CN103285269A - Traditional Chinese medicine preparation for treating child anorexia and preparation method thereof - Google Patents

Abstract

The invention discloses a traditional Chinese medicine preparation for treating child anorexia and a preparation method thereof. The preparation is prepared from atractylodes rhizome stir-fried with bran, bighead atractylodes rhizome fried with earth, Poria cocos, coix seed, fried bitter orange, Chinese yam, licorice, dried orange peel, fried medicated leaven, soluble starch and cane sugar. The traditional Chinese medicine preparation provided by the invention has the advantages of a good curative effect, safety, reliability, capacity of effectively improving the appetite, face color, appetite and symptoms like abdominal distension of children, convenience in administration, rapid drug release and a definite therapeutic effect, and the preparation is a safe and reliable traditional Chinese medicine preparation for treating child anorexia.

Description

A kind of Chinese medicine preparation for the treatment of infantile anorexia and preparation method thereof

Technical field

The present invention relates to technical field of Chinese medicines, particularly relate to a kind of Chinese medicine preparation for the treatment of infantile anorexia and preparation method thereof.

Background technology

Infantile anorexia refers to long-term loss of appetite or disappearance, is reduced to cardinal symptom with appetite, it is a kind of chronic digestible dysfunction syndrome, diseases such as normal companion's belch, abdominal distention, dysporia, cause insufficiency of generating and transforming QI and blood because chronic dietary is uncomfortable, as seen body is thin partially, and performances such as lustreless complexion are usual diseases of childhood, frequently-occurring disease, more 1-6 year children's sees, and ascendant trend is year by year arranged.

The reason of infantile anorexia has a lot, and common have a bad dietary habit: can not quantitatively have meal, long-time hungry after a full meal has been upset the gastrointestinal rule, causes the minimizing of Digestive system, no hunger sensation on time.On the contrary, eat too many snacks between twice meal, make stomach keep one and half full states forever, the hope when fixed point is had a meal will reduce, thereby does not have appetite; Also have the pica because of the head of a family to influence child, cause child's monophagia: child is subjected to the head of a family's hint in daily life, and unusual having a liking for partially appearred in some food, causes the unbalanced of nutrition, then can cause malnutrition for a long time, causes anorexia.Also have environment change: feed and environment have close relationship.Because environmental change, domestic misfortune, or for the first time away from father and mother etc., make child's dietary habit can not obtain very fast adaptation, cause child's appetite to subtract greatly.If can not adjust as early as possible, the time has been grown, and will cause anorexia.Moreover psychological factor: the head of a family blindly competes with child's food-intake, emphasizes when having a meal or stipulates how many children eats, and the time has been grown, and makes child produce aversion.Or the custom time lesson child that is at table, child have a meal the time will psychentonia, depressed, cause appetite to descend, cause anorexia.And have the Chinese medicine preparation of special efficacy also rare for infantile anorexia at present.

Summary of the invention

Technical problem to be solved by this invention is the defective that overcomes prior art, a kind of good effect is provided, safe and reliable, can effectively improve children's's symptom such as appetite, complexion, spirit, abdominal distention, taking convenience, release is rapid, Chinese medicine preparation of the treatment infantile anorexia of determined curative effect and preparation method thereof.

In order to solve the problems of the technologies described above, the present invention adopts following technical scheme:

According to listed as parts by weight, the Chinese medicine preparation that the present invention treats infantile anorexia is to be prepared from by raw material of Chinese medicine parched with bran Rhizoma Atractylodis 468～268g, Rhizoma Atractylodis Macrocephalae (parched with earth) 468～268g, Poria 468～268g, Semen Coicis 468～268g, Fructus Aurantii (parched) 280～160g, Rhizoma Dioscoreae 468～268g, Radix Glycyrrhizae 280～160g, Pericarpium Citri Reticulatae 280～160g, stir-fry Massa Medicata Fermentata 280～160g, soluble starch 150～40g sucrose 400～200g.

Preferably, above-mentioned Chinese medicine preparation is to be prepared from by parched with bran Rhizoma Atractylodis 368.1g, Rhizoma Atractylodis Macrocephalae (parched with earth) 368.1g, Poria 368.1g, Semen Coicis 368.1g, Fructus Aurantii (parched) 220.9g, Rhizoma Dioscoreae 368.1g, Radix Glycyrrhizae 220.9g, Pericarpium Citri Reticulatae 220.9g, stir-fry Massa Medicata Fermentata 220.9g, soluble starch 100g, sucrose 300g.

The present invention also provides the preferred for preparation method of aforementioned Chinese medicine preparation: above nine flavor medical materials, the parched with bran Rhizoma Atractylodis, Rhizoma Atractylodis Macrocephalae (parched with earth), Pericarpium Citri Reticulatae, Fructus Aurantii (parched) adds the water logging of 8 times of weight and steeped 2 hours, extracted 3 hours with volatile oil extractor, collecting volatile oil deposits in addition, medicinal residues and Semen Coicis, Rhizoma Dioscoreae, Radix Glycyrrhizae, fry Massa Medicata Fermentata, the decocting that Poria adds 8 times of weight at every turn boils 3 times, each 0.5 hour, merge 3 times decocting liquid, filter, it is 1.30～1.35(60 ℃ that the filtrate normal pressure is concentrated into relative density) thick extractum, 80 ℃ of decompressions (2.67kPa) got dry extract in dry 24 hours, dried cream powder is broken into fine powder (crossing 100 mesh sieves) and sucrose and soluble starch mix homogeneously, 95% ethanol, 90～140ml soft material processed, and 14 mesh sieves are granulated, 60 ℃ of dryings 48 hours, 12 mesh sieve granulate spray into the volatile oil mixing, make granule, divide packing, namely get the activating the spleen granule.

Infantile anorexia mainly is dysfunction of the spleen in transportation: the normal or few China of complexion, and do not think to receive and eat or monophagia, very then refuse into diet, belch is felt sick, and body is thin partially, and it is uncomfortable to defecate, light red tongue, Tai Bai or thin greasy, thready pulse is still strong.

The many splenopathys of children's, " when being earlier with the reason " academic thought, catch the feature of taste " be benefit with fortune " and the characteristic of " be benefit with the happiness ", follow the principle of " desiring to make spleen strong; not to be valued for fortune in benefit ", based on " activating the spleen ", carrying according to " decoction of four noble drugs " in " formulary of peaceful benevolent dispensary " and " Pingwei San " two sideizations and to form through proved recipe---activating the spleen looses, dry to comply with the spleen happiness, dislike wet, initiatively, the main habit that rises is created " activating the spleen looses ", the activating the spleen stomach function regulating certainly, be intended to make in order the normal lifting relation of taste, recover its intrinsic function of motion, make spleen soil vigorous, thereby reach the purpose of curing anorexia.

Trade name of the present invention: activating the spleen granule

Experiment one: preparation process research

(1) prescription drug physicochemical property and pharmacological research

The parched with bran Rhizoma Atractylodis(feverfew Atractylis chinensis Atractylodes chinenesis(DC.) dry rhizome of Koidz.) chemical constituent is concluded following a few class: (1) volatile oil: atisine chloride atractydin, hinesol, sagittol, atractylone, atractylin, β-selinene, left-handed Bisabolol terpene alcohol etc. ^[2](2) polyacetylene chemical compound: atractylin alcohol, acetyl group atractylin alcohol.(3) glycoside: atractyloside, fructofuranoside, 10,11,14-trihydroxy more wound-3-ketone-11-O-β-D-glycopyranoside, different Lignum pterocarpi indici alcohol ketone-β-D-glycopyranoside, (2E, 8E) decadinene 4,6-diine 1,10-glycol-1-O-β-D glycopyranoside.The ALR-5a-1-1(arabinogalactan), ALR-a (ALR-5b-2-2), ALR-b (ALR-c-3-1) (4) polysaccharide:.(5) vitamin: vitamin A, vitamin D.

Parched with bran Rhizoma Atractylodis acrid in the mouth, hardship, warm in nature.Return spleen, stomach, Liver Channel.Have drying damp and strengthening spleen, expelling wind and cold, the effect that makes eye bright.Cure mainly retention of dampness in middle-JIAO, distension and fullness in the abdomen is had loose bowels, edema, and beriberi, rheumatic arthralgia, anemofrigid cold, nyctalopia, eyes dusk is puckery.The acrid in the mouth hardship of Rhizoma Atractylodis, gas perfume (or spice) warm in nature, dampness is with strong activating the spleen gas; Arduous and fragrant, can rise and can fall, the long and same usefulness of Ligusticum slnense is used for all melancholia; The hot hardship of loosing is dry, and the diaphoresis that can dehumidify is used for damp at all cards of table with cold expelling; Xin Xiang can remove bad odor, keeps away foul; The Rhizoma Atractylodis parched with bran has the effect that relaxes its dry property, strengthens spleen invigorating.

The pharmacological research data shows: Rhizoma Atractylodis have certain facilitation to gastrointestinal motility, β-eudesmol, atractylol are the main effective ingredient of this effect, and atractylol extract and water extract have dual regulation to gastrointestinal smooth muscle.Rhizoma Atractylodis decocting liquid can suppress the motion of " insufficiency of the spleen " animal intestinal propulsion, and antagonism is had loose bowels; Can reduce serum copper and improve serum zinc, improve " insufficiency of the spleen " animal metabolism function, weight increase, and by improving serum levels of iron, increase the synthetic of hemoglobin, improve erythrocytic function.

Rhzoma Atractylodis Lanceae volatile oil, water boiling and extraction thing have activity and show that in we it is rational that Rhizoma Atractylodis take two lifting manipulations to extract.

Rhizoma Atractylodis Macrocephalae (parched with earth)(be the feverfew Rhizoma Atractylodis Macrocephalae Atractylodes macrocephalaKoidz. dry rhizome, this product are the process of preparing Chinese medicine processed goods of the Rhizoma Atractylodis Macrocephalae) chemical constituent concludes following a few class: (1) volatile oil: α-and β-Humuleno, atractylone, 7-selinene, γ-elemene, α-curcumene, eudesmol, Palmic acid, hinesol etc.(2) polyacetylene alcohols: 14-acetyl group-12-Herba Senecionis Scandentis acyl group-8-cis Rhizoma Atractylodis Macrocephalae triol, 14-acetyl group-trans Rhizoma Atractylodis Macrocephalae triol of 12-Herba Senecionis Scandentis acyl group-8-etc.(3) polysaccharide composition: fructose, inulin, mannose etc.(4) amino acids composition: winter propylhomoserin, serine, glutamic acid, alanine, isoleucine, arginine, histidine, lysine etc.(5) sesquiterpene lactones constituents: atractyloide-I-II-III, 8 β-ethyoxyl atractyloide-II, atractylenolide (II), atractylenolide (III), atractylenolide (IV), double blank art lactone (V), Rhizoma Atractylodis Macrocephalae lactams (VI), juniper camphor (VII).

Rhizoma Atractylodis Macrocephalae (parched with earth) bitter in the mouth, sweet, warm in nature.Return spleen, stomach warp.Has invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive effect.Cure mainly the deficiency-weakness of spleen-QI spiritlessness and weakness, lack of appetite abdominal distention, big loose stool is thin; Fluid-retention stagnating in the interior, dysuria, edema, dizziness due to fluid-retention; The arthralgia chiefly caused by damp pathogen limb aching pain, spontaneous sweating due to deficiency of QI; Frequent fetal movement.This product master goes into spleen channel, energy and middle QI invigorating, and invigorating the spleen and stomach is the key medicine for the treatment of syndrome of spleen-deficiency; Parching with earth can strengthen the effect of drying damp and strengthening spleen antidiarrheal.

The pharmacological research data shows, the Rhizoma Atractylodis polysaccharide that extracts from the Rhizoma Atractylodis Macrocephalae (PAM) has regulating action to the mouse spleen lymphocyte immunologic function, in certain concentration range, can activate separately or collaborative ConA/PHA promotion lymphocyte transformation, and can obviously improve the level of ivL-2 secretion, this regulating action is relevant with receptor, agonist isoproterenol.The Rhizoma Atractylodis Macrocephalae can strengthen the phagocytic function of reticuloendothelial system; Leukopenia there is the rising effect; Can also improve lymhocyte transformation rate and natural Flos Rosae Rugosae formation rate, promote cellular immune function, and obviously increase serum IgG, the effect that strengthening the spleen and stomach, strong health is arranged and improve body resistance against diseases.The Rhizoma Atractylodis Macrocephalae is right ShouldSharp gastric ulcer has very strong preventive effect, and its mechanism is to relax the general underactivity that causes under the stress state, and its active component is atractylone, has the effect of similar ACTH.Heavy dose of Rhizoma Atractylodis Macrocephalae water decoction can promote the gastrointestinal of mice to promote motion.Rhizoma Atractylodis Macrocephalae volatile oil suppresses autonomic movement and the antagonism BaCl of intestinal tube ₂Effect stronger.

Rhizoma Atractylodis Macrocephalae volatile oil, water boiling and extraction thing have activity and show that in we it is rational that the Rhizoma Atractylodis Macrocephalae takes two lifting manipulations to extract preparation activating the spleen granules.

Poria(be Polyporaceae fungus Poria Poria cocos(Schw.) dry sclerotia of Wol) chemical constituent is concluded following a few class: (1) triterpenoid compound: pachymic acid, dehydrogenation pachymic acid, polyporic acid, Pilus Caprae seu Ovis steroid-8-alkene type triterpene, Pilus Caprae seu Ovis steroid-7,9 (11)-diene type triterpenes, 3,4-open loop-Pilus Caprae seu Ovis steroid-7,9 (11) diene type triterpenes etc.(2) polysaccharide compound: the β-D-glucose of pachyman, pachymaran and height (1,3), (1,6), branch etc.(3) fatty acid compound: sad, undecanoic acid, lauric acid, dodecoic acid, Palmic acid, Poria cyclic ketones diene triterpenic acid etc.(4) other: ergosterol class, natural gum, chitin, protein, fat, sterol, lecithin, D-glucose, adenine, histidine, choline etc.; Inorganic constituents SiO ₂, Ca, Mg, Fe, K, Na, S, P, Mn, Cl, contain β-pachyman enzyme in addition, and the trace albumin enzyme.

Poria sweet in the mouth, light, property is flat.GUIXIN, spleen, lung, kidney channel.Has promoting diuresis to eliminate damp pathogen, invigorating the spleen and regulating the stomach, the effect of mind tranquilizing and the heart calming.Be used for dysuria, the edema distension, the phlegm retention cough with dyspnea, vomiting, insufficiency of the spleen food FE is few, have loose bowels, palpitation and restlessness, insomnia forgetfulness, the nebulousurine of passing out semen.The traditional Chinese medical science is thought, the wet reciprocal causation of insufficiency of the spleen and water is so no matter insufficiency of the spleen still water wets spreads unchecked, and all answers first-selected Poria and effect splendid.

Poria and Rhizoma Atractylodis Macrocephalae compatibility are used, the sweet temperature of the Rhizoma Atractylodis Macrocephalae, the spleen strengthening and damp drying, gas hemopoietic, relatively invigorating middle warmer.With Poria two medicine adapteds, have logical in keeping.The Rhizoma Atractylodis Macrocephalae promotes transporting and transforming function of the spleen and stomach water wet, and Poria wets water and goes from urine, and the mutual-assistance is usefulness, brings out the best in each other.Be mainly used in treating and insufficiency of the spleenly stop that the wet feeling of fullness of holding drink under the arm is not eaten, had a dizzy spell, just disease such as unfavorable, edema.

Pharmacological research shows: Rhizoma Atractylodis Macrocephalae Poria soup decoct has tangible regulating and controlling effect, prompting NT(Rats with Spleen-deficiency neurotensin to the gut hormone of Rats with Spleen-deficiency such as gastrin, motilin, vasoactive intestinal peptide etc.) rising and the syndrome of spleen-deficiency of content have certain relation.Rhizoma Atractylodis Macrocephalae Poria soup may suppress the release of NT, thereby recovers spleen and stomach function to regulate digesting and assimilating of gastrointestinal.

We are the compatibility prescription of Poria and the Rhizoma Atractylodis Macrocephalae, and pharmacological evaluation shows that Rhizoma Atractylodis Macrocephalae Poria soup decocts extract and has activity and show that in we it is rational that Poria is taked the preparation method of water boiling and extraction.

Rhizoma Dioscoreae(Dioscoreaceae plant Rhizoma Dioscoreae Dioscorea oppositaThunb. dry rhizome) chemical constituent is concluded following a few class: (1) fatty acid compound: hexadecylic acid, linoleic acid, oleic acid, linolenic acid etc.

(2) polysaccharide compound: mannocarolose Ia Ib Ic, RP etc.(3) ester type compound: cupreol acetate, citric acid mono-methyl, the two methyl ester of citric acid, trimethyl citrate etc.(4) amino acids: threonine, valine, methionine, phenylalanine, isoleucine, leucine, lysine etc.(5) trace element: P, Fe, Zn, Cu, Co, Cr, K, Na, Ca, Mg, Mn, Ni, PbCr, Cd etc. (6) other:Mannan, 3,4-dihydroxy benzenes ethamine, phytic acid, choline, Rhizoma Dioscoreae alkali, glycoprotein, polyphenol enzyme etc.

Rhizoma Dioscoreae sweet in the mouth, flat.Return spleen, lung, kidney channel.The effect of have spleen reinforcing, support lung, reinforce the kidney, benefit is smart.Cure mainly diarrhea due to hypofunction of the spleen, lack of appetite edema, cough due to deficiency of the lung, the frequent micturition of quenching one's thirst, suffer from a deficiency of the kidney, seminal emission, leukorrhagia.External is controlled too fat to move, scrofula.Compendium of Material Medica record Rhizoma Dioscoreae " tonify deficiency is thin, except cold and heat pathogen, invigorating middle warmer, and physical strength profiting, longue meat, reinforcing YIN-essence is obeyed normal hearing and eyesight for a long time, makes light of one's life by commiting suicide and prolongs life." Rhizoma Dioscoreae is one of dietotherapeutic plant, has protection, immunomodulating and the multiple pharmacological effect such as antitumor, mutation of antioxidation, defying age, blood sugar lowering, the protection of falling blood ester, renal ischemic reperfusion injury, hepatic injury.

Pharmacological research shows: medicine efficacy screening is carried out at the gastrointestinal function experiment DUISHANYAO decocting liquid opposed polarity position of model of spleen deficiency mice, the result shows, aspect inhibition mice with spleen deficiency gastric emptying, the product corresponding site is given birth at Rhizoma Dioscoreae (parched with bran) water extract dichloromethane extraction position stronger pharmacological action, aspect inhibition mice with spleen deficiency intestinal propulsion functions, Rhizoma Dioscoreae (parched with bran) water extract dichloromethane and n-butanol extraction position are given birth to the product corresponding site and are all demonstrated stronger pharmacological action.Rhizoma Dioscoreae medicated porridge has some improvement to Spleen Rats to the preventive effect that is formed with of Rats with Spleen-deficiency.

The Rhizoma Dioscoreae water extract has the effect of regulating spleen and stomach function and shows that Rhizoma Dioscoreae employing water boiling and extraction is rational in we.

Semen Coicis(grass Semen Coicis Coix lacryma-jobiL. var. Ma-yuen(Roman.) dry mature kernal of Stapf) chemical constituent is concluded following a few class: (1) fatty acid compound: Palmic acid, stearic acid, 18 carbon monoenoic acids, octadecadienoic acid, myristic acid and palmitate, stearate, cetylate etc.(2) phytosterin compound: Resina Ferulae acyl stigmasterol, Resina Ferulae acyl brassicasterol, α, beta, gamma-sitosterol and stigmasterol etc.(3) benzothiazole ketone compounds: Coixol.(4) polysaccharide compound: Semen Coicis Polysaccharide A, B, C, neutral glucosan 1 ~ 7, acidic polysaccharose CA-1 and CA-2.(5) trace element: Mg, Ca, Fe, Zn, Cu, Co, Gi, Cr etc.(6) amino acids: arginine, lysine, valine, leucine, cystine, proline, glutamic acid etc.

Semen Coicis sweet in the mouth, light, cold nature.Return spleen, stomach, lung meridian.Has the dampness removing spleen invigorating, arthralgia relieving by relaxing muscles and tendons, clearing away heat and discharging pus.Cure mainly the edema beriberi, dribbling urination, damp-warm diseases is had loose bowels, leukorrhagia, rheumatic arthralgia, passages through which vital energy circulates contracture, lung abscess, acute appendicitis verruca plana." medicine justice " carries: " energy spleen invigorating the moon, big beneficial the intestines and stomach cures mainly diarrhea due to hypofunction of the spleen "." spleen " of the traditional Chinese medical science contained human consumption, immunity, endocrine, cardiovascular system all multi-functional of motor system of unifying in fact, for example digests and assimilates, blood glucose regulation and control, immunomodulating, muscle nutrition and motion etc.

Pharmacological research shows: Semen Coicis water extract obviously increases phagocytic percentage and the phagocytic index of Turnover of Mouse Peritoneal Macrophages, significantly increases serum hemolysin content, enhancing body's immunological function.The Semen Coicis polysaccharide may have the decomposition of the hepatic glycogen of inhibition, muscle glycogen zymolysis, suppresses glyconeogenesis, thereby reaches the purpose that blood sugar level reduces.Semen Coicis 75% ethanol extract suppresses the formation of water logging irritability mice ulcer, the acid mice ulcer of salt, suppresses Folium Sennae property diarrhea of mouse, slowly promotes the rat bile secretion ^[13]Semen Coicis is as the cultivated plant of food medicine dual-purpose, and rich in proteins, fat, aminoacid and trace element etc. possess very high nutritive value.

The activity that the Semen Coicis water extract has spleen invigorating shows that Semen Coicis employing water boiling and extraction is rational in we.

Radix Glycyrrhizae(glycyrrhizic legume Glycyrrhiza uralensisFisch., Glycyrrhiza inflata Bat. Glycyrrhiza inflataBat. or Glycyrrhiza glabra L. Glycyrrhiza glabraL. dry root and rhizome) mainly to contain with the pentacyclic triterpene be the triterpene saponin of aglycon: glycyrrhizin, enoxolone; Other triterpene saponin: Glycyrrhiza uralensis Fisch. saponin A, B, glyuranolide, uralenolide, glycyrrhizin A ₃, B ₂, C ₂, D ₃, E ₂, F ₃, G ₂, H ₂, J ₂, K ₂Flavone compound: Radix Glycyrrhizae aglycon, liquirtin, isoliquiritin unit, isoliquiritin, Neoliquiritin, Neoisoliquiritin, licoricidin (+)-Licoricidin., the sharp ketone of Radix Glycyrrhizae, formononetin, different formononetin, Licurazid, 5-O-methyl licoricidin (+)-Licoricidin., glycyrrhizin-4'-celery glycosyl (1 → 2) glucoside, glycyrrhizin-7,4'-diglucoside; And chemical constituent such as alkaloids, polysaccharide.

Radix Glycyrrhizae is sweet, is slightly cold.GUIXIN, lung, spleen, stomach warp.Have reinforcing the heart temper, eliminating phlegm and stopping cough is relievingd asthma, relieving spasm to stop pain, heat-clearing and toxic substances removing, the effect of the mediation property of medicine.Cure mainly the asthenia lack of appetite, the leanness yellowish complexion, shortness of breath and palpitation, the stomachache loose stool, the anxious pain of extremity contraction, dirty dry, cough and asthma, laryngopharynx swelling and pain, peptic ulcer, ulcer sores is separated poison of drug and alimentary toxicosis.Digestive tract power abnormity disease belongs to disease categories such as " feeling of fullness " in Chinese medicine, and weakness of the spleen and stomach, mechanism of qi retardance, lifting mistake department are its main pathogenesis, and be main relevant with the imbalance of functions such as spleen, stomach, liver.

Pharmacological evaluation shows: the stomach motion weakened gradually after 10% Radix Glycyrrhizae extractum 4ml/kg irritated stomach to rabbit, the stomach motion almost all stops after 30 minutes, motion has the obvious suppression effect to the liquorice beverage decoct to the isolated rabbit intestinal smooth muscle, can significantly reduce frequency and the amplitude of intestinal tube wriggling, action time is longer than atropine, give wanting to reduce the enterokinesia amplitude in back five minutes is atropinic 1.71 times, and can strengthen atropine to the inhibitory action of intestinal tube, is single with atropinic 2.87 times.The Radix Glycyrrhizae water extract is to also having the obvious suppression effect carrying the rabbit intestinal tube, and effect is stronger.Radix Glycyrrhizae extractum 250ml/kg is suppressed for after the rat skin lower injection administration 40% pylorus ligation ulcer.

Thereby the liquorice beverage decoct has the effect that improves spleen and stomach function that reaches of regulating gastrointestinal function, and it is rational that therefore our Radix Glycyrrhizae is adopted water boiling and extraction.

Fry Massa Medicata Fermentata(be medicines such as Herba polygoni hydropiperis, Herba Artemisiae Annuae, Semen Armeniacae Amarum add flour or wheat bran mixed after, the herbal leaven of making through fermentation) mainly contain compositions such as yeast, amylase, vitamin B complex, ergosterol, protein, fat, volatile oil and human body trace elements necessary.

Fry Massa Medicata Fermentata sweet in the mouth, suffering, warm in nature.Return the taste warp.Has promoting digestion and removing stagnation, invigorating the spleen and regulating the stomach.Cure mainly retention of food and drink, dyspepsia, distension and fullness in the abdomen, inappetence, vomiting dysentery.Say in " Bencao Jingshu ": " ancients use bent, the song that namely brews alcoholic beverages, and the sweet temperature of its abnormal smells from the patient, the special food stagnation removing of property, the stagnant gas of row taste, the internal organs that loose are air-cooled ", stir-fry is with strengthening the invigorating the spleen and regulating the stomach food digesting action.Many, the borborygmus diarrhoea indigestion and loss of appetite with distension and fullness in the abdomen, lack of appetite with its treatment of the traditional Chinese medical science serve as mainly to show syndrome of spleen-deficiency.

Pharmacological experiment study shows: mice with spleen deficiency is after feeding with the Massa Medicata Fermentata water decoction, and the enterobacteria of feces and colonic contents, enterococcus, bacillus bifidus, lactobacillus and bacteroid quantity are recovered normal range gradually.Light microscopic, Electronic Speculum show colon's injury repairing.Contain digestive enzyme compositions such as amylase and pepsin in the Massa Medicata Fermentata infusion, Massa Medicata Fermentata contains digestive enzyme compositions such as amylase and protease, and can promote the intestinal propulsion function, helps to improve digestive tract power and enzymic digestion function.And after the Massa Medicata Fermentata parch, can improve its prolease activity, but give birth to the Massa Medicata Fermentata amylase activity higherly, and promote that the intestinal propulsion function is better, the prompting Massa Medicata Fermentata give birth to or parch should have different functions and indication.

The Massa Medicata Fermentata water decoction has the effect that improves spleen and stomach function, and it is rational that therefore our Massa Medicata Fermentata adopts water boiling and extraction.

Pericarpium Citri Reticulatae(be rutaceae orange Citrus reticulatesThe dry mature skin of Blanc and variety thereof) chemical constituent is concluded following a few class: (1) volatile oil: limonene, γ-Song Youxi, beta-myrcene, α-trip's alkene, nopinene, camphene, phellandrene, gima ethylenic, cadinene etc.(2) flavonoid: sweet, the new Pericarpium Citri junoris of Pericarpium Citri junoris is sweet, Nobiletin, Pericarpium Citri grandis is sweet, the Pericarpium Citri grandis Folium Symplocoris Caudatae is sweet, 3,5,6,7,8,3', 4'-Heptamethoxyflavone, 5,6,7,3', 4'-pentamethoxyl flavone, 1,5,6,7,3', 4'-hexa methoxy flavone, 1,5,7,8,3', 4'-hexa methoxy flavone, 7-hydroxyl-3,5,6,3', 4'-pentamethoxyl flavone, 5-hydroxyl-6,7,8,3', 4'-pentamethoxyl flavone etc.(3) trace element: K, Na, Ca, Mg, Cu, Zn, Fe, Sr, Mn etc.(4) other: inositol, vitamin B ₁, vitamin C etc.

Pericarpium Citri Reticulatae acrid in the mouth, bitter in the mouth, warm in nature.Return spleen, stomach, lung meridian.Have regulating QI and lowering the adverseness, whet the appetite in the accent, drying dampness to eliminate phlegm.Cure mainly the wet resistance of stagnation of QI in spleen and stomach, chest and diaphragm is full vexed, abdominal distention, anorexia, vomiting, difficulty in urination and defecation; The waste gas retardance, cough is grasped too much.Also control acute mastitis from the beginning of.Ming Dynasty's Li Shizhen (1518-1593 A.D.) cloud: " then mend with tonic, then rush down with cathartic, then rise with Hydrargyri Oxydum Rubrum, then fall with falling medicine.Spleen is the mother of Primordial Qi, and lung is the label of taking the photograph gas, so Pericarpium Citri tangerinae is two medicines through edema caused by disorder of QI, but with join and the reinforcing and reducing lifting also ".Illustrate that the Pericarpium Citri Reticulatae purposes is wide, consumption is big, has fine effect aspect cardiovascular, gastrointestinal tract, respiratory tract, endocrine, anticancer, defying age, skin maintenance, the nutrition tonify deficiency.

Pharmacological experiment study shows: Pericarpium Citri Reticulatae decocting liquid has obvious facilitation to the ptyalin enzymatic activity, and this is the experimental basis of Pericarpium Citri Reticulatae regulating qi-flowing for strengthening spleen effect.The Pericarpium Citri Reticulatae water decoction has booster action to the gastric emptying due to the metoclopramide.The Pericarpium Citri Reticulatae water decoction can also significantly suppress the spontaneous activity of the stripped duodenal obstruction of rabbit, makes to shrink to reduce, and tonicity descends, and is the dose-effect reaction relation.This studies prompting, and Hesperidin may not be the main component that Pericarpium Citri Reticulatae suppresses bowel movement, the depression effect of Pericarpium Citri Reticulatae mainly by cholinoceptor, 5-HT is receptor-mediated or smooth muscle is directly done.The contained volatile oil of Pericarpium Citri Reticulatae has gentle stimulation to gastrointestinal tract, but pneumatosis in the intestinal tube is got rid of in the secretion of facilitating digestion liquid, has shown the effectiveness of fragrant spleen invigorating and the therapeutic method to keep the adverse QI flowing downwards of dispeling the wind.

Pericarpium Citri Reticulatae volatile oil, water boiling and extraction thing have activity and show that in we it is rational that Pericarpium Citri Reticulatae takes two lifting manipulations to extract.

Fructus Aurantii (parched)(Folium Symplocoris Caudatae plant Citrus aurantium Linn. Citrus aurantiumL. and the dry immature fruit of variety) chemical constituent concludes following a few class: (1) volatile oil: limonene, 3,77-dimethyl-1,6-octadiene-3-alcohol, beta-myrcene, cis-caryophyllene, caryophyllene oxide, big root leaf alkene B etc.(2) flavonoid: Hesperidin, neohesperidin, naringin, different skin glycosides, Xin Shengye glycosides, Neoponcirin, Nobiletin, rutin, sinensetin, Folium Symplocoris Caudatae naringin, Radix seu Folium Tosicodendri Delavayi glucoside, the tangeretin taken out.(3) alkaloids: Neosynephrine, N monomethyl tyramine, tyramine, hordenine, nor-to light forint etc.Trace element such as (4) trace element: Mo, Cd, Be, Ni, Ti, Cr, Fe, B, Al, TI, P, Sr, Pt, Mg, Zn, Li, Na, Cu, Ba, Sn.

Fructus Aurantii (parched) bitter in the mouth, acid, cold nature.Return lung, spleen, stomach, large intestine channel.Effect with regulating the flow of QI to ease the stomach, the stagnant relieving distension of row.Cure mainly in the breast side of body stagnation of QI, distension pain, accumulation of food in the stomach and intes tine due to indigestion, the phlegm retention stop, diseases such as gastroptosis, proctoptosis, uterine prolapse.Fry with relaxing its hot strong property, specially help digestion in regulating the flow of vital energy.

Pharmacological research shows: the Fructus Aurantii decoct exsomatizes to mice intestine in vitro, rabbit and at the body gastrointestinal motility inhibitory action is significantly arranged all at body intestinal tube and anesthesia Canis familiaris L..But certain excitation appears in the slow fistula test of stomach and intestinal fistula test, and it is strong that gastrointestinal is shunk.Fructus Aurantii volatile oil has obvious inhibitory action to rat, guinea pig in vitro intestinal smooth muscle normal contraction; To Bacl2, the spastic contraction that Ach and histamine phosphate cause has obvious relaxation effect.

Fructus Aurantii volatile oil, water boiling and extraction thing have activity and show that in we it is rational that Fructus Aurantii takes two lifting manipulations to extract.

(2) the basic technology route determines

We are Chinese medicine compound, are applied to clinical with granule.According to traditional medication custom, the method that adopts water boiling and extraction to concentrate prepares granule, because gained water extract extractum is bitter, child takes difficult, so be adjuvant with sucrose.Its basic technology route is: Rhizoma Atractylodis Macrocephalae (parched with earth), parched with bran Rhizoma Atractylodis, Pericarpium Citri Reticulatae, all the other five tastes medical material water boiling and extraction → water extracts of Fructus Aurantii (parched) extracting in water volatile oil → adding concentrate, the dry an amount of sucrose of extract powder → adding and the soluble starch → mixing of getting, spray into volatile oil → packing, finished product.

Three, medical material pre-treating technology research

Parched with bran Rhizoma Atractylodis, Rhizoma Atractylodis Macrocephalae (parched with earth), Pericarpium Citri Reticulatae, Fructus Aurantii (parched), Radix Glycyrrhizae, Semen Coicis, Poria, Rhizoma Dioscoreae are that " 2010 editions one one of Chinese pharmacopoeia is recorded product.Fry Massa Medicata Fermentata and be based on Bozhou City " company standard " of firm decoction pieces Co., Ltd., Factory forever.Side's Chinese crude drug is identified by the Han Yunxia deputy director pharmacist of Chinese medicine of Song Zhencai.

The parched with bran Rhizoma AtractylodisThis product is the feverfew Atractylis chinensis Atractylodes chinenesis(DC.) dry rhizome of Koidz..Two seasons of spring and autumn excavate, and remove silt, dry, and hit fibrous root.

Rhizoma Atractylodis Macrocephalae (parched with earth)This product is the feverfew Rhizoma Atractylodis Macrocephalae Atractylodes macrocephalaKoidz. dry rhizome, this product are the process of preparing Chinese medicine processed goods of the Rhizoma Atractylodis Macrocephalae.Winter the bottom leaf withered and yellow, excavate when upper leaf becomes fragile, remove silt, dry or dry, remove fibrous root again.

PoriaThis product is Polyporaceae fungus Poria Poria cocos(Schw.) dry sclerotia of Wol.More than excavating the 7-9 month, remove silt after digging out, bright Poria is pressed the different parts cutting, dry in the shade, be called " Poria piece " and " Poria sheet ".

Semen CoicisThis product grass Semen Coicis Coix lacryma-jobiL. var. Ma-yuen(Roman.) dry mature kernal of Stapf.Tap plant during fruit maturation autumn, dries, and lays fruit, dries again, except decapsidate, yellowish-brown kind skin and impurity, collects kernel.

Rhizoma DioscoreaeThis product is Dioscoreaceae plant Rhizoma Dioscoreae Dioscorea oppositaThunb. dry rhizome.Winter, stem and leaf was excavated after withering, and cut the root head, cleaned, and removed crust and fibrous root, drying, or take advantage of fresh-cut sheet, drying.

Radix GlycyrrhizaeThis product is glycyrrhizic legume Glycyrrhiza uralensisFisch., Glycyrrhiza inflata Bat. Glycy-rrhiza inflataBat. or Glycyrrhiza glabra L. Glycyrrhiza glabraL. dry root and rhizome.Spring, Qiu Erji excavate, and remove fibrous root, dry.

Fry Massa Medicata FermentataThis product be medicines such as Herba polygoni hydropiperis, Herba Artemisiae Annuae, Semen Armeniacae Amarum add flour or wheat bran mixed after, the herbal leaven of making through fermentation.With bright Herba polygoni hydropiperis, Herba Artemisiae Annuae, each 7 kg of Herba Xanthii grass, juice is beaten in chopping, Semen Phaseoli, each 4 kg of Semen Armeniacae Amarum, roll into powder, get wheat bran 60 kg, flour 40 kg, mix and spare, more surplus flour pulping pasty state with medicine-feeding with wheat bran and most of flour, pour in the spice of mixing, stir with wooden stick, to being linked to be pie, move on the plank that to flatten about 1cm thick, be cut into 3 centimetres square fritter by knife, shone half to 1, in the big bamboo of banking up is flat, the loam cake gunnysack, straw bag or rice straw, make its fermentation, treat that its surface bears mycelia, take out and dry.

Fructus Aurantii (parched)This product is Folium Symplocoris Caudatae plant Citrus aurantium Linn. Citrus aurantiumL. and the dry immature fruit of variety.Gather when peel is still green July, to the middle part crosscut be two halves, dry or cold drying.

Pericarpium Citri ReticulataeThis product is rutaceae orange Citrus reticulatesThe dry mature skin of Blanc and variety thereof.Pluck mature fruit, strip peel, dry or cold drying.

Four, the screening of process conditions

(1) Study on extraction

The mensuration of 1 medical material water absorption rate

Take by weighing 1/2 recipe quantity medical material (except the volatile oil) and amount to 32g, add 10 times of water gagings and soak, soak different time, filter, claim wet medicine weight (no longer increase to medical material weight till), measure the medical material water absorption rate, formula following (the results are shown in Table 1-1).

By table 1-1 as can be known, the medical material water absorption rate is 199.3%, is handled easily, is 200% to calculate with water absorption rate, and namely the medical material water absorption is heavy 2.0 times of medical material.Add the water of 2.0 times of amounts when therefore water is carried first.

Single factor of 2 soak times is investigated

Under the condition that satisfies the medical material water absorption rate, investigate soak time, to the influence of prescription paste-forming rate, serve as to investigate index with the total solid matters yield, optimize the soak time that prescription place cream rate is had the greatest impact.

Test method and result

2.1.1 sample preparation

Take by weighing 1 times of recipe quantity medical material and amount to 74g, add 8 times of water gagings first, add 6 times of water gagings back 2 times, soak 0 h, 1h, 2h, 3h, 5h respectively, decoct 3 times, each 0.5h filters, merging filtrate, and medicinal liquid is fixed molten to 1000ml, standby.

The total solid matters yield is measured

Each precision is got two parts of 10ml from above-mentioned filtrate, to the evaporating dish of constant weight, and water bath method, measure according to dry weightless mensuration (" an appendix IX of Chinese pharmacopoeia version in 2010 G), calculate the total solid matters yield, formula following (the results are shown in Table 2-1, variance analysis sees Table 2-2).

W is the weight of solids in the 10ml filtrate, and V is constant volume, and Wt is the sample weight that feeds intake.

One factor analysis of variance shows: P＜0.05 illustrates that different soak times has significant difference; Simultaneously, for there was no significant difference between 2h, 3h, the 5h, the paste-forming rate average of 2h was much larger than 1 hour.According to the needs of saving cost, selecting soak time for use is 2h.

Single factor of volatile oil extraction process is investigated

3.1 single factor of volatile oil extraction time is investigated

Take by weighing parched with bran Rhizoma Atractylodis 30g, Rhizoma Atractylodis Macrocephalae (parched) 30g, Pericarpium Citri Reticulatae 18g, Fructus Aurantii 18g amount to 96g, be ground into coarse powder (crossing 10 mesh sieves), mix homogeneously adds 8 times of water gagings, soaks two hours, extracts volatile oil with volatile oil extractor, extract 1h, 2h, 3h, 4h, 5h respectively, 6h collects volatile oil, and other deposits, and calculates the volatile oil extraction ratio, formula following (the results are shown in Table 3-1, variance analysis sees Table 3-2).

V is the volatile oil volume, and Wt is the sample weight that feeds intake.

One factor analysis of variance shows: P＜0.05 illustrates that different soak times has significant difference; Simultaneously, for there was no significant difference between 3h, 4h, 5h, the 6h, the extraction ratio average of 3h is much larger than 1 and 1 hour hour.According to the needs of saving cost, selecting extraction time for use is 3h.

Single factor of pulverizing medicinal materials granularity is investigated

Take by weighing parched with bran Rhizoma Atractylodis 30g, Rhizoma Atractylodis Macrocephalae (parched) 30g, Pericarpium Citri Reticulatae 18g, Fructus Aurantii 18g amount to 96g, be ground into coarse powder (crossing 10 mesh sieves), coarse powder (crossing 24 mesh sieves), middle powder (crossing 65 mesh sieves) respectively and do not pulverize, mix homogeneously adds 8 times of water gagings, soaked two hours, and extracted volatile oil with volatile oil extractor, extract 3h respectively and collect volatile oil, other deposits, calculate the volatile oil extraction ratio, formula following (the results are shown in Table 3-3, variance analysis sees Table 3-4).

V is the volatile oil volume, and Wt is the sample weight that feeds intake.

One factor analysis of variance shows: P＜0.05 illustrates that different grinding particle sizes has significant difference; Simultaneously, for there was no significant difference between coarse powder, coarse powder, the middle powder, be ground into the long-range extraction ratio of not pulverizing of extraction ratio average of coarse powder.But according to easy to operate needs, select coarse powder for use.

The quadrature factor of decocting process

Under the condition that satisfies the medical material water absorption rate, parched with bran Rhizoma Atractylodis, Rhizoma Atractylodis Macrocephalae (parched with earth), Pericarpium Citri Reticulatae, Fructus Aurantii (parched) soak 2h, extract volatile oil with volatile oil extractor, add all the other five tastes medical materials, mix and decoct, investigate the principal element of amount of water, decocting time, three influence decoctions of decoction number of times effect, by each factor 3 level, use L ₉(3 ⁴) orthogonal table arrangement test (table 4-1).Boiled process adopts orthogonal test to carry out 1 screening (table 4-2), serves as to investigate index with the total solid matters yield, and extraction process is inquired into.Quadrature variance analysis as a result and factor level analysis in table 4-3, table 4-4.

Test method and result

4.1.1 sample preparation

Take by weighing 1 times of recipe quantity medical material 74g, test (table 4-2) (soaking 2h for the first time) by orthogonal test table, medicinal liquid filters, and concentrates to be settled to 1000ml.Standby.

4.1.2 the total solid matters yield is measured

Measure according to the 2.1.2 method.

Be index with the total solid matters yield, analyze and can get from table 4-3, table 4-4: factor C has statistical significance, is principal element, and factor A, B do not have the significance influence, are secondary cause.With reference to the mean estimated value of C factor level, this test index total solid matters yield height is more good, therefore selects C factor level 3; For secondary cause A, B, select A level 1 according to saving cost and production needs, B level 1, then this prescription extraction optimum process condition is: A ₁B ₁C ₃, namely medical material soaks 2h, and 6 times of water gagings decoct (adding 2 times of water gagings for the first time), each 0.5 hour 3 times.

The process certification experiment of three batch samples

Get parched with bran Rhizoma Atractylodis, Rhizoma Atractylodis Macrocephalae (parched with earth), Poria, Semen Coicis, Rhizoma Dioscoreae, Pericarpium Citri Reticulatae, Fructus Aurantii (parched), stir-fry Massa Medicata Fermentata, licorice medicinal materials, press optimum extraction process condition A ₁B ₁C ₃Extract, measure the total solid matters yield, the result shows (seeing Table 4-5): total solid matters yield meansigma methods is 24.55%, RSD=2.85%, illustrates that process stabilizing is feasible.

Concentrate with dry

5.1 the extractum relative density is to the influence of extract dry time

7 times of recipe quantity medical material 518g are extracted according to optimised process, and decocting liquid filters, and is standby.Precision is measured the equivalent extracting solution, and to different relative densities, in 80 ℃ of dryings, time length sees drying to concentrate (traditional handicraft concentrates).The results are shown in Table 5-1.

Result of the test shows: when extractum was concentrated into relative density and is 1.30-1.35 and 1.35-1.40, dry used time phase difference was little, but was easier to operation during 1.30-1.35, was 1.30-1.35 so select extractum is concentrated into relative density.

Baking temperature is to the influence of extract dry time

Get said extracted liquid 500ml, being concentrated into relative density is 1.30-1.35, is dried to constant weight with different temperatures, sees drying the time.See Table 5-2.

By table 5-2 as can be known, 80 ℃ of drying under reduced pressure speed are fast, and extractum is easy to pulverize.When baking temperature is 90 ℃, because of the too high change that might cause its effective ingredient of its temperature, so do not adopt.Therefore adopt 80 ℃ of drying under reduced pressure extractum.

(2) preparations shaping technical study

The preparation of 6 extract powders

Get the medical material of recipe quantity, according to the preferred technology of activating the spleen granule technical study extract, concentrate, drying under reduced pressure handle dry extract.Dry extract is pulverized, and crosses 80 mesh sieves, gets dry extract and soaks powder, and is moistureproof standby.The different batches activating the spleen Chinese crude drug paste-forming rate experimental data of loosing sees Table 6.

The result: by 8 batches experiment, its average paste-forming rate is 22.20%.

The dosage form selection foundation

We formed by parched with bran Rhizoma Atractylodis, Rhizoma Atractylodis Macrocephalae (parched with earth), Poria etc., we be Song Zhencai's department of pediatrics long-term clinical practice through proved recipe, former side's usage is decoction oral.In conjunction with our medical material physicochemical property and pharmacological research data thereof, the medicine of respectively distinguishing the flavor of in the side adopts water extraction, and paste-forming rate 22% after the water purification, because the recipe quantity of this kind is bigger, we are advisable to select granule or powder, but the powder hygroscopicity is stronger, and mouthfeel also is difficult for allotment.If select tablet, owing to when tabletting, also need mix certain adjuvant, strengthened dose, add simultaneously and be pressed into tablet, disintegrate need have individual process, and the absorption of medicine is slower, and need carry out coating behind the tabletting, operation is more numerous and diverse, has increased production cost, and the exploitation of this product, the crude drug price is lower, increase operation and also just increase production cost, for extensive patients provides inexpensive, medicable kind, we determine to select granule to be advisable.

The prescription adjuvant is preferred

Because we are applicable to the child in 1-6 year, thus mouthfeel is had relatively high expectations, and the former extract powder flavor of this product is bitter, is difficult to take, and need add suitable adjuvant so be prepared into qualified granule.According to literature research, at present water solublity commonly used preferably correctives mainly contain sucrose and lactose.But be correctives with the lactose, child's gastrointestinal tract is had certain influence, cause untoward reaction such as children's diarrhea easily, and the price of lactose is more expensive.So selecting sucrose for use is correctives.Bitter at its flavor, the character that is difficult to take, adjuvant is selected sucrose, starch, is the kind of the preferred adjuvant of index with supplementary product consumption, hydroscopicity, molding difficulty or ease, mouthfeel.In dry extract: the mixed powder that the prescription ratio of adjuvant (6:4) is prepared three kinds of different excipient respectively places the exsiccator of the saturated solution (relative humidity 75%) of airtight built-in NaCl, is calculated as follows hydroscopicity.The results are shown in Table 8-2.

Ratio of briquetting is measured

According to " to the granule granularity requirements, getting granule 20 g can not and can must not surpass 15% by the summation of No. 5 sieves by No. 1 sieve under an appendix I of Chinese pharmacopoeia version in 2010 the C item.

Hydroscopicity is measured

Put into the granule of about 1 g in the flat weighing botle of 5 ml that are dried to constant weight bottom, jog is evenly distributed it, and accurate the title decides, the weighing bottle cap is opened, and places in the climatic chamber (25 ℃ of design temperatures, humidity 75%), place 24 h, take out the fixed and calculating hydroscopicity of title immediately.

Measure angle of repose

Adopt the fixed funnel method, be about to 3 funnels series connection and be fixed in suitable height place on the graph paper of horizontal positioned, making the funnel end opening is H apart from the distance of graph paper, carefully granule is poured in the uppermost funnel along hopper walls, till the cone tip of bottom funnel medicated powder touches bell mouth, measure the diameter R of cone bottom by graph paper this moment, calculates angle of repose.

Comprehensive grading and interpretation of result

Above-mentioned test result is carried out overall merit, for the preparation of granule, hygroscopicity and mouldability outbalance, weight respectively accounted for 35 fens, dissolved respectively to account for rate and angle of repose 15 fens.By following formula plan comprehensive grading.

According to the result of the test of table 8-2, with reference to comprehensive grading, select for use sucrose, starch as this pharmaceutical adjunct, and extract powder: sucrose: the ratio of starch is 6:3:1.

The granule critical relative humidity is measured

The packing ambient humidity is very big to granule filling (packing) influence, is necessary to measure the critical relative humidity of granule.Precision takes by weighing some parts of granule (every part of 2 g) respectively, be tiled in the 5 ml weighing botles of dry constant weight, the accurate title, decide, put into climatic chamber (set humidity and see Table 9-1) respectively and open the weighing bottle cap, weigh after keeping 7 days under 25 ℃, the weight change of working sample is calculated hydroscopicity, be vertical coordinate with the hydroscopicity, relative humidity (RH%) is the abscissa curve plotting.Make tangent line respectively from the curve two ends, the abscissa of two point of intersection of tangents correspondences is critical relative humidity (CRH), and the result shows that the critical relative humidity of granule is about 57%.Therefore when granulation, packing and storage, ambient humidity must be controlled below 57%, to reduce moisture to the influence of pharmaceutical properties and stability.

Prescription day dose is determined

Be 74g according to former clinical prescription crude drug amount, be child's two daily consumptions, by 22.20% paste-forming rate, taking the extractum total amount every day is 8.21g.Now press the preparation prescription amount and convert, take the about 13.69g of grain amount every day, draft day clothes 3 times, take one bag at every turn, every bag 5 gram.Substantially satisfy former clinical prescription day and obey the crude drug amount.

Packing

To spray into the granule mixing of volatile oil, packing is gone in the medicinal aluminum-plastic composite membrane, every bag of 5 g, 6 bags of every packings.Sealing is preserved, and investigates through preliminarily stabilised, and room temperature (relative humidity control 52%) was preserved 180 days down, and granule still keeps good fluidity, does not have the no moisture absorption, air slaking, stiff, the phenomenon such as spoiled of luming.

Pilot scale

Carry out 10 times of productions of three batches of amplifications by working out preparation process condition, the production technology index is carried out comprehensive assessment, medical material and finished product are carried out performance rating, investigate this product preparation technology's reasonability.By data show in the table 11, should produce 2000 bags of (5g/ bag) finished products by feeding intake theory, granule finished product net yield is not less than 80%.The explained hereafter condition meets the big production requirement of factory, and operability is stronger, and finished product, medical material, semi-manufactured goods quality are controlled, and end product quality is stable.

Experiment two: clinical drug efficacy study

One, EXPERIMENTAL DESIGN

1.1. object of study source

All cases derive from the infant that Song Zhencai's outpatient service in 1997 to 2007 meets the standard of including in.

The case choice criteria

1.2.1 diagnostic criteria

1.2.1.1 Western medicine diagnose standard: (according to chief editors' such as Hu Yamei, Jiang Zaifang " all good fortune hall practical paidonosologies ", People's Health Publisher 2002 years])

Inappetence sees that food is greedy, goes into sick preceding the minimizing more than 1/3 of amount, and the morbidity shortest time is more than 2 weeks, gets rid of the other system disease.

The tcm syndrome diagnostic criteria(with reference to " new Chinese medicine clinical research guideline ", Ministry of Health of the People's Republic of China 1997)

Dysfunction of the spleen in transportation: the normal or few China of complexion, do not think to receive and eat or monophagia, very then refuse into diet, belch is felt sick, and body is thin partially, and it is uncomfortable to defecate, light red tongue, Tai Bai or thin greasy, thready pulse is still strong.

Include standard in

1. meet Western medicine diagnose standard and tcm syndrome diagnostic criteria;

② Age is in 1-14 year;

3. the course of disease 〉=2 weeks;

4. do not use dyspepsia and intestinal stasis relieving Chinese medicine and digestant in nearly 1 week;

5. the head of a family or experimenter guardian sign Informed Consent Form.

Exclusion standard

1. do not meet the standard of including in;

2. other disease, drug-induced detest the trencherman or fail to get rid of other disease (as diseases such as anorexia nervosas), drug-induced is detested the trencherman;

3. to this medicine allergy sufferers;

4. be associated with primary diseases such as serious rickets, cardiovascular, cerebrovascular, liver, kidney and hemopoietic system, congenital diseases and infantile consumption patient.

The rejecting standard

1. do not take medicine in accordance with regulations;

2. do not finish the course for the treatment of and anaphylaxis or serious adverse reaction person occur, should end test;

3. the duration of test patient anxious heavy complication person occurs and should end test.

. observation index

1.3.1 background information is observed

Observe the project of the preceding two groups of samples for the treatment of, comprise demography data (age segmentation, sex, height, body weight), disease baseline (each symptom, integration before the course of disease of disease, the treatment) and urine D-xylose are drained.

1.3.2 curative effect index is observed

Observe the project of the two groups of samples in treatment front and back, preceding (the 1st day) and treatment back were observed in the 5th day, the 15th day and curative effect is judged to treating, and comprised clinical efficacy and traditional Chinese medical science disease observation of curative effect.

Clinical comprehensive therapeutic effect is to carry out efficacy determination from appetite and appetite recovery situation, and traditional Chinese medical science disease curative effect is to carry out efficacy determination by the total mark of disease.

Above-mentioned curative effect judging standard sees the sick therapeutic evaluation standard of this paper 3.5.1 infantile anorexia for details

1.3.3 the disease integration is observed

Be the observation item of two samples before and after the treatment, (the 1st day) before treating and treatment back were observed in the 5th day, the 15th day, comprise cardinal symptom integration, minor symptom integration and total mark.

The individual event disease is observed

Observe the project of the two groups of samples in treatment front and back, before treating and treatment back was observed in the 5th day, the 15th day, comprise appetite/appetite, complexion, Mental fatigue, abdominal distention, polydipsia, be tired of aspects such as urgency, yellow urine, vomiting.

Urine D-xylose is drained and is observed

Observe the project of the two groups of samples in treatment front and back, (the 1st day) before treating and treatment back (the 15th day) are observed.

Time point is observed

Observe the ageing project for the treatment of back treatment group, symptom, the sign for the treatment of the 1st day, 5 days, 10 days, 15 days are carried out the total mark statistics, carried out statistical procedures with the 15th day, the 10th day with the 15th day total mark with the 10th day, the 5th day with the 15th day, the 5th day with the 10th day, the 1st day with the 5th day, the 1st day by the 1st day, observe activating the spleen and distribute the window of opportunity of waving curative effect.

The dependency of age bracket is observed

Observe the project for the treatment of back treatment group, by 1-3 year and 3-6 the year, 3-6 year and 6-14 the year, 1-3 year and 6-14 the year three comparisons of age bracket aspect the disease total mark, diffusing and age of evaluation activating the spleen has or not dependency.

Safety is observed

Observe the project of the two groups of samples in treatment back, have the result of the event of having no adverse reaction and routine blood test that infant is observed by infant, with clear and definite its safety.

Treat after one month and observe with anti-

By carrying out after 1 month with anti-primary symptom and individual event symptom being observed to treating, estimate the late result that activating the spleen looses.

. research method

1.4.1 object of study grouping

90 routine infants are single at random blindly to be divided into treatment and to organize 60 examples, and matched group 30 examples are gone into group according to the 2:1 ratio.

Therapeutic Method

(1) treatment group:

Example number: 60 examples

The Therapeutic Principle: invigorating the spleen and benefiting QI, circulation of qi promoting helps fortune

Medication: activating the spleen raw edge clothes

Form: Rhizoma Atractylodis, Rhizoma Atractylodis Macrocephalae (parched), Poria, Rhizoma Dioscoreae, Semen Coicis, Pericarpium Citri Reticulatae, Fructus Aurantii, Massa Medicata Fermentata, Radix Glycyrrhizae.

Usage: be decocted in water for oral dose, extracting juice 50-100ml gives various dose according to all ages and classes, divides 3-4 time 1 dose of every day, observes 1 state of an illness in per 5 days, and 15 days was 1 course for the treatment of.

1-3 year: Rhizoma Atractylodis 5g, Rhizoma Atractylodis Macrocephalae (parched) 5g, Poria 5g, Rhizoma Dioscoreae 5g, Semen Coicis 5g, Pericarpium Citri Reticulatae 3g, Fructus Aurantii 3g, Massa Medicata Fermentata 5g, Radix Glycyrrhizae 3g;

3-6 year: Rhizoma Atractylodis 6g, Rhizoma Atractylodis Macrocephalae (parched) 6g, Poria 6g, Rhizoma Dioscoreae 6g, Semen Coicis 6g, Pericarpium Citri Reticulatae 4g, Fructus Aurantii 4g, Massa Medicata Fermentata 6g, Radix Glycyrrhizae 4g;

6-10 year: Rhizoma Atractylodis 8g, Rhizoma Atractylodis Macrocephalae (parched) 8g, Poria 8g, Rhizoma Dioscoreae 8g, Semen Coicis 8g, Pericarpium Citri Reticulatae 6g, Fructus Aurantii 6g, Massa Medicata Fermentata 8g, Radix Glycyrrhizae 6g;

10-14 year: Rhizoma Atractylodis 10g, Rhizoma Atractylodis Macrocephalae (parched) 10g, Poria 10g, Rhizoma Dioscoreae 10g, Semen Coicis 10g, Pericarpium Citri Reticulatae 8g, Fructus Aurantii 8g, Massa Medicata Fermentata 10g, Radix Glycyrrhizae 8g.

Taboo: period in a medicine avoids pungent food, raw meat is cold, greasy product.

(2) matched group:

Example number: 30 examples

Medication: zinc sulfate oral liquid (Shandong Yikang Pharmaceutical Co., Ltd., the accurate word H20003609 of traditional Chinese medicines)

Specification: 10ml/20mg

Usage: oral, oral one day 10ml (zinc content 20mg) of 1-10 year children's divides clothes 2 times; Oral one day 20ml (zinc content 40mg) of 11-14 year children's divides clothes 2 times.(formulate according to Chinese Soclety of Nutrition (1981).）

It is reported that zinc deficiency can cause that periglottis hypertrophy and parakeratosis blocked the taste bud aperture, sense of taste sensitivity is descended, thereby cause anorexia ^[3]There is research to show that also apocleisis serum of children zinc is starkly lower than normal children ^[4]Chen Yi ^[5]Organize treatment 100 routine infantile anorexia diseases in contrast with the zinc sulfate oral liquid, curative effect is better.Xu Shi ^[6]Using sulfated zinc is treated the sick children's of 46 routine infantile anorexias, has also obtained better curative effect.Department of pediatrics has been generally acknowledged oral zinc sulfate oral liquid treatment infantile anorexia disease commonly used, so this research is matched group with the zinc sulfate oral liquid.

Efficacy determination

1.5.1 the sick therapeutic evaluation standard of infantile anorexia

" new Chinese medicine clinical research guideline " with reference to Ministry of Health of the People's Republic of China's promulgation in 1997 ^[2]

1.5.1.1 apocleisis comprehensive therapeutic effect evaluation criterion: divide level Four: clinical recovery, produce effects, effective, invalid

1. clinical recovery appetite and appetite all return to normal level;

2. produce effects appetite is obviously recovered, and appetite returns to 3 ∕ 4 of previous level;

3. effectively appetite has improvement, and appetite is recovered to some extent, but does not reach 3 ∕ 4 of previous level;

4. invalid appetite and appetite all do not have improvement.

Traditional Chinese medical science disease integration therapeutic evaluation standard: divide level Four: clinical recovery, produce effects, effective, invalid

1. clinical recovery: tcm clinical practice symptom, sign disappear or basic the disappearance, and the syndrome integration reduces 〉=95%;

2. produce effects: tcm clinical practice symptom, sign are obviously improved, and the syndrome integration reduces 〉=70%;

3. effective: tcm clinical practice symptom, sign all take a favorable turn, and the syndrome integration reduces 〉=30%;

4. invalid: even tcm clinical practice symptom, sign all do not have obvious improvement and increase the weight of, the syndrome integration reduces＜30%;

Annotate: computing formula (nimodipine method) is: [total mark before (integration before the treatment-treatment back integration) ÷ treatment] * 100%.

Statistical procedures

Adopt the SPSS17.0 statistical software to set up data base and statistical analysis.Ranked data adopt recovery from illness, produce effects, effective, invalid representation, adopt rank test, the clinical efficacy of relatively treatment group and matched group; Measurement data adopts

± SD represents, after normal distribution-test and homogeneity test of variance, meets the employing t check that normality distributes, and incongruent employing non parametric tests is mainly used in the analysis that traditional Chinese medical science disease integration and D-xylose are drained; And consider to influence result's principal element such as the course of disease, age, sex etc., carry out harmony to check, with the comparability between the assurance group.

Two, result of the test

2.1. MAIN OUTCOME MEASURES result and analysis

Comprise the judgement of apocleisis comprehensive therapeutic effect and traditional Chinese medical science disease curative effect.Comprehensive therapeutic effect is to carry out efficacy determination from appetite and appetite recovery situation; Traditional Chinese medical science disease curative effect is to carry out efficacy determination by the disease total mark, and method adopts the nimodipine method.

Apocleisis comprehensive therapeutic effect result

In sum: two groups aspect curative effect of disease and traditional Chinese medical science disease curative effect, the activating the spleen group of loosing all is better than zinc sulfate Zu ﹙ P ﹤ 0.001 ﹚; Be better than zinc sulfate Zu ﹙ P ﹤ 0.001 ﹚ in the diffusing group of activating the spleen aspect total disease integration, primary symptom integration, the inferior disease integration; Aspect the individual event symptom, activating the spleen looses to organize and is being better than zinc sulfate Zu ﹙ P ﹤ 0.05 ﹚ aspect appetite, complexion, spirit, abdominal distention, polydipsia, the yellow urine; Aspect the drainage of D-xylose, activating the spleen looses to organize and is better than zinc sulfate group (P ﹤ 0.05); The safety aspect, laboratory safety index no change before and after two groups of treatments, two groups of equal tool safeties of Therapeutic Method; Treat after 1 month with in anti-, the activating the spleen group of loosing is being better than zinc sulfate Zu ﹙ P ﹤ 0.05 ﹚ aspect appetite, complexion, spirit, abdominal distention, polydipsia, yellow urine, the vomiting.

. safety analysis

All case treatment viewing duration is not seen obvious adverse reaction, and clinical practice has safety.

Three, result and conclusion

3.1. result:

1. two groups are compared aspect infantile anorexia disease comprehensive therapeutic effect, and difference has statistical significance (P ﹤ 0.001), and activating the spleen looses to organize and is better than the zinc sulfate group;

2. compare aspect infantile anorexia tcm syndrome comprehensive therapeutic effect, difference has statistical significance (P ﹤ 0.001), and activating the spleen looses to organize and is better than the zinc sulfate group;

3. improve relatively in infantile anorexia individual event disease (appetite, complexion, spirit, abdominal distention, drinking-water, yellow urine), difference has statistical significance (P ﹤ 0.05), and activating the spleen looses to organize and is better than the zinc sulfate group;

4. two groups of D-xyloses are drained relatively, and difference has statistical significance (P ﹤ 0.05), and the activating the spleen group of loosing is better than the zinc sulfate group aspect the intestinal absorption ability improving;

5. two groups of treatments are followed up a case by regular visits to the activating the spleen group disease of loosing after January and are improved and be better than the zinc sulfate group on lasting;

6. two groups of infants all have no adverse reaction.

Conclusion:

Activating the spleen looses to organize and all is being better than zinc sulfate aspect infantile anorexia curative effect of disease and the traditional Chinese medical science disease curative effect; Activating the spleen is dispersed in aspects such as improving appetite, complexion, spirit, abdominal distention and is better than zinc sulfate; Activating the spleen is dispersed in and improves small intestinal absorption function aspect and be better than zinc sulfate; The diffusing no bad event of activating the spleen takes place in the research, and is safe and reliable.

Treatment children's spleen is disease, " when being earlier with the reason " academic thought, catch the feature of taste " be benefit with fortune " and the characteristic of " be benefit with the happiness ", follow the principle of " desiring to make spleen strong; not to be valued for fortune in benefit ", based on " activating the spleen ", carrying according to " decoction of four noble drugs " in " formulary of peaceful benevolent dispensary " and " Pingwei San " two sideizations and to form through proved recipe---activating the spleen looses, dry to comply with the spleen happiness, dislike wet, initiatively, the main habit that rises, from wound " activating the spleen looses " activating the spleen stomach function regulating, be intended to make in order the normal lifting relation of taste, recover its intrinsic function of motion, make spleen soil vigorous, thereby reach the purpose of curing anorexia.I loose by institute's paediatric applications activating the spleen, and clinical efficacy is remarkable.

Activating the spleen looses and had both followed the determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs system of the traditional Chinese medical science, meets doctor trained in Western medicine evidence-based medicine EBM theory again, and the report that has no side effect during its medicine is formed can be used as new drug development and is used for clinical application.

Four, model case

4.1. the anorexia of children's's dysfunction of the spleen in transportation card.Control with invigorating the spleen and regulating the stomach, removing food stagnancyization stagnates,

[case numbering]: 078H012

Lin, woman, June.Go to a doctor on November 17th, 1997.

Main suit: lack of appetite February, increased the weight of 3 days.

First visit:Closely February, the head of a family was too messy to infant interpolation diatery supplement, and the sucking amount reduces, and the head of a family finds infant tongue fur " burnt hair ", obeyed " lactasinum " certainly, poor effect, but the diatery supplement interpolation does not stop.Be reluctant to eat breast milk in nearly 3 days, very refusing to eat, stool is pressed from both sides the indigestion food debris in the pasty state, about 2-3 time of day, do not tell, still can sleep after being ill, in high spirits, there is not heating.Infant is breast feeding.Inscribe disease: lack of appetite, very refusing to eat, stool in the pasty state, folder indigestion food debris, day about 2-3 time, it is noisy to cry before nothing is rushed down, sleep can, in high spirits, the improper feeding history is arranged.The complexion in high spirits of prestige is normal, and bregma is smooth, and pharyngeal (-), the body of the tongue point is red, and tongue fur is covered with, thick being bored with, sallow, fingerprint is purple to stagnate.Cardiopulmonary (-).Abdomen is flat soft.The diagnosis anorexia is held indigestion type under the arm.Method is worked as invigorating the spleen and regulating the stomach, and removing food stagnancyization stagnates, and the side intends the diffusing plus-minus of activating the spleen.Prescription: Rhizoma Atractylodis 6g, Pericarpium Citri Reticulatae 3g, Poria 6g, Fructus Crataegi 6g, Fructus Aurantii Immaturus 3g, Radix Paeoniae Alba 6g, Radix Scutellariae 6g, Fructus Hordei Germinatus 6g, Radix Glycyrrhizae 6g.2 doses.Be decocted in water for oral dose, obey 10ml at every turn, every day 5～6 times, 2 days 1 dose.Advise and stop to add diatery supplement; Based on breast feeding, suitable a small amount of many meal; Replenish moisture content.Instruct and feed.

Two examine (on December 8th, 1997):Can suck a small amount of breast milk behind the medicine, drinking-water, but the stool amount is many, the folder granule, and about 4～5 times of day, the urine amount is many, does not have heating.The pale tongue in high spirits of prestige, the yellow fur ash, thick being bored with moved back, and the thin purple of fingerprint does not stagnate.Medicine is suited the medicine to the illness, and food stagnation goes out from stool, so the stool amount is many, inferior increasing shows as diarrhea due to improper diet.The machine that the long-pending spleen fortune then of disappearing has hinge can advance a little milk; Because of infant young, weakness of the spleen and stomach, warm-dryness syndrome impairment of YIN or too consume gas too probably, former side removes Fructus Aurantii Immaturus, Fructus Crataegi adds Rhizoma Dioscoreae, Semen Nelumbinis, the Rhizoma Atractylodis Macrocephalae recovers splenic function to help spleen fortune.Prescription: Rhizoma Atractylodis 6g, Pericarpium Citri Reticulatae 3g, Poria 6g, Radix Scutellariae 6g, Fructus Hordei Germinatus 6g, Rhizoma Dioscoreae 6g, Semen Nelumbinis 6g, Rhizoma Atractylodis Macrocephalae 6g, Radix Glycyrrhizae 6g.3 doses, decoction method and doctor's advice are the same.

Three examine (on December 11st, 1997):The back appetite of taking medicine increases obviously, still based on breast milk, does not freshen diatery supplement, but loose stool, and amount is many, no granule and residue, and about 3 times of day, sneeze is arranged recently, watery nasal discharge is not generated heat and is coughed.Swallow red, red tongue, yellowish fur band ash.Though appetite increases, spleen fortune is not multiple, and the wet fortuneization of water is unable, so still the diarrhoea amount is many; Cause is felt exopathogen again, sneeze, and watery nasal discharge increases the weight of the taste burden again, so thick fur is greasy.Mistake that primary disease is insufficiency of the spleen fortune, retention of water-damp has exopathogen concurrently, controls and should QI invigorating help the fortune removing dampness, and assistant is with dispelling wind.The side intends the diffusing plus-minus of activating the spleen.Prescription: Rhizoma Atractylodis 6g, Radix Paeoniae Alba 6g, Rhizoma Dioscoreae 10g, Semen Coicis 10g, KOUREN 3g, Caulis Perillae 3g, Radix Saposhnikoviae 6g, Poria 10g, bubble ginseng 6g, Fructus Hordei Germinatus 6g, Massa Medicata Fermentata 6g, Radix Glycyrrhizae 6g.3 doses, be decocted in water for oral dose, obey 10ml at every turn, every day 5～6 times, 2 days 1 dose.Doctor's advice is the same.

(December was-22 days on the 15th in 1997) are examined in the four diagnostic methods-five:Suffer from diarrhoea after taking medicine and end, stool is shaped, about 1～2 time of day, and except breast milk, a small amount of rice water of having taken food, sneeze, thin nasal discharge are healed, pale tongue, the yellow fur ash is thick slightly, the fingerprint purple.Water paddyization, the wet fortune of water, spleen fortune is overcome difficulties, thus rush down end, appetite recovers, diseases caused by exogenous pathogenic factor are separated, add a small amount of diatery supplement on a small quantity after stool normal, the medicine card is kept former side and is advanced 4 doses more relatively.Advise head of a family's diatery supplement to add: a small amount of light milk, rice water, note observing stool. 22 daysFive examine appetite recovers as before, can advance a small amount of diatery supplement, and stool is shaped, and all diseases are healed.

The specific embodiment

Embodiment 1:Raw material: parched with bran Rhizoma Atractylodis 368.1g, Rhizoma Atractylodis Macrocephalae (parched with earth) 368.1g, Poria 368.1g,

Semen Coicis 368.1g, Fructus Aurantii (parched) 220.9g, Rhizoma Dioscoreae 368.1g, Radix Glycyrrhizae 220.9g, Pericarpium Citri Reticulatae 220.9g, stir-fry Massa Medicata Fermentata 220.9g, soluble starch 100g, sucrose 300g.

Preparation method: above nine flavor medical materials, the parched with bran Rhizoma Atractylodis, Rhizoma Atractylodis Macrocephalae (parched with earth), Pericarpium Citri Reticulatae, Fructus Aurantii (parched) adds the water logging of 8 times of weight and steeped 2 hours, extracted 3 hours with volatile oil extractor, collecting volatile oil 19ml deposits in addition, medicinal residues and Semen Coicis, Rhizoma Dioscoreae, Radix Glycyrrhizae, fry Massa Medicata Fermentata, the decocting that Poria respectively adds 8 times of weight at every turn boils 3 times, each 0.5 hour, merge 3 times decocting liquid, filter, it is 1.30～1.35(60 ℃ that the filtrate normal pressure is concentrated into relative density) thick extractum, 80 ℃ of decompressions (2.67kPa) got dry extract in dry 24 hours, dried cream powder is broken into fine powder (crossing 100 mesh sieves) and sucrose 300g and soluble starch 100g mix homogeneously, 95% ethanol, 90～140ml soft material processed, and 14 mesh sieves are granulated, 60 ℃ of dryings 48 hours, 12 mesh sieve granulate spray into the volatile oil mixing, make 1000g, divide packing, namely get the activating the spleen granule.

Usage and dosage: day clothes 3 times, take one bag, every bag 5 gram at every turn.

Embodiment 2:Raw material: parched with bran Rhizoma Atractylodis 468g, Rhizoma Atractylodis Macrocephalae (parched with earth) 468g, Poria 468g, Semen Coicis 468g, Fructus Aurantii (parched) 280g, Rhizoma Dioscoreae 468g, Radix Glycyrrhizae 280g, Pericarpium Citri Reticulatae 280g, stir-fry Massa Medicata Fermentata 280g, soluble starch 150g sucrose 400g.

Preparation method: above nine flavor medical materials, the parched with bran Rhizoma Atractylodis, Rhizoma Atractylodis Macrocephalae (parched with earth), Pericarpium Citri Reticulatae, Fructus Aurantii (parched) adds the water logging of 8 times of weight and steeped 2 hours, extracted 3 hours with volatile oil extractor, collecting volatile oil deposits in addition, medicinal residues and Semen Coicis, Rhizoma Dioscoreae, Radix Glycyrrhizae, fry Massa Medicata Fermentata, the decocting that Poria respectively adds 8 times of weight at every turn boils 3 times, each 0.5 hour, merge 3 times decocting liquid, filter, it is 1.30～1.35(60 ℃ that the filtrate normal pressure is concentrated into relative density) thick extractum, 80 ℃ of decompressions (2.67kPa) got dry extract in dry 24 hours, dried cream powder is broken into fine powder (crossing 100 mesh sieves) and sucrose and soluble starch mix homogeneously, 95% ethanol, 90 ~ 140ml soft material processed, and 14 mesh sieves are granulated, 60 ℃ of dryings 48 hours, 12 mesh sieve granulate spray into the volatile oil mixing, make granule, divide packing, namely get the activating the spleen granule.

Embodiment 3:Raw material parched with bran Rhizoma Atractylodis 268g, Rhizoma Atractylodis Macrocephalae (parched with earth) 268g, Poria 268g, Semen Coicis 268g, Fructus Aurantii (parched) 160g, Rhizoma Dioscoreae 268g, Radix Glycyrrhizae 160g, Pericarpium Citri Reticulatae 160g, stir-fry Massa Medicata Fermentata 60g, soluble starch 40g sucrose 200g.

Preparation method: above nine flavor medical materials, the parched with bran Rhizoma Atractylodis, Rhizoma Atractylodis Macrocephalae (parched with earth), Pericarpium Citri Reticulatae, Fructus Aurantii (parched) adds the water logging of 8 times of weight and steeped 2 hours, extracted 3 hours with volatile oil extractor, collecting volatile oil deposits in addition, medicinal residues and Semen Coicis, Rhizoma Dioscoreae, Radix Glycyrrhizae, fry Massa Medicata Fermentata, the decocting that Poria adds 8 times of weight at every turn boils 3 times, each 0.5 hour, merge 3 times decocting liquid, filter, it is 1.30～1.35(60 ℃ that the filtrate normal pressure is concentrated into relative density) thick extractum, 80 ℃ of decompressions (2.67kPa) got dry extract in dry 24 hours, dried cream powder is broken into fine powder (crossing 100 mesh sieves) and sucrose and soluble starch mix homogeneously, 95% ethanol, 90 ~ 140ml soft material processed, and 14 mesh sieves are granulated, 60 ℃ of dryings 48 hours, 12 mesh sieve granulate spray into the volatile oil mixing, make granule, divide packing, namely get the activating the spleen granule.

Claims (3)

1. Chinese medicine preparation for the treatment of infantile anorexia is characterized in that: according to listed as parts by weight, it be by raw material of Chinese medicine parched with bran Rhizoma Atractylodis 468～268g, Rhizoma Atractylodis Macrocephalae (parched with earth) 468～268g, Poria 468～268g,

Semen Coicis 468～268g, Fructus Aurantii (parched) 280～160g, Rhizoma Dioscoreae 468～268g, Radix Glycyrrhizae 280～160g, Pericarpium Citri Reticulatae 280～160g, stir-fry Massa Medicata Fermentata 280～160g, soluble starch 150～40g sucrose 400～200g are prepared from.

2. according to the Chinese medicine preparation of the described treatment infantile anorexia of claim 1, it is characterized in that: according to listed as parts by weight, it be by raw material of Chinese medicine parched with bran Rhizoma Atractylodis 368.1g, Rhizoma Atractylodis Macrocephalae (parched with earth) 368.1g, Poria 368.1g,

Semen Coicis 368.1g, Fructus Aurantii (parched) 220.9g, Rhizoma Dioscoreae 368.1g, Radix Glycyrrhizae 220.9g, Pericarpium Citri Reticulatae 220.9g, stir-fry Massa Medicata Fermentata 220.9g, soluble starch 100g, sucrose 300g are prepared from.

3. the preparation method of the Chinese medicine preparation of claim 1 or 2 described treatment infantile anorexia, it is characterized in that: above nine flavor medical materials, the parched with bran Rhizoma Atractylodis, Rhizoma Atractylodis Macrocephalae (parched with earth), Pericarpium Citri Reticulatae, Fructus Aurantii (parched) adds the water logging of 8 times of weight and steeped 2 hours, extracted 3 hours with volatile oil extractor, collecting volatile oil deposits in addition, medicinal residues and Semen Coicis, Rhizoma Dioscoreae, Radix Glycyrrhizae, fry Massa Medicata Fermentata, the decocting that Poria adds 8 times of weight at every turn boils 3 times, each 0.5 hour, merges 3 times decocting liquid, filter, it is 1.30～1.35(60 ℃ that the filtrate normal pressure is concentrated into relative density) thick extractum, dry 24 hours of 80 ℃ of decompression 2.67kPa, dried cream powder is broken into fine powder and crosses 100 mesh sieves and sucrose and soluble starch mix homogeneously, 95% ethanol, 90～140ml soft material processed, 14 mesh sieves are granulated, 60 ℃ of dryings 48 hours, 12 mesh sieve granulate, spray into the volatile oil mixing, make granule, divide packing, namely.