CN101185668A - Novel preparation for preventing and controlling acquired immuno-deficiency syndrome and protecting liver and detoxication - Google Patents
Novel preparation for preventing and controlling acquired immuno-deficiency syndrome and protecting liver and detoxication Download PDFInfo
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Abstract
The invention relates to an oral drug/ health care product for strengthening immunity to prevent AIDS and protecting liver and eliminating toxicity, which consists of three effective extracts of natural plants: honeysuckle, chrysanthemum and crowndaisy chrysanthemum. The invention is characterized in that the invention adopts medicine and food homologous plants, which are pure natural plant medicine/ health care products; the extracts combination includes chlorogenic acid and dicaffeoylquinic acid, and the prepared medicine/ health care products can be used in protecting and nourishing liver, heat-clearing and detoxicating, strengthening immune system and preventing AIDS.
Description
The present invention is the compositions that extract became by Flos Lonicerae, Flos Chrysanthemi and Caulis et Folium Chrysanthemi segeti, be the health product that have the liver protecting and nourishing enhancing immunity and prevent and treat acquired immune deficiency syndrome (AIDS), said composition can be prepared into oral liquid, capsule as required, tablet, a series of dosage forms such as gel and chewable tablet.
One, background
Flos Lonicerae: original name Radix Ophiopogonis, Chinese Pharmacopoeia one one of version in 2005 is recorded the flower of just opening for dry flower or the band of caprifoliaceae plant Radix Ophiopogonis Lonicera japonica Thunb..Nature and flavor are sweet, and are cold.Return lung, the heart, stomach warp.Function is a heat-clearing and toxic substances removing, wind-heat dissipating.Be used for the carbuncle furuncle, sore throat, erysipelas, toxic-heat and blood stasis, anemopyretic cold, epidemic febrile disease heating.2002, in the health ministry " about the notice of further standard healthy food material management " clear and definite Flos Lonicerae be food be again medicine.The chemical constitution study of Flos Lonicerae shows that it contains organic acids, flavonoid, triterpene saponin and volatilization wet goods.That its activity mainly contains is antibacterial, antiviral, analgesic, antiinflammatory, hemostasis, antioxidation, antifertility and blood fat reducing, protect the liver and regulate the effect of immunologic function.
Flos Chrysanthemi: Chinese Pharmacopoeia one one of version in 2005 is recorded the dry capitulum into feverfew chrysanthemum Chrysanthemummorifolium Ramat..Nature and flavor are sweet, bitter, are slightly cold.Return lung, Liver Channel.Function is the wind heat clearing away of loosing, and suppressing the hyperactive liver makes eye bright.Be used for anemopyretic cold, it is dizzy to have a headache, conjunctival congestion and swelling pain, and eyes is dim-sighted." the medical center bun is wanted " cloud: " go into lung and the row irritability, lowering the adverse flow of QI."; " book on Chinese herbal medicine justice " cloud: " perverse and unreasonable manner of subduing the hyperfunction of the liver wood."; The supplement to the Herbal cloud: " control all dizziness due to wind, the alcoholic intoxication furuncle is swollen.”。2002, in the health ministry " about the notice of further standard healthy food material management " clear and definite Flos Chrysanthemi be food be again medicine.The chemical constitution study of Flos Chrysanthemi shows that it contains organic acid and esters, multiple flavone and glycoside, volatile oil, plant sterol and triterpenes, and Flos Chrysanthemi also contains the biogenic aminoacid of multiple human body, trace element etc. in addition.Pharmacological research show Flos Chrysanthemi have antibiotic, antiviral, malaria, defying age, antiinflammatory, antimutagenic, antitumor, analgesic, increase capillary resistance, suppress effects such as platelet aggregation, in recent years discover that it has the effect that protects the liver and regulate immunologic function.
In addition, the extract of Flos Chrysanthemi has very strong antioxidation, but enhancing body is removed the ability of free radical and inhibition radical reaction, prevents over-drastic lipid peroxidation, and liver is shielded.Chinese medicine Flos Chrysanthemi decocting liquid coloclysis has certain immunoregulation effect, and mucomembranous immune system is regulated in the expression of patients of ulcerative colitis adhesion molecule capable of blocking, helps the recovery of disease.In addition, the extracting solution of Flos Chrysanthemi can also improve the immunity of human body, strengthens the adaptive capacity of human body to surrounding.
Caulis et Folium Chrysanthemi segeti (Chrysanthemum Coronarium L.var.Spatiosum Bailey): different name: Chrysanthemum carinatum Schousb., Herba Artemisiae Sieversianae, Flos Chrysanthemi dish, tarragon, spring chrysanthemum are feverfew.Caulis et Folium Chrysanthemi segeti originates in China, is one of main vegetable of China, also have some areas with it as ornamental plant or Chinese herbal medicine, all there is cultivation in national most of area.Acrid-sweet flavor, property is flat.Go into spleen, stomach two warps.Function is and taste that sharp two just.Principle of Correct Diet: " sweet, flat, nontoxic." " a thousand pieces of gold dietetic therapy " cloud: " gas of feeling at ease is supported taste to the Caulis et Folium Chrysanthemi segeti function, the expectorant drink." " daily book on Chinese herbal medicine " cloud: " the row irritability, it is painful to control swelling and hanging down of either of the testes gas, diuresis for energy." " must join book on Chinese herbal medicine " cloud: " sharp the intestines and stomach, promoting blood circulation remove the disease due to obstruction of QI of middle-JIAO foul smell to energy." so all incoordination between the spleen and stomach, difficulty in urination and defecation, all diseases of cough with copious phlegm, nothing is not suitable for.The chemical constitution study of Caulis et Folium Chrysanthemi segeti shows: it contains aminoacid such as serine, asparagine, threonine, alanine, glutamine, β-Gamma Amino Butyric Acid; Gossypitrin (Gossypitrin), skin glycosides (Quercimeritrin), chlorogenic acid (Chlorogenic acid), coumarin, herniarin (Herniarin), umbelliferone (Umbeliferone) and scopoletin (Scopoletin), long-chain fatty acid etc.Caulis et Folium Chrysanthemi segeti has leukopenia, the anticancer isoreactivity that higher antioxidant activity, antitachycardia, anti-tumor chemotherapeutic cause, simultaneously tool emetic, eliminate the phlegm, effects such as diaphoresis, blood pressure lowering, heart tonifying.
Plant extracts such as Caulis et Folium Chrysanthemi segeti can both reduce chronic inflammatory diseases and to the healthy and beneficial of human body.In addition, Caulis et Folium Chrysanthemi segeti contains materials such as abundant volatile essential oil and choline, and the latter can promote the have additional nutrients absorption of material of gastrointestinal peristalsis, promotes the decomposition of protein metabolism and fat.Caulis et Folium Chrysanthemi segeti also is important ferrum, calcium complement agent.
Dicaffeoylquinic acid: (PLA's Acta Pharmaceutica Sinicas such as research report Sun Yan honor are arranged; 2004; 20 (2): 81～84) adopt liver primitive cell culture and carbon tetrachloride damage method; observe this material to hepatocellular protective effect; and tentatively inquire into dicaffeoylquinic acid by experiment in vitro and protect hepatocellular mechanism of action; dicaffeoylquinic acid does not have the overt toxicity effect in 7.8～250mg/L concentration to hepatocyte as a result; can promote the hepatocyte growth of normal and carbon tetrachloride damage and strengthen cell viability; reduce aspartic acid transferring enzyme (AST) activity of cell conditioned medium, suppress hepatocellular apoptosis and change damaged cell cycle that carbon tetrachloride causes.And other experiments (life science, 2001,5 (4): 355～357 are arranged; Henan Medical Univ.'s journal, 1993,28 (1): 31-33) show that dicaffeoylquinic acid can promote impaired hepatocellular DNA synthetic, quicken the division growth of cell, alleviate hepatocellular degeneration necrosis, suppress inflammatory reaction, have significant hepatocyte protection effect; Its mechanism of action suppresses impaired hepatocellular apoptosis, and can obviously reduce aspartic acid transferring enzyme level for promoting hepatocellular propagation and vigor.Dicaffeoylquinic acid can significantly reduce rat blood serum LN, HA, and MDA, NO content obviously improves liver tissues inflammatory and fibrosis state, has anti-complex factors and causes rat liver fibrosis and lipid peroxidation.In addition, dicaffeoylquinic acid can significantly suppress the NIH/3T3 cell proliferation, obviously suppresses collagen and hyaluronic synthetic, has a significant effect of anti hepatic fibrosis external.The other end of the year 2005 by pharmacy in the river, Jiangxi (group) Co., Ltd investment and with the anti-AIDS new drug dicaffeoyl quinic acid of the common development of Chinese Military Medical Science Institute, after through strict animal pharmacodynamics test and safety testing, formally entered human clinical trial's stage by State Food and Drug Administration's approval.
Two, compound basis
Chemical liver injury is meant the hepatic injury that is caused by the chemical Hepatoxic substance.These chemical substances comprise the hepatic injury that ethanol and some drugs cause, and alcoholic hepatic injury also is modal at present.These poisonous substances are general susceptible in the crowd, and incubation period is short, and the process of pathological changes is directly related with the dosage of infection, can cause liver hepatic necrosis, fatty distortion, liver cirrhosis, cholestasis, hepatic fibrosis even hepatocarcinoma in various degree.
1, Chinese medicine health preserving, health care theoretical foundation
The hepatopathy that chemical liver injury causes is not though the traditional Chinese medical science has this name of disease.But relate to alcoholic liver disease, Chinese medicine is early on the books.As the alcoholic liver disease of the alcoholic jaundice in " Medical Treasures of the Golden Chamber jaundice abnormal pulse disease is also controlled " with regard to similar dried western medicine.And for example, " disease is controlled jaundice with internal injury because of arteries and veins ": " alcoholic jaundice because of, its people is thing with wine, or when drink great drink, drunk deeply when the wind entry, hold concurrently with the long-pending heat of fat meat and fine grain, steam mutually and make, then the card of alcoholic jaundice becomes." pointed out the origin cause of formation and the pathology of alcoholic jaundice.The various places scholar systematically discusses the etiology and pathology of alcoholic liver disease in recent years.Think many because of polydipsia usually, have a liking for that the food delicious food is thick is bored with.Stop Jiao in the place, influence transporting and transforming function of the spleen and stomach, wine humidogene expectorant, stagnation of phlegm mechanism of qi, liver spleen form the change of retention of dampness due to stagnation of QI with sick; Qi disease involving blood, qi depression to blood stasis; If stagnation of phlegm-damp in middle-JIAO, with the passing of time heat-transformation, damp and hot gluing is accumulate in liver and gall, makes bile excessive, satisfies into jaundice.Wang Tianshu etc. think that the formation of alcoholic fatty liver is many because of accumulateing easy impairing the liver gallbladder in the damp and hot alcoholism, and impairing the spleen and stomach causes depression and stagnation of QI, blood-vessel obstructive, turbid interior the giving birth to of expectorant, the mutual accumulating in the costal region formation of QI and blood expectorant mass in the abdomen.So the formation basic pathogenesis of primary disease is that the pyretic toxicity turbid damp pents up in liver, should be rule of treatment with the heat-clearing and toxic substances removing in view of the above.
Internal organs (liver) intrinsic heat, the fire-toxin knot is poly-.Control based on heat-clearing and toxic substances removing, the removing summer-heat of accumulation of heat fire-toxin is dissipated.Flos Lonicerae is sweet cold in the side, and two clearing heat in QI system heat in blood poison are monarch drug.Flos Chrysanthemi, nature and flavor are sweet, bitter, are slightly cold, and return lung, Liver Channel, and heat-clearing and toxic substances removing is arranged, and the merit that suppressing the hyperactive liver makes eye bright is ministerial drug.The monarch and his subjects share, and the power of removing summer-heat is stronger, and can coolly loose and stop up knot, with the detumescence pain.Caulis et Folium Chrysanthemi segeti, acrid-sweet flavor, property is flat, can manage it irritability, with Disperse hepatic depression; Again can and taste, sharp two just, with invigorating the spleen for eliminating dampness, the expectorant drink makes evil poison that outlet be arranged, and is adjuvant.Each medicine of full side is played heat-clearing and toxic substances removing altogether, soothing liver and strengthening spleen, the merit of the sharp expectorant of removing dampness.
2, modern medical theory foundation
Modern clinical practice and pharmacological research show:
Flos Lonicerae contains di-coffee mesitoyl quinine acid, chlorogenic acid, triterpene saponin material, and the hepatoprotective effect of these materials is very clear and definite.Particularly the di-coffee mesitoyl quinine acid material can promote impaired hepatocellular DNA synthetic, quicken the division growth of cell, alleviate hepatocellular degeneration necrosis, suppress inflammatory reaction, can significantly reduce rat blood serum laminin (LN), hyaluronic acid (HA), malonaldehyde (MDA), nitric oxide (NO) content obviously improves liver tissues inflammatory and fibrosis state, have anti-complex factors and cause rat liver fibrosis and lipid peroxidation, have significant hepatocyte protection effect; Dicaffeoylquinic acid can effectively suppress HIV (human immunodeficiency virus), and its side effect is little, and more effective than HAART.Flos Lonicerae also has antiinflammatory, antiviral and immunoregulatory effect.
Flos Chrysanthemi can reduce the accumulating amount of cholesterol at liver, prevents the infringement of hypercholesterolemia to liver, thereby reaches the effect that protects the liver; Flos Chrysanthemi also has very strong antioxidation, but enhancing body is removed the ability of free radical and inhibition radical reaction, prevents over-drastic lipid peroxidation, and liver is shielded; Flos Chrysanthemi can improve the immunity of human body simultaneously, strengthens the adaptive capacity of human body to surrounding.
The contained aldehydes matter of Caulis et Folium Chrysanthemi segeti has and has higher antioxidant activity, reduces oxidative stress, blocking oxide stress product to hepatocellular toxic effect, can reach antioxidation, hepatoprotective effect; Caulis et Folium Chrysanthemi segeti helps the cholesterol of intestinal is got rid of external, helps digestion and cholesterol reducing, and the liver injury due to the hypercholesterolemia is had prevention effect.The adjustable cellular immune function of Caulis et Folium Chrysanthemi segeti is brought into play its significant antiinflammatory action.
Each composition is being brought into play the effect that protects the liver with enhancing immunity by each link of effect body in the prescription.
3, the effective dose and the safe edible dosage of each raw material in the prescription
The extract amount of Flos Lonicerae is equivalent to 12 grams of crude drug in the prescription, in the scope of application (9 grams～12 grams) of state-promulgated pharmacopoeia 2005; The extract amount of Flos Chrysanthemi is equivalent to 6 grams of crude drug, in the scope of application (5 grams～9 grams) of state-promulgated pharmacopoeia 2005; Caulis et Folium Chrysanthemi segeti extract amount is equivalent to former dry product 5 grams, in the scope of application of food.
In three kinds of compositions, Flos Lonicerae and Flos Chrysanthemi be food be again medicine, Caulis et Folium Chrysanthemi segeti is a vegetable.Documents and materials show the taboo that does not have compatibility between them, and wherein the compatibility of Flos Lonicerae and Flos Chrysanthemi is applied in the preparation of clinical application, health food, food and drink is extensive use of.Their use is safe.
Domesticly at present exist the various health product that utilize Flos Lonicerae and Flos Chrysanthemi to be prepared from the market, some does not have clear and definite quality standard yet, though have quality standard also all with chlorogenic acid contents as index.Yet we discover that with chlorogenic acid content be the quality standard that single index can not be controlled this type of liver health product well, that is to say that this single index can not be corresponding well with the health active function.We discover that further the content of controlling dicaffeoylquinic acid simultaneously can more effectively be controlled the functional effect of these product.We make thing with the extract of Caulis et Folium Chrysanthemi segeti as assistant under study for action in addition, have also strengthened the health care of health product well.Thereby originally discover and adopt " dicaffeoylquinic acid " to be this new oral health-care preparation of standard fabrication simultaneously, effect with liver protecting and nourishing, heat-clearing and toxic substances removing and enhancing immunity, can be used for the auxiliary treatment of weak and sickly, excessive drinking for a long time or the hepatic injury that causes of hepatopathy, also can be used for the control of acquired immune deficiency syndrome (AIDS).
Three, embodiment
(1) zoopery
1, liver protecting and nourishing experiment
Material: 60 of adult SD rats, male and female are not limit, quality (220 ± 10) g.
Method: random packet, 20 every group; Just outside the normal control, all the other respectively organize all subcutaneous injection CCl weekly
4(1ml/kg) twice, adjust dose weekly, totally 12 weeks; From start injection CCl
4Rise, be administered once by drug dose every day; Totally 12 weeks; When experiment finishes:
A, press kit method blood sampling and measure each index; B, get one of hepatic tissue, homogenate is pressed kit method and is measured hydroxyproline content; C, get one of hepatic tissue, histopathologic examination is done in HE dyeing, calculates the collagen volume integral.Route of administration is an intraperitoneal injection, and Halth-care composition is the 30mg/kg administration.
Experimental data such as following table,
Table 1 Halth-care composition is to CCl
4Due to the influence (n=20) of liver function after the rat chronic hepatic injury
| Group | Dosage | AST(U/L) | ALT(U/L) | TP(g/L) | ALB(g/L) |
| The normal control group | 1ml/kg | 142.7±46.0 | 67.4±25.6 | 65.7±10.4 | 14.1±1.9 |
| Model control group | 0.5mg/kg | 1990±379.1 | 873.4±198.2 | 33.1±8.1 | 11.9±3.4 |
| Halth-care composition | 30mg/kg | 194.6±54.2 | 145.9±57.3 | 67.1±13.7 | 13.9±1.4 |
Table 2 Halth-care composition is to CCl
4Due to the influence (n=20) of rat chronic hepatic injury heptic fibrosis
| Group | Dosage | HP(ng/mL) | PIIIP(mg/mL) | CIV(ng/mL) |
| The normal control group | 1ml/kg | 62.5±17.2 | 1.92±0.33 | 24.6±4.1 |
| Model control group | 0.5mg/kg | 462.7±168.2 | 15.67±4.12 | 82.4±21.0 |
| Halth-care composition | 30mg/kg | 106.8±40.6 | 2.19±1.43 | 31.8±10.5 |
Table 3 Halth-care composition is to CCl
4Due to the influence (n=20) of collagen volume integral after the rat chronic hepatic injury
| Group | Dosage | The collagen volume integral (CVF, %) |
| The normal control group | 1ml/kg | 3.1±1.7 |
| Model control group | 0.5mg/kg | 21.4±9.8 |
| Halth-care composition | 30mg/kg | 4.3±2.7 |
Experimental result:
Function, biochemistry detection the results are shown in Table 1,2: model control group AST, ALT, TP, HP, PIIIP and CIV have compared utmost point significant difference (P＜0.01) with the normal control group; comparing with model control group to the Halth-care composition group all has utmost point significant difference (P＜0.01), illustrates that Halth-care composition has liver-protective effect.
The pathology testing result sees Table 3: the collagen volume integral of model control group has been compared utmost point significant difference (P＜0.01) with the normal control group, and comparing with model control group to the Halth-care composition group all has utmost point significant difference (P＜0.01) to illustrate that Halth-care composition has chronic CCl
4The rat liver fibrosis that brings out therapeutical effect arranged.
This result shows: the curative effect that truly has liver protecting and nourishing of these health product.
2, enhancing immunity experiment
(A) get 200 of kunming mices, body weight 11～13g, male and female half and half are divided into 4 groups at random, 50 every group.(1) blank group, the equivalent normal saline; (2) model control group, the equivalent normal saline; (3) ribavirin group 40mg/kg, 7.5mg/ml; (4) health product group 30mg/kg.Below respectively organize the equal gastric infusion of mice, irritate gastric capacity 10ml/kg, 1 time/* 6 days, in administration respectively organized in the 2nd day mice (except that the blank group) under the ether light anaesthesia to increase malicious 3 times viral allantois drop nose infecting mouse, every Mus 30 μ l (20 LD
50Challenging dose).Observe zoogenetic infection sequela symptom, record infects death toll after 14 days, and calculates protective rate and average survival natural law, and the result is as shown in the table:
According to experimental result as can be seen these health product the mice of influenza a virus infection is had protective effect, though protective rate does not reach 50%, with model control group than significant protective effect is still arranged, and can prolong infecting mouse survival natural law.
Table 4 health product are to by the protective effect of the mice of influenza a virus infection
(B) get 60 of cleaning level ICR mices, body weight 20 ± 3g, male and female half and half.Experiment is divided into 3 groups, i.e. normal group, model group, health product group.IgG, IgM, IFN-γ and IL-2 check by the ELISA detection kit.
Normal group is conventional raises.1 subcutaneous injection cyclophosphamide 40mg/kg next day of model group, totally 8 times.The health product group is irritated the stomach health product simultaneously in modeling every day, and continuous 14 days, and the 1h eye socket is got blood after the last administration, surveys IgG, IgM, IFN-γ and IL-2 by each test kit operation instructions respectively; Mice is taken off cervical vertebra put to death, cut open that to get the thymus box the spleen-distension, weigh, ask organ index.Thymus index=(thymic weight/body weight) * 100%; Index and spleen index=(spleen weight/body weight) * 100%.
With data with statistical software analyze following form:
Table 5 is respectively organized the comparison (X ± S) of mouse humoral immune function
| Group | Number of animals | Dosage (/kg) | IgG(g/L) | IgM(g/L) |
| Normal group | 20 | 20ml | 7.14±1.02 | 241.65±34.68 |
| Model group | 20 | 40ml | 5.01±0.61 | 110.25±22.37 |
| Health product | 20 | 30ml | 4.35±1.65 | 276.5±51.34 |
Table 6 is respectively organized the comparison (X ± S) of mouse cell immunologic function
| Group | Number of animals | Dosage (/kg) | IFN-γ(ng/ml) | IL-2(ng/ml) |
| Normal group | 20 | 20ml | 3.47±0.62 | 3.12±1.02 |
| Model group | 20 | 40ml | 2.26±0.34 | 2.34±0.56 |
| Health product | 20 | 30ml | 4.13±1.46 | 3.52±0.75 |
Each mouse thymus exponential sum index and spleen index comparison of table 7 (X ± S)
| Group | Number of animals | Dosage (/kg) | Thymus index (* 10 -4) | Index and spleen index (* 10 -4) |
| Normal group | 20 | 20ml | 18.08±6.62 | 31.21±7.02 |
| Model group | 20 | 40ml | 12.62±8.34 | 27.04±10.56 |
| Health product | 20 | 30ml | 14.13±3.64 | 33.71±9.75 |
Though health product do not make significant difference to organ index in the experimental data, from table 5,6 and 7, can draw these product and significantly improve humoral immunization and cellular immunity.Conclusion: so these health product are by the effect of enhance immunity function.
3, anti-AIDS test
Medicine: this medicine/health product capsule, blank are filled with the capsule of starch, and positive control is AZT.
9 of Rhesus Macacus, 5～6kg/, about 6 years old age, sign health, serum detects SIV, SRV and STLV-1 antiviral antibody feminine gender.Each 3 of test group, blank group and matched groups.By an amount of intravenous injection infected monkey of SIV virus liquid.
The test monkey infects back 2 hours oral administrations, continuous 2 months.Blank group is given the starch capsule suitable with medicine.AZT positive controls continuous oral AZT8 week.Each group was observed two months again after the drug withdrawal.
Can check in 6,9,13,15,20,28,43,57,80,115 days and respectively organize experimental monkey groups routine blood test, CD by infecting the back
4 +Lymphocyte subgroup, plasma viral titre, whole blood virus titer, lymph node, hepatic and renal function etc.
Table 8 is respectively organized monkey WBC and CD
4 +Lymphocyte subgroup (ul)
These medicine/health product can effectively suppress acute SIV virus as can be seen from the above table, effectively prevent and treat acquired immune deficiency syndrome (AIDS).
(2) health product sample high-efficient liquid phase analysis collection of illustrative plates
In order to control capsule quality, we adopt the method for measuring chlorogenic acid in the Chinese Pharmacopoeia 2005 editions (an one) under the Flos Lonicerae item, and to chlorogenic acid, 3, the content of 5-dicaffeoylquinic acid has carried out assay, and collection of illustrative plates is as follows:
In above-mentioned liquid phase collection of illustrative plates, chlorogenic acid and 3,5-dicaffeoylquinic acid appearance time is respectively: 5.032 minutes and 10.782 minutes, can be separated preferably with composition.
And this capsule done the preliminarily stabilised property testing:
A, influence factor's experiment
A) hot test
Capsule sample is placed 40 ℃ of calorstats, and sampling in the 5th, 10 day, analysis result and 0 day data relatively the results are shown in following table.
40 ℃ of hot test results of capsule
Brief summary: 40 ℃ of hot tests show that this product effective ingredient slightly reduces.
B) high wet test
It is the hermetic container of 75%RH that capsule sample is placed relative humidity, in the 5th, 10 day sample analysis, compares with 0 day data, the results are shown in following table.
Capsule high humidity result of the test (75%RH)
Brief summary: the high humidity test data shows that this product easily draws wetly, and suggestion adds and places desiccant in the packing.
C) exposure experiments to light
Sample was shone 10 days down except that the daylight lamp that unlap is placed on the 4500Lx light intensity,, compare, the results are shown in following table with 0 day data in 5 days, 10 days difference sample analysis.
Capsule exposure experiments to light result
Brief summary: exposure experiments to light shows that active constituent content descends.
D) hot and humid and refrigeration test
Sample is exposed in 100% humidity, 60 ℃ constant-temperature enclosed container, sample analysis after 5 days, the result shows that moisture absorption becomes pasty state.
Cold preservation is in-5 ℃, and sampling in the 10th day, every indexs such as appearance luster, active constituent content were not seen change.
Brief summary: the high temperature and humidity test data show the content pasty stateization, and sample is defective.
B, accelerated tests
With this product simulation listing packing, put relative humidity and be 60%, temperature is 30 ℃ following 6 months of constant temperature and humidity condition, and respectively at 1,2,3 month and 6 months sample analysis, and contrasted in 0 month, the results are shown in Table.
30 ℃ of accelerated test results of capsule
Brief summary: accelerated test is observed and was shown that active constituent content all had decline slightly in 6 months, but still in acceptability limit.
The investigation that keeps sample of C, room temperature
With this product simulation listing packing, seasoning between the laboratory reserved sample observing in 0,3,6,12,18,24,36 month sample analysis, the results are shown in following table:
The capsule room temperature result of the test (25 ℃ ± 1) that keeps sample
Brief summary: it is no problem that room temperature placement in 2 years is preserved.
Sum up: humidity is to the effect maximum of these health product in the related factors influence, and therefore packing is noted controlled humidity and place desiccant in big packing.The simulation listing is packaged in room temperature and keeps away the wet wet quite stable of preserving of keeping away in addition, and sample is still qualified after 24 months.
(3) medicament preparation
Below will describe several example of formulations of the present invention, but content of the present invention is including, but not limited to this.
Embodiment one: the tablet of health product
Flos Lonicerae extract 120g
Flos Chrysanthemi extract 100g
Caulis et Folium Chrysanthemi segeti extract 80g
Other suitable adjuvant 20g such as sweeting agent, lubricant
Behind the above-mentioned substance mix homogeneously,, be pressed into 1000 with carrying out the tabletting preparation behind dry granulation and the granulate.
Embodiment two: the capsule of health product
Flos Lonicerae extract 120g
Flos Chrysanthemi extract 100g
Caulis et Folium Chrysanthemi segeti extract 90g
Other suitable adjuvant 15g such as lubricant
Behind the above-mentioned substance mix homogeneously, be encapsulated in 1000 capsules under the gnotobasis and get final product.
Embodiment three: the oral liquid of health product
Flos Lonicerae extract 130g
Flos Chrysanthemi extract 100g
Caulis et Folium Chrysanthemi segeti extract 85g
Appropriate solvent 2L such as water
Press oral formulations technology, the extract of Flos Lonicerae, Flos Chrysanthemi and Caulis et Folium Chrysanthemi segeti is dissolved in the solvent, fully behind the mix homogeneously, be packed as 1000.
Embodiment four: the gel of health product
Flos Lonicerae extract 120g
Flos Chrysanthemi extract 100g
Caulis et Folium Chrysanthemi segeti extract 90g
Agarose isogel medium 8g
Water 4L
Press gel preparation preparation technology, after above-mentioned substance is fully mixed, under proper temperature, heat, become, during heavy-gravity aqueous mixture, resulting mixture is distributed into 1000 parts, get final product after to be cooled the condensing up to all substances.
Embodiment five: the effervescent tablet of health product
Flos Lonicerae extract 120g
Flos Chrysanthemi extract 100g
Caulis et Folium Chrysanthemi segeti extract 90g
Tartaric acid 7g
Sodium bicarbonate 5g
Magnesium stearate 2g
Carboxymethyl starch sodium 1g
Starch 10g
Correctives is an amount of
Mixing behind the dry granulation, asepticly is pressed into 1000.
Claims (8)
1. oral drug/the health-care preparation of the prepared one-tenth of natural plant extracts.
2. according to claim 1, it is characterized in that medicine/health product are by extract of a certain proportion of Flos Lonicerae, Flos Chrysanthemi and Caulis et Folium Chrysanthemi segeti and the preparation that the acceptable medicine/the health-care preparation adjuvant combines.
3. according to claim 2, it is characterized in that containing in this medicine/health-care preparation the main component of Flos Lonicerae, Flos Chrysanthemi and Caulis et Folium Chrysanthemi segeti.The part by weight scope that wherein contains Flos Lonicerae, Flos Chrysanthemi and Caulis et Folium Chrysanthemi segeti extract is a Flos Lonicerae: Flos Chrysanthemi: Caulis et Folium Chrysanthemi segeti=(1～10): (1～10): (1～10), wherein again with Flos Lonicerae: Flos Chrysanthemi: Caulis et Folium Chrysanthemi segeti=6: 5: 4 is an optimal proportion, best results.
4. according to claim 3, it is characterized in that wherein system of unit dosage is 0.05g-1g, and the total composition of contained three is calculated by weight and is not less than 0.05g.
5. according to claim 3 and 4, it is characterized in that these medicine/health product can be prepared into various oral formulations forms, pass through gastrointestinal administration as a series of dosage forms such as oral liquid, capsule, tablet, gel, chewable tablet, effervescent tablet and dispersible tablets.
6. according to claim 5, contained dicaffeoylquinic acid proportion is 0.1%-60% in the different dosage form that it is characterized in that being made, and chlorogenic acid content is 0.1%-50%.
7. according to claim 3, it is characterized by such ratio, three's combination can appear in the prescription of other any type of medicine/health product.
8. according to claim 6, it is characterized by the control that said preparation can be used for liver protecting and nourishing, heat-clearing and toxic substances removing, enhancing immunity and acquired immune deficiency syndrome (AIDS).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2006101235635A CN101185668A (en) | 2006-11-15 | 2006-11-15 | Novel preparation for preventing and controlling acquired immuno-deficiency syndrome and protecting liver and detoxication |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2006101235635A CN101185668A (en) | 2006-11-15 | 2006-11-15 | Novel preparation for preventing and controlling acquired immuno-deficiency syndrome and protecting liver and detoxication |
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| Publication Number | Publication Date |
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| CN101185668A true CN101185668A (en) | 2008-05-28 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNA2006101235635A Pending CN101185668A (en) | 2006-11-15 | 2006-11-15 | Novel preparation for preventing and controlling acquired immuno-deficiency syndrome and protecting liver and detoxication |
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| CN (1) | CN101185668A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2011016432A1 (en) * | 2009-08-06 | 2011-02-10 | 国立大学法人北海道大学 | Immune balance-regulating agent |
| CN105708896A (en) * | 2016-04-05 | 2016-06-29 | 黄群德 | Traditional Chinese medicine preparation for treating AIDS (acquired immune deficiency syndrome) |
| AU2017385661B2 (en) * | 2016-12-30 | 2020-03-05 | Cosmax Nbt, Inc. | Composition for prevention and treatment of muscular diseases or for improvement of muscle function containing 3,5-dicaffeoylquinic acid or chrysanthemum extract |
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| CN1850144A (en) * | 2006-03-03 | 2006-10-25 | 浙江大学 | Chinese medicine extract for resisting AIDS virus and preparing method |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011016432A1 (en) * | 2009-08-06 | 2011-02-10 | 国立大学法人北海道大学 | Immune balance-regulating agent |
| CN105708896A (en) * | 2016-04-05 | 2016-06-29 | 黄群德 | Traditional Chinese medicine preparation for treating AIDS (acquired immune deficiency syndrome) |
| AU2017385661B2 (en) * | 2016-12-30 | 2020-03-05 | Cosmax Nbt, Inc. | Composition for prevention and treatment of muscular diseases or for improvement of muscle function containing 3,5-dicaffeoylquinic acid or chrysanthemum extract |
| AU2020200225B2 (en) * | 2016-12-30 | 2021-07-08 | Cosmax Nbt, Inc. | Composition for improvement of muscle function containing 3,5-dicaffeoylquinic acid or chrysanthemum extract |
| US11160840B2 (en) | 2016-12-30 | 2021-11-02 | Industry-Academic Cooperation Foundation, Yonsei University | Composition for improvement of muscle function containing 3,5-dicaffeoylquinic acid or chrysanthemum extract |
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