CN104800235A - Pharmaceutical composition of baicalin and paeoniflorin - Google Patents
Pharmaceutical composition of baicalin and paeoniflorin Download PDFInfo
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- CN104800235A CN104800235A CN201510194496.5A CN201510194496A CN104800235A CN 104800235 A CN104800235 A CN 104800235A CN 201510194496 A CN201510194496 A CN 201510194496A CN 104800235 A CN104800235 A CN 104800235A
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Abstract
The invention relates to pharmaceutical compositions, in particular to a pharmaceutical composition of baicalin and paeoniflorin. The pharmaceutical composition is prepared from baicalin and paeoniflorin. The baicalin and paeoniflorin pharmaceutical composition has the advantages of being capable of preventing and treating cardiovascular disease and obvious in curative effect, and can be used for intravenous administration.
Description
Technical field
The present invention relates to a kind of Pharmaceutical composition for preventing or treat cardiovascular and cerebrovascular disease, be specifically related to the pharmaceutical composition of a kind of baicalin and peoniflorin.
Background technology
In recent years along with progress and the development of society and economy, the living standard of people also significantly improves, but competitive pressure is also increasing, especially adolescent lives irregular, diet is science not, cardiovascular and cerebrovascular disease is rejuvenation thereupon also, many youngsters also start to suffer from cardiovascular and cerebrovascular disease, as arrhythmia, hypertension etc., old people due to organ and every physiological function start decline, the ability that blood vessel regulates voluntarily is much worse than in the past, very easily cause blood vessel blockage, tube wall fragility increases, thus cause angiorrhexis, cause various cardiovascular and cerebrovascular disease, as cerebral hemorrhage, apoplexy etc.
The dry root of baikal skullcap root system Labiatae Radix Scutellariae (Scutellaria baicalensis Georgi).There is the effects such as heat clearing and damp drying, eliminating fire and detoxication, arresting bleeding and miscarriage prevention.Modern study shows in Radix Scutellariae containing compositions such as flavonoid, phenolic glycoside, alcohol glycosides, volatile oil, trace element, aminoacid; wherein baicalin is its principle active component, have antibacterial, antiviral, inflammation-inhibiting react, protect the liver, function of gallbladder promoting, diuresis, antioxidation, protection cardiovascular, the multiple pharmacological effect such as anticancer.Baicalin poorly water-soluble, facile hydrolysis, there is hepato-enteric circulation in oral administration, bioavailability is extremely low, less than 10%.
The root of Radix Paeoniae system ranunculaceae plant Radix Paeoniae (Paeonia lactiflora Pall), Paeonia suffruticosa (P.suffrsticosaAndr), Paeonia delavayi (P.delavayi Franch), has the effect such as clearing away heat and cooling blood, eliminating stasis to stop pain.Peoniflorin is mainly contain effective constituent in Radix Paeoniae, in recent years pharmacological research finds, peoniflorin has blood vessel dilating, antalgic and sedative, antiinflammatory antiulcer, antipyretic spasmolytic, diuresis, anti-stress Peptic Ulcers, dilating coronary blood vessel, antagonism acute myocardial ischemia, suppresses the pharmacological actions widely such as platelet aggregation, atherosclerosis, anti-cardiac muscle or brain tissue impairment.Can be used for the aspects such as the treatment of coronary heart disease, Senile disease health invigorating and immunologic function, antiinflammatory cough-relieving, eliminating phlegm and relieving asthma.Peoniflorin facile hydrolysis, simultaneously to responsive to temperature.Its polarity is large, and water solublity is slightly good, fat-soluble difference, and oral administration bioavailability is extremely low, is only 3% ~ 4%.
The compound Chinese medicinal preparation be made up of Radix Scutellariae or Radix Paeoniae etc. has played important function in prevention and therapy cardiovascular and cerebrovascular disease, liver and gall diseases, but oral administration need onset after gastrointestinal absorption, onset time is long, absorb not exclusively, can not meet critical emergency case to quick-acting requirements, and aqueous injection have impact on Drug safety because of the stability problem of medicine.
Through retrieval, not yet finding that employing baicalin and peoniflorin mutual association make the relevant report for treating cardiovascular and cerebrovascular disease, more not having both couplings to have the relevant report of curing protrusion effect.
Summary of the invention
The object of this invention is to provide a kind of for preventing or treat the baicalin of cardiovascular and cerebrovascular disease and the pharmaceutical composition of peoniflorin.
The technical solution used in the present invention is a kind of pharmaceutical composition for preventing or treat cardiovascular and cerebrovascular disease, comprises baicalin and peoniflorin.
As preferably, the mass ratio of described baicalin and peoniflorin is 1 ~ 9:1 ~ 9.
As preferably, the mass ratio of described baicalin and peoniflorin is 1 ~ 5:1 ~ 5.
As preferably, the dosage form of described pharmaceutical composition is oral formulations or injection.
The oral formulations of pharmaceutical composition of the present invention can be selected from tablet, capsule, pill, powder, granule, solution, suspension, syrup, tea and masticatory.It is combined by active component baicalin, peoniflorin and pharmaceutically suitable carrier well-known to those skilled in the art and prepares.Pharmaceutically suitable carrier comprises excipient, as the implant of sugar and so on, comprises lactose, sucrose, mannose and/or Sorbitol; Cellulose preparation, as corn starch, wheaten starch, rice fecula, potato starch, gelatin, methylcellulose, hydroxypropyl emthylcellulose sodium etc.
As preferably, described injection is injectable powder.
As preferably, containing filler in described injectable powder.
As preferably, described filler is selected from the one in mannitol, lactose, glucosan, inositol, meglumine or glucose, or their arbitrary proportion mixture.
A preparation method for described pharmaceutical composition, comprises the following steps: densely join; Coarse filtration; Rarely to join; Fine straining; Lyophilizing.
Described dense joining is dissolved in water for injection by filler, then add baicalin and peoniflorin dissolves, and adjust ph to 7 ~ 9, add active carbon, and heated and stirred obtains concentrated wiring liquid; Described coarse filtration is first filtered with the titanium rod filter decarburization that aperture is 1.0 μm by concentrated wiring liquid, then be the microporous filter membrane pressure filtration of 0.45 μm with aperture, obtains coarse filtration liquid; Described fine straining is the microporous filter membrane aseptic filtration of 0.22 μm by rare for gained dosing aperture, obtains fine straining liquid; Described lyophilizing is that gained fine straining liquid is incubated 0.5 ~ 1 hour under-42 DEG C ~-45 DEG C conditions; Again 2 × 10
-1under the vacuum condition of below MPa, be warming up to-10 DEG C ,-10 DEG C of insulations 1 ~ 3 hour; Continue to be warming up to 0 DEG C, be incubated 2 ~ 3 hours, be then warming up to 3 DEG C, be incubated 1 ~ 2 hour; Finally make temperature rise to 42 DEG C with the speed of 3 DEG C per half an hour, be incubated 10 ~ 12 hours.
Beneficial effect of the present invention is: (1) gained pharmaceutical composition determined curative effect, can be used for regulating blood pressure, angina pectoris, the treatment of coronary heart disease, has protective effect to cardiovascular and cerebrovascular vessel damage; Gained pharmaceutical composition also can be used for intravenously administrable, rapid-action.(2) adopt this preparation method gained better stability of preparation, safety is controlled, rapid-action, is convenient to keeping, storage and transport.
Detailed description of the invention
For making those skilled in the art understand production technology of the present invention and technique effect in detail, introduce application of the present invention and technique effect further with concrete production instance below.
Embodiment 1
Accurately take mannitol 1500g and be placed in dense preparing tank, inject and use water 9000ml, stirring makes to dissolve completely, add baicalin 200g, peoniflorin 800g, stirring makes to dissolve completely, adjust pH to 8.5, stirring makes mix homogeneously, add needle-use activated carbon 50g, heat while stirring at the temperature of 80 DEG C 30 minutes, filter with the titanium rod filter decarburization that aperture is 1.0 μm, be the microporous filter membrane pressure filtration of 0.45 μm again with aperture, import in dilute preparing tank through pipeline, mend water for injection 10000ml, stirring makes mix homogeneously, be the microporous filter membrane aseptic filtration of 0.22 μm again with aperture, be sub-packed in the cillin bottle that sterilization treatment crosses by every bottle of 2ml, the plug of false add sterilization treatment, lyophilizing, Vacuum Pressure plug, roll lid, packaging, obtained finished product 4982 bottles, every bottle containing baicalin 40mg, peoniflorin 160mg.Investigate through long-time stability, when 36 months, the indices of product is compared with when 0 month, does not substantially change.
Embodiment 2
Accurately take glucose 1000g and be placed in dense preparing tank, inject and use water 9000ml, stirring makes to dissolve completely, add baicalin 150g, peoniflorin 350g, stirring makes to dissolve completely, adjust pH to 7.8, stirring makes mix homogeneously, add needle-use activated carbon 60g, heat while stirring at the temperature of 90 DEG C 25 minutes, filter with the titanium rod filter decarburization that aperture is 1.0 μm, be the microporous filter membrane pressure filtration of 0.45 μm again with aperture, import in dilute preparing tank through pipeline, mend water for injection 10000ml, stirring makes mix homogeneously, be the microporous filter membrane aseptic filtration of 0.22 μm again with aperture, be sub-packed in the cillin bottle that sterilization treatment crosses by every bottle of 2ml, the plug of false add sterilization treatment, lyophilizing, Vacuum Pressure plug, roll lid, packaging, obtained finished product 4918 bottles, every bottle containing baicalin 30mg, peoniflorin 70mg.Investigate through long-time stability, when 36 months, the indices of product is compared with when 0 month, does not substantially change.
Embodiment 3
Accurately take glucosan 1000g and be placed in dense preparing tank, inject and use water 9000ml, stirring makes to dissolve completely, add baicalin 1500g, peoniflorin 1500g, stirring makes to dissolve completely, adjust pH to 8.8, stirring makes mix homogeneously, add needle-use activated carbon 50g, heat while stirring at the temperature of 80 DEG C 35 minutes, filter with the titanium rod filter decarburization that aperture is 1.0 μm, be the microporous filter membrane pressure filtration of 0.45 μm again with aperture, import in dilute preparing tank through pipeline, mend water for injection 10000ml, stirring makes mix homogeneously, be the microporous filter membrane aseptic filtration of 0.22 μm again with aperture, be sub-packed in the cillin bottle that sterilization treatment crosses by every bottle of 2ml, the plug of false add sterilization treatment, lyophilizing, Vacuum Pressure plug, roll lid, packaging, obtained finished product 4916 bottles, every bottle containing baicalin 300mg, peoniflorin 300mg.Investigate through long-time stability, when 36 months, the indices of product is compared with when 0 month, does not substantially change.
Embodiment 4
Accurately take lactose 1500g and be placed in dense preparing tank, inject and use water 9000ml, stirring makes to dissolve completely, add baicalin 800g, peoniflorin 200g, stirring makes to dissolve completely, adjust pH to 7.5, stirring makes mix homogeneously, add needle-use activated carbon 40g, heat while stirring at the temperature of 93 DEG C 30 minutes, filter with the titanium rod filter decarburization that aperture is 1.0 μm, be the microporous filter membrane pressure filtration of 0.45 μm again with aperture, import in dilute preparing tank through pipeline, mend water for injection 10000ml, stirring makes mix homogeneously, be the microporous filter membrane aseptic filtration of 0.22 μm again with aperture, be sub-packed in the cillin bottle that sterilization treatment crosses by every bottle of 2ml, the plug of false add sterilization treatment, lyophilizing, Vacuum Pressure plug, roll lid, packaging, obtained finished product 4966 bottles, every bottle containing baicalin 160mg, peoniflorin 40mg.Investigate through long-time stability, when 36 months, the indices of product is compared with when 0 month, does not substantially change.
Embodiment 5
Accurately take mannitol 700g, Dextran 8 00g is placed in dense preparing tank, inject and use water 9000ml, stirring makes to dissolve completely, add baicalin 1500g, peoniflorin 1000g, stirring makes to dissolve completely, adjust pH to 8.5, stirring makes mix homogeneously, add needle-use activated carbon 50g, heat while stirring at the temperature of 80 DEG C 30 minutes, filter with the titanium rod filter decarburization that aperture is 1.0 μm, be the microporous filter membrane pressure filtration of 0.45 μm again with aperture, import in dilute preparing tank through pipeline, mend water for injection 10000ml, stirring makes mix homogeneously, be the microporous filter membrane aseptic filtration of 0.22 μm again with aperture, be sub-packed in the cillin bottle that sterilization treatment crosses by every bottle of 2ml, the plug of false add sterilization treatment, lyophilizing, Vacuum Pressure plug, roll lid, packaging, obtained finished product 4982 bottles, every bottle containing baicalin 300mg, peoniflorin 200mg.Investigate through long-time stability, when 36 months, the indices of product is compared with when 0 month, does not substantially change.
Embodiment 6
Take baicalin 150g, peoniflorin 450g, mixing, adds appropriate amount of starch, micropowder silica gel, makes 1000.Wherein every sheet is containing baicalin 150mg, peoniflorin 450mg.Investigate through long-time stability, when 36 months, the indices of product is compared with when 0 month, does not substantially change.
In above-described embodiment, indices refers to the content etc. of baicalin, peoniflorin.
In above-described embodiment, to be via hole diameter be that the filtering with microporous membrane gained fine straining liquid of 0.22 μm is incubated 0.5 ~ 1 hour under-42 DEG C ~-45 DEG C conditions in lyophilizing; Again 2 × 10
-1under the vacuum condition of below MPa, be warming up to-10 DEG C ,-10 DEG C of insulations 1 ~ 3 hour; Continue to be warming up to 0 DEG C, be incubated 2 ~ 3 hours, be then warming up to 3 DEG C, be incubated 1 ~ 2 hour; Finally make temperature rise to 42 DEG C with the speed of 3 DEG C per half an hour, be incubated 10 ~ 12 hours.
For verifying safety of the present invention and effectiveness, the following test of special do:
1, anxious poison research
Test method: 20 rabbit, 10 female, is divided into 4 groups at random, often organizes 5, and by the appropriate water-soluble rear gavage of medicine, observe 7 days once a day, leading indicator: the activity of animal, feed, defecation, fur, heart rate, blood pressure, breathing etc. have without exception etc.
Sacrificed by exsanguination rabbit after last administration.Dissect, observe the change of liver, kidney, heart.
Given the test agent: embodiment 1 products obtained therefrom.To be people's consumption 5 times, the dosage respectively administration of 10 times, 20 times.
Negative control group: same volume normal saline.
Result:
(1) general reaction: administration and viewing duration, tested group and negative control group animal activity, feed, defecation, fur etc. all without exception, body weight, breathing, heart rate Non Apparent Abnormality.
(2) during administration, test medicine blood pressure slightly declines, and negative control group is without obvious change.
(3) anatomic observation, all are normal for the liver of tested group and negative control group, kidney, heart, there is not abnormal or damage.
2, the research of hypertensive clinical effectiveness is treated
To 120 routine primary hypertension patients, adopt embodiment 1-3 and the quiet note of normal saline, often organize each 30 examples, carry out the observation of 2 weeks by a definite date.
Reach mark blood pressure refers to that treating rear blood pressure is reduced to≤135/85mmHg; Blood pressure lowering effectively refers to the front reduction >=20mmHg and/or diastolic pressure >=10mmHg for the treatment of after-contraction pressure ratio treatment; Or systolic pressure >=10mmHg diastolic pressure reduction >=5mmHg simultaneously.
Result: the effective percentage average out to 90% of various embodiments of the present invention, compliance rate average out to 75%, inefficiency average out to 10%.Normal saline group is without significant change.
Oral administration embodiment 6 gained tablet is after 1 month, effective percentage average out to 89%, compliance rate average out to 70%, inefficiency average out to 11%.
3, the clinical effectiveness research of coronary heart disease is treated
In order to study the clinical effectiveness of pharmaceutical composition of the present invention, prepare lyophilized injectable powder according to embodiment 4.
Select 90 routine cases, wherein man 45 example, female 45 example, the age 30-65 year between, diagnosis meet WHO name ischemic heart desease diagnostic criteria, wherein patient with angina pectoris 30 example, heart failure patients with coronary heart disease 30 example, with myocardial infarction Treating 30 Cases of Coronary Heart Disease.
Statistical method: adopt t inspection
The test for the treatment of patient with angina pectoris
30 routine sufferers are divided into 2 groups at random, often organize each 15 examples, two groups of no difference of science of statistics on age, distressed number of times, electrocardiogram, matched group is normal saline, and tested group is embodiment 4 products obtained therefrom.Be intravenous administration.According to following standard determination curative effect:
Effective: angina pectoris disappears, electrocardiogram recovers normal or ST section recover more than rising 0.05mv, T ripple by being inverted, low flat turn is upright.
Effective: angina pectoris alleviates or attack times pain number of times reduces, electrocardiogram to go up 0.05mv after moving down the treatment of ST section, but does not reach normal level.
Invalid: angina pectoris is not alleviated, electrocardiogram is without change.
Result:
Effective 11 examples of the embodiment of the present invention 4, effective 4 examples, invalid 0 example.Matched group is without significant change.
The test for the treatment of heart failure patients with coronary heart disease
30 routine sufferers are divided into 2 groups at random, often organize each 15 examples, two groups of no difference of science of statistics on age, distressed number of times, electrocardiogram, matched group is normal saline, and tested group is embodiment 4 products obtained therefrom.Be intravenous administration.Observe following index:
(1) treatment left ventricular diastolic dimensions, left room end systolic diameter, Left Ventricular Ejection Fraction is measured, as the index of observing Cardiac Function of Patients.
(2) average heart rate and 24 hours arrhythmia numbers is observed.Administration is after 3 days, the change before and after comparison therapy.
Result:
Through the embodiment of the present invention 4 intravenous injection after 3 days, before comparing injection, LVED (Left Ventricular End Systolic Dimension), left room end systolic diameter, Left Ventricular Ejection Fraction, average heart rate and 24 hours arrhythmia numbers are all significantly improved.Matched group is without significant change.
The test for the treatment of myocardial infarction coronary heart disease
30 routine sufferers are divided into 2 groups at random, often organize each 15 examples, two groups of no difference of science of statistics on age, distressed number of times, electrocardiogram, matched group is normal saline, and tested group is embodiment 5 products obtained therefrom.Be intravenous administration.According to following standard determination curative effect:
Effective: pain disappears, electrocardiogram recovers normal or ST section recover more than rising 0.05mv, T ripple by being inverted, low flat turn be upright, myocardial infarction symptoms disappearance.
Effective: pain relief or attack times pain number of times reduce, electrocardiogram gos up after moving down the treatment of ST section 0.05mv, but does not reach normal level, and myocardial infarction symptoms is for disappearing.
Invalid: pain is not alleviated, electrocardiogram is without change, and myocardial infarction symptoms is unchanged.
Result:
Effective 9 examples of the embodiment of the present invention 5, effective 4 examples, invalid 2 examples.Matched group is without significant change.
Find in the process for the treatment of angina pectoris, coronary heart disease, the present invention can reduce thrombus in vivo quantity, and the thrombosis of formation is partly or entirely dissolved, and reduces whole blood and Plasma Viscosity.Illustrate, the present invention has obvious anti-thrombosis function.
To sum up, the present composition has outstanding effect in treatment cardiovascular and cerebrovascular disease, and medicine is after intravenous injection, safe and reliable, does not also find toxic and side effects.
Finally it should be noted that, above embodiment is the unrestricted technical scheme of the present invention in order to explanation only, although with reference to above-described embodiment to invention has been detailed description, those skilled in the art are to be understood that, still can modify to the present invention or equivalent replacement, and not departing from any modification or partial replacement of the spirit and scope of the present invention, it all should be encompassed in right of the present invention.
Claims (9)
1. for preventing or treat a pharmaceutical composition for cardiovascular and cerebrovascular disease, it is characterized in that: comprise baicalin and peoniflorin.
2. the pharmaceutical composition for preventing or treat cardiovascular and cerebrovascular disease according to claim 1, is characterized in that: the mass ratio of described baicalin and peoniflorin is 1 ~ 9:1 ~ 9.
3. the pharmaceutical composition for preventing or treat cardiovascular and cerebrovascular disease according to claim 1, is characterized in that: the mass ratio of described baicalin and peoniflorin is 1 ~ 5:1 ~ 5.
4. the pharmaceutical composition for preventing or treat cardiovascular and cerebrovascular disease according to claim 1, is characterized in that: the dosage form of described pharmaceutical composition is oral formulations or injection.
5. the pharmaceutical composition for preventing or treat cardiovascular and cerebrovascular disease according to claim 4, is characterized in that: described injection is injectable powder.
6. the pharmaceutical composition for preventing or treat cardiovascular and cerebrovascular disease according to claim 5, is characterized in that: containing filler in described injectable powder.
7. the pharmaceutical composition for preventing or treat cardiovascular and cerebrovascular disease according to claim 6, it is characterized in that: described filler is selected from the one in mannitol, lactose, glucosan, inositol, meglumine or glucose, or their arbitrary proportion mixture.
8. based on a preparation method for pharmaceutical composition described in claim 6 or 7, it is characterized in that, comprise the following steps: densely to join; Coarse filtration; Rarely to join; Fine straining; Lyophilizing.
9. the preparation method of pharmaceutical composition according to claim 8, it is characterized in that, described dense joining is dissolved in water for injection by filler, add baicalin again and peoniflorin dissolves, adjust ph to 7 ~ 9, add active carbon, heated and stirred, obtains concentrated wiring liquid; Described coarse filtration is first filtered with the titanium rod filter decarburization that aperture is 1.0 μm by concentrated wiring liquid, then be the microporous filter membrane pressure filtration of 0.45 μm with aperture, obtains coarse filtration liquid; Described fine straining is the microporous filter membrane aseptic filtration of 0.22 μm by rare for gained dosing aperture, obtains fine straining liquid; Described lyophilizing is that gained fine straining liquid is incubated 0.5 ~ 1 hour under-42 DEG C ~-45 DEG C conditions; Again 2 × 10
-1under the vacuum condition of below MPa, be warming up to-10 DEG C ,-10 DEG C of insulations 1 ~ 3 hour; Continue to be warming up to 0 DEG C, be incubated 2 ~ 3 hours, be then warming up to 3 DEG C, be incubated 1 ~ 2 hour; Finally make temperature rise to 42 DEG C with the speed of 3 DEG C per half an hour, be incubated 10 ~ 12 hours.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN113599358A (en) * | 2021-09-26 | 2021-11-05 | 天津红日药业股份有限公司 | Chinese medicinal powder for injection and its preparation method |
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| CN102988398A (en) * | 2012-12-20 | 2013-03-27 | 济南杏林生物技术有限公司 | Traditional Chinese medicine composition mixture for treating ischemic cerebrovascular disease and preparation method thereof |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102988398A (en) * | 2012-12-20 | 2013-03-27 | 济南杏林生物技术有限公司 | Traditional Chinese medicine composition mixture for treating ischemic cerebrovascular disease and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113599358A (en) * | 2021-09-26 | 2021-11-05 | 天津红日药业股份有限公司 | Chinese medicinal powder for injection and its preparation method |
| CN113599358B (en) * | 2021-09-26 | 2023-01-17 | 天津红日药业股份有限公司 | Chinese medicinal powder for injection and its preparation method |
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Application publication date: 20150729 |