US20060263457A1

US20060263457A1 - Pharmaceutical composition for treatment of emiction disorders caused by benign prostate hyperplasia (BPH) and the method

Info

Publication number: US20060263457A1
Application number: US11/452,663
Authority: US
Inventors: Zouguang Zhang; Yufen Wang
Original assignee: BEIJING WONNER BIOTECH Ltd Co
Current assignee: BEIJING WONNER BIOTECH Ltd Co
Priority date: 2003-03-28
Filing date: 2006-06-14
Publication date: 2006-11-23
Also published as: US7556828B2; WO2004084924A1; CN1305487C; US20050220904A1; AU2003236105A1; CN1533800A

Abstract

A pharmaceutical composition with higher curative effect on benign prostate hyperplasia and emiction disorders is disclosed. It uses plants such as ginseng and gingko as well as cassia twig, cinnamon and liquorices both for food and medicine as raw materials. These raw materials are decocted or extracted separately in ethanol solution or water, then concentrated and dried to make the said pharmaceutical composition. Because this pharmaceutical composition is not toxic and has no side effect, it can be prepared as a medicament and healthy food to treat and improve benign prostate hyperplasia and emiction disorders caused by benign prostate hyperplasia.

Description

TECHNICAL FIELD

This Invention relates to a kind of pharmaceutical composition with its main efficacy for improvement and treatment of emiction disorders caused by benign prostate hyperplasia (BPH). It can be used as medicament and healthy food.
This Invention also relates to a preparation method of the pharmaceutical composition with its main efficacy for improvement and treatment of emiction disorders caused by benign prostate hyperplasia (BPH).

BACKGROUND OF THE INVENTION

The emiction disorder caused by benign prostate hyperplasia (BPH) is a kind of familiar and frequently-occurring disease that harms and distresses the health of old and middle-aged men. Especially with the increase of aged population in recent years, its incidence rises continuously. Taking the United States of America as an example, almost one third of American adult men have BPH diseases statistically. In China, the BPH incidence trends to go up swiftly. According to the investigation, up to now the incidence of Chinese men above 41 years old has risen from 6.6% in 1936 to 30.5%.
The modern medical studies have proven that there are two factors leading to lower urethra hamperness caused by prostate hypertrophy, that is, dynamic and static factors. At present, two major categories of medicaments are used clinically to treat BPH: α1-adrenal receptor blocking agent and 5α-reductase inhibitor (antiandrogen). The α1-adrenal receptor blocking agent acts on smooth muscles of prostate gland and neck of bladder to reduce their tension. Thus the dynamic factor of blocked exit of urinary bladder is released to abate or remove the clinical symptoms. Its representative medicaments are HARNAL, TERAZOSIN, etc. The 5α-reductase inhibitor inhibits Prostate Hyperplasia with inhibiting testosterone from being transformed into DHT, with its representative medicaments such as PROSCAR. These two kinds of medicaments have obvious curative effect in treatment and improvement of BPH dysuria, but they have also different degrees of side effects for patients. The frequently used compound medicaments of pure plants for clinical treatment of BPH are CEFASABAL and PROSTAT pollen preparation. The features of these medicaments are secure, but usually with long period of treatment, e.g., with poor immediate curative effect.
From the viewpoint of the Chinese Traditional Medicine, the emiction disorder caused by BPH belongs to the category of dysuria and blocking. The dysuria said in the Chinese Traditional Medicine refers to difficult emiction, slim and fragile urine line and blocked urine. When man pisses uneasily and difficultly with light degree of seriousness, it is dysuria. When man can not piss or it is blocked with a full lower abdomen and acute degree of seriousness, it is called blocking. The medical principle of the compound preparation of Chinese traditional medicaments for treatment of BPH is a multiple targeting and multiple directing treatments. Its advantage is that patients are treated as a whole and it is safe. But its shortcoming is as same as the compound medicaments of pure plants in the modern medicine.
In the prior art, the Chinese Patent No. 98113889.6 describes a kind of capsule and its preparation method. With that method, the raw materials such as rough gentian, dried rehmannia root, Tuckahoe, celery wormwood, root of Chinese thorowax, tulip, cordate houttuynia and devilpepper are decocted in 8-fold water for 2 hours first, and the decoction is filtered. Secondly, it is decocted in 5-fold water for a hour, and the decoction is filtered. Thirdly, it is decocted in 3-fold water for a hour, and the decoction is filtered. Then the three decoctions are combined, decompressed, and concentrated as a dry extract. After it is dried, it is comminuted and put in capsules. It has effects of clearing away the heat-evil and expelling superficial evils, relieving rheumatic pains; colds, etc and reducing swellings, relaxing the liver-fire and dispelling melancholy, and activating blood circulation to dissipate blood stasis. It is applicable for diseases such as acute and chronic prostatitis, prostate hypertrophy, etc. In the clinical observation, it has obvious curative effects, and the symptom of dysuria is obviously improved. And its efficiency rate reaches 90%. But its prescription is relatively complicated, especially with uncertain effect on emiction disorders.

SUMMARY OF THE INVENTION

In order to overcome the shortcomings in the prior art, the object of this invention is to provide a kind of pharmaceutical composition with its main efficacy for improvement and treatment of emiction disorders caused by benign prostate hyperplasia (BPH), especially a kind of medicament of plants, which can be used both as medicament and healthy food.
This kind of pharmaceutical composition made of raw materials both as medicament and food has no noxious effect (side effect) and can be taken as a medicament for treatment of BPH emiction disorders for a long time. And it can also be used as healthy food for antiaging immunity-raising purposes.
Based on the principles, methods, prescriptions and medicaments about dysuria and blocking in the Chinese traditional medicine and combined with treatment mechanism of the modern medicine, the solution of the pharmaceutical composition in this invention is researched and developed and is a kind of Chinese medicament of pure plants with its main efficacy for improvement and treatment of emiction disorders caused by benign prostate hyperplasia (BPH). Its features are obvious curative effect and safe with strong immediate curative effect. It can initially improve the subjective and objective body symptoms of BPH patients only after it is taken for a week. When taking for a long time, it can also raise immunity and antiaging capability of patients.
The other object of this invention is to provide a preparation method of the above mentioned pharmaceutical composition with its main efficacy for improvement and treatment of emiction disorders caused by benign prostate hyperplasia (BPH).
In order to reach the aim in this invention, this invention provides the following technical solution.
In the first embodiment, this invention refers especially to a pharmaceutical composition with its main efficacy for improvement and treatment of emiction disorders caused by benign prostate hyperplasia (BPH), characterized by comprising 9-45 shares of Ginseng and 20-100 shares of core of Gingko, preferably 18-36 shares of Ginseng and 40-80 shares of core of Gingko based on the weight ratio.
The said pharmaceutical composition is more preferably prepared with the components with the weight ratio of 27 shares of Ginseng and 60 shares of core of Gingko.
In the second embodiment, 2-30 weight shares of cinnamon and 2-10 shares of liquorices can be further included in the pharmaceutical composition with its main efficacy for improvement and treatment of emiction disorders caused by benign prostate hyperplasia (BPH) to enhance the anti-inflammatory and inhibitive effect on prostate hypertrophy.
In the third embodiment, on the basis of the second embodiment, 6-12 weight shares of cassia twig can be further added in the pharmaceutical composition with its main efficacy for improvement and treatment of emiction disorders caused by benign prostate hyperplasia (BPH) to strengthen the diuretic effect of the pharmaceutical composition in this invention.
The said pharmaceutical composition in this invention contains the pharmaceutically acceptable carriers or additives and the said composition can be any pharmaceutical form, preferably powder or tablets.
This invention also directs to an extract of the invented pharmaceutical composition with its main efficacy for improvement and treatment of emiction disorders caused by benign prostate hyperplasia (BPH). The said extract is obtained with the following method, comprising:

1. soaking and extracting 9-45 weight shares of ginseng in ethanol or water, following by separation and purification by means of chromatography and dry to get the first extract;
2. soaking and extracting 20-100 weight shares of core of gingko in ethanol solution or water, following by separation and purification by means of chromatography and dry to get the second extract;
3. mixing the first extract obtained from the step 1 and the second extract obtained from the step 2 following by crushing and sieving to get the invented extract.

In the above mentioned method, 18-36 weight shares of ginseng and 40-80 weight shares of core of gingko are preferable, 20 weight shares of ginseng and 60 weight shares of core of gingko are more preferable.
In the above mentioned method, the extract out of the water or ethanol solution of 2-30 weight shares of cinnamon and 2-10 weight shares of liquorices can also be added.
In the above mentioned method, the extract out of the water or ethanol solution of 6-12 weight shares of cassia twig can also be added.
The said extract can be processed as any types of medicament in pharmacy. The said extract can contain the pharmaceutical acceptable carriers or additives.
In addition, the present invention also relates to a method for pharmaceutical extracts with its main efficacy for improvement and treatment of emiction disorders caused by benign prostate hyperplasia (BPH). The method comprises the following steps of:

1. soaking and extracting 9-45 weight shares of ginseng in ethanol or water, following by separation and purification by means of chromatography and dry to get the first extract;
2. soaking and extracting 20-100 weight shares of core of gingko in ethanol solution or water, following by separation and purification by means of chromatography and dry to get the second extract;

3. mixing the first extract obtained from the step 1 and the second extract obtained from the step 2 following by crushing and sieving to get the invented extract.
In accordance with the second embodiment of this invention, 2-30 weight shares of cinnamon and 2-10 weight shares of liquorices are soaked and extracted in water or ethanol solution, concentrated and dried to get extract. Then the obtained extract is further crushed with the first and second extracts obtained in Step 1 and 2 together to get the extract of present invention.
In accordance with the third embodiment of this invention, 6-12 weight shares of cassia twig are in water or ethanol solution extracted, concentrated and dried to obtain another extract. Then it is crushed with the extract of this invention obtained in the second embodiment together to get the other extract of this invention.
In addition, the present invention also concerns a method, by which extracts are made for a kind of pharmaceutical composition with its main efficacy for improvement and treatment of emiction disorders caused by benign prostate hyperplasia (BPH). The method comprises the following steps, characterized by that 9-45 weight shares of ginseng, 20-100 weight shares of core of gingko, 6-12 weight shares of cassia twig, 2-30 weight shares of cinnamon and 2-10 weight shares of liquorices are decocted in water or ethanol solution to obtain their separate extracts. And the separated extracts are concentrated separately to obtain their paste extracts. Then they are dried separately to obtain the water or ethanol extracts followed by mixing together and crushed.
In other words, it is well known by all the skilled person in the art that all the raw materials said in this invention can be extracted with the known methods to prepare and obtain their own dry extracts separately. Then after they are dried, crushed, sifted out and mixed, the mixture made of all the raw materials in this invention is obtained.
According to the present invention, ginseng, its original plant is Panax gineng C. A. Mey, and its rootstock can be used. According to different processing methods, the medical commercial garden ginsengs, also called the seedling ginsengs, include red ginseng, strake ginseng, sugar-dipped ginseng, white ginseng, sun-dried ginseng, suncured white ginseng root, nipped ginseng and Dali ginseng. Additionally, it can include wild ginseng, migrated ginseng, Korean ginseng and Korean red ginseng.
The core of gingko, its original plant is Ginkgo biloba L. The medical part used in this invention is its dried seeds without their crusts
The cassia twig is the young twig of the Cinnmomum cassia Presl.
The cinnamon is the dried tree or twigs bark of the Cinnmomum cassia Presl.
The liquorices are the roots and root-shaped stems of the Glycyrrhiza uralensis Fisch.
The pharmaceutical composition or extracts of this invention can be used to make healthy food or food complements.
The pharmaceutical composition or extracts of this invention can be used as a medicament with its main efficacy for improvement and treatment of emiction disorders caused by benign prostate hyperplasia (BPH). It has antiaging functions. When man takes it for a long time, it can not only improve emiction disorders, but also enhance human immunity. The pharmaceutical composition or extracts have the following features and advantages:

1. The raw materials of the pharmaceutical composition or extracts said in this Invention are all natural edible plants both for medicaments and food. All the components apply with the regulations of the “Management Methods of Healthy Food” and the “Medicine Act” of the PRC. They have no toxic or side effect. And man can take it for a long time.
2. In the field of improvement and treatment of emiction disorders caused by benign prostate hyperplasia (BPH), the pharmaceutical composition or extracts in this invention has obvious efficacy and strong immediate curative effect. It can initially improve the subjective and objective body symptoms of BPH patients only after it is taken for a week. When it is taken for a long time, it can also raise immunity and antiaging capability of patients.
3. It has antiaging functions. When man takes it for a long time, it can not only improve emiction disorders, but also enhance human immunity.
4. The pharmaceutical composition or extracts has not only proven in human and animal tests that it can improve and treat effectively emiction disorders caused by benign prostate hyperplasia (BPH), but also the contents and action mechanism of its main functional factors (ginseng saponin, cassia aldehyde, etc.) have been found out.
5. The pharmaceutical composition or extracts need not to be decocted with easy transportation and medicine-taking. It applies with the regulations of the Health Act of the PRC.
6. The pharmaceutical composition or extracts have the potential values for further development of series of products (food, healthy food and medicaments).

The application of the pharmaceutical composition or extracts are given below:

1. This product can be used as antiaging food and healthy food that improve emiction disorders caused by benign prostate hyperplasia (BPH) and enhance human immunity.
2. This product can be used as medicament that improves and treats emiction disorders caused by benign prostate hyperplasia (BPH)

DESCRIPTION OF THE DRAWINGS

FIG. 1 describes the processing procedures of this invented method.
FIG. 2 describes another processing procedure of this invented method.
FIG. 3 describes another processing procedure of this invented method.

DETAILED DESCRIPTION OF THE INVENTION

In combination with the FIGS. 1, 2 and 3, the present invention is explained in details as follows.

EXAMPLE 1

Referring to FIG. 1, 27 kg of ginseng was soaked and extracted in 70% ethanol solution. And then it was chromatographed, purified and dried to get the ethanol extract. 60 kg core of gingko was decocted in water, filtered, concentrated and dried to get the water dry extracts. The ethanol extract and water dry extract obtained in the above mentioned steps were mixed together and crushed, sifted with a 80-mesh screen to obtain the extract of the present invention.

EXAMPLE 2

Repeating the same procedures in Example 1 except that 9 kg of ginseng and 20 kg of core of gingko were soaked and extracted in the ethanol solution separately.

EXAMPLE 3

Repeating the same procedures in Example 1 except that 45 kg of ginseng and 100 kg core of gingko were decocted in water separately.

EXAMPLE 4

Referring to FIG. 1, 27 kg of ginseng was soaked and extracted in 70% ethanol solution. And then it was chromatographed, purified and dried to obtain ethanol extract.
60 kg of core of gingko, 3 kg of cinnamon, 3 kg of liquorices and 9 kg of cassia twig were decocted in water, filtered, concentrated and dried to obtain dry water extracts.
The ethanol and dry water extracts obtained in the above mentioned steps were mixed together and crushed, sifted with a 80-mesh screen to obtain the extract of the invention. The composition of this invention was prepared directly into capsules with the method known by person skilled in the art.

EXAMPLE 5

Repeating the same procedures in Example 4 except that 45 kg of ginseng, 100 kg core of gingko, 2 kg of cinnamon, and 2 kg of liquorices were extracted in ethanol solution or water separately. Then they were mixed and crushed to obtain the extract of the invention.

EXAMPLE 6

Repeating the same procedures in Example 4, except that 9 kg of ginseng, 20 kg of core of gingko, 30 kg of cinnamon, and 10 kg of liquorices were extracted in ethanol solution or water separately. Then they were mixed and crushed to obtain the extract of the invention. The composition of the invention was prepared directly into powder with the method known by person skilled in the art.

EXAMPLE 7

Repeating the same procedure in Example 6 except that 12 kg of cassia twig was added.

EXAMPLE 8

Repeating the same procedures in Example 5 except that 6 kg of cassia twig was added.

EXAMPLE 9

Referring to FIG. 3, 27 kg of ginseng was soaked and extracted in 70% ethanol solution. And then it was chromatographed, purified and dried to obtain the ethanol extract. 60 kg of core of gingko was soaked and extracted in water. It was filtered, concentrated, and dried to obtain the dry water extract. Then the ethanol and dry water extracts obtained in the above mentioned steps were mixed and crushed to obtain the extract.
24 kg of cinnamon and 6 kg of liquorices were mixed and decocted in 95% ethanol solution. After it was filtered and concentrated, it is absorbed with a proper amount of officinal calcium hydrogen phosphate, and then dried to obtain the dry ethanol extract.
The dry ethanol extract of ginseng and the dry water extract of core of gingko obtained in the above steps were mixed with the dry ethanol extracts of cinnamon and liquorices together, crushed and filtered with 80-mesh screen to obtain the extract said in this invention. The combination or composition of this invention was prepared directly into powder with the method known by person skilled in the art.

EXAMPLE 10

Again referring to FIG. 3, repeating the same procedures in Example 9 except that 18 kg of ginseng, 40 kg of core of gingko, 2 kg of cinnamon and 2 kg of liquorices were decocted and extracted in water.
The dry water extracts of ginseng and gingko were dried together with the dry water extracts of cinnamon and liquorices to make the dry extract of the combination.

EXAMPLE 11

27 kg of ginseng, 60 kg of core of gingko, 9 kg of cassia twig, 3 kg of cinnamon and 3 kg of liquorices were taken. Then the said ginseng, gingko, cassia twig, cinnamon and liquorices were decocted in water or 70% ethanol solution and filtered separately to obtain their own extracts. They were concentrated to obtain their dry extracts, and then were dried to obtain their own dry water or ethanol extracts separately. Finally, the obtained dry extracts were crushed and filtered with an 80-mesh screen to be mixed together to obtain the extract of the invention.

EXAMPLE 12

9 kg of ginseng and 20 kg of core gingko were taken. With the method known by the person skilled in the art, they were directly crushed and filter with an 80-mesh screen to obtain the pharmaceutical composition of the invention. Accordingly with the method known by the person skilled in the art, they were directly pressed and made into tablets.

EXAMPLE 13

45 kg of ginseng, 100 kg of core of gingko, 30 kg of cinnamon and 10 kg of liquorices were taken. With the method known by the person skilled in the art, they were directly crushed and filtered with an 80-mesh screen to obtain the pharmaceutical composition of the invention. Then with the method known by the person skilled in the art, they were directly pressed and made into tablets.

EXAMPLE 14

Repeating the same procedures in Example 13 except that 12 kg of cassia twig was added, crushed and sifted out.

EXAMPLE 15

Repeating the same procedure in Example 13 except hat 18 kg of ginseng, 40 kg of core of gingko, 3 kg of cinnamon, 4 kg of liquorices and 6 kg of cassia twig were crushed into powder. Then with the method known by the person skilled in the art, the composition of the invention is made into capsules.

EXPERIMENTING EXAMPLE 1

Impacts on prostate hyperplasia of rats caused by testosterone propionate by medicaments of anti prostate hyperplasia and the extracts of this invention were done as below.

Experimental Materials

Medicaments:

1. PROSCAR: tablets, produced by Merck & Co., Inc., (UK) Co. The medicament was prepared into 0.5 mg/ml medicament.
2. Saw Palmett tablets, produced by Zhejiang Conba Pharmaceutical Co. Ltd. It was prepared with distilled water into 0.5 mg/ml medical liquid.
3. Longbishu Capsules: produced by SHIJIAZHUAN KEDI Pharmaceutical Co., Ltd. It was prepared with distilled water into 0.18 g/ml medical liquid.
4. The extract was taken from Example 9. The extract was prepared into 6 g/ml medical liquid.
5. Estradiol Benzoate Injection
6. Testosterone propionate Injection
Test Method and Results

The 130 g-150 g male Wistar rats were taken as test animals and anaesthetized with ether. Both of their testis were removed under axenic conditions and bred for a week after operation. The rats were divided at random into 6 groups, 6 in each group. All groups of animals were hyped with 5 mg/Kg testosterone propionate dissolved in prepared peanut oil per day. And they were simultaneously medicated, that is, the contrast groups were drunk by force with physiological salt solution. The medicine-taking groups were drunk by force with 5 mg/Kg PROSCAR, 5 g/Kg Saw Palmetto, 1.8 g/Kg longbishu, 6 g/Kg extract obtained from Example 9 in this invention, with the medicine-taking 1 ml/100 g volume; and for hypodermic injection of 50 μg/Kg estradiol benzoate, the volume was 0.05 ml/Kg, once a day and continuously for 30 days. In 24 hours after the last medicine-taking, all the rats were killed. The whole prostate glands were anatomized. The prostate glands were placed in formalin. All the fat were removed away after the prostate glands were taken out. The liquid on the surface was dried with filter papers. They were weighed with a tissue balance to calculate the weight (factors) of prostate glands. Table 1 shows the results.

TABLE 1


Impact on Prostate Gland Factors (mg/100 g) of Rats by medicaments
of anti prostate hyperplasia x ± SD

					Sum of
					three
					lobes
	Dosage/volume				(anterior,
	g/kg	Number			head and
	weight	of	Anterior	Inhibition	posterior	Inhibition
Medicament	g/kg	animals	lobe	rate %	lobes)	rate %

Contrast	—	10	284.7 ± 75.7		721.2 ± 129.7
group

estradiol	50	μg/Kg	10	180.1 ± 55.8	36.7**	585.3 ± 80.5	18.8**
benzoate
PROSCAR
	5	mg/Kg	10	164.2 ± 31.4	42.3**	453.4 ± 59.1	37.1**
Saw Palmett	5	g/Kg	10	250.6 ± 40.9	11.9**	656.5 ± 88.1	4.7**
Longbishu	1.8	g/Kg	10	231.4 ± 37.0	18.7**	650.2 ± 68.1	9.8**
The extract	6	g(crude	10	190.2 ± 30.3	33.2**	497.9 ± 81.1	30.9**
		drug)/Kg

Note:
compared with the contrast groups:
*P < 0.05,
**P < 0.01

EXPERIMENTING EXAMPLE 2

Study on the Action of Anti Prostate Hyperplasia by the Extract in this Invention

In order to evaluate the action of anti prostate hyperplasia by the extract in this Invention, the anti-inflammatory action of the extract in this intention and its impact on prostate hyperplasia caused by Testosterone Propionate were observed in this experiment.
Experimental Materials
1. Animals: 1) Wistar rats and 2) mice of Kunming origin
2. Medicaments:
2.1 The extract obtained in Example 9 in this invention
2.2 Estradiol benzoate Injection
2.3 Testosterone Propionate injection
2.4 Hydrocortisone acetate injection
Experimental Method and Results
1. Impact on Otic Swelling caused by Mixed Inflammatory Solution of Croton Oil

60 18-22 g male mice were selected and divided in 6 groups randomly, 10 in each group: a contrast group of physiological salt solution, a group of hydrocortisone, a group of Saw Palmett, and three dosage groups of the extract obtained in Example 9 in this invention (1.5, 3.0 and 6.0 g/kg). They were drunk by force with the medicaments in the stomachs, once a day, and continuously for 5 days. After the last medicament, the mixed inflammatory solution of croton oil (2% croton oil, 20% anhydrous ethanol, 5% distilled water and 73% ether) was applied on the both front and rear sides of the left ears of animals, 0.05 ml each mouse. Four hours after inflammation, the mice were killed with a disjointed cervical vertebra method. The two ears were cut along the auricle baseline. The equal parts of the two ears with the same area were cut off and weighed on weighing scales to test twisting force. When the weight of the right ear was subtracted from the weight of the left ear of each mouse, it got the swelling degree. The swelling degrees between the contrast groups and the medicine-taking groups were processed statistically; the swelling inhibition rate was got. Table 2 shows the results.

TABLE 2


Impact on otic swelling degrees caused by mixed inflammatory
solution of croton oil by the extract in this Invention

			Swelling
			degree		Inhab-
		Number of	(mg)		itation
Groups	Dosage	animals	(x ± SD)	P	rate %

Contrast

			10	17.85 ± 2.05
group
The said	1.5	g/kg	10	15.25 ± 2.26	<0.05	14.56
extract
The said	3	g/kg	10	13.10 ± 1.45	<0.01	26.61
extract
The said	6	g/kg	10	11.55 ± 2.38	<0.01	35.29
extract
Saw Palmett	2.5	g/kg	10	12.65 ± 1.30	<0.01	29.13
Hydrocortisone	20	mg/kg	10	9.50 ± 2.93	<0.01	46.77

The results have shown that the high, middle and low dosages of the extract in this invention can all obviously reduce the swelling degrees of mouse otic inflammation caused by the mixed inflammatory solution of croton oil. The extract in this Invention has an anti-inflammatory action.

EXPERIMENTING EXAMPLE 3

Impact on Permeability of Mice Celiac Capillary Vessels

The same experimental materials and animals as in Experimenting Example 2 were used. But it was different that 60 18-22 g male mice were selected and divided in 6 groups in accordance with their weight, 10 in each group: a contrast group of physiological salt solution, a group of hydrocortisone, a group of Saw Palmett, and three dosage groups of the extract obtained in Example 9 in this invention (1.5, 3.0 and 6.0 g/kg). They were drunk by force with the medicaments in the stomachs once a day, and continuously for 5 days. One hour after the last medicament, they were intravenously injected with 0.5% Evans blue in a 5 ml/kg dosage. After 5 minutes, 0.7% acetic acid in a dose of 10 ml/mg was injected in their abdomens. After 30 minutes, they were killed with a disjointed cervical vertebra method. Their abdomens were washed many times with distilled water. The washing solution was changed to the total amount of 10 ml/mg, and 0.1N NaOH 0.1 mL was added. After it was placed for 30 minutes, the light density of mice celiac transudate was measured with a colorimetry of a 721 spectrophotometer. Table 3 shows the results.

TABLE 3


impact on permeability of capillary vessels
by the extract in this Invention

		Number	Evans blue		Inhibi-
		of	transudate (OD		tion rate
Groups	Dosage	animals	x ± SD)	P	(%)

Contrast			10	0.166 ± 0.04
The said	1.5	g/kg	10	0.133 ± 0.030	>0.05	19.87
extract
The said	3	g/kg	10	0.117 ± 0.031	<0.01	29.52
extract
The said	6	g/kg	10	0.100 ± 0.027	<0.01	39.75
extract
Saw Palmett	2.5	g/kg	10	0.122 ± 0.033	<0.05	26.51
Hydrocortisone	20	mg/kg	10	0.092 ± 0.019	<0.01	44.58

The results have shown that the high, middle and low dosages of the extract in this invention can all obviously reduce the permeability of mice celiac capillary vessels and make the Evans blue transudate decline. It shows that the extract in this Invention has an anti-inflammatory action.

EXPERIMENTING EXAMPLE 4

Impact on Tampon Granuloma of Rats

The same experimental materials and animals as in Experimenting Example 2 were used. But it was different that 60 150-180 g male rats were used. Under the ether anaesthesia and normal disinfection, two ±1 mg sterilized tampons were embedded under the inguinal skins on the both sides. On the same day of operation, the 60 rats were randomly divided in 6 groups, 10 in each group: a contrast group of physiological salt solution, a group of hydrocortisone, a group of Saw Palmett, and three dosage groups of the extract obtained in Example 9 in this invention. They were drunk by force with the medicaments in the stomachs once a day, and continuously for 7 days. On the eighth day, they were killed with a disjointed cervical vertebra method. The tampons were taken out and placed in a 60° C. oven for 12 hours and then weighed. Table 4 shows the results.

TABLE 4


impact on tampon granuloma of rats

			Weight of
			tampon
		Number	granuloma
		of	(mg		Inhibition
Groups	Dosage	animals	x ± SD)	P	rate %

Contrast

			10	45.95 ± 9.03
The said	1.5	g/kg	10	40.30 ± 7.32	>0.05	12.30
extract
The said	3	g/kg	10	38.05 ± 6.17	<0.05	17.19
extract
The said	6	g/kg	10	32.15 ± 5.41	<0.01	30.03
extract
Saw Palmett	2.5	g/kg	10	42.30 ± 6.36	>0.05	7.94
hydrocortisone	20	mg/kg	10	26.45 ± 2.61	<0.01	42.43

The results have shown that the high and middle dosages of the extract in this Invention can all obviously inhibit the hyperplasia of tampon granuloma of rats. t shows that the extract in this invention has an anti-inflammatory action.

EXPERIMENTING EXAMPLE 5

Impact on Rat Prostate Hyperplasia caused by Testosterone Propionate

The same experimental materials and animals as in Experimenting Example 2 were used. But it was different that 60 130-150 g male Wistar rats were used. Under the conditions of ether anaesthesia and sterilization, the testis of both sides were removed. They were bred for a week after the operation. The rats were randomly divided in 5 groups, 10 in each group. Each group of animals were hyped with 5 mg/kg testosterone propionate dissolved in prepared oil once a day. And at the same time they were treated with medicaments. For the contrast group, they were drunk by force with physiological saline solution; for the medicine-fed group, they were drunk by force with 1.5, 3 and 6 g/kg extract obtained in Example 9 in this invention separately with a medicine-taking volume of 1 m/100 g. For the positive contrast group, they were hyped with 50 ug/kg estradiol benzoate with a volume of 0.05 ml/100 g, once a day and continuously for 30 days. After the last medicament, the rats were killed. The whole prostate glands were anatomized. The prostate glands were placed in formalin. All the fat was removed away after the prostate glands were taken out. The liquid on the surface were dried with filter papers. And the prostate glands were placed in 70% ethanol and fixed for 24 hours. Then they were taken out and placed on filter papers. The anterior, head and posterior lobes of prostate glands were separated and weighed a weighing scale to test twisting force to calculate the factors of all the lobes of prostate glands. The transverse diameter, diameter and height of the anterior lobes of prostate glands were measured with a two-foot vernier. When the three dimensions multiply, the volume of the anterior lobe of a prostate gland was got. Lastly, all the anterior lobes were examined with tectology, and the diameter of prostate gland cavity and the height of glandular epithelium cells were measured. The non-pairing t examinations among the groups were made for all the indexes. The obviousness of average difference were compared between the medicine-taking and contrast groups. Table 5 and 6 show the results.
1. Impact on Weight of Prostate Glands of Rats
30 days after the rats took the medicament, in comparison with the contrast group, the 1.5 g, 3 g and 6 g crude drug/kg of the extract in this invention have the inhibition rates of 23.2% (P<0.01), 31.26% (P<0.01), and 34.46% (P<0.01) for prostate anterior lobe separately, and the inhibition rate of estradiol is 35.3% (P<0.01); the inhibition rates for head lobes are 13.5%, 36.5% (P<0.01), and 46.0% (P<0.01) separately, the group of estradiol is 30.2% (P<0.05); the inhibition rates for posterior lobe are 9.6%, 15.3%, and 20.8% separately, the inhibition rate of estradiol is 12.5%. The results have shown that the extract in this invention has an obvious inhibitive action on the weight of anterior and head lobes with no obvious influence on posterior lobe.

2. Impact on the Volume of Prostate Anterior Lobe of Rats

TABLE 5


Impact on rat prostate factors (mg/100 g) of all lobes by
the extract in this invention x ± SD

	Dosage	Number of
Groups	(g/Kg body weight)	animals	Anterior lobe	Head lobe	Rear lobe

Contrast

			10	196.7 ± 41.1	73.4 ± 22.3	54.1 ± 12.8
The said	1.5	g/kg	10	151.0 ± 28.1**	63.5 ± 7.3	48.9 ± 11.9
extract
The said	3.0	g/kg	10	135.2 ± 40.9**	46.6 ± 16.5**	45.8 ± 15.3
extract
The said	6.0	g/kg	10	128.9 ± 26.3**	39.6 ± 13.5**	42.7 ± 12.3
extract
Estradiol	50	μg/kg	10	127.2 ± 23.4**	51.2 ± 10.7*	47.3 −+ 14.4
benzoate

Note:
in comparison with the contrast group:
*P < 0.05,
**P < 0.01

30 days after the rats took the medicament, in comparison with the contrast group, the 1.5 g, 3 g and 6 g of crude drug/kg of the extract in this invention have the inhibition rates of 18.2%, 31.1% (P<0.01), and 40.3% (P<0.01), and the inhibition rate of estradiol is 45.5% (P<0.01). The results have shown that the extract in this Invention has an obvious inhibitive action on the volume of prostate gland.

TABLE 6


Impact on the volume of prostate anterior lobe of
rats by the extract in this invention X ± SD

			Volume of anterior
	Dosage (g/kg	Number	lobe
Medicament	weight)	of animals	(cm3)

Contrast group			10	0.77 ± 0.21
The said extract	1.5	g/kg	10	0.63 ± 0.17
The said extract	3.0	g/kg	10	0.53 ± 0.13**
The said extract	6.0	g/kg	10	0.46 ± 0.13**
Estradiol	50	μg/kg	10	0.42 ± 0.12**

Note:
in comparison with the contrast group:
*P < 0.05,
**P < 0.01

3. Impact on the Diameter of Prostate Gland Cavity and the Height of Glandular Epithelium Cells of Rats
30 days after the rats took medicament continuously, the microscopic examination has shown that the prostate gland body of the anterior, head and posterior lobes has obvious hyperplasia with enlarged acinus. There were epithelioid papillas going into gland cavity. On the hyperplastic glandular epithelium, an active excreting activity could be seen. The glandular epithelium cells appeared in high column-form or multi-layer form without clear cell boundaries. The nucleus was placed on the base with parts of cell plasm in a grain form. The glandular cavity was full of secretion. The hyperplasia of connective tissue between acini can also be observed. The histological changes in the medicine-taking groups were nearly the same. The hyperplasia of anterior and head glandular body was not so obvious as the contrast group. The hyperplasia of posterior lobe could still be observed with the similar pathologic changes as in the contrast group. But in comparison with the contrast group, the extract in this invention can obviously inhibit the hyperplasia of the diameter of the glandular cavity of prostate anterior and head lobes. The estradiol can also obviously inhibit the hyperplasia of the diameter of prostate anterior and head glandular cavity. In all the groups, no obvious influence was observed on the diameter of posterior glandular cavity and the height of glandular epithelium cells of all the lobes. The results have shown that the extract in this invention can inhibit hyperplasia of diameter of prostate anterior and head glandular cavity.

EXPERIMENTING EXAMPLE 6

Impact on Prostate Hypernlasia caused by Implantation of Urine Genital Sinus of Mice

60 30-35 g male mice with the age of 7-10 weeks were selected. Under the injected celiac anaesthesia with 50 mg/kg pentobarbital, the inferior belly was cut open and the prostate gland was separated carefully. A small hole was made in the celiac prostate gland with a needle. Then three urine genital sinus tissues with 16-day fetal age were implanted in the celiac anterior lobe. Another mouse was taken and its celiac prostate gland was probed twice with a needle as a blank contrast of false operation. Then the belly was sutured. On the same day, taking the 10 animals as the blank contrast group of false operation, the other 50 animals were divided in 5 groups, 10 in each group: a contrast group, three dosage groups of the extract in Example 9 in this invention, and a group of positive contrast Saw Palmett. They were drunk by force with the medicament in the stomachs once a day and continuously for 30 days. After the last medicament, the mice were killed and paunched. The prostate glands were taken out and weighed with a tissue scale. The results were used to examine the obviousness of difference between the medicine-taking group and the contrast group with the t examination method and to calculate the inhibition rate. (see Table 7)

TABLE 7


Impact on prostate hyperplasia caused by implantation of
urine genital sinus of mice by the extract in this invention

			Weight of
			prostate
			gland
		Number of	(mg/10 g		Inhibition
Groups	Dosage	animals	x ± SD)	P	rate %

Blank

			10	17.9 ± 6.32
contrast
Contrast
			10	63.4 ± 11.4
The said	1.5	g/kg	10	53 ± 7.4	<0.05	16.4
extract
The said	3	g/kg	10	45.8 ± 4.8	<0.01	27.8
extract
The said	6	g/kg	10	41 ± 6.6	<0.01	35.3
extract
Saw Palmett	2.5	g/kg	10	49.6 ± 8.6	<0.01	21.8

The experimental results have proven that the prostate hyperplasia is obviously caused with the implantation of urine genital sinus of mice. 30 days after the mice took the extract in this Invention, the high, middle and low dosage groups can reduce the weight of prostate glands of mice with obvious difference in comparison with the contrast group. It has shown that the extract can obviously inhibit the prostate hyperplasia caused by the implantation of urine genital sinus of mice.

EXPERIMENTING EXAMPLE 7

Curative Effect on Senile BPH Patients with the Extract in this Invention

Method:
In June-August 2002, the inventor treated 46 cases of BPH patients with the age of above 51-70 with the extract obtained in Example 4 in this invention. It was taken with warm water in the morning and evening with an empty stomach in a dose of 1.0 g/tablet, once a tablet, twice a day. They were treated and observed for one week and 4 weeks.
Results:
Patients: The subjective symptoms were obviously improved. One week and 4 weeks after the treatment, the IPSS was averagely reduced by 16.6% and 30% separately. And the MFR was averagely increased by 14.2% and 33% separately. After four-week treatment, according to the measurement with an ultrasonic wave scanning Type B, the average residue urine was reduced by 36%. The extract in this invention has no impact on the pulse and blood pressure of the patients who take the extract in this Invention.

CONCLUSION

The extract in this invention is safe and effective for senile BPH patients. It can make the subjective symptoms and objective body symptoms of patients as well as their life improve obviously without obvious serious side effect.
1. Data and Methods
1.1 Clinical Data
There were 46 cases of male patients with an age of 51-78, averaging 63.2. In accordance with their chief complaints, they suffered from dysuria. After finger examination of anus, examination with an ultrasonic wave scanner Type B, etc., the diseases such as sclerosis of neurogenic urinary bladder and neck of bladder, carcinoma of prostate, etc. and other diseases that have impact on emiction. In accordance with the clinical diagnose, they are suffered from BPH: IPSS>22 in average; MFR=10.6 ml/s (one urine volume>152 ml); and bladder residue urine=51.6 ml in average in accordance with the ultrasonic wave scanner Type B.
1.2 Treatment Methods
2 weeks before treatment, they were not allowed to take diuretic medicaments. In the treatment, they took the extract in this Invention, once a tablet, twice a day, and they should take it in the morning and evening with a empty stomach and drink warm water together. They were treated and observed for one week and four weeks. Before the treatment, 1 week and 4 weeks after medicament supply, IPSS, urine flow rate, bladder residue urine, pulse and blood pressure were measured separately. During the treatment, all the other curative BPH medicaments and medicaments that have influence on emiction were stopped. The side effects were recorded. The examination and evaluation were processed with the t check statistics.
2. Results
2.1 IPSS Evaluation
Before the treatment, one week and four weeks after the treatment, the average IPSS value was 24.6±3.4, 20.5±3.2, 17.2±4.1 in average separately. The IPSS values have obvious difference between the values of one week and four weeks after the treatment (P<0.01), and the IPSS was reduced by 16.6% and 30% separately. (see Table 8)
2.2 Maximum Flow Rate (MFR)
Before the treatment, one week and four weeks after the treatment, the recorded MFR was (10.6±4.1)ml/s, (12.1±4.4)ml/s, and (14.1±3.8)ml/s separately. The difference before and after the treatment was obvious (P<0.01), and the MFR were increased by 14.2% and 33% in average separately. (see Table 8)
2.3 Bladder Residue Urine
Before the treatment and one week and four weeks after the treatment, in accordance with the celiac measurement with a ultrasonic wave scanner Type B, the bladder residue urine was (51.6±38)ml, (41±32)ml, and (33±26)m1 separately with obvious difference (P<0.01), and the average residue urine was reduced by 20.5% and 36%. (see Table 8)
2.4 Side Effects

Before the treatment, one week and four weeks after the treatment, no obvious changes occurred in the pulse and blood pressure of patients, and also without depressed blood pressure.

TABLE 8


Comparison of improved urine flow before
and after taking the extract in this invention

	Before	1 week after	4 weeks after
Time	treatment	treatment	treatment	P

I-PSS value	24.6 ± 3.4	20.5 ± 3.2	17.2 ± 4.1	<0.01
		(↓ 16.6%)	(↓ 30%)
MFR(ml/s)	10.6 ± 4.1	12.1 ± 4.4	14.1 ± 3.8	<0.01
		(↑ 14.2%)	(↑ 33%)
Residue urine	51.6 ± 38	41 ± 32	33 ± 26	<0.01
(ml)		(↓ 20.5%)	(↓ 36%)

3. Discussion
From the viewpoint of the Chinese Traditional Medicine, the emiction disorder caused by BPH belongs to the category of dysuria and blocking. The dysuria said in the Chinese Traditional Medicine refers to difficult emiction, slim and fragile urine line and blocked urine. When man pisses uneasily and difficultly with light degree of seriousness, it is dysuria. When man can not piss or it is blocked with a full lower abdomen and acute degree of seriousness, it is called blocking. Based on the principles, methods, prescriptions and medicaments about dysuria and blocking in the Chinese traditional medicine and combined with treatment mechanism of the modern medicine, the solution of the pharmaceutical composition in this invention is researched and developed and is a kind of Chinese medicament of pure plants with its main efficacy for improvement and treatment of emiction disorders caused by benign prostate hyperplasia (BPH). Its features are obvious curative effect and safe with strong immediate curative effect.
The clinical experiments have shown that the said extract in this invention can improve the subjective and objective symptoms of senile BPH patients with its strong immediate curative effect. One week after treatment, it can reduce patients' IPSS by 16.6% in average, and increase patients' MFR by 14.2% in average, and reduce patients' residue urine by 20.5% in average. In addition, side effects occur very rarely when the extract of the Chinese traditional medicament is taken to treat emiction disorders caused by BPH.

Claims

1-8. (canceled)

9. A pharmaceutical extract, characterized by that the extract is obtained by the following steps of:

soaking and extracting 9-45 weight shares of ginseng in ethanol or water, following by separation and purification by means of chromatography and drying to get a first extract;

soaking and extracting 20-100 weight shares of core of gingko in ethanol solution or water, following by separation and purification by means of chromatography and drying to get a second extract;

mixing the first extract and the second extract following by crushing and sieving to get said pharmaceutical extract.

10. The pharmaceutical extract of claim 9, wherein said first extract is obtained from 18-36 shares of ginseng and said second extract is obtained from 40-80 shares of core of gingko based on the weight ratio.

11. The pharmaceutical extract of claim 9, wherein said first extract is obtained from 27 shares of ginseng and said second extract is obtained from 60 shares of core of gingko based on the weight ratio.

12. The pharmaceutical extract of claim 9, further comprising a third extract obtained from the water or ethanol extract from addition of 2-30 shares of cinnamon and 2-10 shares of liquorices.

13. The pharmaceutical extract of claim 9, further comprising a fourth extract obtained from the water or ethanol extract from 6-12 shares of cassia twig.

14. The pharmaceutical extract of claim 9, wherein the said extract is prepared as any medicament type pharmaceutically.

15. The pharmaceutical extract of claim 9, comprising pharmaceutically acceptable carriers.

16. (canceled)

17. A method of preparation of a pharmaceutical extract, comprising the following steps of:

mixing the first extract and the second extract.

18. The method of claim 17, further comprising extracting 2-30 weight shares of cinnamon and 2-10 weight shares of liquorices in water or ethanol to have a third extract, and mixing the first extract and the second extract with the third extract.

19. The method of claim 18, further comprising extracting 6-12 weight shares of cassia twig in water or ethanol to have a fourth extract, and mixing the first extract, the second extract and the third extract with the fourth extract.

20-22. (canceled)

23. The use of the pharmaceutical extract of claim 9 in preparation of medicament for improvement and treatment of emiction disorders caused by BHP.

24. The use of the pharmaceutical extract of claim 9 in production of food and healthy food.

25. (canceled)

26. The method of claim 17, wherein said first extract is obtained from 18-36 weight shares of ginseng and said second extract is obtained from 40-80 weight shares of core of gingko based on the weight ratio.

27. The method of claim 17, wherein said first extract is obtained from 27 weight shares of ginseng and said second extract is obtained from 60 weight shares of core of gingko based on the weight ratio.