CN104940479A - TCM composition for treating AD diseases - Google Patents
TCM composition for treating AD diseases Download PDFInfo
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- CN104940479A CN104940479A CN201510298678.7A CN201510298678A CN104940479A CN 104940479 A CN104940479 A CN 104940479A CN 201510298678 A CN201510298678 A CN 201510298678A CN 104940479 A CN104940479 A CN 104940479A
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Abstract
The invention discloses a TCM composition for treating AD diseases, which comprises the following raw materials in weight part: 95-110 parts of ginseng, 250-270 parts of processed radix polygalae, 385-410 parts of rhizoma acori graminei, 250-270 parts of poria cocos, 24-28 parts of pilose antler, 385-410 parts of cistanche, 500-550 parts of abalone shell, 500-550 parts of kudzu vine roots, and 50-55 parts of ephedra stem. According to the invention, the early effect of the TCM composition in treating AD diseases is affirmed, and the TCM composition can better improve the cognitive competence of patients and shorten the P300 latency. The curative effect of the TCM composition is better than that of Piracetam. Meanwhile, the TCM composition can reduce the alpha-beta 42 and Tae protein content in the blood plasmas of patients. The results of further experiments on animals prove that, a ginseng antler brain-invigorating capsule, provided by the invention, can improve the memory and the anti-radical effect of AD rats, and is capable of up regulating the expression of apoptosis inhibition bcl-2 and down regulating the expression of apoptosis induction bax at the same time.
Description
Technical field
The present invention relates to a kind of medicine for the treatment of AD disease, be specifically related to a kind of ginseng and pilose antler supplementing the brain capsule being used for the treatment of AD disease.
Background technology
AD disease is also Alzheimer, that is we practise the alzheimer disease of title now, or presenile dementia.Its English abbreviation is exactly AD.AD disease is one of modal senile central nervous system disease of modern society, and modern medicine is thought, AD disease is a kind of brain function decline property disease gradually of irreversibility.Up to now, there is no any method effectively can treating and block this disease.So once suffer from this disease, that just only has undoubtedly waits for its exhaustion gradually, until dead.
According to AD pathogenic process, AD combination of Chinese and Western medicine etiology and pathogenesis is inquired into, in conjunction with the five internal organs correlation theory of traditional Chinese medical science great master DENG Tie-tao professor, present invention finds " heart kidney is correlated with " theoretical contacting with AD, and preliminary identification " simultaneous illness in the heart and kidney " is the pathologic basis that AD occurs.The traditional Chinese medical science " heart kidney is correlated with " theory is based on yin-yang and five elements and the theory of visceral outward manifestation, and communicate with each other in physiological function according to internal organs, the principle that pathology develops mutually, embodies organic conception.Therefore, according to " heart kidney is correlated with " theoretical contacting with AD, Chinese medicine preparation treatment AD disease is adopted to be feasible.Technical scheme of the present invention proposes based on this background just.
Summary of the invention
Technical problem to be solved by this invention is the theory of Chinese medical science based on " simultaneous illness in the heart and kidney ", provides a kind of Chinese medicine composition (ginseng and pilose antler supplementing the brain capsule) being used for the treatment of AD disease, to realize the object by Chinese medicine preparation treatment AD disease.
Technical scheme of the present invention is such:
Treat a Chinese medicine composition for AD disease, it is made up of the crude drug of following parts by weight: Radix Ginseng 95 ~ 110 parts, Radix Polygalae (processed) 260 ~ 270 parts, Rhizoma Acori Graminei 385 ~ 410 parts, 250 ~ 270 parts, Poria, 24 ~ 28 parts, Cornu Cervi Pantotrichum, Herba Cistanches 385 ~ 410 parts, Concha Haliotidis 500 ~ 550 parts, Radix Puerariae 500 ~ 550 parts, 50 ~ 55 parts, Herba Ephedrae.
Preferably, it is made up of the crude drug of following parts by weight: Radix Ginseng 106.4 parts, Radix Polygalae (processed) 266 parts, Rhizoma Acori Graminei 399 parts, 266 parts, Poria, 26.6 parts, Cornu Cervi Pantotrichum, Herba Cistanches 399 parts, Concha Haliotidis 532 parts, Radix Puerariae 532 parts, 53.2 parts, Herba Ephedrae.
Fang Zhong: monarch is with Radix Ginseng reinforce functional activities of the heart, nourishing the brain and improving intelligence, minister Cornu Cervi Pantotrichum kidney tonifying, essence replenishing, the flourish brain of raw marrow, assistant Radix Polygalae, Poria, Rhizoma Acori Graminei reinforcing the heart are had one's ideas straightened out refreshment, help the power of Radix Ginseng reinforcing the heart Fructus Alpiniae Oxyphyllae, the replenishing essence of Herba Cistanches the kidney warming is strong superintends and directs, and increases the merit of Cornu Cervi Pantotrichum kidney tonifying brain-strengthening, the floating sun in Concha Haliotidis subduing the hyperactivity of YANG, to contain the high caused upward floating of YANG in deficiency condition of liver of suffering from a deficiency of the kidney, help with Radix Puerariae blood circulation promoting and blood stasis dispelling, dredging collateral, Herba Ephedrae ventilation meridian.All medicines share, reinforcing the heart gas, fill out kidney essense, dredging collateral closes, opening or cleaning key, heart kidney is also adjusted, and for AD pathology link, can play good response to treatment.
each component physical and chemical properties of drugs, pharmacological research and preparation method:
radix Ginseng(Araliaceae Radix Ginseng
panax ginsengc. the dry root welding technology of A. Mey.) Radix Ginseng is containing triterpenoid saponins: ginsenoside Ro, Ra
2, Ra
3, Rb
1, Rb
2, Rb
3, Rc, Re, Rf, Rg
1, Rg
2, Rg
3, Rh
1, Rh
2, Rh
4, R
s1, Rs
2, Rs
3, polyacetyleneginsenoside Ro, Panax Notoginseng saponin R
1, R
4, Radix Panacis Quinquefolii saponin R
1, R
2deng; Polyacetylene constituents: Panaxynol, panaxydol, panaxytiol etc.; Volatile oil: australene, nopinene, β-panacene, α-Humuleno, ginsinsene etc.; Polysaccharide composition: ginseng polysaccharide A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, U; Component polypeptides: ginseng polypeptide I, II, fresh ginseng polypeptide I, II, III, IV; Alkaloids composition: N
9the compositions such as-formyl 3-methyl-4-carboline, loline, choline, β-Ka quinoline-1-carboxylic acid, ethyl ester.
Radix Ginseng, sweet, micro-hardship, tepor.Return spleen, lung, the heart, kidney channel.Strongly invigorating primordial QI, multiple arteries and veins takes off admittedly, and invigorating the spleen to benefit the lung, promotes the production of body fluid and nourish blood, Fructus Alpiniae Oxyphyllae of calming the nerves.For weak body and prostration, cold extremities faint pulse, insufficiency of the spleen lack of appetite, the deficiency of the lung is breathed with cough, and Tianjin wound is thirsty, and interior-heat is quenched one's thirst, deficiency of qi and blood, prolonged illness weakness with emaciation, palpitation with fear insomnia, sexual impotence cold womb.
Modern pharmacological research shows, Radix Ginseng mainly has the pharmacological action of following six aspects: 1. slow down aging, improves physical stress ability: Radix Ginseng and decoct can strengthen organism adaptation, have resisting fatigue, anti-hypoxia, anti-low temperature, high temperature resistance, the stress such as antinoise; 2. on the impact of central nervous system: Radix Ginseng can regulate the balance of central nervous system stimulant process and process of inhibition.By the research that Radix Ginseng affects animal brain electrical activity, result shows: it all has impact to excited and suppression two kinds of nervous process, but the corticocerebral process of excitation of main reinforcement.Owing to acting on process of inhibition simultaneously, therefore make suppression be tending towards concentrated, make differentiation accelerate and more complete.Radix Ginseng scalable function of nervous system, makes anxiety cause disorderly nervous process to be recovered.Ginsenoside Rb's class has maincenter sedation, Rb
1, Rb
2, Rc mixing Saponin has stable effect; Rg class has central excitation effect.Ginsenoside is Small Dose Excitement on the impact of maincenter, heavy dose of suppression.Radix Ginseng water logging agent 5 g/Kg lumbar injection obviously can reduce the spontaneous activity of mice.Radix Ginseng water logging agent also can be fainted from fear caused by anti-cocaine, strychnine and pentetrazole, and can reduce convulsions mortality rate.There is report to point out, the stable effect of the existing calmness of the rough neutral Saponin of Radix Ginseng, also have analgesia, flesh pine and cooling effect; 3. the impact of Endocrine system: Radix Ginseng can make adrenal gland that is normal and excision side adrenal gland rat loose; During Cavia porcellus is urinated, 17-KS content reduces; Make rat eosinophilia, in adrenal cortex, vitamin C and cholesterol reduce, and in urine, ACTH increases.Under the stressed conditions such as hypobaric hypoxia state, Radix Ginseng can make Vitamin C content in adult rat adrenal tissue not lower.Radix Ginseng can improve the ability of mice withstand high temperatures low temperature, but after extracing adrenal gland, this effect disappears; 4. immunoloregulation function: ginsenoside can strengthen the ability of cleaning up of the many animals such as mice to Colloidal charcoal particles in blood etc., significantly promotes that animal's antibody produces; 5. on the impact of blood circulation: Radix Ginseng has first excited rear suppression to animal hearts, Small Dose Excitement, heavy dose of inhibitory action; 6. other: Auto-regulator metabolism, antitumor.
In conjunction with the characteristic that the effective ingredient of Radix Ginseng, pharmacological research, clinical practice and function cure mainly, Radix Ginseng adds the preparation technology of extract powder mixing after adopting pulverizing in the present invention.
radix Polygalae (processed)(milk wort Radix Polygalae
polygala tenuifoliaor ovum leaf Radix Polygalae Willd.
polygala sibiricathe processed product of dry root L.) payta is containing triterpenoid saponins: senega-saponin A,B,C,D, E, F, G, Roots of Polygala tenuifolia element, tenuifolosodes A, B; Anthrone constituents: polygalaxanthone III, 7-O, methylmangiferin, lancerin, 1,2,3,4,7-pentamethoxyl anthrone, 1,2,3,7-tetramethoxy anthrone, 1,3,7-trihydroxy anthrone, 1,6,7-trihydroxy-2,3-dimethoxy anthrone, 1,7-dimethoxy-2,3-methylenedioxyxanthone; Alkaloids composition: N
9-formoxyl 3-methyl-4-carboline, 1-butoxy carbonyl-B-carboline, 1-carbethoxyl group-B-carboline, 1-methoxycarbonyl group-B-carboline, perlolyrine, 3-methyl-4-carboline and 3-methyl-4-carboline fall; Sugar and lactone component: isolation identification oligosaccharide polyester tenuifolioses A, B, C, D, E, F, G, N, I, J, K, L, M, N, O, P, sibiricoses A from payta
5, A
6, 3`, 6-disinapoyl sucrose.In addition, from Radix Polygalae, a kind of dopamine receptor activities compound is also isolated: tetrahydro columbamine.
Radix Polygalae (processed), bitter, pungent, temperature.GUIXIN, kidney, lung meridian.Have Fructus Alpiniae Oxyphyllae of calming the nerves, the traffic mind, eliminates the phlegm, effect of detumescence.The insomnia and dreamful sleep caused for disarmony between the heart and kidney, forgetful palpitation with fear, staring spells, expectoration is not well, sore and toxic, breast swell and pain.
Modern pharmacological research shows, Radix Polygalae (processed) mainly has the pharmacological action of following seven aspects: 1. calm: Radix Polygalae root bark, full root and core all have synergism to barbiturate.After Radix Polygalae water extract rat oral gavage, in blood and bile, active substance 3,4,5-trimethoxy cinnamic acid, methyl-3,4,5-trimethoxy cinnamic acid methyl ester and the p-methoxycinnamic acid that can extend the pentobarbital sodium length of one's sleep are found; 2. Fructus Alpiniae Oxyphyllae: after rat oral gavage gives Radix Polygalae extract, rat conditioned response and UCR increased frequency, diencephalon nadide (NAD
+), in Hippocampus, tail stricture of vagina core and brain stem, nadide (NADH) concentration obviously increases, and shows that Radix Polygalae has physique strengthening and intelligence benefiting and strengthens the effect of the regional metabolism of brain.Polygalic acid can raise m receptor density and choline acetyl transfers enzyme activity in brain, and suppress acetylcholinesterase activity, the Cholinergic that can improve alzheimer disease to a certain extent goes down; 3. relieving cough and expelling phlegm: be separated in Radix Polygalae and obtain 4 new saponin, wherein saponin 3D is the main component of eliminating the phlegm, 2D and 3C is the main component of antitussive effect; 4. blood pressure lowering: polygalic acid can reduce mean arterial pressure after rat anesthesia, reduces Conscious Rat and renal hypertensive rat systolic pressure; 5. on the impact of smooth muscle: polygalic acid H is to isolated rabbit ileum, thoracic aorta strips, guinea-pig tracheal strip and the equal tool excitation of unpregnancy rat uterus smooth muscle in rutting period; 6. antibacterial: Radix Polygalae decoct can suppress Diplococcus pneumoniae; 7. other: Radix Polygalae also has antimutagenic, defying age and antitumor action.
In conjunction with the characteristic that the effective ingredient of Radix Polygalae (processed), pharmacological research, clinical practice and function cure mainly, the preparation technology that Radix Polygalae (processed) adopts water extraction and group's medicine to decoct altogether in the present invention.
rhizoma Acori Graminei(acorus gramineus araceae plant
acorus tatarinowii Schottdry rhizome) root of Rhizoma Acori Graminei stem portion is mainly containing volatile oil: beta-Asarone, α-asaricin, cis methylisoeugenol, transmethyl isoeugenol, elemicin, caryophyllene, acoradiene, cedrene, estragole, money Pu ketenes, safrole, eugenol, asarylaldehyde, Patchoulene, Camphora etc.Containing 2,4,5-trimethoxy formic acid, vanillic acid, asarylaldehyde, succinic acid, suberic acid, 5 hydroxymethyl furfural, 2,5-dimethoxy-benzoquinones etc. in the decocting liquid of Rhizoma Acori Graminei rhizome.In addition, also containing isoacoramone, cis-epoxyasarone, threo-1`, 2`-dihydroxyasarone, erythro-1`, 2`-dihydroxyasarone etc.
Rhizoma Acori Graminei, pungent, bitter, temperature.GUIXIN, stomach warp.Have eliminating phlegm of having one's ideas straightened out, refreshment Fructus Alpiniae Oxyphyllae, removing dampness is whetted the appetite.For coma epilepsy, forgetful insomnia, Hiccough and deaf, gastral cavity painful abdominal mass is not hungry, a mouthful dysentery of keeping silent.
Modern pharmacological research shows, Rhizoma Acori Graminei mainly has the pharmacological action of following seven aspects: 1. on the impact of central nervous system: Rhizoma Acori Graminei Aqueous extracts total volatile oil, the decoct that deoils all can strengthen the syngignoscism of barbital sodium to mice of sub-threshold dose.The effect of collaborative picrotoxin (picrotoxin) the stimulating central nervous system system of Rhizoma Acori Graminei Aqueous extracts oil, makes tic number of times and mortality rate increase.Adopt maximal electroshock seizure method and the research of pentetrazole Minimum Threshold outbreak method to show, Rhizoma Acori Graminei decoct energy Chinese People's Anti-Japanese Military and Political College Mus is fainted from fear, γ-aminobutyric acid (GABA) neuronal damage that can also prevent faints from fear causes; 2. learning and memory is promoted: the memory acquisition disturbance that Rhizoma Acori Graminei decoct gavage consolidates obstacle to the mouse memory that sodium nitrite is caused, scopolamine causes and the reproducibility dysmnesia that ethanol causes all improve significantly, and can also promote the Memory acquisition of normal mouse; 3. to the effect of brain: deoil decoct and the rat model of oil-containing water extract to cerebral ischemia re-pouring of Rhizoma Acori Graminei all has protective effect, can alleviate cerebral edema, reduce rat brain cortex neuronal apoptosis; Rhizoma Acori Graminei oil-containing water extract can also reduce Apoptosis in Rat Hippocampus; 4. relieving asthma: Rhizoma Acori Graminei total volatile oil significantly can suppress the guinea pig trachea spasmodic contraction caused by histamine and acetylcholine, and the obvious dose-effect relationship of tool; 5. on the impact of digestive system: the Rhizoma Acori Graminei decoct that deoils can suppress the Spontaneous Contraction of isolated rabbit intestinal tube, the intestinal tube spasm caused by antagonism acetylcholine, histamine and barium chloride, strengthens rat in body intestinal motility and mouse small intestine motion, promotes rat bile secretion.The contraction movement of supernatant after Rhizoma Acori Graminei water extract-alcohol precipitation to the Stomach duodenum of rat all has inhibitory action; 6. arrhythmia: Rhizoma Acori Graminei volatile oil can resist rabbit arrhythmia caused by rat ventricular caused by aconitine and epinephrine and barium chloride; 7. antibacterial: Rhizoma Acori Gramineii extract liquid all has inhibitory action in various degree to streptococcus, Bacillus thuringiensis, aerobacteria, staphylococcus aureus, bacillus subtilis, staphylococcus epidermidis, Bacillus proteus and escherichia coli in agar plate dilution method experiment; 8. other: Rhizoma Acori Graminei also has the effect such as anti-stress and antidepressant.
In conjunction with the characteristic that the effective ingredient of Rhizoma Acori Graminei, pharmacological research, clinical practice and function cure mainly, the preparation technology that Rhizoma Acori Graminei adopts water extraction and group's medicine to decoct altogether in the present invention.
poria(Polyporaceae Poria
poria cocos(Schw.) dry sclerotia of Wolf) sclerotium of Poria is containing polysaccharide composition: β-pachyman, pachymaran etc., triterpenes components: loose Siberian cocklebur acid, Poria is calculated, TA, eburicoic acid, dehydroeburicoic acid, 7,9 (11)-DHPAs, pachymic acid methyl ester, β-Amyrin acetas, 3 beta-hydroxy-16 α-acetoxyl group Pilus Caprae seu Ovis steroid-7,9 (11), 24-triolefin-21-acid, dehydropachymic acid, 3 beta-hydroxies-Pilus Caprae seu Ovis steroid-7,9 (11), 24-triolefin-21-acid, Ergota steroid-7,22-diene-3 β-ol, 3 β-acetyl group-16 Alpha-hydroxies-Pilus Caprae seu Ovis steroid-7,9 (11), 24 (31)-triolefin-21-acid, 3 β, 16 alpha-dihydroxy-s-Pilus Caprae seu Ovis steroid-7,9 (11), 24 (31)-triolefin-21-acid, 16 Alpha-hydroxy-3-carbonyl-Pilus Caprae seu Ovis steroid-7,9 (11), 24 (31)-triolefin-21-acid, 3-O-acetyl-16 α-hydroxytrametenolic acid, 16 α-hydroxydehydropachymic acid, 16 α-hydroxytrametenolic acid, dehydrotumulosic acid, 3 β-P-hydroxybenzoic acid dehydrogenation soil not in acid, 3-epidehydrotumulosic acid, 25-hydroxy-3-epidehydrotumulosic acid, dehydroabietic acid methyl ester, the acid of 3-hydrogenation pine Siberian cocklebur, Poria eo-acid A, B, C, D, G, H, AM, DM and dehydrotrametenolic acid, polyporenic acid C.In addition, also ergosterol, sad, dodecylic acid, lauric acid, dodecenoic acid, dodecylene acid esters is contained in Poria.
Poria is sweet, light, flat.GUIXIN, lung, spleen, kidney channel.There is promoting diuresis to eliminate damp pathogen, spleen invigorating, mind calming.For edema oliguria, phlegm retention vertigo and palpitation, insufficiency of the spleen lack of appetite, have loose bowels in loose stool, irritability, palpitation with fear insomnia.
Modern pharmacological research shows, Poria mainly has the pharmacological action of following five aspects: 1. diuresis: Poria preserved material lumbar injection has diuresis to normal rabbits; 2. antibacterial, antiinflammatory: Poria decocting liquid is outer all has inhibitory action to staphylococcus aureus, Staphylococcus albus, Pseudomonas aeruginosa, anthrax bacillus, escherichia coli, alpha streptococcus, group B streptococcus; Pachyman xylol induced mice ear swells and caused by aseptic cotton balls, subcutaneous rat granuloma all has inhibitory action; Water-alcohol extraction and triterpenes components pachymic acid in Poria, dehydrotumulosic acid are external to the phospholipase A in snake venom
2inhibited; 3. immunity is strengthened: the external propagation suppressing human leukemia cell line HL-60 and U937 of pachyman; Poria decocting liquid gavage, obviously can strengthen the ability that mouse antibodies cellulation produces antibody, improve the humoral immunization of mice; Carboxymethyl pachyman is external can obviously promote Turnover of Mouse Peritoneal Macrophages secretion of tumour necrosis factor-alpha, and promotes the propagation of mice spleen mixed lymphocytes; Carboxymethyl pachyman subcutaneous injection can obviously increase lewis lung cancer in mice, S
180tumor-bearing mice Peritoneal macrophage function; 4. antitumor: pachyman extract sulphation and carboxy methylation object are outward to S
180and stomach cancer cell MKN-45 and SGC-7901 has remarkable active anticancer; Pachymic acid is external has suppression and proliferation-inducing apoptotic effect to Human Prostate Cancer Cells, and its action intensity is relevant to dosage and action time; 5. other: Poria or its extract also have improve renal function, the effect such as blood sugar lowering, defying age, parasite killing, antioxidation, preventing or arresting vomiting, promotion melanocyte increase, anti-hemolysis and radioprotective.
In conjunction with the characteristic that the effective ingredient of Poria, pharmacological research, clinical practice and function cure mainly, the preparation technology that Poria adopts water extraction and group's medicine to decoct altogether in the present invention.
cornu Cervi Pantotrichum(animal in deer family Cervus nippon Temminck
cervus nippontemminck or Cervus elaphus linnaeus
cervus elaphusthe young horn of the unossified close raw fine hair of stag of Linnaeus) in Cornu Cervi Pantotrichum containing multiple organic compound, mainly containing aminoacid, fatty acid, containing nitrogen compound, in addition containing polysaccharide and to compositions such as the useful various trace elements of human body.Containing kinds more than 20 such as aspartic acid, threonine, serine, glutamic acid, glycine, alanine, valine, methionine, isoleucine, leucine, tyrosine, phenylalanine, lysine, histidine, arginine, proline in Cornu Cervi Pantotrichum; Nitrogen-containing compound comprises: uracil, hypoxanthine, urine liver, urea, nicotinic acid and creatinine, and in total polyamine, the amount of putrescine is maximum, and spermidine takes second place, and spermine is minimum.Polyamine compounds in polyamine compounds Cornu Cervi Pantotrichum is also a class important activity composition, and they can stimulate nucleic acid and protein synthesis, and the polyamine content of Cornu Cervi Pantotrichum tip is higher, and successively decreases from top to bottom.
Cornu Cervi Pantotrichum, sweet, salty, temperature.Return kidney, Liver Channel.There is invigorating kidney-YANG, benefiting essence-blood, bone and muscle strengthening, adjust punching to appoint, effect of holder sore.For insufficiency of kidney-YANG, blood and essence asthenia, sexual impotence spermatorrhea, cold womb is infertile, weakness and emaciation, Mental fatigue, and fear of cold is dizzy, tinnitus, and deaf, spinal column cold type of pain, muscles and bones flaccidity is soft, bleeding not during menses, and carbuncle of yin nature is not held back.
Modern pharmacological research shows, Cornu Cervi Pantotrichum mainly has the pharmacological action of following five aspects: 1. to the effect of cardiovascular system: Cornu Cervi Pantotrichum plays protective effect to a certain extent by raising ischemic myocardial tissue SOD activity, the secondary injury of reduction MDA content to ischemic myocardium; In addition, Cornu Cervi Pantotrichum also can alleviate myocardial cell injury, dilating coronary blood vessel, increases blood supply and the protecting myocardial cell film integrality promote that myocardial function recovers of cardiac muscle; 2. to neural effect: antler polypeptide has the neural adhesion effect of prevention; And the effect of radiation-induced spinal cord neural cell apoptosis can be suppressed; 3. antioxidation: Cornu Cervi Pantotrichum extract have significantly free radical resisting to protein and nucleic acid damaging ability; 4. on the impact of reproductive system: Cornu Cervi Pantotrichum has the effect promoting female ovariectomized mouse uterine growth, and is proportionate with the dosage of Cornu Cervi Pantotrichum; 5. other: Cornu Cervi Pantotrichum also has anti-stress effect; To humoral immunization and the cellular immune function of recovering hypoimmunity model mice; Promote union of fracture; Antitumor action; Protective effect is had to mouse carbon tetrachloride acute liver damage; Obvious inhibitory action is had to the early apoptosis of osteoarthritis chondrocyte.
In conjunction with the characteristic that the effective ingredient of Cornu Cervi Pantotrichum, pharmacological research, clinical practice and function cure mainly, Cornu Cervi Pantotrichum adds the preparation technology of extract powder mixing after adopting pulverizing in the present invention.
herba Cistanches(orobanchaceae plant cistanche
cistanche deserticolay. C. Ma or Cistanche Tubulosa
cistanche tubulosa(Schrenk) fleshy stem of the dry zone scale leaf of Wight) fleshy stem of Herba Cistanches band scale leaf is mainly containing phenethyl alcohol glycoside compounds: cistanoside A, B, C, F, H, different boschnaloside C, echinacoside, verbascoside, different verbascoside, 2`-acetyl group Mao Ruimao glucosides, Cistanche Tubulosa glycosides B, osmanthuside B, rhodioside; Iridoid constituents: 8-shows Semen Strychni acid, 6-deoxycatalpol, catalpol Herba Cistanches element; Phenylpropanol methods of glycosides: ligustrin, ligustrin A-3`-α-L-rhamnopyranosyloxyhy glucosides, different ligustrin-3`-α-L-rhamnopyranosyloxyhy glucosides etc.; In addition containing Liriodendrin, betanin and galactitol and polysaccharide composition.
Herba Cistanches, sweet, salty, temperature.Return kidney, large intestine channel.There is kidney-replenishing, benefiting essence-blood, loosening bowel to relieve constipation.For insufficiency of kidney-YANG, blood and essence asthenia, sexual impotence is infertile, soreness of the waist and knees, and muscles and bones is unable, dryness of the intestine constipation.
Modern pharmacological research shows, Herba Cistanches mainly has the pharmacological action of following six aspects: 1. androgen-like action: Herba Cistanches decocting liquid gavage obviously can increase the body weight of " insufficiency of kidney-YANG " mice that hydrocortisone causes, its cold-resistant time of obvious prolongation, demonstrate certain yang invigorating functions.The raw product of Herba Cistanches and the molten part gavage of processed product decocting thing alcohol significantly can increase the seminal vesicle weight of prostate of castration Immature rat, the testis of normal mouse and rat, seminal vesicle prostate are increased weight, has androgen-like action; 2. on immune impact: Cistanoside oral administration obviously can increase the phagocytic activity of macrophage and the weight of immune organ in Mouse Blood.Herba Cistanches polysaccharides can promote that cell enters division stage, has facilitation to mouse chest cell propagation; 3. slow down aging: Cistanoside energy strong inhibition external activity oxygen-derived free radicals.Herba Cistanches total glycosides gavage can significantly improve the activity of the subacute aging mice superoxide dismutase caused by D-galactose, significantly reduces the content of the lipid peroxide in brain, liver, has antioxidation and delaying senility function.Herba Cistanches decocting liquid can also extend the average life of fruit bat; 4. protect ischemic myocardium: Herba Cistanches total glycosides can obviously improve rat ischemia electrocardiogram, reduce myocardial infarction area, improve the vigor of phosphocreatinase in cardiac muscular tissue; 5. on the impact of central nervous system: Herba Cistanches extract water-soluble portion, has sedation, can significant prolongation mice hexobarbital length of one's sleep, reduce rat voluntary activity; 6. other: Herba Cistanches extract gavage has good protective effect to septic shock Acute Lung Injury; Intravenous injection Herba Cistanches clear paste significantly can reduce maximum pressure when rat bladder is urinated, and improves urinary function.
In conjunction with the characteristic that the effective ingredient of Herba Cistanches, pharmacological research, clinical practice and function cure mainly, the preparation technology that Herba Cistanches adopts water extraction and group's medicine to decoct altogether in the present invention.
concha Haliotidis(Bao Ke animal
haliotis diversicolorreeve, haliotis discus hannai Ino
haliotis discushannai Ino, sheep Bao
haliotis ovinagmelin, haliotis ruber
haliotis ruber(Leach), ear Bao
haliotis asininalinnaeus or white Bao
haliotis laevigata(Donovan) shell) Concha Haliotidis is mainly containing following three major types chemical composition: 1. inorganic salts: main containing Calcium carbonate composition and other inorganic salts compositions, as phosphate, sulfate, silicate etc.; 2. trace element: containing trace element such as calcium, magnesium, copper, ferrum, zinc, manganese, molybdenum, cobalt, strontium, lead, chromium, selenium, copper, iodine, hydrargyrum.Wherein, Concha Haliotidis contains the very abundant SiO be easily absorbed by the body
2, its content ranks first in the mineral medicinal material of Known Species; 3. aminoacid: containing several amino acids in Concha Haliotidis.The keratoprotein of pearl-like gloss in Concha Haliotidis, obtains 16 seed amino acids through salt hydrolysis; 4. other compositions: also contain a small amount of as other organic compositions such as polysaccharide in Concha Haliotidis.Organic destroyed after calcining, carbonate is decomposed, and produces calcium oxide.
Concha Haliotidis is salty, cold.Return Liver Channel.There is suppressing the hyperactive liver and subsiding YANG, effect of liver heat removing and eyesight improving.Dizzy for having a headache, cataract, blurring of vision, optic atrohic blindness nyctalopia.
Modern pharmacological research shows, Concha Haliotidis mainly has the pharmacological action of following three aspects: 1. circulation and blood system: Concha Haliotidis water extract energy Angiotensin-converting enzyme inhibition (ACE) is active, has strong and lasting hypotensive effect; 2. digestive system: because Concha Haliotidis master is antacid material containing calcium carbonate, calcium carbonate be in and the effective ingredient of gastric acid, in having and the effect of gastric acid.Experiment proof 1 g Concha Haliotidis powder can in and concentration be artificial gastric acid 166.2 ~ 168.1 mL of 0.1 mmol/L, be used for the treatment of the patient of the hyperchlorhydria such as gastric ulcer, gastritis, there is good effect; 3. antibacterial action: Concha Haliotidis hydrolyzed solution has obvious bacteriostasis to escherichia coli, staphylococcus aureus, bacillus subtilis, tetrad micrococcus, saccharomyces cerevisiae and saccharomyces carlsbergensis, also can treat the diseases such as keratitis, cataract, uveitis.
In conjunction with the characteristic that the effective ingredient of Concha Haliotidis, pharmacological research, clinical practice and function cure mainly, the preparation technology that Concha Haliotidis adopts water extraction and group's medicine to decoct altogether in the present invention.
radix Puerariae(legume pueraria lobata
pueraria lobata(Willd.) dry root of Ohwi) the root isoflavone-containing constituents of Radix Puerariae: puerarin, daidzein, daiazi, 3`-hydroxyl puerarin, 3`-methoxy puerarin, 6 "-O-D-xylosyl puerarin, biochanin A, formoononetin, genistein, tectorigenin, 7,4`-dimethoxy tectorigenins, 3`-hydroxyl puerarin-4`-O-deoxidation hexoside and 3`-methoxyl group-6 "-O-D-xylosyl puerarin etc.; Saponin component: the triterpene saponin being aglycon with sophoradiol, cantoniensis triol, soyasapogenol A, B, Radix Puerariae soap alcohol A, C and Radix Puerariae soap alcohol B methyl ester, as Radix Puerariae saponin A
1, A
2, A
3, Ar, SA
4, SB
1, soybean saponin SA
3, I etc.
Radix Puerariae, sweet, pungent, cool.Return spleen, stomach, lung meridian.There is expelling pathogenic factors from muscles for reducing heat, promoting the production of body fluid to quench thirst, rash, yang invigorating antidiarrheal, dredge the meridian passage, deinebriating effect.For fever caused by exogenous pathogens headache, stiff nape and back, thirsty, quench one's thirst, measles without adequate eruption, hematodiarrhoea, has loose bowels, dizziness and headache, apoplectic hemiplegia, obstruction of qi in the chest and cardialgia, damage of the spleen and stomach caused by alcoholism.
Modern pharmacological research shows, Radix Puerariae mainly has the pharmacological action of following six aspects: 1. protect ischemic myocardium to the impact of cardiovascular system: I.: puerarin gavage can suppress the apoptosis in myocardial ischemia-reperfusion injury, increases bcl-2 and reduces the expression of Bax; II. arrhythmia: external L-type calcium channel electric current and the inward rectifyimg potassium channel suppressing rat myocardial cell of puerarin; III. blood fat reducing puerarin oral administration can reduce hyperlipidemia rats thromboxane A
2with the ratio of prostacyclin, the characteristic of hypercholesterolemia experimental atherosclerosis in rats can also be reduced; IV. other: puerarin is external promotes vascular smooth muscle apoptosis; Puerarin gavage also effectively can regulate the dynamic equilibrium between diabetic vascular complications rat plasma Endothelin-nitric oxide, Endothelin-atrial natriuretic peptide, suppresses the formation of aorta of diabetic rats nonenzymatic glycosylation; 2. carbohydrate metabolism is regulated: puerarin oral administration can activate the islets of langerhans infringement that oxidase active protection rat hydrogen peroxide causes; 3. protect the liver: puerarin gavage can protect hepatic injury, induced activation apoptosis on hepatic stellate cells, effectively reverse the hepatic fibrosis in mice of chemical induction, also there is protective effect to the acute liver injury of rats of tetrachloro-methane induction; 4. other: Radix Puerariae also has anti-bone-loss; Neuroprotective unit cell; Protection acute lung injury; Antitumor and estrogen-like effects; Daiazi contained by Radix Puerariae and daidzein also have antipyretic and analgesic effect, and its saponin component has anticomplementary activity.
In conjunction with the characteristic that the effective ingredient of Radix Puerariae, pharmacological research, clinical practice and function cure mainly, the preparation technology that Radix Puerariae adopts water extraction and group's medicine to decoct altogether in side of the present invention.
herba Ephedrae(Ephedraceae plant plait Herba Ephedrae
ephedra sinicastapf, epheday intermedia
ephedra intermediaschrenk et C. A. Mey. or ephedra equisetina
ephedra equisetinabge. dry herb stem) principle active component in Caulis Ephedrae is the alkaloid of three pairs of stereoisomers, that is: sanedrine, sodium salicylate, left-handed demethyl ephedrine, dextrorotation Nor pseudo ephedrine, left-handed methylephedrine and dextrorotation methyl pseudoephedrine, another containing alkaloid Herba Ephedrae oxazolone.Volatile oil is the another principle active component of Herba Ephedrae, mainly contains 1-alpha-terpineol, γ-eudesmol, also containing 2，3，5，6-tetramethylpyrazine, α, β-composition such as terpinenol, dihydrocarveol.Still containing flavone compound apigenin, tricin, kaempferol, herbacetin, 3-methoxyl group herbacetin, apigenin-5-rhamnoside etc.
Herba Ephedrae, pungent, micro-hardship, temperature.Return lung, urinary bladder channel.There is relieving the exterior syndrome by diaphoresis, depressed lung-energy dispersing, effect of inducing diuresis to remove edema.For anemofrigid cold, cough with asthma uncomfortable in chest, edema due to wind pathogen edema.
Modern pharmacological research shows, Herba Ephedrae mainly contains the pharmacological action of following five aspects: 1. diaphoresis: Oral Administration in Rats ephedrine and left-handed methylephedrine can impel vola diaphoresis; 2. analgesia, antiinflammatory: ephedrine gavage obviously reduces rat and mouse writhing number of times caused by glacial acetic acid, suppresses dimethylbenzene induced mice auricle edema; Teamster's tea gavage can make normal saline Neulized inhalation cause lungs of asthmatic guinea pigs bronchial wall and lung tissue inflammatory cell infiltration minimizing around, and in bronchoalveolar lavage fluid, cell number and cytokine interleukin element 5 concentration obviously reduce; 3. relieving asthma, antitussive, to eliminate the phlegm: Herba Ephedrae water extract has obvious antitussive effect to the cough caused by mechanical stimulus; 4. central excitation: water maze algoscopy shows, ephedrine hydrochloride, methylephedrine gavage have promotion memory effect to normal mouse, significantly can improve reproducibility dysmnesia caused by remember consolidation disorders caused by dysmnesia caused by scopolamine, sodium nitrite and ethanol; 5. other: Herba Ephedrae water extract lumbar injection can make the transient rising of normal mouse blood glucose decline lastingly afterwards.Herba Ephedrae alkaloid can significantly reduce by the company's of making urea mycin blood glucose of causing hyperglycemia mice.
In conjunction with the characteristic that the effective ingredient of Herba Ephedrae, pharmacological research, clinical practice and function cure mainly, Herba Ephedrae adds the preparation technology of extract powder mixing after adopting pulverizing in the present invention.
Therefore, the preparation were established of this medicine of the present invention is determined as follows: the Six-element medical materials such as Radix Polygalae (processed), Rhizoma Acori Graminei, Poria decoct with water that extraction → Aqueous extracts is concentrated, drying gets dry extract → separately gets Radix Ginseng, Cornu Cervi Pantotrichum, Herba Ephedrae is pulverized respectively and mix in proportion with dried cream powder, subpackage → finished product.
Ginseng and pilose antler supplementing the brain capsule for treating AD of the present invention acts on certainly in early days, and better can improve Patients ' Cognitive ability, shorten P300 incubation period, its curative effect is better than piracetam.Reduce AD patients blood plasma A β 42 and Tau protein content.Further animal experiment study confirms, ginseng and pilose antler supplementing the brain capsule of the present invention can improve AD Rats With Memory and anti-radical action, and can go up die suppression bcl-2 and lower key of key and die and induce the expression of bax.
Below in conjunction with control experiment and model case, the technique effect to this medicine of the present invention is described:
Control experiment: include experimenter 130 altogether in, is diagnosed as MCI in conjunction with its comprehensive cognitive function status.Ginseng and pilose antler supplementing the brain capsule for treating group age (67.43 ± 6. 80) year of the present invention, wherein male 41 example (41%), women 59 example (59%), illiteracy accounts for 7%, primary school's schooling accounts for 26%, and junior middle school's schooling accounts for 24%, and the above schooling of senior middle school/special secondary school accounts for 49%; Huperzine A matched group patient age (64.73 ± 6. 11) year, wherein male 12 example (40%), women 18 example (60%), illiteracy accounts for 6.7%, primary school's schooling accounts for 20%, and junior middle school's schooling accounts for 23%, and the above schooling of senior middle school/special secondary school accounts for 50.3%.Ginseng and pilose antler supplementing the brain capsule for treating group and Huperzine A matched group sex, age, schooling form no significant difference (
p>0.05), between two groups of data, there is comparability.
Therapeutic Method: ginseng and pilose antler supplementing the brain capsule for treating group oral ginseng and pilose antler supplementing the brain capsule is (primarily of compositions such as Radix Ginseng, Rhizoma Acori Graminei, Cornu Cervi Pantotrichum, Radix Morindae Officinaliss, make capsule, 0.48g/ grain), 4 tablets/time, oral, day 3 times, take March continuously, carry out respective handling for hypertension, coronary heart disease, diabetes, hyperlipidemia etc. are disease accompanied simultaneously.
The oral Huperzine A of Huperzine A matched group, each 0.1 mg(2 grain), every day 3 times, the March course for the treatment of, or follow the doctor's advice.React according to after the state of an illness and medication, consumption and the course for the treatment of can increase and decrease as one sees fit.Daily dose must not more than 0.45 mg(9 grain).
Efficacy assessment standard: using mini-mentalstate examination table (MMSE) score as Primary Reference index, adopts nimodipine method computing formula:
Evaluation criteria: effective >=20%; Effectively >=10%; Invalid <10%.
The course for the treatment of: one month be a course for the treatment of.Continuous use observed the symptoms after 3 courses for the treatment of, sign improve situation, untoward reaction and Ureteral Calculus during patient blood glucose, electrolyte, Liver and kidney merit, hematuria just conventional dynamic change situation.
Statistical procedures: adopt SPSS16.0 statistical software to carry out date processing.Before and after treatment, sample average represents with x ± s, and measurement data adopts t inspection, enumeration data X
2inspection, ranked data Ridit checks.
p<0.05 indicates significant difference or dependency,
p>0.05 represents there was no significant difference.
Experimental result
(1) each Indexes Comparison (see table 1) before and after ginseng and pilose antler supplementing the brain capsule for treating.
Table 1 analysis result shows: before and after the treatment of ginseng and pilose antler supplementing the brain capsule for treating group in orientation force, immediate memory, attention and computing power, Delay recall, linguistic competence, MMSE total score, TCM syndrome integration difference all have statistical significance (
p<0.05).Before orientation force after treatment, immediate memory, attention and computing power, Delay recall, linguistic competence, MMSE scale score score value are all significantly higher than treatment (
p<0.01).TCM syndrome integration after treatment then remarkable lower than treatment before (
p<0.01).
(2) each Indexes Comparison (see table 2) before and after Huperzine A treatment.
Table 2 analysis result show: before and after Huperzine A treatment of control group in orientation force, attention and computing power, Delay recall, MMSE scale score, TCM syndrome integration difference all have statistical significance (
p<0.05).Before orientation force after treatment, attention and computing power, Delay recall, MMSE scale total score score value are all significantly higher than treatment (
p<0.01).TCM syndrome integration after treatment then remarkable lower than treatment before (
p<0.01).Immediate memory, linguistic competence before and after treatment then do not have significant difference (
p>0.05).
(3) comparative analysis (see table 3) after ginseng and pilose antler supplementing the brain capsule, Huperzine A treatment.
Table 3 analysis result shows: after treatment ginseng and pilose antler supplementing the brain capsule for treating group and Huperzine A matched group difference in orientation force, Delay recall power, MMSE scale score, TCM syndrome integration all have statistical significance (
p<0.05).Treatment after ginseng and pilose antler supplementing the brain capsule for treating group Delay recall power comparatively Huperzine A matched group make moderate progress (
p<0.05).The MMSE scale score of ginseng and pilose antler supplementing the brain capsule for treating group, TCM syndrome integration aspect comparatively Huperzine A matched group significantly improve (
p<0.01).The orientation force aspect of Huperzine A matched group comparatively ginseng and pilose antler supplementing the brain Capsules group significantly improve (
p<0.01).After treatment immediate memory, attention and computing power, the linguistic competence of two groups then do not have significant difference (
p>0.05).
(4) ginseng and pilose antler supplementing the brain capsule for treating group, Huperzine A matched group comprehensive therapeutic effect (see table 4).
Result: table 4 shows, ginseng and pilose antler supplementing the brain capsule for treating group total effective rate 88%, Huperzine A matched group total effective rate 83.3%; And associative list 1,2,3, total effective rate no significant difference between ginseng and pilose antler supplementing the brain capsule for treating group, Huperzine A matched group two groups (
p>0.05).Two groups of comprehensive therapeutic effect results, MMSE scale, Chinese medicine syndrome integral scale all point out the two all to have obvious therapeutic action to MCI.
Safety analysis: during all cases Ureteral Calculus, close Monitoring Blood Glucose, electrolyte, Liver and kidney merit, hematuria be conventional and electrocardiogram just, and all unchanged, clinical practice has safety.Without special untoward reaction after ginseng and pilose antler supplementing the brain capsule for treating group, Huperzine A matched group patient consumes.
Conclusion:
" ginseng and pilose antler supplementing the brain capsule " of the present invention, clinical application treatment MCI, early stage AD have good therapeutic effect.Fang Zhongjun Radix Ginseng reinforce functional activities of the heart, nourishing the brain and improving intelligence, the flourish brain of minister Cornu Cervi Pantotrichum kidney tonifying, essence replenishing, raw marrow, assistant Radix Polygalae (processed), Rhizoma Acori Graminei reinforcing the heart are had one's ideas straightened out refreshment, the power of ginseng of helping others reinforcing the heart Fructus Alpiniae Oxyphyllae, the replenishing essence of Herba Cistanches the kidney warming is strong superintends and directs, and increases the merit of Cornu Cervi Pantotrichum kidney tonifying brain-strengthening, the floating sun in Concha Haliotidis subduing the hyperactivity of YANG, to contain the high caused upward floating of YANG in deficiency condition of liver of suffering from a deficiency of the kidney, help with Radix Puerariae blood circulation promoting and blood stasis dispelling, dredging collateral, all medicines share, reinforcing the heart gas, fill out kidney essense, dredging collateral closes, opening or cleaning key, heart kidney is also adjusted, and for AD pathology link, can play good response to treatment.Pharmacological research shows, Radix Ginseng can improve ability of learning and memory, and gen-seng can improve the brain function of old man, and especially attention and long-term elaborative faculty, can make reagency improve; Phosphate of pilose antler compounds can strengthen the ability of learning and memory of mice, and gangliosides contained by Cornu Cervi Pantotrichum has obvious facilitation to the acquisition of mouse memory, consolidation and reproduction three phases, and brain internal protein content can be made obviously to increase; Poria has antioxidation, and can improve cerebrovascular reactivity, improves microcirculation, has tranquilizing effect again; Radix Polygalae (processed) has promotion intelligence and cerebral protection; Rhizoma Acori Graminei has the effect of promotion learning and memory, and plays central nervous system's sedation by reducing monoamine neurotransmitter; Radix Puerariae anticoagulant, improve cerebral blood circulation, and have antioxidation and improve learning and memory function effect; Concha Haliotidis is improved intelligence effect.Display we composition medicine can play from multiple link and improve cognitive function effect, thus produces good response to treatment to MCI, early stage AD.Observation shows, the effect in the raising overall score value of MMSE and Improving memory, attention, orientation, computing power and linguistic competence etc. of ginseng and pilose antler supplementing the brain capsule is obvious, general curative effect is seemingly better than huperzine A, and safety non-toxic, being suitable for long-term taking, is treatment alzheimer disease advanced low-grade cognitive disorder (MCI) Chinese medicine preparation safely and effectively.
Model case:
Lu, female, 57 years old, because " hypomnesis 3+ " goes to a doctor in December in 2012 on the 31st.Patient engenders hypomnesis without obvious inducement before 3+, to remember for main companion's computing power declines, without dystropy, do not give diagnosis and treatment, nearly 1+ starts to occur that executive capability declines, and not competent in the past skilled thing is as cooking etc., gait is slow, in random little step.Medical " Guizhou Province People ' s Hospital " makes a definite diagnosis MCI, carries out associated treatment (specifically not quite clear) symptom and has no improvement, rear medical No. 2 Affiliated Hospital of Guiyang College of Traditional Chinese Medicine.Disease is seen: hypomnesis, lassitude, bradykinesia, refreshing tired somnolence, soreness of the waist and knees, dizzy tinnitus, shortness of breath and palpitation, insomnia and dreamful sleep, pale tongue with white fur, deep-thready pulse or heavy micro-.Tcm diagnosis is " forgetful ", and card belongs to deficiency of spleen and stomach, gives ginseng and pilose antler supplementing the brain capsule for treating, oral 4 tablets/time, day 3 times.After March, during further consultation, executive capability, memory take a turn for the better, and tongue arteries and veins is substantially the same.Prompting treatment effectively.
Accompanying drawing explanation
Fig. 1 is puerarin reference substance chromatogram;
Fig. 2 is decocting process orthogonal experiment chromatogram one;
Fig. 3 is decocting process orthogonal experiment chromatogram two;
Fig. 4 is decocting process orthogonal experiment chromatogram three;
Fig. 5 is decocting process orthogonal experiment chromatogram four;
Fig. 6 is decocting process orthogonal experiment chromatogram five;
Fig. 7 is the process certification experiment chromatogram of water extraction process three batch sample;
Fig. 8 is ginseng and pilose antler supplementing the brain capsule sucting wet curve figure.
Detailed description of the invention
Below in conjunction with drawings and Examples, the present invention is described in further detail, but protection scope of the present invention is not by any restriction of specific embodiment, but be limited by claim.
embodiment 1:
Get Radix Ginseng 106.4 g, Radix Polygalae (processed) 266 g, Rhizoma Acori Graminei 399 g, Poria 266 g, Cornu Cervi Pantotrichum 26.6 g, Herba Cistanches 399 g, Concha Haliotidis 532 g, Radix Puerariae 532 g, Herba Ephedrae 53.2 g nine taste medical material, Radix Ginseng, Cornu Cervi Pantotrichum, Herba Ephedrae are ground into fine powder; The Six-element medical materials such as all the other Radix Puerariaes, add 8 times of water (add water 9.5 times first, soak 1 hour) by weight and decoct 3 times, each 0.5 hour, collecting decoction, filter.It is 1.35 ~ 1.40(60 DEG C that filtrate normal pressure is concentrated into relative density) thick extractum, be placed in 80 DEG C of constant pressure and dries.Dried cream powder is broken into fine powder (crossing 65 mesh sieves) and mixs homogeneously with Radix Ginseng powder 106.4 g, Pulveratum Cornu Cervi Pantotrichum 26.6 g, Herba Ephedrae powder 53.2 g, loads 0# hard capsule and makes 1000, to obtain final product.
(1) Study on extraction
the mensuration of 1 medical material water absorption rate
Take 1/5 recipe quantity medical material (except Radix Ginseng, Cornu Cervi Pantotrichum, Herba Ephedrae) and amount to 18 g, add 10 times amount water soakings, soak different time, filter, claim wet medicine weight (to medical material weight no longer increases), measure medical material water absorption rate, formula following (the results are shown in Table 1-1).
Quality (g) under mb-medical material water suction saturation
Mg-medical material quality (g) in the dry state
From table 1-1, medical material water absorption rate is 138.7%, for convenience of operation, be 140% calculating with water absorption rate, namely medical material water absorption is heavy 1.4 times of medical material, for convenience of production calculation, when decocting with water first, add 1.5 times of water gagings with whole water extraction medical material, the aqueous phase that will add with theoretical water absorption rate closes not quite, therefore first water extraction time to add 1.5 times of water gagings be rational.
the quadrature factor of decocting process
Under the condition meeting medical material water absorption rate, investigate the principal element of amount of water, decoction number of times, decocting time, soak time four impact decoction effect, by each factor 3 level, use L
9(3
4) orthogonal table experiment arrangement (table 2-1).Boiled process adopts orthogonal experiment to carry out screening (table 2-2), with total solid matters yield, puerarin content for inspection target, respectively by after degree of membership translation data, with the score of comprehensive evaluation index=70% puerarin content score+30% total solid matters yield, extraction process is inquired into.Orthogonal result variance analysis and factor level analysis in table 2-2, table 2-3.
sample preparation
Take 1/5 recipe quantity medical material (except Radix Ginseng, Cornu Cervi Pantotrichum, Herba Ephedrae) and amount to 18 g, undertaken testing (table 2-2) by orthogonal design table, filter, merging filtrate, concentration of liquid medicine is settled to 500 ml, for subsequent use.
total solid matters yield measures
From above-mentioned filtrate, each precision draws medicinal liquid 10 mL, and to horizontal heavy evaporating dish, water bath method, measures according to dry weightless mensuration (" Chinese Pharmacopoeia " version in 2010 annex IX G), and calculate total solid matters yield, formula is as follows:
wfor the weight of solids in 10ml filtrate,
vfor constant volume,
wtfor sample charged material weight.
puerarin content measures
2.3.1 instrument and reagent
Agilent 1260 high performance liquid chromatograph; Prunus mume (sieb.) sieb.et zucc. Teller-Tuo benefit AE electronic analytical balance (METTLER TOLEDO 100,000/).
Chromatograph methanol (world company limited of the U.S.); Water (WAHAHA drinking pure water); Puerarin reference substance (Nat'l Pharmaceutical & Biological Products Control Institute, lot number: 110715-200212, for assay); Sample (self-control, laboratory sample).
chromatographic condition and system suitability are tested
Measure according to high performance liquid chromatography (" Chinese Pharmacopoeia " version in 2010 annex VI D).Chromatographic condition: Yi Lite Hypersil C
18(4.6 mm × 250 mm, 5 μm); Mobile phase: methanol-water (25:75); Flow velocity: 1 mLmin
-1; Column temperature 30 DEG C; Determined wavelength: 250 nm.
the preparation of reference substance solution
Precision takes at 50 ~ 70 DEG C of drying under reduced pressure puerarin reference substance of 2 ~ 6 hours, is configured to the solution (see figure 1) of every 1 mL containing puerarin 0.803 mg.
the preparation of need testing solution
Draw above-mentioned filtrate appropriate, filter with 0.45 μm of filter membrane, obtain need testing solution, sample size is 8 ~ 12 μ L.
date processing
Each experiment is carried out according to orthogonal table plan, measures total solid matters yield, puerarin content (see Fig. 2-Fig. 6), and determination data calculates conversion with index degree of membership respectively, the score of comprehensive evaluation index=70% puerarin content score+30% total solid matters yield.
interpretation of result
From table 2-3 analyze can obtain: factor B have statistical significance (
p<0.01), be principal element; Factor D have statistical significance (
p<0.05), be key factor; Factor A, C affect without significance, are secondary cause.Therefore select B factor level 3, D selecting factors level 2, factor A, B, select A level 1, C level 1 according to cost-saving and need of production, then this prescription extracts optimum process condition is A
1b
3c
1d
2, namely medical material soaks 1 h, 8 times amount soak by water 3 times (first time adds 1.5 times of water gagings), each 0.5 hour.
the process certification experiment of three batch samples
Take 1/5 recipe quantity medical material (except Radix Ginseng, Cornu Cervi Pantotrichum, Herba Ephedrae) and amount to 18 g, by optimal extract process A
1b
3c
1d
2extract, measure total solid matters yield, puerarin content, result shows in Table 2-4, Fig. 7, shows that the extraction process drafted is basicly stable feasible.
concentrated and dry
3.1 extractum relative densities are on the impact of extract dry time
Take 1/5 recipe quantity medical material (except Radix Ginseng, Cornu Cervi Pantotrichum, Herba Ephedrae) and amount to 18 g, by optimal extract process A
1b
3c
1d
2extract, collecting decoction, decocting liquid is statically placed in ambient temperature overnight, filters, and concentrates and is settled to 100 ml, for subsequent use.Precision measures equivalent extracting solution, and concentrated (traditional handicraft concentrates), to different relative density, in 80 DEG C of constant pressure and dries, see drying time length.The results are shown in Table 3-1.
table 3-1 extractum phase
Experimental result shows: extractum is concentrated into relative density when being 1.35-1.40, dry shortest time used, and is also easy to crushing operation, therefore to select extractum to be concentrated into relative density be 1.35-1.40.
baking temperature is on the impact of extract dry time
Take 1/5 recipe quantity medical material (except Radix Ginseng, Cornu Cervi Pantotrichum, Herba Ephedrae) and amount to 18 g, by optimal extract process A
1b
3c
1d
2extract, collecting decoction, decocting liquid is statically placed in ambient temperature overnight, filters, and concentrates and is settled to 100 ml, for subsequent use.Precision measures equivalent extracting solution, and concentrated (traditional handicraft concentrates) is 1.35-1.40 to relative density, is dried to constant weight, sees drying the time with different temperatures, different drying mode (constant pressure and dry, drying under reduced pressure).In Table 3-2.
From table 4-2,80 DEG C of drying under reduced pressure are consuming time few, and extractum is easy to pulverize; Normal pressure 80 DEG C of dryings are consuming time consuming time slightly long compared with 80 DEG C of drying under reduced pressure.When baking temperature is 90 DEG C, the change likely causing its effective ingredient because its temperature is too high, therefore do not adopt.Consider, select 80 DEG C of constant pressure and dry extractum.
(2) preparations shaping technical study
4 dosage form selection foundations
Side's taste of Chinese medicine is pulverized and is added except extract powder except Radix Ginseng, Cornu Cervi Pantotrichum, Herba Ephedrae, and all the other group of medicine adopt traditional handicraft water boiling and extraction, and the present invention is advisable to select granule, but granule carries and take not too convenient, and mouthfeel is also not easily allocated; If selection tablet, owing to also needing when tabletting to mix certain adjuvant, increase dose, add simultaneously and be pressed into tablet, disintegrate need have individual process, and the absorption of medicine is slower, and need coating be carried out after tabletting, operation is more numerous and diverse, adds production cost, and exploitation of the present invention, crude drug price is lower, increase operation and also just increase production cost, for extensive patients provides inexpensive, medicable kind, therefore the present invention selects capsule to be advisable.Capsule patient swallow is convenient, compliance is better.
soak by water paste-forming rate is tested
Get the medical material (except Radix Ginseng, Cornu Cervi Pantotrichum, Herba Ephedrae) of suitable recipe quantity, carry out extracting according to preferred optimum extraction process, concentrate, dried obtains dry extract.Dry extract is pulverized, and cross 65 mesh sieves, get dry extract leaching powder, moistureproof for subsequent use.Different batches Golden Crow Jiangu capsule for strengthening bone Chinese crude drug (except Radix Notoginseng) paste-forming rate experimental data, in Table 5-1.
Result: by the experiment of 8 batches, its average paste-forming rate is 13.06%.
the formulating of preparations shaping
This preparation water boiling and extraction gained dry extract, have hygroscopicity strong, the shortcomings such as viscosity is large, being prepared into qualified capsule needs to add suitable adjuvant.By preliminary experiment in early stage, in extract powder, add prescription in proportion and need pulverize the Radix Ginseng, Cornu Cervi Pantotrichum, the Herba Ephedrae protogenic medicinal powder that add, the hygroscopicity of ginseng and pilose antler supplementing the brain capsule medicated powder can be reduced preferably, improve viscosity, without the need to adding other adjuvants and plastic again, therefore by with by water extraction extract powder and the direct mixed-forming of protogenic medicinal powder.
the former powder physical characteristic of medicine is investigated
Prepare the former powder of a collection of ginseng and pilose antler supplementing the brain capsule by optimised process, measure critical relative humidity, stop than angle and bulk density, to investigate production process, to ambient humidity requirement, the mobility of medicated powder and capsule loading amount.
the critical relative humidity of the former powder of medicine measures
Hard capsule filling environment humidity is very large on hard capsule fill impact, is necessary the critical relative humidity measuring the former powder of ginseng and pilose antler supplementing the brain capsule.Tile the former powder of thickness about 2 mm bottom the weighing botle of constant weight, at P
2o
5in exsiccator, be placed to constant weight, prepare 7 increment product altogether, be placed in the drying receptacle filling variable concentrations sulphuric acid and different salt supersaturated solution interior (weighing bottle cap to open) respectively, in 25 DEG C of constant incubators, weigh after keeping 7 d, calculate former powder hydroscopicity, in Table 7-1, Fig. 8.
As shown in Figure 8, take hydroscopicity as vertical coordinate, relative humidity (RH%) is abscissa curve plotting.Make tangent line respectively from curve two ends, abscissa corresponding to two points of intersection of tangents is critical relative humidity (CRH), and result shows that the critical relative humidity of the former powder of ginseng and pilose antler supplementing the brain capsule is about about 57%.Therefore pulverize at extractum and mix with adjuvant, fill capsule and when storing, ambient humidity must control below 57%, to reduce the impact of moisture on pharmaceutical properties and stability.
the angle of repose of the former powder of medicine measures
Adopt fixed funnel method, connect by 3 funnels and be fixed on suitable height place on the graph paper of horizontal positioned, funnel end opening is made to be H(H=3 cm apart from the distance of graph paper), carefully former for medicine powder is poured in uppermost funnel along hopper walls, until the cone tips of bottom funnel medicated powder touches bell mouth, now measure the diameter D bottom cone by graph paper, radius r (r=D/2) can be calculated, according to trigonometric function
, calculate α angle of repose.Repeat experiment 3 times, measurement result is in Table 7-2.Average out to 37.93 °, 3 times measurement result is all less than 40 °, shows that mobility of the present invention is better, is easy to subpackage, can ensures that capsule content uniformity controls.
the bulk density of the former powder of medicine measures
Bulk density adopts graduated cylinder method, and get the medicine of 3 parts of about 5g, accurately weighed, be filled in 10 mL graduated cylinders, hands is put and graduated cylinder is vertically dropped on plank by 5 cm eminences, repeatedly after 5 vibrations, measures drug powder volume, measures 3 times altogether, calculate bulk density.The results are shown in Table 7-3.
determine loading amount
Powder is loaded 0# capsule 400, take out 20 at random and weigh, average quality is 0.4795 g, and the last loading amount of capsule can be decided to be 0.48 g.
Certainly, the embody rule example of more than just invention, the technical scheme that the present invention also has other embodiment, all employings to be equal to replacement or equivalent transformation to be formed, all drops within protection domain of the presently claimed invention.
Claims (2)
1. treat a Chinese medicine composition for AD disease, it is characterized in that: it is made up of the crude drug of following parts by weight: Radix Ginseng 95 ~ 110 parts, Radix Polygalae (processed) 250 ~ 270 parts, Rhizoma Acori Graminei 385 ~ 410 parts, 250 ~ 270 parts, Poria, 24 ~ 28 parts, Cornu Cervi Pantotrichum, Herba Cistanches 385 ~ 410 parts, Concha Haliotidis 500 ~ 550 parts, Radix Puerariae 500 ~ 550 parts, 50 ~ 55 parts, Herba Ephedrae.
2. the Chinese medicine composition for the treatment of AD disease according to claim 1, is characterized in that: it is made up of the crude drug of following parts by weight: Radix Ginseng 106.4 parts, Radix Polygalae (processed) 266 parts, Rhizoma Acori Graminei 399 parts, 266 parts, Poria, 26.6 parts, Cornu Cervi Pantotrichum, Herba Cistanches 399 parts, Concha Haliotidis 532 parts, Radix Puerariae 532 parts, 53.2 parts, Herba Ephedrae.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
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| CN108079009A (en) * | 2016-11-23 | 2018-05-29 | 中国科学院上海药物研究所 | A kind of pharmaceutical composition for being used to treat senile dementia disease |
| CN112336738A (en) * | 2020-12-25 | 2021-02-09 | 孟胜喜 | Traditional Chinese medicine monomer composition for preventing and treating Alzheimer disease and application thereof |
| CN113244218A (en) * | 2021-07-01 | 2021-08-13 | 暨南大学 | Application of formononetin in preparation of medicine for treating or/and preventing depression |
| CN113430146A (en) * | 2021-07-28 | 2021-09-24 | 西安医学院 | Bacillus thuringiensis HW1 strain for efficiently expressing huperzine A and application thereof |
| CN114832006A (en) * | 2022-06-07 | 2022-08-02 | 陕西巨子生物技术有限公司 | Application of ginsenoside Rh4 in preparation of medicine for inhibiting sleep |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108079009A (en) * | 2016-11-23 | 2018-05-29 | 中国科学院上海药物研究所 | A kind of pharmaceutical composition for being used to treat senile dementia disease |
| CN112336738A (en) * | 2020-12-25 | 2021-02-09 | 孟胜喜 | Traditional Chinese medicine monomer composition for preventing and treating Alzheimer disease and application thereof |
| CN112336738B (en) * | 2020-12-25 | 2021-11-19 | 孟胜喜 | Traditional Chinese medicine monomer composition for preventing and treating Alzheimer disease and application thereof |
| CN113244218A (en) * | 2021-07-01 | 2021-08-13 | 暨南大学 | Application of formononetin in preparation of medicine for treating or/and preventing depression |
| CN113430146A (en) * | 2021-07-28 | 2021-09-24 | 西安医学院 | Bacillus thuringiensis HW1 strain for efficiently expressing huperzine A and application thereof |
| CN113430146B (en) * | 2021-07-28 | 2023-03-17 | 西安医学院 | Bacillus thuringiensis HW1 strain for expressing huperzine A and application thereof |
| CN114832006A (en) * | 2022-06-07 | 2022-08-02 | 陕西巨子生物技术有限公司 | Application of ginsenoside Rh4 in preparation of medicine for inhibiting sleep |
| CN114832006B (en) * | 2022-06-07 | 2024-03-08 | 陕西巨子生物技术有限公司 | Application of ginsenoside Rh4 in preparation of medicine for inhibiting sleep |
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Application publication date: 20150930 |