CN1672723A - A kind of medicine for treating climacteric syndrome and preparation method thereof - Google Patents
A kind of medicine for treating climacteric syndrome and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a medicament for treating climacteric syndrome, the active ingredients of which comprise effective extracts of curculigo orchioides, epimedium, angelica, white peony root, radix bupleuri, achyranthes and poria cocos. The preparation method of the medicine comprises the steps of crushing raw materials for extraction into coarse powder, adding 40-85% ethanol for reflux extraction for 2 times, combining extracting solutions, concentrating, adding hot water into the concentrate, cooling, filtering, concentrating the filtrate, passing the concentrate through a treated adsorption resin column, eluting with pure water until the color of an effluent liquid is light, eluting with an alcohol solution until the color of the effluent liquid is light, collecting the alcohol eluate, recovering the solvent under reduced pressure, concentrating the solvent to be thick paste, and preparing the active ingredients into various oral preparations.
Description
Technical field
The present invention relates to a kind of medicine for the treatment of climacteric syndrome and preparation method thereof, belong to the field of Chinese medicines.
Background technology
The situation of existing like product
Existing like product situation sees Table 1.
Table 1 and the similar Chinese medicinal formulae of curative effect of medication of the present invention
| Title | Prescription is formed | Dosage form | Effect | Range of application |
| The goddess in the moon adds beautiful ball | 10 flavors such as Radix Ginseng, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae | Piller | Tonify Qi of the kidney | Kidney-yang deficiency |
| The vibration source capsule | Total Saponin that fruit of Radix Ginseng extracts | Capsule | Strengthening by means of tonics, raise immunity | Endocrine and autonomic nervous dysfunction |
| FUKANGNING PIAN | 18 flavors such as Radix Ginseng, Fructus Lycii, Radix Angelicae Sinensis, Radix Rehmanniae Preparata | Coated tablet | Reinforcing the kidney and supporting YANG, QI invigorating oxygen blood | Climacteric syndrome |
| ANLE PIAN | 8 flavors such as Radix Bupleuri, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Poria, Ramulus Uncariae Cum Uncis | Coated tablet | Soothing liver-QI for relieving depression, arresting convulsion is calmed the nerves | Climacteric syndrome |
| Moth Siberian cocklebur ball | Female Antherea pernyi Guerin-Meneville moth etc. | Pill | Set upright training unit, spleen-benefiting mind-tranquilizing | The male prostate hypertrophy, climacteric syndrome |
The problem that existing product exists
Existing like product all adopts traditional Chinese medicinal preparation method to make, and fabricating technology falls behind, and invalid removal of impurity is low, total extractum recovery rate height; Be generally greater than 10%, active constituent content is low, and the extractum moisture absorption is strong, and preparation stability is poor; Each dose is big.The present invention uses Debulk to separate and purification technique has been removed invalid component to greatest extent, the smart active component that proposes, and total extractum amount has improved preparation stability greatly below 4%, has reduced each dose.The Debulk technology means by inert matter in the elimination Chinese medicine compound and realizes the method for refining its active component fast.This method is set up the therapeutic evaluation standard of Chinese medicine compound according to modern pharmacology and tcm clinical practice theory, use modern extraction, separation and analytical method and eliminate inert matter, highly enriched active component, thereby make with extra care out the multicomponent that meets theory of Chinese medical science, the synergistic height concentrate of many target spots, utilize this concentrate to can be made into various quality controllable modern Chinese medicine preparations, to demonstrate fully the feature of modern Chinese medicine " three little, triple effect, five convenience ".
Summary of the invention
Purpose of the present invention just provides a kind of medicine of more effective treatment climacteric syndrome, and this clinical drug effect is clearer and more definite than existing similar better drug curative effect, therapeutical effect.
Another object of the present invention provides a kind of manufacturing method for above mentioned medicine, and this method is used modern advanced extraction purification techniques, realizes enrichment and purification to effective ingredient, has improved the quality of the pharmaceutical preparations and stability, has reduced each dosage.
Above-mentioned purpose of the present invention is achieved in that
The medicine that the present invention treats climacteric syndrome is to be made by following bulk drugs: 2～10 parts of Rhizoma Curculiginises, 4～6 parts of Herba Epimedii, 4～6 parts of Radix Angelicae Sinensis, 4～6 parts of Radix Paeoniae Alba, 4～6 parts of Radix Bupleuri, 4～6 parts of Radix Achyranthis Bidentataes, 4～6 parts in Poria.Wherein, the proportioning of preferable crude drug is: 4～6 parts of Rhizoma Curculiginises, 4～6 parts of Herba Epimedii, 4～6 parts of Radix Angelicae Sinensis, 4～6 parts of Radix Paeoniae Alba, 4～6 parts of Radix Bupleuri, 4～6 parts of Radix Achyranthis Bidentataes, 4～6 parts in Poria.
The preparation method of medicine of the present invention is as follows:
Described crude drug is ground into coarse powder, gradation adds 40～85% ethanol of 4～10 times of crude drug, reflux, extract, 2 times, each 1～2 hour, merge extractive liquid,, concentrate, add hot water in the residue and make its dissolving, cooling, filter, concentrated filtrate, the macroporous adsorptive resins (weight ratio of resin and extract=0.5～2: 1), with pure water be eluted to effluent very slight color of concentrate by handling well, continue and be eluted to the effluent very slight color with alcoholic solution, collect alcohol eluen, decompression and solvent recovery also is concentrated into the thick paste shape, promptly gets the active ingredient of medicine of the present invention.
Required various conventional adjuvant when above-mentioned active ingredient is added the preparation different dosage form, as disintegrating agent, lubricant, binding agent etc., be prepared into any peroral dosage form commonly used with the method for Chinese medicinal of routine, as capsule, granule, tablet, pill, oral liquid etc.
Treatment climacteric syndrome medicine provided by the present invention and preparation method thereof has following advantage:
1. in the present invention's prescription, Rhizoma Curculiginis property Xin Ganwen goes into liver, kidney two warps, has the effect in the kidney invigorating Yiyang.The sweet fragrant hot temperature of Herba Epimedii is gone into liver, kidney two warps, has kidney invigorating and YANG supporting, the effect of strengthening the tendons and bones.The hot sweetness and bitterness temperature of Radix Angelicae Sinensis is gone into the heart, liver, spleen three warps, have enrich blood, invigorate blood circulation, moisturize, effect such as laxation.The Radix Paeoniae Alba picric acid is slightly cold, and goes into liver,spleen,kidney three warps, has the effect of yin fluid astringing suppressing the hyperactive liver, regulating blood flow to alleviate pains.Radix Bupleuri is bitter flat to be slightly cold, and goes into liver, gallbladder, pericardium three warps, has reconciliation, brings down a fever, the effect of soothing the liver dissipating depression of QI.The Radix Achyranthis Bidentatae picric acid is flat, goes into liver, kidney three warps, has promoting blood circulation to restore menstrual flow, the effect of the sharp numbness of Shujin.Poria is sweet flat, goes into the heart, lung, kidney, spleen, the stomach Five Classics, has that strengthening the spleen nourishes heart, the effect of promoting diuresis to eliminate damp pathogen.Overall view is the side entirely, and the cold of property of medicine temperature is helped mutually, and flavour of a drug sweetness and bitterness is suitable.Go into through the vital organs of the human body, focus on invigorating kidney qi, spleen invigorating is kept fit.All medicines share, and can alleviate the symptom of Woman climacteric, enhancing human body immunity power.
2. preparation process has adopted the Debulk technology, has improved the purity and the product quality of effective ingredient, has overcome the deficiencies in the prior art, has obtained the medicine of the treatment climacteric syndrome of better efficacy.
Description of drawings
Fig. 1 is the process chart of preparation treatment climacteric syndrome medicine.
The specific embodiment
Below by embodiment the present invention is specifically described, and further set forth the beneficial effect of described medicine.Be necessary to be pointed out that at this present embodiment only is used for the present invention is further specified; can not be interpreted as limiting the scope of the invention, the person skilled in the art in this field can make some nonessential improvement and adjustment according to the content of the invention described above.
Embodiment 1
With raw material Rhizoma Curculiginis 4g, Herba Epimedii 6g, Radix Angelicae Sinensis 5g, Radix Paeoniae Alba 8g, Radix Bupleuri 6g, Radix Achyranthis Bidentatae 4g, Poria 10g is ground into coarse powder, adds 85% ethanol liquid of 4 times of recipe quantities, reflux, extract, 2 times, each 1～2 hour, merge extractive liquid, filtered, concentrate, add the hot water dissolving, cooling filters, concentrated filtrate, residue is added to the D101 type macroporous resin adsorption post of handling well, and (the portions of resin extract weight is than=0.5: 1), it is closely colourless to be eluted to the effluent color with pure water, and continuing, it is closely colourless to be eluted to the effluent color with alcoholic solution, collect ethanol elution, decompression recycling ethanol also is concentrated into the thick paste shape, and vacuum drying obtains solid 1.2g, pulverizes, granulate 2 capsules of packing into.
Embodiment 2
With raw material Rhizoma Curculiginis 2g, Herba Epimedii 1g, Radix Angelicae Sinensis 3g, Radix Paeoniae Alba 2g, Radix Bupleuri 4g, Radix Achyranthis Bidentatae 2g, Poria 8g, be ground into coarse powder, add 60% ethanol liquid of 6 times of recipe quantities, reflux, extract, 2 times, each 2 hours, merge extractive liquid, filters, and concentrates, add the hot water dissolving, cooling filters concentrated filtrate, residue is added to the D101 type macroporous resin adsorption post of handling well, and (the portions of resin extract weight is than=0.5: 1), it is closely colourless to be eluted to the effluent color with pure water, continues that it is closely colourless to be eluted to the effluent color with alcoholic solution, collects ethanol elution, decompression recycling ethanol also is concentrated into the thick paste shape, add starch, sucrose, dextrin is made adjuvant, granulates 2 of compressed tabletses.
Embodiment 3
With raw material Rhizoma Curculiginis 5g, Herba Epimedii 7g, Radix Angelicae Sinensis 1g, Radix Paeoniae Alba 3g, Radix Bupleuri 1g, Radix Achyranthis Bidentatae 4g, Poria 3g, be ground into coarse powder, the 40% ethanol liquid that adds 10 times of recipe quantities, reflux, extract, 2 times, each 1.5 hours, merge extractive liquid,, filter, concentrate, add the hot water dissolving, cooling, filter, concentrated filtrate, residue are added to the D101 type macroporous resin adsorption post of handling well, and (the portions of resin extract weight is than=1.2: 1), it is closely colourless to be eluted to the effluent color with pure water, continuing, it is closely colourless to be eluted to the effluent color with alcoholic solution, collect ethanol elution, decompression recycling ethanol also is concentrated into the thick paste shape, and vacuum drying obtains solid 1.0g, pulverize, add adjuvant, granulate 2 capsules of packing into.
Embodiment 4
With raw material Rhizoma Curculiginis 10g, Herba Epimedii 12g, Radix Angelicae Sinensis 8g, Radix Paeoniae Alba 7g, Radix Bupleuri 10g, Radix Achyranthis Bidentatae 10g, Poria 12g, be ground into coarse powder, add 70% ethanol liquid of 5 times of recipe quantities, reflux, extract, 2 times, each 1 hour, merge extractive liquid, filters, and concentrates, add the hot water dissolving, cooling filters concentrated filtrate, residue is added to the D101 type macroporous resin adsorption post of handling well, and (the portions of resin extract weight is than=1.5: 1), it is closely colourless to be eluted to the effluent color with pure water, continues that it is closely colourless to be eluted to the effluent color with alcoholic solution, collects ethanol elution, decompression recycling ethanol also is concentrated into the thick paste shape, add adjuvant, granulate, granule is distributed into two bags.
Embodiment 5
With raw material Rhizoma Curculiginis 8g, Herba Epimedii 10g, Radix Angelicae Sinensis 12g, Radix Paeoniae Alba 20g, Radix Bupleuri 15g, Radix Achyranthis Bidentatae 5g, Poria 20g, be ground into coarse powder, add 50% ethanol liquid of 8 times of recipe quantities, reflux, extract, 2 times, each 2 hours, merge extractive liquid, filters, and concentrates, add the hot water dissolving, cooling filters concentrated filtrate, residue is added to the D101 type macroporous resin adsorption post of handling well, and (the portions of resin extract weight is than=1.8: 1), it is closely colourless to be eluted to the effluent color with pure water, continues that it is closely colourless to be eluted to the effluent color with alcoholic solution, collects ethanol elution, decompression recycling ethanol also is concentrated into the thick paste shape, add adjuvant, granulate, granule is distributed into two bags.
Embodiment 6
With raw material Rhizoma Curculiginis 6g, Herba Epimedii 4g, Radix Angelicae Sinensis 8g, Radix Paeoniae Alba 4g, Radix Bupleuri 3g, Radix Achyranthis Bidentatae 5g, Poria 8g, be ground into coarse powder, the 80% ethanol liquid that adds 7 times of recipe quantities, reflux, extract, 2 times, each 1.5 hours, merge extractive liquid, filters, and concentrates, add the hot water dissolving, cooling filters concentrated filtrate, residue is added to the D101 type macroporous resin adsorption post of handling well, and (the portions of resin extract weight is than=0.7: 1), it is closely colourless to be eluted to the effluent color with pure water, continues that it is closely colourless to be eluted to the effluent color with alcoholic solution, collects ethanol elution, decompression recycling ethanol also is concentrated into the thick paste shape, vacuum drying obtains solid 1.4g, adds starch, sucrose, dextrin is made adjuvant and is granulated 2 of compressed tabletses.
Embodiment 7
With raw material Rhizoma Curculiginis 3g, Herba Epimedii 5g, Radix Angelicae Sinensis 3g, Radix Paeoniae Alba 10g, Radix Bupleuri 5g, Radix Achyranthis Bidentatae 2g, Poria 15g is ground into coarse powder, adds 70% ethanol liquid of 9 times of recipe quantities, reflux, extract, 2 times, each 2 hours, merge extractive liquid, filtered, concentrate, add the hot water dissolving, cooling filters, concentrated filtrate, residue is added to the D101 type macroporous resin adsorption post of handling well, and (the portions of resin extract weight is than=2: 1), it is closely colourless to be eluted to the effluent color with pure water, and continuing, it is closely colourless to be eluted to the effluent color with alcoholic solution, collect ethanol elution, decompression recycling ethanol also is concentrated into the thick paste shape, and vacuum drying obtains solid 0.8g, pulverizes, granulate 2 capsules of packing into.
Embodiment 8
With raw material Rhizoma Curculiginis 4g, Herba Epimedii 6g, Radix Angelicae Sinensis 4g, Radix Paeoniae Alba 6g, Radix Bupleuri 6g, Radix Achyranthis Bidentatae 6g, Poria 5g is ground into coarse powder, adds 70% ethanol liquid of 9 times of recipe quantities, reflux, extract, 2 times, each 2 hours, merge extractive liquid, filtered, concentrate, add the hot water dissolving, cooling filters, concentrated filtrate, residue is added to the D101 type macroporous resin adsorption post of handling well, and (the portions of resin extract weight is than=2: 1), it is closely colourless to be eluted to the effluent color with pure water, and continuing, it is closely colourless to be eluted to the effluent color with alcoholic solution, collect ethanol elution, decompression recycling ethanol also is concentrated into the thick paste shape, and vacuum drying obtains solid 0.8g, pulverizes, granulate 2 capsules of packing into.
Produce the result as a trial among the embodiment 9
Compatibility raw material with 500 times embodiment 3 carries out pilot scale, and the extractum yield is about 3%, and it is stable to make end product quality, makes 1000 capsules, and each dose is 2 capsules, every day 2 times.
Its result sees table 3 for details.
Table 3 is the pilot-scale experiment of embodiment 3
| Product weight (Kg) | Product yield (%) | |
| First | ????3.0 | ????2.8 |
| Second batch | ????3.0 | ????3.5 |
| The 3rd batch | ????3.0 | ????3.1 |
The pharmacological research of embodiment 10, medicine of the present invention
1. material and method
1.1 sample: the active component pressed powder of the embodiment of the invention 1 gained.
1.2 laboratory animal: select female Wistar rats for use, about body weight 260g, secondary is available from the Chinese Academy of Medical Sciences
Institute of lab animals's breeding field, licence numbering: SCXK11-00-0006 gets the back adaptability and fed 3 days.
1.3 dosage: basic, normal, high three dosage of rat are respectively 210,420,1260mg/kg.bw, are equivalent to 5,10,30 times of human body recommended amounts, tried thing and be diluted to debita spissitudo with pure water by above-mentioned dosage, all with every day 10/kg.bw irritate the stomach amount and give.
1.4 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 (Shanghai City experimental apparatus head factory), SD1000 type bone mineral measuring instrument (wheat inspires confidence in Technew SA), Z5000 type atomic absorption spectrophotometer (Zeeman), MK-11 type optical fiber pressure control closed microwave digestion system.Dehydrated alcohol, iodine tincture, pentobarbital sodium, Alendronate sodium sheet (Shijiazhuang Pharmaceutical Group Co Ltd), GBW (E) 080118 calcium constituent titer (national standard material center), lanthanum chloride (Beijing chemical reagents corporation), nitric acid.
1.5 experimental technique
1.5.1 oophorectomize: rat carries out bilateral oophorectomy with 30mg/kg.bw lumbar injection 1% pentobarbital sodium solution after the anesthesia, the penicillin of postoperative intramuscular injection 20,000 units, for three days on end.Sham operated rats is only excised fat about 0.5g after opening the abdominal cavity, keeps bilateral ovaries.
1.5.2 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).
1.5.3 the animal grouping: female Wistar rats is divided into sham operated rats, model control group, positive controls and sample low dose group of the present invention, middle dosage group and high dose group at random by body weight, 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 fine drug powder of the present invention respectively per os give 210,420,1260mg/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.
1.5.4 index determining:
1.5.4.1 body weight and height are measured and food utilization calculates: experimental session, the general situation of routine observation rat, record rats eating amount is weighed weekly and is measured height once; Be calculated as follows food utilization:
1.5.4.2 femur weight in wet base, 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 ten thousand/electronic balance weighing femur weight in wet base, with its length of vernier caliper measurement.Femur is placed 105 ℃ of baking 48h, claim the femur dry weight, continue baking 2h, weighing femur dry weight once more, twice difference is heavy less than 0.3mg, can think to reach constant weight.
1.5.4.3 bone densitometry: after the femur of removal soft tissue is baked to constant weight, under identical conditions, utilize through the standard bone mould
The SD-1000 type bone mineral measuring instrument of type calibration is measured the bone mineral content (BMC) and the bone width (BW) of femur mid point and dry end respectively, is calculated as follows the compact bone (BMD) of each measuring point:
Twice of every some replication.
1.5.4.4 bone calcium is measured: measure according to State Standard of the People's Republic of China GB12398-90.The femur of oven dry is put into the micro-wave digestion pipe, add 5ml nitric acid, in microwave oven, clear up to clear solution; Sample solution after clearing up quantitatively shifts and is settled to 10.0ml with distilled water after catching up with acid; Suitably dilution back adding 0.1g/l lanthanum chloride solution is made matrix and improved liquid, and is to be measured behind the distilled water standardize solution.With GBW (E) 080118 calcium unit series.With Z5000 type atomic absorption spectrophotometer this concentration in 422.7nm place each standard pipe of mensuration and sample cell, be calculated as follows calcium content of bone:
In the formula: C, C
0--be respectively the sample and the calcium concentration in the blank solution (mg/L) that record;
V-sample constant volume (ml); The B-extension rate; M-bone sample dry weight (g).
8.1.6 data statistics: experiment gained data are carried out statistical analysis with independent sample t-method of inspection in the SPSS statistical package, and p＜0.05 is apparent property for difference has.
2. result
2.1 fine drug powder of the present invention is to the influence of rat body weight, height
2.2 fine drug powder of the present invention sees Table 1 to the influence of rat body weight.
Table 1 fine drug powder of the present invention is to the influence of rat body weight
| Group | 0 month body weight (gram) | Body weight in January (gram) | Body weight in February (gram) | Body weight in March (gram) |
| Dosage group high dose group positive controls in the sham operated rats model control group low dose group | ?267.4±9.8 ?267.8±10.1 ?265.8±11.8 ?266.8±11.3 ?267.2±8.7 ?266.5±10.1 | ?312.5±13.6 ?355.9±15.7* ?358.9±19.0 ?360.0±18.3 ?352.1±14.2 ?351.5±14.5 | ?326.2±13.6 ?371.2±15.7** ?372.4±20.1 ?372.4±22.8 ?362.1±15.3 ?364.6±14.6 | ?348.0±16.0 ?388.1±12.8** ?391.0±21.2 ?389.1±24.1 ?380.5±15.3 ?381.5±14.6 |
With sham operated rats than p＜0.05, * * and sham operated rats are than p＜0.01
By table 1 as seen, model control group 1,2, March body weight apparently higher than sham operated rats (p＜0.05), belong to normal phenomenon, positive controls and the basic, normal, high dosage of fine drug powder of the present invention body weight in each and model control group than no significant difference (p＞0.05) in period.
2.3 fine drug powder of the present invention sees Table 2 to the influence of rat height.
Table 2 fine drug powder of the present invention is to the influence of rat height
| Group | Animal (only) | 0 month height (cm) | Height in January (cm) | Height in February (cm) | Height in March (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 | ?22.4±0.3 ?22.4±0.2 ?22.4±0.2 ?22.3±0.3 ?22.3±0.2 ?22.4±0.3 | ?23.2±0.2 ?23.2±0.2 ?23.3±0.2 ?23.3±0.2 ?23.2±0.3 ?23.3±0.2 | ?23.7±0.3 ?23.7±0.2 ?23.8±0.3 ?23.8±0.3 ?23.7±0.3 ?23.8±0.2 | ????24.2±0.3 ????24.2±0.2 ????24.4±0.3 ????24.3±0.3 ????24.2±0.3 ????24.3±0.2 |
By table 2 as seen, each organizes the height in rat each period does not all have significant difference (p＞0.05).
2.4 fine drug powder of the present invention sees Table 3 to the influence of rat body weight weightening finish, total intake and food utilization.
Table 3 fine drug powder of the present invention is to the influence of rat body weight weightening finish, total intake and food utilization
| Group | Animal (only) | Weightening finish (g) | Total intake (g) | Food utilization (%) |
| Dosage group high dose group positive controls in the sham operated rats model control group low dose group | ????10 ????10 ????10 ????10 ????10 ????10 | ?80.6±11.6 ?120.3±9.3** ?125.3±15.8 ?122.3±11.6 ?113.4±11.6 ?115.0±16.4 | ??1567.3±56.1 ??1632.9±64.9 ??1633.1±86.3 ??1637.4±73.4 ??1613.0±92.9 ??1630.1±103.9 | ?5.14±0.67 ?7.37±0.59** ?7.66±0.77 ?7.45±0.62 ?7.02±0.43 ?7.07±1.01 |
* and sham operated rats are than p＜0.01
By table 3 as seen, relatively weight gain is obvious for model control group and sham operated rats, food utilization obviously improves (p＜0.01), and all the other respectively organize rat body weight weightening finish, total intake and food utilization and model control group does not relatively have significant difference ((p＞0.05).
2.5 the health care evaluation of fine drug powder of the present invention
2.5.1 the influence that fine drug powder of the present invention is long to rat femur weight in wet base, dry weight and bone sees Table 4.
The influence that table 4 fine drug powder of the present invention is long to rat femur weight in wet base, dry weight and bone
| Group | Animal (only) | Weight in wet base (g) | Dry weight (g) | Bone long (cm) |
| Metering group high dose group positive controls in the sham operated rats model control group low dose group | ????10 ????10 ????10 ????10 ????10 ????10 | ??0.74±0.04 ??0.69±0.04* ??0.74±0.04* ??0.75±0.5 ##??0.72±0.05 ??0.75±0.03 ## | ??0.566±0.004 ??0.509±0.006** ??0.556±0.001 ##??0.576±0.006 ##??0.552±0.006 #??0.581±0.010 ## | ??3.51±0.04 ??3.53±0.05 ??3.53±0.05 ??3.54±0.04 ??3.51±0.06 ??3.55±0.06 |
* with sham operated rats than p＜0.05; #y in model control group than p＜0.05
* and sham operated rats are than p＜0.01; ## and model control group p＜0.01
By table 4 as seen, model control group rat femur weight in wet base, dry weight and sham operated rats comparison reduce by showing, and by the difference on the statistics (p＜0.05 or p＜0.01); Positive controls and model control group be the femur weight in wet base relatively, and dry weight has increase, and apparent property difference (p＜0.01) is arranged; Fine drug powder of the present invention is low, middle dosage group femur weight in wet base, femur dry weight and model control group relatively have apparent property difference (p＜0.05 or p＜0.01), high dose group femur dry weight and model control group relatively have apparent property difference (p＜0.05), and each dosage group rat femur length does not have apparent property difference (p＞0.05).
2.5.2 fine drug powder of the present invention sees Table 5 to the influence of rat bone mineral content (BMC) and bone density (BMD).
Table 5 fine drug powder of the present invention is to the influence of rat bone femur mid point and femur metaphysis bone mineral content (BMC) and bone density (BMD)
| Group | ??BMC | BMD | ||
| Dosage group high dose group positive controls in the sham operated rats model control group low dose group | Mid point 0.132 ± 0.013 0.112 ± 0.012** 0.125 ± 0.012 #??0.127±0.011 ##??0.124±0.012 #??0.126±0.012 # | Metaphysis 0.267 ± 0.034 0.233 ± 0.023* 0.266 ± 0.038 #0.267±0.024 #0.274±0.036 ##70.263±0.015 # | Mid point 0.388 ± 0.053 0.335 ± 0.024** 0.388 ± 0.039 ##0.374±0.032 #0.391±0.044 ##0.379±0.039 # | Metaphysis 0.499 ± 0.030 0.431 ± 0.038** 0.484 ± 0.033 ##??0.506±0.015 ##??0.495±0.032 ##??0.496±0.026 ## |
* with sham operated rats than p＜0.05; # and model control group are than p＜0.05;
* and false matched group are than p＜0.01; ## and model control group are than p＜0.01.
By table 5 as seen, (p＜0.05 or p＜0.01) positive controls and fine drug powder of the present invention are low than there were significant differences with model control group for sham operated rats rat femur mid point and femur metaphysis bone density (BMD) bone mineral content (BMC), in, high dose group rat femur mid point and femur metaphysis bone density (BMD), relatively there were significant differences (p＜0.05 or p＜0.01) with model control group for bone mineral content (BMC).
2.5.3 fine drug powder of the present invention sees Table 6 to the influence of rat bone calcium content.
Table 6 fine drug powder of the present invention is to the influence of rat bone calcium content
| Group | Dosage (mg/Kg.b.w) | Animal (only) | Calcium content of bone (mg/g) |
| Sham operated rats | ????0 | ????10 | ?313.7±31.8 |
| Model control group | ????0 | ????10 | ?278.7±17.1** |
| Low dose group | ????210 | ????10 | ?311.6±31.7 ## |
| Middle dosage group | ????420 | ????10 | ?302.2±13.2 # |
| High dose group | ????1260 | ????10 | ?305.5±11.5 ## |
| Positive controls | ????1 | ????10 | ?300.3±9.2 # |
* and sham operated rats are than p＜0.01; # and model control group are than p＜0.05; ## and model control group are than p＜0.01
By table 6 as seen, relatively there were significant differences that (p＜0.01) positive controls and fine drug powder of the present invention are low for sham operated rats rat bone calcium content and model control group, in, relatively there were significant differences (p＜0.05 or p＜0.01) for high dose group rat bone calcium content and model control group.
3. conclusion
3.1 giving the fine drug powder result of the test of the present invention of various dose, per os shows, fine drug powder of the present invention is low, middle dosage group rat femur weight in wet base, dry weight, bone density (BMD), there were significant differences (p＜0.05 or p＜0.01) with the model control group ratio for bone mineral content (BMC) and calcium content of bone, fine drug powder high dose group rat femur dry weight of the present invention, bone density (BMD), bone mineral content (BMC), there were significant differences (p＜0.05 or p＜0.01) with the model control group ratio for calcium content of bone, can judge the effect that fine drug powder of the present invention has increases rat bone density.
3.2 the influence to sexual function: fine drug powder of the present invention makes anterior pituitary of rat, ovary, uterus weight; The removal ovary rat pituitary is obviously increased the LH secretory reaction of injection luteinizing hormone releasing hormone (LRH) back, and blood plasma LH level obviously improves, and the mice plasma testosterone concentration is obviously increased, and testis and levator ani m. weightening finish have obviously short sexual function effect.
3.3 immunoregulation effect: fine drug powder of the present invention can make sheep red blood cell (SRBC) (SRBC) immune serum hemolytic antibody level and spleen antibody generation level improve, spleen antibody-producting cell (PFC) number increases, can promote lymphocyte transformation significantly, significantly strengthen macrophage phagocytic function, mouse peritoneal M φ phagocytic rate and phagocytic index are improved.To leukopenia patient's the cellular immune function effect of having clear improvement, treatment back lymphocyte stimulation indices increases, and the immune complex titre has and reduces trend gradually.
3.4 the influence to cardiovascular system: fine drug powder of the present invention obviously increases the dirty coronary flow of guinea-pig heart, and the rabbit myocardial ischemic injury that pituitrin is brought out also has protective effect.
3.5 anti-aging effects: fine drug powder of the present invention can resist D-galactose aging model mouse spleen and significantly be descended by the inductive lymphproliferation response of ConA, and splenocyte lipid peroxide LPS induces
3H-TdR mixes the B cell index obviously to be reduced, degradation effect under hepatocyte lipid peroxide (LPO) the content total superoxide dismutase of rising regulating liver-QI (SOD) vigor.And lipofuscin content is descended.
Embodiment 12 clinical efficacies
1 clinical design considerations
Carry out according to State Administration of Traditional Chinese Medicine's " clinical research guideline of new Chinese medicine treatment climacteric syndrome ".Treatment patient 19 examples are the women.Age 20-30 year 3 examples; 31-40 year 4 examples; 41-50 year 10 examples; 51-60 year 2 examples.The symptom classification: hectic fever, exciting irritability, anxious, depressed etc.
2 observational techniques
2.1 include the case standard in
Meet primary disease diagnostic criteria person, include the observation case in.
2.2 the dosage form of taking medicine
The decoction liquor of crude drug adopts Korea S to originate from moving boiling machine and decocts, and bottled, dose was fried in shallow oil into one bottle on 1st, every bottle of 250ml medicinal liquid.
2.3 consumption instructions about how to take medicine
Obey every day twice (early, evening each once), obey 1/2 bottle at every turn, oral.
The good appetite, taking medicine before meal; Have no appetite, obey half an hour after meal.Take medicine 10 bottles continuously, had a rest 2 days, serve on 10 bottles again, shared 30-40 bottle.
2.3 observation requirement
By the design sheets requirement, adopt unified form, be responsible for observed and recorded, data integrity, every first quarter moon observed and recorded is once.
3 observation index
3.1 health giving quality observation
Subjective symptoms such as hectic fever, exciting irritability, anxious, depressed etc.
The E2 level
Vulvovaginal is checked
3.2 curative effect judging standard
1 time: after oral 40 bottles, treat 5-7 days evaluation curative effects
2 standards: the A subjective symptoms alleviates or disappears
B E2 level has rise on the basis before taking medicine
C pudendum, vagina deliquescing
Significantly: A+B+C
Produce effects: A+B or+C, or B+C
Invalid: A, B, the equal no change of C
4 clinical experiment results
Sum up 20 routine clinical efficacies, 0 example evident in efficacy, produce effects 13 examples, invalid 7 examples.Total effective rate 63.2%.See the following form.
| The example number | Significantly | Produce effects | Invalid | Total effective rate |
| ????19 | ??0(0％) | 12(63.2％) | 7(36.8％) | ????63.2％ |
5. conclusion: the clinical test results that requires to carry out according to national study of tcm new drug shows: medicine oral liquid of the present invention had significant therapeutic effect to climacteric, and most patient has no adverse reaction.Thereby point out medicine of the present invention that the treatment of climacteric syndrome is safety and better curative effect is arranged.
Claims (4)
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| CNB2004100313604A CN100428952C (en) | 2004-03-25 | 2004-03-25 | Medicine for treating climacteric syndrome and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101366903B (en) * | 2008-08-27 | 2011-02-16 | 王素芹 | Traditional Chinese medicine composition for treating climacteric syndrome |
| CN103007077A (en) * | 2012-11-25 | 2013-04-03 | 荣成市崖头美全口腔诊所 | Chinese medicinal composition for treating climacteric syndrome |
| CN103784793A (en) * | 2014-01-15 | 2014-05-14 | 朱峰 | Traditional Chinese medicine for treating climacteric syndrome |
| CN105168456A (en) * | 2015-09-16 | 2015-12-23 | 韩志强 | a kind of tranquilizer |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1086144C (en) * | 1999-12-08 | 2002-06-12 | 张纯贵 | Capsule for tonifying kidney |
-
2004
- 2004-03-25 CN CNB2004100313604A patent/CN100428952C/en not_active Expired - Lifetime
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101366903B (en) * | 2008-08-27 | 2011-02-16 | 王素芹 | Traditional Chinese medicine composition for treating climacteric syndrome |
| CN103007077A (en) * | 2012-11-25 | 2013-04-03 | 荣成市崖头美全口腔诊所 | Chinese medicinal composition for treating climacteric syndrome |
| CN103007077B (en) * | 2012-11-25 | 2014-08-20 | 马兰英 | Chinese medicinal composition for treating climacteric syndrome |
| CN103784793A (en) * | 2014-01-15 | 2014-05-14 | 朱峰 | Traditional Chinese medicine for treating climacteric syndrome |
| CN105168456A (en) * | 2015-09-16 | 2015-12-23 | 韩志强 | a kind of tranquilizer |
| CN110141612A (en) * | 2015-09-16 | 2019-08-20 | 韩志强 | A kind of ANLE PIAN |
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| Publication number | Publication date |
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| CN100428952C (en) | 2008-10-29 |
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