CN101085113A - Traditional Chinese medicine preparation for treating AIDS - Google Patents

Abstract

The invention discloses a prepared traditional Chinese medicinal preparation for treating AIDS which is prepared from the following raw materials (by weight portion): arctium fruit 3-9g, baikal skullcap root 3-9g, mulberry bark 6-12g, hairy vein agrimony 6-12g, Senecio scandens 6-12g, broom cypress fruit 6-12g, ginseng 2-6g, astragalus root 10-25g, root of Chinese trichosannthes 6-12g, Philippine violet herb 6-12g and licorice root 6-12g.

Description

A kind of Chinese medicine preparation for the treatment of acquired immune deficiency syndrome (AIDS)

(1) technical field under

The present invention relates to a kind of Chinese medicine, particularly a kind of Chinese medicine preparation for the treatment of acquired immune deficiency syndrome (AIDS).

(2) background technology

Acquired immune deficiency syndrome (AIDS) is in global bamboo telegraph, and aids infection poison total number of persons has reached more than 6,900 ten thousand till 2005.Newly-increased again the infected 4,300,000 people in 2006.Since the first acquired immune deficiency syndrome (AIDS) case history is reported so far by China in 1985, China has 1,000,000 patients infected hivs approximately, the growth in recent years amplitude surpasses 30%, the latest digital that Ministry of Public Health is announced showed: by on April 30th, 2007, inland of China accumulative total reports patients infected hiv 203527 examples, acquired immune deficiency syndrome (AIDS) patient 52480 examples wherein, dead 16155 examples.Scholarly forecast is arranged, and China propagates as not taking effectively to intervene the action control AIDS, expects China's AIDS viral infection person in 2010 and may reach 1,200 ten thousand.Acquired immune deficiency syndrome (AIDS) is the serious harm people healthy, causes enormous economic loss, becomes current great hygienic issues of China and social problem, directly has influence on the social stability and the development and national economy of China.

Current, though the suitable achievement that the western medicine acquired immune deficiency syndrome (AIDS) obtains, but exist some obvious defects, mainly be cost an arm and a leg, take medicine that program is complicated strict, virus load sharply rebounds after the drug withdrawal, serious toxicity, a large amount of drug resistance strain occur, weakness such as part patient's immunologic function is not improved, poor life quality.And use the treatment by Chinese herbs acquired immune deficiency syndrome (AIDS), have that the medicine source is abundant, cheap, taking convenience, have no side effect, effectively protect and improve immunologic function, early stage interventional therapy, can tackle advantages such as clinical manifestation complicated and changeable.Therefore, the new Chinese medicine of exploitation treatment acquired immune deficiency syndrome (AIDS) is imperative.

(3) summary of the invention

The present invention provides the Chinese medicine preparation of a kind of side effect treatment acquired immune deficiency syndrome (AIDS) little, evident in efficacy in order to remedy the deficiencies in the prior art.

The present invention is achieved through the following technical solutions:

A kind of Chinese medicine preparation for the treatment of acquired immune deficiency syndrome (AIDS), its special character is: be to be made by the raw material of following parts by weight:

Fructus Arctii 3-9g Radix Scutellariae 3-9g Cortex Mori 6-12g Herba Agrimoniae 6-12g Herba Senecionis Scandentis 6-12g Fructus Kochiae 6-12g Radix Ginseng 2-6g Radix Astragali 10-25g Radix Trichosanthis 6-12g Herba Violae 6-12g Radix Glycyrrhizae 6-12g.

But described Chinese medicine preparation is the dosage form of water decoction, granule, capsule, tablet or other pharmacy.

Function: expelling wind and clearing away heat, eliminating phlegm and removing dampness is held concurrently with tonifying the lung.

Cure mainly: acquired immune deficiency syndrome (AIDS) belongs to part of the body cavity above the diaphragm housing the heart and lungs lung and defends card, shows as heating or fever with chills, has sore throat, coughing and wheezing, fatigue and weakness, skin ulcer or erythra, tuberculous lymphadenitis, the thick or few tongue of red tongue of red tongue with yellow fur, rapid pulse or count accurately etc.

In the raw material of the present invention: with can wind and heat dispersing, the Fructus Arctii of the lung qi dispersing that can detoxify again be monarch; Radix Scutellariae, Cortex Mori let out clearly in the lung that fire-toxin expectorant is turbid to be minister; Gas the moon of tonifying the lung such as Radix Ginseng, the Radix Astragali, Radix Trichosanthis, expelling wind and clearing away heats such as Herba Senecionis Scandentis, the Fructus Kochiae, Herba Agrimoniae, Herba Violae remove drenched poison, are assistant; The Radix Glycyrrhizae QI invigorating and in, coordinating the actions of various ingredients in a prescription is for making.

Now will be summarized as follows both at home and abroad to the clinical observation of said preparation:

Domestic observation:

In December, 2005 to 2006 year April, we are to the 10 routine HIV/AIDS patients of attached Beijing You An hospital of the Capital University of Medical Sciences, and medicine of the present invention (is No. 1, Ji hereinafter to be referred as the Chinese mugwort) granule of using by embodiment 1 preparation carries out 3 months by a definite date clinical observation.

1 clinical data

1.1 diagnostic criteria according to State Standard of the People's Republic of China's " HIV/AIDS diagnostic criteria and treatment principle " (GB16000-1995), the HIV that revises of the Center for Disease Control (CDC) in 1993 infects classification, AIDS diagnostic criteria and CD ₄Cell counting is method by stages.

1.2 case is selected

Include standard in: 1. meet the HIV/AIDS of People's Republic of China (PRC) diagnostic criteria; 2. the age is 18～55 years old; 3. CD ₄Cell number is 100-400/mm ³

Exclusion standard: 1. age＜18 year old or＞65 years old; 2. trimester of pregnancy and women breast-feeding their children, the psychotic; 3. acute HIV the infected; 4. serious opportunistic infection and tumor person; 5. the immunodeficiency syndrome person due to the non-HIV; 6. merge to have the inclination, lung, liver, kidney, hemopoietic and the serious primary disease person of hormonal system; 7. the drug addict is accepting drug addiction treatment or just at junkie.1.3 physical data 10 routine patients are the outpatient that peace hospital infection section is helped in Beijing, all are diagnosed as the HIV antibody positive through euzymelinked immunosorbent assay (ELISA) (ELISA) and protein blot method (WB), meet the standard of including in.Male's 9 examples wherein, women's 1 example; Age 23-37 year, average 29.1 years old; Married 2 examples, unmarried 8 examples; Route of transmission 1 example of transfusing blood, same sex contact 7 examples, two property contact 2 examples; HIV the infected's 8 examples, AIDS 2 examples; The PI time is the shortest to be 8 months, is about most 10 years.Clinical manifestation: weak 3 examples, heating 2 examples, cough 7 examples, chest pain 1 example, infections rash 2 examples, spontaneous sweating 1 example, alopecia 1 example, diarrhoea 6 examples, oral erosion 3 examples, pharyngalgia 5 examples.All patient all carries out clinical observation under the informed consent situation.

2 observational techniques

2.1 the medication Chinese mugwort is lucky No. 1, mainly is made up of Fructus Arctii, Radix Scutellariae, Cortex Mori, Radix Ginseng etc.Behind water extract-alcohol precipitation, make granule, every bag 10g (containing crude drug 40g).Prepare by Jinan Li Meng pharmaceutical Co. Ltd.Usage: every day 2 times, each 10g, 1 hour after meal is oral.Do not use other anti-AIDS drugs and immune formulation during the medication, to the opportunistic infection that occurred, can with anti symptom treatment.

2.2 observation item and method

That 2.2.1 collection of tcm symptom sign and body weight determination are mainly observed is weak, heating, cough, chest pain, infections rash, scrofula sucutaneous nodule, spontaneous sweating, alopecia, indigestion and loss of appetite, become thin, diarrhoea, oral erosion, pharyngalgia etc.Adopt integration method, respectively with do not have (0), light (1), in (2), heavy (3) digital integration represent, in 0,1,2, March four time point observe, and in 0, survey breathing, heart rate, blood pressure, body weight March.

2.2.2 t lymphocyte subset group's detection adopts flow cytometer to detect before and after the 10 routine patient treatments (0, March) periphery CD ₃Absolute number, CD ₄Absolute number and percentage ratio, CD ₈Absolute number and percentage ratio, CD ₄/ CD ₈Deng.

2.2.3 plasma viral load adopts fluorescence quantifying PCR method to measure before and after the 10 routine patient treatments (0, March) blood plasma HIV-RNA copy number.

2.2.4 (0, March) routine blood test and liver, renal function etc. before and after the routine patient treatments of safety detection assay 10.

Above test item all carries out in attached Beijing You An hospital of the Capital University of Medical Sciences.

3 criterions of therapeutical effect are estimated from immunologic function, virus load, symptom and sign three aspects according to State Administration of Traditional Chinese Medicine " 5 province's Chinese medicine acquired immune deficiency syndrome (AIDS) project clinical technology scheme (trying) ".

3.1 immune indexes is effective: CD4 rises gradually, treats back CD4 rising 〉=30% or 50/mm ³Stablize: CD4 no change or rising gradually, treat back CD4 and raise or decline＜30% or 50/mm ³Invalid: CD4 decline 〉=30% or 50/mm ³

3.2 virus load is effective: blood plasma HIV-RNA level descends, copy number reduction 〉=0.5log/ml; Stable: the HIV-RNA copy number rises or decline＜0.5log/ml; Invalid: the HIV-RNA level continues to rise copy number rising 〉=0.5log/ml in the blood plasma.

3.3 symptom and sign are effective: the clinical symptoms sign is improved more obvious, and total mark descends 〉=1/3; Stable: the clinical symptoms sign is improved not obvious, and total mark descends＜1/3; Invalid: the clinical symptoms sign does not have improvement or increases the weight of, and total mark does not descend, or increases to some extent.

4 observed results

4.1 immunologic function is mainly with CD ₄Absolute number and CD ₄/ CD ₈Ratio is changed to observation index.Immune indexes variation before and after the 10 routine patient treatments sees Table 1.

HIV/AIDS patient CD before and after table 1 treatment ₄And CD ₄/ CD ₈Change

Numbering	CD 4Absolute number (/mm 3)			CD 4/CD 8Ratio
							Before the treatment	After the treatment	Difference	Before the treatment	After the treatment	Difference
	1 2 3 4 5 6 7 8 9 10	335 339 241 290 401 295 161 313 369 216	339 438 196 269 363 327 147 317 332 233	4 99 -45 -21 -38 32 -14 4 -37 17	0.44 0.36 0.22 0.37 0.17 0.29 0.15 0.30 0.29 0.26	0.42 0.33 0.24 0.42 0.17 0.35 0.19 0.26 0.27 0.23							-0.02 -0.03 0.02 0.05 0 0.06 0.04 -0.04 -0.02 -0.03

The result shows, CD ₄Absolute number increases by 5 examples, reduces by 5 examples; CD ₄/ CD ₈Ratio increases by 4 examples, and no change 1 example reduces by 5 examples.According to criterion of therapeutical effect, effective 1 example is stablized 9 examples, invalid 0 example.

4.2 changing, the plasma viral load before and after the virus load 10 routine patient treatments sees Table 2.

HIV/AIDS patient's virus load changes before and after table 2 treatment

Numbering	Virus load (log/ml)
				Before the treatment	After the treatment	Difference
	1 2 3	5.23 4.60 4.28	4.62 3.78 4.63				-0.61 -0.82 0.35

4 5 6 7 8 9 10

4.99 4.26 4.08 4.65 3.93 4.52 3.26

4.11 4.04 4.54 2.38 4.50 4.23 4.28

-0.88 -0.22 0.46 -2.27 0.57 -0.29 1.02

The result shows that 6 examples descend among the 10 routine patients, wherein fall 〉=0.5log/ml person's 4 examples; Increase by 4 examples, increasing degree 〉=0.5log/ml1 example.According to criterion of therapeutical effect, effective 4 examples are stablized 5 examples, invalid 1 example.

(before the treatment back/treatment) is respectively weak 2/3 example, heating 1/2 example (alleviating 1 example), cough 5/7 example (alleviating 1 example), chest pain 1/1 example, infections rash 0/2 example, spontaneous sweating 1/1 example, alopecia 0/1 example, diarrhoea 5/6 example, oral erosion 2/3 example, pharyngalgia 2/5 example 4.3 symptom and sign and body weight change symptom and sign disappear.Weight increase 〉=2kg person's 2 examples, the person's of stablizing 7 examples, decline 〉=2kg person's 1 example.According to criterion of therapeutical effect, effective 5 examples are stablized 5 examples, invalid 0 example.

4.4 livers before and after the routine patient treatments of safety evaluatio 10, renal function are all no abnormal, routine blood test detects index does not have significant change.Laxativeness appears in 2 examples during the treatment, unprocessed spontaneous remission; Pharyngalgia, itching in the ear tinnitus 2 examples, medication is alleviated.

The external observation:

38 example treatment situation reports in the diagnosis and treatment of Kenya SEEBOUND institute of traditional Chinese medicine between year March in July, 2004 to 2005 are as follows:

1 case is selected

Mainly diagnose according to medical history, clinical symptoms sign and lab testing.All patients all are diagnosed as the HIV antibody positive through euzymelinked immunosorbent assay (ELISA) (ELISA) and Western blotting (WESTERN BLOT).In the diagnosis of the Center for Disease Control (CDC) with by stages on standard (1993) basis, with reference to traditional Chinese medical science differentiation of syndrome according to the pathgenesis of SAN JIAO method MethodsThe cases enrolled.Wherein belong to part of the body cavity above the diaphragm housing the heart and lungs lung and defend card 38 examples, according to clinical manifestation, it is as follows to intend the tcm diagnosis standard certainly:

1. generate heat or fever with chills; 2. cough or dyspnea with rapid and short breath, the few difficulty of expectorant are coughed up or abundant expectoration; 3. the chest pain breast is vexed; 4. skin pruritus, pimple or scabies, ulcer; 5. tuberculous lymphadenitis; 6. pharyngalgia; 7. yellow thick or red tongue few tongue, thready pulse or number of deep red tongue.

Main symptom for 1.～6. any one or more, merge 7. person, can make a definite diagnosis.

2 physical data

Man's 19 examples, women 19 examples; Age 25-65 year; The course of disease 5 months-9 years.Press the CDC classification: AC phase 1 example, ARC phases 26 example, AIDS phases 11 example.Clinical manifestation: heating or fever with chills 19 examples, 37 examples of coughing, dyspnea with rapid and short breath 5 examples of breathing hard, the few difficulty of expectorant is coughed up 9 examples, abundant expectoration 7 examples, chest pain 20 examples, 6 examples uncomfortable in chest, skin pruritus, pimple or furuncle, ulcer 23 examples, tuberculous lymphadenitis 11 examples, pharyngalgia 5 examples, fatigue and weakness 33 examples, indigestion and loss of appetite lack of appetite 26 examples, 20 examples of becoming thin are made 15 examples, lethargy or entanglement 1 example during diarrhoea, hair is withered, sparse 10 examples, dizzy 3 examples, 2 examples of having a headache, cardiopalmus 1 example, limbs twinge 1 example, frequent micturition, dysurea 1 example.

3 Therapeutic Method

With Chinese mugwort is lucky No. 1 granule, by Fructus Arctii, Radix Scutellariae, Cortex Mori etc., makes granule, every bag 10g (containing crude drug 40g); Each 1 bag, serve on 3 months at every day 2 times.During the treatment, do not use other antiviral agents and immunologic function potentiator.

4 observation index and method

The patient is clinic case, adopts treatment front and back self-controlled method, mainly observes the variation of clinical symptoms sign, treatment front and back cd4 cell number and virus load.Detecting instrument produces THE CUAVA SYSTEM with the U.S..The situation of change of observing and write down clinical manifestation the 1st, 2,3 the end of month before treatment and after the treatment.

5 results

5.1 curative effect judgment criteria

With reference to State Administration of Traditional Chinese Medicine's 5 province's Chinese medicine acquired immune deficiency syndrome (AIDS) clinical technology scheme (trying) and clinical practice situations, evaluate from symptom and sign, immunology, virusology aspect.

5.1.1 symptom and sign improves situation

Conscious sensation and doctor's observed and recorded with patient are as the criterion, and are divided into symptom and sign and disappear, obviously improve, improve, do not have and improve fourth class level.

5.1.2 immunologic function criterion (CD ₄Absolute number)

Effectively: CD ₄Lymphocyte count raises 〉=30%; Invalid: CD ₄Lymphocyte count rising＜30% or descender.

5.1.3 virus load criterion

Effectively: virus load reduction 〉=0.5log/ml; Invalid: virus load reduction＜0.5log/ml or rising person.

5.2 curative effect

20 examples 5.2.1 symptom and sign improvement situation symptom and sign disappears are obviously improved 16 examples, improve 2 examples, do not have 0 example of improvement;

5.2.2 immunologic function (CD ₄Absolute number): effective 28 examples, invalid 10 examples.Effective percentage 73.68%;

5.2.3 virus load: effective 19, invalid 19.Effective percentage 50%;

The variation of virus load all has significant differences before and after the treatment.See Table 2.

CD before and after table 1 patient ₄The variation of cell number (

/ mm ³)

n	Before the treatment	After the treatment	The t value	P
					38	318.05±145.72	521.03±87.454	-7.36	＜.0001

The variation of virus load before and after table 2 patient ( * 10 ³Copies/ml)

n	Before the treatment	After the treatment	The t value	P
					38	30.687±28.233	8.7042±8.7407	5.18	＜.0001

(4) specific embodiment

Embodiment 1: get Fructus Arctii 9g, Radix Scutellariae 9g, Cortex Mori 12g, Herba Agrimoniae 12g, Herba Senecionis Scandentis 12g, Fructus Kochiae 12g, Radix Ginseng 6g, Radix Astragali 20g, Radix Trichosanthis 12g, Herba Violae 10g, Radix Glycyrrhizae 12g.Above medicament mixed decocting concentrates, and makes granule, every day 2-3 time, and each 10g, oral.

Embodiment 2: get Fructus Arctii 3g, Radix Scutellariae 3g, Cortex Mori 5g, Herba Agrimoniae 9g, Herba Senecionis Scandentis 9g, Fructus Kochiae 9g, Radix Ginseng 2g, Radix Astragali 15g, Radix Trichosanthis 9g, Herba Violae 8g, Radix Glycyrrhizae 9g.Above medicament mixed decocting concentrates, and makes capsule, every day 2-3 time, and each 6-8 grain, oral.

Embodiment 3: get Fructus Arctii 6g, Radix Scutellariae 6g, Cortex Mori 9g, Herba Agrimoniae 9g, Herba Senecionis Scandentis 9g, Fructus Kochiae 9g, Radix Ginseng 6g, Radix Astragali 19g, Radix Trichosanthis 6g, Herba Violae 12g, Radix Glycyrrhizae 6g.Above medicament mixed decocting, 1 dose of every day, every day 2-3 time, oral.

Embodiment 4: by medicine of the present invention (is lucky No. 1 hereinafter to be referred as Chinese mugwort) the main pharmacodynamics experimental data of embodiment 1 preparation

Our right Chinese mugwort is that lucky No. 1 main pharmacodynamics has been carried out experimentation, now the result is reported as follows:

1 pair of experiment that immunologic function is recovered

1.1 experiment material

Animal: Kunming mouse, male, SPF animal (specific pathogen free animals), body weight 18-20 gram, age 3.5-4 one full year of life.(purchase in Chinese pharmaceutical biological product and identify institute's Experimental Animal Center, animal licence numbering: SCXK (capital) 2005-0004).

Medicine: 1. Chinese mugwort is lucky No. 1 (be made up of tens flavor Chinese medicines such as Fructus Arctii, Radix Scutellariae, Cortex Mori, Radix Ginseng, Medicine Industry Inst., Shandong Prov.'s mesothecium provides, and character is a powder).2. ZHENQI FUZHENG KELI (Jilin Shenyuan Pharmaceutical Co., Ltd., Tonghua produces, authentication code: the accurate word Z22022497 of traditional Chinese medicines, batch number: 040,306 005, valid until in February, 2006)

Reagent: 1. anti-mice CD ₃, CD ₄, CD ₈Monoclonal fluorescent antibody (U.S. eB company produces, and it is that Bioisystech Co., Ltd sells that Shenzhen reaches section).2. encircle spore enzyme element (the big pharmaceutical factory of Switzerland Novartis, batch number: S001 is valid until in JIUYUE, 2008).

Instrument: Couter EPI CS XL type flow cytometer (production of U.S. Coulter Corporation).

1.2 experimental technique:

1.2.1 120 experiment mices are got in the animal grouping, are divided into 6 groups at random, promptly normal control group, model group, Chinese mugwort are lucky No. 1 observation group (totally 3 groups of basic, normal, high dosage), positive drug control group, 20 every group.Wherein, Chinese mugwort is lucky No. 1 observation group: according to adult's dosage (20g medicine/60kg body weight), be established as 5 times, 10 times, 20 times three laboratory observation groups of adult's per kilogram of body weight dosage respectively; Positive drug control group: 10 times of amounts with adult's per kilogram of body weight (30g/60kg) are the ZHENQI FUZHENG KELI dosage.

1.2.2 modeling and administration laboratory animal are at secondary Animal Lab. (laboratory animal occupancy permit: SYXK (capital) 2005-0024, valid until on July 29th, 2010) in raise 3d after, set up the immunosuppressant model mice to mouse peritoneal injection ring spore enzyme element (except the normal control group), the next day, inject once, injects altogether 3 times.Afterwards begin gastric infusion next day in injection for the third time.Each 0.5ml, day once, two weeks of continuous irrigation stomach.Normal control group and model group mice are irritated stomach 0.5 ml distilled water simultaneously.

1.2.3 lymphocyte subpopulation detects the two weeks posterior orbit and gets blood, use anticoagulant heparin, gets the 0.1ml anticoagulation according to the reagent operation instruction and hatches to combine with anti-mouse monoclonal fluorescent antibody and then detect on flow cytometer.Experimental data is checked with t and is carried out statistical analysis.

1.3 experimental result

Experimental result sees Table 1.

Table 1. immunosuppressed mice CD ₃T cell detection results (%)

Experimental result sees Table 2.

Table 2. immunosuppressed mice CD ₄T cell detection results (%)

* compare P＜0.05 with normal control comparison P＜0.01 * * and model group

* * and model group compare P＞0.05 * * * * and model group compares P＜0.01

Experimental result sees Table 3.

Table 3. immunosuppressed mice CD ₄/ CD ₈The ratio result

* compare P＞0.05 with normal control comparison P＜0.05 * * and model group

The result show Chinese mugwort be lucky No. 1 to improving immunosuppressed mice CD ₃T cell percentage and CD ₄The T cell percentage has certain effect, and wherein low dose group (5 times of medication groups) compares CD with model group ₄The raising of T cell percentage is comparatively obvious, and significant difference (P＜0.05) is arranged; CD ₄/ CD ₈The equal no difference of science of statistics of percentage rate (P＞0.05) between each group of ratio.

2 external HIV (human immunodeficiency virus)-resistant activity detect

2.1 experiment material

Medicine and reagent: 1. Chinese mugwort is lucky No. 1; 2. positive control drug azidothymidine AZT (AZT) is available from SIGMA company; 3. tetramethyl azo azoles salt (MTT) is available from SIGMA company.Be mixed with the solution of 5mg/ml during use with PBS, 0.22 μ m membrane filtration; 4. dimethyl sulfoxide (DMSO) is available from SIGMA company;

Human immunodeficiency virus HIV-1 IIIB strain is introduced by the U.S..

Vironostika ^HIV-1 Antigen Microelisa System test kit.

The MT-4 cell, the human T lymphocyte of going down to posterity system.

RPMI1640+10% hyclone cell culture fluid.

96 porocyte culture plates.

The board-like microplate reader of ZS-2 (Xinfeng Electromechanical Tech. Corp., Beijing City).

CO ₂Incubator.

More than detect by Chinese People's Liberation Army acquired immune deficiency syndrome (AIDS) and to confirm that laboratory provides.

2.2 experimental technique

2.2.1 the CPE method is measured the infection titer (TCID of viral pair cell ₅₀) with the MT-4 cell inoculation in 96 orifice plates, every hole 100 μ l, cell concentration is 2.5 * 10 ⁴Individual/ml (final concentration), with virus stock solution used with culture fluid 10 times of dilutions successively totally 8 concentration add in the cell hole every concentration 4 holes, 37 ℃, 5%CO ₂Incubator is cultivated.Use inverted microscope observation of cell pathological changes (CPE) every day.Cytopathy below 25% is being+, 26～50% pathological changes are ++, 51～75% pathological changes are +++, 76～100% pathological changes are ++ ++.Record cytopathy degree (CPE).Calculate the infection titer (TCID of virus with the Reed-Muench method ₅₀).

2.2.2 mtt assay is measured the half toxic concentration (TC of censorship medicine to the MT-4 cell ₅₀) with the MT-4 cell inoculation in 96 orifice plates, every hole 100 μ l, cell concentration is 2.5 * 10 ⁴Individual/ml (final concentration).Add 5000,2500,1250,625,312.5,156.2,78.12,39.06 μ g/ml respectively and be subjected to reagent thing 100 μ l, every concentration 4 holes; The concentration of positive control drug AZT is respectively 400,200,100,50,25,12.25,6.125,3.0625 μ M, every hole 100 μ l, every concentration 4 holes add 5mg/ml MTT dyeing 4h behind the cultivation 3d, suction is abandoned and is reset and added the about 0.5h of DMS0100 μ l dissolving, measures OD with enzyme connection detector _570nmAbsorption value, the Reed-Muench method is calculated TC ₅₀

2.2.3 the antiviral activity that the CPE method is measured the censorship medicine with the MT-4 cell inoculation in 96 orifice plates, every hole 50 μ l, cell concentration is 2.5 * 10 ⁴Individual/ml (final concentration).What add 1250,625,312.5,156.2,78.12,39.06 μ g/ml respectively in different holes is subjected to reagent thing 50 μ l, and every then hole adds 100 μ lHIV-1 virus (100TCID ₅₀).If positive control (cell+AZT+ virus), virus control (cell+virus+culture fluid), cell contrast (cell+culture fluid), medicine contrast (medicine+cell+culture fluid).When virus control porocyte pathological changes is ++ ++ the time, record cytopathy result (cytopathy below 25% is being+, 26～50% pathological changes are ++, 51～75% pathological changes are +++, 76～100% pathological changes are ++ ++, normal cell is-).Test repeats 3 times.Calculate the half-inhibition concentration IC of medicine with the Reed-Muench method to virus ₅₀

2.3 experimental result

2.3.1 HIV-1 IIIB strain is to the TCID of MT-4 cell ₅₀Be 10 ^-5

2.3.2 medicine is to MT-4 cell half toxic concentration (TC ₅₀) censorship medicine maximal non-toxic concentration be 312.5 μ g/ml, cellular morphology is identical with control cells under this concentration.Calculate the half toxic concentration TC of medicine pair cell ₅₀Be 774 μ g/ml; Positive control medicine AZT pair cell half toxic concentration TC ₅₀Be 49.22 μ M.

2.3.3 the antiviral activity of medicine is measured the IC of censorship medicine to HIV-1 IIIB strain ₅₀Value is 298 μ g/ml, and therapeutic index TI is 2.6; Positive control medicine AZT is to HIV-1 IIIB strain IC ₅₀Value 1.96nM, therapeutic index TI is 25112.

Experimental result sees Table 4.

Table 4: the effect that is subjected to reagent thing anti-HIV-1

Be subjected to the reagent thing	Experimental system	TC 50	IC 50	TI
					Chinese mugwort is lucky No. 1 AZT	MT-4/HIV-1IIIB MT-4/HIV-1IIIB	774±15.14μg/ml 49.22±4.62μM	298 ±21.69μg/ml 1.96±0.12nM	2.6 25112

Annotate: TI (Therapeutic Index, therapeutic index)=TC ₅₀/ IC ₅₀

The result shows that in MT-4 cell/HIV-1IIIB and experimental system, Chinese mugwort is that the therapeutic index of lucky No. 1 inhibition virus replication is 2.6, and certain vitro inhibition HIV effect is arranged.

Embodiment 5 Chinese mugworts are lucky No. 1 animal acute toxicity test research (maximum dosage-feeding test)

1. animal: Kunming mouse, body weight 18-22g, male and female half and half, anti-medical Group Co.,Ltd provides credit number by the Shandong, Shandong: No. 20030006, S CXK (Shandong).The raising condition: raise with the mice plastics cage, support female, the male branch, and 5 in every cage, free diet, laboratory temperature are controlled at 18～24 ℃, the well-ventilated, and humidity 40-70% normally raises after three days for examination.

2. tried thing: Chinese mugwort is lucky No. 1: research and develop company limited by the safe female Chinese medicine in Shandong lot number is provided: 040907208.Time spent is mixed with Cmax 0.6g/ml with 0.5% sodium carboxymethyl cellulose.

3. main agents: sodium carboxymethyl cellulose (CMC-Na), white powder provides lot number by Beijing Hua Boyuan Science and Technology Development Center: 980305, concentration is 0.5% when being used for dissolved substance.

Method

40 of Kunming mouses, body weight 18～22g, male and female half and half are divided into 2 groups at random, 20 of administration groups, 20 of matched groups.The administration volume is 0.4ml/10g, and matched group gives with capacity 0.5% sodium carboxymethyl cellulose, fasting after 12 hours in the next day of each 1 oral administration gavage administration sooner or later.Observe reaction of animals and death condition after the administration, every day 1 time, observed continuously 14 days.Before the record medicine and 3,7,14 days the weight of animals and every day the toxic reaction symptom and dead animal distribute, and to dead and observe and finish mice and perform an autopsy on sb perusal record pathological changes situation.

The result

Mice shows no obvious abnormalities after the administration first time, and for the second time movable number of times reduces after the administration, after gradually recover.Observe crissum next day excretion of drug, does not see that other are obviously unusual.

Do not see animal dead in 14 days behind the medicine.Body weight growth in 3,7,14 days is compared with matched group behind the administration group medicine, and basically identical the results are shown in Table 1.

Table 1. Chinese mugwort is the influence of lucky No. 1 administration to mice body weight (g).

	Value (g) before the medicine	Administration 3d body weight (g)	Administration 7d body weight (g)	Administration 14d body weight (g)
					Contrast female	20.5±1.3	22.3±1.2	24.5±1.0	28.2±1.3
Administration is female	20.7±1.3	22.1±0.8	24.3±1.0	28.5±1.4
					Contrast is male	21.0±1.2	23.3±1.3	26.3±1.2	31.2±1.2
The administration hero	20.7±1.1	22.9±1.3	26.4±1.6	30.7±1.8

N＝10，P＞0.05 vs Veh.

Put to death animal after the off-test and cut open inspection, main organs such as the heart, liver, spleen, lung, kidney, brain, stomach, intestinal show no obvious abnormalities.

Conclusion

Chinese mugwort be lucky No. 1 with maximum administration concentration and maximum volume, twice on the one orally give mice 48g/kg, the movable number of times of visible mice reduces after the administration for the second time, after gradually recover.Observe crissum next day excretion of drug, does not see that other are obviously unusual.Do not see animal dead in 14 days, the weight of animals increases normal.

Chinese mugwort is that lucky No. 1 mice maximum dosage-feeding is 48g/kg.

Claims (2)

1. the Chinese medicine preparation of an acquired immune deficiency syndrome (AIDS) is characterized in that: be to be made by the raw material of following parts by weight:

Fructus Arctii 3-9g Radix Scutellariae 3-9g Cortex Mori 6-12g Herba Agrimoniae 6-12g

Herba Senecionis Scandentis 6-12g Fructus Kochiae 6-12g Radix Ginseng 2-6g Radix Astragali 10-25g

Radix Trichosanthis 6-12g Herba Violae 6-12g Radix Glycyrrhizae 6-12g.

2. the Chinese medicine preparation of treatment acquired immune deficiency syndrome (AIDS) according to claim 1 is characterized in that: but described Chinese medicine preparation is the dosage form of water decoction, granule, capsule, tablet or other pharmacy.