CN101628073B - Preparation used for improving sexual function of male and resisting fatigue and preparation method thereof - Google Patents

Abstract

The invention relates to a preparation used for improving the sexual function of a male and resisting fatigue and a preparation method thereof. The preparation is prepared from black bean, semen allii tuberosi, yam, tuckahoe, Chinese wolfberry, Chinese dodder, arginine and zinc gluconate according to the weight ratio of 140-210:120-180:115-175:35-55:30-60:25-40:20-35:0.5-1.5. The preparation used for improving the sexual function of the male and resisting the fatigue and the preparation method thereof, which are provided by the invention, adopt a water cooking extraction method to extract effective components in plant medicines, keep the activity of the effective components and then add the arginine and the zinc gluconate as basic raw materials for replenishing essence and producing sperm, so that the dissolving-out degree of the effective components in the medicines can be greatly enhanced, and the basic raw materials are beneficial to the absorption of the medicines, thereby the bioavailability of the medicines can be enhanced and the curative effect is good. In addition, an experiment proves that the preparation of the invention is innoxious, so that the preparation can not generate toxic or side effect after being taken by a patient for a long time and the safety is good.

Description

A kind ofly be used to improve male's sexual, antifatigue preparation and preparation method thereof

Technical field

The invention belongs to field of medicaments, particularly relate to a kind of be used to improve male's sexual, antifatigue preparation and preparation method thereof.

Background technology

At present, though be used to improve male's sexual on the market and the antifatigue medicament categories is various, general or contain hormone, or be added with the carrier mass that increases penetration power, if the patient takes the former for a long time and will cause endocrine regulation, and if use latter's overlong time will damage body.In order to address the above problem, it is 96109734.5 that the present patent application people submitted a application number to China Intellectual Property Office on 10th in JIUYUE in 1996, and name is called the application for a patent for invention of " a kind of male's sexual, antifatigue medicine of improving " and obtains the authorization.This medicine is to be prepared from by Rhizoma Dioscoreae, Poria, Fructus Lycii, Semen Allii Tuberosi, Semen Nelumbinis Chinese medicine of the five flavours with as Mel, the sucrose of adjuvant.But the inventor finds that through clinical use for many years the power deficiency of the monarch drug Rhizoma Dioscoreae kidney-tonifying sperm-generating of this medicine is not so effect is fine.In addition, lack the basic material of replenishing essence spermatogenesis in this medicine, therefore for not too suitable the modern who suffers from " subhealth state " disease because of rhythm of life soon.

Summary of the invention

In order to address the above problem, the object of the present invention is to provide a kind of safety non-toxic, evident in efficacy being used to improve male's sexual, antifatigue preparation.

Another object of the present invention is to provide a kind of above-mentioned preparation method that is used to improve male's sexual, antifatigue preparation.

It is in order to achieve the above object, provided by the invention that to be used to improve male's sexual, antifatigue preparation be that the following medicine material of weight ratio is made by consumption mainly:

Semen sojae atricolor 140-210 Semen Allii Tuberosi 120-180 Rhizoma Dioscoreae 115-175

Poria 35-55 Fructus Lycii 30-60 Semen Cuscutae 25-40

Arginase 12 0-35 zinc gluconate 0.5-1.5

The described preparation method that is used to improve male's sexual, antifatigue preparation comprises the following step that carries out in order:

1) Semen sojae atricolor, Semen Allii Tuberosi, Rhizoma Dioscoreae, Poria, Fructus Lycii and Semen Cuscutae are carried out weighing and mix homogeneously according to said ratio, the water room temperature that adds 8 times of amounts then soaks 30min down;

2) under 100 ℃ temperature, above-mentioned raw materials was extracted 1 hour afterwards, filter, the water that in filtering residue, adds 6 times of amounts, under 100 ℃ temperature, filtering residue is carried out second extraction then, time is 40min, merge extracted twice liquid, and the extracting solution after will merging is concentrated into relative density 1.2g/cm under 60 ℃ temperature and normal pressure ²More than, leaving standstill more than 48 hours the leaching supernatant under 5 ℃ the temperature afterwards;

3) in above-mentioned supernatant, add arginine and zinc gluconate and mix homogeneously, then according to the pharmaceutical technology of routine and add corresponding common medicinal supplementary material and promptly can be made into and be used to improve male's sexual, antifatigue oral solid formulation, oral liquid according to said ratio.

It is provided by the invention that to be used for improving male's sexual, antifatigue preparation and preparation method thereof be the effective ingredient that the method that adopts decocting in water to extract is extracted medicinal plants, and keep its activity, add arginine, zinc gluconate basic material then as the replenishing essence spermatogenesis, can make so not only that the dissolution of effective ingredient improves greatly in the medicine, and help the absorption of medicine, thereby can improve its bioavailability, so good effect.In addition, the experiment proved that preparation provided by the invention is nontoxic, thereby the patient can not produce toxic and side effects after taking for a long time, so safety is good.In addition, preparation method technology of the present invention is simple, easy to operate.

The specific embodiment

Be used to improve male's sexual, antifatigue preparation and preparation method thereof and be elaborated provided by the invention below in conjunction with specific embodiment.

The Semen sojae atricolor that is used for improving male's sexual, antifatigue preparation provided by the invention, sweet in the mouth, darkish complexion is returned kidney channel, the likeness in form kidney, the kidney master desires, and kidney tonifying, essence replenishing is monarch drug.Rhizoma Dioscoreae, Poria, sweet in the mouth is returned spleen channel, and spleen invigorating eliminating dampness by diuresis benefit is smart, is used to strengthen the effect of monarch drug, is ministerial drug.Semen Allii Tuberosi, Fructus Lycii, Semen Cuscutae, sweet in the mouth is returned the Liver and kidney warp, warm waist knee joint, nourishing the liver and kidney, assistant principal drug assistance strength is adjuvant drug.Add arginine again, zinc gluconate is the basic material of replenishing essence spermatogenesis.Full side pulls together, and plays kidney tonifying, essence replenishing altogether, resisting fatigue, the effect of raising immunity function.

Embodiment 1: oral liquid

1) with 140g Semen sojae atricolor, 112g Semen Allii Tuberosi, 102.5g Rhizoma Dioscoreae, 28g Poria, 32.5g Fructus Lycii and 25g Semen Cuscutae mix homogeneously, the water room temperature that adds 8 times of amounts then soaks 30min down;

2) under 100 ℃ temperature, above-mentioned raw materials was extracted 1 hour afterwards, filter, the water that in filtering residue, adds 6 times of amounts, under 100 ℃ temperature, filtering residue is carried out second extraction then, time is 40min, merge extracted twice liquid, and the extracting solution after will merging is concentrated into relative density 1.2g/cm under 60 ℃ temperature and normal pressure ²More than, leaving standstill more than 48 hours the leaching supernatant under 5 ℃ the temperature afterwards;

3) in above-mentioned supernatant, add 20g arginine and 0.667g zinc gluconate and mix homogeneously, add 0.5g potassium sorbate and an amount of distilled water diluting then and under 100 ℃ temperature, heat after-filtration standby;

4) 50g white sugar, 15g Mel and 300ml distilled water are mixed back boiling sterilization 20min and make liquid glucose, filter;

5) liquid glucose of making in supernatant that process in the step 3) is diluted and the step 4) mixes, adding distil water to total amount is 1000ml and mix homogeneously, promptly can be made into and is used to improve male's sexual, antifatigue oral liquid through 5 μ m mocromembrane filtrations, check, embedding, sterilization, packing then.

Embodiment 2: tablet

1) with 122.5g Semen sojae atricolor, 122g Semen Allii Tuberosi, 93g Rhizoma Dioscoreae, 32.5g Poria, 40g Fructus Lycii and 28g Semen Cuscutae mix homogeneously, the water room temperature that adds 8 times of amounts then soaks 30min down;

2) under 100 ℃ temperature, above-mentioned raw materials was extracted 1 hour afterwards, filter, the water that in filtering residue, adds 6 times of amounts, under 100 ℃ temperature, filtering residue is carried out second extraction then, time is 40min, merges extracted twice liquid, and the extracting solution after will merging is concentrated into more than the relative density 1.2g/cm2 under 60 ℃ temperature and normal pressure, leaving standstill more than 48 hours the leaching supernatant under 5 ℃ the temperature afterwards;

3) in above-mentioned supernatant, add 22.2g arginine and 714.3mg zinc gluconate and mix homogeneously;

4) taking by weighing 60g starch, to make gelatinized corn starch standby;

5) it is standby to take by weighing 550g amylodextrin mixture, and wherein the weight ratio of starch and dextrin is 4: 1;

6) taking by weighing the 200g cane sugar powder, to be broken into powder standby;

7) with above-mentioned steps 3), 5), 6) in mixing of materials, the amylodextrin that adds again in the step 4) is made soft material, and then makes granule, under 55 ℃ temperature dry 2.5 hours, dried pellet moisture content was 4～5%;

8) will add 16g carboxymethyl starch sodium and 10g magnesium stearate mix homogeneously behind the above-mentioned dried granule granulate, compacting promptly can be made into and is used to improve male's sexual, antifatigue tablet.

Embodiment 3: granule

1) with 135g Semen sojae atricolor, 102.5g Semen Allii Tuberosi, 125g Rhizoma Dioscoreae, 30g Poria, 25.5g Fructus Lycii and 22.5g Semen Cuscutae mix homogeneously, the water room temperature that adds 8 times of amounts then soaks 30min down;

2) under 100 ℃ temperature, above-mentioned raw materials was extracted 1 hour afterwards, filter, the water that in filtering residue, adds 6 times of amounts, under 100 ℃ temperature, filtering residue is carried out second extraction then, time is 40min, merge extracted twice liquid, and the extracting solution after will merging is concentrated into relative density 1.2g/cm under 60 ℃ temperature and normal pressure ²More than, leaving standstill more than 48 hours the leaching supernatant under 5 ℃ the temperature afterwards;

3) in above-mentioned supernatant, add 19.5g arginine and 0.85g zinc gluconate and mix homogeneously;

4) taking by weighing 60g starch, to make gelatinized corn starch standby;

5) it is standby to take by weighing the 540g amylodextrin, and wherein the weight ratio of starch and dextrin is 2: 1;

6) taking by weighing 240g sucrose milk-sugar mixture, to be ground into powder standby, and wherein the weight ratio of sucrose and lactose is 5: 3;

7) with above-mentioned steps 3), 5), 6) in mixing of materials, the amylodextrin that adds again in the step 4) is made soft material, and then makes granule, under 55 ℃ temperature dry 2.5 hours, dried pellet moisture content was 4～5%;

8) with behind the above-mentioned dried granule granulate, be packaged into pouch, promptly can be made into and be used to improve male's sexual, antifatigue granule with Aluminum-plastic composite bag.

In order to verify the safety that is used to improve male's sexual, antifatigue preparation provided by the invention, the inventor has carried out toxicity inspection to the oral liquid of being made by the foregoing description 1, and the method for inspection and conclusion are as follows:

One, inspection item: LD50

The method of inspection: horn method

Assay:

Choose 40 of the body weight 180-220gWistar rats that health bureau's Experimental Animal Center provides, with equilibrium at random two step method be divided into four groups, 10 every group, male and female half and half.Preparation is mixed with sample with distilled water diluting, and by listed each group (i.g.QdX1) of dosage contamination in the following table 1, contamination back rat is looked for food separately, drinks water, and observes poisoning symptom at any time.This experiment contamination does not see that animal anomaly and death are arranged later, observes a week, the results are shown in following table 1.

Table 1, respectively organize dosage and animal dead number

2.15g/kg 4.64g/kg 10.0g/kg 21.5g/kg
	0/5 0/5 0/5 0/5 0/5 0/5 0/5 0/5

Check conclusion: the rat LD of this sample ₅₀＞150g/kg.By " toxicological evaluation of food safety procedure ", it is nontoxic that this product belongs to.

Two, inspection item: 30 days feeding trials

The method of inspection: GB15193.13-94

Assay:

The rat of body weight 30-130g is divided into four groups with two step method at random, 20 every group, male and female half and half, single cage is raised, and irritates stomach every day by group, and irritating the stomach amount is 1.6mg/0.1kg, and the feed normal feedstuff, ad lib, drinking-water was fed 30 days.

During the nursing, write down food-intake weekly and weigh, and observe the outer table status of animal, action, morbidity and death condition.In the 15th, 30 day whole rats are carried out hematology's (measuring leukocyte count, RBC number with routine clinical method), biochemical indicator mensuration (glutamate pyruvate transaminase, blood urea nitrogen, total serum protein and albumin, blood glucose, T-CHOL) and pathological examination.

1, clinical examination: each dosage treated animal of this oral liquid is not seen dystropy, poisoning symptom and death.

2, hematology and biochemical test:

(1) institute's survey leukocyte, RBC number are compared with matched group with the hemoglobin value, there are no significant for difference.

Got blood in (2) the 15th days and survey in every value, middle dosage, high dose group buck blood sugar content are higher than matched group (seeing Table 2), and difference has significance, all other and the no significant difference of contrast.The 30th day survey in every value, low dose group and high dose group buck blood sugar content are higher than matched group, difference has significance.Middle dosage group buck glutamate pyruvate transaminase is higher than matched group, and difference has significance.All other and matched group compare, and there are no significant for difference (P＞0.05) to learn check (t check) by statistics.

3, liver/body, kidney/body, testis (uterus)/body ratio:

It is high, middle that dosage group jenny kidney/the body ratio is higher than matched group, and difference has significance; Other each dosage group and normal control group are relatively learned check (t check) P＞0.05 by statistics, and difference does not have significance (seeing Table 3).

4, pathological examination

According to the requirement of program,, do not find obvious pathological changes through perusal.Only liver, kidney, stomach, the intestinal tissue with matched group and high dose group animal carries out pathologic finding.High dose group kidney pathological observation individual animal has slight congestion as a result, and the liver of matched group and high dose group, stomach, intestinal there is no obvious pathological changes.

Table 2,30 days biochemical summary sheets of feeding trial

Sample title: be used to improve male's sexual, antifatigue oral liquid

Group ♀ 1

Dosage g/kg contrast

Blood glucose X ± S 13.83 ± 6.39

Blood urea nitrogen X ± S 30.11 ± 5.60

Glutamate pyruvate transaminase X ± S 67.75 ± 15.87

Total protein X ± S 8.224 ± 0.685

T-CHOL X ± S 73.98 ± 17.08

♀2 ♀3

1.04 4.16

17.77±3.37 17.32±4.01

30.67±2.94 27.72±3.31

76.00±14.05 75.10±13.09

8.341±0.332 8.713±0.668

91.13±13.95 ※ 88.41±26.35

♀4 ♂1

16.64 contrast

17.41±3.36 9.94±4.51

27.05±4.32 28.14±3.17

74.70±7.73 90.60±12.98

8.392±1.447 8.726±0.706

94.37±12.05 92.22±15.23

♂2 ♂3

1.04 4.16

17.18±6.44 ※※ 14.80±4.91

28.34±2.67 26.83±2.33

83.50±11.21 74.57±15.14※

8.533±0.441 8.674±0.537

81.63±10.97 82.49±13.70

♂4

16.64

14.31±4.42

28.96±1.34

78.50±15.58

8.514±0.740

91.29±12.15

Annotate: ※ is P＜0.05, and ※ ※ is P＜0.01

Table 3,30 days feeding trial internal organs index summary sheets

Sample title: be used to improve male's sexual, antifatigue oral liquid

Group ♀ 1	Dosage g/kg contrast	Liver/body weight X ± S 0.0323 ± 0.0042	Kidney/body weight X ± S 0.0077 ± 0.0006	Testis (uterus)/body weight X ± S 0.0017 ± 0.0005	Food utilization X ± S 19.55 ± 3.51
						♀2 ♀3	1.04 4.16	0.0327±0.0014 0.0347±0.0016	0.0073±0.0026 0.0090±0.0007	0.0021±0.0009 0.0020±0.0007	21.82±3.49 19.55±3.51
♀4 ♂1	16.64 contrast	0.0355±0.0033 0.0321±0.0022	0.0091±0.0006 0.0083±0.0006	0.0022±0.0009 0.0116±0.0022	21.21±2.85 24.41±1.73
						♂2 ♂3	1.04 4.16	0.0323±0.0050 0.0346±0.0034	0.0082±0.0013 0.0083±0.0006	0.0120±0.0038 0.0126±0.0027	25.33±2.47 22.11±2.39
♂4	16.64	0.0342±0.0028	0.0085±0.0009	0.0156±0.0113	22.70±3.47

Annotate: ※ is P＜0.05, and ※ ※ is P＜0.01

Check conclusion:

According to toxicological evaluation of food safety procedure (GB15193.13-94), carry out rat with this oral liquid and fed experiment in 30 days.The result shows: clinical examination, each dosage treated animal is not seen dystropy, poisoning symptom and death.Hematology and biochemical test, experimental group animal blood glucose, T-CHOL and the indivedual dosage of glutamate pyruvate transaminase measured value are higher than matched group; Internal organs are weighed, and high, middle dosage group jenny kidney/body ratio is higher than matched group, and difference has significance, other respectively organize each dirty/body than and matched group relatively, difference does not have significance; Pathological examination, liver, gastrointestinal there is no obvious pathological changes.

In order to verify the therapeutic effect that is used to improve male's sexual, antifatigue preparation provided by the invention, the inventor has carried out the sexual function improving detection to the oral liquid of being made by the foregoing description 1, and the method for inspection and conclusion are as follows:

Test item: sexual function improving

Test basis: " the health food function assessment assessment process and the method for inspection "

Result and judgement:

Per os gives the oral liquid 30 days of mice 2.5,5.0,15.0ml/kgb.w, shows as female, male Mus and mates that the male Mus in back catches incubation period, copulation has shortening trend incubation period, catches number of times in 20 minutes, number of copulations obviously increases.Catch rate, mating rate have the trend of raising.Illustrate that this oral liquid has the effect of certain sexual function improving.

Simultaneously, the patient that the inventor utilizes the oral liquid in the above-mentioned preparation that 300 examples are suffered from the renal deficiency type sexual impotence has carried out system's clinical observation, wherein 23 years old～30 years old 46 people, 31 years old～40 years old 65 people, 41 years old～50 years old 74 people, 51 years old～60 years old 66 people, 61 years old～70 years old 49 people, every day 3 times, each ante cibum 10ml, 60 days is 1 course of treatment.Person evident in efficacy after 1-2 course of therapy (penis can erect before having sexual intercourse, and can carry out normality life, other sxs or disappearance) 198 examples account for 66%; Treatment responder (penis can erect before having sexual intercourse, but act and not hard can be carried out sexual life, other sx) 91 examples account for 30.3%; Nonresponder's (have sexual intercourse preceding penis anorthosis or erection time are very short, can not carry out the normality life) 11 examples account for 3.7%, and total effective rate reaches 96.3%.

Simultaneously, the inventor analyzes the relation between therapeutic effect and age, therapeutic effect and the course of disease, and analysis result sees Table 4 respectively, table 5.

Table 4, oral liquid treatment effect provided by the invention and age relation table

By statistical procedures, the result is p value＞0.5, can prove that thus taking oral liquid provided by the invention treats the renal deficiency type sexual impotence with the data in the above-mentioned table 4, and the therapeutic effect of each age group is not changed with the age.

Table 5, oral liquid treatment effect provided by the invention and course of disease relation table

By statistical procedures, the result is p value＞0.5 with the data in the above-mentioned table 5, can prove that thus the curative effect of oral liquid provided by the invention and course of disease length are irrelevant.

The deficiency of the kidney of suffering from a deficiency of the kidney can cause a series of diseases, by clinical verification, take provided by the inventionly be used to improve that male's sexual, antifatigue preparation can play allaying tiredness, replenish energy, improve sleep, appetite stimulator, build up one's resistance to disease, increase immunity, slow down aging, increase semen volume, the effect such as motility of sperm that improves, especially sexual disorder, sexual impotence there is good effect, take for a long time and can make the man in vigorous health, return the real masculine of man.

Claims (1)

1. one kind is used to improve male's sexual, antifatigue preparation, it is characterized in that: described to be used to improve male's sexual, antifatigue preparation be that the following medicine material of weight ratio is made by consumption:

Semen sojae atricolor 140-210 Semen Allii Tuberosi 120-180 Rhizoma Dioscoreae 115-175

Poria 35-55 Fructus Lycii 30-60 Semen Cuscutae 25-40

Arginase 12 0-35 zinc gluconate 0.5-1.5;

Described formulation preparation method comprises the following step that carries out in order:

1) Semen sojae atricolor, Semen Allii Tuberosi, Rhizoma Dioscoreae, Poria, Fructus Lycii and Semen Cuscutae are carried out weighing and mix homogeneously according to said ratio, the water room temperature that adds 8 times of amounts then soaks 30min down;

2) under 100 ℃ temperature, above-mentioned raw materials was extracted 1 hour afterwards, filter, the water that in filtering residue, adds 6 times of amounts, under 100 ℃ temperature, filtering residue is carried out second extraction then, time is 40min, merge extracted twice liquid, and the extracting solution after will merging is concentrated into relative density 1.2g/cm under 60 ℃ temperature and normal pressure ²More than, leaving standstill more than 48 hours the leaching supernatant under 5 ℃ the temperature afterwards;

3) in above-mentioned supernatant, add arginine and zinc gluconate and mix homogeneously, then according to the pharmaceutical technology of routine and add corresponding common medicinal supplementary material and promptly can be made into and be used to improve male's sexual, antifatigue oral solid formulation, oral liquid according to said ratio.