CN101780234B - Method for preparing Xiaoerkang granules - Google Patents

Abstract

The invention discloses a method for preparing Xiaoerkang granules. The method comprises the following steps: weighing the following Chinese medicinal materials in part by weight: 3.32 parts of heterophylly falsestarwort root, 3.32 parts of triquetrous tadehagi herb, 3.32 parts of hawthorn fruit, 1.00 part of dark plum fruit, 1.00 part of cicada slough, 1.70 parts of white paeony root, 1.70 partsof malt, 1.70 parts of Chinese torreya seed, 1.70 parts of areca seed, 0.33 part of dried orange peel, 1.00 part of Indian buead and 1.00 part of rhizoma atractylodis alba; mixing an extract which isobtained by performing water extraction and alcohol sedimentation on the twelve Chinese medicinal materials, a proper amount of cane sugar powder and ethanol; preparing the mixture into granules; anddrying the granules to obtain the Xiaoerkang granules. In the method, water use amount in the water extraction process and ethanol use amount in the alcohol sedimentation process are strictly controlled, so compared with a traditional water extraction and alcohol sedimentation method, the method has a better effect. The prepared Xiaoerkang granules have stable and controllable quality, and stablecontent of n-Butyl alcohol extractive which meets requirements of standard. The method greatly improves qualification rate of the product, and has simple operation and is suitable for industrial production.

Description

The method for preparing of Xiaoerkang granules

Technical field

The present invention relates to the preparation of pharmaceutical formulations field, be specifically related to a kind of method for preparing of Xiaoerkang granules.

Background technology

Existing 'Xiaoerkang ' is that crude drug is processed with Radix Pseudostellariae, Herba Desmodii Triquetri (Herba Tadehagi Triquetri), Fructus Crataegi, Fructus Mume, Periostracum Cicadae, the Radix Paeoniae Alba, Fructus Hordei Germinatus, Semen Torreyae, Semen Arecae, Pericarpium Citri Reticulatae, Poria and the Rhizoma Atractylodis Macrocephalae 12 flavor Chinese crude drugs generally; Has the function that spleen benefiting and stimulating the appetite, dyspepsia and intestinal stasis relieving, anthelmintic pain relieving, arresting convulsion are calmed the nerves; Clinical practice proves that it has the curative effect of highly significant when being used to improve symptoms such as dyspepsia worm dysentery, dysphoria, mental weariness, distension and fullness in the abdomen, shallow complexion.

Mostly 'Xiaoerkang ' is the XIAOER KANG electuary quality standard (WS that records according to the 6th the 21st page in the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation ₃-B-1091-92) the granule of preparation, its specification is the 10g/ bag, produces authentication code: the accurate word Z46020125 of traditional Chinese medicines in approval on 03 09th, 2005.

The method for making of traditional Xiaoerkang granules is: take by weighing 332g Radix Pseudostellariae, 332g Herba Desmodii Triquetri (Herba Tadehagi Triquetri), 332g Fructus Crataegi, 100g Fructus Mume, 100g Periostracum Cicadae, the 170g Radix Paeoniae Alba, 170g Fructus Hordei Germinatus, 170g Semen Torreyae, 170g Semen Arecae, 33g Pericarpium Citri Reticulatae, 100g Poria and the 100g Rhizoma Atractylodis Macrocephalae 12 flavor Chinese crude drugs by recipe quantity; More than 12 the flavor, Fructus Hordei Germinatus, Semen Torreyae, Semen Arecae were soaked 2 hours.All the other Radix Pseudostellariaes etc. nine flavor decocte with water 2 hours filter, and medicinal residues add water, and add medical material such as above-mentioned Fructus Hordei Germinatus and soak decocted 2 hours; Filter, merging filtrate is concentrated into 1/4 of original volume, puts cold; The ethanol that adds equivalent stirs, and placement is spent the night, and filters, and filtering residue adds 50% ethanol and fully stirs; Filter, merge filtrating twice, reclaim ethanol and be concentrated into the thick paste that relative density is 1.2 (60-70 ℃); Qinghuo reagent is a, and it is an amount of to add 4.5 parts of cane sugar powders and ethanol, processes granule, and drying is processed 1000 gram Xiaoerkang granules.

Above-mentioned clear paste is the water extract-alcohol precipitation product; The Xiaoerkang granules of processing is owing to contain n-butanol extract inspection item in the target level of product quality; And the precipitate with ethanol effect quality in the method for preparing is the whether qualified key factor of decision product n-butanol extract; The amount of water of water extraction process is not limited in the prior preparation method; Only require also in the precipitate with ethanol process that 12 flavor medical materials are decocted ethanol that 1/4 back that merging filtrate after 2 times is concentrated into original volume adds equivalent and stir and get final product, this operation can cause in the precipitate with ethanol process ethanol content uncontrollable, finally causes the n-butanol extract content instability of Xiaoerkang granules finished product; Cause the quality of the pharmaceutical preparations unstable, product percent of pass is on the low side.

Summary of the invention

The invention provides a kind of easy and simple to handle, quality controllable and be suitable for the method for preparing of the Xiaoerkang granules of suitability for industrialized production; Fundamentally avoid the unsettled phenomenon of Xiaoerkang granules n-butanol extract content of existing method for preparing preparation, improved the qualification rate of product greatly.

A kind of method for preparing of Xiaoerkang granules takes by weighing following parts by weight of Chinese traditional medicine material:

Radix Pseudostellariae 3.32 Herba Desmodii Triquetri (Herba Tadehagi Triquetri)s 3.32 Fructus Crataegis 3.32 Fructus Mumes 1.00

Periostracum Cicadae 1.00 Radix Paeoniae Albas 1.70 Fructus Hordei Germinatus 1.70 Semen Torreyaes 1.70

Semen Arecae 1.70 Pericarpium Citri Reticulataes 0.33 Poria 1.00 Rhizoma Atractylodis Macrocephalaes 1.00;

Preparation according to the following steps:

(1) takes by weighing Fructus Hordei Germinatus, Semen Torreyae and Semen Arecae three flavor medical materials, add water, soaked 2 hours in 3～8 times of amounts of three flavor medical material gross weights;

(2) take by weighing Radix Pseudostellariae, Herba Desmodii Triquetri (Herba Tadehagi Triquetri), Fructus Crataegi, Fructus Mume, Periostracum Cicadae, the Radix Paeoniae Alba, Pericarpium Citri Reticulatae, Poria and the Rhizoma Atractylodis Macrocephalae nine flavor medical materials, add water, decocted 2 hours, filter in 3～8 times of amounts of nine flavor medical material gross weights; In medicinal residues, add water, and add in the step (1) three flavor medical materials and soak decocted 2 hours, filter in 3～8 times of amounts of nine flavor medical material gross weights; Merging filtrate is concentrated into 60～70 ℃ of relative densities and is a clear paste of 1.18～1.22, puts cold; It is 50% that adding ethanol limit, limit is stirred to the ethanol volumn concentration, and placement is spent the night, and filters; It is that 50% ethanol water fully stirs that filtering residue adds concentration expressed in percentage by volume; Filter, merge filtrating twice, reclaiming ethanol and being concentrated into 60～70 ℃ of relative densities is 1.18～1.22 secondary clear paste;

(3) get secondary clear paste 1 weight portion, adding cane sugar powder 4.5 weight portions and ethanol are an amount of, process granule, promptly make Xiaoerkang granules after the drying.

In order to make in the Xiaoerkang granules n-butanol extract content more stable, preferably preparation according to the following steps:

(1) takes by weighing Fructus Hordei Germinatus, Semen Torreyae and Semen Arecae three flavor medical materials, add water, soaked 2 hours in 5 times of amounts of three flavor medical material gross weights;

(2) take by weighing Radix Pseudostellariae, Herba Desmodii Triquetri (Herba Tadehagi Triquetri), Fructus Crataegi, Fructus Mume, Periostracum Cicadae, the Radix Paeoniae Alba, Pericarpium Citri Reticulatae, Poria and the Rhizoma Atractylodis Macrocephalae nine flavor medical materials, add water, decocted 2 hours in 5 times of amounts of nine flavor medical material gross weights; Filter, in medicinal residues, add water, and add in the step (1) three flavor medical materials and soak decocted 2 hours in 5 times of amounts of nine flavor medical material gross weights; Filter, merging filtrate is concentrated into 60～70 ℃ of relative densities and is a clear paste of 1.2; Put coldly, the limit adds the ethanol limit, and to be stirred to the ethanol volumn concentration be 50% to place and spend the night, and filters; It is that 50% ethanol water fully stirs that filtering residue adds concentration expressed in percentage by volume; Filter, merge filtrating twice, reclaiming ethanol and being concentrated into 60～70 ℃ of relative densities is 1.2 secondary clear paste;

(3) get secondary clear paste 1 weight portion, adding cane sugar powder 4.5 weight portions and ethanol are an amount of, process granule, promptly make Xiaoerkang granules after the drying.

The present invention's two important parameters of concentration that ethanol reaches during to the proportion of 1 clear paste and precipitate with ethanol limit; Make in the clear paste pure soluble components more stable; N-butanol extract content is stable in the final assurance Xiaoerkang granules finished product, guarantees that the quality of the pharmaceutical preparations is stable, and product percent of pass is high.

Saponin (the main medicinal ingredient of Radix Pseudostellariae), alkaloid (the main medicinal ingredient of Semen Arecae) etc. all are dissolved in n-butyl alcohol, are the main components of n-butanol extract in the medicine.The pharmacological action of Saponin comprises: the two-ways regulation immunization; Anti-hypoxia and antifatigue effect; The low-temperature resistance stress effect; Lipotropism matter Oxidation; Effect to the central nervous system; The anti-mutation effect; Kidney there is regulating action, the kidney invigorating.Alkaloid has significant biological activity, is one of effective ingredient important in the Chinese herbal medicine, action range.Therefore, guarantee the content of n-butanol extract in the medicine, very big to the curative effect of medication influence.

These article specification is every packed 10g; Usage and consumption are: warm water delivery service, below one full year of life each 1/2 bag; One to four years old each 1 bag; More than four years old each 2 bags; 3 times on the one.

The crude drug that the present invention adopted specifically describes as follows:

Radix Pseudostellariae is the dried root of pinkwort Radix Ginseng Pseudostellaria heterophylla (Miq.) Pax exPax et Hoffm..Excavate during most of the withering of stem and leaf in summer, clean, remove fibrous root, put and dry or directly dry after the boiling water part omitted is scalded.Dried root is elongated strip shaped or long spindle, is about 2～6 centimetres, about 3～6 millimeter of diameter, and surperficial yellow-white, translucent, fine wrinkle and recessed mark of fibrous root are arranged, the blunt circle of root head often has remaining stem trace on it, and the lower end is gradually thin like the Mus tail.The crisp frangible of matter, the section yellow-white is and bright, and directly the drying in the sun section is a white, and mealiness is arranged, feeble QI, it is little sweet to distinguish the flavor of.

Herba Desmodii Triquetri (Herba Tadehagi Triquetri), another name: razor handle, Cordyceps, Anisomeles indica (L.) Kuntze, cured fish grass, hundred labor tongues, Manitis tongue, the overseas Chinese claims " celestial tea ".For pulse family beggar-ticks plant gourd tea Desmodium triquetrum (L.) DC., be used as medicine with Herb.Xia Qiu gathers, and cleans to chop up, and dries.Using fresh herb can be adopted at any time.Herba Desmodii Triquetri (Herba Tadehagi Triquetri) stem branch fractures more, and base portion is wooden, and is cylindrical, the about 5mm of diameter, and surface red is brown to bronzing; The top herbaceous stem, tool the 3rd buildings are dredged on the rib and are rented hair.The many shrinkages of leaf are curled, and are ovum shape square circle after the flattening to lanceolar, long 6-15cm, wide 1-3.5cm; Surface red is brown, below hairiness on the master pulse, keratin; The long 0.8-3.5cm of petiole, the wealthy wing of tool; Stipule is visible sometimes, lanceolar, light brown.Sometimes visible raceme or flat pod, long 2-5cm has 4-8 nearly square pod joint, by hair.Gas is fragrant, and it is little sweet to distinguish the flavor of.

Fructus Crataegi is the dry mature fruit of rosaceous plant Fructus Pyri Pashiae Crataegus pinnatifida Bge.var.majorN.E.Br. or Fructus Crataegi Crataegus pinnatifida Bge..Gather during fruit maturation autumn, section, drying.Fruit is less, and is type spherical, diameter 0.8～1.4cm, and what have is pressed into pie.The surface is brown to brownish red, and fine and closely woven wrinkle is arranged, and the top depression has the calyx vestiges, and base portion has carpopodium or come off.Matter is hard, and sarcocarp is thin, and it is little sour and astringent to distinguish the flavor of.

Fructus Mume is the dry almost ripe fruit of rose department plant plum Prunus mume (Sieh.) Sieb.et Zucc..Gather when fruit is closely ripe summer, vexed black to complexion changed behind the oven drying at low temperature.These article type of being sphere or oblate spheroid, diameter 1.5～3cm.Surface corvinus or brownish black, shrinkage is uneven, and base portion has circular carpopodium trace.Pit is hard, ellipse, and pale brown color, there is concave point on the surface; Seed is flat avette, and is faint yellow.Feeble QI, flavor is acid extremely.

Periostracum Cicadae is the nymph of cicada Cryptotympana atrata Fabr. Cryptotympana pustulata Fabricius exuviae shell when sprouting wings.Summer, Qiu Erji collect, and remove silt, dry.These article are ovalize and bending is about 3.5cm, wide about 2cm slightly.The surface yellowish-brown, translucent, glossy.Head has 1 pair of filiform antenna, how to have broken, and compound eye is outstanding.The forehead tip is outstanding, and tone is flourishing, the wide weak point of upper lip, and lower lip extends into tubulose.The chest back side is cross splits, and breach is to crimped, 2 pairs of back both sides tool winglets; The outside of belly has 3 pairs on foot, by the yellowish-brown fine, soft fur.Blunt abdominal circle, totally 9 joints.Body is light, and hollow is frangible.Odorless, lightly seasoned.

The Radix Paeoniae Alba is the dry root of ranunculaceae plant Radix Paeoniae Paeonia lactiflora Pall..Summer, Qiu Erji excavate, and clean, and remove and reach radicula end to end, put and boil after removing crust or peeling after boiling in the boiling water again, dry.Dry root is cylindrical, even thickness and straight, long 10～20 centimetres, 1～1.8 centimetre of diameter.The light red brown or white powder in surface, smooth, or significantly vertical wrinkle and mark of fibrous root are arranged, there is the sepia spot at the cork place of not eliminating, accidental horizontal hole skin.Matter is solid and weigh, not frangible.It is brown that section canescence or little is with, and the woody part lonizing radiation are the radial striations shape.Gas does not have, mildly bitter flavor and acid.

Pericarpium Citri Reticulatae is the dry mature skin of rutaceae orange Citrus reticulata Blanco and variety thereof.Medical material is divided into " Pericarpium Citri Reticulatae " and " Pericarpium citri reticuatae chachiensis ".Pluck mature fruit, strip peel, dry or cold drying.Pericarpium Citri Reticulatae: often shell into several lobes, base portion links to each other, and what have is irregular lamellar, thick 1～4mm.Orange red or the rufous of outer surface has fine wrinkle and recessed point-like grease chamber; The inner surface ivory buff, coarse, attach yellow-white or yellowish-brown grain shape vascular bundle.Matter is slightly hard and crisp.Gas is fragrant, acrid in the mouth, hardship.Pericarpium citri reticuatae chachiensis: normal 3 lobes link to each other, and shape is neat, and thickness is even, about 1mm.The point-like grease chamber is bigger, and illumination is looked, and is transparent clear.Matter is soft.

Poria is the dry sclerotia of Polyporaceae fungus Poria Poria cocos (Schw.) Wolf.More than excavating for 7～JIUYUE, remove silt after digging out, after bank up " diaphoresis ", spread out and dry in the air to dry tack free, " diaphoresis " again after wrinkle, big of internal moisture are scattered and disappeared extremely at present for several times repeatedly, dries in the shade, and is called " Poria is individual "; Or bright Poria pressed the different parts cutting, and dry in the shade, be called " Cortex Sclerotii Poriae " respectively and reach " Poria piece ".Poria is individual, is similar round, ellipse, oblateness or irregular agglomerate, and is not of uniform size.Crust is thin, and sepia or dark brown is coarse, and the tool wrinkle contracts with hanging, and part is peeled off sometimes.Matter is solid, plane of disruption graininess, and the proximal edge pale red has tiny honeycomb appearance hole, inner white, minority pale red.Radix Pini massonianae is entertained in the centre that has, and practises and claims " obtaining refreshing piece ".Feeble QI, lightly seasoned, that chews sticks to one's teeth.Cortex Sclerotii Poriae is the Poria crust under cutting, and shape is not of uniform size.The outside sepia to pitchy, inner face white or light brown.Matter is softer, slightly tool elasticity.The Poria piece for removing the peel the Poria of back cutting, is the piece lamellar, and is not of uniform size.White, pale red or light brown.

The Rhizoma Atractylodis Macrocephalae is the dry rhizome of feverfew Rhizoma Atractylodis Macrocephalae Atractylodes macrocephala Koidz..Winter the bottom leaf withered and yellow, excavate when upper leaf becomes fragile, remove silt, dry or dry, remove fibrous root again.These article are irregular plump agglomerate, long 3～13cm, diameter 1.5～7cm.Surface lark or taupe brown have strumae and alternate vertical wrinkle and rill, and have mark of fibrous root, top that residual stem foot and bud trace are arranged.The hard not frangible of matter, section is uneven, and yellow-white has brown xanchromatic point-like grease chamber to be dispersed in to light brown; Oven dry person's angle of rupture matter appearance, color are dark or the crack arranged.Gas delicate fragrance, sweet in the mouth, little suffering, that chews has a little stickiness.

In the inventive method water consumption in the water extraction medical material process and the amount of ethanol in the precipitate with ethanol process are carried out strict control; More traditional decoction and alcohol sedimentation technique is effective; The Xiaoerkang granules steady quality of preparation, controlled, n-butanol extract stable content and conformance with standard requirement have improved the qualification rate of product greatly, and method simple to operate, with short production cycle, need not special devices; Cost is low, yield is high, is suitable for suitability for industrialized production.

The specific embodiment

Embodiment 1

Take by weighing the Chinese crude drug of following weight:

Radix Pseudostellariae 3320g Herba Desmodii Triquetri (Herba Tadehagi Triquetri) 3320g Fructus Crataegi 3320g Fructus Mume 1000g

Periostracum Cicadae 1000g Radix Paeoniae Alba 1700g Fructus Hordei Germinatus 1700g Semen Torreyae 1700g

Semen Arecae 1700g Pericarpium Citri Reticulatae 330g Poria 1000g Rhizoma Atractylodis Macrocephalae 1000g;

Preparation according to the following steps:

(1) takes by weighing Fructus Hordei Germinatus, Semen Torreyae and Semen Arecae three flavor medical materials, add water, soaked 2 hours in 5 times of amounts of three flavor medical material gross weights;

(2) take by weighing Radix Pseudostellariae, Herba Desmodii Triquetri (Herba Tadehagi Triquetri), Fructus Crataegi, Fructus Mume, Periostracum Cicadae, the Radix Paeoniae Alba, Pericarpium Citri Reticulatae, Poria and the Rhizoma Atractylodis Macrocephalae nine flavor medical materials, add water, decocted 2 hours in 5 times of amounts of nine flavor medical material gross weights; Filter, in medicinal residues, add water, and add in the step (1) three flavor medical materials and soak decocted 2 hours in 5 times of amounts of nine flavor medical material gross weights; Filter, merging filtrate is concentrated into 60 ℃ of relative densities and is a clear paste of 1.2; Put coldly, the limit adds the ethanol limit, and to be stirred to the ethanol volumn concentration be 50%, and placement is spent the night; Filter, it is that 50% ethanol water fully stirs that filtering residue adds concentration expressed in percentage by volume, filters; Merge filtrating twice, reclaiming ethanol and being concentrated into 60 ℃ of relative densities is 1.2 secondary clear paste;

(3) with above-mentioned secondary clear paste and cane sugar powder by weight being 1: 4.5 mixed and to add ethanol an amount of, process granule, promptly make the 10000g Xiaoerkang granules after the drying, be distributed into 1000 bags.

Embodiment 2

Take by weighing the Chinese crude drug of following weight:

Radix Pseudostellariae 3320g Herba Desmodii Triquetri (Herba Tadehagi Triquetri) 3320g Fructus Crataegi 3320g Fructus Mume 1000g

Periostracum Cicadae 1000g Radix Paeoniae Alba 1700g Fructus Hordei Germinatus 1700g Semen Torreyae 1700g

Semen Arecae 1700g Pericarpium Citri Reticulatae 330g Poria 1000g Rhizoma Atractylodis Macrocephalae 1000g;

Preparation according to the following steps:

(1) takes by weighing Fructus Hordei Germinatus, Semen Torreyae and Semen Arecae three flavor medical materials, add water, soaked 2 hours in 3 times of amounts of three flavor medical material gross weights;

(2) take by weighing Radix Pseudostellariae, Herba Desmodii Triquetri (Herba Tadehagi Triquetri), Fructus Crataegi, Fructus Mume, Periostracum Cicadae, the Radix Paeoniae Alba, Pericarpium Citri Reticulatae, Poria and the Rhizoma Atractylodis Macrocephalae nine flavor medical materials, add water, decocted 2 hours in 8 times of amounts of nine flavor medical material gross weights; Filter, in medicinal residues, add water, and add in the step (1) three flavor medical materials and soak decocted 2 hours in 8 times of amounts of nine flavor medical material gross weights; Filter, merging filtrate is concentrated into 70 ℃ of relative densities and is a clear paste of 1.2; Put coldly, the limit adds the ethanol limit, and to be stirred to the ethanol volumn concentration be 50%, and placement is spent the night; Filter, it is that 50% ethanol water fully stirs that filtering residue adds concentration expressed in percentage by volume, filters; Merge filtrating twice, reclaiming ethanol and being concentrated into 70 ℃ of relative densities is 1.2 secondary clear paste;

(3) with above-mentioned secondary clear paste and cane sugar powder by weight being 1: 4.5 mixed and to add ethanol an amount of, process granule, promptly make the 10000g Xiaoerkang granules after the drying, be distributed into 1000 bags.

Embodiment 3

Take by weighing the Chinese crude drug of following weight:

Radix Pseudostellariae 3320g Herba Desmodii Triquetri (Herba Tadehagi Triquetri) 3320g Fructus Crataegi 3320g Fructus Mume 1000g

Periostracum Cicadae 1000g Radix Paeoniae Alba 1700g Fructus Hordei Germinatus 1700g Semen Torreyae 1700g

Semen Arecae 1700g Pericarpium Citri Reticulatae 330g Poria 1000g Rhizoma Atractylodis Macrocephalae 1000g;

Preparation according to the following steps:

(1) takes by weighing Fructus Hordei Germinatus, Semen Torreyae and Semen Arecae three flavor medical materials, add water, soaked 2 hours in 8 times of amounts of three flavor medical material gross weights;

(2) take by weighing Radix Pseudostellariae, Herba Desmodii Triquetri (Herba Tadehagi Triquetri), Fructus Crataegi, Fructus Mume, Periostracum Cicadae, the Radix Paeoniae Alba, Pericarpium Citri Reticulatae, Poria and the Rhizoma Atractylodis Macrocephalae nine flavor medical materials, add water, decocted 2 hours in 3 times of amounts of nine flavor medical material gross weights; Filter, in medicinal residues, add water, and add in the step (1) three flavor medical materials and soak decocted 2 hours in 3 times of amounts of nine flavor medical material gross weights; Filter, merging filtrate is concentrated into 65 ℃ of relative densities and is a clear paste of 1.2; Put coldly, the limit adds the ethanol limit, and to be stirred to the ethanol volumn concentration be 50%, and placement is spent the night; Filter, it is that 50% ethanol water fully stirs that filtering residue adds concentration expressed in percentage by volume, filters; Merge filtrating twice, reclaiming ethanol and being concentrated into 65 ℃ of relative densities is 1.2 secondary clear paste;

(3) with above-mentioned secondary clear paste and cane sugar powder by weight being 1: 4.5 mixed and to add ethanol an amount of, process granule, promptly make the 10000g Xiaoerkang granules after the drying, be distributed into 1000 bags.

Embodiment 4

Take by weighing the Chinese crude drug of following weight:

Radix Pseudostellariae 3320g Herba Desmodii Triquetri (Herba Tadehagi Triquetri) 3320g Fructus Crataegi 3320g Fructus Mume 1000g

Periostracum Cicadae 1000g Radix Paeoniae Alba 1700g Fructus Hordei Germinatus 1700g Semen Torreyae 1700g

Semen Arecae 1700g Pericarpium Citri Reticulatae 330g Poria 1000g Rhizoma Atractylodis Macrocephalae 1000g;

Preparation according to the following steps:

(1) takes by weighing Fructus Hordei Germinatus, Semen Torreyae and Semen Arecae three flavor medical materials, add water, soaked 2 hours in 6 times of amounts of three flavor medical material gross weights;

(2) take by weighing Radix Pseudostellariae, Herba Desmodii Triquetri (Herba Tadehagi Triquetri), Fructus Crataegi, Fructus Mume, Periostracum Cicadae, the Radix Paeoniae Alba, Pericarpium Citri Reticulatae, Poria and the Rhizoma Atractylodis Macrocephalae nine flavor medical materials, add water, decocted 2 hours in 4 times of amounts of nine flavor medical material gross weights; Filter, in medicinal residues, add water, and add in the step (1) three flavor medical materials and soak decocted 2 hours in 4 times of amounts of nine flavor medical material gross weights; Filter, merging filtrate is concentrated into 65 ℃ of relative densities and is a clear paste of 1.22; Put coldly, the limit adds the ethanol limit, and to be stirred to the ethanol volumn concentration be 50%, and placement is spent the night; Filter, it is that 50% ethanol water fully stirs that filtering residue adds concentration expressed in percentage by volume, filters; Merge filtrating twice, reclaiming ethanol and being concentrated into 65 ℃ of relative densities is 1.22 secondary clear paste;

(3) with above-mentioned secondary clear paste and cane sugar powder by weight being 1: 4.5 mixed and to add ethanol an amount of, process granule, promptly make the 10000g Xiaoerkang granules after the drying, be distributed into 1000 bags.

Embodiment 5

Take by weighing the Chinese crude drug of following weight:

Radix Pseudostellariae 3320g Herba Desmodii Triquetri (Herba Tadehagi Triquetri) 3320g Fructus Crataegi 3320g Fructus Mume 1000g

Periostracum Cicadae 1000g Radix Paeoniae Alba 1700g Fructus Hordei Germinatus 1700g Semen Torreyae 1700g

Semen Arecae 1700g Pericarpium Citri Reticulatae 330g Poria 1000g Rhizoma Atractylodis Macrocephalae 1000g;

Preparation according to the following steps:

(1) takes by weighing Fructus Hordei Germinatus, Semen Torreyae and Semen Arecae three flavor medical materials, add water, soaked 2 hours in 4 times of amounts of three flavor medical material gross weights;

(2) take by weighing Radix Pseudostellariae, Herba Desmodii Triquetri (Herba Tadehagi Triquetri), Fructus Crataegi, Fructus Mume, Periostracum Cicadae, the Radix Paeoniae Alba, Pericarpium Citri Reticulatae, Poria and the Rhizoma Atractylodis Macrocephalae nine flavor medical materials, add water, decocted 2 hours in 7 times of amounts of nine flavor medical material gross weights; Filter, in medicinal residues, add water, and add in the step (1) three flavor medical materials and soak decocted 2 hours in 7 times of amounts of nine flavor medical material gross weights; Filter, merging filtrate is concentrated into 65 ℃ of relative densities and is a clear paste of 1.18; Put coldly, the limit adds the ethanol limit, and to be stirred to the ethanol volumn concentration be 50%, and placement is spent the night; Filter, it is that 50% ethanol water fully stirs that filtering residue adds concentration expressed in percentage by volume, filters; Merge filtrating twice, reclaiming ethanol and being concentrated into 65 ℃ of relative densities is 1.18 secondary clear paste;

(3) with above-mentioned secondary clear paste and cane sugar powder by weight being 1: 4.5 mixed and to add ethanol an amount of, process granule, promptly make the 10000g Xiaoerkang granules after the drying, be distributed into 1000 bags.

Comparative Examples 1

Take by weighing the Chinese crude drug of following weight:

Radix Pseudostellariae 3320g Herba Desmodii Triquetri (Herba Tadehagi Triquetri) 3320g Fructus Crataegi 3320g Fructus Mume 1000g

Periostracum Cicadae 1000g Radix Paeoniae Alba 1700g Fructus Hordei Germinatus 1700g Semen Torreyae 1700g

Semen Arecae 1700g Pericarpium Citri Reticulatae 330g Poria 1000g Rhizoma Atractylodis Macrocephalae 1000g;

Preparation according to the following steps:

(1) takes by weighing Fructus Hordei Germinatus, Semen Torreyae and Semen Arecae three flavor medical materials, add water, soaked 2 hours in 10 times of amounts of three flavor medical material gross weights;

(2) take by weighing Radix Pseudostellariae, Herba Desmodii Triquetri (Herba Tadehagi Triquetri), Fructus Crataegi, Fructus Mume, Periostracum Cicadae, the Radix Paeoniae Alba, Pericarpium Citri Reticulatae, Poria and the Rhizoma Atractylodis Macrocephalae nine flavor medical materials, add water, decocted 2 hours, filter in 12 times of amounts of nine flavor medical material gross weights; In medicinal residues, add water, and add in the step (1) three flavor medical materials and soak decocted 2 hours, filter merging filtrate in 12 times of amounts of nine flavor medical material gross weights; Be concentrated into 1/4 of original volume, put coldly, the ethanol that adds equal volume amounts stirs; Placement is spent the night, and filters, and it is that 50% ethanol water fully stirs that filtering residue adds concentration expressed in percentage by volume; Filter, merge filtrating twice, reclaiming ethanol and being concentrated into 60 ℃ of relative densities is 1.2 thick paste;

(3) with above-mentioned secondary clear paste and cane sugar powder by weight being 1: 4.5 mixed and to add ethanol an amount of, process granule, promptly make the 10000g Xiaoerkang granules after the drying, be distributed into 1000 bags.

Comparative Examples 2

Except adopting the water of 2 times of amounts in the step (1), all adopt outside the water of 10 times of amounts in the step (2), all the other are operated all with Comparative Examples 1, make 1000 bags of Xiaoerkang granules.

Comparative Examples 3

Except adopting the water of 1 times of amount in the step (1), all adopt outside the water of 2 times of amounts in the step (2), all the other are operated all with Comparative Examples 1, make 1000 bags of Xiaoerkang granules.

Comparative Examples 4

Except adopting the water of 15 times of amounts in the step (1), all adopt outside the water of 6 times of amounts in the step (2), all the other are operated all with Comparative Examples 1, make 1000 bags of Xiaoerkang granules.

Comparative Examples 5

Except adopting the water of 5 times of amounts in the step (1), all adopt outside the water of 10 times of amounts in the step (2), all the other are operated all with Comparative Examples 1, make 1000 bags of Xiaoerkang granules.

The XIAOER KANG electuary quality standard (WS that records according to the 6th the 21st page in the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation ₃-the Xiaoerkang granules that B-1091-92) the foregoing description 1～5 and Comparative Examples 1～5 made is differentiated the detection with n-butanol extract.

Wherein, the detection method of n-butanol extract is following: get these article 20g, claim to decide weight (accurately to 0.01g), the accurate 100ml n-butyl alcohol that adds; Claim to decide the close plug of weight (accurately to 0.01g), place after 1 hour, put in the water-bath reflux 1 hour, put cold; Put to place in the refrigerator and spend the night, take out and place room temperature, the weight of replenish lost filters; The accurate filtrating 25ml that draws puts in the sad heavy evaporating dish, in 105 ℃ of dryings 3 hours, puts in the exsiccator cooling 30 minutes; Precision is weighed, and calculates percentage composition, promptly gets.

Other index under the granule item, all carry out each item index and detect assay such as following table according to the detection method of an appendix I of 2000 editions Pharmacopoeias of People's Republic of China C granule:

	Butanol extract (must not be less than 2.0%)	Other index under discriminating and the granule item	Conclusion
				Embodiment 1	3.2％	Qualified	Qualified
Embodiment 2	2.8％	Qualified	Qualified
				Embodiment 3	2.8％	Qualified	Qualified
Embodiment 4	3.1％	Qualified	Qualified
				Embodiment 5	3.0％	Qualified	Qualified
Comparative Examples 1	1.6％	Qualified	Defective
				Comparative Examples 2	1.5％	Qualified	Defective
Comparative Examples 3	2.1％	Qualified	Qualified
				Comparative Examples 4	2.3％	Qualified	Qualified
Comparative Examples 5	1.6％	Qualified	Defective

This shows that adopt the inventive method to carry out Xiaoerkang granules production, the n-butanol extract increase rate is bigger in the finished product, and the content fluctuation is less, constant product quality, controlled is superior to existing method for preparing.

Claims (2)

1. the method for preparing of an Xiaoerkang granules is characterized in that, takes by weighing following parts by weight of Chinese traditional medicine material:

Radix Pseudostellariae 3.32 Herba Desmodii Triquetri (Herba Tadehagi Triquetri)s 3.32 Fructus Crataegis 3.32 Fructus Mumes 1.00

Periostracum Cicadae 1.00 Radix Paeoniae Albas 1.70 Fructus Hordei Germinatus 1.70 Semen Torreyaes 1.70

Semen Arecae 1.70 Pericarpium Citri Reticulataes 0.33 Poria 1.00 Rhizoma Atractylodis Macrocephalaes 1.00;

Preparation according to the following steps:

(1) takes by weighing Fructus Hordei Germinatus, Semen Torreyae and Semen Arecae three flavor medical materials, add water, soaked 2 hours in 3～8 times of amounts of three flavor medical material gross weights;

(2) take by weighing Radix Pseudostellariae, Herba Desmodii Triquetri (Herba Tadehagi Triquetri), Fructus Crataegi, Fructus Mume, Periostracum Cicadae, the Radix Paeoniae Alba, Pericarpium Citri Reticulatae, Poria and the Rhizoma Atractylodis Macrocephalae nine flavor medical materials, add water, decocted 2 hours, filter in 3～8 times of amounts of nine flavor medical material gross weights; In medicinal residues, add water, and add in the step (1) three flavor medical materials and soak decocted 2 hours, filter in 3～8 times of amounts of nine flavor medical material gross weights; Merging filtrate is concentrated into 60～70 ℃ of relative densities and is a clear paste of 1.18～1.22, puts cold; It is 50% that adding ethanol limit, limit is stirred to the ethanol volumn concentration, and placement is spent the night, and filters; It is that 50% ethanol water fully stirs that filtering residue adds concentration expressed in percentage by volume; Filter, merge filtrating twice, reclaiming ethanol and being concentrated into 60～70 ℃ of relative densities is 1.18～1.22 secondary clear paste;

(3) get secondary clear paste 1 weight portion, add cane sugar powder 4.5 weight portions and ethanol, process granule, promptly make Xiaoerkang granules after the drying.

2. method for preparing as claimed in claim 1 is characterized in that, according to the following steps preparation:

(1) takes by weighing Fructus Hordei Germinatus, Semen Torreyae and Semen Arecae three flavor medical materials, add water, soaked 2 hours in 5 times of amounts of three flavor medical material gross weights;

(2) take by weighing Radix Pseudostellariae, Herba Desmodii Triquetri (Herba Tadehagi Triquetri), Fructus Crataegi, Fructus Mume, Periostracum Cicadae, the Radix Paeoniae Alba, Pericarpium Citri Reticulatae, Poria and the Rhizoma Atractylodis Macrocephalae nine flavor medical materials, add water, decocted 2 hours in 5 times of amounts of nine flavor medical material gross weights; Filter, in medicinal residues, add water, and add in the step (1) three flavor medical materials and soak decocted 2 hours in 5 times of amounts of nine flavor medical material gross weights; Filter, merging filtrate is concentrated into 60～70 ℃ of relative densities and is a clear paste of 1.2; Put coldly, the limit adds the ethanol limit, and to be stirred to the ethanol volumn concentration be 50% to place and spend the night, and filters; It is that 50% ethanol water fully stirs that filtering residue adds concentration expressed in percentage by volume; Filter, merge filtrating twice, reclaiming ethanol and being concentrated into 60～70 ℃ of relative densities is 1.2 secondary clear paste;

(3) get secondary clear paste 1 weight portion, add cane sugar powder 4.5 weight portions and ethanol, process granule, promptly make Xiaoerkang granules after the drying.