CN101537037B - Amaranth berberine tablet and preparation method thereof - Google Patents
Amaranth berberine tablet and preparation method thereof Download PDFInfo
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- CN101537037B CN101537037B CN200810070785A CN200810070785A CN101537037B CN 101537037 B CN101537037 B CN 101537037B CN 200810070785 A CN200810070785 A CN 200810070785A CN 200810070785 A CN200810070785 A CN 200810070785A CN 101537037 B CN101537037 B CN 101537037B
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Abstract
The invention discloses an amaranth berberine tablet and a preparation method thereof. The amaranth berberine tablet is a Chinese medicinal combined preparation comprising the following main components: copperleaf, berberine hydrochloride, liquorice, and appropriate amount of accessories. The preparation method comprises the following steps: setting the main components by the following weight percentage: 65 to 90 percent of the copperleaf, 0.5 to 10 percent of the berberine hydrochloride, and 5 to 15 percent of the liquorice; crushing the liquorice into fine powder; decocting the copperleaf in water twice, putting the decoction liquid together, filtering the mixed decoction liquid, taking the supernatant and concentrating the supernatant into thick paste, adding the liquorice fine powder, mixing the thick paste and the liquorice fine powder evenly, drying the mixture at a low temperature, crushing the mixture into fine powder, adding the berberine hydrochloride and the appropriate amount of the accessories into the fine powder, mixing the fine powder evenly with the berberine hydrochloride and the appropriate amount of the accessories, carrying out granulation and drying, adding appropriate amount of lubricant, pressing the mixture into tablets, and obtaining the finished product without coating or with a film coat. The amaranth berberine tablet consisting of the medicaments and a bulking agent, has good humidity resistance, easy carrying, quick disintegration, and small dosage.
Description
Technical field:
The present invention relates to a kind of Chinese medicinal tablet and process for making thereof, relate in particular to amaranth berberine tablet and preparation method thereof.
Background technology:
Diarrhoea is symptom hyperfunction owing to enterokinesia or that the interior moisture absorption of intestinal tube goes down and causes.It is characterized by the excess moisture of feces, denseness reduces, and weight increases, simultaneously with more frequent defecation.Main cause has: enterotoxin acts on intestinal mucosa, antibacterial, and directly to invade intestinal mucosa, rotavirus diarrhea, hyperalimentation or COF improper etc., wherein modal for bacterial infection so that enterotoxin acts on intestinal mucosa or antibacterial is directly invaded the diarrhoea that intestinal mucosa causes.Existing be used to treat this sick Chinese medicine be used as medicine the medical material kind too much, composition is too complicated, and causes under the deficiency of spleen-QI and stomach-QI situation in diarrhoea, the ability of digesting and assimilating has very big decline; A large amount of unnecessary compositions are the unable to get up therapeutical effect not only, and increases the weight of the intestines and stomach burden, slows down that sb.'s illness took a favorable turn; Especially some composition is difficult for absorbing; Be detained the intestines and stomach, increase osmotic pressure in the enteric cavity, increase the weight of the state of an illness of suffering from diarrhoea.One Chinese patent application CN03113039.9; Denomination of invention " medicine of treatment colitis and preparation method thereof "; A kind of medicine of treating colitis and preparation method thereof is disclosed, by 18 flavor Chinese medicines such as Rhizoma Drynariae, Cortex Phellodendri, the Radix Paeoniae Alba, the Rhizoma Atractylodis Macrocephalae, Herba Solidaginis, the Radix Linderae, Radix Codonopsis, Herba Acalyphae, Cortex Magnoliae Officinalis, Poria, Rhizoma Alismatis, windproof, Semen Coicis, Radix Et Rhizoma Rhei, Ramulus Cinnamomi, Pericarpium Citri Reticulatae, Semen Arecae, Radix Glycyrrhizae through pulverizing, ethanol extraction, decoction, concentrate, working procedure processing such as vacuum drying pulverizing becomes oral formulations.Pharmacodynamics test proves that the present invention has the immunity of adjusting, antiinflammatory action to Cavia porcellus cell immune response ulcer colitis and rat ulcer colitis; Various acute inflammation and chronic granulation tissue hyperplasia all there is significant antiinflammatory action; The mice hot plate method, the analgesic test result of electrostimulation and chemical stimulation method proves that the present invention has analgesic activity; In addition, exsomatize and show all that in the body experiment the present invention has the effect of regulating intestine movement function.Prescription of the present invention is unique, and is without any side effects.And Chinese patent CN02134196.6; Denomination of invention " a kind of medicine of treating intestinal tract disease "; A kind of medicine of treating intestinal tract disease is disclosed; It is with Pericarpium Granati extractum, Radix Pulsatillae extractum, the Radix Aucklandiae, berberine hydrochloride as raw material, press the Chinese patent medicine that the conventional formulation prepared becomes, be a kind of medicine of processing by Seedling medicine theory.It adopts comparatively in the localities Chinese medicinal herbses of seeing as raw material more, and is with low cost.The function that anti-inflammation, astringing to arrest diarrhea are arranged.Have the making of being easy to, cost is lower, the characteristics that therapeutic effect is good.Can be used for treating diseases such as dysentery, enteritis.Prescription: it is the Chinese patent medicine that becomes by the conventional formulation prepared with following materials of weight proportions: 218~328 parts of Pericarpium Granati extractum, 62~94 parts of Radix Pulsatillae extractum, 9~13 parts of the Radix Aucklandiae, 40~60 parts of berberine hydrochloride.
Summary of the invention:
The purpose of this invention is to provide the rapid disintegrate of a kind of ability, amaranth berberine preparation that humidity resistance is good and preparation method thereof, overcome the above-mentioned drawback of prior art, improve the quality and the curative effect of product, satisfy the needs of medical treatment better.Amaranth berberine tablet formulation according to the invention is simple, is convenient to produce, and ingredient is simplified, and be unlikely to contain accessory ingredient too much down to increase the intestines and stomach burden, and toxic and side effects is little.
Technical solution of the present invention is a kind of heat clearing and damp drying antidiarrheal amaranth berberine preparation, is a kind of Chinese medicine composition preparation, and it is characterized in that it is to be processed by the following weight proportion raw material: main component is the tablet of Herba Acalyphae, berberine hydrochloride, Radix Glycyrrhizae.Herba Acalyphae 65-90%, berberine hydrochloride 0.5-10%; Radix Glycyrrhizae 5-20%, adjuvant 5-15%, lubricant are 0.25-2%.Optimization formula Herba Acalyphae 80-89%, berberine hydrochloride 0.5-1.8%; Radix Glycyrrhizae 5-14%, adjuvant 5-13%, lubricant are 0.25-1%.Or optimization formula Herba Acalyphae 65-78%, berberine hydrochloride 1.5-10%; Radix Glycyrrhizae 12-20%, adjuvant 8-15%, lubricant are 0.25-1%.Drug regimen in this formula range all has pharmacological effect described below, and the clinical use of this medicine is safe.
The method for preparing of amaranth berberine tablet is:
(1) Radix Glycyrrhizae powder is broken into fine powder, subsequent use;
(2) with Herba Acalyphae decocte with water secondary, collecting decoction filters, and gets supernatant concentration and becomes thick paste, adds the Radix Glycyrrhizae fine powder, mixing, and cold drying is ground into fine powder, and is subsequent use;
(3) with fine powder and the berberine hydrochloride and an amount of adjuvant mix homogeneously of step (2), granulate, drying, subsequent use;
Adjuvant is selected from one or more the various combination in lactose, calcium sulfate, xylitol, microcrystalline Cellulose, polyvinylpolypyrrolidone, starch, dextrin, micropowder silica gel, low-substituted hydroxypropyl cellulose, the carboxymethyl starch sodium.
(4) with adding suitable lubricant in step (3) the gained granule, compacting is in blocks, and plain sheet is coating or bag film-coat not;
Lubricant is selected from one or more the various combination in magnesium stearate, Pulvis Talci, the micropowder silica gel;
Radix Glycyrrhizae powder generally is broken into fine powder in above-mentioned steps (1);
At above-mentioned steps (2) Herba Acalyphae decocte with water secondary, general decocting temperature is 100 ℃, is generally 1.5 hours for the first time; Be generally 1 hour for the second time; Collecting decoction filters, and decocting liquid generally is condensed into the thick paste of relative density 1.20~1.22 (75-80 ℃) under vacuum 0.08,75-80 ℃.Described thick paste adds the Radix Glycyrrhizae fine powder, mixing, and the general temperature of cold drying is a 30-80 ℃ of vacuum drying, is ground into 100 order fine powders.
The main basis of the preparation of amaranth berberine tablet of the present invention: be monarch drug with the Herba Acalyphae in the prescription, Herba Acalyphae is commonly called as the wild flax grass, has heat-clearing and toxic substances removing, and the merit of dampness removing convergence is the choice drug of treatment hygropyretic dysentery among the people; Be equipped with berberine hydrochloride, have the inhibiting bacteria and diminishing inflammation function, be ministerial drug; The Radix Glycyrrhizae relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription is for assistant makes.The Quan Fangsan mutual compatibility of distinguishing the flavor of, the effect of tool heat clearing and damp drying antidiarrheal.Be used for the acute diarrhea person that belongs to the damp-heat syndrome, disease is seen: times of defecation increases, and is just rare half congealed, diarrhea urgently or not smooth, burning sensation of the anus, dysphoria with smothery sensation is thirsty, stomachache, yellowish or reddish urine, greasy fur on tongue.For the safety and the effectiveness that prove the amaranth berberine preparation, we have carried out the each side systematic research, as follows:
One, amaranth berberine preparation medicine pharmacological research:
1. extracorporeal bacteria inhibitor test: adopt serial dilution, single Herba Acalyphae or berberine are indicated as bacteriostasis to shigella flexneri, and the amaranth berberine preparation shows and is bactericidal action under finite concentration.The amaranth berberine preparation supplies examination bacterium such as staphylococcus aureus, Mohs Bacillus proteus, Salmonella typhimurium, enterocolitis bacillus extremely responsive to other; To bacillus pyocyaneus, enterotoxigenic escherichia coli medium sensitivity.
2. antibiotic and anti-diarrhea effect in the body:
(1) antibiotic in the body, the vivo bacteria corrosion action of employing mouse peritoneal infectable infection dysentery bacterium test evaluation amaranth berberine preparation and corresponding dosage Herba Acalyphae extractum and berberine, the result shows that amaranth berberine preparation curative effect is superior to berberine.
(2) anti-diarrhea effect: the diarrhea of mouse effect that 1. anti-Oleum Ricini causes, the result shows that amaranth berberine preparation effective dose is 480 ~ 600mg/kg (promptly containing berberine 40-50mg/kg and corresponding Herba Acalyphae).2. anti-Folium Sennae decoct causes the diarrhea of mouse effect, and the result shows that the amaranth berberine preparation of 500mg/kg (being berberine 40mg/kg and corresponding dosage) all has obvious minimizing diarrhoea number of times, but the effect of amaranth berberine preparation is more lasting.Proof Herba Acalyphae and berberine share to be processed the amaranth berberine preparation and can strengthen drug effect.
Two, amaranth berberine preparation toxicological study:
1. acute toxicity test: with amaranth berberine preparation Cmax, maximum volume is given mouse stomach.Dose 10g/kg (this dosage is equivalent to 417 times of people's consumption) does not see untoward reaction, and in 12 hours, repeats once, observes and does not see untoward reaction and death in 7 days, fails to record its oral LD50.
2. long term toxicity test: the high, medium and low three kinds of dosage of this medicine, every day three times, do not see all that specificity changes, and explained that the clinical use of this medicine is safe for rat oral gavage, all no abnormal discovery of each item observation index, each histoorgan of pathologic finding in continuous 30 days.
The amaranth berberine preparation is higher than using Herba Acalyphae or berberine hydrochloride curative effect separately, and can significantly reduce the consumption of Western medicine antibiosis berberine hydrochloride, and clinical practice is safe and effective.
Advantage of the present invention: amaranth berberine tablet according to the invention has the effect of good heat clearing and damp drying antidiarrheal preparation, and amaranth berberine tablet is made up of medicine and filler, and humidity resistance is good, is easy to carry, and rapidly disintegrate, dose are little.Amaranth berberine tablet formulation according to the invention is simple, is convenient to produce, and ingredient is simplified, and be unlikely to contain accessory ingredient too much down to increase the intestines and stomach burden, and toxic and side effects is little.Method for preparing of the present invention be a kind of efficiently, the accurate controllable preparation method of quality.Tablet, changes dosage form and manages as new drug research according to the relevant laws and regulations of China's drug control as a kind of pharmaceutical dosage form.Preparation technology of the present invention is simple, can make some effective ingredient of medical material be difficult for being destroyed, and has improved drug effect; In addition, the traditional preparation process method directly adds the licorice medicinal materials fine powder, is unfavorable for human consumption; Especially under diarrhoea, deficiency of spleen-QI and stomach-QI situation, be difficult to digest and assimilate, effective ingredient is difficult for abundant stripping; The performance drug effect, and crude drug directly be used as medicine must the sterilization, increased production stage.Drug regimen in formula range all has described pharmacological effect, and the clinical use of this medicine is safe.
The specific embodiment:
Describe the present invention below in conjunction with embodiment:
The magistral medicines of following examples all has the above-mentioned described pharmacological effect of the present invention, and the clinical use of this medicine is safe.
Embodiment one
To prepare 1000 amaranth berberine tablets is example, and method for preparing is:
(1) consumption of getting the raw materials ready of main constituent is:
Herba Acalyphae 1667g; Radix Glycyrrhizae 266g; Berberine hydrochloride 33.3g;
(2) the 266g Radix Glycyrrhizae powder is broken into fine powder, subsequent use;
(3) with 1667g Herba Acalyphae decocte with water secondary, the decocting temperature is 100 ℃, is 1.5 hours for the first time, is 1 hour for the second time, and collecting decoction filters, and decocting liquid is condensed into the thick paste of relative density 1.20 (75 ℃) under 0.08,75 ℃ of vacuums.Described thick paste adds step (2) Radix Glycyrrhizae fine powder, mixing, and the cold drying temperature is 65 ℃ of vacuum dryings, is ground into 100 order fine powders.Collecting decoction filters, and gets supernatant concentration and becomes thick paste, adds the Radix Glycyrrhizae fine powder, mixing, and cold drying is ground into fine powder, and is subsequent use;
(4) with fine powder and the berberine hydrochloride of above-mentioned formula ratio and an amount of adjuvant mix homogeneously of (3), granulate, drying, subsequent use;
An amount of adjuvant can be 5% starch, 5% microcrystalline Cellulose, 2% low-substituted hydroxypropyl cellulose, and its metering radix is the gross weight of fine powder.
(5) with adding suitable lubricant in (4) gained granule, compacting with coating premix mixture coating, promptly gets in flakes;
Lubricant is 0.5% magnesium stearate, and its metering radix is the granule gross weight.
Embodiment two
To prepare 1000 amaranth berberine tablets is example, and method for preparing is:
(1) consumption of getting the raw materials ready of main constituent is:
Herba Acalyphae 1667g; Radix Glycyrrhizae 280g; Berberine hydrochloride 35g;
(2) Radix Glycyrrhizae powder with above-mentioned formula ratio is broken into fine powder, and is subsequent use;
(3) with the Herba Acalyphae decocte with water secondary of above-mentioned formula ratio, the decocting temperature is 100 ℃, is 1.5 hours for the first time, is 1 hour for the second time, and collecting decoction filters, and decocting liquid is condensed into the thick paste of relative density 1.20 (75 ℃) under 0.08,75 ℃ of vacuums.Described thick paste adds step (2) Radix Glycyrrhizae fine powder, mixing, and the cold drying temperature is 50 ℃ of vacuum dryings, is ground into 100 order fine powders.Collecting decoction filters, and gets supernatant concentration and becomes thick paste, adds the Radix Glycyrrhizae fine powder, mixing, and cold drying is ground into fine powder, and is subsequent use;
(4) with fine powder and the berberine hydrochloride of above-mentioned formula ratio and an amount of adjuvant mix homogeneously of (3), granulate, drying, subsequent use;
Adjuvant is 4.5% starch, 5% microcrystalline Cellulose, 2.1% low-substituted hydroxypropyl cellulose, and its metering radix is the gross weight of fine powder.
(5) with adding suitable lubricant in (4) gained granule, compacting with coating premix mixture coating, promptly gets in flakes;
Lubricant is 2% magnesium stearate, and its metering radix is the granule gross weight.
Embodiment three
To prepare 1000 amaranth berberine tablets is example, and method for preparing is:
(1) consumption of getting the raw materials ready of main constituent is:
Herba Acalyphae 1667g; Radix Glycyrrhizae 250g; Berberine hydrochloride 30g;
(2) Radix Glycyrrhizae powder with above-mentioned formula ratio is broken into fine powder, and is subsequent use;
(3) with the Herba Acalyphae decocte with water secondary of above-mentioned formula ratio, the decocting temperature is 100 ℃, is 1.5 hours for the first time, is 1 hour for the second time, and collecting decoction filters, and decocting liquid is condensed into the thick paste of relative density 1.20 (75 ℃) under 0.08,75 ℃ of vacuums.Described thick paste adds step (2) Radix Glycyrrhizae fine powder, mixing, and the cold drying temperature is 60 ℃ of vacuum dryings, is ground into 100 order fine powders.Collecting decoction filters, and gets supernatant concentration and becomes thick paste, adds the Radix Glycyrrhizae fine powder, mixing, and cold drying is ground into fine powder, and is subsequent use;
(4) with fine powder and the berberine hydrochloride of above-mentioned formula ratio and an amount of adjuvant mix homogeneously of (3), granulate, drying, subsequent use;
Adjuvant is 4% starch, 4% microcrystalline Cellulose, 1.1% low-substituted hydroxypropyl cellulose, and its metering radix is the gross weight of fine powder.
(5) with adding suitable lubricant in (4) gained granule, compacting with coating premix mixture coating, promptly gets in flakes;
Lubricant is 1% magnesium stearate, and its metering radix is the granule gross weight.
Embodiment four
To prepare 1000 amaranth berberine tablets is example, and method for preparing is:
(1) consumption of getting the raw materials ready of main constituent is:
Herba Acalyphae 1667g; Radix Glycyrrhizae 230g; Berberine hydrochloride 25g;
(2) Radix Glycyrrhizae powder with above-mentioned formula ratio is broken into fine powder, and is subsequent use;
(3) with the Herba Acalyphae decocte with water secondary of above-mentioned formula ratio, the decocting temperature is 100 ℃, is 1.5 hours for the first time, is 1 hour for the second time, and collecting decoction filters, and decocting liquid is condensed into the thick paste of relative density 1.20 (75 ℃) under 0.08,75 ℃ of vacuums.Described thick paste adds step (2) Radix Glycyrrhizae fine powder, mixing, and the cold drying temperature is 50 ℃ of vacuum dryings, is ground into 100 order fine powders.Collecting decoction filters, and gets supernatant concentration and becomes thick paste, adds the Radix Glycyrrhizae fine powder, mixing, and cold drying is ground into fine powder, and is subsequent use;
(4) with fine powder and the berberine hydrochloride of above-mentioned formula ratio and an amount of adjuvant mix homogeneously of (3), granulate, drying, subsequent use;
Adjuvant is 4.5% starch, 4.5% microcrystalline Cellulose, 2% low-substituted hydroxypropyl cellulose, and its metering radix is the gross weight of fine powder.
(5) with adding suitable lubricant in (4) gained granule, compacting with coating premix mixture coating, promptly gets in flakes;
Lubricant is 1.5% magnesium stearate, and its metering radix is the granule gross weight.
Embodiment five
To prepare 1000 amaranth berberine tablets is example, and method for preparing is:
(1) consumption of getting the raw materials ready of main constituent is:
Herba Acalyphae 1667g; Radix Glycyrrhizae 400g; Berberine hydrochloride 80g;
(2) Radix Glycyrrhizae powder with above-mentioned formula ratio is broken into fine powder, and is subsequent use;
(3) with the Herba Acalyphae decocte with water secondary of above-mentioned formula ratio, the decocting temperature is 100 ℃, is 1.5 hours for the first time, is 1 hour for the second time, and collecting decoction filters, and decocting liquid is condensed into the thick paste of relative density 1.20 (75 ℃) under 0.08,75 ℃ of vacuums.Described thick paste adds step (2) Radix Glycyrrhizae fine powder, mixing, and the cold drying temperature is 50 ℃ of vacuum dryings, is ground into 100 order fine powders.Collecting decoction filters, and gets supernatant concentration and becomes thick paste, adds the Radix Glycyrrhizae fine powder, mixing, and cold drying is ground into fine powder, and is subsequent use;
(4) with fine powder and the berberine hydrochloride of above-mentioned formula ratio and an amount of adjuvant mix homogeneously of (3), granulate, drying, subsequent use;
Adjuvant is 5% starch, 5% microcrystalline Cellulose, 2% low-substituted hydroxypropyl cellulose, and its metering radix is the gross weight of fine powder.
(5) with adding suitable lubricant in (4) gained granule, compacting with coating premix mixture coating, promptly gets in flakes;
Lubricant is 0.25% magnesium stearate, and its metering radix is the granule gross weight.
Embodiment six
To prepare 1000 amaranth berberine tablets is example, and method for preparing is:
(1) consumption of getting the raw materials ready of main constituent is:
Herba Acalyphae 1667g; Radix Glycyrrhizae 110g; Berberine hydrochloride 18g;
(2) Radix Glycyrrhizae powder with above-mentioned formula ratio is broken into fine powder, and is subsequent use;
(3) with the Herba Acalyphae decocte with water secondary of above-mentioned formula ratio, the decocting temperature is 100 ℃, is 1.5 hours for the first time, is 1 hour for the second time, and collecting decoction filters, and decocting liquid is condensed into the thick paste of relative density 1.20 (75 ℃) under 0.08,75 ℃ of vacuums.Described thick paste adds step (2) Radix Glycyrrhizae fine powder, mixing, and the cold drying temperature is 50 ℃ of vacuum dryings, is ground into 100 order fine powders.Collecting decoction filters, and gets supernatant concentration and becomes thick paste, adds the Radix Glycyrrhizae fine powder, mixing, and cold drying is ground into fine powder, and is subsequent use;
(4) with fine powder and the berberine hydrochloride of above-mentioned formula ratio and an amount of adjuvant mix homogeneously of (3), granulate, drying, subsequent use;
Adjuvant is 5% starch, 5% microcrystalline Cellulose, 2% low-substituted hydroxypropyl cellulose, and its metering radix is the gross weight of fine powder.
(5) with adding suitable lubricant in (4) gained granule, compacting with coating premix mixture coating, promptly gets in flakes;
Lubricant is 0.25% magnesium stearate, and its metering radix is the granule gross weight.
Embodiment seven
To prepare 1000 amaranth berberine tablets is example, and method for preparing is:
(1) consumption of getting the raw materials ready of main constituent is:
Herba Acalyphae 1667g; Radix Glycyrrhizae 150g; Berberine hydrochloride 20g;
(2) Radix Glycyrrhizae powder with above-mentioned formula ratio is broken into fine powder, and is subsequent use;
(3) with the Herba Acalyphae decocte with water secondary of above-mentioned formula ratio, the decocting temperature is 100 ℃, is 1.5 hours for the first time, is 1 hour for the second time, and collecting decoction filters, and decocting liquid is condensed into the thick paste of relative density 1.20 (75 ℃) under 0.08,75 ℃ of vacuums.Described thick paste adds step (2) Radix Glycyrrhizae fine powder, mixing, and the cold drying temperature is 50 ℃ of vacuum dryings, is ground into 100 order fine powders.Collecting decoction filters, and gets supernatant concentration and becomes thick paste, adds the Radix Glycyrrhizae fine powder, mixing, and cold drying is ground into fine powder, and is subsequent use;
(4) with fine powder and the berberine hydrochloride of above-mentioned formula ratio and an amount of adjuvant mix homogeneously of (3), granulate, drying, subsequent use;
Adjuvant is 5% starch, 5% microcrystalline Cellulose, 2% low-substituted hydroxypropyl cellulose, and its metering radix is the gross weight of fine powder.
(5) with adding suitable lubricant in (4) gained granule, compacting with coating premix mixture coating, promptly gets in flakes;
Lubricant is 0.3% magnesium stearate, and its metering radix is the granule gross weight.
Claims (1)
1. the method for preparing of an amaranth berberine tablet comprises following steps:
(1) Radix Glycyrrhizae powder is broken into fine powder, subsequent use;
(2) with Herba Acalyphae decocte with water secondary, collecting decoction filters, and gets supernatant concentration and becomes thick paste, adds the Radix Glycyrrhizae fine powder, mixing, and cold drying is ground into fine powder, and is subsequent use;
(3) with fine powder and the berberine hydrochloride and an amount of adjuvant mix homogeneously of step (2), granulate, drying, subsequent use;
Adjuvant is selected from one or more the various combination in lactose, calcium sulfate, xylitol, microcrystalline Cellulose, polyvinylpolypyrrolidone, starch, dextrin, micropowder silica gel, low-substituted hydroxypropyl cellulose, the carboxymethyl starch sodium;
(4) with adding suitable lubricant in step (3) the gained granule, compacting is in blocks, and plain sheet is coating or bag film-coat not;
Lubricant is selected from one or more the various combination in magnesium stearate, Pulvis Talci, the micropowder silica gel;
Radix Glycyrrhizae powder is broken into fine powder in step (1);
Herba Acalyphae decocte with water secondary in step (2), the decocting temperature is 100 ℃, is 1.5 hours for the first time; Be 1 hour for the second time, collecting decoction filters; Decocting liquid is condensed into the thick paste of relative density 1.20~1.22 (75-80 ℃) under vacuum 0.08,75-80 ℃, described thick paste adds Radix Glycyrrhizae fine powder, mixing; The cold drying temperature is a 30-80 ℃ of vacuum drying, is ground into 100 order fine powders;
Above-mentioned Herba Acalyphae 1667g; Radix Glycyrrhizae 266g; Berberine hydrochloride 33.3g, adjuvant 5-15wt%, lubricant are 0.25-2wt%.
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叶孝礼等."止泻定"治疗小儿感染性腹泻111例临床观察.《福建医药杂志》.1984,(第03期),11. |
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