and given isodose normal saline.Once a day, successive administration is 90 days.After the last administration 2 hours, abdominal aortic blood prepared serum, detected serum estradiol content with test kit.Compare between organizing.
The result: model group with compare serum estradiol and significantly reduce, difference has statistical significance (P＜0.01), explain that modeling is successfully.The present composition modeling rat blood serum estradiol content that can obviously raise significantly raises with the model group serum estradiol (P＜0.01), explains that medicine of the present invention has certain rising effect to castrated rats estrogen.The result sees the following form.
Table is respectively organized serum estradiol content relatively
## and normal control group compare, P＜0.01; * and model group compare, P＜0.01.
Claims (1)
1. one kind is improved or the Chinese medicine composition of insomnia and perspiration symptom appears in the prevention perimenopausal syndrome; It is characterized in that this Chinese medicine composition is to be processed by following bulk drugs: 80 parts in Fructus Piperis; 40 parts of the Flos Sophorae Immaturus, the Fructus Piperis of above-mentioned weight proportion, the Flos Sophorae Immaturus mix, and add 8 times of amount 60% ethanol; Reflux, extract, 1 hour is filtered; Filtering residue adds 6 times of amount 60% ethanol, and heating decocted 0.5 hour, filtered, and filtrating merges; Put high speed centrifuge and separate solid content, get supernatant; The supernatant concentrating under reduced pressure becomes the thick paste shape, and drying is pulverized, and gets fine powder after sieving, and fine powder adds adjuvant, and tabletting is processed tablet.
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| US10869495B2 (en) * | 2015-10-19 | 2020-12-22 | Famenity Co., Ltd. | Functional composition for improvement and prevention of estrogen deficiency in menopausal women |
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| CN1895291A (en) * | 2006-06-09 | 2007-01-17 | 陈永丽 | Nano-Chinese medicinal biological product and its preparation |
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| CN1895291A (en) * | 2006-06-09 | 2007-01-17 | 陈永丽 | Nano-Chinese medicinal biological product and its preparation |
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