CN102895432A - Prescription and preparation method of rejoicing powder having new dosage form - Google Patents
Prescription and preparation method of rejoicing powder having new dosage form Download PDFInfo
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Abstract
The invention relates to a prescription and a preparation method of rejoicing powder having a new dosage form and used for preventing or treating the senile dementia, and belongs to the biological medicine field. The rejoicing powder having a new dosage form is based on rejoicing powder having an ancient classic prescription and treats Radix Polygalae, Acorus gramineus and the like as primary medicines, the primary medicines are pretreated, partial or all medicines are extracted with water or an organic solvent in necessity to obtain effective components, the primary medicines or the effective components are mixed with proper medicinal auxiliary materials, and the rejoicing powder having the new dosage form is prepared through a certain preparation technology. The traditional prescription and the traditional technology for preparing the powder through simply crushing all medicines are changed in the invention, a new method and a new technology are applied against modern clinic medicine use characteristics to prepare the novel powder, and technological products have the characteristics of safety, effectiveness, controllable quality, convenient taking and the like of modern medicines, have the advantages of high biological utilization degrees of the effective components, fast effectiveness, substantial improvement of the product quality, and effective guarantee of the basic efficacies comprising qi benefiting, heart nourishing, nerve calming and tranquilizing, and have unique clinic application values in the prevention and the treatment of the senile dementia.
Description
Technical field
The present invention relates to field of medicaments, be specifically related to prepare take Chinese medicine as raw material the herbal mixture of prevention or treatment senile dementia, belong to biomedicine field.
Background technology
The senile dementia card is divided into Alzheimer (AD), vascular dementia (VD), and both comprehensive dementias.Wherein Alzheimer accounts for 2/3 of whole dementia, has become No. four human killer.
At present China more than 60 years old the old man approximately have 1.29 hundred million, account for 10.15% of total population, prevalence of dementia is 3.0-4.0% in the aging population, over-65s old man prevalence is 4.0-5.0%, account for 10% more than 75 years old, account for 20% more than 85 years old, can find out every increase of old people's age 10 years old, sickness rate increases by 1 times.Therefore, develop a kind of medicine for the treatment of the senile dementia card and not only have great academic significance, have more far-reaching social meaning.
Western medicine senile dementia card mainly contains cholinesterase inhibitor, cerebral circulation improving agent, calcium ion antagonist, neurotrophic factor, antioxidant, estrogen etc. at present.Because the Western medicine uncertain therapeutic efficacy is cut, toxic and side effects is large, adds that pathogenesis is not yet clear and definite so far, filters out the chemical compound difficulty that can effectively prevent and treat this card according to chemical drugs research and development pattern larger.Therefore, take Chinese medical theory as the basis, from Chinese medicine, seek the active drug of control, become the major trend of domestic research.
Modern pharmacological research shows that Kaixin San has widely pharmacological action, particularly obvious effect is being arranged aspect nootropics defying age, the antioxidation.Kaixin San has prolongation life cycle, improves the old and feeble and effect of the learning and memory decline that occurs of companion.Its nootropic effect may be to bring into play by directly acting on the movable relevant synapse transmittance process of the physiological process of maincenter learning and memory, especially Hippocampus and learning and memory.Therefore, Kaixin San is expected to bringing into play its advantage aspect the treatment alzheimer disease.Make a general survey of the research of Kaixin San preparation aspect, mainly continue to use traditional preparation method, this has limited the application and development of Kaixin San.Therefore, can make the general new life that sends of this Chinese medicine prescription to the further investigation of Kaixin San novel form, enlarge its application aspect modern clinic.
Summary of the invention
The present invention provides the formulation and technology and preparation method thereof of the Kaixin San novel form of a kind of prevention or treatment senile dementia, it is characterized in that with medical material prescriptions such as Radix Polygalae, Rhizoma Acori Graminei, Poria, Radix Ginsengs, through pretreatment, or the extraction separation of passing through again obtains effective ingredient, and science be equipped with other pharmaceutic adjuvants, through certain preparation technology, the novel form with Qi-benefiting and heart-nourishing, tranquilizing the mind function that is prepared into has unique clinical value to prevention and the treatment of senile dementia.
The traditional Chinese medical science sees in the discussion of " dementia ", " refreshing slow-witted ", " melancholia " etc. the discussion of senile dementia, and the traditional Chinese medical science thinks that the etiology and pathogenesis of senile dementia mainly comprises, the essence of suffering from a deficiency of the kidney is not given birth to marrow, and the brain key loses supports; Zang-fu disharmony, deficiency of qi and blood, brain key lose supports; The expectorant stasis blocking stagnates, dysfunction of YANG-orifices etc.Control and work as strengthening spleen, tonifying kidney, supplying vital essence and marrow; Nourishing qi and blood is filled out the marrow brain-strengthening; The eliminating phlegm of having one's ideas straightened out, the refreshment Fructus Alpiniae Oxyphyllae.
The present invention be take ancient times the classic prescriptions Kaixin San as the basis, adopt the modern pharmaceutical technology to be prepared from.Kaixin San is first appeared in " prescriptions worth thousand gold " of the Tang Dynasty Sun Simiao, and it is to be comprised of " Radix Polygalae, Radix Ginseng each four minutes, two liang in Poria, Rhizoma Acori Graminei one or two "." lead and forget ".Representative prescription for Qi-benefiting and heart-nourishing, tranquilizing the mind is mainly used in treating deficiency of heart-QI, and mind is not peaceful, the cards such as forgetful insomnia.
Concrete technical scheme of the present invention is as follows:
One kind the prevention or the treatment senile dementia the Kaixin San novel form, each composition according to percentage by weight is: medical material 1.5--98%, pharmaceutic adjuvant 0--95%, its Chinese crude drug is comprised of Radix Polygalae, Rhizoma Acori Graminei etc.
2. preparation technology
Medicine of the present invention can be prepared into the new method of preparation various oral, injections and external new formulation.Preparation process is as follows:
One, with after the medical material clean dry, crushing screening.
Two, the medical material after will pulverizing mixes, also part or all of medical material can be passed through first water or organic solvent or water and ORGANIC SOLVENT MIXTURES effective component extracting after, again it is mixed with other medicated powder.
Three, add one or more conventional adjuvants, also can not add adjuvant.
Four, according to different clinical needs, be prepared into oral solid formulation, oral liquid or injection or external preparation or Emulsion or mucosa delivery preparation according to new technology.
Five, quality inspection.
Six, adopt different containers to load according to different dosage form.
Technical characterstic of the present invention or advantage are as follows:
The present invention will provide for the medicine for treatment of senile dementia new selection.Kaixin San is the substantially square of Fructus Alpiniae Oxyphyllae class prescription.Modern pharmacological research shows that Kaixin San has widely pharmacological action, particularly obvious effect is being arranged aspect nootropics defying age, the antioxidation.Utilize the modern pharmaceutical technology, Kaixin San be developed to various novel forms, have advantages of safe and effective, carry and taking convenience.Its main innovate point is as follows:
1. change traditional simply being used as medicine with full powder and made the preparation process of powder, used modern new agent technology, made it the final quality controllable novel formulation that obtains.
2. new formulation has changed the prescription that conventional formulation does not increase other potentiation medical material and do not add any adjuvant, according to needing to add flexibly the auxiliary material of using, novel formulation is not only quality controllable, more meets the characteristics of clinical application, can long term storage, mildew resistant moistureproof, and be convenient for carrying and be easy to take; Especially oral solid formulation is through not only covering the bad smell of Chinese medicine behind the film coating, and product quality is able to remarkable lifting.
3. the present technique product has been invented the mucosa delivery preparation that is particularly suitable for the brain administration mainly for the medication of old people's anti-senile dementia disease, makes it greatly to improve in quick absorption, target administration, therapeutic effect Jiang.
4. where necessary, extract the effective ingredient of medicine and make concentrate formulation, not only can reduce dosage, and effective ingredient is easier to absorb, curative effect greatly improves.
Specific embodiments
Embodiment 1:
Prescription: Radix Polygalae 50g, Rhizoma Acori Graminei 100g.
Preparation method: cross 80 mesh sieves after Radix Polygalae, Rhizoma Acori Graminei are pulverized.With medicated powder with equivalent incremental method mix homogeneously.Add 10% microcrystalline Cellulose, 15% polyvinylpolypyrrolidone, 6% sucrose, mix homogeneously, alcoholic solution with 4% hydroxypropyl methylcellulose (606) is binding agent soft material processed, crossing 18 mesh sieves granulates, 60 ℃ of oven dry 1h cross 20 mesh sieve granulate, add 0.6% magnesium stearate mix homogeneously, insert No. 0 or No. 1 capsule, make altogether hard capsule.
Embodiment 2:
Prescription: Radix Ginseng, Radix Polygalae, each 50g of Rhizoma Acori Graminei, Poria 100g.
Preparation method: cross 80 mesh sieves after Radix Ginseng, Radix Polygalae, Rhizoma Acori Graminei are pulverized, cross 150 mesh sieves after Poria is pulverized.With the four Chinese medicine powder with equivalent incremental method mix homogeneously.Add 20% microcrystalline Cellulose, 25% disintegrating agent, disintegrating agent is that polyvinylpolypyrrolidone and carboxymethyl starch sodium were according to 1: 1 mix homogeneously, aqueous solution with 1% carboxymethyl cellulose is binding agent soft material processed, cross 18 mesh sieves and granulate, 60 ℃ of oven dry 1h cross 20 mesh sieve granulate, add 6% micropowder silica gel and 0.6% magnesium stearate mix homogeneously, intermediate check, tabletting dispersible tablet.
Embodiment 3
Prescription:
Medical material: Radix Ginseng, Radix Polygalae, Rhizoma Acori Graminei, Semen Cuscutae, Radix Rehmanniae, Cortex Lycii, Fructus Schisandrae Chinensis, Semen Ziziphi Spinosae, Radix Angelicae Sinensis, Rhizoma Chuanxiong are respectively got 1000 grams (decoction pieces);
Adjuvant: Macrogol 200, HP-β-CD, sodium lauryl sulphate, Borneolum Syntheticum, pure water, ethanol.
Preparation method:
1. clean 2-3 time with pure water, add the pure water of octuple amount, extract, filter and to get extract for the first time with percolation under the high temperature, filtering residue again with the pure water percolation extraction of 4 times of amounts filter the second time extracting solution; Merge secondary raffinate, to be condensed into thick paste for subsequent use.
2. adjuvant is dissolved among 15% the ethanol water for subsequent use.
3. 1 thick paste is joined among 2 ethanol waters heated and stirred dissolving.
4. filtration, quality inspection.
5. fill is in spray bottle, namely get Kaixin San (oral cavity/nose) spray.
Claims (10)
1. the formulation and technology and preparation method thereof of the Kaixin San novel form of a prevention or treatment senile dementia, it is characterized in that being formed by medical materials such as Radix Polygalae, Rhizoma Acori Graminei, through pretreatment, or each medical material separately is mixed into separately or by a certain percentage the certain extracting method effective component extracting of compositions application, scientifically be equipped with certain pharmaceutic adjuvant, the novel form that the certain preparation technology of process forms.Function with Qi-benefiting and heart-nourishing, tranquilizing the mind has unique clinical value to the prevention of senile dementia and treatment.
2. medical material claimed in claim 1 forms, and comprises main Chinese medicinal materials and thinks that needs strengthen therapeutic efficiency and add in case of necessity and assist medical material and form.
3. main Chinese medicinal materials claimed in claim 2 comprises following two kinds or several composition, and each composition forms as following weight percent:
Radix Polygalae: 0.5-98%
Rhizoma Acori Graminei: 1-98%
Poria 0-96%
Radix Ginseng: 0-96%
4. auxiliary medical material claimed in claim 2 refers to following composition:
Rhizoma Chuanxiong, Radix Angelicae Sinensis, Poria cum Radix Pini, Radix Aconiti Lateralis Preparata, Semen Ziziphi Spinosae, Cortex Cinnamomi, Arillus Longan, the Rhizoma Atractylodis Macrocephalae, Fructus Jujubae, Dens Draconis, Radix Angelicae Pubescentis, Herba Asari, succinum, Radix Curcumae, Dens Draconis, Radix Saposhnikoviae, Fructus Aurantii Immaturus, Radix Platycodonis, the Rhizoma Pinelliae, Pericarpium Citri Reticulatae, Massa Medicata Fermentata, the Cortex Eucommiae, the Radix Aucklandiae, Semen Euryales, Radix Asparagi, Radix Ophiopogonis, Os Draconis, the Radix Astragali, Radix Codonopsis, Radix Salviae Miltiorrhizae, Fructus Lycii, Rhizoma Polygonati, Bulbus Lilii, Herba Dendrobii, Fructus Ligustri Lucidi, Herba Ecliptae, Carapax et Plastrum Testudinis, Radix Dipsaci, Rhizoma Coptidis, Radix Scrophulariae, Rhizoma Zingiberis Recens, Radix Glycyrrhizae, Radix Rehmanniae Preparata, Herba Cistanches, Radix Rehmanniae, Arillus Longan, Radix Morindae Officinalis, Semen Cuscutae, Radix Paeoniae Alba, Herba Taxilli, RHIIZOMA DIOSCOREAE fr0m Henan of China, Semen Phaseoli, Cortex Lycii, Semen Platycladi, Fructus Corni, the Fructus Gleditsia pod, Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis, Semen Sinapis Albae, Cornu Saigae Tataricae fillings etc.;
Abovely auxiliaryly can be the compositions of one or several, also can not add with medical material, the weight percent content of each be: 0-95%.
5. claim 1 is described is equipped with certain pharmaceutic adjuvant, refers to following composition:
Borneolum Syntheticum, microcrystalline Cellulose, starch, pregelatinized Starch, carboxymethyl starch sodium, dextrin, calcium sulfate (containing two hydrates), calcium hydrogen phosphate, micropowder silica gel, Polyethylene Glycol, poloxamer, hydroxypropyl emthylcellulose, hydroxypropyl cellulose, sodium carboxymethyl cellulose, methylcellulose, polyvidone, carbomer, sodium polyacrylate, ethyl cellulose, hydroxyethyl-cellulose, polyvinylpyrrolidone, polyacrylic resin, Cera Flava, hydrogenated vegetable oil, stearic acid, Brazil wax, glyceryl stearate, propylene glycol stearate, octadecanol, low-substituted hydroxypropyl cellulose, gelatin, xanthan gum, carrageenan, gellan gum (containing deacetylated gellan gum), beta-schardinger dextrin-(containing hydroxypropylβ-cyclodextrin), 2,3-lauryl alcohol ester, dimethyl sulfoxide, glycerol, ethanol, propanol, propylene glycol, Polyethylene Glycol (or polyethylene glycol monolaurate), vegetable oil, ethyl acetate, polysorbate, dodecylbenzene sodium sulfonate, sodium laurate, sodium lauryl sulphate, benzalkonium chloride, capric acid, cetrimonium bromide, cetylpyridinium chloride, chitosan, chitosan-4-sulfo-butylamine, chitosan-4-thioglycolic acid, citric acid, sodium bicarbonate, dextran sulfate, azone, EDTA, ethylene glycol, 1B, lysalbinic acid, LYSO-PHOSPHATIDYLCHOLINE LYSOPC, menthol, Mel, methyl oleate, oleic acid, lecithin, polyoxyethylene (20) cetyl ether, poly-L-arginine, 5-methoxyl group sodium salicylate, sodium citrate, NaTDC, EDETATE SODIUM salt, sweet cyclodextrin (and related polymer), Oleum Caryophylli, xylitol, glycyrrhizin, mannitol, lactose, sucrose, glucose, all kinds of sweeting agents, sodium alginate, Herba Menthae (essence), synthetic essence (or natural essence), potassium sorbate, sodium benzoate, aluminum chloride, rubber, zinc oxide, Colophonium, lanoline, gasoline, liquid Paraffin, vaseline, Pulvis Talci etc.;
Above pharmaceutic adjuvant can be the compositions of one or several compositions, also can not add, and the weight percent content of each is: 0-95%.
6. extracting method claimed in claim 1 is characterized in that, extracting method comprises steam distillation, CO
2Supercritical extraction, circumfluence method, infusion process, decocting method, percolation, ultrasonic extraction etc.;
Extract the mixture that solvent refers to make water or organic solvent or waters organic solvent.
7. preparation technology claimed in claim 1, refer to following preparation technology: through pretreated medical material, all or part of pulverizing, or part (or all) effective component extracting, add pharmaceutic adjuvant, mix and blend, again through pelletizing forming, and through certain moisture-proof dosing technology processing etc. make oral solid formulation (such as tablet, capsule etc.) mixed water-soluble or other solvent is made oral liquid external soft (firmly) unguentum or spray or be dissolved in solvent more after filtration sterilization filling be prepared into injection or Emulsion etc.
8. moisture-proof dosing technology claimed in claim 7 is processed, and the oral solid formulation film coatings such as the tablet that refers to be prepared into, micropill, drop pill, granule are namely at the more stable high molecular polymer clothing film of top layer outsourcing one deck of medicine sheet (ball) core.
9. high molecular polymer in the film coating claimed in claim 8 mainly comprises one or more compositions of following composition:
Hydroxypropyl emthylcellulose, polyvinyl alcohol, polyvinyl alcohol-polyethyleneglycol-graft copolymer, hydroxypropyl cellulose, Polyethylene Glycol, polyvinylpyrrolidone, acrylic resin, hydroxypropylmethyl cellulose phthalate, cellulose acetate, phthalic acid ester, Lac, ethyl cellulose (EC), zein, Opadry
, Opaglos, Colorcon
, ETHOCEL, METHOCEL, EUDRAGIT, propylene glycol, glycerol, phthalic acid ester, citrate, sebacate, sodium lauryl sulphate, tween, Oleum Ricini, glyceryl monostearate, Pulvis Talci, micropowder silica gel, magnesium stearate, pigment etc.;
Above high molecular polymer can water or ethanol make solvent dissolve make coating solution routinely the coating method coating get final product.
10. novel form claimed in claim 1, it is characterized in that it comprises following dosage form: tablet (comprising dispersible tablet, controlled release tablet, fast-release tablet), capsule (comprising sustained and controlled release capsule), granule, pill (containing concentrated pill), drop pill, suppository, membrane, lozenge, spray, oral liquid, concentrated oral liquid, syrup, unguentum, cataplasma, effervescent, oral cavity disintegration tablet, micropill, Emulsion, injection, and nanometer formulation.
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