CN101670027A - Compound fleece-flower root oral liquid, preparation method thereof and quality control method - Google Patents
Compound fleece-flower root oral liquid, preparation method thereof and quality control method Download PDFInfo
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Abstract
The invention relates to Chinese herbal preparation, in particular to compound fleece-flower root oral liquid with the functions of nourishing the liver and kidney, invigorating the brain and promoting mentality, a preparation method and a quality control method. 1000 ml of Chinese herbal preparation is prepared by 266.7g of the tuber of multiflower knotweed, 200g of the fruit of Chinese wolfberry, 166.7g of polygala root, 133.3 of glassleaved sweetflag rhizome, 133.3g of mulberry, 66.7g of ginseng, 33.3 of Chinese data, 360ml of simple syrup and 2.7g of sodium benzoate. The clinical observation of 235 patients shows that the Chinese herbal preparation can obviously improve symptoms such as dementia, mentality weakness, deficiency of liver-yin and kidney-yin of hypomnesis patients, heart qi insufficient and the like, can increase mentality, improves dementia, has benign regulative action on blood pressure, probably has the functions of lipid lowering and non-specific humoral immune function regulation, has no bad effects on liver and kidney blood systems, has no side effect, has 62.55% of obvious effect rate, 96.17% of total effective rate, can increase the mentality by taking forlong time, defers senility and builds up the health of people.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation, promptly have nourishing the liver and kidney, the compound fleece-flower root oral liquid of brain tonic and intelligence development functions and preparation method and method of quality control.
Background technology
In the prior art, progress along with science, people are urgent further to the requirement that increases intelligence, hypomnesis after being ill, senile hypomnesis, children mental retardation and the primary and secondary students of multiple disease (cerebral arteriosclerosis cerebral embolism, hypertension, diseases such as senile dementia) are at the product of seeking to increase intelligence, improvement memory, alleviate mental fatigue.Yet present domestic external enwergy increases IQ product reliable for effect and still lacks.
Summary of the invention
The objective of the invention is provides a kind of at the hypophrenia, dull-witted medicable compound fleece-flower root oral liquid and preparation method and method of quality control at above-mentioned situation.
Technical solution of the present invention is: compound fleece-flower root oral liquid comprises that following weight crude drug makes: Radix Polygoni Multiflori (system) 266.7g, Fructus Lycii 200g, Radix Polygalae 166.7g, Rhizoma Acori Graminei 133.3g, Fructus Mori 133.3g, Radix Ginseng 66.7g, Fructus Jujubae 33.3g, simple syrup 360ml, sodium benzoate 2.7g makes 1000ml.
Motherland's medical science has its unique classified description to people's spiritual thinking activities.In close relations with intelligence, main have the inclination, liver, kidney etc. are dirty.We's principal agent selects for use Radix Polygoni Multiflori bitter sweet and puckery, and is warm and not dry.Change the astringent or styptic treatment for spontaneous sweating vital essence of cloudy hemopoietic, kind invigorating the liver and kidney, muscle reinforcing and bone strengthening, black beard and hair is to the good medicine that is enriching blood and replenishing vital essence." Radix Polygoni Multiflori record " has the record of " long muscle benefit is smart, can eat, and physical strength profiting, long skin is prolonged life ".Structure Fructus Lycii sweet in the mouth, gas is flat, and quality is moistened, energy tonifying liver blood, the kidney tonifying essence, supporting YANG QI, strengthening bone and muscle is to nourish blood to mend the good merchantable brand of essence." Bencao Jingshu " said: " Fructus Lycii moistens and nourishes, double can bringing down a fever, and specially in the kidney invigorating, lung moistening is promoted the production of body fluid, QI invigorating.Be the Liver and kidney kidney-YIN being deficient, tired interior-heat, the key medicine of tonification.Two medicines are listed as monarch drug, and the special liver and kidney tonifying of merit adds and fills brain with the brain-strengthening house of mental activity.Minister is slightly cold with the sweet acid of Fructus Mori, and refrigerant profit is fallen, energy kidney nourishing water, tonifying liver blood, born fluid, profit cardiopulmonary, black beard and hair." Bencao Jingshu " said: " Fructus Mori, sweet cold beneficial blood and heat extraction is removing heat from blood are enriched blood the medicine of tonifying YIN.So soul peace and refreshing from clear peaceful is sent out in gods are then clever " record.Radix Polygalae temperature bitter in the mouth, kind restoring normal coordination between the heart and kidney makes regulation between water and fire, can the beneficial motive, tranquilizing mind, the spasmolytic wisdom of throbbing with fear out." herbal classic " says " control the cough with dyspnea damaging the spleen and stomach, tonifying for the deficiency removes pathogen, sharp nine orifices, Fructus Alpiniae Oxyphyllae is intelligent, normal hearing and eyesight is not forgotten ".The hot temperature of Rhizoma Acori Graminei, key leads to the mind, eliminating phlegm saliva, Li Qingyang happily." not Lu " be said: " audition improvement order, beneficial intelligence ", the auxiliary monarch drug conscience kidney of three ministerial drugs is taken into account, and can strengthen the merit of holding up empty benefit damages, and assistant is with the Radix Ginseng strongly invigorating primordial QI, and special strengthening spleen and lung is apt to shake the spleen sun, Zi Huayuan, lung benefiting gas fills hundred arteries and veins, promoting the production of body fluid to quench thirst, the mind calming and mentality promoting." herbal classic " carries: " tonifying five ZANG-organs, peace spirit is decided soul, and spasmolytic is throbbed with fear, and removes pathogen, makes eye bright, happy Fructus Alpiniae Oxyphyllae." must join not only three cloudy and reasons of monarch-minister drug, and strengthening spleen and lung is arranged, taste are strong to be transported then the precise and tiny QI and blood of paddyization and gives birth to; all dirty gas of lung master, the prosperous then surplus dirty shade that is subjected to of lung qi, be benefit the five internal organs biochemistry with the collaborative the monarch and his subjects of Radix Ginseng machine then fountainhead have from; thereby energy is abundant, hypermnesia, intelligence is when can be quick.Make with the Fructus Jujubae contract group spleen QI invigorating of building up one's health by taking tonic not only, nourishing blood to tranquillize the mind, and the energy of tool " with hundred medicines " (" herbal classic ").All medicines share, and play strengthening and nourishing marrow and essence altogether, the effect of nourishing the brain and improving intelligence.
Method for making: above seven flavors, get Rhizoma Acori Graminei, Fructus Mori is extracted volatile oil with steam distillation, the aqueous solution after distillation device is in addition collected; The five tastes such as medicinal residues and all the other Radix Polygoni Multiflori add 8,6,6 times of water gagings and decoct three times, and each 1.5 hours, collecting decoction, filter, filtrate and above-mentioned aqueous solution merge, and are concentrated into 450ml, and adding ethanol to determining alcohol is 60%, stir, left standstill 24 hours, and filtered, being evaporated to relative density is the thick paste of 1.5 (80 ℃), thin up is to 450ml, and relative density is 1.20-1.25 (50 ℃); Put-5 ℃ freezing 24 hours, after room temperature is dissolved, filter, add simple syrup 360ml, sodium benzoate 2.7g and above-mentioned volatile oil add water to 1000ml again, stir, filter, packing, sterilization, promptly.
Above-mentioned preparation is not limited thereto, and can also be mixed and made into tablet, capsule (soft capsule), granule, powder, pill, liquid preparation or other conventional formulation by pharmaceutical carrier, additive or adjuvant commonly used in above-mentioned each medicinal raw material and the pharmacy.
Pharmacological evaluation
1, observes the influence of compound fleece-flower root oral liquid through diving tower method, food maze method and electric maze method to learning and memory.Experimental results show that this product has the effect of the memory acquisition disturbance due to the anti-Anisodine, increases large and small Mus direction identification ability.Illustrate that compound fleece-flower root oral liquid has the effect of the learning and memory of promotion.
2, observed low anti-weary oxygen of compound fleece-flower root oral liquid wrong reaction number of times in diving tower and antifatigue ability through the animal model experiment of suffering from a deficiency of the kidney.The result shows that this product can resist because of the induced mice learning and memory of suffering from a deficiency of the kidney goes down, and strengthens antioxygen, anti-fatigue ability.
3, compound fleece-flower root oral liquid can increase large and small Mus brain DNA, RNA and protein content.Compound fleece-flower root oral liquid increases nucleic acid in intelligence effect and the brain, and protein content is relevant.
4, compound fleece-flower root oral liquid can increase NA and DA content in the rat brain.It is relevant with monoamine transmitters change in the brain to illustrate that compound fleece-flower root oral liquid increases the intelligence effect.
5, compound fleece-flower root oral liquid can reduce LPO content in blood plasma and the liver, increases SOD activity in the erythrocyte, reduces MAO-B content in the cerebral tissue, illustrates that this product has anti-aging effects.
Toxicologic study: l, acute toxicity testing: give the compound fleece-flower root oral liquid of 20 mouse stomach 3.33g/ml, each 0.7ml/ only irritates stomach three times in 24 hours, and integral dose is 874.23 times that 349.66g/kg is equivalent to the clinical application amount.Observed after the administration 7, the mice diet is normal, the hair color light, activity freely, weight increase is breathed steadily, gets other untoward reaction and death.Illustrate that this product toxicity is very little.2, long term toxicity test: compound fleece-flower root oral liquid 40,20 and 10ml/kg give rat oral gavage, and every day 1 time, continuous 90 days, the abnormal change of the weight of animals, hemogram and hepatic and renal function was seen at the end as a result.Pathologic finding and matched group do not have significant difference more yet.Little in conjunction with acute toxicity testing explanation this product toxicity.
Function with cure mainly: nourishing the liver and kidney, nourishing the brain and improving intelligence.Be used for that the heart, liver, deficiency of the kidney yin cause have a dizzy spell, disease such as forgetful insomnia, soreness of the waist and knees, spiritlessness and weakness.
Usage and consumption: oral, a 10ml, every day three times.
Advantage of the present invention is: 1, through clinical to 235 routine clinical observations, this product can not only improve obviously that dementia, intelligence are weak, hypomnesis patient's the hepatic and renal YIN deficiency, symptoms such as deficiency of heart-QI, and can improve intelligence, improve dull-witted, to the good property regulating action of blood pressure possibility, also may have the effect of blood fat reducing, the non-specific humoral immune function of adjusting, Liver and kidney and blood system are had no adverse effects, bed is observed an end and is seen side effect, obvious effective rate 62.55%, total effective rate 96.17%.2, clothes can increase intelligence, slow down aging, health invigorating for a long time.
Below in conjunction with embodiment embodiments of the present invention are described in further detail.
The specific embodiment
Embodiment 1
Compound fleece-flower root oral liquid is made by following weight crude drug: Radix Polygoni Multiflori Preparata 266.7g, and Fructus Lycii 200g, Radix Polygalae 166.7g, Rhizoma Acori Graminei 133.3g, Fructus Mori 133.3g, Radix Ginseng 66.7g, Fructus Jujubae 33.3g, simple syrup 360ml, sodium benzoate 2.7g makes 1000ml.
Embodiment 2
The compound fleece-flower root oral liquid preparation method: above seven flavors, get Rhizoma Acori Graminei, Fructus Mori is extracted volatile oil with steam distillation, the aqueous solution after distillation device is in addition collected; The five tastes such as medicinal residues and all the other Radix Polygoni Multiflori add 8,6,6 times of water gagings and decoct three times, and each 1.5 hours, collecting decoction, filter, filtrate and above-mentioned aqueous solution merge, and are concentrated into 450ml, and adding ethanol to determining alcohol is 60%, stir, left standstill 24 hours, and filtered, being evaporated to relative density is the thick paste of 1.5 (80 ℃), thin up is to 450ml, and relative density is 1.20-1.25 (50 ℃); Put-5 ℃ freezing 24 hours, after room temperature is dissolved, filter, add simple syrup 360ml, sodium benzoate 2.7g and above-mentioned volatile oil add water to 1000ml again, stir, filter, packing, sterilization, promptly.
Experimental example 1
The discrimination method of compound fleece-flower root oral liquid
Comprise following any or several combination in this method:
(1) gets this product 50ml, add diethyl ether and extract 2 times, each 20ml, discard ether solution, with water saturated n-butanol extraction 3 times, each 30ml, merge n-butyl alcohol liquid, be concentrated into about 30ml, use 2% saturated sodium hydroxide solution extraction of n-butyl alcohol 2 times, each 30ml discards alkali liquor, and the water 30ml that the reuse n-butyl alcohol is saturated extracts, discard water layer, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Other gets the ginsenoside Rg
1Reference substance adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw each 6 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with 0.3% sodium carboxymethyl cellulose, (15: 40: 22: 10) lower floor's solution of placing below 10 ℃ was developing solvent, launched, and took out with chloroform-ethyl acetate-methanol-water, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to dry by the fire to the speckle colour developing with 105 ℃, inspects under the daylight; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(2) get this product 50ml, add diethyl ether and extract 2 times, each 20ml, discard ether solution, with water saturated n-butanol extraction 3 times, each 30ml, merge n-butyl alcohol liquid, be concentrated into about 30ml, the ammonia solution saturated with n-butyl alcohol extracts 2 times, each 30ml, discard alkali liquor, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Other gets Radix Polygalae control medicinal material 5g, decocts with water 2 hours, puts coldly, filters, and filtrate is concentrated into about 15ml, with water saturation n-butanol extraction 2 times, and each 15ml, merging n-butyl alcohol liquid, evaporate to dryness, residue add methanol 1ml makes dissolving, in contrast medical material solution; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw each 6 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with 0.3% sodium carboxymethyl cellulose, with benzene-ethyl acetate-formic acid (13: 4: 0.5) is developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
(3) get this product 50ml, add hydrochloric acid 1ml, reflux, extract, 1 hour, ether extraction 2 times are used in cooling immediately, each 50ml, merge extractive liquid,, evaporate to dryness, residue add chloroform 2ml makes dissolving, as supplying the brilliant solution of examination; Other gets the emodin reference substance, and chlorination is copied into the solution that every 1ml contains 1mg, in contrast product solution; Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005), draw each 5 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with 0.3% sodium carboxymethyl cellulose, upper solution with petroleum ether (60-90 ℃)-ethyl acetate-formic acid (13: 5: 1) is developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical orange-yellow fluorescence speckle; Put in the ammonia smoked after, inspect under the daylight, speckle becomes redness.
Experimental example 2
The content assaying method of compound fleece-flower root oral liquid
Measure according to high performance liquid chromatography (appendix VID of Chinese Pharmacopoeia version in 2005);
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Acetonitrile-water (25: 75) is a mobile phase; The detection wavelength is 320nm; Number of theoretical plate is by 2,3,5, and 4 '-tetrahydroxystilbene-2-O-β-D-glucoside peak calculates should be not less than 2000.
The preparation of contrast solution: precision takes by weighing 2,3,5, and 4 '-tetrahydroxystilbene-2-O-β-D-glucoside reference substance is an amount of, adds Diluted Alcohol and makes the solution that every 1ml contains 0.1mg, promptly.
The preparation of need testing solution: precision is measured this product 1ml, puts D
101On the macroporous adsorptive resins (the about 1.5cm of internal diameter, packed height 10cm), with the flow velocity eluting of per minute 2.0ml, discard water elution liquid, use the Diluted Alcohol eluting, discard Diluted Alcohol eluent 7-9ml, collect eluent 100ml, evaporate to dryness, residue adds the Diluted Alcohol dissolving, puts in the 10ml measuring bottle, adds Diluted Alcohol and is diluted to scale, shake up, promptly.
Accurate respectively reference substance solution and each the 5 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
The every 10ml of this product contains 2,3,5,4 '-tetrahydroxystilbene-2-O-β-D-glucoside (C
20H
22O
9) meter, must not be less than 6.0mg.
Experimental example 3
The compound fleece-flower root oral liquid clinical report
Compound fleece-flower root oral liquid increases the clinical observation of intelligence health-care effect and sums up--the Jilin Prov. Inst. of Chinese Medicine and Chinese Medical Science
Increase the intelligence health-care effect for what observe the checking compound fleece-flower root oral liquid, to 235 routine Chinese medical discriminations is that the patient that mentally handicapped, memory in various degree obviously goes down that has of the hepatic and renal YIN deficiency, deficiency of heart-QI or double turbid phlegm blocking the clear orifices carries out clinical observation, obtain curative effect preferably, now be reported as follows:
1, clinical data
This organizes 235 examples, male's 1 56 examples wherein, women's 79 examples: age: 40 years old 15 example, 40-49 year 19 examples, 50-59 year 45 examples, 156 examples more than 60 years old; The course of disease: 1 year 40 example, 1-3 109 examples, 4-5 37 examples, 6 years 49 examples.
2 observational techniques
(1) diagnosis and efficacy assessment standard
Diagnosis with efficacy assessment standard all according to the suffering from a deficiency of the kidney of national combination of Chinese and Western medicine senile disease and deficiency syndrome Professional Committee " the dialectical reference standard of Chinese medicine deficiency-syndrome ", deficiency of the liver, have a guilty conscience, yin deficiency syndrome, judge with reference to " diagnosis of Research of Senile Dementia Treated, differentiation of symptoms and signs for classification of syndrome and efficacy assessment standard ".Symptom is by light :+, in: ++, heavy: +++fill in a form.
Efficacy assessment standard:
Produce effects: cardinal symptom is recovered substantially, and is conscious, directed sound, and it is correct to answer a question, and is quick on the draw, and takes care of oneself, and can carry out general social activity.Primary symptom disappear (heavy +++→ light+or heavy +++, in ++, light+→-) 3 produce effects+2 improvements of cardinal symptom, 4 produce effects+1 are invalid, 2 produce effects+3 improvements.
Effectively: main mental symptom weakens to some extent, or part disappears, life is taken care of oneself substantially, and answering a question is in the main true, but bradykinesia, intelligence and personality still have partial impairment.Primary symptom alleviate (+++→ ++, ++ →+) 10 improvements of 1 produce effects of cardinal symptom, take a turn for the better more than 3.
Invalid: cardinal symptom does not have change, or the state of an illness has development, can't take care of oneself, and it is incorrect to answer a question, mental dementia.
(2) case is selected: all Chinese medical discriminations that meets are deficiency of yang of liver and kidney, deficiency of heart-QI or double turbid phlegm blocking the clear orifices [comprise that Western medicine diagnose is alzheimer disease, cerebrovascular, hide from slow-witted (multiple infarction dementia and cerebral hemorrhage, brain. dull-witted behind thrombosis, the cerebral embolism)] and Combination dementia, lobar atrophy, barotropy hydrocephalus, the auspicious angiopathy of brain starch, the intelligence that autonomic nervous dysfunction causes subtracts inferior outpatient service and inpatient; There is not other serious diseases observer that affects the treatment; All can be used as the object of observation.
(3) observe medicine: compound fleece-flower root oral liquid is provided by Tonghua Baishan Pharmaceutical Ltd, usage: each oral 10ml.Every day 3 times, 30 days was 1 course of treatment.With the relevant strengthening by means of tonics medicine of stopping using in first three week of this medicine, with other relevant medicines of forbidding during this medicine.
(4) statistical method: adopt paired t-test and rank test to carry out statistical analysis.
3, observed result
(1) compound fleece-flower root oral liquid is to the improvement of symptom
Table 1 compound fleece-flower root oral liquid is to the improvement of symptom
| Insomnia forgetfulness | Dysnoesia | Have a dizzy spell | |
| ??+++?++?+- | ??+++?++?+?- | ??+++?++?+?- | |
| Before the medication | ??78?91??59???7 | ??34??75??112??14 | ??59?110?55??11 |
| After the medication | ??2??31??104??98 | ??0???24??79???132 | ??3??20??96??116 |
| The P value | ??＜0.01(u＝13.86) | ??＜0.01(u＝14.64) | ??＜0.01(u＝14.02) |
| Soreness of the waist and knees | Spiritlessness and weakness | Feverish sensation in the palms and soles | Shortness of breath and palpitation |
| ??+++?++?+- | ??+++?++?+- | ??+++?++?+- | ??+++?++?+- |
| ??36?105?73?30 | ??33?93??90??13 | ??26??41??65??101 | ??19?61??75??80 |
| ??1??15??77?102 | ??2??21??77??133 | ??10??20??32??173 | ??0??18??62??155 |
| ??＜0.01(u＝13.01) | ??＜0.01(u＝13.50) | ??＜0.01(u＝7.16) | ??＜0.01(u＝3.34) |
As seen from the above table, compound fleece-flower root oral liquid can obviously improve symptoms such as the hepatic and renal YIN deficiency, deficiency of heart-QI.
(2) compound fleece-flower root oral liquid is to the influence of intelligence
Table 2 compound fleece-flower root oral liquid is to the X that influences of intelligence
-± S branch
Improve dull-witted the improvement by intelligence after the visible medication of table 2.Illustrating that compound fleece-flower root oral liquid has increases the intelligence effect preferably.
(3) compound fleece-flower root oral liquid is to hemoglobin, leukocytic influence
Table 3 compound fleece-flower root oral liquid is to hemoglobin, the leukocytic X that influences
-± S
| ??n | Hemoglobin (g/L) | Leukocyte count (* 10 9/L) |
| Medication preceding 230 | ??126.81±17.59 | ??8.02±2.91 |
| After the medication 230 | ??129.24±16.08 | ??7.63±1.85 |
| The P value | ??＜0.05(t＝2.54) | ??＜0.05(t＝2.49) |
Increased by hemoglobin after the visible medication of table 3, leukocyte descends to some extent. but all in fluctuation normal range, so can think blood system is had no adverse effects.
(4) compound fleece-flower root oral liquid is to the influence of blood pressure
Table 4 compound fleece-flower root oral liquid influences X ± S Kpa to blood pressure
| ??n | Systolic pressure | Diastolic pressure |
| Medication preceding 230 | ??18.98±3.36 | ??11.86±1.70 |
| After the medication 230 | ??18.17±3.07 | ??11.52±1.37 |
| The P value | ??＜0.01(t＝8.03) | ??＜0.01(t＝15.33) |
Be pressed with institute by the visible medication bleeding from anus of table 4 and descend, but fluctuate, point out this product depletion of blood voltage rise high side effect, may certain optimum regulating action or certain hypotensive effect be arranged blood pressure in normal range.
(5) compound fleece-flower root oral liquid is to the influence of blood fat
Table 5 compound fleece-flower root oral liquid influences X+S mmol/L to blood fat
| ??n | Cholesterol | Triglyceride |
| Medication preceding 58 | ??4.69±1.14 | ??1.05±0.81 |
| After the medication 58 | ??3.89±1.01 | ??0.73±0.44 |
| The P value | ??＜0.01(t＝5.93) | ??＜0.01(t＝3.31) |
As seen descended to some extent with cholesterolemia, triglyceride behind the Qi Zhiling by table 5, prompting this product has certain effect for reducing fat.
(6) compound fleece-flower root oral liquid is to the influence of immunoglobulin
Table 6 compound fleece-flower root oral liquid influences X ± S g/L to immunoglobulin
| ??n | ??IgG | ??IgA | ??IgM |
| Medication preceding 82 | ??11.30±2.38 | ??1.37±0.66 | ??1.38±0.43 |
| After the medication 82 | ??11.69±2.27 | ??1.76±0.50 | ??1.46±0.40 |
| The P value | ??＜0.05(t＝1.83) | ??＞0.10(t＝30.70) | ??＞0.10(t＝1.63) |
As seen take behind the compound fleece-flower root oral liquid rabbit epidemic disease globulin by table 6 and increase before than medication, wherein IgG is before medication, so this product has the effect of regulating non-characteristic humoral immune function.
(7) compound fleece-flower root oral liquid is to the influence of routine urinalysis liver function
Through 235 routine clinical observations with routine urinalysis, liver function behind this medicine than medication before no abnormal change, as seen this medicine has no adverse effects to liver, renal function.Do not see other side effect in addition yet.
(8) total effects
Produce effects 147 examples in 235 examples, obvious effective rate 62.55%, effective 79 examples, effective percentage 33.62%, total effective rate 96.17%, invalid 9 examples, inefficiency 3.83%.
4, brief summary
Through us to 235 routine clinical observations, this product can not only improve obviously that dementia, intelligence are weak, hypomnesis patient's the hepatic and renal YIN deficiency, symptoms such as deficiency of heart-QI, and can improve intelligence, improve dull-witted, to the good property regulating action of blood pressure possibility, also may have the effect of blood fat reducing, the non-specific humoral immune function of adjusting, Liver and kidney and blood system are had no adverse effects, bed is observed an end and is seen side effect, obvious effective rate 62.55%, total effective rate 96.17%.This product is taken easy to carry, and the medicine source is rich and easy to get, and is cheap, and the curative effect height can be and increases the intelligence health-care good product, is worthy of popularization.
Claims (5)
1. compound fleece-flower root oral liquid is characterized in that comprising that following weight crude drug makes: Radix Polygoni Multiflori Preparata 266.7g, Fructus Lycii 200g, Radix Polygalae 166.7g, Rhizoma Acori Graminei 133.3g, Fructus Mori 133.3g, Radix Ginseng 66.7g, Fructus Jujubae 33.3g.
2. according to the described compound fleece-flower root oral liquid of claim 1, it is characterized in that comprising simple syrup 360ml, sodium benzoate 2.7g makes 1000ml.
3. the preparation method of a compound fleece-flower root oral liquid as claimed in claim 2 is characterized in that step is as follows: get Rhizoma Acori Graminei, Fructus Mori is extracted volatile oil with steam distillation, the aqueous solution after distillation device is in addition collected; The five tastes such as medicinal residues and all the other Radix Polygoni Multiflori add 8,6,6 times of water gagings and decoct three times, and each 1.5 hours, collecting decoction, filter, filtrate and above-mentioned aqueous solution merge, and are concentrated into 450ml, adding ethanol to determining alcohol is 60%, stirs, and leaves standstill 24 hours, filter, be evaporated to relative density and be 1.5,80 ℃ thick paste, thin up is to 450ml, relative density is 1.20-1.25,50 ℃; Put-5 ℃ freezing 24 hours, after room temperature is dissolved, filter, add simple syrup 360ml, sodium benzoate 2.7g and above-mentioned volatile oil add water to 1000ml again, stir, filter, packing, sterilization, promptly.
4. the discrimination method of compound fleece-flower root oral liquid as claimed in claim 2 is characterized in that comprising in this method following any or several combination:
(1) gets this product 50ml, add diethyl ether and extract 2 times, each 20ml, discard ether solution, with water saturated n-butanol extraction 3 times, each 30ml, merge n-butyl alcohol liquid, be concentrated into about 30ml, use 2% saturated sodium hydroxide solution extraction of n-butyl alcohol 2 times, each 30ml discards alkali liquor, and the water 30ml that the reuse n-butyl alcohol is saturated extracts, discard water layer, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Other gets ginsenoside Rg1's reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw each 6 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with 0.3% sodium carboxymethyl cellulose, (15: 40: 22: 10) lower floor's solution of placing below 10 ℃ was developing solvent, launched, and took out with chloroform-ethyl acetate-methanol-water, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to dry by the fire to the speckle colour developing with 105 ℃, inspects under the daylight; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color;
(2) get this product 50ml, add diethyl ether and extract 2 times, each 20ml, discard ether solution, with water saturated n-butanol extraction 3 times, each 30ml, merge n-butyl alcohol liquid, be concentrated into about 30ml, the ammonia solution saturated with n-butyl alcohol extracts 2 times, each 30ml, discard alkali liquor, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Other gets Radix Polygalae control medicinal material 5g, decocts with water 2 hours, puts coldly, filters, and filtrate is concentrated into about 15ml, with water saturation n-butanol extraction 2 times, and each 15ml, merging n-butyl alcohol liquid, evaporate to dryness, residue add methanol 1ml makes dissolving, in contrast medical material solution; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw each 6 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with 0.3% sodium carboxymethyl cellulose, with benzene-ethyl acetate-formic acid (13: 4: 0.5) is developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color;
(3) get this product 50ml, add hydrochloric acid 1ml, reflux, extract, 1 hour, ether extraction 2 times are used in cooling immediately, each 50ml, merge extractive liquid,, evaporate to dryness, residue add chloroform 2ml makes dissolving, as supplying the brilliant solution of examination; Other gets the emodin reference substance, and chlorination is copied into the solution that every 1ml contains 1mg, in contrast product solution; Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005), draw each 5 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with 0.3% sodium carboxymethyl cellulose, upper solution with petroleum ether-ethyl acetate-formic acid (13: 5: 1) is developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical orange-yellow fluorescence speckle; Put in the ammonia smoked after, inspect under the daylight, speckle becomes redness.
5. the content assaying method of compound fleece-flower root oral liquid as claimed in claim 2 is characterized in that method is as follows:
Measure according to high performance liquid chromatography (appendix VID of Chinese Pharmacopoeia version in 2005);
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Acetonitrile-water (25: 75) is a mobile phase; The detection wavelength is 320nm; Number of theoretical plate is by 2,3,5, and 4 '-tetrahydroxystilbene-2-O-β-D-glucoside peak calculates should be not less than 2000;
The preparation of contrast solution: precision takes by weighing 2,3,5, and 4 '-tetrahydroxystilbene-2-O-β-D-glucoside reference substance is an amount of, adds Diluted Alcohol and makes the solution that every 1ml contains 0.1mg, promptly;
The preparation of need testing solution: precision is measured this product 1ml, puts on the D101 macroporous adsorptive resins, with the flow velocity eluting of per minute 2.0ml, discard water elution liquid, use the Diluted Alcohol eluting, discard Diluted Alcohol eluent 7-9ml, collect eluent 100ml, evaporate to dryness, residue adds the Diluted Alcohol dissolving, puts in the 10ml measuring bottle, adds Diluted Alcohol and is diluted to scale, shake up, promptly;
Accurate respectively reference substance solution and each the 5 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly;
The every 10ml of this product contains 2,3,5, and 4 '-tetrahydroxystilbene-2-O-β-D-glucoside (C20H22O9) meter must not be less than 6.0mg.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104950069A (en) * | 2015-06-23 | 2015-09-30 | 南京海昌中药集团有限公司 | Method for detecting quality of depression-relieving heart-comforting tablet |
| CN106248841A (en) * | 2016-08-29 | 2016-12-21 | 贵州信邦制药股份有限公司 | The content assaying method of Radix Polygoni Multiflori Preparata in anti-rheumatism medicated wine |
| CN108404021A (en) * | 2018-05-29 | 2018-08-17 | 郑州大学第附属医院 | It is a kind of to be used to prevent Chinese medicine composition of Cognitive capacity obstacle of the senile citizen and preparation method thereof |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1256896A (en) * | 1998-12-16 | 2000-06-21 | 南析 | Fresh fruit juice beverage and preparation method |
| CN1115156C (en) * | 2000-04-17 | 2003-07-23 | 李熙德 | Antisenility Chinese medicine |
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2009
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104950069A (en) * | 2015-06-23 | 2015-09-30 | 南京海昌中药集团有限公司 | Method for detecting quality of depression-relieving heart-comforting tablet |
| CN104950069B (en) * | 2015-06-23 | 2016-08-24 | 南京海昌中药集团有限公司 | A kind of resolving depression satisfactory tablet quality detection method |
| CN106248841A (en) * | 2016-08-29 | 2016-12-21 | 贵州信邦制药股份有限公司 | The content assaying method of Radix Polygoni Multiflori Preparata in anti-rheumatism medicated wine |
| CN108404021A (en) * | 2018-05-29 | 2018-08-17 | 郑州大学第附属医院 | It is a kind of to be used to prevent Chinese medicine composition of Cognitive capacity obstacle of the senile citizen and preparation method thereof |
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Effective date of registration: 20170424 Address after: 134100 Tonghua, Sichuan Province, Tonghua Qu Chuan Development Zone, Jilin Patentee after: Tonghua Baishan Pharmaceutical Ltd Address before: 134100 Jilin County, Tonghua Bay Bay Development Zone Tonghua Bai Shan pharmaceutical Limited by Share Ltd Patentee before: Hua Yuqiang |
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