CN1329056C - Medicine composition - Google Patents
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- CN1329056C CN1329056C CNB2005101182722A CN200510118272A CN1329056C CN 1329056 C CN1329056 C CN 1329056C CN B2005101182722 A CNB2005101182722 A CN B2005101182722A CN 200510118272 A CN200510118272 A CN 200510118272A CN 1329056 C CN1329056 C CN 1329056C
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- Medicines Containing Plant Substances (AREA)
Abstract
The present invention relates to a Chinese medicinal composition, a medicine which contains the Chinese medicinal composition and a preparation method and application of the medicine, wherein the components of the composition comprise: 2 to 10 parts of epimedium herb, 2 to 10 parts of barbary wolfberry fruit, 2 to 10 parts of common cnidium fruit, 2 to 10 parts of angelica, 0.5 to 2 parts of cassia bark, 2 to 6 parts of cornel, 2 to 10 parts of desertliving cistanche, 2 to 6 parts of dodder seed and 2 to 6 parts of mantis egg-case. The sources of the components can be traditional Chinese medicinal materials or the water extract of the traditional Chinese medicinal materials, and the quantity of the water extract is equal to the quantity of crude medicines of the traditional Chinese medicinal materials. The Chinese medicinal composition of the present invention can be used for treating diseases of insufficiency of kidney yang, deficiency of essence and blood, etc.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, specifically, be a kind ofly to have warming the kidney to activate YANG, replenishing essence and give birth to marrow, the Chinese medicine composition of the effect of arresting seminal emission, the component of said composition can include and directly be ground into Chinese crude drug that powder is used as medicine and the Chinese medicine extract that obtains through extraction.
Background technology
The disease that insufficiency of kidney-YANG, essence and blood lose due to the void is commonly encountered diseases and frequently-occurring disease, its sickness rate height, the course of disease are long, cardinal symptom shows as limbs cold, soreness of the waist and knees, nocturia are anxious frequently, the few dream etc. of having a dizzy spell, pass out semen, and the purpose of treatment is to promote the recovery of function, reduce sequela, improve patient's ability to work and quality of life, and prevent the disease recurrence.
The medicine that is used for the treatment of kidney deficiency now is a lot, as: remittance core SHENBAO HEJI, Herba Cistanches kidney invigorating tablet, NANBAO JIAONANG etc., in the clinical practice, these effect of drugs are also not obvious, so a kind of medicine for the treatment of such disease of market in urgent need exploitation.
Summary of the invention
The inventor comes from theory of Chinese medical science, sums up experience in many ways, through practice, has been developed into a kind of Chinese medicine composition, and said composition is a pure Chinese medicinal preparation, can improve the thanks to empty syndrome of insufficiency of kidney-YANG, essence and blood greatly, and determined curative effect, and is safe and effective.
The object of the present invention is to provide a kind of Chinese medicine composition and comprise the medicine of said composition, this medicine has warming the kidney to activate YANG, marrow is given birth in replenishing essence, the effect of arresting seminal emission, be mainly used in clinically treatment insufficiency of kidney-YANG, essence and blood lose due to the void asthenia win thin and aversion to cold and cold limbs, soreness of the waist and knees, have a dizzy spell, diseases such as nocturia frequency, seminal emission.
The present invention also aims to provide manufacturing method for above mentioned medicine, the medicine of by this method, can obtain having warming the kidney to activate YANG, marrow, arresting seminal emission effect are given birth in replenishing essence.
The present invention also aims to provide aforementioned pharmaceutical compositions to be used for the treatment of the purposes that insufficiency of kidney-YANG, essence and blood lose empty disease.
In order to achieve the above object, the invention provides a kind of Chinese medicine composition, component comprises Herba Epimedii 2-10 part, Fructus Lycii 2-10 part, Fructus Cnidii 2-10 part, Radix Angelicae Sinensis 2-10 part, Cortex Cinnamomi 0.5-2 part, Fructus Corni 2-6 part, Herba Cistanches 2-10 part, Semen Cuscutae 2-6 part and Ootheca Mantidis 2-6 part in the said composition, and the source of described component can be Chinese crude drug or the Chinese medicine water extract that is equivalent to above-mentioned Chinese crude drug crude drug amount.Above umber is the weight portion of component.
Above-mentioned composition of the present invention is that to lose void at insufficiency of kidney-YANG, essence and blood be systematic treating side's medicine that main disease is set up, and has warming the kidney to activate YANG, replenishing essence life marrow, the effect of arresting seminal emission, it is formed for Chinese medicine compound, and the medicine source of crude drug is extensive, has no side effect, reasonable recipe, curative effect is good.
In the compositions of the present invention; can select the whole starch of flavour of a drug; also can all extract the back is used as medicine with the form of alcohol/water extract; can also selection portion branch fecula and all the other components are used as medicine with extract; as long as comprised said components; said composition can reach the drug effect that treatment insufficiency of kidney-YANG, essence and blood lose empty disease, promptly within the category that the present invention protected.In a preferred embodiment of the invention, component Fructus Cnidii, Radix Angelicae Sinensis, Cortex Cinnamomi and Fructus Corni are alcohol extract, all the other components of said composition are from water extract, and described water extract is used water extraction after concentrate resulting extractum or dry extract for the Chinese crude drug crude drug; Described Fructus Cnidii drug effect is carried for bag.
In a preferred embodiment of the invention, component of aforementioned pharmaceutical compositions (weight portion) and proportion optimization are: 125 parts of 187.5 parts of Herba Epimedii, 187.5 parts of Fructus Lycii, 187.5 parts of Fructus Cnidiis, 187.5 parts of Radix Angelicae Sinensis, 32 parts of Cortex Cinnamomis, 125 parts of Fructus Corni, 187.5 parts of Herba Cistanches, 125 parts of Semen Cuscutae and Ootheca Mantidiss.
The present invention also provides a kind of treatment insufficiency of kidney-YANG, essence and blood to lose empty medicine, it comprises above-mentioned Chinese medicine composition and pharmacy acceptable auxiliary, difference according to pharmaceutical dosage form, selected adjuvant is also different, and in this pharmaceutical preparation, the effective ingredient content Determination of Icariin is at least 0.48mg/g, and, for clear and definite more effective ingredient of the present invention, preferably, at least also contain ursolic acid 0.1mg/g in this medicine.
Above-mentioned pharmaceutical preparation can be any dosage form that comprises that described flavour of a drug are formed, be preferably peroral dosage form, it is that on the pharmacy meaning all can supply oral dosage form, honeyed pill, condensed water honeyed pill, the watered pill, granule, capsule, tablet, powder, unguentum and oral liquid etc., preferred condensed water honeyed pill, the watered pill, granule, capsule and oral liquid; In an embodiment of the present invention, more preferably granule.The tcm syndrome curative effect that experiment showed, medicine of the present invention obviously is better than existing Chinese patent medicine, has confirmed that it is for to lose the square medicine of empty disease at treatment insufficiency of kidney-YANG, the essence and blood of different diseases.
The present invention also provides manufacturing method for above mentioned medicine, comprising: Fructus Cnidii, Radix Angelicae Sinensis, Cortex Cinnamomi and Fructus Corni are added alcohol extraction, be condensed into alcohol extraction cream; Remaining Chinese crude drug water is carried, i.e. Herba Epimedii, Fructus Lycii, Herba Cistanches, Semen Cuscutae and Ootheca Mantidis water extraction, and extract is condensed into extractum, and (water extracts at least once, each amount of water is more than 1 times of crude drug, preferred 5-10 times, decocting time was at least 0.5 hour, preferred 1-8 hour); With above-mentioned alcohol extraction cream mix with extractum, dry and pulverize.
Above-mentioned steps is a routine operation, and visual medical material situation difference takes the circumstances into consideration to change process conditions, and it is conventionally known to one of skill in the art, for example also the medical material of medicinal residues after the alcohol extraction and water extraction can be merged and use water extraction jointly.
At the difference of needed product, the preparation process of medicine of the present invention also can be different, but are the preparation process routine operation, describe no longer one by one.For example, when needs are made granule, granulate, to be prepared into the granule product with Icing Sugar, dextrin; When needs prepared the condensed water honeyed pill, this step also can comprise with the hydromel of 5%-25% carried out (comprising crude drug powder and extract dry extract) process of general system contraction to dried medicated powder, to make condensed water honeyed pill product.
The preparation method of above-mentioned granule is specially: Fructus Cnidii (bag is carried), Radix Angelicae Sinensis, Cortex Cinnamomi and Fructus Corni are added 75% alcohol reflux, be condensed into alcohol extract; Medicinal residues merging after all the other Chinese medicines (being Herba Epimedii, Fructus Lycii, Herba Cistanches, Semen Cuscutae and Ootheca Mantidis) and the alcohol extraction (decocts with water with water extraction jointly, the preferred decoction 3 times, amount of water is about 5-10 times of crude drug, decocting time is 1-5 hour), collecting decoction, filter, (relative density is 1.20-1.30 to concentrated filtrate to suitable concentration, 80 ℃) obtain extract extractum, add above-mentioned four kinds of Chinese medicine crude drug alcohol extracts again, mixing, it is concentrated that (relative density is 1.30-1.35,80 ℃) become clear paste, promptly obtain compositions of the present invention.
Then the invention described above compositions is added the Icing Sugar of first-class parts by weight (with weight such as clear paste) and wait the dextrin of parts by weight, granulate with conventional method, drying, granulate can obtain granule.
In above-mentioned preferred embodiment, the design of the concrete parameter of preparation were established is according to the character of different Chinese crude drugs and pharmacological action difference, definite with screening by analysis optimization technology.
The Chinese crude drug that is adopted in the compositions of the present invention is the medical material that version pharmacopeia in 2000 is recorded, and through identifying, every index all meets the pharmacopeia regulation.
The physical and chemical identification of compositions of the present invention and medicine: the monarch drug in the Herba Epimedii side of being wherein, wherein contained icariin is its main effective ingredient, has multiple pharmacologically active, so will measure in the present composition content Determination of Icariin as the main quality control index of this product, assay is according to high performance liquid chromatography (one one of Chinese Pharmacopoeia version in 2000, appendix VID) measures, adopt content Determination of Icariin in the high effective liquid chromatography for measuring product in the present invention, evidence, this method sensitivity, favorable reproducibility.
Ursolic acid is the effective ingredient of component Fructus Corni among the present invention, content of ursolic acid is feasible as the controlling index of preparation inherent quality in the mensuration product, but in follow-up test, the applicant finds that containing the survey method according to conventional theoretical ursolic acid of instructing exists not enough, one of reason is the ursolic acid instability, can not correctly reflect the quality of product with its content as the index of quality control, therefore tentatively be decided to be and at least also contain ursolic acid 0.1mg/g in this medicine.
Icariin (C in compositions and the medicine
33H
40O
15) assay: measure content Determination of Icariin in the product according to high performance liquid chromatography (appendix VID of Chinese Pharmacopoeia version in 2000), contain icariin in the product of the present invention and should be no less than 0.48mg/g.
The inspection of arsenic salt and heavy metal in the medicine of the present invention: press one one of Chinese Pharmacopoeia version in 2000, regulation under appendix IXE, the IXF item, arsenic salt and heavy metal that this product 3 batch samples are contained are checked the result is respectively less than 2/1000000ths and 10/1000000ths, all in prescribed limit.
Health examination in the medicine of the present invention:, meet hygiology standard promulgated by the ministries or commissions of the Central Government through health examination.
The present invention also provides the application in above-mentioned composition loses diseases such as asthenia due to the void is won thin, aversion to cold and cold limbs, soreness of the waist and knees, had a dizzy spell, nocturia frequency, seminal emission at preparation treatment insufficiency of kidney-YANG, essence and blood the medicine.
Compositions of the present invention finds through its pharmacodynamics of animal experimental observation, with 0.6,0.4,0.2g/kg dosage gastric infusion, can obviously increase sperm count and mobility (P＜0.05, P＜0.01; Improve level of serum testosterone and the dirty body ratio of gonad; The spermatogenesis ability that can improve testis is seen by testicular histology, to castrated rats, can prolong positive tool erects the time, hydrogen is examined pine cause the YANG asthenia disease mice, can prolong the low temperature swimming time, improve the free tire of the gentle forelimb of anus and lift number of times, illustrate that medicine of the present invention has kidney invigorating and YANG supporting, marrow is given birth in replenishing essence, the effect of arresting seminal emission, the pharmacological basis that provides for clinical practice.
The pharmacology pharmacodynamic experiment
Test method and result
1. to the influence of sperm count, mobility
Animal: SD strain rat (male) is divided into 5 groups at random, 10 every group;
Contrast: normal saline group;
Medicine: the large, medium and small dosage of the compositions of the embodiment of the invention 1 (claiming leaves of pulse plants Qi the kidney invigorating granule again) (0.6,0.4,0.2g/g) hereinafter to be referred as leaves of pulse plants Qi granule;
Positive control drug: NANBAO JIAONANG (Tonghua, Jilin Golden Horse Pharmaceutical, 0.3g/kg, 1.8g/day);
Every day gastric infusion once, continuous 7 days, after the last administration 4 hours, cut open the belly and win testis, epididymis and respectively get one, put to contain in the 1% glucose ringer solution and gently grind well, draw one and put on the clean slide, under mirror, observe sperm is counted, observe the sperm motility situation, result such as table 1.
The table 1 pair sperm quantity and the percentile influence of sperm of living (X ± s, n=10)
| Group | Dosage (g/kg) | Sperm sum * 10 4/ml | Sperm count alive * 10 4/ml | Sperm percentage rate % lives | Necrospermia subnumber * 10 4/ml | Necrospermia percentage rate % |
| Contrast NANBAO JIAONANG leaves of pulse plants Qi granule leaves of pulse plants Qi granule leaves of pulse plants Qi granule | 0.4 0.6 0.4 0.2 | 220.6±124.1 226.1±108.9 193.3±99.4 193.0±111.8 222.1±113.8 | 116.3±70.8 143.4±89.6 135.4±84.5 109.5±60.9 116.6±61.1 | 52.7 63.3 70.0 56.7 52.5 | 104.3±62.7 81.7±37.3 58.2±21.9 81.5±54.5 105.6±55.5 | 47.3 36.7 30.0 43.3 47.5 |
The result: NANBAO JIAONANG and leaves of pulse plants Qi granule are given rat oral gavage administration 17d, the sperm sum of swimming out of there is not obviously influence, the sperm count alive of NANBAO JIAONANG and leaves of pulse plants Qi granule 0.4g/kg and 0.6g/kg group and the sperm percentage rate of living have the trend of increasing than matched group, but relatively do not have significant difference with matched group statistically.The vigor of sperm alive that microscopically is observed each treated animal is all stronger, and the sperm of NANBAO JIAONANG group and leaves of pulse plants Qi granule 0.6g/kg treated animal is active than matched group.
2. to the influence of the dirty hierarchy number of rat gonad
Animal this medication of dividing into groups is the same, experiment latter stage puts to death animal, wins testis, epididymis, adrenal gland, prostate, seminal vesicle, claims weight in wet base with torsion balance; Obtain dirty body ratio, as table 2.
Table 2 male rat gonad pair childhood and accessory sex organ's influence (X ± s, n=10)
| Group | Dosage (g/kg) | Testis (g/100g) | Preputial glands (mg/100g) | Seminal fluid capsule+prostate (mg/100g) | Thymus (mg/100g) | Spleen (mg/100g) |
| Matched group leaves of pulse plants Qi granule leaves of pulse plants Qi granule leaves of pulse plants Qi granule NANBAO JIAONANG | 0.4 0.6 0.4 0.2 | 1.07±0.10 1.26±0.14* 1.26±0.21* 1.12±0.07 1.16±0.07* | 47.35±5.67 47.67±2.45 49.35±6.03 47.39±8.36 47.33±4.32 | 247.67±32.20 275.56±19.33* 267.34±27.35 276.67±35.86 260.26±34.31 | 230.25±22.78 243.95±14.85 257.23±16.86 246.23±54.94 244.96±20.26 | 483.34±45.15 507.65±71.38 560.93±63.09* 475.15±69.11 535.64±78.51 |
Annotate: compare * P＜0.05 with matched group
The present composition can obviously promote the growth of male childhood of rat testicle, and big or middle dosage group all can make rat testicle weight increase; NANBAO JIAONANG also has positive effect, seminal fluid capsule and prostatic growth are also had certain facilitation, but only heavy dose of group of effect is obvious; The growth of preputial glands there is not obvious influence.
3. insufficiency of kidney-YANG rat yang invigorating functions is influenced
Animal: SD is a rat, and is male, body weight 98-110g
Medicine: the present composition, NANBAO JIAONANG.
Method: get 70 of SD kind rats, ♂, 100 ± 10g is divided into 7 groups:
(1) normal control group (distilled water 20mg/kg);
(2) castration model group (distilled water 20ml/kg);
(3) androlin group;
(4) the heavy dose of group of the present composition (0.6g/kg), middle dosage group (0.4g/kg), small dose group (0.2g/kg);
(5) positive drug NANBAO JIAONANG (0.2g/kg);
Except that the normal control group, all the other each treated animals are anaesthetized under the aseptic condition of back with 3% pentobarbital 1.2ml110g intraperitoneal injection of anesthesia, excision bilateral testes and epididymis are sewed up wound, next day after the operation, each treated animal begins to weigh, gastric infusion, once a day, capacity 2ml/100g, continuous 12 days, 1h after the last administration, YSD type physiology use instrument (Bangbu radio factory product) constant current 4mA stimulation in rats penis more, observe erection incubation period and persistent period.Result such as table 3.
Table 3 pair castrated rats penile erectile function influence (X ± s, n=10)
| Group | Dosage (g/kg) | Erection incubation period (S) |
| Normal control castration model testosterone propionate leaves of pulse plants Qi particle leaves of pulse plants Qi particle leaves of pulse plants Qi particle NANBAO JIAONANG | Equal-volume water equal-volume water 0.002 0.60 0.40 0.20 0.40 | 16.26±6.29 36.45±19.32** 14.03±7.93** 19.10±8.77* 18.94±10.26* 20.11±8.14* 20.57±7.67* |
Annotate: compare * P＜0.05 with model control group, * * P＜0.01; Compare * * P＜0.01 with the normal control group
By 3 tables as seen, compare with the castration model, leaves of pulse plants Qi granule, positive drug androlin, NANBAO JIAONANG all can obviously shorten castrated rats erection incubation period; Leaves of pulse plants Qi granule can improve the castrated rats penis to the outside stimulus irritability, the erection time, can obviously shorten castrated rats erection incubation period, and prolong erection time P＜0.01.With the aforementioned result explanation, leaves of pulse plants Qi granule has obvious yang invigorating functions.
4. hydrogen is examined the influence that pine causes the mice syndrome of deficiency of kidney-YANG
Animal: the ICR kind is a mice, and is male, body weight 20 ± 2g
Medicine: leaves of pulse plants Qi granule, NANBAO JIAONANG, face the time spent to be made into desired concn with distilled water.
Method: 60 of ICR kind mices, male, body weight 20 ± 2g, with 5 groups of branches, 10 every group,
Normal control group (distilled water 20ml/kg); Insufficiency of kidney-YANG model group (distilled water 20ml/kg); Positive drug NANBAO JIAONANG (0.40g/kg); The large, medium and small dosage group of leaves of pulse plants Qi granule; Irritate stomach once for every day each treated animal, continuous 12 days, except that blank, all the other are respectively organized mouse muscle injection hydrogen and examine 50mg/kg, and the 12nd day, 1h (last day, animal was not injected the oxidation cortisone) write down each treated animal body weight behind the filling stomach, anus temperature 2min, the mice forelimb is praised number of times on approximately, subsequently mice is put into 4 ± 1 ℃ of about cold water, observes the mice swimming time.Result such as table 4.
Table 4 leaves of pulse plants Qi granule to the influence of yang deficiency animal (X ± s, n=10)
| Group | Dosage (g/kg) | Autonomic activities number of times (10min) | The low temperature swimming time-to-live (s) | Before the administration | After body weight (g) administration | Difference |
| Contrast model of yang asthenia Herba Cistanches the kidney invigorating leaves of pulse plants Qi granule leaves of pulse plants Qi granule leaves of pulse plants Qi granule | Equal-volume water 25mg 0.40 0.60 0.40 0.20 | 2008±531 1338±493** 1785±363* 1840±389** 1706±429* 1626±401* | 547±197.0 394.3±166.22 562.1±157.90* 694.6±168.00*** 651.5±290.40* 569.8±146.50* | 19.5±0.85 19.5±0.85 19.4±1.07 19.4±1.07 19.2±1.03 19.5±0.85 | 25.02±1.85 22.8±2.45 23.22±1.80 23.91±2.38 23.18±1.36 23.38±2.00 | 5.52 3.30 3.82 4.51 3.98 3.88 |
Compare * P＜0.05, * * P＜0.01 with the normal control group; Compare * P＜0.005 with model group, * * P＜0.001, * * * P＜0.001 (down together)
By visible large, medium and small dosage group of leaves of pulse plants Qi granule of table 4 and positive drug NANBAO JIAONANG, all can alleviate the mice YANG asthenia disease that hydrocortisone causes, can prolong the time (P＜0.05) of mice low temperature survival.Increase the autonomic activities number of times of mice, increase resisting fatigue, the tolerance to cold of mice, and can delay the trend of hydrocortisone induced mice weight loss.Leaves of pulse plants Qi granule is examined the yang deficiency syndrome mice to hydrogen very strong therapeutical effect, as can obviously increasing body temperature P＜0.01, prolongs swimming time P＜0.01, increases forelimb and lifts number of times P＜0.01.Illustrated and improved the effect of body physiological function kidney invigorating and YANG supporting.
5. to the influence of rat mating ability
Table 5. leaves of pulse plants Qi granule to the influence of rat mating ability (X ± s, n=10)
| Group | Dosage (g/kg) | Pounce on and catch (in the 20min) | Ejaculation (in the 20min) | ||||
| Incubation period (s) | Number of times | ％ | Incubation period (s) | Number of times | ％ | ||
| Normal control group NANBAO JIAONANG leaves of pulse plants Qi granule leaves of pulse plants Qi granule leaves of pulse plants Qi granule | Equal-volume water 0.40 0.60 0.40 0.20 | 292.63±67.31 195.63±68.86* 171.40±65.20** 194.67±70.34* 191.78±53.93** | 9.13±4.25 15.63±5.50* 15.40±6.69* 12.11±5.40 8.89±4.54 | 80 80 100 90 90 | 903.75±142.68 78 3.00±265.31 505.43±237.18* 654.00±201.17 664.4±367.88 | 2.75±1.71 3.60±1.14 5.00±1.15* 3.40±2.30 3.40±3.78 | 40 60 70 50 50 |
Annotate: compare * P＜0.05, * * P＜0.01 with matched group
This laboratory observation arrives, never after male Mus rat of adult property that mated with female Mus and female Mus meet, the administration group all can make the male rat mating ability obviously improve, pouncing on of the interior animal of wherein heavy dose of group 20min caught, ejaculation frequency increases, pouncing on incubation period and the ejaculation latency of catching female Mus obviously shortens, compare with the normal control group, significant difference is arranged.
Above-mentioned experimental result finds that 1. the present composition can obviously increase rat epididymis sperm count and sperm motility degree; 2. can obviously improve level of serum testosterone; 3. increase the dirty hierarchy number of gonad; 4. can obviously shorten erection incubation period to castration yang deficiency syndrome rat, prolong the duration; 5. can obviously improve the spermatogenesis storage sperm ability of testis; 6. can obviously improve the yang deficiency symptom of hydrocortisone yang deficiency syndrome mice.
Illustrate that the present composition has warming the kidney to activate YANG, replenishing essence to give birth to marrow, the effect of arresting seminal emission.
6. anxious poison and long poison experiment
Do not have excitement, uneasiness, play, jump, perpendicular hair after the mice administration, shed tears, sialorrhea, protruding eye, writhing response phenomenon, inside branch animal peace and quiet in 1 hour after the administration.Observed 7 days, mice was put to death in the back of weighing in the 8th day, dissected and found gastric filling, and intestinal does not have flatulence.Dissect the perusal heart, liver, spleen, lung, kidney, adrenal gland, thymus, ovary, uterus, seminal vesicle, prostate, testis, stomach, intestinal and thoracic cavity, abdominal cavity, the affair organ is all no abnormal.Body weight is 22.37 ± 1.80g/kg before the administration, and body weight was 25.35 ± 2.45g/kg in the 8th day.
Conclusion: medicine of the present invention does not detect LD for the ICR mouse stomach
50, maximum dosage-feeding is 20g/kg, is equivalent to Coming-of-Age Day 50 times with dosage.
The result shows through the rat long term toxicity test, with heavy dose of (5 times of adult's dosage of medicine of the present invention, 10 times and 25 times of amounts) to rat continuous oral 90d and 180d, growth promoter (body weight gain), hemopoietic function, liver function and the equal non-toxic reaction of renal function to rat, to the toxic infringement sexually transmitted disease (STD) reason of the also last discovery of organs such as the rat heart, liver, lung, kidney, brain change in organization, show that medicine of the present invention does not have long term toxicity.
Clinical trial
Adopt the method for randomized controlled to investigate its curative effect and untoward reaction, observe patient's 300 examples altogether, wherein 200 examples are organized in treatment, treatment group tcm syndrome cure-remarkable-effectiveness rate 28.3%, total effective rate 88.7%, matched group cure-remarkable-effectiveness rate 23.9%, 76.12%, two group of tcm syndrome curative effect of total effective rate is relatively, learn by statistics and handle, there is significant difference P＜0.05, and the treatment group is better than matched group.The treatment group is not seen tangible untoward reaction.
In sum, the present composition loses diseases such as asthenia due to the void is won thin and aversion to cold and cold limbs, soreness of the waist and knees, had a dizzy spell, nocturia frequency, seminal emission to insufficiency of kidney-YANG, essence and blood improvement is better than contrasting medicine, and the result of clinical trial shows determined curative effect, and is safe and effective.
The specific embodiment
For more clear explanation goal of the invention and technical scheme, be described in further detail by following embodiment.
Embodiment 1:
Present composition prescription: Herba Epimedii 187.5g, Fructus Lycii 187.5g, Fructus Cnidii 187.5g, Radix Angelicae Sinensis 187.5g, Cortex Cinnamomi 32g, Fructus Corni 125g, Herba Cistanches 187.5g, Semen Cuscutae 125g and Ootheca Mantidis 125g.
Preparation method:
Fructus Cnidii (bag is carried), Radix Angelicae Sinensis, Cortex Cinnamomi and Fructus Corni are added 75% alcohol reflux, be condensed into alcohol extract; Medicinal residues merging after all the other Chinese medicines (being Herba Epimedii, Fructus Lycii, Herba Cistanches, Semen Cuscutae and Ootheca Mantidis) and the alcohol extraction decocts with water 3 times, amount of water is about 7.5 times of crude drug, decocting time is 1-5 hour, collecting decoction, filter, concentrated filtrate to relative density is 1.20-1.30 (80 ℃), obtain extract extractum, add above-mentioned four kinds of Chinese medicine crude drug alcohol extracts again, mixing, being concentrated into relative density is that 1.30-1.35 (80 ℃) becomes clear paste, promptly obtains compositions of the present invention, about 330～350g.
Then 1 part of the invention described above compositions is added 1 portion of Icing Sugar and 1 part of dextrin, granulate, drying, granulate can obtain granule (1000g; Pack back 3～8g/ bag).
After measured, contain icariin 0.49mg/g in this medicine, contain ursolic acid 0.15mg/g.
Embodiment 2:
Prescription: 2 parts of 5 parts of Herba Epimedii, 2 parts of Fructus Lycii, 2 parts of Fructus Cnidiis, 2 parts of Radix Angelicae Sinensis, 0.5 part of Cortex Cinnamomi, 2 parts of Fructus Corni, 5 parts of Herba Cistanches, 2 parts of Semen Cuscutae and Ootheca Mantidiss.
Preparation method: preparation of compositions is with embodiment 1; Make tablet.
After testing, contain icariin 0.50mg/g in this tablet dose, contain ursolic acid 0.11mg/g.
Embodiment 3:
Prescription: 6 parts of 10 parts of Herba Epimedii, 10 parts of Fructus Lycii, 10 parts of Fructus Cnidiis, 10 parts of Radix Angelicae Sinensis, 2 parts of Cortex Cinnamomis, 6 parts of Fructus Corni, 10 parts of Herba Cistanches, 6 parts of Semen Cuscutae and Ootheca Mantidiss.
Preparation method: preparation of compositions is with embodiment 1; Make capsule.
After testing, contain icariin 0.49mg/g in this capsule, contain ursolic acid 0.13mg/g.
Embodiment 4:
Prescription: 23 parts of 2 parts of Herba Epimedii, 8 parts of Fructus Lycii, 8 parts of Fructus Cnidiis, 8 parts of Radix Angelicae Sinensis, 1 part of Cortex Cinnamomi, 6 parts of Fructus Corni, 3 parts of Herba Cistanches, 23 parts of Semen Cuscutae and Ootheca Mantidiss.
Preparation method: preparation of compositions is with embodiment 1;
Preparation method according to the conventional watered pill is made the watered pill with said composition, after testing, contains icariin 0.53mg/g in this watered pill, contains ursolic acid 0.13mg/g.
Embodiment 5:
3 parts of prescription 8 parts of Herba Epimedii, 4 parts of Fructus Lycii, 6 parts of Fructus Cnidiis, 6 parts of Radix Angelicae Sinensis, 1.5 parts of Cortex Cinnamomis, 3 parts of Fructus Corni, 3 parts of Herba Cistanches, 3 parts of Semen Cuscutae and Ootheca Mantidiss.
Preparation method: preparation of compositions is with embodiment 1;
Preparation method according to conventional capsule is made capsule with said composition, after testing, contains icariin 0.51mg/g in this capsule, contains ursolic acid 0.12mg/g.
More than described the preferred embodiment for the present invention, so it is not in order to limit the present invention.Those skilled in the art can not depart from the improvement and the variation of category of the present invention and spirit to embodiment disclosed herein.
Claims (9)
1, a kind of thanks to empty Chinese medicine composition of insufficiency of kidney-YANG, essence and blood for the treatment of is made up of the Chinese medicine of following weight parts: Herba Epimedii 2-10 part, Fructus Lycii 2-10 part, Fructus Cnidii 2-10 part, Radix Angelicae Sinensis 2-10 part, Cortex Cinnamomi 0.5-2 part, Fructus Corni 2-6 part, Herba Cistanches 2-10 part, Semen Cuscutae 2-6 part and Ootheca Mantidis 2-6 part.
2. the described Chinese medicine composition of claim 1, wherein, 125 parts of 187.5 parts of Herba Epimedii, 187.5 parts of Fructus Lycii, 187.5 parts of Fructus Cnidiis, 187.5 parts of Radix Angelicae Sinensis, 32 parts of Cortex Cinnamomis, 125 parts of Fructus Corni, 187.5 parts of Herba Cistanches, 125 parts of Semen Cuscutae and Ootheca Mantidiss.
3. treat insufficiency of kidney-YANG, essence and blood and lose empty medicine for one kind, wherein made by claim 1 or 2 each described Chinese medicine compositions and pharmacy acceptable auxiliary, content Determination of Icariin is at least 0.48mg/g in this pharmaceutical preparation.
4. the described medicine of claim 3 wherein, at least also contains ursolic acid 0.1mg/g in this medicine.
5. the described medicine of claim 3, wherein said medicine is a peroral dosage form, it is honeyed pill, condensed water honeyed pill, the watered pill, granule, capsule, tablet, powder, unguentum or oral liquid.
6. the described medicine of claim 3, wherein said medicine is granule, capsule or the watered pill.
7. the preparation method of the described medicine of claim 3 may further comprise the steps:
(1) Fructus Cnidii, Radix Angelicae Sinensis, Cortex Cinnamomi and Fructus Corni are added alcohol extraction, be condensed into alcohol extraction cream;
(2) with Herba Epimedii, Fructus Lycii, Herba Cistanches, Semen Cuscutae, Ootheca Mantidis water extraction, extract is condensed into extractum;
(3) above-mentioned alcohol extraction cream is mixed with extractum, dry and pulverize.
8. the preparation method of medicine as claimed in claim 7, wherein, described step can comprise that also the medical material with the medicinal residues after (1) alcohol extraction and (2) merges common process with water extraction.
9. the described compositions of claim 1 is lost application in the medicine of empty disease at preparation treatment insufficiency of kidney-YANG, essence and blood.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1184659A (en) * | 1997-11-14 | 1998-06-17 | 张锡昆 | Traditional Chinese medicine for tonifying kidney and strengthening spleen and stomach |
| CN1416835A (en) * | 2001-11-08 | 2003-05-14 | 钟凯 | Chinese medicine prepn for treating male's sexual dysfunction systematically |
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| CN1184659A (en) * | 1997-11-14 | 1998-06-17 | 张锡昆 | Traditional Chinese medicine for tonifying kidney and strengthening spleen and stomach |
| CN1416835A (en) * | 2001-11-08 | 2003-05-14 | 钟凯 | Chinese medicine prepn for treating male's sexual dysfunction systematically |
Non-Patent Citations (1)
| Title |
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| 生精赞育汤治疗男性不育症50例疗效观察 郑东利等，河北中医，第11卷第1期 1989 * |
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Owner name: LIU YUJIA Free format text: FORMER OWNER: HEILONGJIANG TIANYI PHARMACEUTICAL CO., LTD. Effective date: 20131029 |
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Free format text: CORRECT: ADDRESS; FROM: 163316 DAQING, HEILONGJIANG PROVINCE TO: 150000 HARBIN, HEILONGJIANG PROVINCE |
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Effective date of registration: 20131029 Address after: 1404 room 150000, building Wang, building 30, Gan Gan Road, Harbin Development Zone, Heilongjiang, China Patentee after: Liu Yujia Address before: 163316 Jianshe Road high tech Zone, Heilongjiang, No. 245, Patentee before: Heilongjiang Tianyi Pharmaceutical Co., Ltd. |
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Effective date of registration: 20191025 Address after: 150000 cattle industry park, Wuchang City, Heilongjiang, Harbin Patentee after: Harbin Meijun Pharmaceutical Co., Ltd Address before: 1404 room 150000, building Wang, building 30, Gan Gan Road, Harbin Development Zone, Heilongjiang, China Patentee before: Liu Yujia |