CN103830353A - Pharmaceutical composition and application - Google Patents
Pharmaceutical composition and application Download PDFInfo
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- CN103830353A CN103830353A CN201210486130.1A CN201210486130A CN103830353A CN 103830353 A CN103830353 A CN 103830353A CN 201210486130 A CN201210486130 A CN 201210486130A CN 103830353 A CN103830353 A CN 103830353A
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- danshensu
- peoniflorin
- pharmaceutical composition
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Abstract
The invention relates to a pharmaceutical composition containing tanshinol and paeoniflorin and an application thereof in preparing a medicine for treating cardiovascular and cerebrovascular diseases. The invention provides a pharmaceutical composition containing a tanshinol extract and a paeoniflorin extract, wherein the tanshinol extract contains greater than 50% and less than 100% of tanshinol, and the paeoniflorin extract contains greater than 50% and less than 100% of paeoniflorin. The invention also provides an application of the pharmaceutical composition in preparing a medicine for treating cardiovascular and cerebrovascular diseases.
Description
Summary
The invention provides a kind of pharmaceutical composition that contains danshensu extract and extract product of paeoniflorin, wherein in danshensu extract, contain 100%3 danshensus 350%, in extract product of paeoniflorin, contain 100%3 peoniflorins 350%.The present invention also provides in the medicine of this pharmaceutical composition in preparation treatment cardiovascular and cerebrovascular disease and has applied.
Technical field
The present invention relates to a kind of pharmaceutical composition that contains danshensu and peoniflorin and the application in the medicine of preparation treatment cardiovascular and cerebrovascular disease thereof.
Background technology
Danshensu (chemistry β-3 by name, 4-dihydroxyphenyl lactic acid) extracts and obtains from Radix Salviae Miltiorrhizae, is the effective ingredient of Radix Salviae Miltiorrhizae.Bibliographical information danshensu has certain protective effect [Jiang Wende aspect cardiovascular and cerebrovascular disease, Chen Yuhua, Wang Yingping, etc. danshensu and two kinds of water solublity Components in Salvia miltiorrhizas resist myocardial ischemia and to research coronarius. Shanghai the first medical college journal, 1982,9 (1): 13-94.; Tang Lihui, Wang Xiaoming, Liang Dianquan, etc. the protective effect of danshensu to myocardial ischemia/reperfusion injury in rats. Chinese Journal of Pathophysiology, 1989,6 (2): 65-9.; Tension force, Wang Xiaoming, Liang Dianquan, etc. danshensu is on myocardial ischemia in rats/perfusion causes the impact of mitochondrion variation and the discussion of the mechanism of action thereof again. Chinese Journal of Pathophysiology, 1990,6 (6): 420-423.; Chang Yingzi, Liang Dianquan, Wang Xiaoming, the protective effect etc. danshensu to Rat Myocardial Mitochondrial H'-ATP enzyme damage due to oxygen-derived free radicals. Chinese Journal of Pathophysiology, 1991,7 (5): 449-452.; Su Xiaohua, Liang Dianquan, Wang Xiaoming. the protective effect of danshensu (DS-182) to Rat Myocardial Mitochondrial oxygen free radical injury. Chinese Journal of Pathophysiology, 1992,8 (2): 122-124.].
Peoniflorin extracts and obtains from Radix Paeoniae Rubra, the Radix Paeoniae Alba, Cortex Moutan, become amorphous powder, tool hygroscopicity, has many-sided effects such as calmness, spasmolytic, antiinflammatory, anti-stress ulcer disease, dilating coronary blood vessel, antagonism acute myocardial ischemia and anticoagulant.
The inventor, by a large amount of experimentatioies, has invented a kind of pharmaceutical composition that contains danshensu and peoniflorin, and it has synergy to the effect in cardiovascular and cerebrovascular disease.
Summary of the invention
The invention provides a kind of pharmaceutical composition that contains danshensu extract and extract product of paeoniflorin, the danshensu that wherein contains 100%3 danshensus 350% in danshensu extract, contains 100%3 peoniflorins 350% in extract product of paeoniflorin.
The invention provides the application of the pharmaceutical composition that contains danshensu and peoniflorin in preparation treatment or prevention cardiovascular and cerebrovascular disease.
The invention provides the application of the pharmaceutical composition that contains danshensu and peoniflorin in the medicine of preparation treatment or prevention myocardial ischemia.
The invention provides the application of the pharmaceutical composition that contains danshensu and peoniflorin in the medicine of preparation treatment or prevention brain injury.
Pharmaceutical composition of the present invention is 1:(0.01～100 containing the ratio of danshensu and peoniflorin), be preferably 1:(0.2 ~ 10).
Pharmaceutical composition provided by the invention can exist with the form of injectable powder, injection, tablet, capsule, soft capsule, drop pill or oral liquid, is preferably freeze-dried powder.Various dosage form provided by the invention all can adopt pharmacy conventional method to be prepared from.
Pharmaceutical composition provided by the invention is when for cardiovascular and cerebrovascular disease, and its using dosage scope is 100 mg～3000 mg, is preferably 200 mg～1000 mg.
The inventor has carried out following test and has confirmed that the pharmaceutical composition that contains danshensu and peoniflorin is at the drug effect of preparing treatment or prevention cardiovascular and cerebrovascular disease, and its effect is far better than alone same dosage danshensu or peoniflorin (the following examples are used for more detailed description the present invention, but and do not mean that the present invention only limits to this).
Detailed description of the invention
embodiment 1danshensu and peoniflorin preparation
Get Radix Salviae Miltiorrhizae 10kg, with the water soaking heating extraction secondary of 12 times of amounts, merging filtrate after filtering, heavy with 10% sulphuric acid acid after concentrated, centrifugal and precipitation separation, precipitation regulates pH value that it is dissolved with sodium hydroxide solution, according to passing through D101 macroporous adsorptive resins than adsorbance 1:1 (amount of resin and medical material amount), uses 20kg macroporous resin packed column.First with 5 times of volume deionized-distilled water eluting, then with 10 times of column volume eluting of 30% alcoholic solution, collect eluent, obtain danshensu composition.35 DEG C of concentrating under reduced pressure are removed ethanol, regulate pH value to refine, and concentrated solution obtains the loose crystal type powder of brown color through lyophilizing.Wherein contain danshensu more than 50%.
Get Radix Paeoniae Rubra 10kg, 70% ethanol difference reflux, extract, 3 times, each 1.5h, each 30L, merge extractive liquid, filter, reclaim under reduced pressure is to dry, residue is with suitable quantity of water heating for dissolving, sucking filtration, filtrate adds (ratio of dry cream and resin is 15:20) on a macroporous adsorptive resins filling in advance, after slowly dripping, first wash with water to the reaction of reducing sugar be negative (Molish reaction detection), use the ethanol elution of 20% concentration instead, merge eluent, reclaim under reduced pressure is to dry, obtain Radix Paeoniae Rubra total glycosides 530g, add a silicagel column filling in advance, with chloroform-methanol (1:10) eluting, merge eluent, reclaim under reduced pressure is to dry, wherein paeoniflorin content is 91.4%.
embodiment 2danshensu and the preparation of peoniflorin composite freeze-dried powder
Get danshensu 30g, peoniflorin 60g injects water 2000 ml after mixing, and regulates pH value that it is dissolved, with mannitol 8g, stirring and dissolving, ultrafiltration, obtains apyrogenic clear liquor, pours in 10 ml cillin bottles, 2 ml/ only, press the lyophilizing of freeze-dried powder technique, make every system containing danshensu 30 mg, the freeze-dried powder of peoniflorin 60 mg.
test example 1: danshensu and the peoniflorin compositions impact on myocardial ischemia in rats damage
(1) material.
Danshensu extract (content is more than 50%), danshensu (content is more than 90%), peoniflorin (content is more than 90%), danshensu and peoniflorin compositions: described method preparation to specifications.
NBT (N-BT), is provided by Military Medical Science Institute's medical supply station.
Laboratory animal: regular grade SD rat, male, body weight 280 g-350 g.
(2) method and result.
Animal is divided into model control group (normal saline) at random, Nifedipine group (6mg/kg), danshensu group (3mg/kg), danshensu group (9mg/kg), peoniflorin group (6mg/kg), peoniflorin group (18mg/kg), danshensu (3mg/kg)+peoniflorin (6mg/kg) small dose group, danshensu extract (counting 3mg/kg with danshensu)+peoniflorin (6mg/kg) small dose group, danshensu (6mg/kg)+peoniflorin (12mg/kg) dosage group, danshensu (20mg/kg)+peoniflorin (40mg/kg) oral dose group, danshensu (33mg/kg)+peoniflorin (67mg/kg) dosage group, danshensu (100mg/kg)+peoniflorin (200mg/kg) dosage group.Every group 10.After fasting 12 hours, ip. urethane (1.2 g/kg) anesthesia, surveys limbs II lead electrocardiogram.Cut off left front fur, iodine tincture and alcohol disinfecting, along left border of sternum 1cm place, cut off thoracic wall muscle and two ribs, open rapidly thoracic cavity, expose heart, between arterial cone and left auricle, ligation left coronary artery, puts back to heart immediately, squeezes thoracic cavity air, use mosquito forceps closed-chest, cause Model Rats with Acute Myocardial Ischemia.Nifedipine group is gastric infusion before anesthesia, composition oral dosage group successive administration 3 days, and after administration in the 2nd day, fasting is after 16 hours, and administration in the 3rd day was performed the operation after 30 minutes, and all the other respectively organize postoperative with both intravenous injection relative medicines.Record before administration and administration after 1.5h, 3h electrocardiogram, measure the lift-off value of electrocardiogram J point, after 6h, take out heart, clean with cold saline after ,-20 DEG C of refrigerator freezings spend the night.Next day, freezing heart is cut into 5 by ligation place to apex uniform thickness, immerse in freshly prepared 0.25% N-BT phosphate buffer (pH 7.4).37 DEG C of water-bath jolting 10～15 min.Blot the dyeing liquor of slice surface with filter paper, separate coloured portions and the part of being unstained, weigh, compute infarct size.Infarct size (%)=infarction part weight/(non-infarction part weight+infarction part weight) × 100%.Data are used
± s represents, between organizing
tstatistical procedures is carried out in inspection.
Result is as shown in table 1, and myocardial ischemia is after 6 hours, and obvious kitchen range shape ischemic region appears in model group rat heart muscle, reaches 26% left and right.3mg/kg danshensu and 6 mg/kg peoniflorin groups fail to reduce rising, the minimizing ischemic areas of limb lead electrocardiogram J point, 9 mg/kg danshensus and 18 mg/kg peoniflorin groups, composition oral dosage group [danshensu (20 mg/kg)+peoniflorin (40 mg/kg)] all reduce rising, the minimizing ischemic areas of limb lead electrocardiogram J point to a certain extent, composition dosage group 1[danshensu (3 mg/kg)+peoniflorin (6 mg/kg)], composition dosage group 2[danshensu extract (3 mg/kg)+peoniflorin (6 mg/kg)] reduce significantly the rising of limb lead electrocardiogram J point, reduce ischemic areas (with model group comparison, p<0.01), composition dosage group 1[danshensu (3 mg/kg)+peoniflorin (6 mg/kg)], composition dosage group 2[danshensu extract (3 mg/kg)+peoniflorin (6 mg/kg)] rising to limb lead electrocardiogram J point, reduce ischemic areas and 9 mg/kg danshensus and more also have significant difference (p<0.05), composition dosage group 3[danshensu (6 mg/kg)+peoniflorin (12 mg/kg)] reduce significantly limb lead electrocardiogram J point rising, reduce ischemic areas (with model group comparison, p<0.01), the rising to limb lead electrocardiogram J point, minimizing ischemic areas and 18 mg/kg peoniflorins more also have significant difference (p<0.05), composition dosage group 4[danshensu (33 mg/kg)+peoniflorin (67 mg/kg)] reduce extremely significantly limb lead electrocardiogram J point rising, reduce ischemic areas (with model group comparison, p<0.001), composition dosage group 5[danshensu (100 mg/kg)+peoniflorin (200 mg/kg)] reduce very significantly limb lead electrocardiogram J point rising, reduce ischemic areas (with model group comparison, p<0.001).
The impact on myocardial ischemia in rats damage of table 1 danshensu, peoniflorin, danshensu and peoniflorin compositions
With model control group comparison,
*p< 0.05,
*p< 0.01,
* *p< 0.001.
With dosage group comparison in danshensu,
#p< 0.05; With dosage group comparison in peoniflorin,
mp< 0.05.
Claims (5)
1. contain a pharmaceutical composition for danshensu extract and extract product of paeoniflorin, be characterised in that in danshensu extract and contain 100%3 danshensus 350%, in extract product of paeoniflorin, contain 100%3 peoniflorins 350%.
2. compositions according to claim 1, the ratio of danshensu and peoniflorin is 1:0.01～100.
3. in the medicine of the arbitrary described pharmaceutical composition of claim 1-2 in preparation treatment cardiovascular and cerebrovascular disease, apply.
4. application according to claim 3, the application of pharmaceutical composition in the medicine of preparation treatment myocardial ischemia.
5. application according to claim 3, the application of pharmaceutical composition in the medicine of preparation treatment brain injury.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210486130.1A CN103830353A (en) | 2012-11-26 | 2012-11-26 | Pharmaceutical composition and application |
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|---|---|---|---|
| CN201210486130.1A CN103830353A (en) | 2012-11-26 | 2012-11-26 | Pharmaceutical composition and application |
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| CN103830353A true CN103830353A (en) | 2014-06-04 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115887478A (en) * | 2022-11-17 | 2023-04-04 | 中国中医科学院中医基础理论研究所 | Application of composition in preparation of medicine for treating cerebral ischemia and medicine for treating cerebral ischemia |
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- 2012-11-26 CN CN201210486130.1A patent/CN103830353A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115887478A (en) * | 2022-11-17 | 2023-04-04 | 中国中医科学院中医基础理论研究所 | Application of composition in preparation of medicine for treating cerebral ischemia and medicine for treating cerebral ischemia |
| CN115887478B (en) * | 2022-11-17 | 2023-09-08 | 中国中医科学院中医基础理论研究所 | Application of composition in preparation of medicine for treating cerebral ischemia and medicine for treating cerebral ischemia |
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Application publication date: 20140604 |