CN1806840A - Chinese medicinal compound preparation and its preparing process - Google Patents
Chinese medicinal compound preparation and its preparing process Download PDFInfo
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Abstract
The invention relates to a compound medicinal preparation for treating female's climacteric metancholia and its preparing process, wherein the preparation is made from forest frog's oviduct, barren wort, active ingredients for nourishing blood and relieving mental stress, and medicinal auxiliary materials. The medicament can be made into various medically acceptable oral preparations.
Description
Technical field
The present invention relates to a kind of compound preparation for the treatment of female dimacteric syndrome, is the compound Chinese medicinal preparation of feedstock production with Chinese medicine specifically, the invention still further relates to the preparation method of this medicine.
Background technology
Generally during 45～55 years old, the women to experience ovarian function by vigorous to decline gradually, transition period, i.e. a climacteric of last complete obiteration.The clinical statistics data shows that 75%～85% women can suffer from the puzzlement of climacteric syndrome climacteric, light or heavy various clinical symptoms more or less appear, relate to each system of health, wherein annual having is no less than 15% patient and treats especially because of paying attention to deficiency or malpractice to serious symptom needs.At present, doctor trained in Western medicine clinically extensive use gonadal hormone replacement therapy (hormone replacement therapy, HRT) treatment female dimacteric syndrome.But have more side effect, increased the ill probability of diseases such as breast carcinoma, carcinoma of endometrium, ovarian cancer behind the life-time service, and may produce untoward reaction such as irregular hemorrhage, the weight increase of vagina.
Motherland's traditional medicine is called cracked ends front and back syndrome to the history in existing thousands of years of understanding of climacteric syndrome, claims again " menopausal syndrome " that its symptom sporadically appears in symptoms such as senile metrorrhagia, hysteria, hectic fever due to YIN-deficiency, Bulbus Lilii syndrome.Clinical manifestation is: warm sweating, hectic fever is flushing, dysphoria with feverish sensation in the chest palms and soles, soreness of the waist and knees, xerosis cutis, numb scratchy (formication); Or appearance limbs edema, the abdomen loose stool of rising, coldness of the body with chills, lethargy; Dim complexion, nocturia increases, clear urine in large amounts; Or dizziness and tinnitus, the soreness of waist is weak, spontaneous sweating; Or spirit depressing, sigh uncomfortable in chest, the irritability of worrying even cry and laugh by turns, without any apparent reason more; Or severe palpitation, insomnia and dreamful sleep, indigestion and loss of appetite; Or the confusion of the menstrual cycle, metrorrhagia such as replaces at serial symptom.Be equivalent to the various symptoms that " climacteric syndrome " showed in the doctor trained in Western medicine, as the paroxysmal hectic fever, sweating, cardiopalmus are had palpitation chest distress, it is dizzy to have a headache, insomnia and dreamful sleep, or depressed worried, spirit is uneasy, emotional, hypomnesis, inappetence, or abdominal distention is suffered from diarrhoea, or edema, or unstable blood pressure, fluctuated, or paraesthesia etc.The traditional Chinese medical science thinks that climacteric syndrome is that menses will exhaust because of kidney qi depletion before and after menopause, appoints and dashes the loss of two arteries and veins, and asthenia of essence and blood, internal organs lose in moistening foster, due to the imbalance of YIN and YANG.Suffering from a deficiency of the kidney is it, clinical with deficiency of the kidney yin in the majority or with insufficiency of kidney-YANG the two and deposit.The tcm clinical practice medication is taken from natural, and special effect and toxic and side effects are minimum, are gradually accepted by extensive patients.At present, relevant conventional formulation, the health promoting product of circulation and tcm clinical practice use on the medical market at home, how because of the specificity curative effect is very definite, integrated artistic falls behind relatively, the not high reason of scientific and technological level has limited related industry development scale, particularly formulating aspect quality standard that the international market integrates with mutually, lacking the guardian technique input of corresponding research and development.State's internal therapy climacteric Chinese patent medicine mainly contain GENGNIANAN, climacteric health, ZHENHELING PIAN, loyal granule etc., these medicines have certain curative effect clinically, but also have the following disadvantages: medicine is formed spininess certain disease is established, and clinical limitation is arranged; It is many that prescription is formed flavour of a drug, complicated component, difficult quality control; Extraction process is tradition comparatively; The prescription flavour of a drug are many, and patient's taking dose is bigger, general every day 3 times, each 5～6 (grains), patient is difficult to bear sometimes.
Summary of the invention
The object of the present invention is to provide a kind of compound Chinese medicinal preparation for the treatment of female dimacteric syndrome, said preparation can effectively be alleviated the clinical symptoms of climacteric women, improves endocrine, has the effect that prevents and delay Senile disease simultaneously.
Another object of the present invention provides the preparation method of this compound Chinese medicinal preparation.
Pharmaceutical preparation of the present invention is to be the various medically acceptable oral formulations of active component and pharmaceutic adjuvant composition with Oviductus Ranae, Herba Epimedii, nourishing the blood and yin class, mind tranquilizing and the heart calming class medicine.Its constituent percentage by weight is: Oviductus Ranae 2～10%, Herba Epimedii 10～20%, nourishing the blood and yin class medicine 40～60%, mind tranquilizing and the heart calming class medicine 20～30%.The shared optimum weight ratio of the active component of wherein said preparation is: Oviductus Ranae 5.4%, Herba Epimedii 16.2%, nourishing the blood and yin class 54.1%, mind tranquilizing and the heart calming class medicine 24.3%.Nourishing the blood and yin class medicine of the present invention is selected from Radix Polygoni Multiflori Preparata, Radix Cynanchi Auriculati, Radix Rehmanniae Preparata, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Colla Corii Asini, Rhizoma Polygonati, Fructus Lycii, Fructus Mori, Herba Ecliptae, Fructus Ligustri Lucidi, Semen sesami Niger, Carapax et Plastrum Testudinis, Carapax Trionycis etc.Mind tranquilizing and the heart calming class medicine of the present invention is selected from Flos Albiziae, Cortex Albiziae, Semen Ziziphi Spinosae, Semen Platycladi, Radix Polygalae, Poria, Magnetitum, Os Draconis, succinum etc.
Oral formulations of the present invention is tablet, capsule, soft gelatin capsule (soft capsule), granule, pill (concentrated pill, honeyed pill, the watered pill) etc.The prescription of described preparation can contain the said medicine active component, and one or more adjuvants commonly used, for example starch, pregelatinized Starch, sucrose, dextrin, lactose, calcium sulfate, calcium hydrogen phosphate, microcrystalline Cellulose, mannitol, food plant wet goods filler; Wetting agent such as water, ethanol, starch slurry, refined honey, liquid glucose; Binding agents such as sodium carboxymethyl cellulose, gelatin, arabic gum, hydroxypropyl emthylcellulose, polyvinylpyrrolidone; Disintegrating agents such as agar, ethyl cellulose, carboxymethyl starch sodium, calcium carbonate, crospolyvinylpyrrolidone; Lubricants such as magnesium stearate, Pulvis Talci, hydrogenated vegetable oil, micropowder silica gel, Polyethylene Glycol; Correctivess such as stevioside, menthol, essence, cyclamate, sorbitol.
The preparation that the present invention treats the compound Chinese medicinal preparation of climacteric syndrome comprises the following steps:
(1) measure Herba Epimedii, nourishing the blood and yin class medicine, mind tranquilizing and the heart calming class medicine by prescription, steeped 30 minutes with 35～75% ethanol or water logging, soak and extract 2～3 times, each 1～3h, each solubilization dosage are 5～10 times of medical material weight.Merge extractive liquid, filters, and is concentrated into relative density 1.05～1.20, and spray drying gets extract powder; If the nourishing the blood and yin medicine is a Colla Corii Asini, then merge with alcohol (or water) extracted extract after the molten, and be concentrated into relative density 1.05～1.20, spray drying gets extract powder.
(2) Oviductus Ranae microwave sterilizating is pulverized with the low-temperature fine powder machine.
(3) Oviductus Ranae superfine powder flour mixes with extract powder, adds suitable pharmaceutic adjuvant, makes various oral formulations according to a conventional method.
An important feature of compound Chinese medicinal preparation of the present invention has the kidney invigorating and essence nourishing exactly, nourishing lung-YIN, the effect of the resolving depression of calming the nerves, can be used for the irritated irritability that female dimacteric syndrome causes, palpitation and insomnia, headache uncomfortable in chest, abnormal emotion-thought, hypomnesis, symptoms such as waist and leg ache.
Modern medicine proves, the Women hormonal change is with ovarian function decline, the hypothalamic pituitary gonadal axis due to the estrogen decrease change into key link.On the cell membrane of the tissue at more than 400 position and organ estrogen receptor is arranged in each women's body, when estrogen decrease, these tissues and organ will be found the variation in degeneration or the metabolism, it is uneven to cause climacteric women to occur in multisystems such as spirit, psychology, neuroendocrines, and then the symptom that a series of neuroendocrines are lacked of proper care appears, promptly the traditional Chinese medical science is how dirty with sick.Attend to one thing and lose sight of another unavoidably with simple HRT.The principle of Dialectic Relationship between the then available negative and positive internal organs of traditional medicine and treating different diseases with the same therapeutic principle, treating the same disease with different methods, treating both the principal and secondary aspects of a disease is dealt with problems from the overall situation.
The traditional Chinese medical science thinks that climacteric syndrome is that menses will exhaust because of kidney qi depletion before and after menopause, appoints and dashes the loss of two arteries and veins, and asthenia of essence and blood, internal organs lose in moistening foster, due to the imbalance of YIN and YANG.Suffering from a deficiency of the kidney is it, clinical with deficiency of the kidney yin in the majority or with insufficiency of kidney-YANG the two and deposit.Oviductus Ranae nourishing kidney, spleen reinforcing, lung benefiting that preparation of the present invention is used are to be monarch drug, are equipped with nourishing the blood and yin class invigorating liver and kidney, and benefiting essence-blood is cold not dry, become three cloudy also benefits to receive the merit that the kidney invigorating effects a permanent cure altogether.Mind tranquilizing and the heart calming class medicine is calmed the nerves, resolving depression, happy will, giving consideration to both the incidental and fundamental.The Herba Epimedii acrid in the mouth is warm in nature, kidney invigorating and YANG supporting, and this gets the meaning for the treatment of YIN within YANG, and then cloudy positive helping and fountainhead is inexhaustible can prevent the stagnant greasy fraud of product generation of cloudy benefits of prodrug again.Full side four medicines, negative and positive are also controlled, and Cause ﹠ Symptom Solution is mended and oiliness.
Oviductus Ranae has another name called Oviductus Ranae, breathes out ant oil, Oviductus Ranae, Oviductus Ranae, oviductus ranae, is the fallopian tube of the female frog of Rana temporaria chensinensis David Rana temporariachensinensis David, has the effect of the kidney invigorating and essence nourishing, nourishing YIN and moistening the lung.
Herba Epimedii is the aerial parts of Berberidaceae plant Herba Epimedii Epimedium breviconum Maxim., arrow leaf Herba Epimedii E.sagittatum (Sieb.et Zucc.) Maxim., pubescence Herba Epimedii E.pubescens Maxim., Epimedium wushanense E.wushanense T.S.Ying or Herba Epimedii E.koreanum Nakai, has kidney-replenishing, bone and muscle strengthening, effects such as wind-damp dispelling.Mainly contain flavone and flavonoid glycoside, polysaccharide, alkaloids composition.Modern pharmacology experiment showed, that it has the cardiovascular and cerebrovascular vessel of increasing blood flow, promotes effects such as hemopoietic function, immunologic function and bone metabolism, defying age, antitumor.
Nourishing the blood and yin class medicine such as Radix Polygoni Multiflori Preparata are the process of preparing Chinese medicine processed goods of polygonum multiflorum thunb Polygonum multiflorum Thunb., have invigorating the liver and kidney, benefiting essence-blood, black beard and hair, the effect of bone and muscle strengthening.Main component has lecithin, hydroxyanthraquinone compounds, microelements of calcium, ferrum, zinc, manganese, copper etc.Modern pharmacology experimental results show that effects such as it has defying age, blood fat reducing, immunity, protects the liver, antiinflammatory, analgesia, and is wherein remarkable with anti-aging effects.
Nourishing the blood and yin class medicine such as Radix Cynanchi Auriculati are the tuber of Asclepiadaceae plant Cynanchum bungei Decne Cynanchum bungei Decne., cynanchum auriculatum Royle C.auriculatum Royle ex Wight or mountain on the other way round cynanchum auriculatum Royle ex Wight C.wilfordi (Maxim.) Hemsl., have the effect that the YIN nourishing of enriching blood, strong, convergence vital essence, crow must hair color.
Nourishing the blood and yin class medicine such as Radix Rehmanniae Preparata are the process of preparing Chinese medicine processed goods of scrophulariaceae rehmannia glutinosa plant Rehmannia glutinosa (Gaertn.) Libosch., has nourishing the blood and yin, mend the effect that essence is added marrow, the main chemical compositions of Radix Rehmanniae is glycoside, saccharide, organic acid and amino acids, and based on glycoside, again based on cyclenes ether glycoside, catalpol is its main effective ingredient, has blood sugar lowering, diuresis and laxative action in glycoside.
Nourishing the blood and yin class medicine is as working as the root that is classified as umbelliferae angelica Angelica sinensis (Oliv.) Diels., having enriches blood invigorates blood circulation, the effect of pain relieving intestine moistening, the main chemical compositions of Radix Angelicae Sinensis are phthalide analog compound, Coumarins, flavonoid, organic acid and polysaccharides such as ligustilide.
The nourishing the blood and yin class medicine such as the Radix Paeoniae Alba are the root of ranunculaceae plant Paeonia lactiflor Pall., have the effect of the yin fluid astringing of nourishing blood, easing the affected liver to relieve pain, suppressing liver-YANG.
Nourishing the blood and yin class medicine such as Colla Corii Asini are the skin of equine species donkey Equus asinus L., boil the blob of viscose that forms after floating the bubble unhairing, have tonifying blood and arresting bleeding, the effect of nourishing YIN and moistening the lung.
Nourishing the blood and yin class medicine such as Rhizoma Polygonati are liliaceous plant Rhizoma Polygonati Polygonatum sibiricun Redoute or capsule silk Rhizoma Polygonati P.cyrtonema Hua. Jin Shi Rhizoma Polygonati P.kingianum Coll et Hemsl., and the root that belongs to some kind of plant together, have the effect of lung moistening YIN nourishing, invigorating the spleen and replenishing QI.Its chemical constituent mainly contains polygonatum polysaccharide, steroidal saponin, flavone compound, alkaloid, cardiac glycoside, lignanoid, vitamin and the multiple chemical compounds such as aminoacid useful to human body, has physiologically actives such as defying age, reducing blood sugar and blood fat, immunomodulating, antiinflammatory, resisting pathogenic microbes, atherosclerosis, improvement memory.
Nourishing the blood and yin class medicine such as Fructus Lycii are the mature fruit of plant of Solanaceae lycium barbarum Lycium barbarum L. and Fructus Lycii L.chinense Mill., have nourishing the liver and kidney, make eye bright, the effect of lung moistening.Its chemical constituent mainly contains lycium barbarum polysaccharide, aminoacid, trace element etc., has antibacterial, antimutagenic, blood fat reducing, blood sugar lowering, the anti-ageing physiologically active of waiting for a long time.Its main effective ingredient is the lycium barbarum polysaccharide constituents.
Nourishing the blood and yin class medicine such as Fructus Mori are the mature fruit cluster of moraceae plants mulberry Morus alba L., have nourishing YIN and supplementing blood, an effect of the intestine moistening of promoting the production of body fluid.Its chemical constituent mainly contains lipid, free acid, saccharide, vitamin, phospholipid and trace element etc., has physiologically actives such as the immunity of adjusting, defying age, blood sugar lowering, blood fat reducing, hepatoprotective.
Nourishing the blood and yin class medicine such as Herba Ecliptae are the herb of feverfew Eclipta prostrata Eclipta prostrata L., have the effect of nourishing YIN for benefiting the kidney, cooling blood for hemostasis.Its chemical constituent mainly contains compositions such as oleanane type and taraxerane type triterpene saponin, thiophene-based, 1,8,9-trihydroxy-3-methoxy-benzo[4,5 class, flavonoid.
Nourishing the blood and yin class medicine such as Fructus Ligustri Lucidi are the mature fruit of oleaceae plant Fructus Ligustri Lucidi Ligustrum lucidum Ait., have the effect of liver and kidney tonifying, clearing away heat to improve acuity of vision.Its chemical constituent mainly contains organic acid, polysaccharide, phospholipid, aminoacid and trace element, has antibiotic, antiviral, antiinflammatory, reducing blood sugar and blood fat, protects the liver, defying age, anticancer and improve pharmacological action such as immunologic function.Its main effective ingredient is a polysaccharide compound.
Nourishing the blood and yin class medicine such as Semen sesami Niger are the mature seed of Pedaliaceae plant sesame Sesamum indicum DC., the effect that has enrich and benefit essence and blood, moisturizes laxation.Its chemical constituent mainly contains sesamin, asarinin, volatile oil, trace element etc., has physiologically actives such as antitumor, antioxidation.
Nourishing the blood and yin class medicine such as Carapax et Plastrum Testudinis are the sternite of Testudinidae animal Testudinis Chinemys reevesii (Gray), have nourishing YIN for suppressing the hyperactive YANG, replenishing kidney and strengthening bone, an effect of the reinforcing the heart of nourishing blood.
Nourishing the blood and yin class medicine such as Carapax Trionycis are the carapace of Trionychidae animal Trionyx sinensis Wiegmann Amyda sinensis (Wicgmann), have the effect of nourishing YIN for suppressing the hyperactive YANG, hard masses softening and resolving.Its chemical constituent mainly contains protein, aminoacid, phospholipid and trace element, has physiologically actives such as resisting fatigue, anoxia enduring, anti-hepatic fibrosis, antitumor.
Mind tranquilizing and the heart calming class medicine such as Flos Albiziae are the dry inflorescence of leguminous plant Herba Albiziae Albizia julibrissin Durazz., have the effect of resolving stagnation for tranquilization.Its main chemical compositions is flavonoid glycoside, volatilization wet goods composition, has physiologically actives such as antidepressant, calmness, hypnosis.
Mind tranquilizing and the heart calming class medicine such as Cortex Albiziae are the bark of leguminous plant Herba Albiziae Albizia julibrissin Durazz. or Alibizia Kalkora (Roxb.) Prain A.kalkora (Roxb.) Prain, have the resolving depression of calming the nerves, the effect of promoting blood circulation and detumescence.Its main chemical constituent has triterpene saponin, flavonoid, lignanoids etc.Its ethanol extract shows tangible immune-enhancing activity and antitumaous effect, and its ethanol extract and water extract all show stronger calmness, antibiotic, antifertility isoreactivity.
Mind tranquilizing and the heart calming class medicine such as Semen Ziziphi Spinosae are the mature seed of Rhamnaceae plant Ziziphi Spinosae Ziziphus jujuba Mill., have tranquilizing by nourishing the heart, the effect of arresting sweating.
Mind tranquilizing and the heart calming class medicine such as Semen Platycladi are the kernel of Cupressaceae plant Cacumen Platycladi Biota orientalis (L.) Endl., have tranquilizing by nourishing the heart, the effect of loosening bowel to relieve constipation.Main component has volatile oil, fatty oils etc.
Mind tranquilizing and the heart calming class medicine such as Radix Polygalae are the root of milk wort Radix Polygalae Polygala tenuifolia Willd. or wide leaf Radix Polygalae P.sibirica L., have mind tranquilizing and the heart calming, eliminate the phlegm and have one's ideas straightened out, the effect of subduing inflammation.
Mind tranquilizing and the heart calming class medicine such as Poria are the sclerotium of Polyporaceae fungus Poria Poria cocos (Schw.) Wolf, have the effect of spleen-benefiting mind-tranquilizing, promoting diuresis to eliminate damp pathogen.Mainly contain steroidal saponin, triterpene saponin, polysaccharide composition, have antitumor, antiinflammatory, immune isoreactivity.
Mind tranquilizing and the heart calming class medicine such as Magnetitum are the Ore of magnetic iron ore Magnetite, have the effect of subduing hyperactive YANG to ease mental disorders, hearing-improing and eyesight improving, helping inspiration to relieve asthma.Main iron content and various trace elements have calmness, hypnosis, antiinflammatory, convulsion isoreactivity.
Mind tranquilizing and the heart calming class medicine such as Os Draconis are mammals such as Hippocampal cortex, rhinoceros class, deer class, bovine, resemble the skeleton fossil of class etc. in ancient times, have suppressing the hyperactive liver and subsiding YANG, tranquillizing and allaying excitement, the astringent or styptic treatment for spontaneous sweating effect of convergence.Main calcic, aminoacid and various trace elements have physiologically actives such as tranquilizing soporific, antidepressant, convulsion.
Mind tranquilizing and the heart calming class medicine such as succinum are the resin of Pinaceae pine genus plant in ancient times, through being transformed for many years, having that arresting convulsion is calmed the nerves, the effect of promoting blood circulation to remove blood stasis, inducing diuresis for treating stranguria syndrome in the buried layer.Mainly resinous, volatile oil, trace element etc. have physiologically actives such as analgesia, calmness, convulsion.
Characteristics according to above-mentioned nourishing the blood and yin class, mind tranquilizing and the heart calming class medicine ingredient, if Radix Polygoni Multiflori Preparata, Radix Cynanchi Auriculati, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Herba Ecliptae, Semen sesami Niger, Flos Albiziae, Cortex Albiziae, Semen Ziziphi Spinosae, Semen Platycladi, Radix Polygalae, Poria are then selected the extraction process of 35～75% alcohol extraction processes as preparation.If Radix Rehmanniae Preparata, Rhizoma Polygonati, Fructus Lycii, Fructus Mori, Fructus Ligustri Lucidi, Carapax et Plastrum Testudinis, Carapax Trionycis, Magnetitum, Os Draconis, succinum are then selected the extraction process of extraction process by water as preparation.If Colla Corii Asini then after the molten, mixes with alcohol (or water) extracted extract, spray drying gets extract powder.
The concentrate drying of Chinese medicine extraction liquid has influence on the quality of product.Spray drying makes the medicinal liquid heated time short, and rate of drying is fast, and effective ingredient destroys few, and good product quality is so adopt spray drying to prepare extract powder.
For guaranteeing stability of formulation of the present invention, reduce the hygroscopicity of extract powder, increase mobile to be fit to the industrialization growth, in the preparation of preparation of the present invention, adopt Oviductus Ranae superfine powder flour and extract powder to mix, add an amount of pharmaceutic adjuvant again, can improve stability of formulation, increase mobile, can make full use of herb resource again, save cost.
Be below capsule preparations of the present invention (pacify more capsule, form) the Pharmacodynamic test of active extract data relevant (pacify more capsule is made as large, medium and small three dosage groups, the positive matched group of GENGNIANAN group) with function by Oviductus Ranae, Herba Epimedii, Radix Polygoni Multiflori Preparata, Flos Albiziae:
1 pacifies more capsule to the pentobarbital sodium inducing mouse synergism of the length of one's sleep
Adopt pentobarbital sodium inducing mouse sleep test, observe the more capsular collaborative short sleep effect of peace, the results are shown in Table 1.1.
Table 1.1 is pacified more capsule to the influence of the length of one's sleep of pentobarbital sodium inducing mouse
| Group | Dosage (g/kg) | Number of animals (only) | Sleep time (min) |
| Blank group GENGNIANAN group is pacified more heavy dose of group of the middle dosage group peace of small dose group peace | 0 2.0 0.41 0.82 1.65 | 10 10 10 10 10 | 9.75±1.48 11.58±2.19 * 11.83±1.94 ** 14.83±4.57 ** 16.92±4.29 *** |
Compare with the blank group:
*: P＜0.05;
*: P＜0.01;
* *: P＜0.001.
Compare with the blank group, the sleep time of GENGNIANAN group, An Gengzhong, heavy dose of group obviously prolongs (P＜0.05,0.01 and 0.001).Pacifying more, capsule dosage shows the effect that it has collaborative pentobarbital sodium greater than the length of one's sleep of 0.41g/kg (crude drug amount) energy significant prolongation pentobarbital sodium inducing mouse.
2 pacify more capsule studies the mice analgesic activity
Adopt acetic acid induced mice writhing method, observe the more capsular analgesic activity of peace, the results are shown in Table 2.1.
Table 2.1 is pacified the influence that capsule Dichlorodiphenyl Acetate induced mice is more turned round the body number of times
| Group | Dosage (g/kg) | Number of animals (only) | Turn round the body number of times |
| Blank group GENGNIANAN group is pacified more heavy dose of group of the middle dosage group peace of small dose group peace | 0 2.0 1.65 3.30 6.60 | 12 12 12 12 12 | 41.5±10.7 17.5±5.6 *** 25.6±4.5 *** 23.8±6.4 *** 16.1±7.8 *** |
Compare with the blank group:
* *: P＜0.001.
Compare with the blank group, the GENGNIANAN group, pacify more that the mouse writhing number of times of each dosage group of capsule significantly reduces (P＜0.001).Pacify capsule dosage more and can significantly reduce mouse writhing number of times due to the glacial acetic acid, show that peace has more stronger analgesic effect greater than 1.65g/kg (crude drug amount).
3 pacify more capsule to the influence of pilocarpine induced mice perspiration
Adopt the sweating test of pilocarpine inducing mouse, observe the more capsular inhibition perspiration of peace, the results are shown in Table 3.1.
Table 3.1 is pacified more capsule to the variation of pilocarpine induced mice sweat gland tube chamber cavity incidence rate
| Group | Dosage (g/kg) | 0.65% pilocarpine (ml/10g) | Number of animals (only) | Sweat gland tube chamber cavity incidence rate (%) |
| Blank group pilocarpine group GENGNIANAN group is pacified more heavy dose of group of the middle dosage group peace of small dose group peace | 0 0 2.0 1.65 3.30 6.60 | 0 0.1 0.1 0.1 0.1 0.1 | 10 10 10 10 10 10 | 15.6±2.1 51.4±7.8 *** 36.8±8.1 ***### 38.8±9.8 ***### 34.2±6.2 ***### 25.2±5.8 ***### |
Compare with the blank group:
*: P＜0.001; Compare with the pilocarpine group:
##: P＜0.01.
With the blank group relatively, the GENGNIANAN group, pacify more that the sweat gland tube chamber cavity incidence rate of the large, medium and small dosage group of capsule mice significantly increases (P＜0.001); With the pilocarpine group relatively, the GENGNIANAN group, pacify more that the large, medium and small dosage group of capsule significantly reduces (P＜0.001).Pacify the large, medium and small dosage of capsule more and all can obviously alleviate mice diaphoresis degree due to the pilocarpine.This results suggest, peace more have certain inhibitory action to the sympathetic activation of domination sweat gland.
4 pacify more capsule to the influence of mice forced swimming time and mouse tail suspension dead time
Adopt the test of mice forced swimming test and outstanding tail, observe more capsular antidepressant of peace and antifatigue effect, the results are shown in Table 4.1 and table 4.2.
Table 4.1 is pacified more capsule to the influence of mice forced swimming time
| Group | Dosage (g/kg) | Number of animals (only) | Dead time in 10 minutes (second) |
| Blank group GENGNIANAN group is pacified more heavy dose of group of the middle dosage group peace of small dose group peace | 0 2.0 1.65 3.30 6.60 | 15 15 15 15 15 | 143.9±42.9 75.1±34.8 *** 141.0±36.7 93.1±40.5 ** 80.0±45.1 *** |
Compare with the blank group:
*: P＜0.01,
* *: P＜0.001.
Table 4.2 is pacified more capsule to the influence of mouse tail suspension dead time
| Group | Dosage (g/kg) | Number of animals (only) | Dead time in 6 minutes (second) |
| Blank group GENGNIANAN group is pacified more heavy dose of group of the middle dosage group peace of small dose group peace | 0 2.0 1.65 3.30 6.60 | 13 13 13 13 13 | 133.5±45.5 92.0±41.1 * 112.5±28.1 91.0±44.9 * 80.7±20.7 *** |
Compare with the blank group:
*: P＜0.05,
* *: P＜0.001.
Compare with the blank group, the GENGNIANAN group, (P＜0.01-0.001) also significantly reduces that (P＜0.05-0.001) pacifies more the capsule low dose group and then do not have obvious influence the outstanding tail dead time to pacify more that the mice non-swimming time of the middle and high dosage group of capsule significantly reduces.Pacify more that capsule dosage can significantly reduce mice forced swimming dead time and mouse tail suspension dead time greater than 3.3g/kg (crude drug amount), show that peace has more certain antidepressant and antifatigue effect.
5 pacify more capsule to the influence of removal ovary rat gonadal hormone content and uterus weight
Adopt female rats removal ovary model, observe and pacify more capsule rat blood serum estrogen (estradiol E
2), the influence of androgen (testosterone T), lutropin (LH) and follicle stimulating hormone (FSH) hormonal readiness.The results are shown in Table 5.1, table 5.2, table 5.3.
Table 5.1 is pacified more capsule to E in the removal ovary rat periphery serum
2Influence with T content
| Group | Dosage (g/kg) | Number of animals (only) | E 2 (pmol/L) | T (nmol/L) |
| Blank group model group GENGNIANAN group is pacified more heavy dose of group of the middle dosage group peace of small dose group peace | 0 0 2.0 0.82 1.65 3.30 | 10 10 10 10 10 10 | 23.26±3.18 12.70±2.35 *** 12.41±2.51 *** 12.71±2.95 *** 13.25±2.45 *** 12.51±3.49 *** | 0.25±0.04 0.24±0.03 0.23±0.03 0.25±0.04 0.25±0.04 0.23±0.03 |
Compare with the blank group:
* *: P＜0.001; Compare the equal P＞0.05. of each administration group with model group
Compare E in the model group rat periphery serum with the blank group
2All significantly reduce (P＜0.001) with T content, GENGNIANAN group and pacify the more large, medium and small dosage group of capsule and model group comparison, E
2With T content there are no significant difference (P＞0.05).
Table 5.2 is pacified more capsule to the influence of FSH and LH content in the removal ovary rat periphery serum
| Group | Dosage (g/kg) | Number of animals (only) | FSH (IU/L) | LH (IU/L) |
| Blank group model group GENGNIANAN group is pacified more heavy dose of group of the middle dosage group peace of small dose group peace | 0 0 2.0 0.82 1.65 3.30 | 10 10 10 10 10 10 | 1.22±0.37 3.29±0.66 *** 3.71±0.76 *** 3.16±0.91 *** 3.10±0.62 *** 3.43±0.80 *** | 0.55±0.19 0.65±0.13 0.58±0.15 0.43±0.08 ### 0.46±0.13 ## 0.45±0.09 ### |
Compare with the blank group:
* *: P＜0.001; Compare ##:P＜0.01, ###:P＜0.001 with model group.
Compare all significantly risings (P＜0.001) of FSH content in model group, GENGNIANAN group and the more large, medium and small dosage group rat periphery serum of peace with the blank group; Compare with model group, FSH content does not all have significant difference (P＞0.05) in GENGNIANAN group and the more large, medium and small dosage group rat periphery serum of peace.
With the blank group relatively, model group, GENGNIANAN group, An Gengda, in and in the small dose group rat periphery serum LH content all do not have significant difference (P＞0.05); With model group relatively, An Gengda, in and LH content significantly descends in the small dose group rat periphery serum that (P＜0.01-0.001), the GENGNIANAN group does not then have significant difference (P＞0.05).
Table 5.3 is pacified more capsule to removal ovary rat uterus index variation
| Group | Dosage (g/kg) | Number of animals (only) | Uterus index (mg/100g) |
| Blank group model group GENGNIANAN group is pacified more heavy dose of group of the middle dosage group peace of small dose group peace | 0 0 2.0 0.82 1.65 3.30 | 10 10 10 10 10 10 | 182.2±61.0 32.4±5.4 *** 39.1±9.4 *** 36.0±5.3 *** 36.2±4.5 *** 39.2±8.8 *** |
Compare with the blank group:
* *: p＜0.001, compare the equal P＞0.05. of each administration group with model group
Model group, GENGNIANAN group and An Gengda, in and small dose group rat uterus index all significantly reduce (P＜0.001) than the blank group.GENGNIANAN group, An Gengda, in compare there was no significant difference then with model group with small dose group rat uterus index.
Pacify more capsule to E in the removal ovary rat periphery serum
2, T and FSH content do not make significant difference, LH content then significantly reduces; Removal ovary rat uterus index is not made significant difference the effect of no estrogen sample.
Above result shows: pacifying more, capsule has collaborative pentobarbital sodium to urge the mice sleep effect; Has stronger analgesic activity; Sympathetic activation to the domination sweat gland has certain inhibitory action; Antidepressant and antifatigue effect are arranged; The effect of no estrogen sample.Pointing out preparation of the present invention is not by inducing estrogenic generation or directly producing the curative effect that estrogen-like effects is brought into play the treatment climacteric syndrome, but the effect by above-mentioned others is carried out Comprehensive Treatment to menopause syndrome, and this is for its prolonged application and reduce untoward reaction assurance is provided.
The specific embodiment
Embodiment 1
Prescription Oviductus Ranae 40g
Radix Polygoni Multiflori Preparata 400g
Flos Albiziae 180g
Herba Epimedii 120g
Micropowder silica gel is an amount of
(1) get Radix Polygoni Multiflori Preparata, Flos Albiziae, Herba Epimedii, 40% soak with ethanol 30min extracts 2 times, and each 2h, each alcohol adding amount are 8 times of medical material weight.Merge extractive liquid, is concentrated into relative density 1.08, and spray drying gets extract powder 180g ± 20g.
(2) Oviductus Ranae micronizing is mixed with extract powder, and it is an amount of to add micropowder silica gel, alcohol granulation, and drying, granulate, encapsulated, make 1000 altogether.
Embodiment 2
Prescription Oviductus Ranae 40g
Radix Polygoni Multiflori Preparata 400g
Flos Albiziae 180g
Herba Epimedii 120g
Edible vegetable oil is an amount of
(1) get Oviductus Ranae, Flos Albiziae, Herba Epimedii, 40% soak with ethanol 30min extracts 2 times, and each 2h, each alcohol adding amount are 8 times of medical material weight.Merge extractive liquid, is concentrated into relative density 1.08, and spray drying gets extract powder 180g ± 20g.
(2) Oviductus Ranae micronizing is mixed with extract powder, and it is an amount of to add vegetable oil, 1000 of system soft capsules.
Embodiment 3
Prescription Oviductus Ranae 40g
Radix Polygoni Multiflori Preparata 400g
Flos Albiziae 180g
Herba Epimedii 120g
Starch is an amount of
Magnesium stearate is an amount of
(1) get Radix Polygoni Multiflori Preparata, Flos Albiziae, Herba Epimedii, 40% soak with ethanol 30min extracts 2 times, and each 2h, each alcohol adding amount are 8 times of medical material weight.Merge extractive liquid, is concentrated into relative density 1.08, and spray drying gets extract powder 180g ± 20g.
(2) Oviductus Ranae micronizing is mixed with extract powder, and it is an amount of to add starch, alcohol granulation, and drying, granulate adds magnesium stearate, and tabletting is made 1000 altogether.
Embodiment 4
Prescription Oviductus Ranae 40g
Radix Polygoni Multiflori Preparata 400g
Flos Albiziae 180g
Herba Epimedii 120g
Refined honey is an amount of
(1) get Radix Polygoni Multiflori Preparata, Flos Albiziae, Herba Epimedii, 40% soak with ethanol 30min extracts 2 times, and each 2h, each alcohol adding amount are 8 times of medical material weight.Merge extractive liquid, is concentrated into relative density 1.08, and spray drying gets extract powder 180g ± 20g.
(2) Oviductus Ranae micronizing is mixed with extract powder, and it is an amount of to add refined honey, mixed concentrated pill, and drying, whole ball, pill 1000 balls are made in packing altogether.
Embodiment 5
Prescription Oviductus Ranae 40g
Radix Cynanchi Auriculati 300g
Semen Ziziphi Spinosae 150g
Herba Epimedii 120g
Edible vegetable oil is an amount of
(1) get Radix Cynanchi Auriculati, Semen Ziziphi Spinosae, Herba Epimedii, 50% soak with ethanol 30min extracts 2 times, and each 2h, each alcohol adding amount are 9 times of medical material weight.Merge extractive liquid, is concentrated into relative density 1.10, and spray drying gets extract powder 140g ± 20g.
(2) Oviductus Ranae micronizing is mixed with extract powder, and it is an amount of to add vegetable oil, makes 1000 of soft capsules altogether.
Embodiment 6
Prescription Oviductus Ranae 40g
Radix Angelicae Sinensis 400g
Radix Polygalae 150g
Herba Epimedii 120g
Starch is an amount of
Magnesium stearate is an amount of
(1) get Radix Angelicae Sinensis, Radix Polygalae, Herba Epimedii, 60% soak with ethanol 30min extracts 2 times, and each 2h, each alcohol adding amount are 10 times of medical material weight.Merge extractive liquid, is concentrated into relative density 1.12, and spray drying gets extract powder 160g ± 20g.
(2) Oviductus Ranae micronizing is mixed with extract powder, adds starch, alcohol granulation, and drying, granulate adds magnesium stearate, and tabletting is made 1000 altogether.
Embodiment 7
Prescription Oviductus Ranae 40g
Radix Rehmanniae Preparata 350g
Os Draconis 160g
Herba Epimedii 110g
Stevioside is an amount of
(1) get Radix Rehmanniae Preparata, Os Draconis, Herba Epimedii, water logging bubble 30min extracts 2 times, and each 2h, each amount of water are 8 times of medical material weight.Merge extractive liquid, is concentrated into relative density 1.15, and spray drying gets extract powder 140g ± 20g.
(2) Oviductus Ranae micronizing is mixed with extract powder, adds stevioside, alcohol granulation, and drying, granulate, 1000 bags of granules are made in packing.
Embodiment 8
Prescription Oviductus Ranae 40g
Rhizoma Polygonati 400g
Succinum 150g
Herba Epimedii 100g
Refined honey is an amount of
(1) get Rhizoma Polygonati, succinum, Herba Epimedii, water logging bubble 30min extracts 2 times, and each 2h, each amount of water are 9 times of medical material weight.Merge extractive liquid, is concentrated into relative density 1.09, and spray drying gets extract powder 140g ± 20g.
(2) Oviductus Ranae micronizing is mixed with extract powder, and it is an amount of to add refined honey, mixed concentrated pill, and drying, whole ball, 1000 balls are made in packing altogether.
Claims (8)
1, a kind of compound Chinese medicinal preparation for the treatment of female dimacteric syndrome is characterized in that it is the medicament of being made by following weight percentages: Oviductus Ranae 2～10%, Herba Epimedii 10～20%, nourishing the blood and yin class medicine 40～60%, mind tranquilizing and the heart calming class medicine 20～30%.
2, the compound Chinese medicinal preparation of treatment female dimacteric syndrome according to claim 1 is characterized in that the preferred weight percent of each raw material is: Oviductus Ranae 5.4%, Herba Epimedii 16.2%, nourishing the blood and yin class medicine 54.1%, mind tranquilizing and the heart calming class medicine 24.3%.
3,, it is characterized in that described nourishing the blood and yin class medicine is selected from Radix Polygoni Multiflori Preparata, Radix Cynanchi Auriculati, Radix Rehmanniae Preparata, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Colla Corii Asini, Rhizoma Polygonati, Fructus Lycii, Fructus Mori, Herba Ecliptae, Fructus Ligustri Lucidi, Semen sesami Niger, Carapax et Plastrum Testudinis, Carapax Trionycis according to the compound Chinese medicinal preparation of claim 1,2 described treatment female dimacteric syndromes.
4,, it is characterized in that described mind tranquilizing and the heart calming class medicine is selected from Flos Albiziae, Cortex Albiziae, Semen Ziziphi Spinosae, Semen Platycladi, Radix Polygalae, Poria, Magnetitum, Os Draconis, succinum according to the compound Chinese medicinal preparation of claim 1,2 described treatment female dimacteric syndromes.
5,, it is characterized in that described compound preparation is a said oral formulations on any pharmaceutics according to the compound Chinese medicinal preparation of claim 1,2,3 or 4 described treatment female dimacteric syndromes.
6, the compound Chinese medicinal preparation of treatment female dimacteric syndrome according to claim 5 is characterized in that said oral formulations is tablet, capsule, soft gelatin capsule (soft capsule), granule, pill (concentrated pill, honeyed pill, the watered pill).
7, the preparation method of the compound Chinese medicinal preparation of treatment female dimacteric syndrome according to claim 6, the preparation that it is characterized in that said preparation comprises the following steps: to get Herba Epimedii, nourishing the blood and yin class, mind tranquilizing and the heart calming class medicine, ethanol with 35～75% or water extraction 2～3 times, merge extractive liquid,, be concentrated into relative density 1.05～1.20, spray drying gets extract powder; If the nourishing the blood and yin medicine is a Colla Corii Asini, then merge with alcohol (or water) extracted extract after the molten, and be concentrated into relative density 1.05～1.20, spray drying gets extract powder; The Oviductus Ranae micronizing is mixed with extract powder, adds suitable pharmaceutic adjuvant, makes various oral formulations according to a conventional method.
8, the preparation method of the compound Chinese medicinal preparation of treatment female dimacteric syndrome according to claim 7, it is characterized in that adopting Radix Polygoni Multiflori Preparata, Radix Cynanchi Auriculati, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Herba Ecliptae, Semen sesami Niger, Flos Albiziae, Cortex Albiziae, Semen Ziziphi Spinosae, Semen Platycladi, Radix Polygalae, Poria, select the preparation of 35～75% alcohol extraction processes; Adopt Radix Rehmanniae Preparata, Rhizoma Polygonati, Fructus Lycii, Fructus Mori, Fructus Ligustri Lucidi, Carapax et Plastrum Testudinis, Carapax Trionycis, Magnetitum, Os Draconis, succinum, then select the extraction process by water preparation.
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| CN102526531A (en) * | 2012-02-21 | 2012-07-04 | 王光辉 | Rehmannia root, prepared rehmannia root and Chinese wolfberry root-bark yin-nourishing and pulse-regulating paste for treating menopausal syndrome |
| CN102688260A (en) * | 2012-05-17 | 2012-09-26 | 广州军区广州总医院 | Medicinal composition for treating vaginal dryness |
| CN102784302A (en) * | 2012-08-01 | 2012-11-21 | 马念芳 | Method for preparing traditional Chinese medicine for treating insomnia caused by deficiency of kidney yin |
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| CN103690782A (en) * | 2013-12-23 | 2014-04-02 | 山东省中医药研究院 | Traditional Chinese medicine composition for treating climacteric syndrome, and preparation method and quality detection method thereof |
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| CN1217675C (en) * | 2001-01-18 | 2005-09-07 | 南方医科大学 | Medicine for treating menopausal syndrome and preparation process thereof |
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| CN102688260A (en) * | 2012-05-17 | 2012-09-26 | 广州军区广州总医院 | Medicinal composition for treating vaginal dryness |
| CN102688260B (en) * | 2012-05-17 | 2013-04-17 | 广州军区广州总医院 | Medicinal composition for treating vaginal dryness |
| CN102784302A (en) * | 2012-08-01 | 2012-11-21 | 马念芳 | Method for preparing traditional Chinese medicine for treating insomnia caused by deficiency of kidney yin |
| CN102784318A (en) * | 2012-08-01 | 2012-11-21 | 马念芳 | Preparation method of traditional Chinese medicine for treating frequent and urgent micturition insomnia |
| CN102784302B (en) * | 2012-08-01 | 2013-11-13 | 窦爱侠 | Method for preparing traditional Chinese medicine for treating insomnia caused by deficiency of kidney yin |
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| CN103690782A (en) * | 2013-12-23 | 2014-04-02 | 山东省中医药研究院 | Traditional Chinese medicine composition for treating climacteric syndrome, and preparation method and quality detection method thereof |
| CN104606351A (en) * | 2014-12-31 | 2015-05-13 | 广州至信中药饮片有限公司 | Medicated diet prepared from five kinds of ginseng, Chinese caterpillar fungus and Chinese forest frogs, and preparation method of medicated diet |
| WO2017210849A1 (en) * | 2016-06-07 | 2017-12-14 | 王渊博 | Traditional chinese medicine formula for tonifying spleen |
| CN115624604A (en) * | 2022-09-07 | 2023-01-20 | 北京市鼓楼中医医院 | Traditional Chinese medicine composition for treating climacteric syndrome and depression and preparation method and application thereof |
| CN115624604B (en) * | 2022-09-07 | 2023-10-24 | 北京市鼓楼中医医院 | Traditional Chinese medicine composition for treating climacteric depression and preparation method and application thereof |
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