CN1615956A - Ginseng sini injection four treating cold limbs and preparing method - Google Patents
Ginseng sini injection four treating cold limbs and preparing method Download PDFInfo
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Abstract
The ginseng Sini injection for treating Jue syndrome and chest Bi-syndrome consists of giant typhonium tuber slice or Heishun slice, ginger, red sage or ginseng, fried licrorice, medicine supplementary material and water for injection. It may be prepared into injection, transfusion liquid and freeze dried powder for injection. Its preparation process includes preparing Sini decoction with Heishun slice, ginger and fried licrorice via decoction, filtering and alcohol deposition and concentration; treating the Sini decoction dregs via sulfuric acid deposition, drying, acetone extraction and filtering to obtain glycyrrhizic acid and glycyrrhetic acid; processing red sage or ginseng via alcohol reflux, ethyl ether extraction and other step to obtain ginsenoside; treating the red sage or ginseng dregs to obtain ginseng polysaccharide; and other steps. The present invention is used in treating shock, angina pectoris, myocardial infarction and heart failure, and has high bioavailability and other advantages.
Description
Technical field
The present invention relates to a kind of recuperating depleted YANG and rescuing the patient from collapse, multiple arteries and veins nourishes heart, supplementing QI to prevent collapse, warming middle-JIAO to dispel cold (heresy), be used for the treatment of the cold Sheng of the deficiency of YIN, the moon sun that declines takes off, new drug---the Radix Ginseng cold limbs injection of emergency case serious symptom such as syncope of excessive YIN keeping YANG externally (all kinds of shocks such as heart source property, hypovolemic, damaging, toxic) and chest arthralgia precordial pain syndrome (angina pectoris), myocardial infarction, heart failure.Another object of the present invention is the extracts active ingredients purification with decoction for Resuscitation (Radix Aconiti Lateralis Preparata or Radix Aconiti Lateralis Preparata, Rhizoma Zingiberis, Radix Glycyrrhizae Preparata or Radix Glycyrrhizae) and Radix Ginseng Rubra or Radix Ginseng, makes the injection with small volume, high-capacity injection and the lyophilized injectable powder that are fit to intravenously administrable.The present invention has significant cardiotonic, significantly strengthen myocardial contraction, significantly increase coronary flow, extremely significantly improve the preceding microcirculation arterial blood flow of shock patients blood pressure rise, shorten erythrocyte electrophoretic time, alleviate the enteric hemorrhage necrosis, strengthen cardiac pumping function, significantly increase the heart blood discharge amount, improve vitals and blood vessel oxygen metabolism, improve myocardial ischemia, raise and stabilizing blood pressure, heart rate is had good dual regulation unusually, strengthen thrombin activity and prolong prothrombin time, anticoagulant and thrombosis have excitation to hypophysis-adrenal cortex function, possess the central analgesia, calm, pharmacological actions such as antiinflammatory.The present invention adds Radix Ginseng Rubra by decoction for Resuscitation (Radix Aconiti Lateralis Preparata or Radix Aconiti Lateralis Preparata, Rhizoma Zingiberis, Radix Glycyrrhizae Preparata or Radix Glycyrrhizae) or Radix Ginseng extract is made, the extraction, the purifying process that relate to extraction, purifying process and the Radix Ginseng Rubra of decoction for Resuscitation (Radix Aconiti Lateralis Preparata or Radix Aconiti Lateralis Preparata, Rhizoma Zingiberis, Radix Glycyrrhizae Preparata or Radix Glycyrrhizae), the preparation methoies such as preparation technology of Radix Ginseng cold limbs injection.
Background technology
The syncope of theory of Chinese medical science indication, that card sees that mind is indifferent, pale complexion, flushing cyanosis, cold spontaneous sweating, extremity are fainted is contrary, weak breathing, faint pulse knot generation or wait wild.It is the shock category of modern medicine.Shock is meant the acute disturbance of blood circulation that causes because of a variety of causes (as massive hemorrhage, wound, burn, infection, allergy, heart pump failure etc.), the microcirculation arterial blood flow sharply reduces, and is the general pathological process of the complexity of random and structural damage thereby cause each vitals founction metabolism.Patient shows as that mind is blunt, green around the gills, the limbs being moist and cold, cold sweat, the thin speed of pulsation, blood pressure drops, hypourocrinia etc.Shock is left the prelude of body as life, as critically ill pointer, by ancient Chinese medicine doctor is paid attention to.Health ministry Development of Health Service situation in 2003 statistical communique shows that mortality rate is arranged malignant tumor, cerebrovascular disease, respiratory system disease, cardiovascular system diseases, damage and the poisoning of the first five, and the probability that shock occurs is the highest.Along with process of industrialization quickening, environmental pollution, competition social mentality pressure increase the weight of, aged tendency of population, convenient traffic, family's external activity are frequent, the disease that mortality rate is taken the first four place the position has become commonly encountered diseases, frequently-occurring disease, and damage and poisoning are also in rising trend year by year.Therefore, a kind of safe, quick-acting, shock new drug efficiently of modern society's urgent needs.
The chest arthralgia precordial pain syndrome of theory of Chinese medical science indication, " Ling Shu Miraculous Pivot or Divine Axis faint disease a piece of writing ": " angina pectoris, bluish colour of the limbs extending up to the elbows and knees, very pained "." Medical Treasures of the Golden Chamber ": " pain over the chest and back is losed heart for the disease of the thoracic obstruction, dyspnea and expectoration, pulse at CUN KOU being deep and slow, GUAN being pulse faint, tense and rapid ".Card sees that chest pain is uncomfortable in chest, and shortness of breath and palpitation, purplish tongue, deep pulse is trickle or knot generation etc.Belonging to modern medicine coronary atherosclerotic heart disease (abbreviation coronary heart disease) category, is one of the highest disease of present industrialized country M ﹠ M.Show that according to health ministry Development of Health Service situation in 2003 statistical communique heart disease comes the 4th in China resident major causes of death, account for 76.2/10 ten thousand of population, year death toll about 1,030,000.The number that the U.S. dies from coronary heart disease every year reaches 600,000, is used for annual about 5,000,000,000 dollars of the expense of coronary heart disease diagnosis and treatment.Therefore, coronary heart disease is called as industrialized country " first killer ".
The medicine that is used for the treatment of shock and coronary heart disease at present, still based on chemical drugs, determined curative effect, but toxic and side effects is bigger, and untoward reaction is more.Existing Chinese medicine preparation effect is desirable not enough, is representative with SHENFU ZHUSHEYE, SHENMAI ZHUSHEYE, SHENGMAI ZHUSHEYE etc., is used for syncope, and it is evident in efficacy to join attached recuperating depleted YANG and rescuing the patient from collapse, and so arteries and veins takes off deficiency admittedly again; Rhizoma Zingiberis Recens, giving birth to arteries and veins, to take off multiple arteries and veins admittedly effective, the merit of recuperating depleted YANG and rescuing the patient from collapse a little less than.Be used for chest arthralgia precordial pain syndrome, it is anxious to join the attached sun deficiency of vital energy that declines of separating, and but can not only throb with fear by mind calming, and clots absorbing reduces phlegm; Rhizoma Zingiberis Recens, living arteries and veins QI invigorating are given birth to significantly cloudy, right yang invigorating pain relieving deficiency.Though cold limbs Tonga Radix Ginseng side regards as recuperating depleted YANG and rescuing the patient from collapse through ancient Chinese medicine doctor, the multiple arteries and veins that nourishes heart, QI invigorating state are taken off, the classics side of the warming middle-JIAO to dispel cold, and any preparation listing is not so arranged so far yet, only stay in crude drug in whole prescription decoct.Characteristics according to syncope and chest arthralgia precordial pain syndrome etiology and pathogenesis, for providing, all kinds of shocks of clinical treatment and cardiovascular diseases can be applicable to emergency case, rescue, also can be applicable to efficient, quick-acting, the safety of the treating both the principal and secondary aspects of a disease of serious symptom rescue, so the new drug that more meets modernization of Chinese medicine requirement is upright topic exploitation Radix Ginseng cold limbs injection.
Summary of the invention
The objective of the invention is to, problem at present anti-shock medicament and the existence of treatment medicaments for coronary disease, for the world of medicine provides a kind of bioavailability height, the blood drug level height, fast and the lasting stability of drug action, the better new drug of clinical safety---Radix Ginseng cold limbs injection is comprising low capacity Radix Ginseng cold limbs injection, high capacity Radix Ginseng cold limbs sodium chloride injection, high capacity Radix Ginseng cold limbs glucose injection and injection Radix Ginseng cold limbs (lyophilized injectable powder).
Another object of the present invention provides the preparation method of this Radix Ginseng cold limbs injection.
The objective of the invention is to realize by the medicine that following prescription and preparation technology produce.
A kind of compositions of Radix Ginseng cold limbs injection, form by decoction for Resuscitation (Radix Aconiti Lateralis Preparata or Radix Aconiti Lateralis Preparata, Rhizoma Zingiberis, Radix Glycyrrhizae Preparata or Radix Glycyrrhizae) extract, Radix Ginseng Rubra or Radix Ginseng extract, proper quantity of medicinal auxiliary material and water for injection, it is characterized in that, used decoction for Resuscitation (Radix Aconiti Lateralis Preparata or Radix Aconiti Lateralis Preparata, Rhizoma Zingiberis, Radix Glycyrrhizae Preparata or Radix Glycyrrhizae) extract mainly contains aconitum carmichaeli debx. Total alkaloids, gingerol, glycyrrhizic acid, enoxolone, and Radix Ginseng Rubra or Radix Ginseng extract are ginsenoside, ginseng polysaccharide.
Additional technical feature is:
A. low capacity Radix Ginseng cold limbs injection, (contain ginsenoside 1.8～5.4mg, ginseng polysaccharide 37.5～112.5mg), Radix Glycyrrhizae Preparata 3～9g add injection water to 5～20ml for Radix Aconiti Lateralis Preparata (Radix Aconiti Lateralis Preparata) 3～9g, Rhizoma Zingiberis 2～6g, Radix Ginseng Rubra or Radix Ginseng 1.5～4.5g.
B. high capacity Radix Ginseng cold limbs sodium chloride injection, Radix Aconiti Lateralis Preparata (Radix Aconiti Lateralis Preparata) 3～9g, Rhizoma Zingiberis 2～6g, Radix Ginseng Rubra or Radix Ginseng 1.5～4.5g (contain ginsenoside 1.8～5.4mg, the ginseng polysaccharide 37.5～112.5mg), Radix Glycyrrhizae Preparata 3～9g, 0.9% sodium chloride of injection total amount adds injection water to 50～200ml.
C. high capacity Radix Ginseng cold limbs glucose injection, Radix Aconiti Lateralis Preparata (Radix Aconiti Lateralis Preparata) 3～9g, Rhizoma Zingiberis 2～6g, Radix Ginseng Rubra or Radix Ginseng 1.5～4.5g (contain ginsenoside 1.8～5.4mg, ginseng polysaccharide 37.5～112.5mg), Radix Glycyrrhizae Preparata (Radix Glycyrrhizae) 3～9g, 5% glucose of injection total amount adds injection water to 50～200ml.
D. injection Radix Ginseng cold limbs (lyophilized injectable powder), Radix Aconiti Lateralis Preparata (Radix Aconiti Lateralis Preparata) 1.5～4.5g, Rhizoma Zingiberis 1～3g, Radix Ginseng Rubra or Radix Ginseng 1～3g (contain ginsenoside 1.2～3.6mg, the ginseng polysaccharide 25～75mg), Radix Glycyrrhizae Preparata (Radix Glycyrrhizae) 1.5～4.5g, make bulking agent with the mannitol of 100～300mg or xylitol or sorbitol, add injection water to 2～4ml, 0.25～0.5g lyophilized injectable powder is made in lyophilization.
Radix Ginseng cold limbs injection of the present invention, extraction and purification process by decoction for Resuscitation (Radix Aconiti Lateralis Preparata or Radix Aconiti Lateralis Preparata, Rhizoma Zingiberis, Radix Glycyrrhizae Preparata or Radix Glycyrrhizae) extract, the extraction and purification process of Radix Ginseng Rubra or Radix Ginseng extract and process for preparation of injection are formed, wherein the extraction process of Radix Ginseng Rubra (Radix Ginseng) extract is ginsenoside's extraction and ginseng polysaccharide's extraction, it is characterized in that:
The ginsenoside extracts and may further comprise the steps: gets Radix Ginseng Rubra or Radix Ginseng, uses alcohol reflux, use extracted with diethyl ether, and sec-butyl alcohol or n-butanol extraction, the ethanol precipitation purification, filtrate to clear paste promptly gets ginsenoside extract.
The ginseng polysaccharide extracts and may further comprise the steps: Radix Ginseng Rubra behind the ethanol extraction or medicine residues of Radix Ginseng promptly get the ginseng polysaccharide through water extract-alcohol precipitation, polyamide absorption and chromatographic column eluting, separation and purification, eluent precipitate with ethanol, precipitation drying.
The extraction process of decoction for Resuscitation (Radix Aconiti Lateralis Preparata or Radix Aconiti Lateralis Preparata, Rhizoma Zingiberis, Radix Glycyrrhizae Preparata or Radix Glycyrrhizae) extract is: get Radix Aconiti Lateralis Preparata or Radix Aconiti Lateralis Preparata, Rhizoma Zingiberis, process Radix Glycyrrhizae or Radix Glycyrrhizae three flavor medical materials, in 3: 2: 3 ratios, decocting in water filters successively, filtrate adds the Different concentrations of alcohol precipitation and concentrates, and promptly gets the decoction for Resuscitation extracting solution.
The decoction for Resuscitation filtering residue adds sulfuric acid precipitation successively, abandoning supernatant, and collecting precipitation, vacuum drying is pulverized, acetone extract, filtered and recycled acetone, vacuum drying promptly gets glycyrrhizic acid, enoxolone extract.
Radix Ginseng cold limbs process for preparation of injection is: ginsenoside's extracting solution and the decoction for Resuscitation extracting solution of getting recipe quantity mix, and filter clear and bright, standby; Get recipe quantity glycyrrhizic acid, enoxolone extract, add the injection water, regulate pH with ammonia, heating for dissolving adds ginsenoside's extracting solution and decoction for Resuscitation extracting solution mixed liquor, heated and boiled, and activated carbon adsorption is filtered clear and bright standby; Get the ginseng polysaccharide of recipe quantity, add the injection water and boil dissolving, filter clear and bright, activated carbon adsorption, it is clear and bright to take off charcoal, adds the mixed liquor of ginsenoside, decoction for Resuscitation, glycyrrhizic acid, enoxolone extracting solution, add to the full amount of water for injection, regulate pH, fine straining is clear and bright, embedding, cooling, lamp inspection, packing, product inspection; Packing lyophilization, packing, product inspection are promptly under the lyophilized injectable powder aseptic condition.
The invention has the advantages that, the bioavailability height, the blood drug level height, the fast and lasting stability of drug action, safety is better.By decoction for Resuscitation extract and Radix Ginseng Rubra (Radix Ginseng) extract formula, drug effect proof Antishock function is obvious, quick-acting and lasting stability; Treatment angina pectoris, anti-myocardial infarction, heart failure are evident in efficacy.
The theoretical foundation of Radix Ginseng cold limbs injection treatment syncope (all kinds of shock) of the present invention and chest arthralgia precordial pain syndrome (angina pectoris) is as follows:
Theory of Chinese medical science thinks, the pathogeny of syncope mainly is the nutrient blood of caving in of cold pathogenic warmth poison, extremely consumes cloudy functional activities of the body fluid blood, causes that healthy energy is lost greatly, QI and blood is disorderly contrary; Or because of antiperspirant, tell, descend, consumption impairment of QI the moon such as hemorrhagic disorder and consumption of essence, wound, poisoning; Or the prolonged illness internal organs are deficient, more meet exopathogen invasion, improper diet, the stimulation of feelings will etc. the internal organs negative and positive of qi and blood is damaged more.Evil malicious impatency is in interior, positive QI consumed take off in outside, cause YIN and YANG exhausted simultaneously eventually and alarm in life.Negative and positive are the outline of life.Solitary YIN is not given birth to, and solely sun is not long, and negative and positive alternate, YIN and YANG balancing are then given birth to, and yin and yang imbalance is then sick, and negative and positive are from exhausted then dead.The moon declines and gives birth to and to faint contraryly, and sun declines and forms the depletion syndrome, and the card that takes off of fainting declines based on heart kidney yang gas, almost wild.In the face of life on the point of dying, the recuperating depleted YANG and rescuing the patient from collapse that is bound to, the multiple arteries and veins that nourishes heart, supplementing QI to prevent collapse, warming middle-JIAO to dispel cold (heresy).It is from a strategic height to cure holy Zhong Jing, and later age in critically ill, is lost and row is big kind with rescue life by wound cold limbs Tonga Radix Ginseng side.
Cold limbs Tonga Radix Ginseng side is monarch with the Radix Aconiti Lateralis Preparata, the big heat of Da Xin, on help heart-yang, middle warming the spleen sun, following kidney-replenishing." interior warp " said: " cold-evil wins, and is flat with hot ".The temperature invigorating kidney-YANG, the main fire from the gater of life of mending drastically with the cold relieving heresy, is directly walked the kidney palace, heavily rises congenital gas; Rhizoma Zingiberis is the most trustworthy ministers, help again hot, popular cloud: " Radix Aconiti Lateralis Preparata does not have Jiang Bure ".Warming middle-JIAO to dispel cold is in keeping and the warming the spleen sun, to draw the gas of the day after tomorrow wild; Radix Ginseng Rubra is assistant, strongly invigorating primordial QI, and multiple arteries and veins takes off admittedly, and nourishing qi to stop is assisted a ruler in governing a country the positive compress whole body that JIANGFU will be retrieved, and reinvents cloudy Tianjin, links up negative and positive; Radix Glycyrrhizae Preparata is for making, and the replenishing vital QI with drugs of warm nature yang-energy during emergency is transferred, is made the dry strong of JIANGFU, presses down the high benefit of Radix Ginseng Rubra." the Jing Yue's complete work book on Chinese herbal medicine is just " cloud: " poison get separate its poison, just medicine gets its property of sum, goes into gas with the gas medicine, goes into blood with the blood medicine ".Especially as the nothing of " state is old " toward can not, benefit is benefit then.
The heaviest person that syncope is hindered, the heart, kidney, brain, spleen, lung are cured the disease and are asked basic, and cold limbs Tonga Radix Ginseng side four medicines share, the Radix Aconiti Lateralis Preparata invigorating kidney-YANG, Rhizoma Zingiberis warming the spleen sun, the Radix Ginseng Rubra benefit motive, Radix Glycyrrhizae Preparata is in harmonious proportion, and presses down the benefit of completing of ginseng, makes the dry strong of JIANGFU; Radix Aconiti Lateralis Preparata is apt to away, and Rhizoma Zingiberis is kind to be kept, the two mutual reinforcement between, and the merit of recuperating depleted YANG and rescuing the patient from collapse is stronger; The Radix Ginseng Rubra supplementing QI for promoting the production of body fluid helping cloudy giving birth to, takes off Fu Mai admittedly and share with Radix Glycyrrhizae Preparata; Attached Rhizoma Zingiberis Recens is hot, joins careless sweet temperature, and " interior warp " said: " cold-evil wins, and is flat with hot ", " cold excessive in interior, as to control with sweet heat ".We walk, keep, mend and have both, YIN and YANG balance regulating, and that medicine letter power is specially imitated is grand, is that recuperating depleted YANG is given birth to cloudy big dose, the good recipe that rescuing faints takes off admittedly, and doctor family checking at all times, rationally feasible.
Chest arthralgia precordial pain syndrome, mainly by blood stasis due to qi deficiency, the visceral-qi deficiency, the gasification imbalance, blood operation in Tianjin is not smooth, gets into expectorant with fixed attention with the bringing about the spread of body fluid, the not smooth one-tenth stasis of blood of blood, expectorant stasis of blood impatency, heart arteries and veins is obstructed, due to venation is obstructed.Especially with kidney yang deficiency, it is main that heart lacks the source of vital function.The heart occupies the part of the body cavity above the diaphragm housing the heart and lungs, belongs to the main fire of sun, and kidney occupies the part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels, belongs to cloudy main water, and kidney-water ascending to coordinate with the heart makes heart-fire being not overabudant, and heart-fire descending into the kidney makes the kidney being not cold, and so coordination between the heart and kidney is coordinated negative and positive, and is coordinating water and fire.The heart is a monarch fire, and kidney is hidden fire mutually, the fiery mutual promotion of monarch's phase, mutual restriction.Kidney is hidden Yuanyang, and Yuanyang is the root of all sun, so that kidney yang deficiency, heart-yang also declines thereupon.So chest arthralgia precordial pain syndrome, sick position is at the heart, and old complaint is at kidney.Deficiency of heart-YANG declines, the unable promotion motive, and " interior warp " said: " qi as the commander of blood, blood being the mother of qi ".The weak stagnation of QI that forms of the motive, the stagnation of QI is blood stasis then; Kidney yang deficiency, the five internal organs lack the source of vital function, and body fluid lacks the warm expectorant that forms of kidney yang; Phlegm and blood stasis and hinder arteries and veins, arteries and veins hinders into numbness, and numbness is then obstructed, and stagnation of QI and blood may bring about pain is then vexed, then throb with fear, so the body of the tongue purple is deep red, faint pulse knot generation.
Cold limbs Tonga Radix Ginseng side, the Radix Aconiti Lateralis Preparata invigorating kidney-YANG makes the root of having of heart-yang life; Rhizoma Zingiberis warming the spleen sun is with the thick heart-yang base of the day after tomorrow; Radix Ginseng Rubra master reinforcing the heart gas, multiple arteries and veins is taken the photograph blood, and vital base and primordial QI consolidating is met positive GUIXIN; The invigorating middle warmer of Radix Glycyrrhizae Preparata QI invigorating, coordinating the actions of various ingredients in a prescription.Four medicines share, and kidney-replenishing is started with, with the high aspiration sun; Strongly invigorating primordial QI, basic with the solid heart; Yang-energyization is educated, with the comfortable network of Tong Xinmai.So we are used for chest arthralgia precordial pain syndrome, meet theory of Chinese medical science, and are rationally feasible.
Modern pharmacy studies have shown that after the Radix Aconiti Lateralis Preparata long-time heating decocted and concocts, contained aconitine was hydrolyzed to aconine, strengthens myocardial contraction, increases cardiac output, has cardiotonic preferably; Can significantly increase coronary flow, blood vessel dilating improves myocardial ischemia, reduces myocardial oxygen consumption, has good antiarrhythmic effect; Rising blood T lymhocyte transformation rate, SC content is increased, the enhancing human body immunity function, can obviously resist the reduction of mean aortic pressure power, left ventricular systolic pressure power and left ventricle rising maximum rate, Antishock function is stronger, excited hypophysis adrenal cortex function, antiinflammatory, analgesia, and to various heart diseases and other diseases with heart failure sure effect is arranged.
Rhizoma Zingiberis has antiulcer, suppresses gastric secretion, reduces gastric acidity; Have the cholinolytic antihistamine effect and suppress the intestinal tube activity; Significantly increase choleresis, are better than function of gallbladder promoting intensity and action time NaTDC; Oxygen lack resistant function; To platelet Cycloxygenase, thromboxance B
2(TXB
2) and the biosynthetic inhibition of prostaglandin, have antithrombotic and antiplatelet aggregative activity; Shrink central and peripheral vessel, have and boost and cardiotonic; Suppress the prostate biosynthesis and have the antipyretic-antalgic antiinflammatory action.
Radix Ginseng Rubra has the effect of " adaptogen " sample, has resisting fatigue, anti-hypoxia, radioprotective, increases the content of DNA, RNA in the muscle, and brain is had dual regulation; The human body immunity improving function; Improve blood and hemopoietic function; Has heart tonifying, antiarrhythmic effect; Effect such as defying age and nootropics.
Radix Glycyrrhizae Preparata can obviously suppress △ in the liver
4+-5 β-reductase; Can delay the metabolic rate of 17-hydroxy-11-dehydrocorticosterone, prolong its action time and intensity, showing has the effect of 17-hydroxy-11-dehydrocorticosterone sample; Reduce gastric juice amount, total acidity and free acidity, suppress the gastric secretion that acetylcholine and histamine cause, have antiulcer action; Cover the pharyngolaryngeal mucosa of inflammation, relax inflammatory stimulus, the performance antitussive effect promotes the secretion of throat and bronchus, makes the easy expectoration of expectorant, presents phlegm-dispelling functions; Suppress
3H-acetic acid and [
3H] to participate in the smooth muscle cell lipid synthetic for linoleic acid, suppress the formation of microsome cholesterol and significantly reduce plasma cholesterol and triglyceride content, have remarkable effect for reducing blood fat, suppress histamine release, promote cellular immunization antibody to generate, the enhancing human body immunity function, multiple virus is had remarkable inhibitory action, and arrhythmia also has antitumor, protects the liver, anti peroxidation of lipid, suppress lipase, strengthen effects such as internal ear auditory function.
Cold limbs Tonga Radix Ginseng side is the classics side of Chinese traditional treatment syncope and chest arthralgia precordial pain syndrome, and pharmacological effect mutual reinforcement between, Xiang Zuo, the mutual-assistance, the mutual-detoxication, making an appointment possesses, and the JIANGFU mutual reinforcement between is makeed an appointment, and joins careless mutual reinforcement between, makes an appointment, and joins attached assistant mutually, the mutual-assistance of JIANGFU grass, the Rhizoma Zingiberis Recens grass and the attached mutual-detoxication.Rhizoma Zingiberis has helped attached with invigorating kidney-YANG, Radix Aconiti Lateralis Preparata helps Rhizoma Zingiberis with the warming the spleen sun, Radix Glycyrrhizae Preparata helps the Radix Ginseng Rubra QI invigorating, Radix Ginseng Rubra is assisted a ruler in governing a country the Radix Aconiti Lateralis Preparata recuperating the depleted YANG to cure collapse-syndrome as emergency treatment, and Radix Glycyrrhizae Preparata makes the JIANGFU drug effect better, and Rhizoma Zingiberis, Radix Glycyrrhizae Preparata kill the poison of Radix Aconiti Lateralis Preparata, Radix Glycyrrhizae Preparata Radix Aconiti Lateralis Preparata dry strong, press down the high benefit of Radix Ginseng Rubra, Radix Aconiti Lateralis Preparata is apt to away, and Rhizoma Zingiberis is kind to be kept, the JIANGFU coupling is kept to walk approximately, four medicines share, and have both strengthened recuperating depleted YANG and rescuing the patient from collapse, and multiple arteries and veins nourishes heart, supplementing QI to prevent collapse, warming middle-JIAO to dispel cold, the drug action of treatment syncope and chest arthralgia precordial pain syndrome is fallen again and is pressed down toxicity, dry strong and improved clinical drug safety.
Experiment showed, Radix Aconiti Lateralis Preparata list usefulness, be prone to arrhythmia, due to the contained aconitine of Radix Aconiti Lateralis Preparata, it is the effective ingredient of separating the Radix Aconiti Lateralis Preparata poison that Radix Glycyrrhizae Preparata contains Flavonoid substances, the arrhythmia that energy antagonism aconitine causes.Radix Glycyrrhizae Preparata and Radix Aconiti Lateralis Preparata are with decocting, and the decocting rate of enoxolone reaches more than 80% in the licoflavone, and the decocting rate that Radix Glycyrrhizae is singly fried in shallow oil only is about 50%, and the same stripping of frying in shallow oil the composition that more helps detoxifying of Radix Glycyrrhizae and Radix Aconiti Lateralis Preparata be described; Mel is rich in several amino acids in the Radix Glycyrrhizae Preparata, can combine salify with aconitine, and is soluble in water, both improved drug effect, can reduce toxicity again.Radix Ginseng Rubra energy enhancing body can significantly reduce Radix Aconiti Lateralis Preparata and accelerate heart rate the nonspecific resistance that harmful substance stimulates, and causes ARR toxic and side effects.The effect that Rhizoma Zingiberis is separated the poison of Radix Aconiti Lateralis Preparata is similar to Radix Glycyrrhizae.In cold limbs Tonga Radix Ginseng side, the toxicity of Radix Aconiti Lateralis Preparata has reduced by 30 times.
Pharmacological toxicology result of study of the present invention shows: Radix Ginseng cold limbs injection can significantly improve the microcirculation arterial blood flow, has the reinforcement myocardial contraction, adjust heart rate, raise and stabilizing blood pressure, strengthen cardiac pumping function, increase the heart blood discharge amount, reduce peripheral vascular resistance, improve heart and blood vessel oxygen metabolism, improve the blood supply of vitals such as the heart, kidney, brain, lung and tissue, blood viscosity lowering, increase coronary flow, improve myocardial ischemia, suppress thrombosis, strengthen thrombin activity and prolong prothrombin time, reduce capillary permeability etc.Be used for clinically by setting clinical use amount, do not see any toxic and side effects and untoward reaction.
A. the antibody gram studies show that; Radix Ginseng cold limbs injection energy coronary artery dilator; increase coronary flow; improve the preceding blood capillary blood flow of shock patients blood pressure rise; shorten erythrocyte electrophoretic time; alleviate the enteric hemorrhage necrosis; improve hypoxia-bearing capability; anesthetized dog acute heart failure and cardiogenic shock that pentobarbital sodium is brought out have significant protective effect, and rising LVSP reduces LVEDP; increase dp/dtmax; increase CO, SBP and DEP, significantly reduce traumatic shock mouse death rate (P＜0.01), significantly reduce septic shock mortality of mice (P＜0.01).
B. heart tonifying studies show that: Radix Ginseng cold limbs injection can strengthen cardiac contractility ability and diastole ability, significantly increases coronary flow, and the average femoral artery pressure that raises increases cardiac output, and cardiotonic is obvious.
C. the blood pressure that raises studies show that: Radix Ginseng cold limbs injection can significantly improve the microcirculation arterial blood flow, strengthen myocardial contraction, increase coronary flow, strengthen cardiac pumping function, improve cardiac output, reduce peripheral vascular resistance, reduce the capillary vessel permeability, have rapid rising blood pressure, and blood pressure rises to and can keep stable effect after normal.
D. adjusting heart rate studies show that: Radix Ginseng cold limbs injection has the effect of slowing down to the shock patients heart rate from the pleth, and to because of the conduction block decreased heart rate has tangible antagonism again, showing has benign dual regulation unusually to heart rate.
E. resist myocardial ischemia and studies show that: Radix Ginseng cold limbs injection is coronary artery dilator significantly, reduces the ischemic myocardium MDA content, removes oxygen-derived free radicals, and tangible function of resisting myocardial ischemia is arranged.Simultaneously oxygen-derived free radicals is had restitution to induced myocardial injury, showing has protective effect to cardiac muscle.
F. heart failure resistance studies show that: Radix Ginseng cold limbs injection can strengthen cardiac pumping function, strengthen myocardial contraction, increase heart stroke volume (SV), improve fractional shortening of the ventricular minor semi axis (△ D%), improve stroke volume index (SVI), improve Bicuspid valve one interventricular septum spacing (EPSS), improve cardiac index (CI), therefore, has good heart failure resistance effect.
G. acute toxicity test shows, 899 times and 719 times by 60kg body weight adult intravenously administrable consumption per day give to observe 14 days after mice or the rat drug administration by injection, animal does not have death, food ration of animal and body weight do not have obvious minimizing, observe all no abnormal discovery of vitals (heart, liver, lung, kidney etc.) after putting to death animal, all the other are no abnormality seen also.
H. long term toxicity test shows, to 100.38 times of pharmaceutical compositions of Beagle dog intravenous drip adult intravenously administrable consumption per day 90 days and drug withdrawal 15 days, shows no obvious abnormalities continuously, does not also have obvious retardance toxic reaction.
I. clinical experimental study shows, Radix Ginseng cold limbs injection is to syncope (all kinds of shocks such as heart source property, hypovolemic, damaging, toxic) obvious effective rate 73.6%, effective percentage 26.4%, total effective rate 100%; To chest arthralgia precordial pain syndrome (angina pectoris) obvious effective rate 71.8%, effective percentage 27.1%, total effective rate 98.9%; To emergency case serious symptom determined curative effects such as myocardial infarction, heart failure, safety is controlled.
Description of drawings:
Fig. 1 is the extraction process flow chart of decoction for Resuscitation extract of the present invention
Fig. 2 is the extraction process flow chart of Radix Ginseng Rubra of the present invention (Radix Ginseng) extract
Fig. 3 is a low capacity Radix Ginseng cold limbs injection preparation technology flow chart of the present invention
Fig. 4 is a high capacity Radix Ginseng cold limbs chloride injection liquid preparing process flow chart of the present invention
Fig. 5 is a high capacity Radix Ginseng cold limbs glucose injection liquid preparing process flow chart of the present invention
Fig. 6 is injection Radix Ginseng cold limbs of the present invention (freeze-dried powder) preparation technology flow chart
The specific embodiment:
Extraction process:
A. the extraction of decoction for Resuscitation extract: get Radix Aconiti Lateralis Preparata, Rhizoma Zingiberis and Radix Glycyrrhizae Preparata three flavor medical materials, add 6 times of water gagings and decoct each 1.5 hours 3 times, merge decoction liquor, filter, filtrate is concentrated into 4000ml (every 1ml is equivalent to medical material 2g), add ethanol and make concentration of alcohol reach 80%, standing over night filters, filtering residue is standby, be concentrated into 2000ml (every 1ml is equivalent to medical material 4g) behind the filtrate recycling ethanol, add ethanol and make concentration of alcohol reach 85%, standing over night, filter, filtering residue is standby; Be concentrated into 1000ml (every 1ml is equivalent to medical material 8g approximately) behind the filtrate recycling ethanol, add ethanol and make concentration of alcohol reach more than 90% standing over night, filter, filtering residue is standby, filtrate recycling ethanol, and be concentrated into 1000ml (every 1ml is equivalent to medical material 8g), add 2 times of water gagings to 3000ml, and regulate about pH value to 4.5 with 10% hydrochloric acid solution, cold preservation is spent the night, filter, filtrate is concentrated into 1000ml (every 1ml is equivalent to medical material 8g), gets the cold limbs extracting solution, and is standby; Merge 3 times filtering residue, the water that adds 3 times of medical material amounts stirs evenly, and under agitation slowly adds sulphuric acid, make sulfuric acid content reach about 5% (V/V) standing over night, abandoning supernatant, the water that adds 3 times of medical material amounts again stirs evenly, and adds sulphuric acid again and makes sulfuric acid content reach about 5% standing over night, abandoning supernatant is handled once with method, after the abandoning supernatant again, collecting precipitation, dry under 70～80 ℃, pulverize, put in the reflux, the acetone extract 2 times that adds 5 times of dry powder amounts, each 30 minutes, merge backflow, filter, at 55 ℃ of following reclaim under reduced pressure acetone, dry under 70～80 ℃, get glycyrrhizic acid, the enoxolone extract, standby.
B. ginsenoside's extraction: get Radix Ginseng Rubra section,, measure extraction 1.5 hours with 8 times at every turn with 75% alcohol reflux 4 times, merge extractive liquid, filters filtrate recycling ethanol, be concentrated into relative density about 1.05 (60 ℃ of mensuration), be chilled to room temperature,, discard ether solution with 1/4 amount extracted with diethyl ether 3 times, heated and boiled, fling to residual ether, filter, filtrate is chilled to room temperature, with water saturated equal-volume sec-butyl alcohol extraction 4 times, merge sec-butyl alcohol, wash 2 times, discard water liquid with the water collection of 1/4 amount, the reclaim under reduced pressure sec-butyl alcohol, be concentrated into relative density 1.05～1.10 (60 ℃ of mensuration), add ethanol, make concentration of alcohol reach 40%, cold preservation is spent the night, filter, filtrate is concentrated into the clear paste that every 1ml is equivalent to medical material 5g approximately, promptly gets ginsenoside extract.
C. ginseng polysaccharide's extraction: the medicinal residues behind the ethanol extraction, decoct 3 times with 10 times of water gagings, each 1.0 hours, merge decoction liquor, filter, filtrate is concentrated into relative density 1.10～1.20 (60 ℃ of mensuration), adds ethanol, makes ethanol content reach 80%, left standstill 12 hours, the leaching precipitation, dry under 70～80 ℃, promptly get the Radix Ginseng crude polysaccharides, add 30 times of water boil dissolvings, cold preservation is spent the night, and gets supernatant concentration to relative density about 1.20 (60 ℃ of mensuration), adds the 300g polyamide and mixes thoroughly, dry, be loaded in the chromatographic column (post footpath and post height ratio 1: 8～10), water 4500ml collects eluent with per minute 20ml speed eluting, be concentrated into relative density about 1.20 (60 ℃ of mensuration), add ethanol and make ethanol content reach 80%, stir evenly, left standstill 12 hours, the leaching precipitation, precipitation absolute ethanol washing 2～3 times, dry under 70～80 ℃, promptly get the ginseng polysaccharide.
Embodiment A low capacity Radix Ginseng cold limbs injection
By decoction for Resuscitation (Radix Aconiti Lateralis Preparata or Radix Aconiti Lateralis Preparata 3～9g, Rhizoma Zingiberis 2～6g, Radix Glycyrrhizae Preparata or Radix Glycyrrhizae 3～9g) extracts, Radix Ginseng 1.5～4.5g extract (contains ginsenoside 1.8～5.4mg in the Radix Ginseng Rubra, the ginseng polysaccharide 37.5～112.5mg), and water for injection adds to 5～20ml and forms.
Example 1 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 3g, Rhizoma Zingiberis 2g, Radix Glycyrrhizae Preparata 3g) extract, Radix Ginseng Rubra 1.5g extract (ginsenoside 1.8g, ginseng polysaccharide 37.5mg), and water for injection 5ml forms.
Example 2 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 6g, Rhizoma Zingiberis 4g, Radix Glycyrrhizae Preparata 6g) extract, and Radix Ginseng 1.5g extract (ginsenoside 3.6mg, ginseng polysaccharide 75mg) adds injection water 5ml and forms.
Example 3 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 9g, Rhizoma Zingiberis 6g, Radix Glycyrrhizae Preparata 9g) extract, Radix Ginseng 4.5g extract (ginsenoside 5.4mg, ginseng polysaccharide 112.5mg), and water for injection 5ml forms.
Example 4 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 3g, Rhizoma Zingiberis 2g, Radix Glycyrrhizae Preparata 3g) extract, Radix Ginseng Rubra 1.5g extract (ginsenoside 1.8mg, ginseng polysaccharide 37.5mg), and water for injection 5ml forms.
Example 5 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 3g, Rhizoma Zingiberis 2g, Radix Glycyrrhizae Preparata 3g) extract, Radix Ginseng 1.5g extract (ginsenoside 1.8mg, ginseng polysaccharide 37.5mg), and water for injection 5ml forms.
Example 6 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 9g, Rhizoma Zingiberis 6g, Radix Glycyrrhizae Preparata 9g) extract, Radix Ginseng Rubra 4.5g extract (ginsenoside 5.4g, ginseng polysaccharide 112.5mg), and water for injection 10ml forms.
Example 7 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 9g, Rhizoma Zingiberis 6g, Radix Glycyrrhizae Preparata 9g) extract, Radix Ginseng Rubra 4.5g extract (ginsenoside 5.4g, ginseng polysaccharide 112.5mg), and water for injection 20ml forms.
Prepare low capacity Radix Ginseng cold limbs injection as follows:
Get decoction for Resuscitation (Radix Aconiti Lateralis Preparata 3g, Rhizoma Zingiberis 2g, the Radix Glycyrrhizae Preparata 3g) extracting solution of recipe quantity, (Radix Ginseng Rubra 1.5g) mixes with ginsenoside's extracting solution, filter clear and bright, standby, get recipe quantity glycyrrhizic acid, enoxolone extract, the water for injection that adds recipe quantity 15% stirs evenly, and regulates about pH8 heating for dissolving with 10% ammonia, add decoction for Resuscitation, ginsenoside's extracting solution mixing for standby use liquid, regulate about pH6.5, the about 10min of heated and boiled is when treating that temperature is reduced to 70～80 ℃, adding 2% (W/V) active carbon stirs evenly, adsorb about 10min, during stir 2～3 times, filter clear and bright standby; Get the ginseng polysaccharide of recipe quantity, water for injection with recipe quantity 60% boils dissolving, filter clear and bright, filtrate adds 0.3% (W/V) active carbon and stirs evenly, adsorb about 15min, stir during this time 2～3 times, filtering decarbonization, clear and bright after, add the decoction for Resuscitation extracting solution, ginsenoside's extracting solution, glycyrrhizic acid, in the mixed liquor of enoxolone extracting solution, add to the full amount of water for injection, regulate about pH to 7.0, through 0.65 μ m, 0.45 μ m, 0.22 μ m fine straining is clear and bright, after the inspection of semifinished product is qualified, embedding is in the bent neck ampoule of 5ml, in 105 ℃ of sterilization 30min, through leak detection, lamp inspection, lettering, packing, product inspection promptly.
Embodiment B high capacity Radix Ginseng cold limbs sodium chloride injection
By decoction for Resuscitation (Radix Aconiti Lateralis Preparata or Radix Aconiti Lateralis Preparata 3～9g, Rhizoma Zingiberis 2～6g, Radix Glycyrrhizae Preparata or Radix Glycyrrhizae 3～9g) extracts, Radix Ginseng Rubra or Radix Ginseng 1.5～4.5g extract (contain ginsenoside 1.8～5.4mg, ginseng polysaccharide 37.5～112.5mg), the sodium chloride of total composition 0.9%, water for injection add to 50～200ml and form.
Example 1 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 3g, Rhizoma Zingiberis 2g, Radix Glycyrrhizae Preparata 3g) extract, and Radix Ginseng Rubra 1.5g extract (containing ginsenoside 1.8mg, ginseng polysaccharide 37.5mg), sodium chloride 0.45g, water for injection add to 50ml and form.
Example 2 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 6g, Rhizoma Zingiberis 4g, Radix Glycyrrhizae Preparata 6g) extract, Radix Ginseng Rubra 3g extract (containing ginsenoside 3.6mg, ginseng polysaccharide 75mg), and sodium chloride 0.9g, water for injection add to 100ml and form.
Example 3 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 9g, Rhizoma Zingiberis 6g, Radix Glycyrrhizae Preparata 9g) extract, Radix Ginseng Rubra 4.5g extract (containing ginsenoside 5.4mg, ginseng polysaccharide 112.5mg), and sodium chloride 1.8g, water for injection add to 200ml and form.
Example 4 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 3g, Rhizoma Zingiberis 2g, Radix Glycyrrhizae Preparata 3g) extract, Radix Ginseng 1.5g extract (containing ginsenoside 1.8mg, ginseng polysaccharide 37.5mg), and sodium chloride 0.9g, water for injection add to 100ml and form.
Example 5 is by decoction for Resuscitation (giving birth to Radix Aconiti Lateralis Preparata 3g, Rhizoma Zingiberis 2g, Radix Glycyrrhizae Preparata 3g) extract, Radix Ginseng Rubra 1.5g extract (containing ginsenoside 1.8mg, ginseng polysaccharide 37.5mg), and sodium chloride 0.9g, water for injection add to 100ml and form.
Example 6 is by decoction for Resuscitation (white along sheet 3g, Rhizoma Zingiberis 2g, Radix Glycyrrhizae 3g) extract, Radix Ginseng 1.5g extract (containing ginsenoside 1.8mg, ginseng polysaccharide 37.5mg), and sodium chloride 0.9g, water for injection add to 100ml and form.
Prepare high capacity Radix Ginseng cold limbs sodium chloride injection as follows:
Get recipe quantity decoction for Resuscitation extracting solution and ginsenoside's extracting solution mixing for standby use liquid, add recipe quantity glycyrrhizic acid, enoxolone extract reserve liquid, add recipe quantity ginseng polysaccharide extract reserve liquid again, make mixing for standby use liquid, add sodium chloride 0.9%, add to the full amount of water for injection, stir evenly, regulate pH value about 5.5, clear and bright with 0.65 μ m, 0.45 μ m and the compound mocromembrane filter of 0.22 μ m fine straining, after the inspection of semifinished product was qualified, embedding was in 50～200ml transfusion glass bottle, 105 ℃ of sterilization 30min, through cooling, lamp inspection, decals, product inspection, packing promptly.
Embodiment C high capacity Radix Ginseng cold limbs glucose injection
(Radix Aconiti Lateralis Preparata or Radix Aconiti Lateralis Preparata 3～9g, Rhizoma Zingiberis 2～6g, Radix Glycyrrhizae Preparata or Radix Glycyrrhizae 3～9g) extracts, Radix Ginseng Rubra or Radix Ginseng 1.5～4.5g extract (contain ginsenoside 1.8～5.4mg by decoction for Resuscitation, the glucose of ginseng polysaccharide's 37.5～112.5mg) total composition 5%, water for injection add to 50～200ml and form.
Example 1 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 3g, Rhizoma Zingiberis 2g, Radix Glycyrrhizae Preparata 3g) extract, and Radix Ginseng Rubra 1.5g extract (containing ginsenoside 1.8mg, ginseng polysaccharide 37.5mg), glucose 2.5g, water for injection add to 50ml and form.
Example 2 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 6g, Rhizoma Zingiberis 4g, Radix Glycyrrhizae Preparata 6g) extract, and Radix Ginseng Rubra 3g extract (containing ginsenoside 3.6mg, ginseng polysaccharide 75mg), glucose 5g, water for injection add to 100ml and form.
Example 3 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 9g, Rhizoma Zingiberis 6g, Radix Glycyrrhizae Preparata 9g) extract, and Radix Ginseng Rubra 4.5g extract (containing ginsenoside 5.4mg, ginseng polysaccharide 112.5mg), glucose 10g, water for injection add to 200ml and form.
Example 4 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 3g, Rhizoma Zingiberis 2g, Radix Glycyrrhizae 3g) extract, and Radix Ginseng 1.5g extract (containing ginsenoside 1.8mg, ginseng polysaccharide 37.5mg), glucose 5g, water for injection add to 100ml and form.
Example 5 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 3g, Rhizoma Zingiberis 2g, Radix Glycyrrhizae Preparata 3g) extract, and Radix Ginseng Rubra 1.5g extract (containing ginsenoside 1.8mg, ginseng polysaccharide 37.5mg), glucose 5g, water for injection add to 100ml and form.
Example 6 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 9g, Rhizoma Zingiberis 6g, Radix Glycyrrhizae 9g) extract, and Radix Ginseng 4.5g extract (containing ginsenoside 5.4mg, ginseng polysaccharide 112.5mg), glucose 10g, water for injection add to 200ml and form.
Make high capacity Radix Ginseng cold limbs glucose injection as follows:
Get recipe quantity decoction for Resuscitation extract and ginsenoside extract mixing for standby use liquid, add recipe quantity glycyrrhizic acid, enoxolone extract reserve liquid, add recipe quantity ginseng polysaccharide extract reserve liquid again, make mixing for standby use liquid, add 5% glucose, add to the full amount of water for injection, stir evenly, regulate pH value about 5.0, clear and bright with 0.65 μ m, 0.45 μ m, the compound mocromembrane filter of 0.22 μ m fine straining, after the inspection of semifinished product is qualified, embedding is in 50～200ml transfusion glass bottle, 105 ℃ of sterilization 30min, through cooling, lamp inspection, decals, product inspection, packing promptly.
Embodiment D injection Radix Ginseng cold limbs lyophilized injectable powder
By decoction for Resuscitation (Radix Aconiti Lateralis Preparata or Radix Aconiti Lateralis Preparata 1.5～4.5g, Rhizoma Zingiberis 1～3g, Radix Glycyrrhizae Preparata or Radix Glycyrrhizae 1.5～4.5g) extracts, Radix Ginseng Rubra or Radix Ginseng 1～3g extract (contain ginsenoside 1.2～3.6mg, ginseng polysaccharide 25～75mg), mannitol or sorbitol or xylitol 100～300mg, add injection water 2～4ml, 0.25～0.5g lyophilized injectable powder is made in lyophilization.
Example 1 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 1.5g, Rhizoma Zingiberis 1g, Radix Glycyrrhizae Preparata 1.5g) extract, and Radix Ginseng Rubra 1g extract (containing ginsenoside 1.2mg, ginseng polysaccharide 25mg), mannitol 100mg add injection water 2ml, and the 0.25g lyophilized injectable powder is made in lyophilization.
Example 2 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 3g, Rhizoma Zingiberis 2g, Radix Glycyrrhizae Preparata 3g) extract, and Radix Ginseng Rubra 1.5g extract (containing ginsenoside 1.8mg, ginseng polysaccharide 37.5mg), mannitol 200mg add injection water 3ml, and the 0.4g lyophilized injectable powder is made in lyophilization.
Example 3 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 4.5g, Rhizoma Zingiberis 3g, Radix Glycyrrhizae Preparata 4.5g) extract, and Radix Ginseng Rubra 3g extract (containing ginsenoside 3.6mg, ginseng polysaccharide 75mg), mannitol 300mg add injection water 4ml, and the 0.5g lyophilized injectable powder is made in lyophilization.
Example 4 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 1.5g, Rhizoma Zingiberis 1g, Radix Glycyrrhizae 1.5g) extract, and Radix Ginseng 1g extract (containing ginsenoside 1.2mg, ginseng polysaccharide 25mg), sorbitol 100mg add injection water 2ml, and the 0.25g lyophilized injectable powder is made in lyophilization.
Example 5 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 3g, Rhizoma Zingiberis 2g, Radix Glycyrrhizae Preparata 3g) extract, and Radix Ginseng 2g extract (containing ginsenoside 2.4mg, ginseng polysaccharide 50mg), xylitol 100mg add injection water 2ml, and the 0.4g lyophilized injectable powder is made in lyophilization.
Example 6 is by decoction for Resuscitation (Radix Aconiti Lateralis Preparata 3g, Rhizoma Zingiberis 2g, Radix Glycyrrhizae 3g) extract, and Radix Ginseng 1.5g extract (containing ginsenoside 1.8mg, ginseng polysaccharide 37.5mg), mannitol 100mg add injection water 2ml, and the 0.3g lyophilized injectable powder is made in lyophilization.
Prepare injection Radix Ginseng cold limbs lyophilized injectable powder as follows:
Get the recipe quantity decoction for Resuscitation and extract object space ginsenoside extract mixing for standby use liquid, add the recipe quantity glycyrrhizic acid, enoxolone extract reserve liquid, add recipe quantity ginseng polysaccharide extract reserve liquid again, make mixing for standby use liquid, after the mannitol stirring and dissolving of adding recipe quantity, add to the full amount of water for injection, stir evenly, regulate pH value about 6.5, with 0.65 μ m, 0.45 μ m and the compound mocromembrane filter of 0.22 μ m fine straining are clear and bright, are sub-packed under the aseptic condition in sterilized 7～10ml cillin bottle, at-40～-55 ℃ of following pre-freeze 2～3h, the lyophilization of starting shooting again, before evacuation, coagulator is cooled to-50～-60 ℃ earlier, in the phase I, vacuum maintains about the 0.1mmHg post, sublimation temperature-20～-30 ℃, dry 6～8h, when treating that crystal exists in the goods (having removed 90% above moisture content), enter the second stage drying, this moment, the temperature with shelf in the drying baker rose to about 30 ℃, and kept constant, continue about dry 5h, taking-up is sealed, and decals is through product inspection, and packing promptly.
Claims (10)
1, a kind of Radix Ginseng cold limbs injection composition, it is characterized in that: with decoction for Resuscitation is that Radix Ginseng cold limbs injection is made in extract, Radix Ginseng Rubra or Radix Ginseng extract, pharmaceutic adjuvant, the water for injection combination of Radix Aconiti Lateralis Preparata, Rhizoma Zingiberis, Radix Glycyrrhizae Preparata, the decoction for Resuscitation extract mainly contains aconitum carmichaeli debx. Total alkaloids, gingerol, glycyrrhizic acid, enoxolone, and Radix Ginseng Rubra or Radix Ginseng extract mainly contain ginsenoside and ginseng polysaccharide.
2, according to the described Radix Ginseng cold limbs of claim 1 injection composition, it is characterized in that: contain decoction for Resuscitation (Radix Aconiti Lateralis Preparata or Radix Aconiti Lateralis Preparata 3～9g, Rhizoma Zingiberis 2～6g, Radix Glycyrrhizae Preparata or Radix Glycyrrhizae 3～9g) extracts, Radix Ginseng Rubra or Radix Ginseng 1.5～4.5g extract (contain that ginsenoside 1.8mg～5.4mg, ginseng polysaccharide 37.5mg～112.5mg), water for injection adds to 5ml～20ml and makes Radix Ginseng cold limbs injection with small volume.
3, according to the described Radix Ginseng cold limbs of claim 1 injection composition, it is characterized in that: contain decoction for Resuscitation (Radix Aconiti Lateralis Preparata or Radix Aconiti Lateralis Preparata 3～9g, Rhizoma Zingiberis 2～6g, Radix Glycyrrhizae Preparata or Radix Glycyrrhizae 3～9g) extracts, Radix Ginseng Rubra or Radix Ginseng 1.5～4.5g extract (contain ginsenoside 1.8mg～5.4mg, ginseng polysaccharide 37.5mg～112.5mg), the sodium chloride of injection total amount 0.9%, water for injection add to 5ml～20ml and make high capacity Radix Ginseng cold limbs sodium chloride injection.
4, according to the described Radix Ginseng cold limbs of claim 1 injection composition, it is characterized in that: contain decoction for Resuscitation (Radix Aconiti Lateralis Preparata or Radix Aconiti Lateralis Preparata 3～9g, Rhizoma Zingiberis 2～6g, Radix Glycyrrhizae Preparata or Radix Glycyrrhizae 3～9g) extracts, Radix Ginseng Rubra or Radix Ginseng 1.5～4.5g extract (contain ginsenoside 1.8mg～5.4mg, ginseng polysaccharide 37.5mg～112.5mg), notes thank to the glucose of liquid total amount 5%, water for injection adds to 50ml～200ml, makes high capacity Radix Ginseng cold limbs glucose injection.
5, according to the described Radix Ginseng cold limbs of claim 1 injection composition, it is characterized in that: contain decoction for Resuscitation (Radix Aconiti Lateralis Preparata or Radix Aconiti Lateralis Preparata 1.5～4.5g, Rhizoma Zingiberis 1～3g, Radix Glycyrrhizae Preparata or Radix Glycyrrhizae 1.5～4.5g) extracts, Radix Ginseng Rubra or Radix Ginseng 1～3g extract (contain ginsenoside 1.2mg～3.6mg, ginseng polysaccharide 25mg～75mg), mannitol (sorbitol or xylitol) 100～300mg, add injection water 2ml～4ml, 0.2～0.4g injection Radix Ginseng cold limbs lyophilized injectable powder is made in lyophilization.
6, according to the extraction process of described decoction for Resuscitation of claim 1 and Radix Ginseng Rubra extract, the decoction for Resuscitation extraction process is characterized in that: Radix Aconiti Lateralis Preparata, Rhizoma Zingiberis, the Radix Glycyrrhizae Preparata of getting recipe quantity add water and decoct successively, merging decoction liquor filters concentrated, with different content ethanol precipitation, filtration, concentrated, get the cold limbs extracting solution successively; Filtering residue adds water successively, adds sulfuric acid precipitation again, and acetone extract gets glycyrrhizic acid and enoxolone; The Radix Ginseng Rubra extraction process is characterized in that: the Radix Ginseng Rubra medical material is successively through alcohol reflux, extracted with diethyl ether, sec-butyl alcohol or n-butanol extraction, the ethanol precipitation purification, filter the ginsenoside, the Radix Ginseng Rubra medicinal residues are through water extract-alcohol precipitation, polyamide absorption and the separation and purification of chromatography eluting, the eluent precipitate with ethanol gets the ginseng polysaccharide.
7, according to claim 1,2 described preparation low capacity Radix Ginseng cold limbs injection, it is characterized in that: get recipe quantity cold limbs extracting solution and ginsenoside's extracting solution is made mixing for standby use liquid, add glycyrrhizic acid, the enoxolone extract reserve liquid of recipe quantity, add recipe quantity ginseng polysaccharide extract reserve liquid again, add to the full amount of water for injection, regulate pH, fine straining is clear and bright, after the inspection of semifinished product is qualified, embedding is in the bent neck ampoule of 5～20ml, sterilization, leak detection, lamp inspection, lettering, product inspection, packing is promptly.
8, according to claim 1,3 described preparation high capacity Radix Ginseng cold limbs sodium chloride injections, it is characterized in that: get recipe quantity cold limbs extracting solution and ginsenoside's extracting solution is made mixing for standby use liquid, the glycyrrhizic acid, the enoxolone extract reserve liquid that add recipe quantity, add recipe quantity ginseng polysaccharide extract reserve liquid again, add sodium chloride 0.9%, add to the full amount of water for injection, regulate pH, fine straining is clear and bright, after the inspection of semifinished product is qualified, embedding in 50～200ml infusion bottle, sterilization, lamp inspection, decals, product inspection, the packing promptly.
9, according to claim 1,4 described preparation high capacity Radix Ginseng cold limbs glucose injections, it is characterized in that: get recipe quantity cold limbs extracting solution and ginsenoside's extracting solution is made mixing for standby use liquid, the glycyrrhizic acid, the enoxolone extract reserve liquid that add recipe quantity, add recipe quantity ginseng polysaccharide extract reserve liquid again, add glucose 5%, add to the full amount of water for injection, regulate pH, fine straining is clear and bright, after the inspection of semifinished product is qualified, embedding is in 50～200ml infusion bottle, and sterilization, lamp inspection, decals, product inspection, packing are promptly.
10, according to claim 1,5 described preparation injection Radix Ginseng cold limbs lyophilized injectable powders, it is characterized in that: get recipe quantity cold limbs extracting solution and ginsenoside's extracting solution is made mixing for standby use liquid, the glycyrrhizic acid, the enoxolone extract reserve liquid that add recipe quantity, add recipe quantity ginseng polysaccharide extract reserve liquid again, the mannitol that adds recipe quantity, filling thanks to water to full dose, regulate pH, pack under the aseptic condition and sterilize in 7～10ml cillin bottle, pre-freeze, lyophilization successively, make 0.2～0.4g lyophilized injectable powder, seal, decals, product inspection, packing promptly.
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|---|---|---|---|
| CN200410040711A CN100574799C (en) | 2004-09-20 | 2004-09-20 | Radix Ginseng cold limbs injection and preparation method |
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| CN200410040711A CN100574799C (en) | 2004-09-20 | 2004-09-20 | Radix Ginseng cold limbs injection and preparation method |
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| CN1615956A true CN1615956A (en) | 2005-05-18 |
| CN100574799C CN100574799C (en) | 2009-12-30 |
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| CN (1) | CN100574799C (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2010133016A1 (en) * | 2009-05-21 | 2010-11-25 | Zhang Zuoguang | Pharmaceutical composition for treating depression, preparation method and use therefor |
| CN102205013A (en) * | 2011-05-26 | 2011-10-05 | 南京中医药大学 | Method for processing giant typhonium rhizome |
| CN103272012A (en) * | 2012-06-15 | 2013-09-04 | 成都中医药大学 | Aconite and licorice extractive as well as preparation method and application thereof |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102552861A (en) * | 2012-02-27 | 2012-07-11 | 吉林省中医药科学院 | Ginseng Sini granules and preparing method thereof |
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2004
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2010133016A1 (en) * | 2009-05-21 | 2010-11-25 | Zhang Zuoguang | Pharmaceutical composition for treating depression, preparation method and use therefor |
| CN102205013A (en) * | 2011-05-26 | 2011-10-05 | 南京中医药大学 | Method for processing giant typhonium rhizome |
| CN103272012A (en) * | 2012-06-15 | 2013-09-04 | 成都中医药大学 | Aconite and licorice extractive as well as preparation method and application thereof |
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| Publication number | Publication date |
|---|---|
| CN100574799C (en) | 2009-12-30 |
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