CN1102328A - Natural composition oral medicine for treating male sterility - Google Patents

Abstract

The oral medicine in the form of liquid or solid is made of 8 Chinese-mnedicinal components such as pipe fish, mantis egg-case, ginseng, sea cucumber, raspberry fruit, etc. and can cure male sterility caused by aspermia, less or weak sperm, and sexual disfunction.

Description

Natural composition oral medicine for treating male sterility

What the present invention relates to is a kind of combination of oral medication that is used to control the medicine male infertility of being made up of natural medicinal ingredients.

In reproductive system disease, male infertility is a comparatively common class disease.Its origin cause of formation has organic and branch non-organic, and is many with the non-organic cause of disease wherein.Statistics report is for example arranged, and the person accounts for 50% due to azoospermia such as wherein few because of sperm quantity, mobility difference, few smart, the azoospermia.At present this class treatment of conditions is still lacked certain effective method and medicine.Modern medicine, and what use is the hormones chemicals, as clomiphene (" foreign medical science family planning fascicle " 1986(3) 138), zitazonium (" spermology magazine " 1990(2) 68) etc. promoting sexual gland hormone, male sex hormone drug.In the Chinese medicine traditional medicine, though the appellation of " andrology " is arranged for a long time, owing to limited by historical conditions, for example it does not still have the sperm notion, more lacks the detection index of the Observations Means and the qualitative, quantitative of Clinical Laboratory, therefore only rests on traditional macroscopic view understanding stage.By " Zhejiang Journal of Traditional Chinese Medicine " 1989(8) determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs introduced in the argumentation of male infertility progress due to the relevant Chinese medicine dysspermatism of 378-380, specially Therapeutic Principle such as side's treatment and treatment based on differentiation of disease and method can be known and understand Chinese medicine limitation in this respect.Therefore, though have be widely adopted such as medicines such as " WUZIYANZONG WAN ", its treatment specific aim and curative effect all can not be satisfactory.

Recently, being that the basic research medicine for the treatment of this class disease also more with traditional proved recipe has a report, and what wherein be widely used has types of drugs such as Fructus Lycii, Fructus Rubi, Semen Allii Tuberosi." Guiyang College of Traditional Chinese Medicine's journal " 1986(4) 43-44 has introduced a kind of based on " WUZIYANZONG WAN ", cooperate pink Sini San, clearly through soup, the scrofula that disappears are loose, the sideization of closing sanctions such as Zengye Tang, LIUWEI DIHUANG TANG form " spermatogenesis is diffusing ", and also provide tens of kinds of medicines that when different syndromes, increase and decrease usefulness on this basis." Jiangxi Chinese medicine " 1990,21(2) 13-14 has introduced a kind ofly by tens of kinds of " Ren Shi life essence producing bolus " capsules that medicine is formed such as Herba Epimedii, Rhizoma Curculiginis, Radix Morindae Officinalis, Actinolitum, Herba Cistanches, and the required decocting of being made up of different pharmaceutical that uses respectively takes liquid when also providing different syndromes patient to take this medicine.This shows that though these medicines all have certain curative effect, medicine is formed huge, dialectical selection is complicated, has obviously increased complexity and the inconvenience used.

The objective of the invention is to according to above-mentioned situation,,, provide a kind of and turn out to be the convenient and simple again oral drugs that are used for the treatment of male infertility reliable for effect through animal experiment and Preliminary Clinical Observation in conjunction with the modern medicine means based on Chinese medicine.

Chinese medicine and modern medicine have proved all that with level male's spermatogenesis process is the reproductive physiology process of a complexity, relates to the influence of body several factors and internal condition from different perspectives.Based on the Chinese medicine traditional theory, in conjunction with the clinical effect of single medicine and modern age pharmacologic agent experimental research achievements, the composition (weight) that the invention provides medicine is: 1.8～2.8 parts of Solenognathus, 2.5～4 parts of Ootheca Mantidiss, 1.3～1.9 parts of Radix Ginsengs, 1.2～1.8 parts of Stichopus japonicuss, 1.5～2 parts of Fructus Rubies, 1.2～1.8 parts of Semen Allii Tuberosi, 1.5～2 parts of Fructus Lycii, 1 part of Galla Chinensis.This pharmaceutical composition be have spermatogenesis, educate essence, strong smart basic composition.On this compositions basis, can also add 1.4～2 parts of Hippocampus (being weight) again, 1 part of Fructus Cnidii, 1.3～1.9 parts of Hangzhoupro crust halberds, 1.5～2 parts of Radix Et Caulis Acanthopanacis Senticosis, 2.5～3.5 parts of Air Bladder pseudosciaenae seu Acipenser, 1.8～2.5 parts of Herba Cynomoriis.After adding back 6 kinds of helper components, except that spermatogenesis, educate essence, the strong smart effect, more help sterile due to the therapeutic dysfunction.

Said medicine of the present invention combination is to be based upon on the basis of " the kidney invigorating is smart with benefit, educates smart in kidney tonifying ".According to Chinese medicine interdependence between yin and yang theory, it is considered herein that, when educating essence, also should abide by treating YIN within YANG, the method for treatment for the treatment of YANG within YIN.Seminal fluid both had been considered as integral body, had also answered the dialectical understanding of forked rubbing, treated this class disease with the principle of the mutual agent of negative and positive.Observe by clinical practice, adding the product of paying attention to the essence and blood YIN nourishing when essence is mended marrow, then cloudy smart easy giving birth to.But the increase of motility of sperm needs agitating of yang-energy again, therefore should also be noted that simultaneously tonifying YANG is to impel the increase of motility of sperm.In forming, said medicine of the present invention includes animal and plant two big class natural drug material compositions.Solenognathus, Hippocampus, Stichopus japonicus etc. have adds the smart function of mending marrow, promoting spermatogenesis, wherein Solenognathus more merit doubly to Hippocampus, and it with after Semen Allii Tuberosi cooperates more because of there being active property of walking to scurry to have the merit of invigorating blood circulation.Semen Allii Tuberosi then utilizes its hot logical property performance to relax and transfers irritability, and the mechanism of qi bar is reached.Ootheca Mantidis not only has replenishing vital essence function, also has the poly-Tibetan of receiving, sting, receives the effect of taking the photograph.Except that Semen Allii Tuberosi, Fructus Rubi, Fructus Lycii, Galla Chinensis etc. also all have liver and kidney tonifying, make the syngenetic effect of essence and blood, and Galla Chinensis still has bionical effect and strengthens the reproductive physiology function, make the messenger drug of guiding and use.Hippocampus, Air Bladder pseudosciaenae seu Acipenser energy QI and blood regulating, the microcirculation improvement environment.Pharmaceutical properties such as Hangzhoupro crust halberd, Herba Cynomorii are soft and moist, and Radix Et Caulis Acanthopanacis Senticosi has the effect of the former state of adaptation, can the enhancing human body immunity function.Simultaneously, these several medicines in back also all have the function of the kidney warming reinforcing the kidney and supporting YANG.

The preparation of medicine of the present invention can be carried out according to a conventional method.Remove Radix Ginseng and Hangzhoupro crust halberd in the component with 60～85% alcohol reflux 2～3 times, effective component extracting also is condensed into outside the thick paste, and all the other each components are decocting 2～4 times routinely all, 0.5-2 hour at every turn.Decocting liquid concentrates most thick extractum by the pharmacopeia regulation, merges with above-mentioned ethanol extraction thick paste.The extractum of this merging can be made the oral agents of pharmaceutically acceptable various fluid patterns by the pharmacopeia regulation.After in addition each crude drug raw material of aforementioned pharmaceutical compositions of the present invention all being pulverized, with solid excipient filling component form and above-mentioned merging extractum by powder: after extractum is 1: 3.5～6 mixed, promptly curable and can further make the oral agents of solid-state patterns such as pharmaceutically acceptable ball, sheet, capsule.Medication characteristics and actual observation according to Chinese medicine show that each crude drug component changes in the medicine of the present invention, and practical effect is not produced evident difference in above-mentioned given amount ranges.For example, can be as shown in table 1 as some instantiations of medicine of the present invention, but these examples to should not be construed as be the qualification that the scope of the invention has been done.

Being that relevant animal experiment has been carried out on the basis by the pharmaceutical composition of the present invention of example 1 or example 2 forms wherein.

1. toxicity test

With body weight is that the healthy ICR white mice of 20 ± 2 grams are divided into two groups, all by the 9.6g(crude drug)/kg dosage (380 times of quite clinical consumptions) gavages administration with crude drug powder and decocting liquid respectively and does acute toxicity test.Altogether administration is 7 days, the equal activity of two treated animals freely, the defecation no abnormality seen, none is only dead.Put to death animal after 7 days, the no abnormal discovery of perusal internal organs becomes celestial.

Pure lines SD rat with body weight 80～120 grams makes long term toxicity test.(be equivalent to 100 times of clinical consumptions, 50 times and 5 times respectively and gavaged administration continuously 90 days, at any time according to body weight adjustment dosage, matched group gavages the distilled water with volume during the administration by per kilogram of body weight 3.6 gram (being crude drug) 1.8 grams and 0.18 gram respectively.The appetite of each administration treated animal, mobility and defecation and matched group no significant difference during the administration.Administration treated animal hair color is more smooth more lovely than matched group, and administration treated animal body weight all increases fast than matched group, and obvious with middle dosage group especially.Get the experimental animal arterial blood after 90 days and do the inspections of liver function (glutamate pyruvate transaminase, zinc sulfate turbidity), renal function (serum urea nitrogen, serum creatinine) and hemogram (erythrocyte, hematochrome, leukocyte and differential counting thereof); Separate each treated animal of agent respectively and observe internal organs, the form of organ, color and luster, and core, after organizational routines such as liver, kidney, brain, adrenal gland fix, dewater, cut into slicess, dye, microscopy observation morphological changes of various tissue components.Testing result shows that medicine of the present invention does not only have obvious damage to the rat hemogram, and the generation of erythrocyte and hematochrome is still had certain promotion.Liver function, renal function and important internal organs there is not the obvious damage effect yet.Though some index has the fluctuation of certain amplitude with the dosage increase, all in range of normal value.

These results illustrate that all the degree of safety of medicine of the present invention is big.

2. general pharmacodynamics test

Be divided into four groups at random with complete male ICR white mice, test group gavages administration by high, medium and low dosage respectively, and matched group is to gavage with the volume normal saline, and successive administration is checked body weight, testis and epididymis weight after 12 days, the results are shown in Table 2.Statistical result between test group and matched group result shows that all there were significant differences between each dosage group and matched group.

Through pure lines SD rat is experimental animal, gavages administration by 1.8g/kg and 0.18g/kg dosage group respectively, and matched group is to gavage with the volume normal saline.The hemogram testing result of the body weight change after 40 days and 90 days deferred shares of stock arterial blood works sees Table 3.And the statistical procedures between the matched group result also demonstrates significant difference or highly significant between medicine-feeding test group and matched group.

3. preliminary clinical trial is observed

With the capsule of medicine of the present invention [0.5 gram (crude drug)/grain] by every day three times, each three granule amounts are taken, with take " WUZIYANZONG WAN " medicine group and do that clinical control is observed and the semen analysis inspection, wherein the observed result to sperm growth, development sees Table 4, and Comparison of therapeutic the results are shown in Table 5.These results fully show and have proved that pharmaceutical composition of the present invention has significant spermatogenesis, educates essence and strong smart effect, to the therapeutic effect ideal of few azoospermia, and can be used for passing out semen, the treatment of the other types male infertility due to the spermatorrhea, premature ejaculation etc.

Table 1

Unit of weight: gram	Example 1	Example 2	Example 3	Example 4
					Solenognathus	2552	2227	2160	3000
Ootheca Mantidis	3364	3955	3240	4375
					Radix Ginseng	1740	1834	1404	2250
Stichopus japonicus	1508	1965	1296	1875
					Fructus Rubi	1856	2096	1728	2500
Semen Allii Tuberosi	1624	1965	1296	2000
					Fructus Lycii	2088	2358	1836	2500
Galla Chinensis	1160	1310	1080	1250
					Hippocampus			1620	1750
Fructus Cnidii			1080	1250
					Hangzhoupro crust halberd			1404	1875
Radix Et Caulis Acanthopanacis Senticosi			1620	2000
					Air Bladder pseudosciaenae seu Acipenser			2700	3375
Herba Cynomorii			1944	2500

Claims (4)

1, a kind ofly forms with material composition, be used for the treatment of the oral drugs of male infertility, it is characterized in that consisting of (weight portion) by multiple crude drug

Solenognathus 1.8～2.8

Mulberry spiral shell Octopus ocellatus Gray 2.5～4

Radix Ginseng 1.3～1.9

Stichopus japonicus 1.2～1.8

Fructus Rubi 1.5～2

Semen Allii Tuberosi 1.2～1.8

Fructus Lycii 1.5～2

Galla Chinensis 1.

2, medicine as claimed in claim 1, can also add following composition (weight portion) in it is characterized in that forming:

Hippocampus 1.4～2

Fructus Cnidii 1

Hangzhoupro crust halberd 1.3～1.9

Radix Et Caulis Acanthopanacis Senticosi 1.5～2

Air Bladder pseudosciaenae seu Acipenser 2.5～3.5

Herba Cynomorii 1.8～2.5.

3, medicine as claimed in claim 1 or 2 is characterized in that said medicine is the solid type oral formulations.

4, medicine as claimed in claim 3, it is characterized in that said medicine for by the former medicated powder of crude drug with by the resulting conventional extractum of the same former medicine of forming with 1: 3.5～6(weight) the solid type oral formulations that forms of combination drying.