CN105288454A - Preparation method and uses of Xiaozheng Fuzheng traditional Chinese medicine composition - Google Patents
Preparation method and uses of Xiaozheng Fuzheng traditional Chinese medicine composition Download PDFInfo
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Abstract
The invention provides a preparation method of a Xiaozheng Fuzheng traditional Chinese medicine composition and aims to solve the problems that a current traditional Chinese medicine composition has low acting speed, low curative rate and inconvenience of long-term administration. The finished composition is made from Scolopendra, Scorpio, Bombyx Batryticatus, Rhizoma Paridis, Radix Curcumae, Rhizoma Atractylodis Macrocephalae, Poria, Endothelium Corneum Gigeriae Galli, Fructus Aurantii, Cortex Magnoliae Officinalis, Herba Artemisiae Scopariae, Folium Pyrrosiae, Radix Ophiopogonis, Fructus Lycii and Radix Stemonae. Effective ingredients in the herbs are extracted by means of protease enzymolysis, ethanol extraction, water extraction, supercritical extraction and the like according to differences between physicochemical properties of the effective ingredients in the herbs. The effective ingredients can be accurately enriched through the reacting provided by the invention, bioavailability is improved, and pharmacological activity is enhanced; dosage is further reduced for a patient, and the adverse effect caused by impurities in medicines is reduced. The invention discovers that the uses of Xiaozheng Fuzheng traditional Chinese medicine in treating senile dementia.
Description
Technical field
The present invention relates to technical field of Chinese medicines, be specially a kind of Preparation method and use of Xiao Disorder Fuzheng herbs compositions.
Background technology
The sickness rate of cancer is increasing year by year, has become the first killer jeopardizing human survival.Cancer is systemic disease, treatment of cancer finally capture the effective treatment depending on medicine.Nowadays, in cancer therapy drug, antibiotic, antimetabolite, plant amedica, biological gene, immune drug are widely used in clinical treatment, treatment of cancer is a a progressive step forward, extend life span, but the toxicity due to cancer therapy drug limits the increase of drug dose and the associating of multi-medicament, thus also limit the curative effect of medicine.What reason no matter cancer be caused by, and ascribing to is the pathological reaction that a kind of evil poison knot gathers eventually.No matter it is long wherein, the main clinical manifestation of most of cancer is distinctive lump.Therefore, detoxicating and resolving stagnation of pathogens, its lump that disappears is the concrete utilization of the traditional Chinese medical science " eliminating evil " principle in treatment of cancer, becomes the key point of Chinese medicine in Therapeutic cancer disease.One for the treatment of means that current Therapeutic cancer is very important is the method for excision, but the medicine of Therapeutic cancer that also do not match with operation in existing Chinese medicine.
Senile dementia, also claims Alzheimer, is a kind of persistence higher nerve functional activity obstacle, namely under the state not having disturbance of consciousness, and the obstacle of the aspects such as memory, thinking, analysis judgement, visual space identification, emotion.With the nervous system degenerative disease that memory and cognitive decrease are main clinical manifestation, its main pathological characters is a large amount of senile plaque, neurofibrillary tangles, amyloid beta deposition and neuron vacuolar degeneration and lose in a large number, and its cause of disease is relevant with neurotransmitter defect, inflammation, radical damage, amyloid, neurotoxicity, hormonoprivia, apoptosis etc.Senile dementia is mainly in elderly population, and due to the growth at age, the key element affecting each side of environment etc. result in the generation of senile dementia.The manifest symptom of senile dementia is hypomnesis and increases the weight of in Progressive symmetric erythrokeratodermia, bradykinesia, and possessiveness lowers, and interest reduces, and often stubbornlys adhere one's opinion, and personality changes, often centered by oneself, is easily got angry, good suspection.Muscle power and body weight decline gradually, and bradykinesia, body leans forward, amimia, and muscular tension generally increases, and gait is tiny, sometimes occurs Progressive symmetric erythrokeratodermia hemiplegia, aphasia, and late period is with bladder rectal dysfunction or general paralysis, or head and hand tremble, tic.The course of disease several years to many decades not etc., from the beginning of with spontaneous remission, but final many because of the complication such as secondary infection dead.Along with the arrival of aging society, the patient of senile dementia progressively increases.Its treatment is seemed particularly important.
The Drug therapy senile dementias such as current Western medicine many employings acetylcholine precursor thing, lecithin, trifluoperazine, though said medicine has certain curative effect, with side effect such as Nausea and vomiting, and bring serious burden to liver and kidney metabolism.In addition, usually use vasodilation class medicine clinically, as vincamine etc., it is only applicable to the slight patient of part, and side effect is larger.At present, there is the inapparent problem of curative effect in treatment by Chinese herbs, is difficult to fundamentally cure senile dementia.
Prior art document 1CN1931352A disclose Bombyx Batryticatus, Scolopendra, Scorpio, the Rhizoma Atractylodis Macrocephalae, Poria, Rhizoma Paridis, Endothelium Corneum Gigeriae Galli, Fructus Aurantii, Cortex Magnoliae Officinalis, Radix Curcumae, Herba Artemisiae Scopariae, Folium Pyrrosiae, Radix Ophiopogonis, Fructus Lycii, Radix Stemonae composition Chinese medicine composition and be used for the treatment of the adjuvant therapy medicaments of patients with lung cancer that the insufficiency of the spleen stagnation of QI has ecchymosis card concurrently, and share with chemotherapy the symptom that has some improvement, improve the effect of T lymphocyte immunologic function.It discloses following preparation method to decoct with water, filter, filtrate concentrates and adds ethanol, leaves standstill, filters, and removing ethanol, adds customary adjuvant, make required dosage form.Prior art document 2CN102139085A discloses the purposes that a kind of Xiao Disorder Fuzheng herbs is used for the treatment of cancer, by taking the crude drug Scolopendra of parts by weight, Scorpio, Bombyx Batryticatus, Rhizoma Paridis, Radix Curcumae, the Rhizoma Atractylodis Macrocephalae, Poria, Endothelium Corneum Gigeriae Galli, Fructus Aurantii, Cortex Magnoliae Officinalis, Herba Artemisiae Scopariae, Folium Pyrrosiae, Radix Ophiopogonis, Fructus Lycii and the Radix Stemonae, decoct with water, pour out decoction liquor, filter, filtrate concentrates, then add ethanol, leave standstill, filter, reclaim ethanol, then to add water and sodium benzoate obtains the oral administration solution of Chinese medicine composition.
Owing to containing a large amount of saccharide, phlegmatic temperament and tannin composition in prescription, these medical materials are after water boiling and extraction, it is in the medicine of a warm nature liquid of water that impurity component wherein can be dissolved in solvent, during heat filter, saccharide, phlegmatic temperament and tannin still can be passed through, finally concentrate and obtain the extractum comparing thickness, these impurity are just stayed in extractum.The existence of these impurity can cause some side effect, makes product not reach higher quality.For liquid preparation, due to the cause of saccharide and tannin, at its lay up period, certainly lead to precipitation or mycete; For pill or tablet, and saccharide, mucilaginous existence, both easily microbiological contamination and leaching is transfinited very easily aborning, thus affects the quality of the pharmaceutical preparations.
Summary of the invention
The object of this invention is to provide a kind of Xiao Disorder Fuzheng herbs preparation method of composition, the Chinese medicine composition that this preparation method prepares can effectively improve effective active matter concentration, reduces impurity content in Chinese medicine composition, thus minimizing treats dosage, reduce side effect, relieve patient ' s burden.Another object of the present invention is and find that this Chinese medicine composition can play good prevention effect for alzheimer disease.To sum up, for achieving the above object, the present invention adopts following technical scheme:
Be prepared from by described parts by weight by following raw material medicaments: Scolopendra 10-30, Scorpio 20-40, Bombyx Batryticatus 100-200, Rhizoma Paridis 50-150, Radix Curcumae 100-200, Rhizoma Atractylodis Macrocephalae 100-200, Poria 100-200, Endothelium Corneum Gigeriae Galli 100-200, Fructus Aurantii 100-200, Cortex Magnoliae Officinalis 30-100, Herba Artemisiae Scopariae 50-150, Folium Pyrrosiae 100-200, Radix Ophiopogonis 100-200, Fructus Lycii 200-400, Radix Stemonae 50-150.
Be prepared from by described parts by weight by following raw material medicaments: Scolopendra 15-25, Scorpio 25-35, Bombyx Batryticatus 130-170, Rhizoma Paridis 80-120, Radix Curcumae 130-170, Rhizoma Atractylodis Macrocephalae 130-170, Poria 130-170, Endothelium Corneum Gigeriae Galli 130-170, Fructus Aurantii 130-170, Cortex Magnoliae Officinalis 50-70, Herba Artemisiae Scopariae 80-120, Folium Pyrrosiae 130-170, Radix Ophiopogonis 130-170, Fructus Lycii 250-350, Radix Stemonae 70-130.
Be prepared from by described parts by weight by following raw material medicaments: Scolopendra 20, Scorpio 30, Bombyx Batryticatus 150, Rhizoma Paridis 100, Radix Curcumae 150, the Rhizoma Atractylodis Macrocephalae 150, Poria 150, Endothelium Corneum Gigeriae Galli 150, Fructus Aurantii 150, Cortex Magnoliae Officinalis 60, Herba Artemisiae Scopariae 100, Folium Pyrrosiae 150, Radix Ophiopogonis 150, Fructus Lycii 300, the Radix Stemonae 100.
Described Endothelium Corneum Gigeriae Galli is Endothelium Corneum Gigeriae Galli (parched).
The described Radix Stemonae is sweet Radix Stemonae (parched).
The invention provides a kind of preparation method of Xiao Disorder Fuzheng herbs compositions, it is characterized in that comprising the steps:
(1) take off the raw material of Chinese medicine stating mass parts: Scolopendra 10-30, Scorpio 20-40, Bombyx Batryticatus 100-200, Rhizoma Paridis 50-150, Radix Curcumae 100-200, Rhizoma Atractylodis Macrocephalae 100-200, Poria 100-200, Endothelium Corneum Gigeriae Galli 100-200, Fructus Aurantii 100-200, Cortex Magnoliae Officinalis 30-100, Herba Artemisiae Scopariae 50-150, Folium Pyrrosiae 100-200, Radix Ophiopogonis 100-200, Fructus Lycii 200-400, Radix Stemonae 50-150;
(2) Scolopendra, Scorpio, Bombyx Batryticatus through three gross mass 8-10 water doubly in 35 ~ 45 DEG C of milling and extracting 2 times, extract supernatant as extracting solution, and the compound protease adding 0.3-0.5% in extracting solution was in 36 ± 3 DEG C of enzymolysis 90 minutes, the enzymolysis solution polypeptide of Ultra filtration membrane wherein 1-10kDa;
(3) obtain aqueous extract A and oil water mixture with water extraction Fructus Lycii, the Rhizoma Atractylodis Macrocephalae and Radix Curcumae, wherein the addition of water is quality of medicinal material 6 ~ 10 times, and extraction time is 3.0 ~ 7.0 hours; Adopt ultrafilter membrane to be separated by described oil water mixture, ultra-filter retentate is volatile oil, and ultrafiltration permeate is as aqueous extract B; By volatile oil beta-cyclodextrin inclusion compound, obtain volatile oil clathrate compound;
(4) with water extraction Rhizoma Paridis, Poria, Endothelium Corneum Gigeriae Galli, Fructus Aurantii, Cortex Magnoliae Officinalis, Herba Artemisiae Scopariae, Folium Pyrrosiae, Radix Ophiopogonis and Radix Stemonae 2-3 time, wherein, in each water extraction process, the addition of water is quality of medicinal material 7 ~ 12 times, and each extraction time is 1 ~ 3 hour, obtains aqueous extract C;
(5) aqueous extract A, aqueous extract B and aqueous extract C are merged, carry out microfiltration, get MF permeate liquid; Wherein, the membrane aperture that microfiltration separating treatment adopts is 0.05 ~ 0.2 μm, membrane material is Al
2o
3ceramic film component, operative temperature 30 ~ 80 DEG C, operating pressure 0.2 ~ 0.8MPa;
(6) when step (5) gained MF permeate liquid being reduced to 60 DEG C, relative density is, after 1.08-1.10, mix homogeneously, obtain the By Chinese Medicines agent being used for the treatment of senile dementia with volatile oil clathrate compound; Or by described MF permeate liquid inlet temperature 140 ~ 170 DEG C, under the condition that leaving air temp is 70 ~ 90 DEG C, spraying dry obtains dry powder, is mixed homogeneously by described dry powder with volatile oil clathrate compound, add dextrin or stevioside, make granule, capsule or tablet.
In addition, the present invention relates to Xiao Disorder Fuzheng herbs compositions also can according to following known conventional method preparation, get the crude drug Scolopendra meeting described parts by weight, Scorpio, Bombyx Batryticatus, Rhizoma Paridis, Radix Curcumae, the Rhizoma Atractylodis Macrocephalae, Poria, Endothelium Corneum Gigeriae Galli, Fructus Aurantii, Cortex Magnoliae Officinalis, Herba Artemisiae Scopariae, Folium Pyrrosiae, Radix Ophiopogonis, Fructus Lycii and the Radix Stemonae, the water adding crude drug gross weight 4-8 times weight decocts, decoct 1-3 hour, pour out decoction liquor, filter, it is 1.12-1.16 that filtrate is concentrated into relative density, be the density under 60 DEG C of conditions, then adding ethanol to alcohol content is 80%, leave standstill 12-48 hour, filter, reclaim ethanol, add the water of 200-800 weight portion, add the sodium benzoate of 3-8 weight portion again, stir evenly, filter, fill, sterilizing and get final product.
The described crude drug gross weight 4-8 water doubly that adds carries out decocting the water specifically adding crude drug gross weight octuple, six times, four times weight respectively, and decoct three times, first time decocts 2 hours, and second time decocts 1.5 hours, and third time decocts 1 hour, merges decoction liquor.Described sterilizing adopts high temperature and high pressure steam sterilization.Described sterilising temp is 110-123 DEG C, sterilization time is 20-40 minute, and pressure is at 0.6 ~ 1MPa.The concentration of described ethanol is 95%.
Beneficial effect of the present invention is as follows: the preparation method of Xiao Disorder Fuzheng herbs compositions provided by the invention, make the scorpion venom antitumor many furans APBMV in Scorpio, diosgenin in Rhizoma Paridis, protocatechuic acid in Fructus Lycii, dihydro Hesperetic acid, atractylone in the Rhizoma Atractylodis Macrocephalae and atractylol, Rhizoma Curcumae diene in Radix Curcumae, the effective ingredient of the fuling triterpene in Poria etc. obtains enrichment, this preparation method gained Xiao Disorder Fuzheng herbs compositions therapeutic effect is good, toxic and side effects is little, preparation method effectively improves effective active matter concentration, reduce impurity content in Chinese medicine composition, be suitable for clinical practice.
Detailed description of the invention
According to following embodiment, the present invention may be better understood.But those skilled in the art will readily understand, concrete material proportion, process conditions and result thereof described by embodiment only for illustration of the present invention, and should can not limit the present invention described in detail in claims yet.
Embodiment 1
Chinese medicine composition is prepared from by described weight by following raw material medicaments: Scolopendra 10g, Scorpio 40g, Bombyx Batryticatus 100g, Rhizoma Paridis 150g, Radix Curcumae 100g, Rhizoma Atractylodis Macrocephalae 200g, Poria 100g, Endothelium Corneum Gigeriae Galli 200g, Fructus Aurantii 100g, Cortex Magnoliae Officinalis 100g, Herba Artemisiae Scopariae 150g, Folium Pyrrosiae 100g, Radix Ophiopogonis 200g, Fructus Lycii 200g, Radix Stemonae 150g.
The concrete preparation method of above-mentioned Xiao Disorder Fuzheng herbs compositions is as follows:
(1) Scolopendra, Scorpio, Bombyx Batryticatus through the water of three's gross mass 8 times in 35 DEG C of milling and extracting 2 times, extract supernatant as extracting solution, and the compound protease adding 0.3% in extracting solution was in 33 DEG C of enzymolysis 90 minutes, enzymolysis solution Ultra filtration membrane wherein 1-10kDa polypeptide;
(2) obtain aqueous extract A and oil water mixture with water extraction Fructus Lycii, the Rhizoma Atractylodis Macrocephalae and Radix Curcumae, wherein the addition of water is quality of medicinal material 6 times, and extraction time is 3.0 hours; Described oil water mixture is adopted Ultra filtration membrane, and ultra-filter retentate is volatile oil, and ultrafiltration permeate is as aqueous extract B; By volatile oil beta-cyclodextrin inclusion compound, obtain volatile oil clathrate compound;
(3) with water extraction Rhizoma Paridis, Poria, Endothelium Corneum Gigeriae Galli, Fructus Aurantii, Cortex Magnoliae Officinalis, Herba Artemisiae Scopariae, Folium Pyrrosiae, Radix Ophiopogonis and the Radix Stemonae 2 times, wherein, in each water extraction process, the addition of water is quality of medicinal material 7 times, and each extraction time is 1 hour, obtains aqueous extract C;
(4) aqueous extract A, aqueous extract B and aqueous extract C are merged, carry out microfiltration, get MF permeate liquid; Wherein, adopt that membrane aperture is 0.05 μm, membrane material is Al
2o
3ceramic film component carry out microfiltration separating treatment, operative temperature 80 DEG C, operating pressure 0.8MPa;
(5) when step (5) gained MF permeate liquid being reduced to 60 DEG C, relative density is, after 1.08-1.10, mix homogeneously, must be used for the treatment of the By Chinese Medicines agent of senile dementia with volatile oil clathrate compound.
Endothelium Corneum Gigeriae Galli described in the present embodiment preferably adopts Endothelium Corneum Gigeriae Galli (parched); The Radix Stemonae preferably adopts sweet Radix Stemonae (parched).
Embodiment 2
Chinese medicine composition is prepared from by described weight by following raw material medicaments: Scolopendra 30g, Scorpio 20g, Bombyx Batryticatus 200g, Rhizoma Paridis 50g, Radix Curcumae 200g, Rhizoma Atractylodis Macrocephalae 100g, Poria 200g, Endothelium Corneum Gigeriae Galli 100g, Fructus Aurantii 200g, Cortex Magnoliae Officinalis 30g, Herba Artemisiae Scopariae 50g, Folium Pyrrosiae 200g, Radix Ophiopogonis 100g, Fructus Lycii 400g, Radix Stemonae 50g.
The concrete preparation method of above-mentioned Xiao Disorder Fuzheng herbs compositions is as follows:
(1) Scolopendra, Scorpio, Bombyx Batryticatus through the water of three's gross mass 10 times in 45 DEG C of milling and extracting 2 times, extract supernatant as extracting solution, and the compound protease adding 0.5% in extracting solution was in 39 DEG C of enzymolysis 90 minutes, enzymolysis solution Ultra filtration membrane wherein 1-10kDa polypeptide;
(2) obtain aqueous extract A and oil water mixture with water extraction Fructus Lycii, the Rhizoma Atractylodis Macrocephalae and Radix Curcumae, wherein the addition of water is quality of medicinal material 10 times, and extraction time is 7.0 hours; Described oil water mixture is adopted Ultra filtration membrane, and ultra-filter retentate is volatile oil, and ultrafiltration permeate is as aqueous extract B; By volatile oil beta-cyclodextrin inclusion compound, obtain volatile oil clathrate compound;
(3) with water extraction Rhizoma Paridis, Poria, Endothelium Corneum Gigeriae Galli, Fructus Aurantii, Cortex Magnoliae Officinalis, Herba Artemisiae Scopariae, Folium Pyrrosiae, Radix Ophiopogonis and Radix Stemonae 2-3 time, wherein, in each water extraction process, the addition of water is quality of medicinal material 12 times, and each extraction time is 3 hours, obtains aqueous extract C;
(4) aqueous extract A, aqueous extract B and aqueous extract C are merged, carry out microfiltration, get MF permeate liquid; Wherein, adopt that membrane aperture is 0.2 μm, membrane material is Al
2o
3ceramic film component carry out microfiltration separating treatment, operative temperature 30 DEG C, operating pressure 0.2MPa;
(5) by step (5) gained MF permeate liquid inlet temperature 170 DEG C, under the condition that leaving air temp is 90 DEG C, spraying dry obtains dry powder, described dry powder is mixed homogeneously with volatile oil clathrate compound, add dextrin or stevioside, make the Chinese medicine granules being used for the treatment of senile dementia.
Embodiment 3
Chinese medicine composition is prepared from by described weight by following raw material medicaments: Scolopendra 10g, Scorpio 40g, Bombyx Batryticatus 100g, Rhizoma Paridis 150g, Radix Curcumae 100g, Rhizoma Atractylodis Macrocephalae 200g, Poria 100g, Endothelium Corneum Gigeriae Galli 200g, Fructus Aurantii 100g, Cortex Magnoliae Officinalis 100g, Herba Artemisiae Scopariae 150g, Folium Pyrrosiae 100g, Radix Ophiopogonis 200g, Fructus Lycii 200g, Radix Stemonae 150g.
The preparation method of above-mentioned Xiao Disorder Fuzheng herbs compositions, get the crude drug Scolopendra of described weight, Scorpio, Bombyx Batryticatus, Rhizoma Paridis, Radix Curcumae, the Rhizoma Atractylodis Macrocephalae, Poria, Endothelium Corneum Gigeriae Galli, Fructus Aurantii, Cortex Magnoliae Officinalis, Herba Artemisiae Scopariae, Folium Pyrrosiae, Radix Ophiopogonis, Fructus Lycii and the Radix Stemonae, add crude drug gross weight 8 times, 6 times, the water of 4 times of weight, decoct 3 times, first time decocts 2 hours, second time decocts 1.5 hours, third time decocts 1 hour, merge decoction liquor, filter, it is 1.12-1.16 that filtrate is concentrated into relative density, be the density under 60 DEG C of conditions, then adding ethanol to alcohol content is 80%, leave standstill 24 hours, filter, reclaim ethanol, add the water of 800g, add the sodium benzoate of 3g again, stir evenly, filter, fill, high temperature and high pressure steam sterilization is adopted to carry out sterilizing and get final product.
Above-mentioned sterilising temp is 123 DEG C, sterilization time is 20 minutes, and pressure is at 0.6MPa.The concentration of ethanol is 95%.
Endothelium Corneum Gigeriae Galli described in the present embodiment preferably adopts Endothelium Corneum Gigeriae Galli (parched); The Radix Stemonae adopts sweet Radix Stemonae (parched).
Embodiment 4
Chinese medicine composition is prepared from by described weight by following raw material medicaments: Scolopendra 30g, Scorpio 20g, Bombyx Batryticatus 200g, Rhizoma Paridis 50g, Radix Curcumae 200g, Rhizoma Atractylodis Macrocephalae 100g, Poria 200g, Endothelium Corneum Gigeriae Galli 100g, Fructus Aurantii 200g, Cortex Magnoliae Officinalis 30g, Herba Artemisiae Scopariae 50g, Folium Pyrrosiae 200g, Radix Ophiopogonis 100g, Fructus Lycii 400g, Radix Stemonae 50g.
The preparation method of above-mentioned Xiao Disorder Fuzheng herbs compositions, get the crude drug Scolopendra meeting and state weight, Scorpio, Bombyx Batryticatus, Rhizoma Paridis, Radix Curcumae, the Rhizoma Atractylodis Macrocephalae, Poria, Endothelium Corneum Gigeriae Galli, Fructus Aurantii, Cortex Magnoliae Officinalis, Herba Artemisiae Scopariae, Folium Pyrrosiae, Radix Ophiopogonis, Fructus Lycii and the Radix Stemonae, add crude drug gross weight 4-8 water doubly to decoct, decoct 1-3 hour, pour out decoction liquor, filter, it is 1.12-1.16 that filtrate is concentrated into relative density, be the density under 60 DEG C of conditions, then adding 95% ethanol to alcohol content is 80%, leave standstill 36 hours, filter, reclaim ethanol, add the water of 200g, add the sodium benzoate of 8g again, stir evenly, filter, fill, high temperature and high pressure steam sterilization is adopted to carry out sterilizing and get final product.Sterilising temp is 110 DEG C, sterilization time is 40 minutes, and pressure is at 0.7MPa.
Embodiment 5:
Chinese medicine composition is prepared from by described weight by following raw material medicaments: Scolopendra 25g, Scorpio 25g, Bombyx Batryticatus 130g, Rhizoma Paridis 120g, Radix Curcumae 130g, Rhizoma Atractylodis Macrocephalae 170g, Poria 130g, Endothelium Corneum Gigeriae Galli 170g, Fructus Aurantii 130g, Cortex Magnoliae Officinalis 70g, Herba Artemisiae Scopariae 120g, Folium Pyrrosiae 170g, Radix Ophiopogonis 130g, Fructus Lycii 350g, Radix Stemonae 130g.
The preparation method of above-mentioned Xiao Disorder Fuzheng herbs compositions, get the crude drug Scolopendra of described weight, Scorpio, Bombyx Batryticatus, Rhizoma Paridis, Radix Curcumae, the Rhizoma Atractylodis Macrocephalae, Poria, Endothelium Corneum Gigeriae Galli, Fructus Aurantii, Cortex Magnoliae Officinalis, Herba Artemisiae Scopariae, Folium Pyrrosiae, Radix Ophiopogonis, Fructus Lycii and the Radix Stemonae, add 1000g water to decoct, decoct 2 hours, pour out decoction liquor, filter, it is 1.12-1.16 that filtrate is concentrated into relative density, be the density under 60 DEG C of conditions, then adding ethanol to alcohol content is 80%, leave standstill 48 hours, filter, reclaim ethanol, add the water of 500g, add the sodium benzoate of 5g again, stir evenly, filter, fill, sterilizing and get final product.
Above-mentioned sterilizing adopts high temperature and high pressure steam sterilization, and sterilising temp is 112 DEG C, sterilization time is 35 minutes, and pressure is at 1MPa.The concentration of ethanol is 95%.
Carry out clinical laboratory data below by way of to Chinese medicine composition of the present invention, further illustrate medicine of the present invention.
Embodiment 6: pharmaceutical composition of the present invention is to the Inhibition test of tumor cells of hepatocellular carcinoma strain
1. material
1.1. blank medicine: physiological saline solution 1g/kg body weight.
Positive control drug: matched group awards cyclophosphamide, dosage is 150mg/kg/d.
The embodiment of the present invention 1 and 2 Xiao Disorder Fuzheng herbs compositions: prepare Xiao Disorder Fuzheng herbs compositions by embodiment 1 and embodiment 2, make the agent of 15mg/ml By Chinese Medicines with 1% Carboxymethyl cellulose sodium aqueous solution, dosage is 200mg/kg/d.
The Chinese medicine composition that the open method of CN1931352A embodiment 1 prepares, dosage is 200mg/kg/d.
The Chinese medicine composition that the open method of CN102139085A embodiment 1 prepares, dosage is 200mg/kg/d.
1.2. animal: KM mice, body weight 22 ± 3 grams.
1.3. tumor strain: hepatocarcinoma HepS22.
2. experimental technique:
Get lotus tumor Mus of going down to posterity to take off cervical vertebra and put to death, cut skin, select tumor growth good, without cancerous tissue that is downright bad or liquefaction, add physiological saline solution by 1: 3, make cancer cell suspension with Potter-Elvehjem Tissue Grinders, at experiment mice axillary fossa subcutaneous vaccination 0.2ml.Inoculation random packet rear next day, often organizes 12.Gastric infusion, once a day, administration was put to death after 10 days.
Weigh, pluck tumor, weigh, calculate tumour inhibiting rate, computing formula is as follows:
3. statistical method
Data acquisition SPSS16.0 software carries out statistical analysis, measurement data with
represent, before and after treatment, Indexes Comparison is adopted
Check with t; Enumeration data adopts X2 inspection.P < 0.05 represents that difference has statistical significance.
4. experimental result
Table 1: medicine of the present invention is on the impact of HepS solid tumor
Compare with model group: & P < 0.05, compare with matched group: * P < 0.05.
Experimental result shows, Chinese medicine composition of the present invention has obvious inhibitory action to mouse experiment liver tumor.The inhibition of this invention Xiao Disorder Fuzheng herbs compositions (embodiment 3 and 4) is better than CN1931352A and CN102139085A, and has significant difference, has statistical significance.
The evaluating drug effect of embodiment 7: Xiao Disorder Fuzheng herbs compositions.
1, laboratory animal and modeling
Screening SD rat 50, male and female half and half, body weight 220-250g; Qualified SD rat will be screened with Morris water maze, be divided into Normal group 10 and modeling group 40 at random.Normal group to normal saline gavage, drinking public water supply.Modeling group is to AlCl
3solution, concentration is 50g/L, and by 500mg/kg/d, gavage when every day the morning nine, continues 2 months.Modeling group started from three month the AlCl that free drinking concentration is 1.6g/L
3solution, continues 3 months.Regularly carry out the situation of change that water maze laboratory measures learning and memory in rats.
Through Morris determined with Morris water during modeling 5 months, modeling group learning and memory in rats level obviously declines, and there were significant differences with Normal group.After modeling success, Chinese medicine composition that the Chinese medicine composition of senile dementia, the embodiment of the present invention 3 and embodiment 4 treat senile dementia often organizes 10 to be divided into by modeling group rat model control group, positive controls, the embodiment of the present invention 1 and embodiment 2 to treat at random.
2, Experimental agents
Blank medicine: 1% Carboxymethyl cellulose sodium aqueous solution.
Positive control drug: trifluoperazine hydrochloride sheet, makes 0.025mg/ml suspension with 1% Carboxymethyl cellulose sodium aqueous solution; Dosage is 150mg/kg/d.
The embodiment of the present invention 1 and 2 Xiao Disorder Fuzheng herbs compositions: prepare Xiao Disorder Fuzheng herbs compositions by embodiment 1 and embodiment 2, make the agent of 15mg/ml By Chinese Medicines with 1% Carboxymethyl cellulose sodium aqueous solution, dosage is 200mg/kg/d.
The embodiment of the present invention 3 and 4 Xiao Disorder Fuzheng herbs compositions: prepare Xiao Disorder Fuzheng herbs compositions by embodiment 3 and embodiment 4, make 25mg/ml suspension with 1% Carboxymethyl cellulose sodium aqueous solution, dosage is 200mg/kg/d.
3, experimental technique and result
Normal group, model control group, positive controls, this invention disappear Disorder Fuzheng herbs compositions respectively gastric infusion, once a day, carry out water maze laboratory after continuous three months.Water maze test comprises orientation navigation test and space exploration experiment.
3.1AlCl
3the memory ability of rat model is affected
Before modeling, 50 qualified rats of screening are positioned to sail training and record its school grade, the school grade of rat significantly improves, by the 6th day through checking its achievement and the 5th day no significant difference, deconditioning.
Rat dye aluminum is after 5 months, the escape latency of model control group in constant-bearing navigation test and search citing obviously extend, obviously reduce in the search time of former safety island place quadrant and exploration distance in space exploration experiment, with Normal group ratio, there is significant difference P < 0.01, showing, there is Spatial memory obstacle in model control group, modeling success.
Table 2AlCl
3on the impact of the constant-bearing navigation ability of rat model
Table 2AlCl
3on the impact of the space exploration ability of rat model
3.2 Xiao Disorder Fuzheng herbs compositionss are to AlCl
3the treatment of guidance model rat
Compared with model group, after gavage treats three months, the escape latency of obvious shortening rat in constant-bearing navigation test and detection range, search time of the former safety island quadrant of rat in space exploration experiment and explore distance and obviously extend, show that Xiao Disorder Fuzheng herbs compositions is to AlCl
3the memory ability of guidance model rat has clear improvement.
Table 3 Xiao Disorder Fuzheng herbs compositions is to AlCl
3the impact of the sizing operational capabilities of guidance model rat
Table 4 Xiao Disorder Fuzheng herbs compositions is to AlCl
3the impact of the space exploration ability of guidance model rat
Embodiment 8: clinical research
Select 100 examples to have patients of senile dementia, use clinical observation half a year, man 58, female 42 example, the age 59-84 year, the mean age 69.20, mild dementia 32 example, moderate dementia 50 example, severe dementia 18 example.Take medicine of the present invention every day twice.
Matched group 60 example has patients of senile dementia, wherein man 36 example, female 24 example, the age 55-79 year, 64.67 years old mean age, mild dementia 23 example, moderate dementia 31 example, moderate dementia 6 example.Take placebo every day twice.Double blind experiment is carried out between treatment group and matched group
1, HDS integral contrast before and after two groups of treatments
| Group | Number of cases | Average before treating | Average after treating | Equal value difference ± standard deviation |
| Experimental group | 100 | 19.51 | 24.61 | 5.1±0.87 |
| Matched group | 60 | 17.95 | 20.68 | 2.73±2.01 |
2, model case
Case 1: Lee, man 61 years old.Family numbers of patients master state, and 2012 ill, is diagnosed as " senile dementia " to examination in hospital.Take lecithin, symptom without improvement, after use again trifluoperazine poor effect, take vincamine again, still to no effect, after other traditional Chinese medical science of seeking medical advice again take other treatments by Chinese herbs, the state of an illness is without improvement.Before taking this compositions, behavior is unsociable and eccentric, and life is slack, and bulesis goes down, and murmurs to oneself, and certainly laughs at, and realizes without audition.Take medicine of the present invention every day twice, after taking first quarter moon continuously, symptom is clearly better, and after 1 month, certainly laugh at, the phenomenon that murmurs to oneself can control, after two months, can participate in collective activity, after three months, behavior autonomy strengthens, and thinking is clear.
Case 2: Cai, female, 72 years old, patient closely over the past half year Progressive symmetric erythrokeratodermia knew and can go down, disturbance of consciousness in various degree, at present not only thing recent amnesia far away, and seriously lose memory, the children of oneself, friends and family are not familiar with, expression is dull-witted, and bradykinesia, gives an irrelevant answer, soliloquy, voice owe clear, idle feelings drowsiness, indigestion and loss of appetite weak, slow movement, haltingly, incontinence of urination and defecation, face is impractical, pale tongue, Bian Zi, white and thin fur, deep,thready and forceless pulse.Be diagnosed as alzheimer disease.Take this medicine every day twice, after taking first quarter moon continuously, symptom is clearly better, and memory, spirit, diet, language all recover normal, and incontinence of urination and defecation is cured, and life can take care of oneself.Follow up a case by regular visits to and do not recur so far.
Case 3: Hao, male, 68 years old.Tell over nearly 2 months, be slow in action, bradyphrenia, lethargy, dull, being irritable and getting angry easily, speech reduces, and acra is not warm.Once suffered from cerebral infarction twice, and left over left limb activity and owe flexibly, to look into head CT and show: the multiple low-density stove in bilateral basal joint district, dimly pale tongue, while there is indentation, moist and slippery fur is greasy, stringy and rolling pulse.Examine as alzheimer disease.Take this medicine every day twice, after taking first quarter moon continuously, symptom is clearly better, and patient's private prosecution is refreshed, before action comparatively flexibly, lower limb are strong, and diet increases, and after following the service 20 doses, all cards disappear, energetic, conscious health is strong, reaction flexibly, can with people's normal communication, speech increases.Follow up a case by regular visits to and do not recur so far.
Case 4: Lee, female, 65 years old.Started to show as behavior before 3 years slow, always ask a problem, forgetful, July last year, be diagnosed as senile dementia in local hospital inspection, go this year check the state of an illness more worsen, show as have a dull expression on one's face, dull-looking, sialorrhea, dysphonia, talk incoherently, bradykinesia, lurch, memory and understandability is poor, judgement and capacity of orientation obviously go down, sometimes stand health to beat backward and stagger, see a doctor in here then.Take this medicine every day twice, after taking first quarter moon continuously, look salubrious, and before action comparatively flexibly, memory and faculty of understanding improve, and after following the service 15 doses, all cards disappear, and lamprophonia, takes action convenient, fully recover.Follow up a case by regular visits to and do not recur so far.
Case 5: grandson, male, 75 years old, suffer from senile dementia as long as five years, time of occurrence disorientation, can not recall the work experience of oneself, hypomnesis, forgets the name of oneself kith and kin, language function obstacle, and repetition of speaking, intelligence declines to some extent.Take this medicine every day twice, after taking first quarter moon continuously, above-mentioned symptom is eased, and intelligence spirit is all improved, and continue medication, above-mentioned symptom is effectively controlled.
Experimental result shows the Chinese herbal medicine compatibility that Chinese medicine composition of the present invention adopts Scolopendra, Scorpio, Bombyx Batryticatus, Rhizoma Paridis, Radix Curcumae, the Rhizoma Atractylodis Macrocephalae, Poria, Endothelium Corneum Gigeriae Galli, Fructus Aurantii, Cortex Magnoliae Officinalis, Herba Artemisiae Scopariae, Folium Pyrrosiae, Radix Ophiopogonis, Fructus Lycii and the Radix Stemonae, scientific and reasonable, mutual synergism, play effect of nourishing the brain and improving intelligence, consciousness-restoring and orifice-opening, kidney tonifying, essence replenishing, benefiting QI for activating blood circulation altogether, there is significant effect, instant effect for treatment senile dementia, cure rate is high, short treating period, has no side effect, and overall clinical efficacy rate reaches more than 90%.
Claims (6)
1. a preparation method for the Disorder Fuzheng herbs compositions that disappears, is characterized in that comprising the steps:
(1) take off the raw material of Chinese medicine stating mass parts: Scolopendra 10-30, Scorpio 20-40, Bombyx Batryticatus 100-200, Rhizoma Paridis 50-150, Radix Curcumae 100-200, Rhizoma Atractylodis Macrocephalae 100-200, Poria 100-200, Endothelium Corneum Gigeriae Galli 100-200, Fructus Aurantii 100-200, Cortex Magnoliae Officinalis 30-100, Herba Artemisiae Scopariae 50-150, Folium Pyrrosiae 100-200, Radix Ophiopogonis 100-200, Fructus Lycii 200-400, Radix Stemonae 50-150;
(2) Scolopendra, Scorpio, Bombyx Batryticatus through three gross mass 8-10 water doubly in 35 ~ 45 DEG C of milling and extracting 2 times, extract supernatant as extracting solution, and the compound protease adding 0.3-0.5% in extracting solution was in 36 ± 3 DEG C of enzymolysis 90 minutes, the enzymolysis solution polypeptide of Ultra filtration membrane wherein 1-10kDa;
(3) obtain aqueous extract A and oil water mixture with water extraction Fructus Lycii, the Rhizoma Atractylodis Macrocephalae and Radix Curcumae, wherein the addition of water is quality of medicinal material 6 ~ 10 times, and extraction time is 3.0 ~ 7.0 hours; Adopt ultrafilter membrane to be separated by described oil water mixture, ultra-filter retentate is volatile oil, and ultrafiltration permeate is as aqueous extract B; By volatile oil beta-cyclodextrin inclusion compound, obtain volatile oil clathrate compound;
(4) with water extraction Rhizoma Paridis, Poria, Endothelium Corneum Gigeriae Galli, Fructus Aurantii, Cortex Magnoliae Officinalis, Herba Artemisiae Scopariae, Folium Pyrrosiae, Radix Ophiopogonis and Radix Stemonae 2-3 time, wherein, in each water extraction process, the addition of water is quality of medicinal material 7 ~ 12 times, and each extraction time is 1 ~ 3 hour, obtains aqueous extract C.
(5) aqueous extract A, aqueous extract B and aqueous extract C are merged, carry out microfiltration, get MF permeate liquid; Wherein, the membrane aperture that microfiltration separating treatment adopts is 0.05 ~ 0.2 μm, membrane material is Al
2o
3ceramic film component, operative temperature 30 ~ 80 DEG C, operating pressure 0.2 ~ 0.8MPa;
(6) when step (5) gained MF permeate liquid being reduced to 60 DEG C, relative density is, after 1.08-1.10, mix homogeneously, obtain the By Chinese Medicines agent being used for the treatment of senile dementia with volatile oil clathrate compound; Or by described MF permeate liquid inlet temperature 140 ~ 170 DEG C, under the condition that leaving air temp is 70 ~ 90 DEG C, spraying dry obtains dry powder, is mixed homogeneously by described dry powder with volatile oil clathrate compound, add dextrin or stevioside, make granule, capsule or tablet.
2. preparation method according to claim 1, wherein crude drug is preferably prepared from by following portions by weight: Scolopendra 15-25, Scorpio 25-35, Bombyx Batryticatus 130-170, Rhizoma Paridis 80-120, Radix Curcumae 130-170, Rhizoma Atractylodis Macrocephalae 130-170, Poria 130-170, Endothelium Corneum Gigeriae Galli 130-170, Fructus Aurantii 130-170, Cortex Magnoliae Officinalis 50-70, Herba Artemisiae Scopariae 80-120, Folium Pyrrosiae 130-170, Radix Ophiopogonis 130-170, Fructus Lycii 250-350, Radix Stemonae 70-130.
3. preparation method according to claim 1, wherein crude drug is preferably prepared from by following portions by weight: Scolopendra 20, Scorpio 30, Bombyx Batryticatus 150, Rhizoma Paridis 100, Radix Curcumae 150, the Rhizoma Atractylodis Macrocephalae 150, Poria 150, Endothelium Corneum Gigeriae Galli 150, Fructus Aurantii 150, Cortex Magnoliae Officinalis 60, Herba Artemisiae Scopariae 100, Folium Pyrrosiae 150, Radix Ophiopogonis 150, Fructus Lycii 300, the Radix Stemonae 100.
4. the preparation method according to any one of claim 1-3, wherein said Endothelium Corneum Gigeriae Galli is Endothelium Corneum Gigeriae Galli (parched).
5. the preparation method according to any one of claim 1-3, the wherein said Radix Stemonae is sweet Radix Stemonae (parched).
6. the preparation-obtained Chinese medicine composition of preparation method according to claim 1 is for the preparation of the purposes of the medicine for the treatment of senile dementia.
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