阅读说明：本技术 一种含青蒿素与火把花的药物组合物、制剂及其制备方法 (A kind of pharmaceutical composition containing qinghaosu and tripterygium hypoglaucum hutch, preparation and preparation method thereof ) 是由 黄崇刚 黄思行 刘剑毅 兰波 占敏霞 梅小利 吴思澜 张莉 施汀兰 黄文涛 涂如 于 2019-09-19 设计创作，主要内容包括：本发明涉及一种含青蒿素与火把花的药物组合物、制剂及其制备方法。药物组合物包括青蒿素与火把花,二者的质量比为0.1～0.2:7.5～15。本发明利用青蒿素与火把花两种成分的协同增效作用,提高了对关节炎的疗效,缩短了治疗时间。(The present invention relates to a kind of pharmaceutical compositions containing qinghaosu and tripterygium hypoglaucum hutch, preparation and preparation method thereof.Pharmaceutical composition includes qinghaosu and tripterygium hypoglaucum hutch, and the mass ratio of the two is 0.1~0.2:7.5~15.The present invention utilizes the synergistic function of qinghaosu and two kinds of ingredients of tripterygium hypoglaucum hutch, improves to arthritic curative effect, shortens treatment time.)

1. a kind of pharmaceutical composition containing qinghaosu and tripterygium hypoglaucum hutch, which is characterized in that including drug activity ingredient, the drug effect is living Property ingredient be made of qinghaosu with tripterygium hypoglaucum hutch, the mass ratio of the two is 0.1~0.2:7.5~15.

2. the pharmaceutical composition according to claim 1 containing qinghaosu and tripterygium hypoglaucum hutch, which is characterized in that qinghaosu and torch Colored mass ratio is 0.05~0.2:7.5.

3. the pharmaceutical composition according to claim 1 containing qinghaosu and tripterygium hypoglaucum hutch, which is characterized in that the tripterygium hypoglaucum hutch is The root extract of tripterygium hypoglaucum hutch.

4. the pharmaceutical composition according to claim 1-3 containing qinghaosu and tripterygium hypoglaucum hutch, which is characterized in that also wrap Include pharmaceutically acceptable at least one adjuvant.

5. the pharmaceutical composition according to claim 4 containing qinghaosu and tripterygium hypoglaucum hutch, which is characterized in that the adjuvant packet It includes solubilizer, preservative, corrigent, wetting agent, disintegrating agent, suspending agent, chelating agent, filler, lubricant, binder, help stream One of agent is a variety of.

6. preparation made of the described in any item pharmaceutical compositions of claim 1-5, which is characterized in that the preparation be tablet, Oral solution, powder, capsule, injection or externally dressing.

7. preparation according to claim 6, which is characterized in that the preparation be tablet, the adjuvant include filler, One of preservative, corrigent, binder, disintegrating agent, lubricant, glidant are a variety of.

8. preparation according to claim 7, which is characterized in that the filler is selected from lactose, dextrin, mannitol and sorb One of alcohol is a variety of；

The binder is microcrystalline cellulose；

The disintegrating agent is sodium alginate；

The lubricant is lauryl sodium sulfate；

The glidant is talcum powder.

9. the preparation method of the described in any item pharmaceutical compositions of claim 1-5, which is characterized in that according to formula, will own Material combination.

10. according to the preparation method of the described in any item preparations of claim 6-8, which is characterized in that according to formula, by all originals Material is according to the preparation flow mixing of default dosage form, preparation.

Technical field

The present invention relates to drug field, in particular to a kind of pharmaceutical composition containing qinghaosu and tripterygium hypoglaucum hutch, preparation and its Preparation method.

Background technique

Arthritis (arthritis) refers to generation in human synovial and its surrounding tissue, by inflammation, infection, degeneration, wound Or inflammatory disease caused by other factors, tens of kinds can be divided into.The arthritic in China has 100,000,000 or more, and number is continuous Increase.Clinical manifestation is the red, swollen, hot of joint, pain, dysfunction and joint deformity, and serious person leads to joint deformity, influences to suffer from Person's quality of life.Half suffers from osteoarthritis in China 50 years old or more crowd according to statistics, in over-65s crowd 90% women and 80% male suffers from osteoarthritis.The illness rate in China is 0.34%~0.36%, and serious person's service life about shortens 10~15 years.Joint The scorching cause of disease is complicated, mainly related with the factors such as autoimmune response, infection, metabolic disorder, wound, retrogression pathological changes, according to Arthritis can be divided into bone, rheumatoid, tatanic, reactive, gouty, rheumatic, suppurative etc. by the cause of disease.

Drug therapy arthritis is clinically mainly used at present, and surgical operation, marrow can just be used by only arriving severe stage Other wound sex therapy such as transplanting.Tripterygium hypoglaucum hutch is a kind of Chinese medicine for being widely used in treatment of arthritis, however single medicine Therapeutic effect is limited, to be improved.

Summary of the invention

The pharmaceutical composition containing qinghaosu and tripterygium hypoglaucum hutch that the purpose of the present invention is to provide a kind of, the composition utilize sweet wormwood The synergistic function of element and two kinds of ingredients of tripterygium hypoglaucum hutch, improves to arthritic curative effect, shortens treatment time.

In order to achieve the goal above, the present invention provides following technical schemes:

A kind of pharmaceutical composition containing qinghaosu and tripterygium hypoglaucum hutch, including qinghaosu and tripterygium hypoglaucum hutch, the mass ratio of the two are 0.1 ~0.2:7.5~15.

It is a discovery of the invention that can improve to arthritic curative effect after qinghaosu is compounded with tripterygium hypoglaucum hutch, shorten treatment time.

Find that pharmaceutical composition of the invention can significantly inhibit small caused by red blood cell using rat, mouse as subjects Mouse hemolytic antibody generates, moreover it is possible to significantly inhibit mouse delayed hypersensitive reaction caused by 2,4-dinitrofluorobenzene, can significantly reduce Rat articular swelling.Test result shows that qinghaosu qinghaosu single compared with after tripterygium hypoglaucum hutch compounding is to Articular swelling Inhibiting rate improve 23.87%, improve 12.31% compared to single tripterygium hypoglaucum hutch inhibiting rate.

In the present invention, the arbitrary value in the range of 0.1~0.2:7.5~15 is can be used in the mass ratio of qinghaosu and tripterygium hypoglaucum hutch, Wherein, when preferably the mass ratio of qinghaosu and tripterygium hypoglaucum hutch is 0.05~0.2:7.5, cooperative synergism effect is more significant.

Tripterygium hypoglaucum hutch of the present invention is the root of tripterygium hypoglaucum hutch, directly extract obtained by, can be used conventional extracting method and , such as extraction etc., i.e., tripterygium hypoglaucum hutch of the present invention are torch flower extract.

Qinghaosu of the present invention can be made by oneself or commercially available.

In some embodiments, pharmaceutical composition further includes pharmaceutically acceptable at least one adjuvant.

In some embodiments, the adjuvant includes solubilizer, preservative, corrigent, wetting agent, disintegrating agent, helps One of suspension, chelating agent, filler, lubricant, binder, glidant are a variety of.

Adjuvant is selected generally according to preparation type.

Arbitrary preparation, such as tablet, oral solution, powder, capsule, injection is made in pharmaceutical composition of the present invention Agent or externally dressing.Different dosage forms select different adjuvants.

By taking tablet as an example, the filler is selected from one of lactose, dextrin, mannitol and sorbierite or a variety of, is making Content in agent is preferably 10~30wt%；

The binder is microcrystalline cellulose, and content in the formulation is preferably 2~8wt%；

The disintegrating agent is sodium alginate, and content in the formulation is preferably 0.5~5wt%.

The lubricant is lauryl sodium sulfate, and content in the formulation is preferably 2~5wt%；

The glidant is talcum powder, and content in the formulation is preferably 1~3wt%.

The above preparation shows good dissolution rate.

By taking oral solution as an example, common adjuvant has solubilizer, preservative, corrigent, suspending agent, wetting agent, surface living Property agent, emulsifier etc..

Pharmaceutical composition of the present invention the preparation method comprises the following steps: according to formula, by all material combinations.

The preparation method of preparation of the present invention is using conventional preparation method, by taking tablet as an example, by all originals Expect that granulation, tabletting after mixing to obtain the final product.Suitable prilling process can be selected according to the type of auxiliary agent and the physico-chemical property of drug.

To sum up, compared with prior art, invention achieves following technical effects:

(1) after qinghaosu is compounded with tripterygium hypoglaucum hutch, synergistic function is generated, improves to arthritic curative effect, shortens Treatment time.

(2) tablet hurtless measure provided by, convenient drug administration, compliance are good.

Specific embodiment

Embodiment of the present invention is described in detail below in conjunction with embodiment, but those skilled in the art will Understand, the following example is merely to illustrate the present invention, and is not construed as limiting the scope of the invention.It is not specified in embodiment specific Condition person carries out according to conventional conditions or manufacturer's recommended conditions.Reagents or instruments used without specified manufacturer is The conventional products that can be obtained by commercially available purchase.

Effect experiment

1, dose design

Qinghaosu dosage: mouse: A1 200mg/kg, A2 100mg/kg；Rat: A3 100mg/kg, A4 50mg/ kg；

Tripterygium hypoglaucum hutch dosage: mouse: B1 is 15g crude drug/kg, and B2 is 7.5g crude drug/kg；Rat: B3 is 7.5g crude drug/kg, B4 is 3.75g crude drug/kg.

2 experiment contents

The influence that 2.1 pairs of mouse hemolytic antibodies generate

2.1.1 drug is prepared

Test group medication: taking 200mg qinghaosu, is added after 0.5%CMC-Na solution is sufficiently milled uniformly and is settled to 20ml, The qinghaosu solution for being 10mg/ml up to concentration；1.1g colguhoumia root medicinal extract (content is 13.64g crude drug/g medicinal extract) is taken, is added 0.5%CMC-Na solution is settled to 20ml to get concentration after sufficiently milling uniformly be 0.75g crude drug/ml colguhoumia root medicinal extract Solution.By prepared concentration be 10mg/ml qinghaosu solution and concentration be that 0.75g crude drug/ml colguhoumia root medicinal extract is molten To get the solution of required proportion (A2:B2), (the final concentration of 5mg/ml of qinghaosu, colguhoumia root are whole after liquid 1:1 mixing by volume Concentration is 0.375g crude drug/ml).

Being settled to 20ml after taking 200mg qinghaosu, addition 0.5%CMC-Na solution sufficiently to mill uniformly to get concentration is The qinghaosu solution of 10mg/ml；2.2g colguhoumia root medicinal extract (content is 13.64g crude drug/g medicinal extract) is taken, 0.5%CMC- is added Na solution is settled to 20ml to get concentration after sufficiently milling uniformly be 1.5g crude drug/ml colguhoumia root medicinal extract solution.It will prepare The qinghaosu solution and concentration that good concentration is 10mg/ml are 1.5g crude drug/ml colguhoumia root medicinal extract solution 1:1 by volume To get the solution of required proportion (A2:B1), (the final concentration of 5mg/ml of qinghaosu, the final concentration of 0.75g of colguhoumia root are raw after mixing Medicine/ml).

Being settled to 20ml after taking 400mg qinghaosu, addition 0.5%CMC-Na solution sufficiently to mill uniformly to get concentration is The qinghaosu solution of 20mg/ml；It takes 1.1g colguhoumia root medicinal extract (13.64g crude drug/g medicinal extract), 0.5%CMC-Na solution is added It is 0.75g crude drug/ml colguhoumia root medicinal extract solution that 20ml is settled to after sufficiently milling uniformly to get concentration.It will be prepared The qinghaosu solution and concentration that concentration is 20mg/ml are that 1:1 is mixed by volume for 0.75g crude drug/ml colguhoumia root medicinal extract solution To get the solution of required proportion (A1:B2), (the final concentration of 10mg/ml of qinghaosu, the final concentration of 0.375g of colguhoumia root are raw after conjunction Medicine/ml).

Being settled to 20ml after taking 400mg qinghaosu, addition 0.5%CMC-Na solution sufficiently to mill uniformly to get concentration is The qinghaosu solution of 20mg/ml；2.2g colguhoumia root medicinal extract (content is 13.64g crude drug/g medicinal extract) is taken, 0.5%CMC- is added Na solution is settled to 20ml to get concentration after sufficiently milling uniformly be 1.5g crude drug/ml colguhoumia root medicinal extract solution.It will prepare The qinghaosu solution and concentration that good concentration is 20mg/ml are 1.5g crude drug/ml colguhoumia root medicinal extract solution 1:1 by volume To get solution (the final concentration of 10mg/ml of qinghaosu, the final concentration of 0.75g of colguhoumia root of required proportion (A1:B1) after mixing Crude drug/ml).

200mg qinghaosu is taken, is added after 0.5%CMC-Na solution is sufficiently milled uniformly and is settled to 20ml to get required Qinghaosu solution (A1) (the final concentration of 10mg/ml of qinghaosu).

1.1g colguhoumia root medicinal extract (content is 13.64g crude drug/g medicinal extract) is taken, 0.5%CMC-Na solution is added and sufficiently grinds Mill uniformly after be settled to 20ml to get required colguhoumia root medicinal extract solution (B1) (the final concentration of 0.75g crude drug of colguhoumia root/ ml)。

2.1.2 experimental method

Under disinfecting action, mouse blood is added in 0.9% sodium chloride injection of 50mL by the venous blood collection under mouse It mixes, is then washed 3 times with 0.9% sodium chloride injection, preceding centrifugal speed twice is 1500r/min, is centrifuged 5min, abandons supernatant The leukocytic cream of liquid and interface is finally centrifuged (2000r/min, 5min) twice in succession again until hematocrit value is constant, by this Value is made into 5% mouse red blood cell suspension with 0.9% sodium chloride injection.

Culling heart blood is carried out to mouse, after waiting for blood to solidify, 2000r/min is centrifuged 5min, the serum mixing of top is drawn, 10% serum is made into physiological saline.

After quarantine and adaptive feeding, choose 56 qualified mouse of health, weight be no more than average weight ± 20%, it is randomly divided into 7 groups, i.e. blank control group, qinghaosu and tripterygium hypoglaucum hutch A2:B2 group, qinghaosu and tripterygium hypoglaucum hutch A1:B2 group, blueness Artemisin and tripterygium hypoglaucum hutch A2:B1 group, qinghaosu and tripterygium hypoglaucum hutch A1:B1 group, qinghaosu A1 group, tripterygium hypoglaucum hutch B1 group, every group of 8 (male and female It is fifty-fifty).After grouping, corresponding drug is given in stomach-filling to each medicine group respectively, and blank control group gives the purified water of respective volume, Administered volume is 0.2ml/10g weight, once a day, successive administration 7 times.

Administration first day, 5% mouse red blood cell suspension is only injected intraperitoneally by 0.2ml/ and is immunized for each group.

1h after the last administration, eyeball take blood, and 3000r/min is centrifuged 10min, serum are separated, with 0.9% sodium chloride injection Serum is diluted 100 times.Dilute serum 1ml is taken, with 5% mouse red blood cell suspension 0.5ml, 10% mice serum (complement) 0.5ml is mixed, and is incubated 30min in 37 DEG C of insulating boxs, 30min stopped reaction in 0 DEG C of ice water is then set, by aforesaid liquid 3000r/ Min is centrifuged 10min, takes supernatant (the supernatant zeroing that mice serum is not added), measures OD at 540nm with spectrophotometer Value.

2.1.3 experimental result

Such as table 1, the different ratio of qinghaosu and tripterygium hypoglaucum hutch generates mouse hemolytic antibody caused by mouse red blood cell equal There is apparent inhibiting effect, it is prompted to have inhibiting effect to humoral immune function.

Table 1

Group	Ratio	OD value (8)
			Blank control	/	1.260±0.709
Qinghaosu: tripterygium hypoglaucum hutch	A2:B2	0.348±0.645
			Qinghaosu: tripterygium hypoglaucum hutch	A1:B2	0.082±0.078
Qinghaosu: tripterygium hypoglaucum hutch	A2:B1	0.265±0.267
			Qinghaosu: tripterygium hypoglaucum hutch	A1:B1	0.105±0.191
Qinghaosu	A1	0.192±0.305
			Tripterygium hypoglaucum hutch	B1	0.149±0.255

2.2 couples of DNFB cause the influence of mouse delayed hypersensitive reaction

2.2.1 drug is prepared

Test group medication: taking 200mg qinghaosu, is added after 0.5%CMC-Na solution is sufficiently milled uniformly and is settled to 20ml, The qinghaosu solution for being 10mg/ml up to concentration；1.1g colguhoumia root medicinal extract (content is 13.64g crude drug/g medicinal extract) is taken, is added 0.5%CMC-Na solution is settled to 20ml to get concentration after sufficiently milling uniformly be 0.75g crude drug/ml colguhoumia root medicinal extract Solution.By prepared concentration be 10mg/ml qinghaosu solution and concentration be that 0.75g crude drug/ml colguhoumia root medicinal extract is molten To get the solution of required proportion (A2:B2), (the final concentration of 5mg/ml of qinghaosu, colguhoumia root are whole after liquid 1:1 mixing by volume Concentration is 0.375g crude drug/ml).

Being settled to 20ml after taking 200mg qinghaosu, addition 0.5%CMC-Na solution sufficiently to mill uniformly to get concentration is The qinghaosu solution of 10mg/ml；2.2g colguhoumia root medicinal extract (content is 13.64g crude drug/g medicinal extract) is taken, 0.5%CMC- is added Na solution is settled to 20ml to get concentration after sufficiently milling uniformly be 1.5g crude drug/ml colguhoumia root medicinal extract solution.It will prepare The qinghaosu solution and concentration that good concentration is 10mg/ml are 1.5g crude drug/ml colguhoumia root medicinal extract solution 1:1 by volume To get the solution of required proportion (A2:B1), (the final concentration of 5mg/ml of qinghaosu, the final concentration of 0.75g of colguhoumia root are raw after mixing Medicine/ml).

Being settled to 20ml after taking 400mg qinghaosu, addition 0.5%CMC-Na solution sufficiently to mill uniformly to get concentration is The qinghaosu solution of 20mg/ml；It takes 1.1g colguhoumia root medicinal extract (13.64g crude drug/g medicinal extract), 0.5%CMC-Na solution is added It is 0.75g crude drug/ml colguhoumia root medicinal extract solution that 20ml is settled to after sufficiently milling uniformly to get concentration.It will be prepared The qinghaosu solution and concentration that concentration is 20mg/ml are that 1:1 is mixed by volume for 0.75g crude drug/ml colguhoumia root medicinal extract solution To get the solution of required proportion (A1:B2), (the final concentration of 10mg/ml of qinghaosu, the final concentration of 0.375g of colguhoumia root are raw after conjunction Medicine/ml).

Being settled to 20ml after taking 400mg qinghaosu, addition 0.5%CMC-Na solution sufficiently to mill uniformly to get concentration is The qinghaosu solution of 20mg/ml；2.2g colguhoumia root medicinal extract (content is 13.64g crude drug/g medicinal extract) is taken, 0.5%CMC- is added Na solution is settled to 20ml to get concentration after sufficiently milling uniformly be 1.5g crude drug/ml colguhoumia root medicinal extract solution.It will prepare The qinghaosu solution and concentration that good concentration is 20mg/ml are 1.5g crude drug/ml colguhoumia root medicinal extract solution 1:1 by volume To get solution (the final concentration of 10mg/ml of qinghaosu, the final concentration of 0.75g of colguhoumia root of required proportion (A1:B1) after mixing Crude drug/ml).

200mg qinghaosu is taken, is added after 0.5%CMC-Na solution is sufficiently milled uniformly and is settled to 20ml to get required Qinghaosu solution (A1) (the final concentration of 10mg/ml of qinghaosu).

1.1g colguhoumia root medicinal extract (content is 13.64g crude drug/g medicinal extract) is taken, 0.5%CMC-Na solution is added and sufficiently grinds Mill uniformly after be settled to 20ml to get required colguhoumia root medicinal extract solution (B1) (the final concentration of 0.75g crude drug of colguhoumia root/ ml)。

2.2.2 experimental method

After quarantine and adaptive feeding, choose 56 qualified mouse of health, weight be no more than average weight ± 20%, it is randomly divided into 7 groups, i.e. blank control group, qinghaosu and tripterygium hypoglaucum hutch A2:B2 group, qinghaosu and tripterygium hypoglaucum hutch A1:B2 group, blueness Artemisin and tripterygium hypoglaucum hutch A2:B1 group, qinghaosu and tripterygium hypoglaucum hutch A1:B1 group, qinghaosu A1 group, tripterygium hypoglaucum hutch B1 group, every group of 8 (male and female It is fifty-fifty).After grouping, corresponding drug is given in stomach-filling to each medicine group respectively, and blank control group gives the purified water of respective volume, Administered volume is 0.2ml/10g weight, once a day, successive administration 7 times.

It is administered the 3rd day, each group mouse uniformly smears 0.5% 2,4-dinitrofluorobenzene acetone olive oil at abdomen unhairing Solution (25ul/ is only) sensitization, is administered the 4th day and strengthens 1 time.

After last dose 1 hour, 0.2%2,4- dinitrofluorobenzene acetone olive oil solution (20ul/ is only) is uniformly applied to Mouse right ear, left ear smear matrix (acetone olive oil), and model control group smears matrix.After 30 minutes, cervical dislocation puts to death mouse, Left and right auricle is cut, auricle is removed with punch (diameter 8mm), claims left and right ear weight, calculate swelling and swelling inhibiting rate, calculate Formula is as follows:

Swelling=auris dextra weight-Zuo Erchong

Swelling inhibiting rate=(model group swelling-medicine group swelling)/model group swelling × 100%

2.2.3 experimental result

Such as table 2, the different ratio of qinghaosu and tripterygium hypoglaucum hutch has apparent inhibition to ear swelling caused by 2,4-dinitrofluorobenzene Effect, prompts it to have apparent inhibiting effect to delayed hypersensitive reaction caused by 2,4-dinitrofluorobenzene, and proportion effect is better than list With.

Table 2

The influence of 2.3 pairs of experimental animal model of CFA induced adjuvant arthritis in rats

2.3.1 drug is prepared

Test group medication: taking 200mg qinghaosu, is added after 0.5%CMC-Na solution is sufficiently milled uniformly and is settled to 20ml, The qinghaosu solution for being 10mg/ml up to concentration；1.1g colguhoumia root medicinal extract (content is 13.64g crude drug/g medicinal extract) is taken, is added 0.5%CMC-Na solution is settled to 20ml to get concentration after sufficiently milling uniformly be 0.75g crude drug/ml colguhoumia root medicinal extract Solution.By prepared concentration be 10mg/ml qinghaosu solution and concentration be that 0.75g crude drug/ml colguhoumia root medicinal extract is molten To get the solution of required proportion (A4:B4), (the final concentration of 5mg/ml of qinghaosu, colguhoumia root are whole after liquid 1:1 mixing by volume Concentration is 0.375g crude drug/ml).

Being settled to 20ml after taking 200mg qinghaosu, addition 0.5%CMC-Na solution sufficiently to mill uniformly to get concentration is The qinghaosu solution of 10mg/ml；2.2g colguhoumia root medicinal extract (content is 13.64g crude drug/g medicinal extract) is taken, 0.5%CMC- is added Na solution is settled to 20ml to get concentration after sufficiently milling uniformly be 1.5g crude drug/ml colguhoumia root medicinal extract solution.It will prepare The qinghaosu solution and concentration that good concentration is 10mg/ml are 1.5g crude drug/ml colguhoumia root medicinal extract solution 1:1 by volume To get the solution of required proportion (A4:B3), (the final concentration of 5mg/ml of qinghaosu, the final concentration of 0.75g of colguhoumia root are raw after mixing Medicine/ml).

Being settled to 20ml after taking 400mg qinghaosu, addition 0.5%CMC-Na solution sufficiently to mill uniformly to get concentration is The qinghaosu solution of 20mg/ml；It takes 1.1g colguhoumia root medicinal extract (13.64g crude drug/g medicinal extract), 0.5%CMC-Na solution is added It is 0.75g crude drug/ml colguhoumia root medicinal extract solution that 20ml is settled to after sufficiently milling uniformly to get concentration.It will be prepared The qinghaosu solution and concentration that concentration is 20mg/ml are that 1:1 is mixed by volume for 0.75g crude drug/ml colguhoumia root medicinal extract solution To get the solution of required proportion (A3:B4), (the final concentration of 10mg/ml of qinghaosu, the final concentration of 0.375g of colguhoumia root are raw after conjunction Medicine/ml).

Being settled to 20ml after taking 400mg qinghaosu, addition 0.5%CMC-Na solution sufficiently to mill uniformly to get concentration is The qinghaosu solution of 20mg/ml；2.2g colguhoumia root medicinal extract (content is 13.64g crude drug/g medicinal extract) is taken, 0.5%CMC- is added Na solution is settled to 20ml to get concentration after sufficiently milling uniformly be 1.5g crude drug/ml colguhoumia root medicinal extract solution.It will prepare The qinghaosu solution and concentration that good concentration is 20mg/ml are 1.5g crude drug/ml colguhoumia root medicinal extract solution 1:1 by volume To get solution (the final concentration of 10mg/ml of qinghaosu, the final concentration of 0.75g of colguhoumia root of required proportion (A3:B3) after mixing Crude drug/ml).

200mg qinghaosu is taken, is added after 0.5%CMC-Na solution is sufficiently milled uniformly and is settled to 20ml to get required Qinghaosu solution (A3) (the final concentration of 10mg/ml of qinghaosu).

1.1g colguhoumia root medicinal extract (content is 13.64g crude drug/g medicinal extract) is taken, 0.5%CMC-Na solution is added and sufficiently grinds Mill uniformly after be settled to 20ml to get required colguhoumia root medicinal extract solution (B3) (the final concentration of 0.75g crude drug of colguhoumia root/ ml)。

2.3.2 experimental method

Reference literature method carries out model preparation: after quarantine and adaptive feeding, the qualified rat of quarantine (being stayed 8 Rat is not processed, half male and half female) Yu Youhou toes intracutaneous injection CFA 0.1mL/ is only.

The 14th day after injection, the successful rat of modeling type is selected to be randomly divided into 7 groups, i.e. model comparison according to Articular swelling Group, qinghaosu and tripterygium hypoglaucum hutch A4:B4 group, qinghaosu and tripterygium hypoglaucum hutch A3:B4 group, qinghaosu and tripterygium hypoglaucum hutch A4:B3 group, qinghaosu with Tripterygium hypoglaucum hutch A3:B3 group, qinghaosu A3 group, tripterygium hypoglaucum hutch B3 group, every group 8 (half male and half female)；It is blank that another 8, which do not process animal, Control group.After grouping, corresponding drug is given in stomach-filling to each medicine group respectively, and blank control group, model control group are given accordingly The purified water of volume, administered volume are 1ml/100g weight, by daily single, successive administration 21 days.

It (the 0th day) and is administered before modeling, before administration and measures the left back foot (secondary disease of all rats respectively on the 7th, 14,21 day Become side) and ankle-joint diameter 1 time of right metapedes, calculate arthroncus swelling.Calculation formula is as follows:

Rat ankle joint diameter before rat ankle joint diameter-modeling after Articular swelling=administration

2.3.3 experimental result

Such as table 3, the different ratio of qinghaosu and tripterygium hypoglaucum hutch has certain therapeutic effect to rat assist agent arthritis, prompts It has apparent therapeutic effect to rat assist agent arthritis subsequent articular swelling.

Table 3

The prompt of Pharmacodynamics screening result of study with rat arthritis model for main evaluation criterion, qinghaosu and tripterygium hypoglaucum hutch A3:B4 proportion (the A1:B2 proportion that the dosage is equal to mouse) had certain effect to rat arthritis model at the 2nd, 3 week, Mouse delayed hypersensitive reaction, the generation experiment of mouse hemolytic antibody should be caused to have apparent inhibiting effect with DNFB is compared.

3, acute toxicity testing result

Experimental method: after quarantine and adaptive feeding, 60 qualified mouse of health are chosen, weight is no more than average ± the 20% of weight is randomly divided into 3 groups, every group 20 (half male and half female).By group, relative medicine is given in stomach-filling respectively, gives medicine body Product is 0.4ml/10g weight, is administered once.

Tripterygium hypoglaucum hutch 200g crude drug/kg: it dead 18, survives 2；

Qinghaosu 4g/kg: dead 8, it survives 12；

Tripterygium hypoglaucum hutch 200g crude drug/kg+ qinghaosu 4g/kg: it dead 14, survives 6.

It can be seen that toxicity is not obviously improved after tripterygium hypoglaucum hutch and qinghaosu combination, it can also be seen that, it is administered from result above When tripterygium hypoglaucum hutch and the dosage of qinghaosu should not be more than the above-mentioned amount having compared with high lethality rate.