CN1747740A - Analgesic composition - Google Patents

Abstract

The present invention relates to an analgesic composition comprising extract of Pulsatillae Radix as active ingredient. Specifically, the present invention relates to the analgesic composition which alleviates pain of cancer patient and has low side effects. The object of the present invention is to provide an analgesic composition comprising an extract of Pulsatillae Radix as active ingredient and one or more ingredient(s) selected from the group consisting extract of Ginseng Radix, extract of Glycyrrhizae, extract of Radix Pericarp of Akebia quinata and extract of Ulmi cortex as auxiliary ingredient(s).

Description

Analgesic composition

Technical field

The present invention relates to contain the analgesic composition of Radix Pulsatillae extract as active component.Particularly, the present invention relates to alleviate cancer patient pain and the lower analgesic composition of side effect.

More specifically, the present invention relates to contain the analgesic composition of the Radix Pulsatillae (Pulsatillae Radix) extract as main active, if necessary, said composition also contains one or more extracts of being selected from the group of being made up of Radix Ginseng (Ginseng Radix) extract, Radix Glycyrrhizae (Glycyrrhizae Radix) extract, Caulis Akebiae (Akebiaquinata) peel extract, Cortex Ulmi Parvifoliae (Cortex Ulmi) peel extract as auxiliary element.

Background technology

The different carcinoma cell of growing on one's body at cancer patient produces different influences to patient.The cancerous cell of growth can cause hyperpyrexia, anorexia, loses weight, microbiosis, anemia, hormonal balance destruction, neurosis, edge tissues or organ are produced compressing, the intestines and stomach or angiemphraxis, irrelevant invasion (indifferent invasion), disorganization, blood circulation or the like by transfer impact three levels of organization (tertissue), toxicant, thereby causes that the violent pain of patient is until death.

Therefore, the very strong analgesic of toxicity is used in the generally very serious and very difficult control of the pain of cancer patient clinically.Because disorganization causes that the example of pain is an osteodynia, osteodynia is to be invaded or transfer to that the stimulation of osseous tissue causes or caused by fracture by cancerous cell.Because patient loses protective capability, owing to destroy protection mechanism or owing to block the delay that causes liquid, cancer patient is very sensitive to microbiosis by treatment of cancer.

The example of the angiemphraxis that is caused by the tumor that occurs in limited tissue is a cerebroma, and pain is because the oncothlipsis blood vessel and the meninges that are grown in the cerebrovascular cause.

The tumor that is grown in the intestinal extends to and/or oppresses and/or blocks intestinal and cause pain.Yet growing tumors had just spread before feels pain sometimes gradually in digestive tract.For example, up to cancer tangible diffusion has been arranged, gastric cancer, cancer of pancreas, rectal cancer and hepatocarcinoma etc. just can cause pain.Another situation is that pain is not to occur in the position of cancer but occur in other position.For example, when in gastrointestinal tract cancer taking place, because stimulus delivery enters into spinal cord by sympathetic nerve, pain occurs in the position far apart from cancer location sometimes.

Analgesic as for treating the pain that is caused by cancer or tumor uses a kind of strong analgesic sometimes with auxiliary element.Using maximum analgesic is the derivant of morphine or morphine.As for these auxiliary elements, then use calcium channel analeptic, comprise antagonist and the part and the anesthetic,general of N-methyl-D-aspartate salt (NMDA) antagonist.

Yet till now, employed analgesic still can not alleviate cancer patient's pain in 100% ground, and has drug resistance and side effect.Therefore, in order to treat cancer pain, it is desirable to develop a kind of analgesic that has anti-tumor activity, light side effect and analgesic effect simultaneously.

With the root of Pulsatilla plant (Radix Pulsatillae) is that the advantage of foundational development analgesic is that the Radix Pulsatillae is effective cancer-resisting substance.In fact, if any cancer or tumor can be treated, pain has just disappeared naturally.According to the inventor's experience, patient's feels pain of taking Radix Pulsatillae preparation alleviates; Even and during the treatment of the Radix Pulsatillae preparation that do not dose a patient with, patient is not well treated and be soon dead, patient represents that still pain alleviates significantly.

The Radix Pulsatillae is the root of Ranunculaceae Pulsatilla plant, and all roots may be used to the present invention.In the medicine, the Radix Pulsatillae can be used for treating child's burning at night, detoxifcation, antidiarrheal, sterilization, kill ameba, antifungal (Chinese medicine encyclopedia) in the Orient.

Recently, there is report to point out that the root of the Radix Pulsatillae has anti-tumor activity and is in clinical trial at present.Prior art is illustrated as follows:

1.Hsu Deng the people: Oriental Materia Medica pp 226-227, Oriental Healing ArtInstitute.1986, CA, USA.

2. Korean Patent is the 72nd, No. 982 and the 312nd, No. 622.

Radix Ginseng has multiple pharmaceutically active, for example relieving stress and anti-diabetic activity.Particularly, according to mouse writhing experiment, the ginsenoside Rf who once was reported among the ginsenoside that Radix Ginseng has has analgesic activity (1).In addition, though the instruction of No. the 5th, 417,979, United States Patent (USP) contains Radix Glycyrrhizae and has the analgesic activity as the natural plant crude drugs compositions of main component, described patent only instructs said composition to can be used as auxiliary element.Yet the characteristic of the selection of main plant medical material, anticancer analgetic medicine or its preparation method are different with the present invention.

1.Mogil JS，Shin YH，McCleskey EW，Kim SC，Na Sy，Brain Res 792，218-228(1998)。

2. United States Patent (USP) the 5th, 417, No. 979.

Radix Glycyrrhizae is used as tonic, neutralizating medicine, analgesic, antidote, cough medicine or repellent in the medicine in the Orient.The various researchs of aspects such as liver protecting, anticancer property have been carried out.

Caulis Hocquartiae peel is the fruit of Caulis Akebiae, is used for the treatment of waist disease, intercostal neuralgia, stomachache, calculus of urethra, menoxenia or diarrhoea.Caulis Hocquartiae peel contains akebin.But, just be used as the open source literature of analgesic up to now relevant for Caulis Hocquartiae peel.

Cortex Ulmi Parvifoliae is bark or the root bark of Elm plant, is used as repellent in the medicine in the Orient.Recently, there is bibliographical information Cortex Ulmi Parvifoliae extract can stop the anaphylaxis (1) of part or whole body.

1.Kim HM，Shin HY，Choi IY，Lee EH，Lee EJ，Action of Ulmi radiciscortex extract on systemic and local anaphylaxis on rats.Gen.Pharmacol.31，483-488(1998)。

Summary of the invention

An object of the present invention is to provide and contain the analgesic composition of Radix Pulsatillae extract as active component.

Another object of the present invention provides a kind of analgesic composition, and said composition contains Radix Pulsatillae extract as active component and contain one or more extracts of being selected from the group of being made up of Radix Ginseng extract, Radix Glycyrrhizae extract, Caulis Hocquartiae peel extract, Cortex Ulmi Parvifoliae extract as auxiliary element.

Which kind of chemical compound of just knowing the Radix Pulsatillae up to now has analgesic effect.However, if any preparation that contains the Radix Pulsatillae has good anticancer effect, pain can alleviate naturally.Therefore, the inventor thinks that the concentration of the cancer-resisting substance that improves the Radix Pulsatillae is very important.

No. the 72nd, 982, Korean Patent and the 312nd, No. 622 instruction are dissolved part with the preparation anticancer preparation with Radix Pulsatillae preparation.Yet the foundation of some cancer-resisting substance formation condition is uncertain, and mainly uses the first of extract.From the Radix Pulsatillae, isolate Hederacoside-3-oxygen-α-L-rhamnopyranosyl (1 → 2)-[β-D-glucopyranosyl (1 → 4)]-α-L-arabopyranose glycosides (Hederagenin-3-O-α-L-rhamnopyranosyl-(1 → 2)-[α-L-glucopyranosyl-(1 → 4)]-β-D-arabinopyranoside) (be numbered SB365) as cancer therapy drug.The inventor attempts to improve the analgesic effect of the Radix Pulsatillae by the preparation of preparation SB365 high concentration enrichment.The operation of extracting is as follows: the chinese Pulsatilla Root of certain umber is joined in the solvent of certain umber, and mixture extracts the different time at a certain temperature, measures the content of SB365.Extract temperature and be lower than 60 ℃, be preferably 20-50 ℃, more preferably 25-35 ℃.Each part Radix Pulsatillae is preferably 2-3 part with 2-10 part solvent.Because chemical reaction is relevant with catalytic action (enzyme) (under the condition of hydrolytic enzyme hydrolysis) with the concentration of substrate, therefore, consider that from the kinetics and the complexity aspect of operational approach keeping the pasty state of mixture is ideal method.In different response time sections, optimal reaction temperature is 30 ℃.

As for the operational approach after extracting, can use common solvent evaporated method, seasoning or freeze-drying, preferably use freeze-drying.

As for the solvent that extracts plant material, can make water, methanol, ethanol, propanol, butanols, dichloromethane, acetone or their mixture, be preferably water, methanol, ethanol or their mixture, more preferably the alcoholic solution of water or 50% (volume/volume).

Compositions of the present invention can be mixed with solution, injection, powder (powder), the tablet that contains the excipient that generally uses at pharmaceutical field, capsular form.

Description of drawings

Fig. 1 represents the thin layer chromatography chromatogram (TLC) of Radix Pulsatillae extract (PKW).

The specific embodiment

The following examples and experiment will be done the present invention and illustrate in greater detail.

General embodiment

General embodiment 1

The preparation of the basic extract of the Radix Pulsatillae

1) with the lower alcohol aqueous solution of the water or 50% (volume/volume) of the Radix Pulsatillae of 1 weight portion and 1-100 weight portion, the gained mixture is covered and cover lid with gauze or filter paper.Mixture is at 60 ℃ or be lower than about 30 minutes of 60 ℃ of following reactions, filtering mixt afterwards.Collect filtrate, with the lower alcohol aqueous solution of the 20-80% (volume/volume) of remaining filtering residue and 2-10 weight portion.Mixture stirs about 15 minutes after-filtration.Filtrate is merged the back reduction vaporization to obtain residue.Add the methanol or the ethanol of 2-10 weight portion in residue, mixture left standstill about 10 minutes.Filter out insoluble matter to obtain solution.Evaporating liquid obtains fallow extract (PKW component).

The yield of PKW component is 28-35 weight %.The PKW component can be used as anticarcinogen or analgesic of the present invention or be used as the basis of compositions.With by any other solvent comparing of extracting of organic solvent, water-containing organic solvent for example, this PKW component has higher SB365 content.

2) with general embodiment 1 1) in the filtrate lyophilization immediately that merges, obtain fallow extract.

General embodiment 2

The preparation of Radix Ginseng extract (PKG)

1) Radix Ginseng of 1 weight portion and the water of 5-100 weight portion are mixed, at room temperature extracted about 2 hours, filter this mixture then.Collect filtrate, with the alcohol-water solution mixing after-filtration of remaining filtering residue and 20-80 volume %.Filtrate is merged the back evaporation, obtain extract.This extract is called as PKG.

2) will this total embodiment 1) in the filtrate lyophilization immediately that merges of gained, obtain Radix Ginseng extract.

General embodiment 3

The preparation of Radix Glycyrrhizae extract (PKly)

1) the Radix Glycyrrhizae powder of 1 weight portion and the water of 2-500 weight portion are mixed, at room temperature extracted about 2 hours, filter and drying, obtain Radix Glycyrrhizae extract (PKly).

2) immediately will be from 1) the filtrate lyophilization that obtains, obtain Radix Glycyrrhizae extract (PKly).

General embodiment 4

The preparation of Caulis Hocquartiae peel extract (PKake)

1) alcohol-water solution with the 20-50% (volume/volume) of the Caulis Hocquartiae peel powder of 1 weight portion and 10-50 weight portion mixes, and at room temperature extracts about 2 hours, filters afterwards and carries out reduction vaporization, obtains Caulis Hocquartiae peel extract (PKake).

2) will be from 1) the filtrate lyophilization that obtains, obtain Caulis Hocquartiae peel extract (PKake).

General embodiment 5

The preparation of Cortex Ulmi Parvifoliae extract (PKu)

1) Cortex Ulmi Parvifoliae powder and the water of 5-50 weight portion or the alcoholic solution of 20-80% (volume/volume) with 1 weight portion mixes mutually, at room temperature extracts about 2 hours, and filtration drying obtains Cortex Ulmi Parvifoliae extract (PKu).

2) immediately will be from 1) the filtrate lyophilization that obtains, obtain Cortex Ulmi Parvifoliae extract (PKu).

Embodiment

Embodiment 1

The preparation of Radix Pulsatillae extract (PKW)

1) in 100 milliliters beaker, adds 30 gram chinese Pulsatilla Root and 60 ml waters, mix obtaining pastel.This pastel covers with a gauze by water-wet, leaves standstill under 30 ℃ 1 hour.This pastel joined in 300 milliliters the beaker,, use magnetic stirrer toward the methanol that wherein adds 240 milliliters.After the stirring, filtering mixt joins the residue on the filter paper in the beaker and adds the alcohol-water solution of 300 milliliter 50% (volume/volume), stirs 20 minutes after-filtration afterwards.Filtrate is merged the back reduction vaporization to dry.The methanol that adds 200 milliliters in exsiccant residue stirs, leaves standstill 1 hour after-filtration.Obtain the residue of 11.3 gram larks after the filtrate drying that obtains, be called PKW, the TLC figure of PKW as shown in Figure 1.In Fig. 1, the left side is the development of the methanol solution of PKE, and the centre is the development of methanol insoluble matter, and the right is the development of SB365.

2) with the lyophilization immediately of last filtrate obtaining the extract of same content, the TLC of this extract figure and Fig. 1 are identical.

Embodiment 2

The preparation of Radix Ginseng extract (PKG)

1) dried powder and 100 ml waters with 15 gram Radix Ginseng radiculas mix, and mixture at room temperature stirs about 1 hour after-filtration.In filter cake, add 100 milliliter of 50% (volume/volume) ethanol water, stir 1 hour after-filtration.Filtrate merges the back evaporation to obtain the brown tar (PKG) of 5.4 grams.

2) with among the embodiment 2 1) filtrate lyophilization immediately after the merging of gained to be to obtain the Radix Ginseng extract of same amount.

Embodiment 3

The preparation of Radix Glycyrrhizae extract (PKly)

1) 4.5 gram Radix Glycyrrhizae powder are distributed in 50 ml waters, at room temperature extracted 1 hour, filtration, drying obtain 1.9 gram Radix Glycyrrhizae extracts (PKly).

2) will be from 1) the filtrate lyophilization immediately that obtains to be to obtain the Radix Glycyrrhizae extract (PKly) of same amount.

Embodiment 4

The preparation of Caulis Hocquartiae peel extract (PKake)

1) alcohol-water solution with 10 gram Caulis Hocquartiae peel powder and 100 milliliter 50% (volume/volume) mixes, and at room temperature extracts 2 hours after-filtration.Filtering residue uses the same method and extracts and filter.Filtrate after evaporation merges is to obtain the brown Caulis Hocquartiae peel extract (PKake) of 3.2 grams.

2) immediately will be from 1) filtrate lyophilization after the merging that obtains to be to obtain the Caulis Hocquartiae peel extracting solution (PKake) of same amount.

Embodiment 5

The preparation of Cortex Ulmi Parvifoliae extract (PKu)

1) methanol aqueous solution with 10 gram Cortex Ulmi Parvifoliae powder and 100 milliliter 50% (volume/volume) mixes, and at room temperature extracts 1 hour after-filtration.Filtering residue uses the same method and extracts and filter.Filtrate after evaporation merges is to obtain the Cortex Ulmi Parvifoliae extract (PKu) of 2.5 grams.

2) will be from 1) filtrate lyophilization immediately after the merging that obtains to be to obtain the Cortex Ulmi Parvifoliae extract (PKu) of same amount.

Prescription

General prescription 1

The prescription of forming by 2 kinds of extracts

The PKG of 0.3,0.6,0.8 and 1.0 weight portions is joined respectively among the PKW of 1 weight portion, mix back acquisition compositions separately.Compositions is called PKWG-0.3, PKWG-0.6, PKWG-0.8 and PKWG-1.0.

General prescription 2

The prescription of forming by 2 kinds of extracts

The PKgly of 0.1,0.2,0.3,0.4 and 0.5 weight portion is joined respectively among the PKW of 1 weight portion, mix back acquisition compositions separately.Compositions is called PKgly0.1, PKgly0.2, PKgly0.3, PKgly0.4 and PKgly0.5.

General prescription 3

The prescription of forming by 2 kinds of extracts

The PKake of 0.1,0.3,0.5,0.7 and 0.9 weight portion is joined respectively among the PKW of 1 weight portion, mix back acquisition compositions separately.Compositions is called PKake0.1, PKake0.3, PKake0.5, PKake0.7 and PKake0.9.

General prescription 4

The prescription of forming by 2 kinds of extracts

The PKu of 0.2,0.5,0.8,1.1 and 1.5 weight portions is joined respectively among the PKW of 1 weight portion, mix back acquisition compositions separately.Compositions is called PKu0.2, PKu0.5, PKu0.8, PKu1.1 and PKu1.5.

The prescription of forming by 3 kinds of extracts

Following prescription is based on the zooperal prescription of being made up of 3 kinds of extracts.

General prescription 5

The prescription of forming by PKW, PKG and PKgly (prescription PGgly)

The PKG of 0.8 weight portion and the PKgly of 0.4 weight portion are joined among the PKW of 1 weight portion, mix obtaining prescription PGgly.

General prescription 6

The prescription of forming by PKW, PKG and PKake (prescription PGake)

The PKG of 0.8 weight portion and the PKake of 0.5 weight portion are joined among the PKW of 1 weight portion, mix obtaining prescription PGake.

General prescription 7

The prescription of forming by PKW, PKG and PKu (prescription PGu)

The PKG of 0.8 weight portion and the PKu of 1.1 weight portions are joined among the PKW of 1 weight portion, mix obtaining prescription PGu.

In fact, on the basis of above-mentioned prescription, PKG, PKgly, PKake and the PKu of weight portion and the PKW of 1 weight portion can form the prescription that contains 2 kinds of extracts arbitrarily.Similarly, on the basis of above-mentioned prescription, also can form the various prescriptions that contain 3 kinds of extracts.In fact, all wt part is all based on 10 PKW that restrain.

Preparation embodiment is described as follows:

Above-mentioned prescription can be made injection, oral formulations etc.

Injection: by dissolving above-mentioned prescription with physiological sodium chloride solution, ringer solution or other nutritive solution and filtering antibacterial or take any other sterilization measure to make injection.

Oral formulations: be mixed with oral formulations with the preparation method of above-mentioned prescription by routine.

Preparation embodiment

Preparation embodiment 1

The preparation of PKW0.8

10 gram PKW are dissolved in 1 liter of physiological sodium chloride solution and filter antibacterial and make solution.

Preparation embodiment 2

The preparation of PKWG0.8

10 gram PKW and 8 gram PKG are dissolved in 1 liter of physiological sodium chloride solution and filter antibacterial and make solution.

Preparation embodiment 3

The preparation of PKWgly0.4

10 gram PKW and 4 gram PKgly are dissolved in 1 liter of physiological sodium chloride solution and filter antibacterial and make solution.

Preparation embodiment 4

The preparation of PKWake0.5

10 gram PKW and 5 gram PKake are dissolved in 1 liter of physiological sodium chloride solution and filter antibacterial and make solution.

Preparation embodiment 5

The preparation of PKWu0.8

10 gram PKW and 8 gram PKu are dissolved in 1 liter of physiological sodium chloride solution and filter antibacterial and make solution.

Preparation embodiment 6

The preparation of PGgly

10 gram PKW, 8 gram PKG and 4 gram PKgly are dissolved in 1 liter of physiological sodium chloride solution and filter antibacterial and make solution.

Preparation embodiment 7

The preparation of PGake

10 gram PKW, 8 gram PKG and 5 gram PKake are dissolved in 1 liter of physiological sodium chloride solution and filter antibacterial and make solution.

Preparation embodiment 8

The preparation of PGu

10 gram PKW, 8 gram PKG and 8 gram PKu are dissolved in 1 liter of physiological sodium chloride solution and filter antibacterial and make solution.

Preparation embodiment 9

0.5 gram PKW and 0.2 gram PKgly are pressed into tablet with the mixed with excipients of using always.

Preparation embodiment 10

0.5 gram PKW and 0.3 gram PKake are made capsule with mixed with excipients blended rubber capsule packing commonly used.

Preparation embodiment 11

0.5 gram PKW and 0.2 gram PKu are dissolved in and form injection in the distilled water, be injected into ampoule and injection is made in sterilization.

Preparation embodiment 12

0.5 gram PKW, 0.4 gram PKG and 0.2 gram PKgly are pressed into tablet with the mixed with excipients of using always.

Preparation embodiment 13

With 1 gram PKW, 0.2 gram PKG and 0.2 gram PKake and mixed with excipients commonly used,, make powder with the package encapsulation that is coated with polyvinyl resin.

Below by experiment embodiment the present invention will be described in more detail.

At first by using animal to screen the analgesic effect of above-mentioned prescription.The prescription that reveals good analgesic effect by option table typically carries out clinical experiment.

EXPERIMENTAL EXAMPLE

Zoopery embodiment

Though it is believed that the pain by using animal to estimate tumour patient is impossible, the mechanism of reduction or eliminate pain is identical for the human or animal.

With the RCI mice as laboratory animal.After giving clothes compositions of the present invention, in the abdominal cavity of mice, inject acetic acid.After the injection, the number of times of body turned round in record (mice is because of misery) in the abdominal cavity of mice.The experimental result of several typical prescription is explained as follows.

EXPERIMENTAL EXAMPLE 1

1) mensuration of analgesic effect on one's body mice

Mice is divided into 17 groups, and every group comprises that 3 body weight are the Mus of 20-25 gram, wherein organize for 1 group in contrast.According to dosage and the time listed as table 1, ejection testing material in 16 groups remaining every mouse peritoneal.At first from matched group to each experimental group, all in the abdominal cavity injection 0.2 milliliter of 0.6 volume % acetic acid.Test the number of times of every mouse writhing in every group in 10 minutes.The suppression ratio note is done to the reduction of turning round the body number of times of the group of clothes test substances and the percentage ratio of turning round the body number of times of matched group.The result is as shown in table 1.

As shown in table 1, PKW, promptly the extract of the Radix Pulsatillae has very strong analgesic effect on mouse model.The compositions PKWG of PKW and PKG, the 3 components composition PGgly of PKW, PKG and PKgly demonstrate 95% or higher suppression ratio.

Table 1 is based on the mouse writhing experiment suppression ratio of PKW prescription

Prescription	Dosage (ml/kg)	Turn round the body number of times	Suppression ratio (%)
				Contrast	Saline	17.6	0
PKW	0.5	1.33	92.4
				1	0.66	92.2
	PKWG0.8	0.5	2.33				86.7
1.5				0.66	92.2
		PKWgly0.4	0.5			6.3	64.2
1.5	1.33			92.4
			PKWake0.5		0.5	10.3	41.4
1.5	4.6	73.8
				PKu0.8	0.5	10.6	39.7
1.5	7.3	58.5
			PGgly		0.5	1	94.3
1.5	0.33	98.1
				PGake	1	11	37.5
2	5.6	68.1
			PGu		1	13.3	24.4
2	3.6	79.5

Acetaminophen is 0.2 mg/kg 0.9 ± 0.05 in the saline

2) volunteer's analgesic effect

From above zoopery, select to have the prescription of good analgesic effect, take to the cancer patient volunteer test substances of this prescription, estimate the analgesic effect of these test substances.As for test substances, we select and use resultful PKW of animal testing and PGake.The consumption of test substances is that PKW is that 0.25 ml/kg and PGgly are 0.25 ml/kg.Give the clothes test substances every day once, totally 4 days (injection for the first time) estimated by inquiry volunteer pain degree.After for the first time injecting 14 days, use the identical clothes method of giving to give clothes 4 days (injection for the second time).After the injection, estimate pain degree for the second time by inquiry volunteer's pain degree.

EXPERIMENTAL EXAMPLE 2

The clinical trial of cancer patient

12 patients that suffer from various cancers have participated in this test.The patient that cancer has reached an advanced stage ceaselessly sorrow states cancer pain.Selection is injected to venous patient resultful PKW of animal testing and PGgly.Other analgesic of stopping using patient always to take.Stop using other analgesic two days later, the test substances of intravenous injection every day 0.25 ml/kg once, totally 4 days (for the first time injection) estimated by inquiry patient's pain degree.After for the first time injecting 14 days, with the administration again of identical medication (injection for the second time).After the injection, come the analgesic effect of evaluation test material by inquiry patient's pain degree for the second time.Test result sees Table 2.

Table 2 cancer volunteer's pain evaluation

The PKW injection

The volunteer	Before the medication	For the first time after the injection	For the second time after the injection
				Kim, O.H. (women, the esophageal carcinoma)	Seriously	Alleviate	Not not bitterly
Kim, D.O. (women, hepatocarcinoma)	Very serious	Alleviate	Alleviate
				Shim, O.C. (women, colorectal cancer)	Seriously	Alleviate	Not not bitterly
Park, J.S. (male, gastric cancer)	Very serious	Alleviate	Not not bitterly
				Park, S.M. (male, carcinoma of parotid gland)	Moderate	Not not bitterly	Not not bitterly
Wang, J.S. (male, pulmonary carcinoma)	Seriously	Alleviate	Alleviate

The PGgly injection

The volunteer	Before the medication	For the first time after the injection	For the second time after the injection
				Kwon, T.Y. (women, uterus carcinoma)	Seriously	Alleviate	Not not bitterly
Lee, C.H. (women, gastric cancer)	Seriously	Alleviate	Alleviate
				Chung, K.C. (male, metastatic carcinoma)	Very serious	Alleviate	Not not bitterly
You, J.I. (male, pulmonary carcinoma)	Moderate	Not not bitterly	Not not bitterly
				Kim, O.G. (women, thyroid carcinoma)	Very serious	Alleviate	Alleviate
Kim, D.C. (male, metastatic carcinoma)	Very serious	Not not bitterly	Not not bitterly

As shown in table 2, the prescription of all Radix Pulsatillae extracts and all shown good analgesic effect based on the prescription of the Radix Pulsatillae.These prescriptions have analgesic effect and anticancer effect simultaneously.For example, because the obstruction that causes by tumor and disorganization alleviates and tumor diminishes and shown analgesic effect as the compositions pharmacological effect simultaneously, so think that this compositions has collaborative analgesic effect.

EXPERIMENTAL EXAMPLE 3

Acute toxicity

Giving 10 body weight is the preparation of injection embodiment 11 in the abdominal cavity of ICR mice of 25-30 gram, 5 milliliters of every injections.There is not animal dead.

Industrial applicibility

The most outstanding advantage of the present composition is to demonstrate the characteristic that has simultaneously pain relieving and anticancer effect. These effects are from existing to separate the pain control method of using anodyne and anticancer be different. In addition, the duration of the analgesic effect of this composition has prolonged. As can be seen from Table 2, even after injecting 15 days for the first time, cancer patient is not complained pain. For the situation of TCA, although stopped to taking composition of the present invention, patient (Kim, O.G., Kim, D.C. and Wang, J.S.) is not until extremely complain pain yet. Therefore the present composition can be as the anodyne that alleviates or treat cancer patient pain.

Claims (4)

1, a kind of analgesic composition, said composition contains Radix Pulsatillae extract as active component.

2, a kind of analgesic composition, said composition contains Radix Pulsatillae extract as key component, and contains one or more extracts of being selected from the group of being made up of Radix Ginseng extract, Radix Glycyrrhizae extract, Caulis Hocquartiae peel extract, Cortex Ulmi Parvifoliae extract as auxiliary element.

3, a kind of analgesic formulations, said preparation contain the compositions of claim 1 or 2 as active component, and wherein, described preparation and conventional auxiliary agent mix and be mixed with the preparation of routine.

4, analgesic formulations according to claim 3, wherein, described preparation is selected from the group of being made up of solution, injection, powder, tablet and capsule.