CN106176775B - Forsythiaside B and poliumoside compatible composition and its application - Google Patents
Forsythiaside B and poliumoside compatible composition and its application Download PDFInfo
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- CN106176775B CN106176775B CN201610499508.XA CN201610499508A CN106176775B CN 106176775 B CN106176775 B CN 106176775B CN 201610499508 A CN201610499508 A CN 201610499508A CN 106176775 B CN106176775 B CN 106176775B
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7032—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a polyol, i.e. compounds having two or more free or esterified hydroxy groups, including the hydroxy group involved in the glycosidic linkage, e.g. monoglucosyldiacylglycerides, lactobionic acid, gangliosides
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Abstract
The invention discloses a kind of pharmaceutical compositions for treating haemorrhage, mainly it is made of forsythiaside B and poliumoside compatibility, the composition of forsythiaside B and poliumoside compatibility is mixed by the medicaments uniformity of following weight ratio: 1 ~ 5 part of forsythiaside B, 1 ~ 5 part of poliumoside, the pharmaceutical composition has synergistic function in anastalsis, mechanism is clear, can be used for haemostatic medicament.
Description
Technical field
The invention belongs to pharmaceutical technology fields, specifically forsythiaside B and poliumoside compatible composition and its application.
Background technique
Bleeding refers to that blood is gone out from blood vessel or heart to tissue space, body cavity or body surface.Bleeding can cause
Courage and uprightness shock, anaemia, purpura can also cause local organization to be destroyed and dysfunction, as brain capsuloganglionic hemorrhage can cause pair
Side hemiplegia of limb, retinal hemorrhage induce blindness.Cause of bleeding is complicated, can cause deficiency of YIN-blood, body is weak, is related to internal medicine
And surgery.For the hemorrhagic conditions of internal medicine or surgery, bleeding is such as efficiently controlled not in time, serious person can threat to life.
Clinically using hemostatic, there are more serious side effects at present: as caused fibrinogen to reduce when hemagglutinase large dosage,
Blood viscosity decline and venous thronbosis；Tranexamic acid then leads to thrombosis, thus disables in operation on urethra；Press down peptide
Enzyme then obviously increases anaphylactoid incidence and increases renal failure, myocardial infarction, heart failure, stroke risk and dead
Rate is died, their extensive uses clinically are limited.Therefore, various out using the small natural active matter treatment of toxic side effect
The research of mass formed by blood stasis is increasingly taken seriously.
Callicarpa kwangtungensis Chun (Callicarpa kwangtungensis It Chun) is Verenaceae (Verbenaceae) Callicarpa
(Callicarpa L.) plant, have astringing to arrest bleeding, dissipate the stasis of blood, it is clearing heat and detoxicating the effect of.It for bleeding from five sense organs or subcutaneous tissue, spits blood, spits blood, hematochezia,
Metrorrhagia and metrostaxis, traumatic hemorrhage etc., for civil clinical gynaecology and the common drug of each section's haemorrhage.Inventor is from the various bleedings of clinical treatment
Disease callicarpa kwangtungensis Chun medicinal material curative for effect sets out, and filters out the total benzyl carbinol glycosides of callicarpa kwangtungensis Chun with anastalsis, chemical research table
Bright, complex chemical composition in the total benzyl carbinol glycosides of callicarpa kwangtungensis Chun mainly contains forsythiaside B and poliumoside.However, folk prescription Fructus Forsythiae
Ester glycosides B, poliumoside are unobvious to mouse bleeding and clotting time effect.Therefore, inventor is on the basis of early-stage study, with small
Mouse bleeding and clotting time are index, select forsythiaside B to carry out new compatibility with two effective components of poliumoside and combine, find
Forsythiaside B and poliumoside compatibility can be obviously shortened the bleeding time and clotting time of mouse, have significant anastalsis.
Summary of the invention
The present invention provides the pharmaceutical compositions of a kind of forsythiaside B for the treatment of haemorrhage and poliumoside compatibility.
The pharmaceutical composition of forsythiaside B and poliumoside compatibility, forsythiaside B and poliumoside weight ratio be 1 ~
5:1~5。
The pharmaceutical composition of forsythiaside B and poliumoside compatibility can be directly medicinal, or piece is made in the suitable auxiliary material of addition
The various dosage forms such as agent, capsule, oral solution, granule, injection carry out using.
The present invention studies mouse bleeding and clotting time by forsythiaside B compatibility poliumoside, both discoveries
With synergistic function (being applied alone forsythiaside B, poliumoside anastalsis unobvious).
The present invention confirm forsythiaside B and poliumoside compatibe drug anastalsis be by increasing platelet counts,
The bleeding time is reduced, achievees the purpose that hemostasis.
Raw material forsythiaside B and poliumoside in the present invention are prepared by the following method: taking the dry stem of callicarpa kwangtungensis Chun medicine
Branch and leaf coarse powder, with water infiltration, 8 ~ 12 times amount solvent refluxing thermal extraction 2 ~ 4 times, 1 ~ 3 hour every time, filter, merging filtrate is dense
Being reduced to relative density is 1.10 ~ 1.25, is successively extracted three times, is collected respectively with isometric ethyl acetate, water-saturated n-butanol
N-butanol extracting liquid is concentrated to dryness.N-butanol extracts the water-soluble rear upper D101 macroporous resin column of medicinal extract, and water, 30% is respectively adopted
Ethyl alcohol, 50% ethyl alcohol, 95% ethanol elution are collected 30% ethanolic moiety, are concentrated to dryness, and equivalent reverse phase silica gel is added and mixes sample, passes through
Middle to suppress standby liquid-phase chromatographic column, with acetonitrile-water (85:15) isocratic elution, every 500mL is a fraction, collects corresponding fraction, is closed
And be concentrated under reduced pressure, fraction 13 ~ 22 obtains forsythiaside B, and fraction 36 ~ 45 obtains poliumoside, and yield is respectively 1% ~ 2% He
0.5% ~ 1%, purity is 92% ~ 95%.
Process of preparing of the invention are as follows: above two taste, mixing add right amount of auxiliary materials, mix, are made and are clinically subjected to
Oral preparation and injection.
The preparation method of the tablet of drug of the present invention is: above two taste taken, starch, carboxymethyl cellulose are added, is pelletized, pressure
Piece obtains tablet；
The preparation method of the capsule of drug of the present invention is: taking above two taste, adds starch, carboxymethyl cellulose, pelletize, fills
Dress, obtains capsule.
The preparation method of medicaments injection of the invention is: taking above two taste, is dissolved in water, is adjusted with sodium hydroxide solution
To 6.0 ~ 8.0, filtering is potted in peace after filtrate sterilizing and cuts open in bottle, sterilizes, obtain injection pH value.
Detailed description of the invention
Fig. 1 is forsythiaside B, poliumoside folk prescription and forsythiaside B and poliumoside compatibility (1:1；2:1) administration is to small
The influence diagram in mouse bleeding time；
Note: the * compared with blank control groupP< 0.05, * *P< 0.01；
4. forsythiaside B of blank control group 2. 1. positive drug group (Yunnan Baiyao) 3. forsythiaside B low dose group
7. poliumoside middle dose group of middle dose group 5. forsythiaside B high dose group, 6. poliumoside low dose group, 8. metal and stone silkworm
9. forsythiaside B of glycosides high dose group and 10. forsythiaside B of poliumoside compatibility (1:1) low dose group and poliumoside compatibility
11. forsythiaside B of (1:1) middle dose group and 12. forsythiaside B of poliumoside compatibility (1:1) high dose group and metal and stone silkworm
13. forsythiaside B of glycosides compatibility (2:1) low dose group and 14. forsythiaside B of poliumoside compatibility (2:1) middle dose group with
Poliumoside compatibility (2:1) high dose group.
Fig. 2 is forsythiaside B, poliumoside folk prescription and forsythiaside B and poliumoside compatibility (1:1；2:1) administration is to small
The influence diagram in mouse clotting time.
Note: the * compared with blank control groupP< 0.05, * *P< 0.01；
4. forsythiaside B of blank control group 2. 1. positive drug group (Yunnan Baiyao) 3. forsythiaside B low dose group
7. poliumoside middle dose group of middle dose group 5. forsythiaside B high dose group, 6. poliumoside low dose group, 8. metal and stone silkworm
9. forsythiaside B of glycosides high dose group and 10. forsythiaside B of poliumoside compatibility (1:1) low dose group and poliumoside compatibility
11. forsythiaside B of (1:1) middle dose group and 12. forsythiaside B of poliumoside compatibility (1:1) high dose group and metal and stone silkworm
13. forsythiaside B of glycosides compatibility (2:1) low dose group and 14. forsythiaside B of poliumoside compatibility (2:1) middle dose group with
Poliumoside compatibility (2:1) high dose group.
Specific embodiment
Below with reference to embodiment, the present invention is further elaborated.The following embodiments of mandatory declaration are for illustrating the present invention
Rather than limiting the invention.Essence according to the present invention belongs to that the present invention claims guarantors to the simple modifications that carry out of the present invention
The range of shield.
Embodiment 1: forsythiaside B, the administration of poliumoside folk prescription and forsythiaside B and poliumoside compatibility (1:1；2:1)
The influence to the mouse bleeding time is administered
Animal: km mouse 140, male, 20 ± 2g of weight reaches the limited public affairs of experimental animal from Hunan Si Laike scape
Department, credit number: SCXK (Hunan) 2011-0003.
Reagent: drug sticks up ester glycosides B and poliumoside for self-control, content equal 98% or more；Yunnan Baiyao (Yunnan Baiyao group
Limited liability company, lot number: ZLA1425)；Sodium carboxymethylcellulose (J&K scientific LTD, lot number: L460M09)；Water
For purified water.
Test method: mouse is fixed, and dew tail cuts at the tail vein 1/2 of left side that (strict control is cut with knife blade in outer
Cut depth depth 3mm wide 2mm), it voluntarily overflows and starts with manual time-keeping to blood, it is primary with filter paper to suck drop of blood every 30s, until
Blood flow stops naturally until (without blood when filter paper is inhaled), as the bleeding time.
Mouse is randomly divided into 8 groups, and every group 10, male.Respectively blank control group (0.5% CMC-Na), forsythiaside B
With poliumoside compatibility (1:1；2:1) low, middle and high dose groups and positive controls (Yunnan Baiyao).Each group continuous gavage administration 3
It, surveys the bleeding time of mouse after last dose 1h.Each group test data is shown in Table 1 and Fig. 1.
Test result: comparing with blank control group, the bleeding time of positive drug group (Yunnan Baiyao) be obviously shortened (P<
0.01=；From the point of view of forsythiaside B, the influence in poliumoside folk prescription administration low, middle and high dose groups mouse bleeding time, effect is not
Obviously (P> 0.05).Bleeding time that middle and high dosage group is administered in forsythiaside B and poliumoside compatibility (1:1) be obviously shortened (P
< 0.01)；Forsythiaside B and poliumoside compatibility (2:1) be administered low, middle dose group bleeding time be obviously shortened (P<
0.01)；Forsythiaside B and poliumoside compatibility (2:1) administration high dose group bleeding time be obviously shortened (P< 0.05)；
1 forsythiaside B of table, the administration of poliumoside folk prescription and forsythiaside B and poliumoside compatibility (1:1；2:1) administration pair
The mouse bleeding time influence (n = 10)
Note: the * compared with blank control groupP< 0.05, * *P< 0.01；
Embodiment 2: forsythiaside B, the administration of poliumoside folk prescription and forsythiaside B and poliumoside compatibility (1:1；2:1)
The influence to clotting time of mice is administered:
Animal: km mouse 140, male, 20 ± 2g of weight reaches the limited public affairs of experimental animal from Hunan Si Laike scape
Department, credit number: SCXK (Hunan) 2011-0003.
Reagent: drug sticks up ester glycosides B and poliumoside for self-control, content equal 98% or more；Yunnan Baiyao (Yunnan Baiyao group
Limited liability company, lot number: ZLA1425)；Sodium carboxymethylcellulose (J&K scientific LTD, lot number: L460M09)；Water
For purified water.
Test method: mouse is fixed, and the capillary for being 1mm with internal diameter insertion mouse endocanthion ball rear vein beard takes blood, is reached
5cm blood column, lays flat desktop.It fractures one small section of capillary every 30s, checks for blood coagulation appearance.Record from capillary blood sampling tube to
There is the time of blood clotting silk, as clotting time.
Mouse is randomly divided into 8 groups, and every group 10, male.Respectively blank control group (0.5% CMC-Na), forsythiaside B
With poliumoside compatibility (1:1；2:1) low, middle and high dose groups and positive controls (Yunnan Baiyao).Each group continuous gavage administration 3
It, surveys the clotting time of mouse after last dose 1h.Each group test data is shown in Table 2 and Fig. 2.
Test result: comparing with blank control group, the bleeding time of positive drug group (Yunnan Baiyao) be obviously shortened (P<
0.01)；Forsythiaside B, poliumoside folk prescription are administered from the point of view of the influence of low, middle and high dose groups clotting time of mice, act on unknown
Aobvious (P> .05)；Forsythiaside B and poliumoside compatibility (1:1) administration low, middle and high dose groups clotting time be obviously shortened (P
< 0.01)；Forsythiaside B and poliumoside (2:1) compatibility be administered low, middle dose group clotting time be obviously shortened (P<
0.01).Show forsythiaside B and poliumoside compatibility (1:1；2:1) it is obviously shortened bleeding time and clotting time.
2 forsythiaside B of table, the administration of poliumoside folk prescription and forsythiaside B and poliumoside compatibility (1:1；2:1) administration pair
Clotting time of mice influence (n = 10)
Note: the * compared with blank control groupP< 0.05, * *P< 0.01；
Embodiment 3: forsythiaside B and poliumoside compatibility (1:1) are administered to rat blood coagulation four and platelet count
It influences:
Animal: SD rat 50, male, 200 ~ 220g of weight reaches the limited public affairs of experimental animal from Hunan Si Laike scape
Department, credit number: SCXK (Hunan) 2013-0004.
Reagent: drug sticks up ester glycosides B and poliumoside for self-control, content equal 98% or more；Yunnan Baiyao (Yunnan Baiyao group
Limited liability company, lot number: ZLA1425)；Sodium carboxymethylcellulose (J&K scientific LTD, lot number: L460M09)；Water
For purified water.
Instrument: high speed freezing centrifuge (ST16R, Thermo Fisher company, Germany)；Automatic coagulation analyzer
(ACL 7000, Instrumentation Laboratory .Co, the U.S.)；Full-automatic differential hematology analyzer
(TEK8510, Jiangxi Tekang Science & Technology Co., Ltd.)
Test method: SD rat 50, male is randomly divided into 5 groups.Respectively blank control group (0.5% CMC-Na), company
Stick up ester glycosides B and poliumoside compatibility (1:1) low (6mg/kg), in (12mg/kg), high dose (24mg/kg) group and positive control
Group (Yunnan Baiyao, 0.33g/kg).Each group distinguishes gastric infusion daily, and successive administration 10 days, after last dose 1h, with 3% penta bars
Rat anesthesia is opened into rat abdominal cavity than appropriate, it is anticoagulant true to be connected to 3.8% sodium citrate with disposable scalp acupuncture for exposure abdominal aorta
Empty heparin tube and the anticoagulant vacuum test tube abdominal aorta of EDTA take blood, mix gently.The anticoagulant vacuum of 3.8% sodium citrate is placed in adopt
Whole blood in blood vessel, 4 DEG C of 3000rpm are centrifuged 10 minutes, take supernatant, survey blood coagulation using ACL7000 automatic coagulation analyzer
Four indices；The whole blood being placed in the anticoagulant vacuum blood collection tube of EDTA, using the change of Automatic Blood Cell Analyzer observation blood platelet
Change.It the results are shown in Table 3 and 4.
Test result: comparing with blank control group, forsythiaside B and poliumoside compatibility (1:1) each dosage group APTT, PT
Time be obviously shortened (P< 0.01), wherein low dose group (P< 0.05)；It may be by increasing platelet counts, reduce out
The blood time, achieve the purpose that hemostasis.
3 forsythiaside B of table and poliumoside compatibility (1:1) be administered to rat blood coagulation four indices influence (n= 10,)
Note: the * compared with blank control groupP< 0.05, * *P< 0.01；
4 forsythiaside B of table and poliumoside compatibility (1:1) be administered rat platelet is counted influence (n= 10,)
Note: the * * compared with blank control groupP< 0.01；
Embodiment 4: forsythiaside B and poliumoside compatibility (1:1) administration ELISA method detection TAT, palatelet-selectin, TXB2,
Influence of the 6-K-PG to blood platelet:
Animal: SD rat 50, male, 200 ~ 220g of weight reaches the limited public affairs of experimental animal from Hunan Si Laike scape
Department, credit number: SCXK (Hunan) 2013-0004.
Reagent: drug forsythiaside B and poliumoside is make by oneself, content equal 98% or more；Yunnan Baiyao (Yunnan Baiyao collection
Limited liability company, group, lot number: ZLA1425)；Sodium carboxymethylcellulose (J&K scientific LTD, lot number: L460M09)；
Water is purified water.
Instrument: high speed freezing centrifuge (ST16R, Thermo Fisher company, Germany)；Automatic coagulation analyzer
(ACL 7000, Instrumentation Laboratory .Co, the U.S.)；Full-automatic differential hematology analyzer
(TEK8510, Jiangxi Tekang Science & Technology Co., Ltd.)
Test method: rat is randomly divided into 5 groups, and every group 10, male.Respectively blank control group (0.5% CMC-Na),
Forsythiaside B (6mg/kg) low with poliumoside compatibility (1:1), in (12mg/kg), high dose (24mg/kg) group and the positive it is right
According to group (Yunnan Baiyao, 0.33g/kg).Each group distinguishes gastric infusion daily, and successive administration 10 days, after last dose 1h, with 3% penta
Rat anesthesia is opened rat abdominal cavity by barbital, and it is anticoagulant to be connected to 3.8% sodium citrate with disposable scalp acupuncture for exposure abdominal aorta
Vacuum blood collection tube and the anticoagulant vacuum test tube abdominal aorta of EDTA take blood, mix gently.EDTA, 3.8% sodium citrate are used respectively
(sodium citrate: blood=1:9) is used as anti-coagulants collect specimen, and by sample after acquisition 30 minutes in 2-8 DEG C
1000 g are centrifuged 15 minutes, take supernatant can be detected, or supernatant is placed in -20 DEG C or -80 DEG C preservations, but should be avoided repeatedly
Freeze thawing.TAT in blood platelet, palatelet-selectin, TXB2,6-K-PG content are determined using ELISA method detection.It the results are shown in Table 5 ~ 8.
Test result: forsythiaside B and poliumoside compatibility (1:1) to fibrin ferment/antithrombin compounds in blood platelet,
6-keto-PGFIa without influence, it is not statistically significant (P> 0.05), there is shadow for the content of TXB2, P-selectin
Ring, have significant difference (P< 0.01).The above results suggest that the anastalsis of forsythiaside B and poliumoside compatibility (1:1)
It may be related with its biologically active pdgf.
5 forsythiaside B of table and poliumoside compatibility (1:1) be administered to TAT content in rat plasma influence (n = 10,)
6 forsythiaside B of table and poliumoside compatibility (1:1) be administered to palatelet-selectin content in rat plasma influence (n
= 10,)
7 forsythiaside B of table and poliumoside compatibility (1:1) be administered to TXB2 content in rat plasma influence (n=10,)
8 forsythiaside B of table and poliumoside compatibility (1:1) be administered to 6-K-PG content in rat plasma influence (n=
10,)
Embodiment 5:
Take forsythiaside B 1g, poliumoside 1g, with water for injection heating stirring sufficiently to dissolve, add water to
1000ml adjusts pH value to 7, stirs evenly, filtering is sub-packed in neutral density glass container, with 100 DEG C of 30min sterilizings of flowing steam, mistake
Filter, refined filtration, encapsulating sterilize, and examine, obtain injection.
Embodiment 6:
Forsythiaside B 2g, poliumoside 1.5g are taken, addition starch, microcrystalline cellulose, talcum powder, 5% starch slurry are appropriate,
It mixes, particle is made, it is dry, it is packed into capsule, quality inspection is packed to obtain the final product.
Embodiment 7:
Forsythiaside B 1.2g, poliumoside 2g are taken, addition starch, microcrystalline cellulose, talcum powder, 5% starch slurry are appropriate,
It mixes, particle is made, dry, tabletting, quality inspection is packed to obtain the final product.
Claims (1)
1. the pharmaceutical composition that forsythiaside B and poliumoside with anastalsis are active pharmaceutical ingredient, it is characterised in that
The two weight is 1:1 or 2:1.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201610499508.XA CN106176775B (en) | 2016-06-30 | 2016-06-30 | Forsythiaside B and poliumoside compatible composition and its application |
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| CN201610499508.XA CN106176775B (en) | 2016-06-30 | 2016-06-30 | Forsythiaside B and poliumoside compatible composition and its application |
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| CN106176775B true CN106176775B (en) | 2019-08-06 |
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| CN102040635B (en) * | 2010-11-23 | 2012-11-07 | 成都普思生物科技有限公司 | Method for efficiently separating and purifying forsythiaside B monomer and poliumoside monomer |
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Non-Patent Citations (1)
| Title |
|---|
| The medicinalusesof Callicarpa L. intraditionalChinesemedicine:An ethnopharmacological,phytochemicalandpharmacologicalreview;Yanhua Tu等;《Journal ofEthnopharmacology》;20130109;第146卷;465-481 |
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Effective date of registration: 20210115 Address after: No. 187, Anyuan East Avenue, Pingxiang economic and Technological Development Zone, Pingxiang City, Jiangxi Province Patentee after: Jiangxi Pinghu medical science and Technology Co Innovation Co.,Ltd. Address before: 330029 No. 1566, Beijing East Road, Jiangxi, Nanchang Patentee before: JIANGXI INSTITUTE FOR DRUG CONTROL |
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