CN101647879B - Traditional Chinese medicine preparation for treating menopausal syndrome with yin deficiency of heart and kidney and preparation method thereof - Google Patents

Traditional Chinese medicine preparation for treating menopausal syndrome with yin deficiency of heart and kidney and preparation method thereof Download PDF

Info

Publication number
CN101647879B
CN101647879B CN2008103037089A CN200810303708A CN101647879B CN 101647879 B CN101647879 B CN 101647879B CN 2008103037089 A CN2008103037089 A CN 2008103037089A CN 200810303708 A CN200810303708 A CN 200810303708A CN 101647879 B CN101647879 B CN 101647879B
Authority
CN
China
Prior art keywords
chinese medicine
climacteric
parts
heart
capsule
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
CN2008103037089A
Other languages
Chinese (zh)
Other versions
CN101647879A (en
Inventor
孔德明
张永萍
徐剑
王明强
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Guizhou Bailing Group Pharmacy Co., Ltd.
Original Assignee
Guiyang College of Traditional Chinese Medicine
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Guiyang College of Traditional Chinese Medicine filed Critical Guiyang College of Traditional Chinese Medicine
Priority to CN2008103037089A priority Critical patent/CN101647879B/en
Publication of CN101647879A publication Critical patent/CN101647879A/en
Application granted granted Critical
Publication of CN101647879B publication Critical patent/CN101647879B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Abstract

The invention discloses a traditional Chinese medicine preparation for treating menopausal syndrome with the yin deficiency of the heart and the kidney and a preparation method thereof. The traditional Chinese medicine preparation is prepared from glossy privet fruit, radix psuedostellariae, aleppo avens and mimosa-tree bark cortex albiziae by ethanol leaching and water leaching, has the obvious functions of treating the fundamental aspect of a disease, tranquilizing the mind and resisting eclampsia, is a novel traditional Chinese medicine for the yin deficiency disease of the heart and the kidney, has a very good therapeutic action to the yin deficiency disease of the heart and the kidney, comprising dizziness, giddiness, hectic fever, night sweat, feverish sensation in the palms and the soles, emotion inquietude, dysphoria, testiness, vexation, insomnia, aching and limp waist and knees, reddened tongue, little moss, thready rapid pulse and the like, provides a novel application choice for extensive patients and has less variety of the raw materials, easy control of the product quality, simple preparation technique, relatively lower cost and larger market potential.

Description

Chinese medicine preparation of the climacteric syndrome of treatment heart deficiency of the kidney yin and preparation method thereof
Technical field
The present invention relates to technical field of Chinese medicines, particularly relate to Chinese medicine preparation of a kind of climacteric syndrome for the treatment of heart deficiency of the kidney yin and preparation method thereof.
Background technology
(climacteric syndrome CS) is meant the deterioration of climacteric women because of ovary to climacteric syndrome, causes organism endocrine imbalance, hypoimmunity and autonomic nervous dysfunction's syndrome.See clinically and warm night sweat, menoxenia, the variation of the mental status, performances such as cardiovascular and urogenital system pathological changes and osteoporosis are the main diseases of puzzlement climacteric women.Climacteric syndrome has a strong impact on the quality of life of climacteric women, and arrival along with aging society, climacteric women day by day increases, according to statistics, 2000, U.S.'s climacteric women reaches 4,000 ten thousand, and China's the year two thousand thirty climacteric women will reach 2.8 hundred million approximately, and the study on prevention of climacteric syndrome has been become demands of social development.Heart deficiency of the kidney yin is a kind of performance of climacteric syndrome.Heart deficiency of the kidney yin comprises deficiency of heart-yin and deficiency of the kidney yin, and the symptom of deficiency of heart-yin is a severe palpitation, and insomnia and dreamful sleep doublely sees that vexed heat, hectic fever, night sweat, two cheekbones are rubescent, red tongue with a little fluid, thready and rapid pulse, and this is a deficiency of heart-yin; Deficiency of the kidney yin is the syndrome of kidney YIN-fluid being insufficient performance, shows as that soreness of waist and knee joint, vertigo and tinnitus, insomnia and dreamful sleep, man's postcoital protrusion are easily lifted, seminal emission, women's infrequent menstruation amenorrhea or see metrorrhagia, emaciated physique, hectic fever night sweat, vexed heat, dry pharynx flushed cheeks, yellow urine dry stool, red tongue with a little fluid, thready and rapid pulse.Heart deficiency of the kidney yin has the total symptom of above-mentioned two kinds of deficiency of YIN concurrently, and its cause of disease is for having a delicate constitution the prolonged illness impairment of YIN.
The traditional Chinese medical science just has the record of " woman ... seventy-seven conception vessel void; taichong channel declines few; exhaustion of kidney-essence with promoting reproductive function; menopause; so senile appearance and loss of fecundity are also " in " interior warp " to the understanding of primary disease, its symptom sporadically appears and reaches in a plurality of diseases such as " melancholia " in " senile metrorrhagia ", " hysteria ", " Bulbus Lilii syndrome ", is referred to as " pre-postmenstrual syndromes ".
Modern medicine adopts Hormone Replacement Therapy (Hormone Replacement Therapy, HRT) treatment more.HRT can effectively remove or alleviate the climacteric syndrome symptom, treatment genitourinary system low estrogen symptom and prevention of osteoporosis etc., its effect is that other medicines are irreplaceable at present, but there are more untoward reaction and potential danger simultaneously, the state-run commune hospital of the U.S. in 2002 is about reporting that the result shows the mid-term that WomanHealth starts (Women ' s Health Initiative) clinical trial: unite HRT group and placebo group continuously relatively, the HRT group has increased the heart disease incident, apoplexy, breast carcinoma, the danger of diseases such as pulmonary infarction, thus premature termination the clinical trial of HRT group.Based on above-mentioned research, increasing climacteric syndrome women turns to alternative care (Alternative therapies), comprising traditional Chinese medicine therapy.
Domestic secular clinical practice proves that Chinese medicine can obviously improve climacteric syndrome patient's physiology and mental symptoms, and untoward reaction is few.Abroad clinical control research to symptoms such as monotaste plant medicine and compound treatment climacteric syndrome vasomotor symptoms, depression and insomnias has been carried out in the application of Chinese medicine and research, think that some plant amedica has estrogen-like effect, and have no side effect, non-carcinogenesis is worth secular clinical use.Based on under tcm clinical efficacy and the background to the new knowledge of HRT drawback, Chinese medicine is faced with the unprecedented new opportunity that goes to the world.
According to the new drug catalogue that State Food and Drug Administration (SFDA) examines announcement, by the end of the end of the year 2005, the new Chinese medicine that is used for the treatment of climacteric syndrome only has 5.The medicine of therefore treating climacteric syndrome is still few, and particularly the new drug of satisfactory effect more lacks.
Summary of the invention
Technical problem to be solved by this invention provides Chinese medicine preparation of a kind of climacteric syndrome that can effectively treat heart deficiency of the kidney yin and preparation method thereof.
In order to solve the problems of the technologies described above, the present invention adopts following technical scheme:
According to listed as parts by weight, the Chinese medicine preparation that the present invention treats the climacteric syndrome of heart deficiency of the kidney yin is to be prepared from for 300~500 parts by 1000~3000 parts of Fructus Ligustri Lucidi, 500~700 parts of Radix Pseudostellariaes, 300~500 parts of Radix seu Herba Gei aleppici and Cortex Albiziae.
Preferably, the Chinese medicine preparation of the climacteric syndrome of above-mentioned treatment heart deficiency of the kidney yin is to be prepared from for 350~450 parts by 1500~2500 parts of Fructus Ligustri Lucidi, 550~650 parts of Radix Pseudostellariaes, 350~450 parts of Radix seu Herba Gei aleppici and Cortex Albiziae.
Best, the Chinese medicine preparation of the climacteric syndrome of aforementioned therapies heart deficiency of the kidney yin is to be prepared from for 400 parts by 2000 parts of Fructus Ligustri Lucidi, 600 parts of Radix Pseudostellariaes, 400 parts of Radix seu Herba Gei aleppici and Cortex Albiziae.
The present invention also provides a kind of preparation method of Chinese medicine preparation of climacteric syndrome of aforementioned therapies heart deficiency of the kidney yin: get Fructus Ligustri Lucidi, add alcohol reflux, filter, filtrate for later use, medicinal residues and Radix Pseudostellariae, Radix seu Herba Gei aleppici, Cortex Albiziae decoct with water, and merge decoction liquor, filter, merge with Fructus Ligustri Lucidi filtrate, concentrate, preparation process is made various dosage forms routinely.
Above-mentioned preparation method is specially: get Fructus Ligustri Lucidi, add 8~12 times of amount 85~95% alcohol reflux 2~4 times, each 0.5~1.5 hour, filter, filtrate for later use, medicinal residues and Radix Pseudostellariae, Radix seu Herba Gei aleppici and Cortex Albiziae add 6~10 times of water gagings and decoct 2~4 times, each 1.5~2.5 hours, merge decoction liquor, filter, merge with Fructus Ligustri Lucidi filtrate, concentrate, preparation process is made various dosage forms routinely.
Aforementioned preparation method is preferably: get Fructus Ligustri Lucidi, add 10 times of amount 85% alcohol reflux 3 times, each 1 hour, filter, filtrate for later use, medicinal residues and Radix Pseudostellariae, Radix seu Herba Gei aleppici and Cortex Albiziae add 8 times of water gagings and decoct 3 times, each 2 hours, merge decoction liquor, filter, merge with Fructus Ligustri Lucidi filtrate, concentrate, make various preparations.
The preparation method of capsule of the present invention: get Fructus Ligustri Lucidi, add 10 times of amount 85% alcohol reflux 3 times, each 1 hour, filter, filtrate for later use, medicinal residues and Radix Pseudostellariae, Radix seu Herba Gei aleppici and Cortex Albiziae add 8 times of water gagings and decoct 3 times, each 2 hours, merge decoction liquor, filter, filtrate concentrates, and drying is pulverized, sieve, add starch, mixing, encapsulated, promptly get capsule.
The function of Chinese medicine preparation of the present invention cures mainly: nourishing YIN to lower pathogenic fire, mind tranquilizing and the heart calming.Be used for heart kidney yin deficient syndrome and see and have a dizzy spell, hectic fever night sweat, feverish sensation in the palms and soles, irritable emotion, irritated irritability, dysphoria and insomnia, soreness of the waist and knees, the few tongue of red tongue, thready and rapid pulse.
Fructus Ligustri Lucidi, the dry mature fruit of Oleaceae plant Fructus Ligustri Lucidi (Ligustrum lucidum Ait.), odorless, sweet in the mouth, little bitterness have the effect that tonifying liver kidney yin, crow must make eye bright.Radix Pseudostellariae (Radix Pesudostellariae), for the tuber of pinkwort pseudostellaria heterophylla (Pseudostellaria heterophylla (Miq.) Pax ex Pax et Hoffm.), sweet, little hardship, tepor has the effect of mending strengthening spleen and lung, supplementing QI for promoting the production of body fluid, controls the cough due to deficiency of the lung, insufficiency of the spleen lack of appetite, cardiopalmus, palpitation with a distress feeling, edema, quench one's thirst, spirit is tired.Radix seu Herba Gei aleppici, Rosaceae avens south Fructus Adinae (Geum japonicumThunb.var.chinense Bolle), hot, bitter, flat, have analgesia, blood pressure lowering, regulating menstruation, the effect of expelling wind and removing dampness is used for hypertension, dizziness headache, menoxenia, lower abdominal pain, leucorrhea, infantile convulsion, diseases such as lumbago, skelalgia of rheumatism.Cortex Albiziae, the dry bark of leguminous plant Herba Albiziae (Albizia julibrissin Durazz.), sweet, flat, GUIXIN, liver, lung meridian have resolving stagnation for tranquilization, and the effect of promoting blood circulation and detumescence is used for irritability, melancholy insomnia, the lung abscess skin ulcer is swollen, falls diseases such as pouncing on the pain of injury.
We's card pathogenesis is a hepatic and renal YIN deficiency, disorder of QI and blood.So waist soreness is arranged, have a dizzy spell or insomnia, the time agitation is arranged, or weak asthenia, lack of appetite, the light red tongue tongue is few, thready pulse." element ask ancient times innocent opinion ": " taichong channel declines few, exhaustion of kidney-essence with promoting reproductive function for woman ... seventy-seven, conception vessel void ", essence and blood sharing the same origin make the women in the time of 45~50 years old because of naturally-aged has based on deficiency of the kidney yin, have the above-mentioned disease of deficiency of liver-blood concurrently.Control when adopting nourishing the liver and kidney, replenishing QI to invigorate the spleen is with nourishing blood to tranquillize the mind.Fructus Ligustri Lucidi nourishes kidney yin in the side, and life essence-filling, marrow-benefitting, and nourishing the liver to improve visual acuity are monarch drug.The yin nourishing of Radix seu Herba Gei aleppici suppressing the hyperactive liver, vigorate qi and replenish the blood, regulating menstruation can be controlled again and have a dizzy spell with principal drug assistance, is ministerial drug.The Cortex Albiziae resolving stagnation for tranquilization nourishes heart and invigorates blood circulation, and treats vexed, insomnia, and helps blood to work freely; The Radix Pseudostellariae replenishing QI to invigorate the spleen promotes the production of body fluid and moisturizes, and can help " the foundation of acquired constitution " to make QI and blood biochemical sufficient with tonify deficiency, again can QI invigorating, help his medicine to transfer the whole body negative and positive of qi and blood altogether to set upright, and be adjuvant drug altogether.Four medicines are shared, and nourishing the liver and kidney is main, have QI and blood concurrently with benefit, and spleen invigorating is invigorated blood circulation and the taste of anti-tonic is greasy, amounts to nourishing the liver and kidney, replenishing QI to invigorate the spleen, the merit of nourishing blood to tranquillize the mind.
Test example one, Study on extraction
1, instrument and reagent
Instrument: LC-2010CHT high performance liquid chromatograph (day island proper Tianjin company); METTLER AE240 electronic balance (the prunus mume (sieb.) sieb.et zucc. Teller takes off benefit instrument [Shanghai] company limited); TCQ500 type ultrasonic cleaner (Beijing Medical Equipment Plant, power 250W~500W); Vacuum drying apparatus (the Shanghai City experimental apparatus ZK-82A of factory type).
Reagent: oleanolic acid (Nat'l Pharmaceutical ﹠ Biological Products Control Institute, lot number 110709-200304); Fructus Ligustri Lucidi, Radix Pseudostellariae, Radix seu Herba Gei aleppici, Cortex Albiziae; Climacteric benefit capsule (capsule of the present invention, Guiyang College of Traditional Chinese Medicine's pharmaceutical preparation prepared in laboratory); Methanol (chromatographically pure), water (ultra-pure water), other reagent are analytical pure.
2, method and result
2.1 chromatographic condition chromatographic column: VP-ODS (50*4.6 looks, 5 μ m), mobile phase: methanol-0.5% Spirit of Mindererus. (85: 15), column temperature: 30 ℃, sample size: 5 μ l, detection wavelength: 210nm.
2.2 the preparation precision of reference substance solution takes by weighing oleanolic acid 3.44mg, adds methanol constant volume to the 5ml measuring bottle, makes the solution that every 1ml contains oleanolic acid 0.688mg.
2.3 the assay of oleanolic acid in the Fructus Ligustri Lucidi
The preparation precision of reference substance solution takes by weighing oleanolic acid 3.44mg, adds methanol constant volume to the 5ml measuring bottle, makes the solution that every 1ml contains oleanolic acid 0.688mg.
Fructus Ligustri Lucidi medicinal material coarse powder 1 gram is got in the preparation of need testing solution, and accurate the title decides.Add ethanol 50ml, reflux 30 minutes is put cold filtration, and it is the same that medicinal residues add ethanol, repeats to reflux 2 times again, and merging filtrate evaporate to dryness, residue add the dehydrated alcohol slight fever makes dissolving, is transferred in the 10ml measuring bottle, and adds ethanol to scale, shakes up as need testing solution both to get.
2.4 the alcohol extraction process of the preferred Fructus Ligustri Lucidi of orthogonal experimental design method
Clearly investigate the size of different factors to oleanolic acid decocting rate influence degree, and preferred optimum extraction process, determine that the investigation factor for adding determining alcohol, alcohol adding amount, extraction time, extraction time, gets three levels respectively and investigate, investigation factor and level see Table 1.Adopt L 9(3 4) orthogonal test table design experiment scheme, with the content of oleanolic acid as assessment indicator.
Table 1 L 9(3 4) design of orthogonal test gauge outfit
2.4.1 method and result take by weighing medical material Fructus Ligustri Lucidi 200g, Radix Pseudostellariae 60g, Radix seu Herba Gei aleppici 40g, Cortex Albiziae 40g, test according to the arrangement of Orthogonal Experiment and Design table, the medicinal liquid of test gained is concentrated into dried, adds anhydrous alcohol solution and be settled to 10ml. and draw reference substance solution, each 5 μ l sample introduction of 9 extracting solution respectively.Measure peak area, calculate oleanolic acid content, result of calculation sees Table 2, table 3.
Table 2 L 9(3 4) orthogonal test table and result
Table 3 analysis of variance table
2.4.3 intuitive analysis is analyzed with the extreme value R in the table 2, to be A>D>C>B in proper order according to K value compare the primary and secondary of each index factor influence that can to get best extraction scheme be that 95% ethanol is measured reflux, extract, 3 times, each 1 hour for 10 times.
2.4.4 analysis of variance table is 2 results show: factor does not make significant difference to result of the test, can draw best extraction process in conjunction with intuitive analysis is 10 times of amounts of ethanol reflux, extract, of 95% 3 times, each 1 hour.But owing to consider commercial viability, 95% concentration of alcohol is too high, now keeps all the other conditions and maintains static, and changes concentration of alcohol, is that index is investigated technology with the content of oleanolic acid.Experimental result such as table 4:
The screening of table 4, concentration of alcohol
Therefore choose 10 times of amounts of 85% ethanol reflux, extract, three times, each one hour.
2.4.5 demonstration test is pressed optimum process condition and extracted three times, carries out confirmatory experiment, three times experimental result oleanolic acid average content is 1.4062mg/ml, RSD=0.21%.Show this stable process conditions, feasible.
2.5 the preferred extraction process by water of orthogonal experimental design method
2.5.1 method and result take by weighing medical material Fructus Ligustri Lucidi 200g, Radix Pseudostellariae 60g, Radix seu Herba Gei aleppici 40g, Cortex Albiziae 40g, decoct according to the requirement under each tested number, concentrate, drying gets dry extract.With amount of water, decocting time, decocting number of times is the examination factor, carries out L 9(3 4) orthogonal test, and with dried cream amount (the accurate filtrate 50ml that draws puts in the evaporating dish that is dried to constant weight, volatilizes, and in 105 ℃ of dryings 3 hours, moves in the exsiccator, cool off 30 minutes, accurately rapidly claims to decide weight, calculating, promptly.) be evaluation index, filter out optimised process.Test arrangement and the results are shown in Table 5, table 6, table 7, the oleanolic acid content assaying method is as follows:
Table 5 empirical factor level
Factor level Amount of water A (doubly) Decocting time B (h) Decoct number of times C (inferior)
1 8 1.0 1
2 10 1.5 2
3 12 2.0 3
The orthogonal experiment data that table 6 is the preferred extraction process by water of index with dried cream yield
Table 7 analysis of variance table
Group The observation number Summation On average Variance
Row 1 3 24.46 8.1533 0.0009
Row 2 3 24.46 8.1533 0.3461
Row 3 3 24.46 8.1533 4.6102
Row 4 3 24.46 8.1533 0.0873
2.5.2 intuitive analysis is considered with dried cream yield, compares the meansigma methods of each factor varying level experimental result, to factor A, maximum horizontal is 1, and to factor B, maximum horizontal is 3, and to factor C, maximum horizontal is 3, and factor D is a blank column.The size of each factor extreme difference R value relatively draws and to the descending order of the dried cream content influence of index factor is: C>B>A.
2.5.3 the variance analysis factor does not make significant difference to result of the test, can draw best extraction process in conjunction with intuitive analysis is that the decocting that adds 8 times of amounts boils each 2 hours 3 times.
2.5.4 the capsular extraction process by water confirmatory experiment of climacteric benefit
Decoct according to optimum process, concentrate, drying gets dry extract.Average dried cream rate is 10.98%, RSD=0.15%.Show this stable process conditions, feasible.
Test example two, Study on Forming
1, measures the angle of repose of climacteric benefit capsule 's content
1.1 experiment material and instrument
Experiment material: climacteric benefit capsule (capsule of the present invention, Guiyang College of Traditional Chinese Medicine's preparation prepared in laboratory, lot number 20060601).
Experiment equipment: glass funnel, iron stand, graph paper
1.2 experimental technique
Adopt fixed funnel method (injection method) to measure angle of repose: to be connected on three glass funnels on the iron stand successively, the bell mouth of descending most funnel slowly adds climacteric benefit capsule 's content from funnel topmost for 1.5cm. carefully apart from the graph paper of horizontal positioned is high, till the medicated powder cone tip of funnel formation bottom touches bell mouth. radius R at the bottom of measuring its heap. measure three times, be calculated as follows its angle of repose of α, average, the results are shown in Table 8.
The measurement result of table 8 climacteric benefit capsule angle of repose
Numbering Pile high H (cm) Heap end radius R (cm) ?tanα Angle of repose α (°) Meansigma methods (°)
1 1.5 2.8 0.54 28.18 27.90
2 1.5 2.9 0.52 27.35
3 1.5 2.8 0.54 28.18
Show that by The above results medicated powder granule α angle of repose=27.90 ° less than 30 °, has good flowability. therefore need not add adjuvant increases its flowability.
2, the bulk density of climacteric benefit capsule 's content is measured
2.1 experiment material and instrument
Experiment material: climacteric benefit capsule (Guiyang College of Traditional Chinese Medicine's preparation prepared in laboratory, lot number 20060601).
Experiment equipment: graduated cylinder, METTLER AE240 electronic balance (prunus mume (sieb.) sieb.et zucc. Teller-Tuo benefit instrument [Shanghai] company limited)
2.2 experimental technique
Adopt the weight by volume method to measure bulk density: to get a certain amount of climacteric benefit capsule 's content, claim its weight m, place circular graduated cylinder, measure its volume V.Measure three times, calculate its bulk density ρ, average, the results are shown in Table 9 by following formula:
The mensuration of table 9 climacteric benefit capsule bulk density
Tested number Content weight m (g) Volume V (mL) Bulk density (g/cm 3) Meansigma methods
1 3.0028 3.4 0.88 0.87
2 3.0017 3.5 0.86
3 3.0054 3.5 0.86
By last Biao Kede, the bulk density of capsule 's content is 0.87g/cm 3
3, the mensuration of critical relative humidity
3.1 experiment material and instrument
Experiment material: climacteric benefit capsule (Guiyang College of Traditional Chinese Medicine's preparation prepared in laboratory, lot number: 20060601).
Experimental apparatus: climatic chamber, exsiccator, flat weighing botle, METTLER AE240 electronic balance (prunus mume (sieb.) sieb.et zucc. Teller-Tuo benefit instrument [Shanghai] company limited)
3.2 experimental technique
Adopt the humidity accelerated test to measure critical relative humidity: get 7 glass exsiccators, dispose the saturated salt solution of a series of different relative humiditys, airtight be placed in 25 ℃ of calorstats promptly got corresponding constant-temperature constant-humidity environment through 24 hours.Get 14 flat weighing botles with cover, after constant weight, be divided into two groups, claim its weight earlier, take by weighing climacteric benefit capsule 's content 1g then and be tiled in each weighing botle, after accurate title is fixed, place 7 exsiccators respectively, its example weight of METHOD FOR CONTINUOUS DETERMINATION no longer changes until the sample equilibrium moisture content in different time sections, reaches moisture equilibrium at dry side.The results are shown in Table 10.
Table 10 climacteric benefit capsule moisture equilibrium at dry side table
The result shows that the capsular critical relative humidity of climacteric benefit is 79%, and prompting is when ambient humidity is higher than 79%, and the hygroscopic capacity of preparation can significantly increase, and causes particulate stability decreases.Therefore, should store under less than 79.3% condition at ambient humidity.
Test example three, the capsular quality examination of climacteric benefit
1, the moisture inspection of climacteric benefit capsule 's content
1.1 experiment material and instrument
Experiment material: climacteric benefit capsule (Guiyang College of Traditional Chinese Medicine's preparation prepared in laboratory).
Experimental apparatus: flat weighing botle, exsiccator, METTLER AE240 electronic balance (prunus mume (sieb.) sieb.et zucc. Teller-Tuo benefit instrument [Shanghai] company limited), far infrared drying oven
1.2 experimental technique
Assay method is by " first method (oven drying method) of an appendix IX of Chinese pharmacopoeia version in 2005 H regulation is carried out: get each 3g of climacteric benefit capsule 's content of three batches, be tiled in the flat weighing botle that is dried to constant weight, thickness is about 3mm, the accurate title, decide, open bottle cap after under 100~105 ℃ the temperature dry 5 hours, bottle cap is built, and dislocation cools off after 30 minutes in exsiccator, the accurate title, decide, under said temperature dry 1 hour again, cooling in accordance with the law, precision is weighed, extremely double difference of weighing is no more than till the 5mg, according to the weight that subtracts mistake, calculate the water content (%) in three batches of test samples, moisture must not surpass 9.0%.It the results are shown in Table 11:
The determination of moisture of table 11 climacteric benefit capsule 's content
Batch 20071128 20071225 20080108
Water content (%) 2.38 3.13 2.66
By last table result as can be known, the moisture of 3 batches of climacteric benefit capsule 's contents meets regulation under the pharmacopeia item all less than 9.0%.
2, the capsular content uniformity inspection of climacteric benefit
2.1 experiment material and instrument
Experiment material: climacteric benefit capsule (Guiyang College of Traditional Chinese Medicine's preparation prepared in laboratory)
Experiment equipment: METTLER AE240 electronic balance (prunus mume (sieb.) sieb.et zucc. Teller-Tuo benefit instrument [Shanghai] company limited)
2.2 experimental technique
Inspection method is by " inspection method of an appendix I of Chinese pharmacopoeia version in 2005 L regulation is carried out: get 10 of climacteric benefit capsules, divide another name fixed its weight, inclining content (must not lose softgel shell), clean with little grooming, softgel shell weight decided in accurate respectively title, obtains the tolerant loading amount of every intragranular.Every loading amount is compared with average loading amount, the content uniformity limit should average loading amount+10% in, the capsule that exceeds the content uniformity limit must not be more than 2, and 1 times of 1 overrun must not be arranged.It the results are shown in Table 12:
The capsular content uniformity inspection of table 12 climacteric benefit
Numbering 1 2 3 4 5
Loading amount (g) 0.4534 0.4568 0.4577 0.4562 0.4601
Numbering 6 7 8 9 10
Loading amount (g) 0.4595 0.4543 0.4580 0.4535 0.4524
Calculated by last table, average loading amount is 0.4562g, and the content uniformity limit all in ± 10%, meets the pharmacopeia regulation.
2.3 the inspection of climacteric benefit capsule disintegration
2.3.1 experiment material and instrument
Experiment material: climacteric benefit capsule (Guiyang College of Traditional Chinese Medicine's pharmaceutical preparation prepared in laboratory)
Experimental apparatus: ZB-1C intelligence disintegration tester (Precision Instrument Factory, Tianjin Univ.)
3.2 experimental technique
Inspection method is by " inspection method of an appendix VII of Chinese pharmacopoeia version in 2005 A regulation is carried out: get 6 of climacteric benefit capsules under the content uniformity, place the glass tubing of intelligent disintegration tester hanging basket respectively, add baffle plate, start disintegration tester and check, capsule each all should be in 30 minutes whole disintegrates and pass through screen cloth.Can not should get 6 retrials in addition all by screen cloth if any 1, all should be up to specification.Measure 3 batches, the results are shown in Table 13:
Table 13 climacteric benefit capsule is checked disintegration
Show that by The above results meet pharmacopeia regulation all less than 30min each capsules disintegration of three lot numbers.
Test example four, pharmacodynamic experiment
Summary: zoopery is the result show: (1) climacteric benefit capsule can significantly increase the weight of removal ovary rat uterus, to the effect of improving of serum estradiol level, and can significantly increase old female mice ovary and adrenal weight.(2) climacteric benefit capsule has tangible sedation to old female mice, and the activity increase of removal ovary mice is also had significant inhibitory effect, and can prolong pentobarbital sodium length of one's sleep, shortens hypnosis incubation period.Show that climacteric benefit capsule has tangible sedative-hypnotic effect.(3) climacteric benefit capsule is to the effect of being significantly improved of " deficiency of YIN " mice weight loss, and the increase of " deficiency of YIN " mice autonomic activities is had tangible reduction effect.Volume of perspiration to normal rat has obvious inhibitory action.
Test objective: the capsular function of climacteric benefit cures mainly and is nourishing the liver and kidney, replenishing QI to invigorate the spleen, mind tranquilizing and the heart calming.Be used for heart kidney yin deficient syndrome and see and have a dizzy spell, hectic fever night sweat, feverish sensation in the palms and soles, irritable emotion, irritated irritability, dysphoria and insomnia, soreness of the waist and knees, the few tongue of red tongue, thready and rapid pulse.Cure mainly its permanent curing action of this laboratory observation, tranquilizing soporific, anticonvulsant action and the influence that deficiency of YIN animal is showed according to its function.For its clinical practice provides experimental basis.
1, material
1.1 the reagent and the unit of providing are provided
Climacteric benefit capsule, being tried thing is medicated powder.Every capsules is adorned 0.4 gram dry powder.Oral, one time 3~4,3 times on the one, every contains crude drug in whole total amount 34g.Be 1 month a clinical course of treatment.Intending consumption clinical every day is equivalent to 306~408g primary crude drug/60kg and (promptly is equivalent to 3.6~4.8g medicated powder/60kg).Research and development centre provides by Guizhou Province's Chinese medicine preparation, lot number: 20051201.
1.2 other medicine and reagent
(1) GENGNIANAN capsule, function cures mainly: nourishing YIN for suppressing the hyperactive YANG, relieving restlessness is calmed the nerves.Be used for climacteric hectic fever sweating, vertigo and tinnitus, fidgety insomnia, blood pressure increases.Usage and dosage: oral, one time 3,3 times on the one, every adorn 0.3 the gram.Dongfeng Pharmaceutical Industry Co., Ltd., Jilin, lot number: 20050108.
(2) diethylstilbestrol tablet, the 0.5mg/ sheet, Hefei joins pharmaceutical Co. Ltd for a long time, lot number: 20051001.
(3) thyroid tablet, 40mg/ sheet, Jinan Wei Erkang Biochem Pharma Inc, lot number: 0505501.
(4) ether, 500ml/ bottle, chemical reagent engineering and technological research development centre, Guangdong Province, lot number: 050810.
(5) pentobarbital sodium, 25g/ bottle, China Medicine (Group) Shanghai Chemical Reagent Co.,, lot number: F20021216.
(6) diazepam inj, 10mg/2ml, Shanghai Xudong Hipu Medicine Co., Ltd, lot number: 010201.
(7) atropine sulfate injection, 0.5mg/ml, Wuxi City the 7th pharmaceutical Co. Ltd, lot number: 04061613.
(8) E2 (estradiol), LH (lutropin), FSH (follicle stimulating hormone) luminescence method are measured test kit and are the production of U.S. Beckman Coulter Inc., and lot number is respectively: 612724,517606,517607.
1.3 animal
(1) Wistar rat, body weight 200~250g, cleaning level.
(2) Kunming mouse, adult mice body weight 18~22g, Aged Mice body weight 30~40g, cleaning level.Animal is female.Guangxi Medical University's medical experiment animal center provides.Laboratory animal production licence number: SCXK osmanthus 2003-0003.Laboratory animal occupancy permit number: SYXK osmanthus 2003-0005; Animal housing's temperature: 25 ± 2 ℃, relative humidity: 60 ± 2%.Raise medical experiment animal center feed prepared, freely drink water with Guangxi Medical University.
2, method is selected
2.1 cure mainly according to the function that is subjected to reagent, carry out the pharmacodynamic study of following project:
To the influence of removal ovary rat, to the influence of old female mice, to the influence of removal ovary spontaneous activity in mice, to sub-threshold dose pentobarbital sodium synergism, to the influence of pentobarbital sodium syngignoscism, to the influence of " deficiency of YIN " mice autonomic activities, body weight and body temperature.
2.2 experimental control
Normal control group: give normal saline;
Positive control drug: Chinese medicine matched group (GENGNIANAN capsule) and western medicine group (diethylstilbestrol, diazepam, atropine);
2.3 route of administration, administration volume and dosage
Route of administration: climacteric benefit capsule, GENGNIANAN capsule, diethylstilbestrol are and irritate stomach (i.g) administration, and diazepam, atropine are intraperitoneal injection.
Gastric infusion volume: rat 10ml/kg, mice 20ml/kg.
Dosage:
Climacteric benefit: take by weighing an amount of medicated powder, prepare to desired concn (guaranteeing the administration constancy of volume) with an amount of dissolved in distilled water.
GENGNIANAN capsule: get medicated powder in the capsule, prepare to desired concn (guaranteeing the administration constancy of volume) with an amount of dissolved in distilled water.
2.4 other contrast medicine:
Diethylstilbestrol: get its tablet, prepare to desired concn (guaranteeing the administration constancy of volume) with an amount of dissolved in distilled water.
Diazepam: stock solution gives mouse peritoneal injection 20ml/kg (25mg/kg) with 4 times of injection normal saline dilutions.
Atropine: give rat skin lower injection stock solution 10ml/kg (5mg/kg).
2.5 date processing
Adopt " Chinese medicine encyclopedia-medicostatistics " statistical package (second edition) of vital statistics teaching and research room of Huaxi Medical Univ to carry out relevant check.Continuous data is represented with x ± s.
3, experimental technique and result
3.1 to estradiol, lutropin, follicle stimulating hormone and the uterus of removal ovary rat, adrenal influence
Extract bilateral ovaries after getting the female rats etherization of growing up, operation back infection.Vaginal smear examination was carried out, continuous 5 days on the 5th day in the operation back.Getting qualified animal (not occurring emotionally changing) is divided into: dosage group, (6) climacteric benefit capsule low dose group in (1) model control group (blank group), (2) Western medicine positive controls, (3) Chinese medicine positive controls, (4) climacteric benefit capsule in high dose group, (5) climacteric benefit capsule.In addition 10 rats are carried out sham-operation, as sham operated rats.Each organizes dosage and approach: model control group and sham operated rats are given the equal-volume distilled water, the Western medicine positive controls is given diethylstilbestrol 0.5mg/kg, the Chinese medicine positive controls is given GENGNIANAN capsule 0.6g/kg, and the high, medium and low dosage group of climacteric benefit capsule is respectively 85.0,42.5,21.25g crude drug/kg.In operation back beginning in the 9th day gastric infusion, every day 1 time, continuous 30 days, the last administration was after 24 hours, and (1) ventral aorta blood sampling separation of serum is put the method for exempting from and measured E 2(estradiol), LH (lutropin), FSH (follicle stimulating hormone); (2) win uterus and the adrenal gland calculating organ coefficient of weighing; (3) and to uterus, adrenal gland carry out histological observation.
The result shows:
(1) climacteric benefit capsule in high dose group can significantly increase the weight of rat uterus, to serum E 2The level effect of improving sees Table 14.
(2) uterus, adrenal gland's pathology histological observation show, climacteric benefit capsule to the female rats removal ovary after uterus and the adrenal gland atrophy, the chamber diameter that occur diminish, pathological changes such as the less and flesh layer of body of gland is thin under the endometrium have the improvement effect, show that uterus, adrenal gland's volume increase, chamber enlarged-diameter (3-4mm), endometrial gland increases.Diethylstilbestrol group uterus and adrenal gland are bigger, chamber diameter 5mm.Intra-uterine membranous layer, flesh confluent monolayer cells are abundanter; GENGNIANAN Capsules group uterus, adrenal gland are big slightly, diameter 2-3mm, and intra-uterine membranous layer, flesh confluent monolayer cells are many slightly.
Table 14 climacteric benefit capsule is to removal ovary rat E 2, LH, FSH level and uterus, adrenal gland's organ coefficient influence (x ± s)
Group Dosage (g/kg) Number of animals Uterus coefficient (mg/g) Adrenal gland's coefficient (mg/g) E 2(pg/ml) LH(mIU/ml) FSH(mIU/ml)
Sham operated rats 10 2.07±0.50 0.34±0.07 28.84±3.33 6.96±1.57 4.27±1.59
Model control group 10 0.75±0.56 ** 0.27±0.03 * 13.47±2.48 ** 9.49±1.58 ** 6.44±1.53 **
The diethylstilbestrol group 0.001 10 2.58±0.57 △△ 0.49±0.07 △△** 16.76±3.11 7.51±1.47 △△ 4.49±1.63
The GENGNIANAN capsule 0.6 10 1.31±0.53 0.31±0.04 15.29±2.95 8.24±1.36 5.25±1.34
Climacteric benefit capsule 85 10 1.21±0.35 0.30±0.05 15.62±2.73 8.18±1.50 5.16±1.64
Climacteric benefit capsule 42.5 10 1.05±0.46 0.29±0.03 15.29±2.56 8.38±1.55 5.22±1.63
Climacteric benefit capsule 21.25 10 0.97±0.23 0.28±0.05 14.43±3.02 8.73±1.51 5.36±1.54
Compare with sham operated rats: * P<0.05, * * P<0.01, compare with model control group: P<0.05, △ △P<0.01
3.2 to old female mice spontaneous activity and uterus, ovary and adrenal influence
Get 60 of 1 age female mices (plant Mus, stop and produce), be divided at random: dosage group, (5) climacteric benefit capsule low dose group in (1) blank group, (2) positive controls, (3) climacteric benefit capsule in high dose group, (4) climacteric benefit capsule.Each organizes dosage and approach: the blank group is given the equal-volume distilled water, positive controls is given GENGNIANAN capsule 1.2g/kg, the high, medium and low dosage group of climacteric benefit capsule is respectively 170.0,85.0,42.5g crude drug/kg, administration immediately after the grouping, each organizes gastric infusion 1 time every day, continuous 20 days, the last administration was after 1 hour, and the mensuration mice was lifted forelimb number of times and activity time in 3 minutes.Experiment finishes the back and puts to death mice, gets uterus, ovary and adrenal gland and weighs, and calculates dirty hierarchy number.
The result shows that climacteric benefit capsule height, middle dosage group have tangible central inhibitory action to old female mice, can obviously reduce the spontaneous activity of Aged Mice.Climacteric benefit capsule in high dose also can significantly increase Aged Mice ovary and adrenal weight, sees Table 15, table 16.
Table 15 climacteric benefit capsule is to the influence of old female mice spontaneous activity (x ± s)
Group Dosage (g/kg) Number of animals Lift the forelimb number of times Activity time
The blank group 12 12.2±1.9 61.3±11.8
The GENGNIANAN capsule 1.2 12 10.5±1.8 * 50.4±10.8 *
Climacteric benefit capsule 170 12 10.2±1.9 * 48.9±11.1 *
Climacteric benefit capsule 85 12 10.6±1.7 * 51.8±9.8 *
Climacteric benefit capsule 42.5 12 11.4±1.9 54.7±10.2
Compare with the blank group: * P<0.05.
Table 16 climacteric benefit capsule is to the influence of old female mice uterus, ovary and the dirty hierarchy number of adrenal gland (x ± s)
Group Dosage (g/kg) Number of animals Uterus coefficient (mg/g) Ovary coefficient (mg/g) Adrenal gland's coefficient (mg/g)
The blank group 12 4.45±1.06 1.21±0.24 0.47±0.08
The GENGNIANAN capsule 1.2 12 5.10±1.30 1.42±0.23 * 0.53±0.07 *
Climacteric benefit capsule 170 12 5.19±1.12 1.47±0.27 * 0.56±0.09 *
Climacteric benefit capsule 85 12 5.05±1.29 1.31±0.20 0.52±0.09
Climacteric benefit capsule 42.5 12 4.48±1.14 1.25±0.23 0.51±0.08
Compare with the blank group: * P<0.05.
3.3 influence to the removal ovary spontaneous activity in mice
To grow up and extract bilateral ovaries behind the female mice etherization, operation back infection.Extract ovary and carried out vaginal smear examination, continuous 5 days on the 5th day.Getting qualified animal (ovariectomy does not have emotionally variation fully) is divided into: dosage group, (6) climacteric benefit capsule low dose group in (1) model control group (blank group), (2) Western medicine positive controls, (3) Chinese medicine positive controls, (4) climacteric benefit capsule in high dose group, (5) climacteric benefit capsule.In addition 12 mices are carried out sham-operation, as sham operated rats.Each organizes dosage and approach: model group and sham operated rats are given the equal-volume distilled water, the Western medicine positive controls is given diethylstilbestrol 1mg/kg, the Chinese medicine positive controls is given GENGNIANAN capsule 1.2g/kg, and the high, medium and low dosage group of climacteric benefit capsule is respectively 170.0,85.0,42.5g crude drug/kg.In operation back beginning in the 9th day gastric infusion, every day 1 time, continuous 20 days, the last administration was after 1 hour, and the mensuration mice was lifted forelimb number of times and activity time in 3 minutes.
The result shows that the spontaneous activity of mice removal ovary obviously increases, and climacteric benefit capsule can reduce the spontaneous activity of removal ovary mice, and wherein high dose group has evident difference, points out it that removal ovary mice is had significant sedation, sees Table 17.
Table 17 climacteric benefit capsule is to the influence of removal ovary spontaneous activity in mice (x ± s)
Compare with sham operated rats: * P<0.05, compare with model control group: P<0.05
3.4 sub-threshold dose pentobarbital sodium synergism to the removal ovary mice
To grow up and extract bilateral ovaries behind the female mice etherization, operation back infection.Extract ovary and carried out vaginal smear examination, continuous 5 days on the 5th day.Get qualified animal (ovariectomy does not have emotionally variation fully) random packet, grouping, medication and dosage are with under 14.3 of the experiments.In beginning in the 9th day administration of operation back, every day 1 time, continuous 16 days, after the last administration 1 hour, each organizes mouse peritoneal injection pentobarbital sodium 30mg/kg, observes that righting reflex loss reaches 1 minute number of animals in 15 minutes, and the percentage rate of righting reflex loss appears in the calculating mice.
The result shows that the synergism to the sub-threshold dose pentobarbital sodium behind the mice removal ovary descends, and climacteric benefit capsule in high dose group sees Table 18 to the effect of being significantly improved of sub-threshold dose pentobarbital sodium synergism.
Table 18 climacteric benefit capsule is to the synergism of removal ovary mice sub-threshold dose pentobarbital sodium (x ± s)
Compare with sham operated rats: * * P<0.01, compare with model control group: P<0.05, △ △P<0.01
3.5 influence to removal ovary mice pentobarbital sodium syngignoscism
To grow up and extract bilateral ovaries behind the female mice etherization, operation back infection.Extract ovary and carried out vaginal smear examination, continuous 5 days on the 5th day.Get qualified animal (ovariectomy does not have emotionally variation fully) random packet, under grouping, medication and dosage are tested 14.3.In beginning in the 9th day administration of operation back, every day 1 time, continuous 18 days, the last administration was after 1 hour, and each organizes mouse peritoneal injection pentobarbital sodium 50mg/kg, the record mice time for falling asleep (incubation period) and the length of one's sleep.
The result shows, behind the mice removal ovary, gives the pentobarbital sodium of HD, and time for falling asleep (incubation period) prolongs, and shorten the length of one's sleep.Climacteric benefit capsule in high dose group can prolong the removal ovary mice the pentobarbital sodium length of one's sleep, shorten hypnosis incubation period, see Table 19.
Table 19 climacteric benefit capsule is to the influence of removal ovary mice pentobarbital sodium syngignoscism (x ± s)
Compare with sham operated rats: * P<0.05, compare with model control group: P<0.05, △ △P<0.01
3.6 influence to " deficiency of YIN " mice autonomic activities, body weight and body temperature
Get 72 of female mices, be divided at random: dosage group, (6) climacteric benefit capsule low dose group in (1) model control group, (2) normal control group, (3) positive controls, (4) climacteric benefit capsule in high dose group, (5) climacteric benefit capsule.Each organizes dosage and approach: model control group and normal control group are given the equal-volume distilled water, positive controls is given GENGNIANAN capsule 1.2g/kg, the high, medium and low dosage group of climacteric benefit capsule is respectively 170.0,85.0,42.5g crude drug/kg, administration immediately after the grouping, each organizes gastric infusion 1 time every day, continuous 15 days, except that the normal control group, each was organized and to thyroid tablet 5mg/ only irritates stomach every day simultaneously in administration.After the last administration 1 hour, the mensuration mice was lifted forelimb number of times and activity time in 3 minutes, write down body weight and the body temperature of mice simultaneously.
The result shows, climacteric benefit capsule in high dose group is to the effect of being significantly improved of " deficiency of YIN " mice weight loss, the increase of " deficiency of YIN " mice autonomic activities also had the obvious suppression effect, but the nothing of deficiency of YIN mouse temperature is obviously influenced, and sees Table 20.
Table 20 climacteric benefit capsule is to the influence of " deficiency of YIN " mice autonomic activities, body weight, body temperature (x ± s)
Group Dosage (g/kg) Number of animals Lift the forelimb number of times Activity time Body weight (administration before and after poor) Body temperature (℃)
The normal control group 12 12.8±2.6 62.3±7.9 -1.4±0.8 38.3±0.6
Model control group 12 15.7±2.5 * 71.5±9.8 * 2.4±1.0 ** 38.7±0.4 *
The GENGNIANAN capsule 1.2 12 13.3±2.1 63.2±8.9 1.5±1.0 38.4±0.5
Climacteric benefit capsule 170 12 13.1±2.3 63.4±9.3 1.6±0.9 38.4±0.5
Climacteric benefit capsule 85 12 13.7±1.8 64.7±9.1 1.8±1.1 38.5±0.6
Climacteric benefit capsule 42.5 12 14.8±2.5 69.3±9.5 2.1±0.8 38.6±0.4
Compare with the normal control group: * P<0.05, compare with model control group: P<0.05.
4, conclusion
(1) the permanent curing action result of the test shows, climacteric benefit capsule can significantly increase the weight of removal ovary rat uterus, serum Lh, FSH level is had certain reduction effect, to serum E 2The level effect of improving, and can significantly increase old female mice ovary and adrenal weight.
(2) tranquilizing soporific, anticonvulsant action result of the test show, climacteric benefit capsule has significant tranquilizing soporific, anticonvulsant action to the removal ovary mice, and increase also has the obvious suppression effect to old female mice voluntary activity.
(3) result of the test that influences to " deficiency of YIN " animal performance shows, climacteric benefit capsule can obviously improve the body weight of " deficiency of YIN " mice, and the increase of " deficiency of YIN " mice voluntary activity is had significantly obviously reduction effect.And intact animal's volume of perspiration there is the obvious suppression effect.
Compared with prior art, Chinese medicine preparation of the present invention has significantly and effects a permanent cure, calm, anticonvulsant action, it is a kind of new Chinese medicine that is used for the climacteric syndrome treatment of heart deficiency of the kidney yin, heart kidney yin deficient syndrome seen have a dizzy spell, hectic fever night sweat, feverish sensation in the palms and soles, irritable emotion, irritated irritability, dysphoria and insomnia, soreness of the waist and knees, the few tongue of red tongue, thready and rapid pulse etc. have fine therapeutical effect, for providing a kind of new medication, extensive patients selects, its raw material type is few, product quality is easy to control, during prescription is formed, except that Radix seu Herba Gei aleppici, be " medicine commonly used that Chinese pharmacopoeia is contained, aboundresources.Radix seu Herba Gei aleppici is Guizhou Province's Miao Ethnomedicine commonly used, record in " Guizhou Province's Chinese medicine ethnic drug quality standard " 2003 editions, resource is quite abundant, Radix seu Herba Gei aleppici has tonify deficiency QI invigorating, calm function of calming the nerves, be used with Fructus Ligustri Lucidi, Radix Pseudostellariae, Cortex Albiziae three flavor medicines, obvious to the curative effect of climacteric syndrome, and also preparation technology is simple, its cost is relatively low, has bigger market potential.
The specific embodiment
Embodiment 1: the preparation of capsule
Raw material: Fructus Ligustri Lucidi 2000g, Radix Pseudostellariae 600g, Radix seu Herba Gei aleppici 400g, Cortex Albiziae 400g
Preparation method: get Fructus Ligustri Lucidi, add 10 times of amount 85% alcohol reflux 3 times, each 1 hour, filter, filtrate for later use, medicinal residues and Radix Pseudostellariae, Radix seu Herba Gei aleppici and Cortex Albiziae add 8 times of water gagings and decoct 3 times, each 2 hours, merge decoction liquor, filter, filtrate concentrates, and drying is pulverized, sieve, add starch, mixing, encapsulated, make 1000 of capsules, every dress 0.4g.
Usage and dosage: oral, 3 times on the one, one time 3~4.
Embodiment 2: the preparation of tablet
Raw material: Fructus Ligustri Lucidi 1000g, Radix Pseudostellariae 630g, Radix seu Herba Gei aleppici 500g, Cortex Albiziae 480g
Preparation method: get Fructus Ligustri Lucidi, add 8 times of amount 95% alcohol reflux 3 times, each 1 hour, filter, filtrate for later use, medicinal residues and Radix Pseudostellariae, Radix seu Herba Gei aleppici and Cortex Albiziae add 10 times of water gagings and decoct 4 times, each 2 hours, merge decoction liquor, filter, filtrate concentrates, and drying is pulverized, sieve, add adjuvant, mixing, tabletting is made 1000 in tablet.
Usage and dosage: oral, 3 times on the one, one time 3~4.
Embodiment 3: the preparation of drop pill
Raw material: Fructus Ligustri Lucidi 1200g, Radix Pseudostellariae 700g, Radix seu Herba Gei aleppici 470g, Cortex Albiziae 300g
Preparation method: get Fructus Ligustri Lucidi, add 10 times of amount 90% alcohol reflux 2 times, each 1.5 hours, filter filtrate for later use, medicinal residues and Radix Pseudostellariae, Radix seu Herba Gei aleppici and Cortex Albiziae add 6 times of water gagings and decoct 4 times, each 1.5 hours, merge decoction liquor, filter, filtrate concentrates, and technology is made 1000 of drop pill routinely.
Usage and dosage: oral, 3 times on the one, one time 3~4 ball.
Embodiment 4: the preparation of capsule
Raw material: Fructus Ligustri Lucidi 2800g, Radix Pseudostellariae 500g, Radix seu Herba Gei aleppici 300g, Cortex Albiziae 500g
Preparation method: get Fructus Ligustri Lucidi, add 12 times of amount 85% alcohol reflux 4 times, each 0.5 hour, filter, filtrate for later use, medicinal residues and Radix Pseudostellariae, Radix seu Herba Gei aleppici and Cortex Albiziae add 10 times of water gagings and decoct 2 times, each 2.5 hours, merge decoction liquor, filter, filtrate concentrates, and drying is pulverized, sieve, add starch, mixing, encapsulated, make 1000 of capsules.
Usage and dosage: oral, 3 times on the one, one time 3~4.
Embodiment 5: the preparation of granule
Raw material: Fructus Ligustri Lucidi 3000g, Radix Pseudostellariae 530g, Radix seu Herba Gei aleppici 320g, Cortex Albiziae 380g
Preparation method: get Fructus Ligustri Lucidi, add 12 times of amount 85% alcohol reflux 4 times, each 1.5 hours, filter, filtrate for later use, medicinal residues and Radix Pseudostellariae, Radix seu Herba Gei aleppici and Cortex Albiziae add 8 times of water gagings and decoct 4 times, each 2 hours, merge decoction liquor, filter, filtrate concentrates, and drying is pulverized, sieve, add starch, mixing, granulate, packing is made 1000 bags of granules.
Usage and dosage: oral, 3 times on the one, one time 3~4 bags.

Claims (6)

1. Chinese medicine preparation for the treatment of the climacteric syndrome of heart deficiency of the kidney yin, it is characterized in that: according to listed as parts by weight, this Chinese medicine preparation is to be prepared from for 300~500 parts by 1000~3000 parts of Fructus Ligustri Lucidi, 500~700 parts of Radix Pseudostellariaes, 300~500 parts of Radix seu Herba Gei aleppici and Cortex Albiziae, preparation method is: get Fructus Ligustri Lucidi, add alcohol reflux, filter, filtrate for later use, medicinal residues and Radix Pseudostellariae, Radix seu Herba Gei aleppici, Cortex Albiziae decoct with water, merge decoction liquor, filter, merge with Fructus Ligustri Lucidi filtrate, concentrate, preparation process is made various dosage forms routinely.
2. according to the Chinese medicine preparation of the climacteric syndrome of the described treatment heart of claim 1 deficiency of the kidney yin, it is characterized in that: according to listed as parts by weight, this Chinese medicine preparation is to be prepared from for 350~450 parts by 1500~2500 parts of Fructus Ligustri Lucidi, 550~650 parts of Radix Pseudostellariaes, 350~450 parts of Radix seu Herba Gei aleppici and Cortex Albiziae.
3. according to the Chinese medicine preparation of the climacteric syndrome of the described treatment heart of claim 2 deficiency of the kidney yin, it is characterized in that: according to listed as parts by weight, this Chinese medicine preparation is to be prepared from for 400 parts by 2000 parts of Fructus Ligustri Lucidi, 600 parts of Radix Pseudostellariaes, 400 parts of Radix seu Herba Gei aleppici and Cortex Albiziae.
4. according to the Chinese medicine preparation of the climacteric syndrome of the described treatment heart of claim 1 deficiency of the kidney yin, it is characterized in that: get Fructus Ligustri Lucidi, add 8~12 times of amount 85~95% alcohol reflux 2~4 times, each 0.5~1.5 hour, filter, filtrate for later use, medicinal residues and Radix Pseudostellariae, Radix seu Herba Gei aleppici and Cortex Albiziae add 6~10 times of water gagings and decoct 2~4 times, each 1.5~2.5 hours, merge decoction liquor, filter, merge with Fructus Ligustri Lucidi filtrate, concentrate, preparation process is made various dosage forms routinely.
5. according to the Chinese medicine preparation of the climacteric syndrome of the described treatment heart of claim 4 deficiency of the kidney yin, it is characterized in that: get Fructus Ligustri Lucidi, add 10 times of amount 85% alcohol reflux 3 times, each 1 hour, filter, filtrate for later use, medicinal residues and Radix Pseudostellariae, Radix seu Herba Gei aleppici and Cortex Albiziae add 8 times of water gagings and decoct 3 times, each 2 hours, merge decoction liquor, filter, merge with Fructus Ligustri Lucidi filtrate, concentrate, preparation process is made various dosage forms routinely.
6. according to the Chinese medicine preparation of the climacteric syndrome of the described treatment heart of claim 5 deficiency of the kidney yin, it is characterized in that: described dosage form is a capsule.
CN2008103037089A 2008-08-13 2008-08-13 Traditional Chinese medicine preparation for treating menopausal syndrome with yin deficiency of heart and kidney and preparation method thereof Active CN101647879B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN2008103037089A CN101647879B (en) 2008-08-13 2008-08-13 Traditional Chinese medicine preparation for treating menopausal syndrome with yin deficiency of heart and kidney and preparation method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN2008103037089A CN101647879B (en) 2008-08-13 2008-08-13 Traditional Chinese medicine preparation for treating menopausal syndrome with yin deficiency of heart and kidney and preparation method thereof

Publications (2)

Publication Number Publication Date
CN101647879A CN101647879A (en) 2010-02-17
CN101647879B true CN101647879B (en) 2011-09-07

Family

ID=41670277

Family Applications (1)

Application Number Title Priority Date Filing Date
CN2008103037089A Active CN101647879B (en) 2008-08-13 2008-08-13 Traditional Chinese medicine preparation for treating menopausal syndrome with yin deficiency of heart and kidney and preparation method thereof

Country Status (1)

Country Link
CN (1) CN101647879B (en)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1468614A (en) * 2002-07-15 2004-01-21 深圳清华现代中医药科技有限公司 Chinese medicine composition for treatnig female's climacteric syndrome and its prepn process
CN1903314A (en) * 2006-08-04 2007-01-31 兰玉岐 Traditional Chinese medicine composition for treating head-ache, ahypnia, palpitate and feeble, and its prepn. method
CN101129736A (en) * 2007-09-24 2008-02-27 北京艺信堂医药研究所 Traditional Chinese medicine composition for treating climacteric syndrome

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1468614A (en) * 2002-07-15 2004-01-21 深圳清华现代中医药科技有限公司 Chinese medicine composition for treatnig female's climacteric syndrome and its prepn process
CN1903314A (en) * 2006-08-04 2007-01-31 兰玉岐 Traditional Chinese medicine composition for treating head-ache, ahypnia, palpitate and feeble, and its prepn. method
CN101129736A (en) * 2007-09-24 2008-02-27 北京艺信堂医药研究所 Traditional Chinese medicine composition for treating climacteric syndrome

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
李春英.更年期综合征的中医治疗.《中国中医基础医学杂志》.2002,第8卷(第10期),57,62. *
王立凤."滋肾清心汤"治疗更年期综合征40例.《江苏中医》.1999,第20卷(第3期),30.

Also Published As

Publication number Publication date
CN101647879A (en) 2010-02-17

Similar Documents

Publication Publication Date Title
CN104771563B (en) The compound Chinese medicinal preparation and preparation method of a kind of kidney tonifying
CN100586462C (en) Granular formulation, tablet or capsule of black-bone chicken and white phoenix and method of preparing the same
CN103372197B (en) Composition for preventing and treating female climacteric syndrome and preparation method thereof
CN102120015A (en) Traditional Chinese medicine for soothing liver and dispersing depressed vital energy and soothing nerves and sedating mind, and preparation method and quality standard thereof
CN103301201B (en) Chinese herbal compound for improving auxiliary anti-tumor of immunity
CN102120020B (en) Medicinal composition for treating hyperplastic diseases of breast and hysteromyoma and preparation method thereof
CN101269170B (en) Medicament for treating climacteric syndrome and preparation method thereof
CN100423766C (en) Chinese medicine composition for treatnig female's climacteric syndrome and its prepn process
CN101972465B (en) Medicinal preparation for treating primary dysmenorrhea and preparation method thereof
CN101822743A (en) Medicine for treating inflammation of female reproductive system and preparation and quality control method thereof
CN104189349A (en) Traditional Chinese medicine composition for treating oligomenorrhea
CN107569612A (en) A kind of medicine for improving sleep and preparation method thereof
CN100408059C (en) Heat-clearing effervescence tablet for infants and its preparing method
CN102048913B (en) Traditional Chinese medicine preparation for treating climacteric syndrome and preparation method thereof
CN1768820A (en) Dysmenorrhea treating pharmaceutical formulation and preparation method thereof
CN102600418A (en) Medicinal composition for treating female climacteric syndrome, and preparation method thereof
CN101647879B (en) Traditional Chinese medicine preparation for treating menopausal syndrome with yin deficiency of heart and kidney and preparation method thereof
CN101461894A (en) Medicament composition for treating female climacteric syndrome and delaying age
CN105250556A (en) Traditional Chinese medicine drug for treating polycystic ovarian syndrome
CN102846849B (en) Traditional Chinese medicine composition for resisting ovarian failure and application thereof
CN102198251B (en) Chinese medicinal composition for treating climacteric syndrome and preparation method thereof
CN102349956B (en) Compound extract for moisturizeing pathogenic dryness and relieving itching and preparation thereof
CN101816747B (en) Medicinal preparation for preventing and treating mental diseases such as insomnia and the like and preparation method thereof
CN100518780C (en) Preparation for treating hysteromyoma and its preparation method
CN103893676B (en) The preparation technology of a kind of Chinese medicine composition treating primary dysmenorrhoea

Legal Events

Date Code Title Description
PB01 Publication
C06 Publication
SE01 Entry into force of request for substantive examination
C10 Entry into substantive examination
GR01 Patent grant
C14 Grant of patent or utility model
TR01 Transfer of patent right

Effective date of registration: 20190513

Address after: 561000 Guizhou Province Anshun Xixiu District Economic and Technological Development Zone Xihang Avenue Guizhou Bailing Enterprise Group Pharmaceutical Co., Ltd.

Patentee after: Guizhou Bailing Group Pharmacy Co., Ltd.

Address before: 550002 No. 50 East Road, Guiyang City, Guizhou Province

Patentee before: Guiyang College of Traditional Chinese Medicine

TR01 Transfer of patent right