Summary of the invention
In order to overcome the deficiencies in the prior art, the invention provides a kind of kidney invigorating and YANG supporting deer postcoital protrusion kidney Chinese medicine preparation and preparation method, this Chinese medicine preparation can effectively be regulated function of human body, the kidney invigorating essence, strong life fire, the hair growth promoting effect of fire, emerging positive heroic undertaking is mutually arranged, the symptomes complice that can Comprehensive Treatment causes by kidney yang deficiency, as diseases such as soreness of waist and knee joint, aversion to cold and cold limbs, the vertigo, lassitudes, its cure rate height, curative effect is obvious.
The invention provides following technical scheme: this Chinese medicine preparation is formulated by following raw materials according percentage ratio by weight: Fructus Tribuli 5-25%, Os Canitis charcoal 5-20%, Bombycis mori 5-20%, red Aeschna melanictera 5-20%, Penis et testis cervi 3-15%, Hippocampus 5-20%, Testis et Pentis Canis 5-20%, Actinolitum 3-15%, Fructus Cnidii 5-20%, Fructus Caryophylli 3-15%, Fructus Psoraleae 2-10%
It is formulated that described raw material is suitable for proportioning by the best by following weight: it is formulated that described raw material is suitable for proportioning by the best by following weight: Fructus Tribuli 12.0%, Os Canitis charcoal 10.9%, Bombycis mori 10.9%, red Aeschna melanictera 10.9%, Penis et testis cervi 7.8%, Hippocampus 9.6%, Testis et Pentis Canis 10.3%, Actinolitum 7.2%, Fructus Cnidii 9.6%, Fructus Caryophylli 6.0%, Fructus Psoraleae 4.8%.
Described Chinese medicine preparation can be made into tablet, capsule, granule, powder, pill, oral liquid, syrup and other clinical acceptable forms.
The preparation method of described tablet, make by following process: (1) is got Fructus Tribuli, Actinolitum, Fructus Cnidii and is ground into thick piece, add above 3-10 times of water gaging of each component gross weight, heating decocts 1-3 time, each 1-4 hour, gradation filtered, merging filtrate, be concentrated into paste, the relative density in the time of its 60 ℃ is 1.0-1.5; (2) get Os Canitis charcoal, red Aeschna melanictera, Penis et testis cervi, Hippocampus, Testis et Pentis Canis and be ground into 60-120 order fine powder; (3) getting above each the component gross weight 3-8 of Bombycis mori, Fructus Caryophylli, Fructus Psoraleae, adding, doubly to measure concentration be 40-80% ethanol, heating and refluxing extraction 2-4 time, 1-3 hour at every turn, gradation filters, merging filtrate reclaims ethanol and is concentrated into paste, and 60 ℃ relative density is 1.0-1.5; (4) ointment that (1) method, (3) method are made mixes with the medicated powder that (2) method makes, and 60-100 ℃ of drying pulverized, and sieves, and starch or dextrin and other adjuvants are made granule, drying, and granulate adds magnesium stearate or other adjuvants, and compacting is in flakes.
The preparation method of described capsule, make by following process: get the ointment that (1) method in the above-mentioned method for preparing tablet thereof, (3) method make and mix with the medicated powder that (2) method makes, 60-100 ℃ of drying pulverized, and sieves, and incapsulates.
The preparation method of described granule, make by following process: get the ointment that (1) method in the above-mentioned method for preparing tablet thereof, (3) method make and mix with the medicated powder that (2) method makes, 60-100 ℃ of drying pulverized, sieve, starch or dextrin and other adjuvants are made granule.
The preparation method of described powder, make by following process: get the ointment that (1) method in the above-mentioned method for preparing tablet thereof, (3) method make and mix with the medicated powder that (2) method makes, 60-100 ℃ of drying pulverized promptly.
The preparation method of described pill, make by following process: get the ointment that (1) method in the above-mentioned method for preparing tablet thereof, (3) method make and mix with the medicated powder that (2) method makes, 60-100 ℃ of drying is ground into powder; The Mel of the grain weight of getting it filled amount 80-130% boils, and filters; Behind medicated powder, 80-130% Mel and 0-15% water mix homogeneously, make pill.
The preparation method of described oral liquid, make by following process: (1) is got Fructus Tribuli, Actinolitum, Fructus Cnidii, Os Canitis charcoal, red Aeschna melanictera, Penis et testis cervi, Hippocampus, Testis et Pentis Canis and is ground into thick piece, add above 3-10 times of water gaging of each component gross weight, heating decocts 1-3 time, each 1-4 hour, gradation filtered, merging filtrate, be concentrated into paste, 60 ℃ of relative densities are 1.0-1.5; (2) getting above each the component gross weight 3-8 of Bombycis mori, Fructus Caryophylli, Fructus Psoraleae, adding, doubly to measure concentration be 40-80% ethanol, heating and refluxing extraction 2-4 time, 1-3 hour at every turn, gradation filters, merging filtrate reclaims ethanol and is concentrated into paste, and 60 ℃ of relative densities are 1.0-1.5; (3) concentrated medicament that (1) method, (2) method is made merges, and filters, and adds the antiseptic of medicinal liquid gross weight 0.1-1%, the correctives mix homogeneously of 0.1-2%, makes oral liquid.
The preparation method of described syrup, make by following process: (1) will merge by the concentrated medicament that above-mentioned oral liquid preparation technology (1), (2) make, and filters; (2) sucrose is dissolved in the distilled water that boils, academic title's concentration is the simple syrup of 85% (g/ml) or 64.7% (g/g); (3) will filter the back medicinal liquid and add in the simple syrup, and add an amount of distilled water and make syrup.
This Chinese medicine preparation has carried out a large amount of clinical trials of a large amount of animal acute toxicity tests, long-term toxicity test for animals, animal pharmacodynamics test and treatment disease, and the use link of this medicine input being treated disease provides science and objective foundation.Its test method and result of the test are as follows respectively:
1, deer postcoital protrusion kidney capsules animal acute toxicity test:
Medicine: deer postcoital protrusion kidney capsules 0.4g powder/grain, be brown ceramic powder, content is 1.82g crude drug/g powder, is made into 0.33g powder/ml (Cmax) with distilled water during experiment, is provided by the LiaoYuan YaDong Medicine Co., Ltd., Jilin Province.
Experimental animal: Kunming mouse, body weight 20-22g, male and female half and half are provided by Norman Bethune Medical University animal portion experimental center, the quality certification number: 98050103.
Purpose: observe the toxic reaction situation of once taking in a large number.
Method and result: get 20 fasting of kunming mice 12 hours, can't help water, in 24 hours, gavage deer postcoital protrusion kidney capsules 3 times, each 0.4ml/10g is heavy, accumulation irritate to be fed maximum volume 2-4ml/20g and (is equivalent to 72g crude drug/kg), observed 7 after the administration, does not have dead the generation, animal activity freely, hair color gloss, diet is as usual, does not see other unusual performance, because of administration volume, concentration all reach to greatest extent, admittedly fail to obtain LD
50, the maximum tolerated dose of its gastric infusion>72g crude drug/kg is equivalent to 396 times of the clinical application amount (0.4g powder/grain * 5 * 3 * 1.82g crude drug/g powder ÷ 60kg=0.182g crude drug/kg).As seen this medicine does not have acute toxic reaction, is a kind of than safe drugs.
2, deer postcoital protrusion kidney capsules long-term toxicity test for animals:
Medicine: deer postcoital protrusion kidney capsules, face the time spent to be made into 40% suspension, provide by the LiaoYuan YaDong Medicine Co., Ltd., Jilin Province.
Experimental animal: rat, portion provides by the Norman Bethune Medical University animal.
Method and result: adopt 80 of adult rat, male and female half and half, body weight 80-120g is divided into four groups at random, and 20 every group, 1) the blank group: irritate stomach with tap water every day; 2) deer postcoital protrusion kidney capsules low dose group: irritate stomach with 1.8g/kg; 3) dosage group in the deer postcoital protrusion kidney capsules, 9g/kg; 4) deer postcoital protrusion kidney capsules high dose group: irritate stomach with 18/kg.Once a day, successive administration three months is observed the rat general state during the successive administration, once surveyed body weight in 10 days, puts to death after March, gets blood and does inspections such as routine blood test, liver function, kidney merit, observes internal organs, carries out histopathologic examination.
Result of the test shows: deer postcoital protrusion kidney capsules is safe and reliable, and rat body weight, kidney merit, liver function and hematological examination are not all had obvious influence.
3, animal pharmacodynamics test
Test objective: cure mainly relevant main pharmacodynamics by animal experiment observation deer postcoital protrusion kidney capsules with function and test, for its clinical practice provides the pharmacodynamics test foundation.
Trial drug: deer postcoital protrusion kidney brown ceramic powder, the time spent is made into the solution of desired concn with distilled water, and use for oral administration is provided by the LiaoYuan YaDong Medicine Co., Ltd., Jilin Province.
Experimental animal: Male Kunming strain mice, rat, body weight is respectively 11-15g, 120 ± 20g, portion provides by the Norman Bethune Medical University animal.
Testis removes art: with the bull mice with etherization after, cut skin of scrotum, extract testis and epididymis, skin suture then.
Test method:
1) deer postcoital protrusion kidney capsules is to the influence of bull castration mouse prostate-Seminal vesicle weight
Remove 40 of gesture mices, be divided into four groups at random, press the drug dose gastric infusion shown in the table 1, once a day, successive administration ten days, matched group are given the equal-volume distilled water, treat after the last administration 1 hour, with the animal sacrificed by decapitation, extract prostate-Seminal vesicle, peel off fat, weigh, the results are shown in Table 1.
By table 1 result as seen, deer postcoital protrusion kidney can make male mice prostate-Seminal vesicle, and weight obviously increases, and three dosed administration groups are compared with matched group all utmost point significant difference P<0.001, illustrates that this medical instrument has yang invigorating functions.
Group | Dosage (g/kg) | Mus number (only) | Prostate-Seminal vesicle | (mg/10g body weight) | Table 1 |
Matched group deer postcoital protrusion kidney deer postcoital protrusion kidney Hui Erchun group | - 2.73 2.27 1.82 | 10 10 10 10 | 4.32±0.491 10.15±0.714 7.97±0.418 6.53±0.567 | P<0.001*** P<0.001*** P<0.05* | |
B) deer postcoital protrusion kidney capsules is to the influence of teenage male mice testis prostate-Seminal vesicle weight
Get 40 of teenage male mices, be divided into 4 groups at random, press the drug dose gastric infusion shown in the table 2, once a day, successive administration ten days, matched group is given the equal-volume distilled water, treats after the last administration 1 hour, and the animal dislocation is put to death, take out testis, prostate-Seminal vesicle, peel off fat, weigh, the results are shown in Table 2.
Group | Dosage (g/kg) | Mus number | Testis heavy (mg/10g) | Prostate-Seminal vesicle (mg/10g body weight) | Table 2 |
Matched group deer postcoital protrusion kidney deer postcoital protrusion kidney Hui Erchun group | - 2.73 2.27 1.82 | 10 10 10 10 | 50.29±2.239 52.99±2.148 51.73±3.216 55.70±2.499 | 31.94±1.498 34.56±3.338 35.58±1.804 39.28±2.204* | |
The result shows: deer postcoital protrusion kidney capsules can make prostate-Seminal vesicle weight obviously increase, and three kinds of dosage all can make testicular weight that increase trend is arranged, but not statistically significant.
C) to the influence of testosterone content in the teenage male rat blood plasma
Get 30 of teenage male rats, be divided into three groups at random, press the drug dose gastric infusion shown in the table 3, once a day, successive administration 15 days, matched group are given the equal-volume distilled water, treat after the last administration 1 hour, with the animal sacrificed by decapitation, get blood, measure the content of testosterone in the blood plasma, the results are shown in Table 3.By table 3 as seen, deer postcoital protrusion kidney is with 0.4g/kg, and the 0.6g/kg dosed administration can make that testosterone concentration has increase trend in the animal blood slurry, but not statistically significant.
Group | Dosage (g/kg) | Mus number (only) | (/ 100mg) the table 3 of testosterone concentration in the blood plasma |
Matched group deer postcoital protrusion kidney deer postcoital protrusion kidney | - 2.73 1.82 | 10 10 10 | 1731.8±76.58 2142.5±85.68 2810.5±96.42* |
D) deer postcoital protrusion kidney is to the influence of erection duration of castration bull rat
Remove 40 of gesture bull rats, be divided into 4 groups at random, press the drug dose gastric infusion shown in the table 4, once a day, successive administration ten days, matched group is given the equal-volume distilled water, with electrical stimulation method, observes the persistent period of erecing.See Table 4.
Group | Dosage (g/kg) | Mus number (only) | The erection time (min) | P | Table 4 |
Normal control group deer postcoital protrusion kidney deer postcoital protrusion kidney deer postcoital protrusion kidney | - 2.73 2.275 1.82g/kg | 10 10 10 10 | 3.2±1.63 8.9±1.43 9.1±1.02 10.1±2.10 | <0.001 <0.001 <0.001 | |
Result of the test shows: three dosage groups of deer postcoital protrusion kidney capsules are compared with matched group, all can prolong erection time P<0.001, illustrate that this medical instrument has yang invigorating functions.
More than a plurality of tests show that deer postcoital protrusion kidney has following function: deer postcoital protrusion kidney has the obvious effect of gain of bull castration mouse prostate-Seminal vesicle, and P<0.01 has significant differences; Teenage male mice testis, prostate-Seminal vesicle weight increase had obvious facilitation; Can increase testosterone content in the teenage male rat blood plasma; Castration bull rat duration of erecing is played the prolongation effect.These result of the tests show: deer postcoital protrusion kidney truly has kidney invigorating and YANG supporting, treatment sexual impotence, strengthens the effect of sexual function.
In order to verify clinical efficacy, this deer postcoital protrusion kidney capsules respectively in the Jilin Prov. Inst. of Chinese Medicine and Chinese Medical Science, No.2 Clinical Hospital of Bethune Medical Univ. and Attached Hospital, Changchun Chinese Medicinal College, 404 examples, 120 examples, 90 examples, 97 routine clinical observations have been passed through respectively, with reference to Ministry of Public Health relevant criterion and clinical guidance principle, at the symptomes complice of insufficiency of kidney-YANG embodiment, case is divided into treatment group and matched group, the treatment group is thrown deer postcoital protrusion kidney capsules, and each 5, every day 3 times, matched group gives NANBAO JIAONANG, sees Table 5
Group | Recovery from illness | Produce effects | Effectively | Invalid | Effective percentage (%) | Table 5 |
303 matched groups 101 are organized in treatment | 77 19 | 92 25 | 108 39 | 26 18 | 91.4 82.2 | |
According to curative effect judging standard, treatment group total effective rate can reach more than 91.4%, the matched group total effective rate is 82.2%, credit is analysed treatment group curative effect and obviously is better than matched group by statistics, P<0.01, simultaneously to soreness of waist and knee joint, the insufficiency of kidney-YANG symptom effects of having clear improvement such as aversion to cold and cold limbs, before and after the treatment notable difference is arranged, obviously be better than the NANBAO matched group, and through caring, liver, multiple inspections such as kidney are found to have no side effect, have no adverse reaction, be the ideal medicament of treatment deficiency of kidney-YANG syndrome, truly have the kidney invigorating essence, strong life fire, hair growth promoting is fire mutually, the effect of emerging positive heroic undertaking, treatment deficiency of kidney-YANG syndrome curative effect is certainly, safe and reliable, application value is arranged.
The specific embodiment
A kind of kidney invigorating and YANG supporting deer postcoital protrusion kidney Chinese medicine preparation can be made into tablet, capsule, granule, powder, pill, oral liquid, syrup and other clinical acceptable forms.
The preparation of raw material that its Chinese medicine preparation is pressed column weight amount percentage ratio forms: Fructus Tribuli 5-25%, Os Canitis charcoal 5-20%, Bombycis mori 5-20%, red Aeschna melanictera 5-20%, Penis et testis cervi 3-15%, Hippocampus 5-20%, Testis et Pentis Canis 5-20%, Actinolitum 3-15%, Fructus Cnidii 5-20%, Fructus Caryophylli 3-15%, Fructus Psoraleae 2-10%.
Its best proportioning is: it is formulated that described raw material is suitable for proportioning by the best by following weight: Fructus Tribuli 12.0%, Os Canitis charcoal 10.9%, Bombycis mori 10.9%, red Aeschna melanictera 10.9%, Penis et testis cervi 7.8%, Hippocampus 9.6%, Testis et Pentis Canis 10.3%, Actinolitum 7.2%, Fructus Cnidii 9.6%, Fructus Caryophylli 6.0%, Fructus Psoraleae 4.8%.
Its weight can take by weighing like this: Fructus Tribuli 12.0g, Os Canitis charcoal 10.9g, Bombycis mori 10.9g, red Aeschna melanictera 10.9g, Penis et testis cervi 7.8g, Hippocampus 9.6g, Testis et Pentis Canis 10.3g, Actinolitum 7.2g, Fructus Cnidii 9.6g, Fructus Caryophylli 6.0g, Fructus Psoraleae 4.8g.
Its tablet is made like this: (1) is got Fructus Tribuli, Actinolitum, Fructus Cnidii and is ground into thick piece, adds above 3-10 times of water gaging of each component gross weight, and heating decocts 1-3 time, each 1-4 hour, gradation filtered, merging filtrate, be concentrated into paste, the relative density in the time of its 60 ℃ is 1.0-1.5; (2) get Os Canitis charcoal, red Aeschna melanictera, Penis et testis cervi, Hippocampus, Testis et Pentis Canis and be ground into 60-120 order fine powder; (3) getting above each the component gross weight 3-8 of Bombycis mori, Fructus Caryophylli, Fructus Psoraleae, adding, doubly to measure concentration be 40-80% ethanol, heating and refluxing extraction 2-4 time, 1-3 hour at every turn, gradation filters, merging filtrate reclaims ethanol and is concentrated into paste, and 60 ℃ relative density is 1.0-1.5; (4) ointment that (1) method, (3) method are made mixes with the medicated powder that (2) method makes, and 60-100 ℃ of drying pulverized, and sieves, and starch or dextrin and other adjuvants are made granule, drying, and granulate adds magnesium stearate or other adjuvants, and compacting is in flakes.
Its capsule is made like this: get the ointment that (1) method in the above-mentioned method for preparing tablet thereof, (3) method make and mix with the medicated powder that (2) method makes, 60-100 ℃ of drying pulverized, and sieves, and incapsulates.
Its granule is made like this: get the ointment that (1) method in the above-mentioned method for preparing tablet thereof, (3) method make and mix with the medicated powder that (2) method makes, 60-100 ℃ of drying pulverized, and sieves, and starch or dextrin and other adjuvants are made granule.
Its powder is made like this: get the ointment that (1) method in the above-mentioned method for preparing tablet thereof, (3) method make and mix with the medicated powder that (2) method makes, 60-100 ℃ of drying pulverized promptly.
Its pill is made like this: get the ointment that (1) method in the above-mentioned method for preparing tablet thereof, (3) method make and mix with the medicated powder that (2) method makes, 60-100 ℃ of drying is ground into powder; The Mel of the grain weight of getting it filled amount 80-130% boils, and filters; Behind medicated powder, 80-130% Mel and 0-15% water mix homogeneously, make pill.
Its oral liquid is made like this: (1) is got Fructus Tribuli, Actinolitum, Fructus Cnidii, Os Canitis charcoal, red Aeschna melanictera, Penis et testis cervi, Hippocampus, Testis et Pentis Canis and is ground into thick piece, add above 3-10 times of water gaging of each component gross weight, heating decocts 1-3 time, each 1-4 hour, gradation filters, merging filtrate is concentrated into paste, and 60 ℃ of relative densities are 1.0-1.5; (2) getting above each the component gross weight 3-8 of Bombycis mori, Fructus Caryophylli, Fructus Psoraleae, adding, doubly to measure concentration be 40-80% ethanol, heating and refluxing extraction 2-4 time, 1-3 hour at every turn, gradation filters, merging filtrate reclaims ethanol and is concentrated into paste, and 60 ℃ of relative densities are 1.0-1.5; (3) concentrated medicament that (1) method, (2) method is made merges, and filters, and adds the antiseptic of medicinal liquid gross weight 0.1-1%, the correctives mix homogeneously of 0.1-2%, makes oral liquid.
Its syrup is made like this: (1) will merge by the concentrated medicament that above-mentioned oral liquid preparation technology (1), (2) make, and filters; (2) sucrose is dissolved in the distilled water that boils, academic title's concentration is the simple syrup of 85% (g/ml) or 64.7% (g/g); (3) will filter the back medicinal liquid and add in the simple syrup, and add an amount of distilled water and make syrup.