CN1176108A - Kidney-warming and Yang-activating medicine - Google Patents

Abstract

The said medicine has musk, pilose antler, Astragalus membranaceus and epimedium as main medicinal components and has the functions of invigorating kidney, dispersing stagnated liver-energy, dredging meridian passage, supporting healthy energy to eliminate evils, raising immunity, etc. It is used to cure weakness of extremities, cold hands and feet, soreness of loins, dizziness, inomnia and other symptoms caused by kidney disease, and it may be also used to cure sexual degradation and sexual dysfunction.

Description

A kind of medicament of warming the kidney to invigorate YANG

The present invention relates to the impotence of man that a kind of influencial family's of being applicable to fire declines and causes, libido is indifferent, soreness of the waist and knees, and aversion to cold and cold limbs, few abdomen or external genitals are sent out cold.The medicament of the warming the kidney to invigorate YANG of condition of illness such as clear urine in large amounts.

Traditional Chinese medical science traditional theory is thought " the kidney being the origin of congenital constitution ".Modern Chinese medicine studies have shown that the Shen has four big functions in human body, that is: urinary system function, the function of reproductive system, functions of immune system and be the function of blood circulation.Be embodied in urinary system, the treatment of diseases of reproductive system and prevention, the maintenance and the improvement of the enhancing of function of immune system and microcirculqtory system function.

Because the important function of kidney in human body, so the prosperity and decline of kidney is directly connected to the power of muscle power, intelligence and the health status of human body.

Safeguard the health of kidney, improve the health level of kidney, could improve the health level of human body.

The object of the present invention is to provide a kind of is the warming the kidney to invigorate YANG medicament and preparation method thereof of main component with the Chinese herbal medicine, but this medicament kidney tonifying, essence replenishing, soothing liver-QI is invigorated blood circulation, active stimulating the menstrual flow, and strengthening body resistance and dispelling evil improves immunologic function, strengthening by means of tonics.

The medicaments preparation method of a kind of warming the kidney to invigorate YANG of the present invention is characterized in that the weight ratio of its major ingredient is:

Cornu Cervi Pantotrichum 1.1-1.3 Herba Epimedii 18-20

Radix Astragali 12-14 Rhizoma Chuanxiong 12-14

Fructus Ligustri Lucidi 11-13 Fructus Cnidii 17-19

Magnetitum 12-14 Radix Morindae Officinalis 3-4

Aspongopus 1.5-2.5 Flos Caryophylli 3-4

Moschus 0.005-0.01

Described medicament prepares according to following process:

More than ten simply, except that Cornu Cervi Pantotrichum, Moschus, Flos Caryophylli is extracted volatile oil, Moschus adds an amount of porphyrize of ethanol, with the Flos Caryophylli volatile oil mixing, uses the beta-cyclodextrin inclusion, drying is ground into fine powder; Pulveratum Cornu Cervi Pantotrichum is broken into fine powder and above-mentioned fine powder and right amount of auxiliary materials mixing, and is standby.

Eight flavors such as all the other Herba Epimedii, with 60% alcohol reflux secondary, each 2 hours merge extractive liquid,, filter, filtrate decompression be concentrated into relative density 1.25-1.30 clear skin, leave standstill, remove uvea, clear skin heating is dissolved and above-mentioned fine powder mixing, drying under reduced pressure becomes dried cream, be ground into particulate, it is an amount of to add magnesium stearate, and mixing gets feeble QI raw meat of the present invention, mildly bitter flavor, the yellowish-brown powder medicine.

Described adjuvant preferably phosphoric acid hydrogen calcium;

But according to the medicament capsule of method preparation of the present invention, the injection that pill maybe can be injected;

Further specify the present invention below in conjunction with embodiment

Embodiment 1

Get Cornu Cervi Pantotrichum 25g, Herba Epimedii 400g, Radix Astragali 280g, Rhizoma Chuanxiong 270g, Fructus Ligustri Lucidi 250g, Fructus Cnidii 380g, Magnetitum 270g, Radix Morindae Officinalis 80g, Aspongopus 40g, Flos Caryophylli 80g, Moschus 0.14g;

More than ten simply, except that Cornu Cervi Pantotrichum, Moschus, Flos Caryophylli steam is oozed, extract volatile oil, Moschus adds an amount of porphyrize of ethanol, with the Flos Caryophylli volatile oil mixing, use the beta-cyclodextrin inclusion, filtration is anhydrated, vacuum drying is ground into fine powder again;

Pulveratum Cornu Cervi Pantotrichum is broken into fine powder and above-mentioned fine powder and 100g calcium hydrogen phosphate mixing, and is standby;

Eight flavors such as all the other Herba Epimedii were with 1200g alcohol reflux secondary, each 2 hours, merge extractive liquid, filters, and removes filtering residue, filtrate decompression is concentrated into the clear skin of relative density 1.25-1.30, leaves standstill, and removes uvea, clear skin heating is dissolved and above-mentioned fine powder mixing, drying under reduced pressure becomes dried cream, is ground into granule, adds magnesium stearate 3g mixing, encapsulated, make 100.

Medicament of the present invention cures mainly sexual hypofunction, and it is aching and limp, weak that sexual dysfunction also can be treated the extremity that cause because of the kidney disease, hands and feet coolness.Soreness of waist and knee joint, Light-headedness, insomnia forgetfulness, nocturnal emission, dreaminess, alopecia, early whitening of beard and hair and muscle power, intelligence are weak etc.

The usage of medicament of the present invention and consumption are oral, a 3-4 grain, 2 times on the one or follow the doctor's advice.

Data

Protect renal aid clinical trial final report and interrelated data

Jinghai Pharmaceutical Co., Ltd., Beijing

On February tenth, 1

Medicament of the present invention was taken the lead by Guang-amen Hospital, China Traditional Chinese Medicine Instl and the hospital of traditional Chinese hospital, Beijing, ancient building, Beijing traditional Chinese medical science andropathy hospital verify treatment sexual impotence case jointly from 31, on January of December-1996 nineteen ninety-five, the random packet controlled trial, wherein 100 examples are organized in treatment, clinical produce effects 35 examples (35%), total effective 86 examples (86%).Matched group 60 examples, clinical demonstration 18 examples (29.9%), total effective 70%, treatment group and matched group comparison, there were significant differences in P＜0.01.

Earlier with summary of clinical verification scheme and back:

One, routine number

The 160 routine function sexual impotence of outpatient service being closed the standard of including in adopt random packet, establish positive controls.Wherein 100 examples are checking treatment group, 60 routine positive matched groups in addition.The contrast medicine is for prolonging Chang Chundan in age

Two, the age

In 160 examples, wherein distributing between the group at age sees Table 1

Table 1 age (year) (example) distributes

100 18 27 33 22 matched groups 60 18 12 13 17 are organized in several 20～30～40～50～60 treatments of total example

Treatment group minimal ages 23 years old, maximum 60 years old age, average 40.3 years old;

Matched group minimal ages 25 years old, maximum 59 years old age, average 39.2 years old;

There is comparability statistical procedures P＞0.05 between two groups.

Three, the course of disease: in 160 examples, the shortest course of disease is 3 months, and is the longest 240 months, and distributing between its course of disease group sees Table 2

Table 2 course of disease distribution (example)

Total routine number 3-6 month 7-12 month 13-24 25-26 month more than 37 months treatment organize 100 33 24 17 11 15 matched groups 60 23 18 856

The treatment group is the shortest 3 months, and is the longest 240 months, average 29.9 months;

Matched group is the shortest 3 months, and is the longest 230 months, average 23.3 months.

The course of disease distribute two groups the contrast P＞0.05 differences not remarkable, comparability is arranged.

Observe and Therapeutic Method

One, Therapeutic Method: random packet, establish positive controls

1, treatment group: medicament capsule of the present invention, each four (0.4g/ grain), every day 2 times is oral.

2, matched group: prolong Chang Chundan in age, each four, every day 3 times.

3, the course of treatment: one month, full one the course of treatment person be the statistics case.

Two, observation index:

(1), safety observation

1, general health check-up project (as hypertension etc.);

2, hematuria routine test;

3, liver, the heart and kidney function test.

(2), health giving quality observation

1, libido, erection degree etc.;

2, syndrome is improved situation;

3, the person of having ready conditions can be serum Lh, FSH, T, PRL;

4, doctrine is observed and is had no adverse reaction, and records faithfully;

5, clinic case should strict control variable factor.

Three, curative effect determinate standard: produce effects: sexual dysfunction symptom transference cure or basic the disappearance, the syndrome integration reduces＞30%, less than 70%; The sexual intercourse chance is success more than 50%.

Effectively: sexual dysfunction symptom Signs takes a turn for the better to some extent, and the syndrome integration reduces 30%, less than 70%; The sexual intercourse chance can success more than 25%.

Invalid, every index does not have improvement after the medication, or the syndrome integration reduces 30%.

Total effects as a result one,

Table 4 total effects comparison sheet

Produce effects enabledisable total effective rate adds up to treatment to organize 35 51 14 86% 86 matched groups 18 24 18,70% 42 tables 4 and shows: treatment is organized in 100 examples, and effectively above person is 86 examples, accounts for 86%

In the matched group, effectively above person is 42 examples.There is significant difference two groups of comparison P＜0.01, and the result shows that treatment group effect is obviously greater than matched group.Two, primary symptom improvement situation sees Table 5 (examples)

Table 5 cardinal symptom is improved information slip (example)

The not hard vagina that can insert of anorthosis erection can not be finished normal sexual intercourse

Treat the back treatment before treating after treating before the treatment back is treated before treating and organize 43 5 47 6 10 2 matched groups 16 4 30 8 14 2

Last table shows: 100 examples are organized in treatment, anorthosis before the treatment wherein, and the not hard person that erects is 90 examples, accounts for 90%, after protecting the renal aid treatment, has 11 routine primary symptoms to fail that this is apt to, and accounts for 12.2%.In the matched group, anorthosis is arranged before the treatment, the not hard person that erects is 46 examples, accounts for 76%; Have 14 routine primary symptoms to fail to improve after clothes prolong the red treatment in Changchun in age, account for 23.3%, two group of relatively P＜0.05, the result shows that protected kidney capsule is better than prolonging Chang Chundan in age to the improvement of functional impotence primary symptom.

Three, inferior disease is improved situation, sees Table 6

Table 6 time disease is improved situation (example)

The cloudy fear of cold of the few abdomen waist arteries and veins libido picture of the tongue pulse condition of being afraid of cold

The aching and limp treatment preceding 74 66 83 92 85 80 of going down that down in spirits sent out cool by device is treated according to back 35 44 38 61 20 20 groups of disappearance rate, (%) preceding 46 54 47 56 50 52-of 52.7 33.3 54.2 33.6 76.4 75.0 convection potentials are according to shining the 23 37 38 61 21 24 groups of disappearance rate in back, (%) 50.0 31.4 23.4 21.4 58 50.8

Last table shows, protected kidney capsule treatment group is compared before the treatment with after the treatment, and few abdomen external genitals is sent out cold, soreness of the waist and knees, and down in spirits, fear of cold is afraid of cold, and hyposexuality grade symptom is obviously improved, and also is better than prolonging the red matched group in Changchun in age.Curative effect and curative effect prospect see Table 7

Table 7 age (year) and therapeutic effect relationship (example)

Total example several 20～30～40～50～60 is controlled produce effects 35 0 11 11 6 and is treated effective 51 10 14 15 12 groups invalid 14 0275

Last table shows: patient age and curative effect do not have dependency relation.Five, the relation of the course of disease and curative effect sees Table 8

The relation of table 8 course of disease and curative effect (example)

Control produce effects 11 8925 the 3-6 month 7-12 month 13-24 month 25-26 month more than 37 months and treat effective 18 13 857 groups invalid 43043 pairs produce effects 47133 according to effective 11 8311 groups invalid 83412

Last table shows, functional (kidney yang deficiency syndrome) sexual impotence, and patient's course of disease length and curative effect do not have mutual relation.Six, the state of an illness (light, in, heavy) sees Table 9 with the relation of curative effect

See Table the relation (example) of 9 state of an illness and curative effect

Heavily control produce effects 10 18 8 in light and treat effective 3 30 18 groups invalid 076 pairs produce effects 594 according to effective 5 11 8 groups invalid 4 10 4

Last table shows that in the treatment group, severity extent and curative effect do not have dependency relation, prolongs Chang Chundan in age but heavy sexual impotence curative effect is better than than protected kidney capsule with matched group.Seven, hormonal readiness analysis in table 10 such as serum testosterone before and after the treatment

Table 10 gonadal hormone analytical table (X=SD)

The example number is treated and to be controlled T 26 400.25=109.16 26 459=113.34NG/DI after the precedent number is treated and treat FSH 20 7.59=2.93 20 7.57=2.68MIU/NI group LH 20 7.06=1.43 20 6.97=1.47MIU/NIPRL 26 8.=3.16 26 9.63=2.41NG/HIE 6 24.33=8.71 6 29.33=6.48HG/HI and control T 20 373.14=115.60 20 359.19=62.45NG/DI and treat FSH 20 10.38=2.17 20 12.14=1.60MIU/NI group LH 20 13.85=3.13 20 14.42=2.17MIU/NI PRL 26 12.66=3.75 26 11.98=3.14NG/HI

In this group checking case, 20 routine patients carry out the hormone serum level comparison check before and after taking medicine and after the course of treatment of taking medicine, and wherein 20 examples are organized in treatment, matched group 20 examples.The result shows, all in normal range, contrasts there was no significant difference before and after the treatment.

Eight, onset time

3 days the fastest onset times in 100 examples are organized in treatment, 15 days onset times at the latest, average 7 days.

4 days the fastest onset times in matched group 60 examples, 15 days onset times at the latest, average 7 days.

Two medicine comparing differences are little.

Model case

1, grandson XX, 45 years old, Fangshan District, Beijing peasant, patient's sexual disorder that began to occur before 3 years, the penis anorthosis increases the weight of gradually, and companion's fear of cold is afraid of cold, soreness of the waist and knees, hyposexuality rises when suppressing urine morning, can erect, once obey medicines such as prolonging Changchun pellet in age and fail to respond to any medical treatment, check all broken strings three times through the penis test wrapper, examine for functional impotence (kidney yang deficiency syndrome) through the clothes protected kidney capsule, treatment course of treatment, it is normal that sexual function recovers, fear of cold is afraid of cold, the soreness of the waist and knees transference cure.Before and after taking medicine, have a blood test, routine urinalysis, liver, renal function be all normal.

2, Shen XX, 50 years old, the cadre lived southern vegetable garden, patient's nothing else inducement occurred libido suddenly and descends the penis anorthosis before 1 year, companion's down in spirits, soreness of the waist and knees, few abdomen is sent out cold, played the erection phenomenon morning, once clothes spent fine and soft dimension hero to fail to respond to any medical treatment, and three times broken string were arranged twice through the inspection of penis test wrapper, examine and be 1 course of treatment of functional impotence clothes protected kidney capsule, libido strengthens, and it is normal that sexual function recovers, the row sexual life of being satisfied with.

Discuss

Sexual impotence is the commonly encountered diseases of male sexual disorder, according to the cause of disease, can be divided into organic and functional (spirituality) two big classes, and wherein the latter occupies the majority.Very functional (kidney yang deficiency syndrome) sexual impotence there is obvious curative effects according to advertisement An Men hospital of the academy of traditional Chinese medicine, Beijing Hospital of Traditional Chinese Medicine and the Gu Lou of Beijing hospital of traditional Chinese hospital andropathy hospital three tame hospital application protected kidney capsules are oral, total effective rate reaches 86%, and prolongs the red matched group in Changchun in age; Curative effect is compared and obviously is better than the latter, simultaneously few abdomen external genitals is sent out cold, soreness of the waist and knees, and aversion to cold and cold limbs, the symptom of insufficiency of kidney-YANG such as hyposexuality has clear improvement.

Brief summary

One, this paper has verified the therapeutical effect of protected kidney capsule to functional (kidney yang deficiency syndrome) sexual impotence, and 100 routine matched group 60 examples, totally 160 examples are organized in treatment.

Two, protected kidney capsule determined curative effect total effective rate reaches 86% greatly, is better than matched group and prolongs Chang Chundan in age (effective percentage 70%) P＜0.01.

Three, do not find that protected kidney capsule has the effect of paying of recent poison and other untoward reaction to human body.

Claims (4)

1, a kind of medicaments preparation method of warming the kidney to invigorate YANG is characterized in that the weight ratio of its major ingredient is:

Cornu Cervi Pantotrichum 1.1-1.3 Herba Epimedii 18-20

Radix Astragali 12-14 Rhizoma Chuanxiong 12-14

Fructus Ligustri Lucidi 11-13 Fructus Cnidii 17-19

Magnetitum 12-14 Radix Morindae Officinalis 3-4

Aspongopus 1.5-2.5 Flos Caryophylli 3-4

Moschus 0.005-0.01

Described medicament prepares according to following process:

More than ten simply, except that Cornu Cervi Pantotrichum, Moschus, Flos Caryophylli is extracted volatile oil, Moschus adds an amount of porphyrize of ethanol, with the Flos Caryophylli volatile oil mixing, uses the beta-cyclodextrin inclusion, drying is ground into fine powder; Pulveratum Cornu Cervi Pantotrichum is broken into fine powder and above-mentioned fine powder and right amount of auxiliary materials mixing, and is standby.

Eight flavors such as all the other Herba Epimedii, with 60% alcohol reflux secondary, each 2 hours merge extractive liquid,, filter, filtrate decompression is concentrated into the clear paste of relative density 1.25-1.30, leaves standstill, remove uvea, the clear paste heating is dissolved and above-mentioned fine powder mixing, drying under reduced pressure becomes dried cream, be ground into particulate, it is an amount of to add magnesium stearate, and mixing gets feeble QI raw meat of the present invention, mildly bitter flavor, the yellowish-brown powder medicine.

2,, it is characterized in that described adjuvant preferably phosphoric acid hydrogen calcium according to the method for claim 1.

3, according to claim 1 or 2 medicaments that prepare.

But 4, the injection that maybe can inject according to the medicament capsule or the pill of claim 3.