CN101461894B - Medicament composition for treating female climacteric syndrome and delaying age - Google Patents
Medicament composition for treating female climacteric syndrome and delaying age Download PDFInfo
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Abstract
The invention discloses a pharmaceutical composition for treating female climacteric syndrome and delaying senility. The pharmaceutical composition is prepared from epimedium, glossy privet fruit, fragrant solomonseal rhizome, black bean, flower of Chinese scholartree, gen-seng, mulberry, raspberry, donkey-hide gelatin, and cordyceps. The raw material drugs are added with the prior auxiliary material, and are prepared into various clinically acceptable dosage forms by the prior process, such as capsule, granule, tablet, oral liquid preparation, water injection or dry powder injection. The invention also provides application of the pharmaceutical composition to prepare medicaments for treating the female climacteric syndrome and delaying the senility, enhancing immune function, and increasing bone density.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, particularly a kind of pharmaceutical composition for the treatment of female dimacteric syndrome and slow down aging, enhancing immunity, bone density improving.
Background technology
After the women enters into the climacteric period, occur easily with hectic fever, hyperhidrosis, cardiopalmus, unstable blood pressure, dizziness, tinnitus, irritability, insomnia, forgetful, constipation, symptom such as tired, be referred to as climacteric syndrome.The sickness rate of diseases such as osteoporosis, blood fat rising, atherosclerotic, diabetes, coronary heart disease and apoplexy also obviously raises in addition.Because these, associated conditions caused estrogen secretion minimizing closely related with the ovarian function decline climacteric, therefore, western medical treatment mainly is a complementing estrogen.This " hormone replacement therapy " be extensive use more than 30 year so far, can effectively improve some symptoms of climacteric syndrome, but life-time service may increase breast carcinoma and onset of endometrial cancer rate.
Chinese medicine is generally pressed sick category such as the traditional Chinese medical science " menopausal syndrome ", " hysteria ", " melancholia " to the research of Women, carry out Study of pathogenesis, clinically, take determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs more, add and subtract with card, comprehensive each family's report, each family gives priority to, and has from the kidney opinion to control, and adopts LIUWEI DIHUANG WAN, ZHIBAI DIHUANG WAN, Yougui Wan, the kidney-Yang-Reinforcing Bolus, ERXIAN TANG more; Control from the liver opinion, adopt Sini San and ERZHI WAN, bupleurum powder for relieving liver-qi, Danzhi Xiaoyao San, YIGUANJIAN etc. to change sanction more; Control from the spleen opinion, adopt five tastes Yigong San powder with marveous Effect, tonifying the spleen drink, Fuzi Lizhong Wan etc. more; Control from the lung opinion, adopt baihe gujin decoction, Radix Glycyrrhizae Rhizoma Zingiberis soup, the BUFEI TANG side of closing plus-minus more; Control from heart opinion, adopt mind-easing tonic bolus with arborvitate seed more; The five internal organs combination of syndromes opinion is controlled, and adopts LIUWEI DIHUANG WAN more, YIGUANJIAN, Yougui Wan, the kidney-Yang-Reinforcing Bolus, the safe ball of friendship, GUIPI TANG, XIAOYAO POWDER etc.These add and subtract medication, the effect of the clinical climacteric syndrome that has clear improvement, but individuation is strong, is difficult for the scientific research of standardization, so that the judgement that affects the treatment.
At present, domestic many medical colleges have carried out positive explore research, many achievements are introduced to the market as Chinese patent medicine, as the climacteric health of GENGNIANAN coated tablet, the production of White Cloud Mountain, Guangzhou pharmaceutical factory, the loyal granule in ground that lobe ZHENHELING PIAN, Hunan Province medical university are given birth to by Chinese medicine three factories in Shanghai City city.Yu Zhimin pushes away a piece of writing, deficiency of the kidney yin type climactero tablet, woman's Yiganning capsule, climacteric Menstruation-Regulating Capsule sheet; Kidney yang deficiency syndrome is suitable for climacteric and finds pleasure in, joins stilbene Hydrargyri Oxydum Rubrum sheet, Herba Cistanches the kidney invigorating ball.Pacify hectic fever sweating, insomnia and dreamful sleep, the susceptible to lose temper due to restlessness of year climacteric sheet to climacteric syndrome, dizziness headache, hypomnesis and blood pressure balance etc. has obvious curative effects.Jin Xiangshu etc. transfer liver soup comprehensive 65 examples of treatment climacteric with nourishing kidney, Zhang Xinyong the kidney invigorating soup treatment primary disease 53 examples that nourish heart.
Summary of the invention
The object of the invention is to provide a kind of pharmaceutical composition, and another purpose of the present invention is to provide the purposes of this pharmaceutical composition.
The present invention seeks to be achieved through the following technical solutions
The crude drug of pharmaceutical composition of the present invention consists of:
Herba Epimedii 15-35 weight portion Fructus Ligustri Lucidi 10-20 weight portion Rhizoma Polygonati Odorati 5-15 weight portion
Semen sojae atricolor 5-15 weight portion Flos Sophorae 5-15 weight portion Fructus Mori 5-15 weight portion
Fructus Rubi 5-15 weight portion Radix Panacis Quinquefolii 1-5 weight portion Colla Corii Asini 2-9 weight portion
Cordyceps 1-5 weight portion.
Above-mentioned raw materials medicine preferred weight proportioning is as follows:
Herba Epimedii 25 weight portion Fructus Ligustri Lucidi 15 weight portion Rhizoma Polygonati Odorati 10 weight portions
Semen sojae atricolor 10 weight portion Flos Sophoraes 10 weight portion Radix Panacis Quinquefoliis 2.5 weight portions
Fructus Mori 10 weight portion Fructus Rubies 10 weight portion Colla Corii Asini 5 weight portions
Cordyceps 2.5 weight portions.
Above-mentioned raw materials medicine preferred weight proportioning is as follows:
Herba Epimedii 16 weight portion Fructus Ligustri Lucidi 18 weight portion Rhizoma Polygonati Odorati 6 weight portions
Semen sojae atricolor 13 weight portion Flos Sophoraes 7 weight portion Fructus Moris 14 weight portions
Fructus Rubi 8 weight portion Radix Panacis Quinquefoliis 4 weight portion Colla Corii Asini 3 weight portions
Cordyceps 4.5 weight portions.
Above-mentioned raw materials medicine preferred weight proportioning is as follows:
Herba Epimedii 32 weight portion Fructus Ligustri Lucidi 12 weight portion Rhizoma Polygonati Odorati 14 weight portions
Semen sojae atricolor 7 weight portion Flos Sophoraes 12 weight portion Fructus Moris 6 weight portions
Fructus Rubi 13 weight portion Radix Panacis Quinquefoliis 2 weight portion Colla Corii Asini 8 weight portions
Cordyceps 1.5 weight portions.
Get pharmaceutical composition above-mentioned raw materials medicine of the present invention, add conventional adjuvant, be prepared into clinical acceptable various dosage forms according to common process, as: capsule, granule, tablet, oral liquid, aqueous injection or lyophilized injectable powder.
Pharmaceutical composition of the present invention is a kind of based on the Chinese medicine the kidney invigorating, be used for Women, it is characterized in that having " integration of edible and medicinal herbs ", " control synchronously " pure Chinese medicine compound, improving the Women health quality, improve Women syndrome, osteoporosis, raising immunologic function, defying age, improving the equal tool in cardiovascular function aspect and significantly act on.Drug combination preparation of the present invention has that consumption is little, active ingredient is high, it is safe, with strong points to take, suitable crowd characteristics widely.
Pharmaceutical composition of the present invention is according to the theory of the original medical science-Chinese medicine and pharmacy of China: " the kidney invigorating gas benefit natural life-span ", " the food medicine in like manner ", " kidney governing reproduction ", " kidney governing bones ", " kidney storing essence, secrete menses ", theory, the nourishing YIN with the kidney invigorating gas, support essence and blood to contain sun, reach " YIN and YANG in a relative equilibrium; spirit and even ", thereby improve environment in the climacteric physiology, reach raising and improve Women syndrome, osteoporosis, raising immunologic function, defying age, improve cardiovascular function.This research experiment and the clinical matched group of all establishing, wherein with the comparative study of HRT method, it acts on suitable and asexual hormone side effect.
Experimentation shows that pharmaceutical composition of the present invention can improve thymus body weight ratio, the half hemolysis value of mice, and the NK cells in mice determination of activity is the positive as a result, has the function of enhancing immunity and has the effect that increases the rat bone density function.
Following experimental example and embodiment are used to further specify but are not limited to the present invention.
Experimental example 1 pharmaceutical composition raise immunity of the present invention zoopery
Medicament composition capsule preparation of the present invention is the capsule of interior dress sepia powder content.Room temperature is preserved, and uses for experiment.
Select for use the healthy ICR mice of SPF level as laboratory animal, wherein the 19.4-21.9g female mice is 60, is divided into 4 groups, 15 every group, as immune I group, carry out organ weight ratio pH-value determination pH, delayed allergy experiment, Turnover of Mouse Peritoneal Macrophages and engulf chicken red blood cell experiment, half hemolysis value (HC
50) mensuration and the mensuration of antibody-producting cell number; 18.1 60 of～19.7g female mices are divided into 4 groups, 15 every group, as immune II group, carry out carbon and clean up experiment; 18.0-18.9g 60 of female mices are divided into 4 groups, 15 every group, as immune III group, carry out inductive mouse lymphocyte transformation experiment of ConA and NK cytoactive and measure.
1.1 the dosage group selection with tried thing and given mode:
Everyone (pressing the 60kg weighing machine) 2.1g every day of recommended dose pharmaceutical composition of the present invention is equivalent to 0.035g/kg BW.10 times of human body recommended amounts are established in experiment, promptly every day 0.350g/kg BW, a upper and lower dosage group: 1.050g/kg BW (30 times) and the 0.035g/kg BW (1 times) of respectively establishing.Sample is prepared with disinfectant, and 0.000g/kg BW dosage group replaces being tried thing with disinfectant.Experiment mice is with outbreeding system mice PP Pipe Compound feed, and per os is irritated stomach once a day and given mice and tried thing, gives continuously to survey every index behind the 30d.The mouse stomach amount is 30mL/kg BW.
1.2 key instrument and reagent:
Animal balance, electronic balance, clean bench, CO2 gas incubator, centrifuge, 721 spectrophotometers, water bath with thermostatic control, microplate reader, microscope etc.
Aseptic operation apparatus, slide gauge (precision 0.01mm), microsyringe, cell counter, the flat Tissue Culture Plate in 24 holes and 96 holes, 96 hole U type Tissue Culture Plates, 96 hole enzyme mark microwell plates, glass dish, gauze, test tube, slide frame, timer, hematochrome suction pipe, microscope slide etc.
Sheep red blood cell (SRBC) (SRBC), normal saline, Hank ' s liquid (pH7.2-7.4), the RPMI1640 culture fluid, your pupil's serum, mycillin, concanavalin A, Con A (ConA), 1% glacial acetic acid, the HCI solution of 1mol/L, acid isopropyl alcohol (the 96mL isopropyl alcohol adds the HCl solution 4ml of 1mol/L), MTT, PBS buffer (pH7.2-7.4), complement (guinea pig serum), the SA buffer, agarose, Dou Shi reagent (sodium bicarbonate 1.0g, high-potassium ferricyanide 0.2g, potassium cyanide 0.05g, adding distil water is to 1000mL), the YAC-1 cell, sodium lactate, the nitro tetrazolium chloride, azophenlyene dimethyl ester sulfate, oxidized form of nicotinamide-adenine dinucleotide, 0.2moI/L Tris-HCl buffer (PH8.2), 2.5%Triton, india ink, 0.1%Na
2CO
3, chicken red blood cell, methanol, Giemsa dye liquor etc.
1.3 experimental technique:
1.3.1 the mensuration of organ weight ratio value
Dislocation was put to death after mice was weighed, and got spleen and thymus, removed most fascia, blotted the organ surface blood stains with filter paper, weighed, and calculated thymus body weight ratio.
1.3.2 half hemolysis value (HC
50) mensuration
Get Sanguis caprae seu ovis.Normal saline washing 3 times, every Mus carries out immunity through lumbar injection 2% (v/v prepares with normal saline) hematocrit SRBC 0.2mL.Behind the 5d, extract eyeball and get blood in centrifuge tube, place about 1h, solidification blood and tube wall are peeled off, serum is fully separated out, the centrifugal 4min of 6000rpm collects serum., get 1mL and put in vitro 400 times of serum dilutions with the SA buffer, add 10% (v/v is with the preparation of SA buffer) hematocrit SRBC 0.5mL successively, complement 1mL (pressing dilution in 1: 8) with the SA buffer.Other establishes the not control tube of increase serum (replacing with the SA buffer).After putting in 37 ℃ of waters bath with thermostatic control insulation 15min, the ice bath cessation reaction.The centrifugal 10min of 2000rpm gets supernatant 1mL, adds Dou Shi reagent 3mL.The get 10% simultaneously hematocrit SRBC 0.25mL of (v/v is with the preparation of SA buffer), add Dou Shi reagent to 4mL in another test tube, abundant mixing, place 10min after, sentence control tube in 540nm and do blankly, measure respectively and respectively manage optical density value.The amount of hemolysin is with half hemolysis value (HC
50) expression, the gained data are measurement data, if the half hemolysis value that is tried the thing group organizes apparently higher than 0.000g/kg BW, and difference has significance (P＜0.05), and this is tried the effect that thing has the half hemolysis value that improves mice decidable.
1.3.3NK the mensuration of cytoactive (lactate dehydrogenase L DH algoscopy)
24h washes target cell YAC-1 cultivations of going down to posterity 3 times with Hank ' s liquid before using before the experiment, and using the RPMI1640 complete culture solution adjustment cell concentration that contains 10% calf serum is 4 * 10
5Individual/mL.Tried the dislocation of mice cervical vertebra and put to death, the aseptic spleen of getting is made splenocyte suspension, uses Hank ' s liquid to wash 2 times, each centrifugal 10min (1000r/min).After the splitting erythrocyte, it is resuspended that reuse 1mL contains RPMI 1640 complete culture solutions of 10% calf serum, living cell counting number (should more than 95%), and adjusting cell concentration is 2 * 10
7Individual mL, making and imitating the target ratio is 50: 1.Get each 100 μ L of target cell and effector lymphocyte, add in U-shaped 96 well culture plates; Target cell nature release aperture adds target cell and each 100 μ L of culture fluid, and the maximum release aperture of target cell adds target cell and each 100 μ L of 2.5%Triton; Above-mentioned every three parallel holes, 37 ℃, 5%CO of all establishing
2Cultivate 4h in the incubator, with 96 orifice plates with the centrifugal 5min of 1500rpm, every hole is drawn supernatant 100 μ L and is put in the 96 hole ELISA Plate, add LDH substrate liquid 100 μ L, reaction 10min, every then hole adds the HCl solution 30 μ L cessation reactions of 1mol/L, surveys the OD value at microplate reader 490nm place, and the NK cytoactive is calculated as follows:
The preparation of NK%=(reacting hole OD-nature release aperture OD)/(maximum release aperture OD-nature release aperture OD) * 100LDH substrate liquid: sodium lactate 5 * 10
-2Mol/L
Nitro tetrazolium chloride 6.6 * 10
-4Mol/L
Azophenlyene dimethyl ester sulfate 2.8 * 10
-4Mol/L
Oxidized form of nicotinamide-adenine dinucleotide 1.3 * 10
-3Mol/L
Mentioned reagent is dissolved in the Tris-HCI buffer of 0.2mol/L (pH8.2)
The gained data are measurement data, if the NK cytoactive of being tried the thing group organizes apparently higher than 0.000g/kg BW, and difference has significance (p＜0.05), and this is tried the ability that thing improves NK cells in mice decidable.
1.4 experimental result
1.4.1 medicament composition capsule preparation of the present invention is to the influence of mice internal organs body weight
Table 1 medicament composition capsule preparation of the present invention to the influence of mouse thymus body weight ratio (
± SD)
| Dosage group (g/kg BW) | Number of animals (only) | Thymus body weight ratio (mg/g) | The P value |
| 0.000 0.035 0.350 1.050 | 15 15 15 15 | 2.46±0.63 3.02±0.52* 2.90±0.60 2.54±0.80 | 0.021 0.068 0.746 |
*P＜0.05
Per os gives medicament composition capsule preparation of the present invention (being made by the embodiment 1) 30d of mice various dose, after initial data carries out homogeneity test of variance, meet the neat requirement of variance, carry out statistical disposition with the comparative approach in twos of mean between one factor analysis of variance method and a plurality of experimental group and matched group.By table 1 as seen, relatively, difference has significance (p＜0.05) between 0.035g/kg BW group and 0.000g/kg BW group.Relatively, there are no significant for difference (p＞0.05) between all the other each dosage groups and 0.000g/kg BW group.Be that medicament composition capsule preparation of the present invention can improve the thymus body weight ratio of mice in 0.035g/kg BW group.
1.4.2 medicament composition capsule preparation of the present invention is to the influence of mouse humoral immune function
Table 2 medicament composition capsule preparation of the present invention is to mice half hemolysis value (HC
50) influence (
± SD)
| Dosage group (g/kg BW) | Number of animals (only) | Half hemolysis value | The P value |
| 0.000 0.035 0.350 1.050 | 12 14 15 15 | 368±129 521±133** 492±145* 431±147 | 0.007 0.026 0.252 |
*p＜0.05 **P＜0.01
Per os gives the medicament composition capsule preparation 30d of the present invention of mice various dose, (making) by embodiment 1, after initial data carries out homogeneity test of variance, meet the neat requirement of variance, carry out statistical disposition with the comparative approach in twos of mean between one factor analysis of variance method and a plurality of experimental group and matched group.By table 2 as seen, between 0.035g/kg BW group and 0.000g/kg BW group, compare, difference has utmost point significance (P＜0.01), between 0.350g/kg BW group and 0.000g/kg BW group, compare, difference has significance (P＜0.05), relatively, difference does not have significance (P＞0.05) between d 1.050g/kg BW group and 0.000g/kg BW group.Be that medicament composition capsule preparation of the present invention all can improve the half hemolysis value of mice in 0.035g/kg BW group, 0.350g/kg BW group.
By table 2 as seen, the medicament composition capsule preparation mouse humoral immune functional examination of the present invention positive as a result.
1.4.3 medicament composition capsule preparation of the present invention is to the active influence of NK cells in mice
Table 3 medicament composition capsule preparation of the present invention to the active influence of NK cells in mice (
± SD)
| Dosage group (g/kg BW) | Number of animals (only) | NK cytoactive (%) | NK cytoactive square root arcsine conversion value | The P value |
| 0.000 0.035 0.350 1.050 | 14 13 15 14 | 44.6±8.0 52.6±10.0 52.4±9.9 50.1±8.7 | 41.9±4.7 46.5±5.9* 46.5±6.1* 45.4±5.0 | 0.031 0.026 0.092 |
P＜0.05
Be medicament composition capsule preparation of the present invention (being made by embodiment 2), all can improve the NK cytoactive of mice in 0.035g/kg BW group, 0.350g/kg BW group, i.e. NK cells in mice determination of activity is the positive as a result.
1.5 experiment brief summary
Per os gives the medicament composition capsule preparation 30d of the present invention of mice various dose, can improve mouse thymus body weight ratio, and the humoral immune function of mice, NK cytoactive measurement result are all positive.This shows that pharmaceutical composition of the present invention has the function of enhancing immunity.
Experimental example 2 pharmaceutical composition bone density improving of the present invention zooperies
Pharmaceutical composition of the present invention, human body recommended amounts are 0.035g/kg BW (by adult 60kg).Basic, normal, high three dosage of rat are respectively 0.175,0.350,1.050g/kg.BW, are equivalent to 5,10,30 times of human body recommended amounts, and the sample prescription does not add calcium, thus each group of this experiment all with every day 10ml/kg.BW irritate the amount of feeding and tried thing.
2.1 laboratory animal
Select female Wistar rats for use, about body weight 280g, get the back adaptability and fed 3 days.
2.2 key instrument and reagent
Operating scissors, mosquito forceps, needle holder, sewing needle, stitching thread, scalpel, ophthalmology tweezer; Irritate stomach pin, syringe, electronic balance (0.1g), ruler, slide gauge, electronic balance (0.0001g, FISHER), LG100B convulsion drying baker, SD-1000 type bone mineral measuring instrument, AA200 type atomic absorption spectrophotometer.Dehydrated alcohol, iodine tincture, pentobarbital sodium, Alendronate sodium sheet, GBW08551-2004 calcium constituent titer (national standard material center), lanthana, perchloric acid, nitric acid.
2.3 experimental technique
2.3.1 oophorectomize
Rat carries out bilateral oophorectomy with 30mg/kg.BW lumbar injection pentobarbital sodium solution after the anesthesia, the penicillin of postoperative intramuscular injection 20,000 units, for three days on end.Sham operated rats is opened the fat that only excises behind the abdominal cavity about 0.5g, keeps bilateral ovaries.
2.3.2 feedstuff preparation
Prepare the feedstuff that does not contain the estrogen activity composition voluntarily with reference to U.S. nutrient research institute (AIN) semi-finished product feed formula and experimental rat full nutrition feed national standard (GB14924-94).
2.3.3 animal grouping
Female Wistar rats is divided into sham operated rats, model control group, positive controls and pharmaceutical composition of the present invention at random by body weight, low dose group, middle dosage group and high dose group, every group of 10 rats.Postoperative began to be tried thing on the 3rd day, sham operated rats and model control group are irritated stomach with deionized water, the positive controls per os gives the alendronate of 1.0mg/kg.BW, the basic, normal, high dosage group of pharmaceutical composition of the present invention respectively per os give 0.175,0.350,1.050g/kg.BW tried thing, respectively organize the rat oral gavage amount and be 10ml/kg.BW every day.The all single cage of every rat of experimental session is raised, and feed self-control feedstuff is freely drunk deionized water, and experiment periods is three months.
2.3.4.1 femur dry weight and length measurment
Last is put to death rat after irritating stomach 24h, peels off the right side femur rapidly, removes muscle and soft tissue, with its length of vernier caliper measurement.Femur is placed 105 ℃ of baking 48h, use ten thousand/electronic balance weighing femur dry weight thereafter, continue baking 2h again, weighing femur dry weight once more, twice difference is heavy less than 0.3mg, can think to reach constant weight.
2.3.4.2 bone densitometry
After the femur of removal soft tissue is baked to constant weight, under identical conditions, utilize and measure femur mid point and metaphyseal bone mineral content (BMC) and bone density (BW) respectively, be calculated as follows the bone density (BMD) of each measuring point through the SD-1000 of standard bone model calibration type bone mineral measuring instrument:
Twice of every some replication.
2.3.4.3 bone calcium is measured
Measure according to State Standard of the People's Republic of China GB/T5009.92-2003.The femur of oven dry is put into digestive tube, add 10ml mixed acid (nitric acid 4: perchloric acid 1), spend the night, put into the digestion of self-controlling electrothermal digestive appartus next day; Postdigestive sample solution quantitatively shifts and is settled to 10.0ml with deionized water after catching up with acid; Add 2% lanthana solution dilution.With GBWO8551-2004. calcium constituent titer with 2% lanthana solution dilution to 0.0,1.0,2.0,3.0,4.0 and 5.0 μ g/ml standard series.With the calcium concentration of AA200 type atomic absorption spectrophotometer in 422.7nm place each standard pipe of mensuration and sample cell, be calculated as follows calcium content of bone:
In the formula: C, CO_-are respectively sample and the calcium concentration in the blank solution (mg/L) that records; V-sample constant volume (ml); The B-extension rate; M-bone sample dry weight (g).
2.4 experimental result
2.4.1 pharmaceutical composition of the present invention is to rat femur dry weight and the long influence of bone
Table 4 pharmaceutical composition of the present invention is to rat femur dry weight and the long influence of bone
| Group | Animal (only) | Dry weight (g) | Bone long (cm) |
| Dosage group high dose group positive controls in the sham operated rats model control group low dose group | 10 10 10 10 10 10 | 0.570±0.025 0.519±0.042 0.550±0.041 0.552±0.032 0.559±0.027 0.570±0.026 | 3.57±0.06 3.55±0.09 3.55±0.05 3.54±0.09 3.57±0.06 3.58±0.07 |
Relatively compare #P＜0.05, ##P＜0.01 with model control group in * * P＜0.01 with sham operated rats
By table 4 as seen, model control group rat femur dry weight and sham operated rats relatively have remarkable reduction, and the difference (P＜0.01) on the statistics is arranged; Positive controls and model control group comparison femur dry weight have increase, and significant difference (P＜0.01) is arranged; Basic, normal, high dosage group femur dry weight of pharmaceutical composition of the present invention (being made by embodiment 3) and model control group relatively have significant difference (P＜0.05 or P＜0.01), and each dosage group rat femur length does not have significant difference (P＞0.05).
2.4.2 pharmaceutical composition of the present invention is to the influence of rat bone mineral content (BMC) bone density (BMD)
Table 5 pharmaceutical composition of the present invention is to the influence of rat femur mid point and femur metaphysis bone mineral content (BMC) and bone density (BMD)
| Group | Mid point | The BMC dry end | Mid point | The BMD dry end |
| Dosage group high dose group positive controls in the sham operated rats model control group low dose group | 0.106±0.013 0.091±0.007 0.100±0.012 0.103±0.015 0.106±0.008 0.108±0.010 | 0.239±0.023 0.197±0.030 0.213±0.028 0.226±0.020 0.231±0.024 0.238±0.026 | 0.372±0.054 0.311±0.025 0.337±0.050 0.354±0.051 0.375±0.059 0.374±0.030 | 0.470±0.035 0.406±0.048 0.443±0.046 0.459±0.035 0.467±0.057 0.462±0.030 |
Compare * * P＜0.01 with sham operated rats; Compare #P＜0.05 with model control group; ##P＜0.01
By table 5 as seen, there were significant differences (P＜0.01) with the model control group ratio for sham operated rats rat femur mid point and femur metaphysis bone density (BMD), bone mineral content (BMC); Relatively there were significant differences (P＜0.01) with model control group for positive controls rat femur mid point and femur metaphysis bone density (BMD), bone mineral content (BMC); Relatively there were significant differences (P＜0.05 or P＜0.01) with model control group for middle and high dosage group rat femur mid point of pharmaceutical composition of the present invention (being made by embodiment 4) and femur metaphysis bone density (BMD), bone mineral content (BMC).
2.4.3 pharmaceutical composition of the present invention is to the influence of rat bone calcium content
Table 6 pharmaceutical composition of the present invention is to the influence of rat bone calcium content
| Group | Dosage (g/kg.BW) | Animal (only) | Calcium content of bone (mg/g) |
| Dosage group high dose group positive controls in the sham operated rats model control group low dose group | 0.000 0.000 0.175 0.350 1.050 0.001 | 10 10 10 10 10 10 | 296.9±41.5 237.9±26.8 264.6±48.6 279.8±35.4 386.3±47.5 291.2±34.3 |
Relatively compare #P＜0.05, ##P＜0.01 with model control group in * * P＜0.01 with sham operated rats
By table 6 as seen, relatively there were significant differences (P＜0.01) for sham operated rats rat bone calcium content and model control group, the middle and high dosage group rat bone calcium content of positive controls and pharmaceutical composition of the present invention (being made by embodiment 1) and model control group comparison there were significant differences property (P＜0.05 or P＜0.01).
2.5 experiment brief summary
The pharmaceutical composition experimental result of the present invention that oral administration gives various dose shows, model control group rat femur dry weight and sham operated rats relatively have remarkable reduction, and have difference (P＜0.01) positive controls and model control group comparison femur dry weight on the statistics that increase is arranged, and significant difference (P＜0.01) is arranged; The basic, normal, high dosage group of pharmaceutical composition of the present invention femur dry weight and model control group relatively have dominance difference (P＜0.05 or P＜0.01), and each organizes rat femur length does not have significant difference (P＞0.05).There were significant differences (P＜0.01) with the model control group ratio for sham operated rats rat femur mid point and femur metaphysis bone density (BMD), bone mineral content (BMC); Relatively there were significant differences (P＜0.01) with model control group for positive controls rat femur mid point and femur metaphysis bone density (BMD), bone mineral content (BMC); Relatively there were significant differences (P＜0.05 or P＜0.01) with model control group for the middle and high dosage group of pharmaceutical composition of the present invention rat femur mid point and femur metaphysis bone density (BMD), bone mineral content (BMC); Relatively there were significant differences (P＜0.01) for sham operated rats rat bone calcium content and model control group, and positive controls and the middle and high dosage group of pharmaceutical composition of the present invention rat bone calcium content and model control group relatively have significant difference (P＜0.05 or P＜0.01).Therefore pharmaceutical composition of the present invention has the effect that increases the rat bone density function.
Experimental example 3 capsule clinical verifications of the present invention
One, diagnostic criteria:
1. all disease diagnostic criterias before and after the menopause:
Card sees that soreness of the waist and knees, dizzy headache, forgetful cardiopalmus, insomnia are easily waken up, menoxenia, alopecia, poliosis increase, tooth gets loose, tinnitus dim eyesight, hyposexuality, pudendum is dry and astringent, the whole body bone aches or have edema, irritated irritability, skin itching, nape aching, articular instability, throat discomfort, constipation with dry stool, nocturia concurrently increases, warms sweating, these symptoms or be the syndrome person of appearance for a long time or temporarily, the women in age 40-60 year.
2. Western medicine diagnose standard: the perimenopausal syndrome diagnostic criteria that health ministry is issued, and can get rid of due to other disease, age 40-60 year women is diagnosable to be climacteric syndrome.
3. include standard in: the 40-60 year women who meets above-mentioned Chinese and western medicine diagnostic criteria just can include in.
4. exclusion standard: though meet the standard of including in, one of following situation person is arranged, should be excluded in outside this test.
1. suffer from psychosis or nervous system disease person; 2. hyperthyroidism person is arranged; 3. organic cardiovascular disease person; 4. once take sex hormone drug closely over the past half year and comprised contraceptive.
5. rejecting standard: meet and fail to treat on request or the examiner after the standard of including in is participated in test.
Two, test method:
1. trial drug: capsule of the present invention: medicament composition capsule preparation of the present invention is the capsule of interior dress sepia powder content.Cebo-Caps: form by no pharmacological action medical starch and capsule, use as blank.
2. the conventional administration of dividing into groups
3. curative effect determinate standard: 1. cure: the symptom complete obiteration; 2. produce effects: symptom disappears substantially; 3. effective: symptom obviously alleviates or takes a turn for the better; 4. invalid: symptom does not have obviously good alleviate or poorer; Three,
Result of the test
Compare with placebo group, the treatment of Chinese drug-treated group of the present invention all can obviously improve 17 clinical symptoms.In the treatment total effective rate, capsule group of the present invention (is all having statistical significance) to the treatment total effective rate of 17 symptoms wherein more than 84%.Wherein the effective percentage to symptoms such as exciting irritability, depressed suspicious, headache, tinnitus, gastrocnemius spasm and pain, lassitude and weak, osteoarthrosis pain and urine are anxious frequently is 100%; Kupperman scoring total value mean changed and group difference assay demonstration in twos before and after the experimenter took medicine, the Kupperman scoring total value significantly reduction of treatment back of Capsules group of the present invention, and the amplitude of reduction is significantly big than placebo group; The scoring of clinical symptoms determining the pathogenesis of ZANG-FU disease based on the differentiation of symptoms and signs changed and group difference result demonstration in twos before and after the experimenter took medicine, and the dirty dialectical scoring of every traditional Chinese medical science after the Capsules group treatment of the present invention all has remarkable decline; With placebo group relatively, it is the most remarkable that Capsules group of the present invention is improved the suffer from a deficiency of the kidney effect of all disease scorings of each pattern of syndrome, fall is respectively deficiency of the kidney yin, deficiency of kidney-QI, kidney insufficiency.Capsule of the present invention improves the curative effect of all disease scorings of deficiency of kidney-QI obviously than matched group height (P＜0.05).
Following embodiment all can realize the described effect of above-mentioned experimental example.
The specific embodiment
Embodiment 1: the preparation of capsule
Herba Epimedii 25kg Fructus Ligustri Lucidi 15kg Rhizoma Polygonati Odorati 10kg Semen sojae atricolor 10kg
Flos Sophorae 10kg Radix Panacis Quinquefolii 2.5kg Fructus Mori 10kg Fructus Rubi 10kg
Colla Corii Asini 5kg Cordyceps 2.5kg.
Get the above-mentioned raw materials medicine, add conventional adjuvant, make powder and go into capsule according to common process decocting in water, precipitate with ethanol, oven dry pulverizing.
Embodiment 2: the preparation of capsule
Herba Epimedii 16kg Fructus Ligustri Lucidi 18kg Rhizoma Polygonati Odorati 6kg Semen sojae atricolor 13kg
Flos Sophorae 7kg Fructus Mori 14kg Fructus Rubi 8kg Radix Panacis Quinquefolii 4kg
Colla Corii Asini 3kg Cordyceps 4.5kg.
Get the above-mentioned raw materials medicine, add conventional adjuvant, make powder and go into capsule according to common process decocting in water, precipitate with ethanol, oven dry pulverizing.
Embodiment 3: the preparation of capsule
Herba Epimedii 32kg Fructus Ligustri Lucidi 12kg Rhizoma Polygonati Odorati 14kg Semen sojae atricolor 7kg
Flos Sophorae 12kg Fructus Mori 6kg Fructus Rubi 13kg Radix Panacis Quinquefolii 2kg
Colla Corii Asini 8kg Cordyceps 1.5kg.
Get the above-mentioned raw materials medicine, add conventional adjuvant, make powder and go into capsule according to common process decocting in water, precipitate with ethanol, oven dry pulverizing.
Embodiment 4: the preparation of granule
Herba Epimedii 25kg Fructus Ligustri Lucidi 15kg Rhizoma Polygonati Odorati 10kg Semen sojae atricolor 10kg
Flos Sophorae 10kg Radix Panacis Quinquefolii 2.5kg Fructus Mori 10kg Fructus Rubi 10kg
Colla Corii Asini 5kg Cordyceps 2.5kg.
Get the above-mentioned raw materials medicine, add conventional adjuvant, make granule according to common process.
Embodiment 5: the preparation of tablet
Herba Epimedii 16kg Fructus Ligustri Lucidi 18kg Rhizoma Polygonati Odorati 6kg Semen sojae atricolor 13kg
Flos Sophorae 7kg Fructus Mori 14kg Fructus Rubi 8kg Radix Panacis Quinquefolii 4kg
Colla Corii Asini 3kg Cordyceps 4.5kg.
Get the above-mentioned raw materials medicine, add conventional adjuvant, make tablet according to common process.
Embodiment 6: the preparation of oral liquid
Herba Epimedii 32kg Fructus Ligustri Lucidi 12kg Rhizoma Polygonati Odorati 14kg Semen sojae atricolor 7kg
Flos Sophorae 12kg Fructus Mori 6kg Fructus Rubi 13kg Radix Panacis Quinquefolii 2kg
Colla Corii Asini 8kg Cordyceps 1.5kg.
Get the above-mentioned raw materials medicine, add conventional adjuvant, make oral liquid according to common process.
Embodiment 7: the preparation of lyophilized injectable powder
Herba Epimedii 16kg Fructus Ligustri Lucidi 12kg Rhizoma Polygonati Odorati 14kg Semen sojae atricolor 13kg
Flos Sophorae 7kg Fructus Mori 6kg Fructus Rubi 12kg Radix Panacis Quinquefolii 4kg
Colla Corii Asini 3kg Cordyceps 1.5kg.
Get the above-mentioned raw materials medicine, add conventional adjuvant, be prepared into lyophilized injectable powder according to common process.
Embodiment 8: the preparation of capsule
Herba Epimedii 32kg Fructus Ligustri Lucidi 18kg Rhizoma Polygonati Odorati 6kg Semen sojae atricolor 7kg
Flos Sophorae 12kg Fructus Mori 14kg Fructus Rubi 5kg Radix Panacis Quinquefolii 2kg
Colla Corii Asini 8kg Cordyceps 4kg.
Get the above-mentioned raw materials medicine, add conventional adjuvant, make powder and go into capsule according to common process decocting in water, precipitate with ethanol, oven dry pulverizing.
Claims (8)
1. pharmaceutical composition for the treatment of female dimacteric syndrome and slow down aging is characterized in that this pharmaceutical composition crude drug consists of:
Herba Epimedii 15-35 weight portion Fructus Ligustri Lucidi 10-20 weight portion Rhizoma Polygonati Odorati 5-15 weight portion
Semen sojae atricolor 5-15 weight portion Flos Sophorae 5-15 weight portion Fructus Mori 5-15 weight portion
Fructus Rubi 5-15 weight portion Radix Panacis Quinquefolii 1-5 weight portion Colla Corii Asini 2-9 weight portion
Cordyceps 1-5 weight portion.
2. pharmaceutical composition as claimed in claim 1 is characterized in that this pharmaceutical composition crude drug consists of:
Herba Epimedii 25 weight portion Fructus Ligustri Lucidi 15 weight portion Rhizoma Polygonati Odorati 10 weight portions
Semen sojae atricolor 10 weight portion Flos Sophoraes 10 weight portion Radix Panacis Quinquefoliis 2.5 weight portions
Fructus Mori 10 weight portion Fructus Rubies 10 weight portion Colla Corii Asini 5 weight portions
Cordyceps 2.5 weight portions.
3. pharmaceutical composition as claimed in claim 1 is characterized in that this pharmaceutical composition crude drug consists of:
Herba Epimedii 16 weight portion Fructus Ligustri Lucidi 18 weight portion Rhizoma Polygonati Odorati 6 weight portions
Semen sojae atricolor 13 weight portion Flos Sophoraes 7 weight portion Fructus Moris 14 weight portions
Fructus Rubi 8 weight portion Radix Panacis Quinquefoliis 4 weight portion Colla Corii Asini 3 weight portions
Cordyceps 4.5 weight portions.
4. pharmaceutical composition as claimed in claim 1 is characterized in that this pharmaceutical composition crude drug consists of:
Herba Epimedii 32 weight portion Fructus Ligustri Lucidi 12 weight portion Rhizoma Polygonati Odorati 14 weight portions
Semen sojae atricolor 7 weight portion Flos Sophoraes 12 weight portion Fructus Moris 6 weight portions
Fructus Rubi 13 weight portion Radix Panacis Quinquefoliis 2 weight portion Colla Corii Asini 8 weight portions
Cordyceps 1.5 weight portions.
5. as the arbitrary described pharmaceutical composition of claim 1-4, it is characterized in that getting the above-mentioned composition crude drug, add conventional adjuvant,, make capsule, granule, tablet, oral liquid, aqueous injection or lyophilized injectable powder according to common process.
6. as the arbitrary described preparation of drug combination method of claim 1-4, it is characterized in that this method is: get crude drug, add conventional adjuvant,, make capsule, granule, tablet, oral liquid, aqueous injection or lyophilized injectable powder according to common process.
7. as the application of the arbitrary described pharmaceutical composition of claim 1-4 in the medicine of preparation treatment female dimacteric syndrome.
8. has application in slow down aging, enhancing immunity or the bone density improving medicine as the arbitrary described pharmaceutical composition of claim 1-4 in preparation.
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| CN103211868B (en) * | 2013-04-11 | 2016-06-01 | 天津天狮生物发展有限公司 | The composition of a kind of preventing osteoporosis |
| CN103305381A (en) * | 2013-06-24 | 2013-09-18 | 芜湖乐锐思信息咨询有限公司 | Flower-fruit wine and production method thereof |
| CN103520487B (en) * | 2013-10-18 | 2015-10-28 | 湖北凤凰白云山药业有限公司 | A kind of purposes of pharmaceutical composition |
| CN104585756B (en) * | 2014-12-31 | 2016-05-04 | 广州至信中药饮片有限公司 | Five ginseng Chinese caterpillar fungus radix polygonati officinalis lotus seeds herbal cuisine and preparation method thereof |
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| CN1413526A (en) * | 2002-08-16 | 2003-04-30 | 韩雪峰 | Anti-senility health-care beverage and preparation method |
| CN1602950A (en) * | 2004-11-09 | 2005-04-06 | 吴捷 | Pharmaceutical composition for treating climacteric syndrome and its preparing process |
| CN1785346A (en) * | 2004-12-30 | 2006-06-14 | 贵州恒霸药业有限责任公司 | Health protection capsule suitable for climateric woman |
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| CN1413526A (en) * | 2002-08-16 | 2003-04-30 | 韩雪峰 | Anti-senility health-care beverage and preparation method |
| CN1602950A (en) * | 2004-11-09 | 2005-04-06 | 吴捷 | Pharmaceutical composition for treating climacteric syndrome and its preparing process |
| CN1785346A (en) * | 2004-12-30 | 2006-06-14 | 贵州恒霸药业有限责任公司 | Health protection capsule suitable for climateric woman |
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