CN101549140B - Traditional Chinese medicine composition for treating AIDS and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating AIDS and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for treating AIDS and preparation method thereof, wherein the traditional Chinese medicine composition comprises the following raw materials by weight parts: mulberry bark 5-20 parts, curcuma 1-10 parts, glycyrrhiza 2-10 parts, creat 1-12 parts, skullcap 1-10 parts and astragalus root 1-10 parts. The traditional Chinese medicine composition is formed by combining various anti-HIV Chinese herb medicines of different target to realize multi-target attack of HIV virus, thereby reducing the HIV viruses in virus carrier, increasing the immunity of the virus carrier, improving the virus carrier live quality and prolonging the survival time. The clinical curative effect shows that: the traditional Chinese medicine composition obviously reduces the number of HIV virus in the patient with AIDS, controls and kills the HIV virus, strengths the immunity of virus carrier without the obvious toxic side effect, suitable for long-term individual administration, matching administration with the Western medicine.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition, relate in particular to a kind of Chinese medicine composition for the treatment of acquired immune deficiency syndrome (AIDS), the invention still further relates to the preparation method of this Chinese medicine composition, belong to the prevention and control field of acquired immune deficiency syndrome (AIDS).
Background technology
Acquired immune deficiency syndrome (AIDS) (AIDS) is named acquired immunodeficiency disease (Acquired immunodeficiency Syndrome) again.(HIV-human immunodeficiency virus) causes that HIV (human immunodeficiency virus) (Human Immunodeficiency Virus) is divided into amphitypy by HIV (human immunodeficiency virus): HIV-1 type and HIV-2 type, they have hypotype separately again.The popular hypotype difference in different regions, also there is some difference in different regions for same hypotype.Hide the intravital HIV of people if Once you begin the breeding, can cause patient's the serious injures and deaths of T lymphocyte, cause immunity degradation, and then inspire a series of relevant diseases.
Acquired immune deficiency syndrome (AIDS) is seriously threatening human existence, and since confirming acquired immune deficiency syndrome (AIDS) first in June, 1981, whole world accumulative total has 6,500 ten thousand people's aids infection poison, wherein 2,500,000 people's death in the period of 25.To the end of the year 2005, the whole world has 3,860 ten thousand patients infected hivs, newly-increased then patients infected hiv 4,100,000 people, and other has 2,800,000 people to die from acquired immune deficiency syndrome (AIDS).
The numerous medical research personnel in the whole world have paid huge effort at present, but do not develop the specific medicament of radical cure acquired immune deficiency syndrome (AIDS) so far as yet, also not can be used for the effective vaccine that prevents.The total principle of treatment acquired immune deficiency syndrome (AIDS) is anti-opportunistic infection and tumor; Kill or suppress HIV virus; The enhancing human body immunity ability.Existing anti-HIV chemicals is based on Western medicine (as efabirenz, non-nucleoside reverse transcriptase inhibitor and protease inhibitor), there are shortcomings such as unsatisfactory curative effect, big, the oral availability of toxic and side effects are low, cost costliness, therefore seek new high-efficiency low-toxicity and cheap inverase is the task of top priority.From natural drug, seek the heat subject that inverase is research at present.Chemical constituent in some plants such as alkaloid compound are (as colchicine, papaverine, camptothecine, chesnut alkali, benzophenanthridine alkaloid, isoquinoline alkaloid etc.), coumarin kind compound is (as fruit and the isolated 8 kinds of coumarin kind compound inophyllum B of branch from Tropical rain forest Guttiferae Calophyllum plant Calophyllum lanigerum, P etc.) and flavone compound (as Radix Astragali element, scutellarin, myricetin, arnentoflavone etc.) etc. the activity that all has anti-HIV, be used for the treatment (Strait Pharmaceutical Journal, 2008) of HIV by many countries.
(application number: Chinese patent 01144951.9) discloses a kind of " Chinese medicine composition of treatment acquired immune deficiency syndrome (AIDS) and preparation method thereof ", and this Chinese medicine composition mainly is made up of the Radix Astragali, tree chicken, Pericarpium Citri Reticulatae, Atractylodes lancea (Thunb.) DC., Partition in Fructus Juglandis, Fructus Jujubae, red ganoderma, Radix Ginseng, crystal sugar for CN 1186042C for Granted publication number.(application number: 03131572.0) Chinese patent discloses " a kind of medicine for the treatment of acquired immune deficiency syndrome (AIDS) itself and preparation method ", and this drug main will be made up of Cortex Moutan, Radix Trichosanthis, Ganoderma, the Radix Rehmanniae, the Radix Paeoniae Alba, Ramulus Cinnamomi, Fructus Aurantii Immaturus, Radix Platycodonis, Rhizoma Zingiberis Recens, Fructus Jujubae, Radix Glycyrrhizae for CN 1202856C for Granted publication number.Granted publication number is that (application number: Chinese patent 95105654.9) discloses " medicine of treatment acquired immune deficiency syndrome (AIDS) and preparation method thereof " to CN 1067570C, and this drug main will be made up of Chinese crude drugs such as Cacumen Securinegae Suffruticosae, Sanguis Draxonis, the Radix Astragali, Radix Codonopsis, Poria, the Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae, Cortex Acanthopancis, He Ziwu, Fructus Jujubae, Caulis Spatholobi, Fructus Rosae Laevigatae, Fructus Trichosanthis shell, the Radix Pulsatillae, Radix Scutellariae, Radix Isatidis, Fructus Gleditsia rice.(application number: Chinese patent 97121020.9) discloses " a kind of Chinese medicine and processing technique thereof for the treatment of acquired immune deficiency syndrome (AIDS) ", and it is by Flos Lonicerae, Fructus Forsythiae, Radix Bupleuri, Herba Artemisiae Scopariae, Rhizoma Polygoni Cuspidati, the Radix Pulsatillae, Radix Isatidis for CN 1067570C for Granted publication number, Herba Taraxaci, Rhizoma Smilacis Glabrae, Rhizoma Osmundae, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Cortex Cinnamomi, Cortex Dictamni, Radix Et Rhizoma Rhei, Herba Epimedii, Fructus Ligustri Lucidi, Cortex Moutan, Radix Ginseng, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis, Polyporus, Herba Hedyotidis Diffusae, Herba Scutellariae Barbatae, Rhizoma Dioscoreae, Fructus Aurantii Immaturus, the Radix Linderae, compositions such as Rhizoma Curcumae.Granted publication number is that (application number: Chinese patent 97123264) discloses " a kind of treatment acquired immune deficiency syndrome (AIDS) Chinese medicine and production method thereof " to CN 1070707C, and it is formulated by SHANSHEN palpus, kuling supplejack root, Ramulus Euonymi, Yunnan-Guizhou Calculus Bovis, day overlord, six kinds of medical herbs of Herba Saussureae Involueratae and Black Aranea, Formica fusca, bamboo Serpentis, four kinds of insects of Xylocopa dissimilis (Lep.).(application number: 03134499.2) Chinese patent discloses " a kind of Chinese medicine for the treatment of acquired immune deficiency syndrome (AIDS) and preparation method thereof ", and this Chinese medicine is that feedstock production forms with multi-flavor drug materials such as Radix Trichosanthis, Bulbus Tulipae, Rhizoma Curcumae, the Rhizoma Pinelliae, Rhizoma Arisaematis, the Radix Astragali, Radix Morindae Officinalis, Radix Codonopsis, Radix Puerariaes for CN 100352490C for Granted publication number.
Though the Chinese medicine composition of existing treatment acquired immune deficiency syndrome (AIDS) all has certain curative effect to acquired immune deficiency syndrome (AIDS), but all in various degree to exist curative effect remarkable inadequately, defective such as cost an arm and a leg, and the water that is adopted is carried, and to exist energy consumption big with traditional extraction processes such as alcohol extractions, problems such as active component can not effectively extract have much room for improvement.
Summary of the invention
The present invention's technical problem at first to be solved is to overcome the deficiencies in the prior art, provide the many target spots of a kind of energy to attack HIV virus, remarkable for AIDS curative effect, and to human body safely, the Chinese medicine composition that has no side effect, used price of medicinal material is cheap, satisfies patient's long-term needs.
For achieving the above object, the present invention is achieved through the following technical solutions:
A kind of Chinese medicine composition for the treatment of acquired immune deficiency syndrome (AIDS), make by each crude drug of following weight portion:
Cortex Mori 5-20 part, Rhizoma Curcumae Longae 1-10 part, Radix Glycyrrhizae 2-10 part, Herba Andrographis 1-12 part, Radix Scutellariae 1-10 part and Radix Astragali 1-10 part.
The weight portion of preferred each crude drug is: 2 parts of 12 parts of Cortex Mori, 6 parts in Rhizoma Curcumae Longae, 5 parts in Radix Glycyrrhizae, 3 parts of Herba Andrographis, 3 parts of Radix Scutellariaes and the Radixs Astragali.
The used various crude drug of the present invention all can be bought from pharmacy and obtain, and its specification meets country or industry standard gets final product.
Chinese medicine composition of the present invention is under Chinese medical theory instructs, and in conjunction with the modern Chinese medicine pharmacy achievement in research prescription of acquired immune deficiency syndrome (AIDS) is formed.This policy is to the acquired immune deficiency syndrome (AIDS) blood stasis due to qi deficiency, the basic pathogenesis of turbid damp pathogenic heat remaining in the interior is seted forth one's views, according to the side's of the choosing medication of acquired immune deficiency syndrome (AIDS) disease characteristics, set about from " eliminating the pathogens from the lung heat-clearing and toxic substances removing, benefiting QI for activating blood circulation blood stasis dispelling ", reach the purpose of " just not hindering clearly; mend and do not stay heresy ", using medicines of both cold and hot natures simultaneously in the side, reinforcement and elimination in combination, the effect of playing strengthening vital QI to eliminate pathogenic factors altogether.
The compatibility of Chinese medicine composition of the present invention is according to being:
Cortex Mori is monarch in the side, and nature and flavor are sweet, cold, go into lung, spleen channel.Get the effect of its eliminating pathogen from the lung for relieving asthma, inducing diuresis to remove edema." the southern regions of the Yunnan Province book on Chinese herbal medicine ": " gold is subjected to fire preparing, and only Cortex Mori can rush down it.End the cough due to lung-heat." " Zhenglei Bencao ": " the tonify deficiency QI invigorating is gone aqueous vapor in the lung." modern pharmacology experiment shows that Cortex Mori has the effect of diuresis preferably and catharsis.The Radix Astragali, Rhizoma Curcumae Longae are minister, and the sweet tepor of the Radix Astragali is gone into lung, spleen channel.Get its benefit and defend consolidating superficial resistance, eliminating the toxic material out by tonification, the effect of strengthening vital QI to eliminate pathogenic factors." book on Chinese herbal medicine converges and says ": " arresting sweating is defended in Radix Astragali, tonifying the lung spleen invigorating in fact, and the medicine of wind dispelling fortune poison also." " Records of Tradition Chinese and Western Medicine in Combination ": " and Radix Astragali, the energy QI invigorating is held concurrently and can be risen gas, and kind temperature is atmosphere (sinking) in the heart." the arduous temperature of Rhizoma Curcumae Longae property, go into spleen, Liver Channel.Get its removing blood stasis circulation of qi promoting, the effect of inducing menstruation to relieve menalgia." Zhenglei Bencao ": " therapeutic method to keep the adverse QI flowing downwards removing blood stasis removes wind heat, subduing inflammation." modern pharmacology experiment shows the effect that the Radix Astragali has heart tonifying, diuresis, blood pressure lowering, protects the liver, improves immunologic function.We add Herba Andrographis in hot temperature, sweet temperature flavour of a drug, Radix Scutellariae two flavor bitter and cold medicines are assistant, Herba Andrographis hardship, cold, and GUIXIN, lung, large intestine, urinary bladder channel have heat-clearing and toxic substances removing, the effect of removing heat from blood detumescence." Quanzhou book on Chinese herbal medicine ": " heat-clearing and toxic substances removing, antiinflammatory detumescent.Control laryngopharyngitis, dysentery, hyperpyrexia." modern pharmacological research shows that Herba Andrographis has the effect of analgesic, antiinflammatory, raising immunologic function.The Radix Scutellariae hardship, cold, return lung, gallbladder, spleen, large intestine, small intestine meridian, heat clearing and damp drying is arranged, the effect of eliminating fire and detoxication." Bencao Tujing ": " the Zhang Zhongjing bitterly disappointed down feeling of fullness that cures the wound, Radix Scutellariae is all used in the XIEXIN TANG four directions, and with its main all heat, so sharp small intestinal is also." " medicine origin ": " Radix Scutellariae is in harmony damp and hot in the lung, and swollen red in the hot order in the treatment, contain on the blood stasis ridge, the medicine that must use." modern pharmacological research shows that Radix Scutellariae has antibiotic, antiviral, antiphlogistic effect.Radix Glycyrrhizae is for making heat-clearing and toxic substances removing, the mediation property of medicine.We's simultaneously using both cold and hot drugs, reinforcement and elimination in combination is played the eliminating the pathogens from the lung heat-clearing and toxic substances removing altogether, the effect of benefiting QI for activating blood circulation blood stasis dispelling
In theory, as long as can press down the medicine that kills HIV virus or disturb any one link in its reproduction process, may be used to the control of acquired immune deficiency syndrome (AIDS).And many Chinese herbal medicine have and press down to kill HIV virus or disturb certain link in its reproduction process, with the effect of the propagation that suppresses HIV virus.Chinese medicine composition of the present invention is combined by the multiple Chinese herbal medicine of the different target spots of anti HIV-1 virus respectively, realize many target spots attack HIV viruses, reach and in virus carrier's body, reduce HIV virus, improve patient's immune function, improve patient's life quality, prolong patient's life span.
Clinical efficacy confirms, Chinese medicine composition of the present invention can significantly reduce the intravital HIV virus load of patient, suppress and kill HIV virus, the immunocompetence that strengthens patient there is no obvious toxic-side effects, is fit to the acquired immune deficiency syndrome (AIDS) patient and takes separately for a long time and also can cooperate Western medicine to take.
Chinese medicine composition of the present invention can be prepared into any acceptable clinically suitable formulations by this area conventional formulation method, for example, can be various oral formulations, described oral formulations is preferably from tablet, granule, capsule, powder, pill, oral liquid, syrup or drop pill etc.
Chinese medicine composition of the present invention also can adopt water to carry the extracting method of combining with alcohol extraction except can adopting traditional water to carry to be prepared with alcohol extraction process, can make the active component stripping to greatest extent, strengthens drug effect.Chinese medicine composition of the present invention adopts microwave-assisted to extract except adopting traditional heating and refluxing extraction and decocting the extraction, has improved efficient, has reduced energy consumption, thereby has greatly reduced production cost.
Preferably, a kind of method for preparing the Chinese medicine composition of above-mentioned treatment acquired immune deficiency syndrome (AIDS), this method may further comprise the steps:
(1) takes by weighing each crude drug by described weight portion;
(2) with crude drug by certain extracting method extract obtain behind the active component after, add preparations shaping behind the pharmaceutic adjuvant.
Wherein, described extracting method can be extraction process by water, alcohol extraction process and with the two extraction process of combining.
Described extraction process by water preferably adopts following steps to realize: each crude drug that will take by weighing mixes, and adds the water of 5-10 times of weight, and heated and boiled, heating and refluxing extraction or microwave-assisted extract 1-4 time, and merge extractive liquid, filters, and concentrates; Wherein, the time of heated and boiled and heating and refluxing extraction is preferably each 30-60 minute, and the time that microwave-assisted extracts is preferably each 1-10 minute.
Described alcohol extraction process preferably adopts following steps to realize: each crude drug that will take by weighing mixes, and adds the ethanol of the 30-80% of 5-10 times of weight, and heated and boiled, heating and refluxing extraction or microwave-assisted extract 1-4 time, and merge extractive liquid, filters, and concentrates; Wherein, the time of heated and boiled or heating and refluxing extraction is preferably each 30-60 minute, and it is each 1-10 minute that microwave-assisted extraction time is preferably.
The described extraction process that extraction process by water and alcohol extraction process are combined preferably adopts following steps to realize:
(1) Cortex Mori and Rhizoma Curcumae Longae are carried out vapor distillation and extract its volatile oil part, with behind the inclusion essential oil volatile oil clathrate compound, standby; The decocting liquid of Cortex Mori and Rhizoma Curcumae Longae is partly filtered, get water extract 1, standby; The medicinal residues of Cortex Mori and Rhizoma Curcumae Longae carry out alcohol reflux or microwave-assisted again and extract, and get ethanol extract 1, and are standby;
(2) Herba Andrographis is carried out ethanol warm macerating dynamic extraction, get ethanol extract 2, standby;
(3) get the Radix Astragali and Radix Glycyrrhizae decocts with water, the back of waiting to seethe with excitement adds Radix Scutellariae, and with the Radix Astragali, the aqueous extract of Radix Glycyrrhizae and Radix Scutellariae merges with above-mentioned water extract 1, merges spray drying behind the continuation concentrating under reduced pressure behind the concentrating under reduced pressure with ethanol extract 1 and 2; Add volatile oil clathrate compound and pharmaceutic adjuvant mixing, promptly.
In order to reach better extraction effect, preferably, in combination extraction process step (1) Cortex Mori and Rhizoma Curcumae Longae added water 3-10 times of weight dipping after 30-60 minute the reuse vapor distillation extracted volatile oil 2-4 hour, collect the volatile oil part, after adding 5% NaCl salt condensation for removing water, use beta-cyclodextrin inclusion compound; Wherein, when using beta-cyclodextrin inclusion compound, the weight ratio of volatile oil and beta-schardinger dextrin-is preferably 1: 12, and baking temperature is preferably 50～55 ℃;
Preferably, the medicinal residues with Cortex Mori and Rhizoma Curcumae Longae in the combination extraction process step (1) add 2-6 times of weight 30-80% alcohol reflux 1-3 time, each 0.5-1.5h, and perhaps microwave extraction is 1-3 time, and each 2-10min filters;
Preferably, the 30-75% ethanol that in combination extraction process step (2) Herba Andrographis is added 2-4 times of weight dynamic extraction 3 times under 50-70 ℃ of temperature, each 1-3h filters;
Preferably, 1-3h is extracted in the just Radix Astragali, Radix Glycyrrhizae and Radix Scutellariae water extraction 3 times at every turn in the step (3), or microwave-assisted extracts each 2-10min 3 times.Amount of water is respectively 6 times, 6 times and 4 times of medical material weight;
The using method of Chinese medicine composition of the present invention and consumption: the dosage of Chinese medicine composition of the present invention depends on factors such as concrete dosage form, patient's age, health status.For oral formulations, its effective dose is calculated with contained crude drug amount in the Chinese medicine composition of the present invention, is each 10-20g, 3 times on the one.
The specific embodiment
Further describe the present invention below in conjunction with specific embodiment, advantage of the present invention and characteristics will be more clear along with description.But these embodiment only are exemplary, scope of the present invention are not constituted any restriction.It will be understood by those skilled in the art that and do not departing under the scope of the present invention and can make amendment or replace, but these modifications and replacing all fall within the scope of protection of the present invention the details of technical solution of the present invention and form.
The preparation of embodiment 1 capsule
Take by weighing each raw material by following weight: Cortex Mori 50g, Rhizoma Curcumae Longae 10g, Radix Glycyrrhizae 20g, Herba Andrographis 10g, Radix Scutellariae 10g, Radix Astragali 100g.
Get Cortex Mori and Rhizoma Curcumae Longae, add 10 times of weight water, flooded 60 minutes, vapor distillation extracted volatile oil 4 hours, collect the volatile oil part, add 5% NaCl salt condensation for removing water after, (weight ratio of volatile oil and beta-schardinger dextrin-is 1: 12 with beta-cyclodextrin inclusion compound, 50 ℃～55 ℃ dryings are pulverized the system fine powder); Decocting liquid filtered while hot, other puts; Medicinal residues add 6 times of weight, 80% alcohol reflux 3 times, and each 1.5h filters; Get Herba Andrographis and add 4 times of weight, 75% ethanol warm macerating (50 ℃) dynamic extraction 3 times, each 3h filters, and merges above-mentioned alcohol extract, reclaims ethanol; Get the Radix Astragali and Radix Glycyrrhizae, add the water microwave-assisted and extract, the back of waiting to seethe with excitement adds Radix Scutellariae, and microwave-assisted extracts 3 times, and each 5min adds water weight and is respectively 6 times, 6 times and 4 times; The decocting liquid filtered while hot merges with above-mentioned water extract, is evaporated to relative density at about 1.08～1.10 o'clock, merges with ethanol extract again, and continuing to be evaporated to relative density is 1.10～1.12 (60 ℃), spray drying; Add volatile oil clathrate compound and an amount of carboxymethylstach sodium, mixing, the capsule of packing into No. 1 is made 1000, promptly.
The preparation of embodiment 2 tablets
Get Cortex Mori 120g, Rhizoma Curcumae Longae 60g, Radix Glycyrrhizae 50g, Herba Andrographis 30g, Radix Scutellariae 30g, Radix Astragali 20g.
Get Cortex Mori and Rhizoma Curcumae Longae, add 3 times of weight water, flooded 30 minutes, vapor distillation extracted volatile oil 2 hours, collected the volatile oil part, add 5% NaCl salt condensation for removing water after, with beta-cyclodextrin inclusion compound (weight ratio of volatile oil and beta-schardinger dextrin-is 1: 12, and 50 ℃～55 ℃ dryings are pulverized the system fine powder); Decocting liquid filtered while hot, other puts; Medicinal residues add 2 times of weight, 80% alcohol reflux 3 times, and each 0.5h filters; Get Herba Andrographis and add 4 times of weight, 35% ethanol warm macerating (50 ℃) dynamic extraction 2 times, each 1h filters, and merges above-mentioned alcohol extract, reclaims ethanol; Get the Radix Astragali, Radix Glycyrrhizae, decoct with water, the back of waiting to seethe with excitement adds Radix Scutellariae, extracts 3 times, each 1h, add water weight and be respectively 6 times, 6 times and 4 times, the decocting liquid filtered while hot merges with above-mentioned water extract, be evaporated to relative density at about 1.08～1.10 o'clock, merge with ethanol extract, continuing to be evaporated to relative density is 1.10～1.12 (60 ℃), spray drying again; Add volatile oil clathrate compound and an amount of carboxymethylstach sodium, mixing is made tablet.
The preparation of embodiment 3 honey pill agents
Get Cortex Mori 200g, Rhizoma Curcumae Longae 100g, Radix Glycyrrhizae 100g, Herba Andrographis 120g, Radix Scutellariae 100g, Radix Astragali 100g.
Get Cortex Mori and Rhizoma Curcumae Longae, add 8 times of weight water, flooded 40 minutes, vapor distillation extracted volatile oil 3 hours, collected the volatile oil part, add 5% NaCl salt condensation for removing water after, with beta-cyclodextrin inclusion compound (weight ratio of volatile oil and beta-schardinger dextrin-is 1: 12, and 50 ℃～55 ℃ dryings are pulverized the system fine powder); Decocting liquid filtered while hot, other puts; Medicinal residues add 4 times of weight, 50% ethanol microwave-assisted and extract 3 times, and each 7min filters; Get Herba Andrographis, add 55% ethanol of 3 times of weight of Herba Andrographis, warm macerating (50 ℃) dynamic extraction 3 times, each 2h filters, and merges above-mentioned alcohol extract, reclaims ethanol.Get the Radix Astragali, Radix Glycyrrhizae, microwave-assisted extracts, and the back of waiting to seethe with excitement adds Radix Scutellariae, and microwave-assisted extracts 3 times, each 9min, add water and doubly measure 6 times, 6 times and 4 times that are respectively medical material weight, the extracting solution filtered while hot merges with above-mentioned water extract, be evaporated to relative density at about 1.08～1.10 o'clock, merge with ethanol extract, continuing to be evaporated to relative density is 1.10～1.12 (60 ℃), spray drying again; Add volatile oil clathrate compound, mixing with this medicated powder and the pure Oleum sesami of getting ready, the Mel mixed by 1: 2: 1, stirs again, makes honeyed pill promptly.
The preparation of embodiment 4 oral liquids
Get Cortex Mori 120g, Rhizoma Curcumae Longae 60g, Radix Glycyrrhizae 50g, Herba Andrographis 30g, Radix Scutellariae 30g, Radix Astragali 20g; Above-mentioned each crude drug is mixed, add the water of 7 times of weight, microwave-assisted extracts 3 times, each 5 minutes.Merge extractive liquid, filters, and is concentrated into every milliliter and contains crude drug 1.0g, adds Mel, bottle packing, every bottle of 20ml.
The preparation of embodiment 5 granules
Get Cortex Mori 120g, Rhizoma Curcumae Longae 60g, Radix Glycyrrhizae 50g, Herba Andrographis 30g, Radix Scutellariae 30g, Radix Astragali 20g; Each crude drug that takes by weighing is mixed, add 75% ethanol of 6 times of weight, heating and refluxing extraction 3 times was extracted 30 minutes at every turn.Merge extractive liquid, filters, and concentrates, and adds 4 times of amount cane sugar powder mixings, makes granule with 10 mesh sieves, and vacuum drying is crossed 10 mesh sieves, is distributed into bag promptly.
The external anti-HIV test of test example 1 Chinese medicine composition of the present invention
The people's such as Weislow O.W. of U.S. NCI method is adopted in vitro tests: MTT or XTT method.Measure Cortex Mori, Rhizoma Curcumae Longae, Herba Andrographis, Radix Scutellariae, the Radix Astragali, Radix Glycyrrhizae and these 6 kinds of crude drug are tested by the Different Weight proportioning are investigated them in external inhibitory action to HIV, measure their IC50 respectively, EC50 and TC50 value.Result of the test sees Table 1.
The external anti-HIV result of the test of table 1
Annotate: activity value EC
50, promptly medicine is to the active concentration value that suppresses at 50% o'clock of HIV.EC
50It is big more to be worth more little then pharmaceutically active.Toxicity value IC
50, promptly the medicine pair cell is killed 50% o'clock concentration value.IC
50It is more little to be worth big more then toxicity.Therapeutic index TC, TC=IC
50/ EC
50, the TC value is big more as can be known, and pharmaceutically active is good more.
Can see from above-mentioned result of the test: descending being respectively of therapeutic index of forming each crude drug of Chinese medicine composition of the present invention: the Cortex Mori＞Radix Scutellariae＞Radix Astragali＞Herba Andrographis＞Rhizoma Curcumae Longae＞Radix Glycyrrhizae, the compound recipe matching principle that meets Chinese medicine composition of the present invention shows that Chinese medicine composition of the present invention has a good anti HIV-1 virus activity external.
External anti-HIV test shows that Chinese medicine composition of the present invention can stop combining of HIV and target cell outside cd4 cell, also can suppress duplicating of HIV of reverse transcriptase prevention and avoid its increment when HIV duplicates.Can also strengthen the immunocompetence of the kill capability enhancing body of natural killer cell, thereby reach the purpose that many target spots are prevented and treated acquired immune deficiency syndrome (AIDS).
The acute toxicity test of test example 2 Chinese medicine compositions of the present invention
1, for the reagent thing: the capsule that the embodiment of the invention 1 is prepared;
2, test method and result: will give 40 mice administrations for the deal more than 100～200 times of the common dosage of reagent thing, and observe its poisoning situation.The result shows that obvious poisoning symptom does not all appear in mice in two weeks, and action, diet and defecation are all normal, and anomalism does not appear in body weight yet, and showing does not have the overt toxicity reaction outside for the reagent object.
The long term toxicity viewing test of test example 3 Chinese medicine compositions of the present invention
1, for the reagent thing: the capsule that the embodiment of the invention 1 is prepared;
2, test method and result: give 20 20 weeks of mice successive administration respectively, the poisoning situation of observing them for 50 times (6g/kg/day) of reagent thing adult's dosage (120mg/kg/day), the dosage of 25 times (3g/kg/day) and 12.5 times (1.5g/kg/day).And be contrast with 20 mices giving normal saline.The result shows that situations such as their action, diet, defecation, build, body weight are all normal.In the 10th week and the 20th week physiochemical indice and the blood parameters of mice detected, and carry out obduction, each organ such as the heart of mice, brain, liver, spleen, lung, kidney is carried out the histopathology observation.Above index is all normal, and illustrating for the reagent thing does not have long term toxicity, has illustrated that also adult's dosage 120mg/kg/day is in safety range.
The viewing test of the clinical efficacy of test example 4 Chinese medicine compositions of the present invention
One, the object of observation: HIV the infected, age-sex respectively account for certain proportion.
Two, diagnostic criteria: 1, HIV antibody is positive, and virus load is 20,000～200,000.2, CD4+ lymphocyte＞200cells/ml.3, there are not other any ill symptomses.4, do not take any other inverase.
Three, test method: this test is an object of study with 120 HIV the infecteds, and patient takes the prepared capsule 15g of embodiment 1, one day 3 times at every turn.HIV carrying capacity, the cd4 cell number behind the Chinese medicine composition of the present invention taken in observation.With 20 week be duration of trial, the intravital HIV carrying capacity of patient, cd4 cell numbers that per 4 weeks observe.
Four, observed result:
Patient accepts Clinical detection after 16 weeks of taking medicine, therapeutic outcome is as follows:
(1) 48 routine HIV the infected virus bearing capacity significantly descend (40%).
(2) 63 routine HIV the infected's virus bearing capacities obviously reduce (52.5%).
(3) 9 routine HIV the infected's virus bearing capacities do not have significant change (7.5%).
Be that obvious effective rate is 40%, total effective rate is 92.5%, and is as shown in table 2.So the invention Chinese medicine composition can significantly reduce the intravital HIV virus load of patient.Simultaneously, the intravital cd4 cell quantity of patient constantly rises, and is as shown in table 3.The 20th week is than taking the preceding cd4 cell 132cells/ml that risen.The immunocompetence that also is patient has obtained remarkable enhancing.
Table 2 patient takes behind the Chinese medicine composition of the present invention 0,4,8,12, the variation of 16,20 all inner virus HIV-RNA
Table 3 patient takes the variation of cd4 cells in 0,4,8,12,16,20 weeks behind the Chinese medicine composition of the present invention
Claims (15)
1. a Chinese medicine composition for the treatment of acquired immune deficiency syndrome (AIDS) is characterized in that, is made by each crude drug of following weight portion: Cortex Mori 5-20 part, Rhizoma Curcumae Longae 1-10 part, Radix Glycyrrhizae 2-10 part, Herba Andrographis 1-12 part, Radix Scutellariae 1-10 part and Radix Astragali 1-10 part.
2. according to the described Chinese medicine composition of claim 1, it is characterized in that the weight portion of each crude drug is: 12 parts of Cortex Mori, 6 parts in Rhizoma Curcumae Longae, 5 parts in Radix Glycyrrhizae, 3 parts of Herba Andrographis, 3 parts of Radix Scutellariaes, 2 parts of the Radixs Astragali.
3. according to claim 1 or 2 described Chinese medicine compositions, it is characterized in that: be prepared into any acceptable clinically preparation by Chinese medicine conventional formulation method.
4. according to the described Chinese medicine composition of claim 3, it is characterized in that: described preparation is an oral formulations.
5. according to the described Chinese medicine composition of claim 4, it is characterized in that: described oral formulations is selected from tablet, granule, capsule, powder, pill or oral liquid.
6. method for preparing claim 1 or 2 described Chinese medicine compositions may further comprise the steps:
(1) takes by weighing each crude drug by described weight portion;
(2) each crude drug water is carried, alcohol extraction or water carried add pharmaceutic adjuvant after the mode of combining with alcohol extraction is extracted the active component of crude drug, preparations shaping, promptly.
7. method according to claim 6 is characterized in that: described water is carried and adopted following steps to realize: each crude drug that will take by weighing mixes, and adds the water of 5-10 times of weight, heated and boiled, heating and refluxing extraction or microwave-assisted extract 1-4 time, merge extractive liquid, filters, and concentrates; Wherein, the time of heated and boiled or heating and refluxing extraction is each 30-60min, and the time that microwave-assisted extracts is each 1-10min.
8. method according to claim 6 is characterized in that: described alcohol extraction adopts following steps to realize: each crude drug that will take by weighing mixes, and adds the ethanol of the 30-80% of 5-10 times of weight, heated and boiled, heating and refluxing extraction or microwave-assisted extract 1-4 time, merge extractive liquid, filters, and concentrates; Wherein, the time of heated and boiled or heating and refluxing extraction is each 30-60min, and microwave-assisted extraction time is each 1-10min.
9. method according to claim 6 is characterized in that: describedly water is put forward the mode of combining with alcohol extraction realize by following steps:
(1) Cortex Mori and Rhizoma Curcumae Longae are carried out vapor distillation and extract its volatile oil part, with behind the inclusion essential oil volatile oil clathrate compound, standby; The decocting liquid of Cortex Mori and Rhizoma Curcumae Longae is partly filtered, get water extract 1, standby; The medicinal residues of Cortex Mori and Rhizoma Curcumae Longae carry out alcohol reflux or microwave-assisted again and extract, and get ethanol extract 1, and are standby;
(2) Herba Andrographis is carried out ethanol warm macerating dynamic extraction, get ethanol extract 2, standby;
(3) get that the Radix Astragali and Radix Glycyrrhizae decoct with water or microwave-assisted extracts, treat that water boiling back adds Radix Scutellariae, the aqueous extract and the above-mentioned water extract 1 of the Radix Astragali, Radix Glycyrrhizae and Radix Scutellariae are merged, merge spray drying behind the continuation concentrating under reduced pressure behind the concentrating under reduced pressure with ethanol extract 1 and ethanol extract 2; Add volatile oil clathrate compound and pharmaceutic adjuvant mixing, preparations shaping, promptly.
10. in accordance with the method for claim 9, it is characterized in that: the reuse vapor distillation extracts volatile oil 2-4h after in the step (1) Cortex Mori and Rhizoma Curcumae Longae being added 3-10 times of weight water retting 30-60min, collect the volatile oil part, add 5% NaCl salt condensation for removing water after, use beta-cyclodextrin inclusion compound.
11. in accordance with the method for claim 10, it is characterized in that: when carrying out enclose with beta-schardinger dextrin-, the weight ratio of volatile oil and beta-schardinger dextrin-is 1: 12, and baking temperature is 50～55 ℃.
12. in accordance with the method for claim 9, it is characterized in that: 30-80% alcohol reflux 1-3 time or the microwave-assisted that in the step (1) medicinal residues of Cortex Mori and Rhizoma Curcumae Longae are added 2-6 times of weight extract filtration 1-3 time.Each reflux extracting time is 0.5-1.5h, and microwave-assisted extraction time is 2-10min.
13. in accordance with the method for claim 9, it is characterized in that: the 30-75% ethanol that in the step (2) Herba Andrographis is added 2-4 times of weight dynamic extraction 3 times under 50-70 ℃ of temperature, extract 1-3h at every turn, filter.
14. in accordance with the method for claim 9, it is characterized in that: with water extraction 3 times of the Radix Astragali, Radix Glycyrrhizae and Radix Scutellariae, extract 1-3h in the step (3) at every turn; The number of times that microwave-assisted extracts is 3 times, extracts 2-10min at every turn; Wherein each amount of water is respectively 6 times, 6 times and 4 times of medical material weight.
15. claim 1 or the 2 described Chinese medicine compositions purposes in the medicine of preparation treatment acquired immune deficiency syndrome (AIDS).
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| CN 200910137525 CN101549140B (en) | 2009-04-28 | 2009-04-28 | Traditional Chinese medicine composition for treating AIDS and preparation method thereof |
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| CN101549140B true CN101549140B (en) | 2011-07-27 |
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| CN113876854A (en) * | 2021-10-25 | 2022-01-04 | 荣昌制药(淄博)有限公司 | Application of Chinese medicinal composition for ventilating lung and relieving asthma in preparation of HIV (human immunodeficiency virus) inhibiting medicament |
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