CN110507700A - A kind of pharmaceutical composition containing qinghaosu and tripterygium hypoglaucum hutch, preparation and preparation method thereof - Google Patents
A kind of pharmaceutical composition containing qinghaosu and tripterygium hypoglaucum hutch, preparation and preparation method thereof Download PDFInfo
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Abstract
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.
Description
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.
Embodiment 1
Composite tablet containing tripterygium hypoglaucum hutch and qinghaosu
Formula: by mass percentage, qinghaosu and tripterygium hypoglaucum hutch 58% (mass ratio of the two is 1:75) in total, lactose
30wt%, microcrystalline cellulose 2wt%, sodium alginate 5wt%, lauryl sodium sulfate 2wt%, talcum powder 3wt%.
Preparation process: all of above raw material is mixed, and suitable quantity of water is added, stirs evenly, wet granulation is dried later, most
Tabletting afterwards.
Embodiment 2
Composite tablet containing tripterygium hypoglaucum hutch and qinghaosu
Formula: by mass percentage, qinghaosu and tripterygium hypoglaucum hutch 75.5% (mass ratio of the two is 1:75) in total, lactose
10wt%, microcrystalline cellulose 8wt%, sodium alginate 0.5wt%, lauryl sodium sulfate 5wt%, talcum powder 1wt%.
Preparation process: all of above raw material is mixed, and suitable quantity of water is added, stirs evenly, wet granulation is dried later, most
Tabletting afterwards.
Dissolution Rate Testing
Test method:
The preparation of test solution: the composite tablet containing tripterygium hypoglaucum hutch and qinghaosu is taken, by dissolution method (Chinese Pharmacopoeia
Two the second methods of annex XC of version in 2010), using 20% ethanol solution 500mL as solvent, revolving speed 100r/min is operated according to methods, warp
20, when 30,60min, solution 20mL is taken, is filtered, precision measures subsequent filtrate 2mL into 25mL measuring bottle, adds 20% ethanol solution
3mL is diluted to scale with 0.2%NaOH solution, shakes up, and with 0.22 μm of filtering with microporous membrane into 10mL measuring bottle, sets 50 DEG C of perseverances
Tepor 30min in tepidarium takes out, is cooled to room temperature, as test solution.
The preparation of reference substance solution: it is appropriate that precision weighs Qinghaosu, is dissolved into 0.25mg/ with ethanol solution
ML stock solution, shakes up, and precision measures this solution 1mL into 25mL measuring bottle, adds water 4mL, by sample solution preparation method, certainly
" being diluted to scale with 0.2%NaOH solution " rises to be operated with method, as reference substance solution.
Blank solution preparation: taking 20% ethanol solution 5mL, set in 25mL measuring bottle, by sample solution preparation method, certainly
" being diluted to scale with 0.2%NaOH solution " rises to be operated with method, as blank solution.
Measurement: qinghaosu concentration is measured using spectrophotometry (two annex IVA of Chinese Pharmacopoeia version in 2010).It calculates
The amount of dissolution of every middle qinghaosu.
The results are shown in Table 4.
Table 4
The foregoing is only a preferred embodiment of the present invention, but scope of protection of the present invention is not limited thereto,
In the technical scope disclosed by the present invention, any changes or substitutions that can be easily thought of by anyone skilled in the art,
It should be covered by the protection scope of the present invention.Therefore, protection scope of the present invention should be with the protection model of the claim
Subject to enclosing.
Claims (10)
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.
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| CN202010516459.2A CN111494457A (en) | 2019-09-19 | 2020-06-09 | Pharmaceutical composition containing artemisinin and herba Polygoni orientalis, preparation and preparation method thereof |
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| KR101277710B1 (en) * | 2010-09-07 | 2013-06-24 | 연세대학교 산학협력단 | Novel Artemisinin or Deoxoartemisinin-glycolipid Hybrid Derivatives and Antiangiogenic Use Thereof |
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