CN104814933A - Gardenia extract freeze-dried powder injection and preparation method thereof - Google Patents
Gardenia extract freeze-dried powder injection and preparation method thereof Download PDFInfo
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- CN104814933A CN104814933A CN201510194279.6A CN201510194279A CN104814933A CN 104814933 A CN104814933 A CN 104814933A CN 201510194279 A CN201510194279 A CN 201510194279A CN 104814933 A CN104814933 A CN 104814933A
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Abstract
The invention relates to the field of a medicinal preparation, in particular to a gardenia extract freeze-dried powder injection and a preparation method thereof. The gardenia extract freeze-dried powder injection is composed of the following components in parts by weight: 1-9 parts of gardenia extract and 1-10 parts of filler. The gardenia extract freeze-dried powder injection provided by the invention has the effects of preventing or treating cardiovascular and cerebrovascular diseases, and is definite in curative effect, and is applicable to intravenous administration.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, be specifically related to a kind of Fructus Gardeniae extract lyophilized injectable powder and preparation method thereof.
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 mature fruit of Chinese medicine Fructus Gardeniae system Maguireothamnus speciosus Fructus Gardeniae (Gardenia jasminoides Ellis).There is effect of pathogenic fire purging relieving restlessness, clearing away heat-damp and promoting diuresis, removing pathogenic heat from blood and toxic substance from the body; Externally used detumescence pain relieving.Clinical, jaundice due to damp-heat, stranguria puckery pain, heat in blood vexed for calentura tell the diseases such as nosebleed, conjunctival congestion and swelling pain, fire-toxin carbuncle sore; External treatment bruise pain.Fructus Gardeniae contains the chemical compositions such as iridoids (Fructus Gardeniae glycoside), flavonoid (gardenin lamp), organic acid ester (chlorogenic acid, Stigma Croci acids).In recent years research finds; Fructus Gardeniae extract has liver, cerebral tissue, pancreatic cell protective effect; bile secretion can be promoted, regulate stomach function, increase SBF, repair orthopedic soft tissues damage, cardioprotection, adjustment blood pressure lowering, the effect such as antipyretic, antibacterial, antiinflammatory, there is medical value widely.Modern pharmacological research proves, jasminoidin is the main pharmacodynamics composition of Fructus Gardeniae.Jasminoidin polarity is large, and good water solubility, fat-soluble difference, oral administration exists hepato-enteric circulation, and bioavailability is extremely low, less than 10%.
The compound Chinese medicinal preparation be made up of Fructus Gardeniae 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.
Summary of the invention
The object of this invention is to provide a kind of Fructus Gardeniae extract lyophilized injectable powder for preventing or treat cardiovascular and cerebrovascular disease.
The technical solution used in the present invention is a kind of Fructus Gardeniae extract lyophilized injectable powder, is made up of the component of following parts by weight: Fructus Gardeniae extract 1 ~ 9 part, filler 1 ~ 10 part.
As preferably, described Fructus Gardeniae extract is the one in jasminoidin or crocin, or their arbitrary proportion mixture.
As preferably, the mass ratio of described jasminoidin and crocin is 1:0.1 ~ 1.
As preferably, described filler is selected from the one in mannitol, lactose, glucosan, inositol, meglumine or glucose, or their arbitrary proportion mixture.
The present invention also provides a kind of preparation method of described Fructus Gardeniae extract lyophilized injectable powder, comprises the following steps: densely join; Coarse filtration; Rarely to join; Fine straining; Lyophilizing.
As preferably, described dense joining is dissolved in water for injection by filler, then add jasminoidin and/or crocin dissolves, and adjust ph to 6 ~ 8, add active carbon, and heated and stirred obtains concentrated wiring liquid.
As preferably, described coarse filtration is first filtered with the titanium rod filter decarburization that aperture is 1.0 μm by gained concentrated wiring liquid, then be the microporous filter membrane pressure filtration of 0.45 μm with aperture, obtains coarse filtration liquid.
As preferably, described fine straining is the microporous filter membrane aseptic filtration of 0.22 μm by rare for gained dosing aperture, obtains fine straining liquid.
As preferably, 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 injectable powder 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 jasminoidin 1500g, stirring makes to dissolve completely, adjust pH to 8, 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 jasminoidin 300mg.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 jasminoidin 150g, 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 jasminoidin 30mg.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 crocin 1500g, stirring makes to dissolve completely, adjust pH to 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 crocin 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 crocin 150g, 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 crocin 30mg.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 jasminoidin 1500g, crocin 750g, stirring makes to dissolve completely, adjust pH to 6, 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 jasminoidin 300mg, crocin 150mg.Investigate through long-time stability, when 36 months, the indices of product is compared with when 0 month, does not substantially change.
Embodiment 6
Accurately take mannitol 700g, Dextran 8 00g is placed in dense preparing tank, inject and use water 9000ml, stirring makes to dissolve completely, add jasminoidin 1500g, crocin 1500g, stirring makes to dissolve completely, adjust pH to 6, 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 jasminoidin 300mg, crocin 300mg.Investigate through long-time stability, when 36 months, the indices of product is compared with when 0 month, does not substantially change.
Embodiment 7
Accurately take mannitol 700g, Dextran 8 00g is placed in dense preparing tank, inject and use water 9000ml, stirring makes to dissolve completely, add jasminoidin 1500g, crocin 150g, stirring makes to dissolve completely, adjust pH to 6, 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 jasminoidin 300mg, crocin 30mg.Investigate through long-time stability, when 36 months, the indices of product is compared with when 0 month, does not substantially change.
Indices in above-described embodiment all refers to the content etc. of jasminoidin and/or crocin.
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 in above-described embodiment; 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: the normal saline of same volume.
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 88% of various embodiments of the present invention, compliance rate average out to 76%, inefficiency average out to 12%.Normal saline group is without significant change.
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 9 examples of the embodiment of the present invention 4, effective 4 examples, invalid 2 examples.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 10 examples of the embodiment of the present invention 5, effective 5 examples, invalid 0 example.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, lyophilized injectable powder of the present invention 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. a Fructus Gardeniae extract lyophilized injectable powder, is characterized in that: be made up of the component of following parts by weight: Fructus Gardeniae extract 1 ~ 9 part, filler 1 ~ 10 part.
2. a kind of Fructus Gardeniae extract lyophilized injectable powder according to claim 1, is characterized in that: described Fructus Gardeniae extract is the one in jasminoidin or crocin, or their arbitrary proportion mixture.
3. a kind of Fructus Gardeniae extract lyophilized injectable powder according to claim 2, is characterized in that: the mass ratio of described jasminoidin and crocin is 1:0.1 ~ 1.
4. a kind of Fructus Gardeniae extract lyophilized injectable powder according to claim 1, is characterized in that: described filler is selected from the one in mannitol, lactose, glucosan, inositol, meglumine or glucose, or their arbitrary proportion mixture.
5. based on a preparation method for Fructus Gardeniae extract lyophilized injectable powder described in claim 1-4 any one, it is characterized in that, comprise the following steps: densely to join; Coarse filtration; Rarely to join; Fine straining; Lyophilizing.
6. the preparation method of Fructus Gardeniae extract lyophilized injectable powder according to claim 5, it is characterized in that, described dense joining is dissolved in water for injection by filler, add jasminoidin again and/or crocin dissolves, adjust ph to 6 ~ 8, add active carbon, heated and stirred, obtains concentrated wiring liquid.
7. the preparation method of Fructus Gardeniae extract lyophilized injectable powder according to claim 5, it is characterized in that, described coarse filtration is first filtered with the titanium rod filter decarburization that aperture is 1.0 μm by gained concentrated wiring liquid, then be the microporous filter membrane pressure filtration of 0.45 μm with aperture, obtains coarse filtration liquid.
8. the preparation method of Fructus Gardeniae extract lyophilized injectable powder according to claim 5, is characterized in that, described fine straining is the microporous filter membrane aseptic filtration of 0.22 μm by rare for gained dosing aperture, obtains fine straining liquid.
9. the preparation method of Fructus Gardeniae extract lyophilized injectable powder according to claim 5, it is characterized in that, 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 (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108553469A (en) * | 2018-04-28 | 2018-09-21 | 广州博济堂医药保健有限公司 | Crocetin or derivatives thereof is preparing the purposes in treating heart failure medications |
| CN113952348A (en) * | 2021-12-13 | 2022-01-21 | 安阳市中医院 | Use of crocin in the treatment of heart failure |
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| CN102212091A (en) * | 2011-04-19 | 2011-10-12 | 肖文辉 | High-purity geniposide as well as preparation and clinical application of preparations thereof |
| CN103830253A (en) * | 2012-11-21 | 2014-06-04 | 青岛百草汇中草药研究所 | Applications of geniposide in preparation of medicines used for treating diabetic nephropathy |
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| WO2004068140A1 (en) * | 2003-01-27 | 2004-08-12 | Medicon Hellas S.A. | A method for the determination of total antioxidant capacity (tac) and corrected total antioxidant capacity (corrtac) in fluids |
| CN102212091A (en) * | 2011-04-19 | 2011-10-12 | 肖文辉 | High-purity geniposide as well as preparation and clinical application of preparations thereof |
| CN103830253A (en) * | 2012-11-21 | 2014-06-04 | 青岛百草汇中草药研究所 | Applications of geniposide in preparation of medicines used for treating diabetic nephropathy |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108553469A (en) * | 2018-04-28 | 2018-09-21 | 广州博济堂医药保健有限公司 | Crocetin or derivatives thereof is preparing the purposes in treating heart failure medications |
| CN113952348A (en) * | 2021-12-13 | 2022-01-21 | 安阳市中医院 | Use of crocin in the treatment of heart failure |
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