CN105521363A - Preparation method and quality control method of traditional Chinese medicine capsule for treating weakness of spleen and stomach - Google Patents
Preparation method and quality control method of traditional Chinese medicine capsule for treating weakness of spleen and stomach Download PDFInfo
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Abstract
The invention discloses a preparation method and a quality control method of a traditional Chinese medicine capsule for treating the weakness of the spleen and the stomach. The preparation method comprises the following steps: taking radix pseudostellariae with half weight and rhizoma dioscoreae, smashing, screening the obtained powder by a sieve, and uniformly mixing the powder after sieving for later use; adding water into the rest radix pseudostellariae, dried tangerine or orange peel, fructus hordei germinatus and hawthorn fruits and decocting, mixing the decoctions, filtering the obtained mixed decoction, carrying out low-temperature vacuum concentration on the filtrate till thick paste is obtained, adding the fine powder obtained into the thick paste, uniformly mixing, making into granules, drying the granules, adding a suitable amount of auxiliary materials, uniformly mixing, and placing the mixture into capsule bodies, thus obtaining the traditional Chinese medicine capsule. The quality control method comprises the following steps: taking the traditional Chinese medicine capsule, and observing under a microscope, wherein needle crystals of calcium oxalate exist in mucin cells or exist independently in a dispersed manner, and have the length of 120-200 mu m and the diameter of 3-4 mu m; cluster crystals of calcium oxalate exist in parenchymal cells. Through the economical as well as scientific and reasonable preparation method, the traditional Chinese medicine capsule for treating the weakness of the spleen and the stomach is prepared, and the quality of the prepared traditional Chinese medicine capsule for treating the weakness of the spleen and the stomach can be effectively controlled by adopting the scientific and reasonable quality control method.
Description
Technical field
The present invention relates to biological pharmacy technical field, specifically, is preparation method and the method for quality control thereof of the Chinese medicinal capsule for the treatment of weakness of the spleen and stomach.
Background technology
Weakness of the spleen and stomach, contains the tcm syndromes such as deficiency of spleen-QI, deficiency of spleen-YANG, failure of the spleen to keep the blood flowing within the vessels, sinking of QI of middle-JIAO, stomach yang deficiency, insufficiency of stomach-QI, deficiency of stomach-YIN and Deficiency and coldness of spleen and stomach.Wherein deficiency of spleen-QI is the fundamental type of weakness of the spleen and stomach, and syndrome of deficiency of spleen qi refers to deficiency of spleen-QI, loses the syndrome that its strong fortune shows.Many because of eating and drinking without temperance, overwork, caused by prolonged illness wasting spleen-QI." deficiency of spleen-QI " one word for "Nei Jing", the discussion of " 70 years old, deficiency of spleen-QI, skin is withered " as having in " Ling Shu Miraculous Pivot or Divine Axis natural life-span " section.Thereafter ancient Chinese medicine doctor is furtherd investigate syndrome of deficiency of spleen qi and is played, and points out that The spleen has the function to transport and transform nutrients, is source of generating QI and blood, is the foundation of acquired constitution.If natural endowment is not enough, or ferritic weakness of the spleen and stomach; Or the day after tomorrow lose in taking good care of, or eating and drinking without temperance, with the passing of time irregular diet, or overstrain, be worried, impairing the spleen and stomach; Or worn with age, or serious disease, after prolonged illness, vigour is not multiple, and lose in taking good care of, all can make temper virtual loss, transportation capabilities are not normal, causes the biochemical weary source of QI and blood, forms syndrome of deficiency of spleen qi.
Its cause of disease is:
Eating and drinking without temperance, overstrain, be worried with the passing of time, innate deficiency, worn with age, just recover from a dangerous illness, taking good care of causes careless can cause weakness of the spleen and stomach." General Treatise on the Cause and Symptoms of Diseases vital organs of the human body sick duke or princess under an emperor the splenopathy wait ": " excessive splenoqi, for shape is had a surplus, then sick abdominal distention, urinates unfavorable, and heavy sensation of the body is bitter hungry, and flaccidity of the lower limbs is not received ... be for temper reality also, then should rush down it.Deficiency of spleen-QI, then flaccidity of the limbs, after let out, dyspepsia vomiting, abdominal swelling, be for temper void also." therefore its cause of disease has three aspects: one is drinking and eating irregularly; Two for overworking; Three due to acute and chronic disease.Above all because of, consumption imapirment of the spleen and stomach, causes taste not enough, and transporting is lost strong, forms weakness of the spleen and stomach.
Its clinical manifestation is:
The common clinical manifestation of weakness of the spleen and stomach: the course of disease is longer, time light when having loose bowels heavy or time when sending out only, loose stool, the light odorless of color, accompanies indigestion food debris, easily rushes down after food, eat many after see that abdominal distention, stool are many, inappetence usually, shallow complexion, tired, body is thin and weak, pale tongue, white and thin fur, deficient pulse is unable.
Then seeing as shown as deficiency of spleen-QI: distension and fullness in the abdomen, is that very mouth does not know taste after food, even anorexia, and large loose stool is thin, lassitude, emaciated physique, limbs asthenia, deficiency of QI with disinclination to talk, and shallow complexion or white, or limbs edema, pale tongue with white fur, moderate pulse is weak unable.
Then seeing as shown as deficiency of spleen-YANG: abdominal distention and anorexia, continuous and dull pain in the abdomen, liking warm pain relieved by pressing, coldness of the body with chills, large loose stool is thin rare clearly.Or limbs are tired heavy, or limbs edema, dysuria, or see that the many matter of leucorrhea is rare.Pale tongue is fat, white, slippery and moist fur.Deep-slow pulse is unable.
Then see as shown as failure of the spleen to keep the blood flowing within the vessels: for deficiency of spleen-QI, then transporting is unable, deficiency of qi and blood, visible lack of appetite, abdominal distention, loose stool, limbs asthenia, deficiency of QI with disinclination to talk, shallow complexion, pale tongue with white fur, moderate pulse is weak.One is multiple bleeding, as having blood in stool, and hematuria, menorrhagia, metrorrhagia etc.Have blood in stool and the person that belongs to failure of the spleen to keep the blood flowing within the vessels, to defecate hematochezia, hemafecia mixes, or bleeding after defecation, and color is purple dark, or it is pitch-dark to defecate, and doublely sees deficiency of spleen-QI symptom; Metrorrhagia and the person that belongs to failure of the spleen to keep the blood flowing within the vessels, show as sudden onset of metrorrhagia, or not to the utmost dripping, and the light matter of color is thin, pale complexion or impractical, lassitude, and extremity are not warm, lazy speech of breathing hard, indigestion and loss of appetite loose stool etc.
Then see as shown as sinking of QI of middle-JIAO: pale white complexion, dizzy easy antiperspirant, loses heart, asthenia, lack of appetite, and loose stool, abdominal part heavily fall, and awareness of defecation frequency, turbid urine is as water from washing rice etc.Be more common in the diseases such as gastroptosis, nephroptosis, uterine prolapse, proctoptosis and chronic diarrhea.
Then see as shown as deficiency of stomach-YIN: see dry mouth with parched lips, noisy, retch, diet reduces, or dysphagia, and after food, chest and diaphragm is uncomfortable, constipation with dry stool, and red tongue center is done, few tongue, or tongue light, dry deep red, thready and rapid pulse etc.
Then see as shown as Deficiency and coldness of spleen and stomach: stomachache is indistinctly, endlessly continuous, cold type of pain is uncomfortable, and like warm pain relieved by pressing, pain of empty stomach very, must eat, delay, tired or eat cold or panic attacks or increase the weight of, general vomiting watery fluid, lack of appetite, spiritlessness and weakness after suffering from cold, hands and feet being not warm, large loose stool is thin, pale tongue with white fur, deficient and weak pulse.
Summary of the invention
The object of the invention is to preparation method and the method for quality control thereof of the Chinese medicinal capsule designing treatment weakness of the spleen and stomach, adopt Radix Pseudostellariae, Pericarpium Citri Reticulatae, Rhizoma Dioscoreae, Fructus Hordei Germinatus and Fructus Crataegi to carry out can be used for the preparation of the Chinese medicinal capsule for the treatment of weakness of the spleen and stomach by a kind of economical and practical, scientific and reasonable preparation method, and the quality of scientific and reasonable method of quality control to the Chinese medicinal capsule of prepared treatment weakness of the spleen and stomach can be adopted to control effectively.
The present invention is achieved through the following technical solutions: the preparation method of the Chinese medicinal capsule for the treatment of weakness of the spleen and stomach, and this Chinese medicinal capsule makes by the following method:
Radix Pseudostellariae 240 ~ 270 weight portion Pericarpium Citri Reticulatae 24 ~ 27 weight portion Rhizoma Dioscoreae 180 ~ 200 weight portion
Fructus Hordei Germinatus 180 ~ 200 weight portion Fructus Crataegi 120 ~ 130 weight portion
The above five tastes, Radix Pseudostellariae and the Rhizoma Dioscoreae powder of getting half weight are broken into 18 ~ 30 order impalpable powders, sieve, mixing, for subsequent use; Remaining Radix Pseudostellariae and Pericarpium Citri Reticulatae, Fructus Hordei Germinatus, Fructus Crataegi decoct with water 1-3 time, each 1.5-2.5 hour, collecting decoction, and filter, filtrate concentrate under reduced pressure at low temperature is to paste, add above-mentioned fine powder, mixing, makes granule, dry, add right amount of auxiliary materials, mixing, incapsulates, to obtain final product.
Further described to better implement the present invention preparation method, this Chinese medicinal capsule makes by the following method:
Radix Pseudostellariae 252 weight portion Pericarpium Citri Reticulatae 24 weight portion Rhizoma Dioscoreae 184 weight portion
Fructus Hordei Germinatus 182 weight portion Fructus Crataegi 124 weight portion
The above five tastes, Radix Pseudostellariae and the Rhizoma Dioscoreae powder of getting 176 weight portions are broken into 18 ~ 30 order impalpable powders, sieve, mixing, for subsequent use; Remaining Radix Pseudostellariae and Pericarpium Citri Reticulatae, Fructus Hordei Germinatus, Fructus Crataegi decoct with water 2 times, each 2.5 hours, collecting decoction, and filter, filtrate concentrate under reduced pressure at low temperature, to paste, adds above-mentioned fine powder, and mixing, makes granule, dry, add right amount of auxiliary materials, and mixing, incapsulates, to obtain final product.
The method of quality control of the Chinese medicinal capsule for the treatment of weakness of the spleen and stomach, this method of quality control contains one or more in following discrimination method:
A. get Chinese medicinal capsule thing, put basis of microscopic observation: needle-like calcium oxalate crystal bundle is present in myxocyte or is dispersed in, long 120 ~ 200 μm, needle diameter 3 ~ 4 μm; Calcium oxalate cluster crystal is present in parenchyma cell;
B. get Chinese medicinal capsule content 2g, add methanol 18ml, supersound process 12 minutes, filter, filtrate is concentrated into 1ml, as need testing solution; Separately get Radix Pseudostellariae control medicinal material 1g, be made in the same way of control medicinal material solution; Test according to thin layer chromatography, draw each 2 μ l of above-mentioned two kinds of solution, put respectively in same with sodium carboxymethyl cellulose be adhesive silica gel g thin-layer plate on, water-glacial acetic acid-n-butyl alcohol with 1: 1:5, for developing solvent, is put with in the developing solvent presaturation expansion cylinder of 16 minutes, is launched, take out, dry, spray with 0.22% ethanol solution of ninhydrin, be heated to spot development at 102 DEG C clear; In test sample chromatograph, on the position corresponding to control medicinal material chromatograph, the speckle of aobvious same color;
C. get Pericarpium Citri Reticulatae control medicinal material 0.2g, make control medicinal material solution by the need testing solution preparation method under B item; Get Hesperidin reference substance again, add methanol and make saturated solution, in contrast product solution; Test according to thin layer chromatography, draw the need testing solution under B item and each 5 μ l of above-mentioned two kinds of solution, put respectively in same take sodium carboxymethyl cellulose as the silica gel g thin-layer plate of adhesive, methanol-acetic acid ethyl ester-water with 4: 38: 6 is for developing solvent, launch, take out, dry, spray is with aluminum chloride test solution, and putting wavelength is inspect under 360nm ultra-violet lamp; In test sample chromatograph, on the position corresponding to control medicinal material chromatograph and reference substance chromatograph, the fluorescence speckle of aobvious same color;
Wherein, this Chinese medicinal capsule makes by the following method:
Radix Pseudostellariae 240 ~ 270 weight portion Pericarpium Citri Reticulatae 24 ~ 27 weight portion Rhizoma Dioscoreae 180 ~ 200 weight portion
Fructus Hordei Germinatus 180 ~ 200 weight portion Fructus Crataegi 120 ~ 130 weight portion
The above five tastes, Radix Pseudostellariae and the Rhizoma Dioscoreae powder of getting half weight are broken into 18 ~ 30 order impalpable powders, sieve, mixing, for subsequent use; Remaining Radix Pseudostellariae and Pericarpium Citri Reticulatae, Fructus Hordei Germinatus, Fructus Crataegi decoct with water 1-3 time, each 1.5-2.5 hour, collecting decoction, and filter, filtrate concentrate under reduced pressure at low temperature is to paste, add above-mentioned fine powder, mixing, makes granule, dry, add right amount of auxiliary materials, mixing, incapsulates, to obtain final product.
The method of quality control of the Chinese medicinal capsule of further described to better implement the present invention treatment weakness of the spleen and stomach, the method is also containing, for example lower content assaying method:
Get Chinese medicinal capsule content, porphyrize, get 1g, weighed, put in apparatus,Soxhlet's, add methanol and make dissolving in right amount, reflux 4.5 ~ 5.5 hours in water-bath, extracting solution reclaims methanol to dry, and the residue 8ml that adds water makes dissolving, with water saturated n-butanol extraction 5 times, each 8ml, merge n-butanol extracting liquid, the 12ml that adds water washs, n-butyl alcohol liquid evaporate to dryness, residue adds methanol makes dissolving in right amount, is quantitatively transferred in 5ml measuring bottle, and be diluted to scale, shake up, as need testing solution; Separately get Hesperidin reference substance, weighed, add methanol and make the solution of every 1ml containing 0.2mg, product solution in contrast; Test according to thin layer chromatography, draw need testing solution 4 μ l, reference substance solution 2 μ l and 4 μ l, respectively cross point in same with sodium carboxymethyl cellulose be adhesive silica gel g thin-layer plate on, the methanol-acetic acid ethyl ester-water with 4: 38: 6, for developing solvent, launches, take out, dry, scan according to thin layer chromatography, wavelength: λ
s=281nm, λ
r=378nm, measures test sample trap integrated value and reference substance trap integrated value, calculates, to obtain final product;
Chinese medicinal capsule every in Hesperidin, must not be less than 0.42 ~ 0.48mg containing Pericarpium Citri Reticulatae.
The present invention compared with prior art, has the following advantages and beneficial effect:
The present invention adopts Radix Pseudostellariae, Pericarpium Citri Reticulatae, Rhizoma Dioscoreae, Fructus Hordei Germinatus and Fructus Crataegi to carry out can be used for the preparation of the Chinese medicinal capsule for the treatment of weakness of the spleen and stomach by a kind of economical and practical, scientific and reasonable preparation method, and the quality of scientific and reasonable method of quality control to the Chinese medicinal capsule of prepared treatment weakness of the spleen and stomach can be adopted to control effectively.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is described in further detail, but embodiments of the present invention are not limited thereto.
Embodiment 1:
The preparation method of the Chinese medicinal capsule for the treatment of weakness of the spleen and stomach and method of quality control thereof, adopt Radix Pseudostellariae, Pericarpium Citri Reticulatae, Rhizoma Dioscoreae, Fructus Hordei Germinatus and Fructus Crataegi to carry out can be used for the preparation of the Chinese medicinal capsule for the treatment of weakness of the spleen and stomach by a kind of economical and practical, scientific and reasonable preparation method, adopt following set-up mode: this Chinese medicinal capsule makes by the following method:
Radix Pseudostellariae 240 ~ 270 weight portion Pericarpium Citri Reticulatae 24 ~ 27 weight portion Rhizoma Dioscoreae 180 ~ 200 weight portion
Fructus Hordei Germinatus 180 ~ 200 weight portion Fructus Crataegi 120 ~ 130 weight portion
The above five tastes, Radix Pseudostellariae and the Rhizoma Dioscoreae powder of getting half weight are broken into 18 ~ 30 order impalpable powders, sieve, mixing, for subsequent use; Remaining Radix Pseudostellariae and Pericarpium Citri Reticulatae, Fructus Hordei Germinatus, Fructus Crataegi decoct with water 1-3 time, each 1.5-2.5 hour, collecting decoction, and filter, filtrate concentrate under reduced pressure at low temperature is to paste, add above-mentioned fine powder, mixing, makes granule, dry, add right amount of auxiliary materials, mixing, incapsulates, to obtain final product.
Embodiment 2:
The present embodiment is at the enterprising one-step optimization in the basis of above-described embodiment, further described to better implement the present invention preparation method, and this Chinese medicinal capsule makes by the following method:
Radix Pseudostellariae 252 weight portion Pericarpium Citri Reticulatae 24 weight portion Rhizoma Dioscoreae 184 weight portion
Fructus Hordei Germinatus 182 weight portion Fructus Crataegi 124 weight portion
The above five tastes, Radix Pseudostellariae and the Rhizoma Dioscoreae powder of getting 176 weight portions are broken into 18 ~ 30 order impalpable powders, sieve, mixing, for subsequent use; Remaining Radix Pseudostellariae and Pericarpium Citri Reticulatae, Fructus Hordei Germinatus, Fructus Crataegi decoct with water 2 times, each 2.5 hours, collecting decoction, and filter, filtrate concentrate under reduced pressure at low temperature, to paste, adds above-mentioned fine powder, and mixing, makes granule, dry, add right amount of auxiliary materials, and mixing, incapsulates, to obtain final product.
Embodiment 3:
The method of quality control of the Chinese medicinal capsule for the treatment of weakness of the spleen and stomach, the quality of scientific and reasonable method of quality control to the Chinese medicinal capsule of prepared treatment weakness of the spleen and stomach can be adopted to control effectively, the following set-up mode of special employing: this method of quality control contains one or more in following discrimination method:
A. get Chinese medicinal capsule thing, put basis of microscopic observation: needle-like calcium oxalate crystal bundle is present in myxocyte or is dispersed in, long 120 ~ 200 μm, needle diameter 3 ~ 4 μm; Calcium oxalate cluster crystal is present in parenchyma cell;
B. get Chinese medicinal capsule content 2g, add methanol 18ml, supersound process 12 minutes, filter, filtrate is concentrated into 1ml, as need testing solution; Separately get Radix Pseudostellariae control medicinal material 1g, be made in the same way of control medicinal material solution; Test according to thin layer chromatography, draw each 2 μ l of above-mentioned two kinds of solution, put respectively in same with sodium carboxymethyl cellulose be adhesive silica gel g thin-layer plate on, water-glacial acetic acid-n-butyl alcohol with 1: 1:5, for developing solvent, is put with in the developing solvent presaturation expansion cylinder of 16 minutes, is launched, take out, dry, spray with 0.22% ethanol solution of ninhydrin, be heated to spot development at 102 DEG C clear; In test sample chromatograph, on the position corresponding to control medicinal material chromatograph, the speckle of aobvious same color;
C. get Pericarpium Citri Reticulatae control medicinal material 0.2g, make control medicinal material solution by the need testing solution preparation method under B item; Get Hesperidin reference substance again, add methanol and make saturated solution, in contrast product solution; Test according to thin layer chromatography, draw the need testing solution under B item and each 5 μ l of above-mentioned two kinds of solution, put respectively in same take sodium carboxymethyl cellulose as the silica gel g thin-layer plate of adhesive, methanol-acetic acid ethyl ester-water with 4: 38: 6 is for developing solvent, launch, take out, dry, spray is with aluminum chloride test solution, and putting wavelength is inspect under 360nm ultra-violet lamp; In test sample chromatograph, on the position corresponding to control medicinal material chromatograph and reference substance chromatograph, the fluorescence speckle of aobvious same color;
Wherein, this Chinese medicinal capsule makes by the following method:
Radix Pseudostellariae 240 ~ 270 weight portion Pericarpium Citri Reticulatae 24 ~ 27 weight portion Rhizoma Dioscoreae 180 ~ 200 weight portion
Fructus Hordei Germinatus 180 ~ 200 weight portion Fructus Crataegi 120 ~ 130 weight portion
The above five tastes, Radix Pseudostellariae and the Rhizoma Dioscoreae powder of getting half weight are broken into 18 ~ 30 order impalpable powders, sieve, mixing, for subsequent use; Remaining Radix Pseudostellariae and Pericarpium Citri Reticulatae, Fructus Hordei Germinatus, Fructus Crataegi decoct with water 1-3 time, each 1.5-2.5 hour, collecting decoction, and filter, filtrate concentrate under reduced pressure at low temperature is to paste, add above-mentioned fine powder, mixing, makes granule, dry, add right amount of auxiliary materials, mixing, incapsulates, to obtain final product.
Embodiment 4:
The present embodiment is at the enterprising one-step optimization in the basis of above-described embodiment, the method for quality control of the Chinese medicinal capsule of further described to better implement the present invention treatment weakness of the spleen and stomach, and the method is also containing, for example lower content assaying method:
Get Chinese medicinal capsule content, porphyrize, get 1g, weighed, put in apparatus,Soxhlet's, add methanol and make dissolving in right amount, reflux 4.5 ~ 5.5 hours in water-bath, extracting solution reclaims methanol to dry, and the residue 8ml that adds water makes dissolving, with water saturated n-butanol extraction 5 times, each 8ml, merge n-butanol extracting liquid, the 12ml that adds water washs, n-butyl alcohol liquid evaporate to dryness, residue adds methanol makes dissolving in right amount, is quantitatively transferred in 5ml measuring bottle, and be diluted to scale, shake up, as need testing solution; Separately get Hesperidin reference substance, weighed, add methanol and make the solution of every 1ml containing 0.2mg, product solution in contrast; Test according to thin layer chromatography, draw need testing solution 4 μ l, reference substance solution 2 μ l and 4 μ l, respectively cross point in same with sodium carboxymethyl cellulose be adhesive silica gel g thin-layer plate on, the methanol-acetic acid ethyl ester-water with 4: 38: 6, for developing solvent, launches, take out, dry, scan according to thin layer chromatography, wavelength: λ
s=281nm, λ
r=378nm, measures test sample trap integrated value and reference substance trap integrated value, calculates, to obtain final product;
Chinese medicinal capsule every in Hesperidin, must not be less than 0.42 ~ 0.48mg containing Pericarpium Citri Reticulatae.
The above is only preferred embodiment of the present invention, and not do any pro forma restriction to the present invention, every any simple modification, equivalent variations done above embodiment according to technical spirit of the present invention, all falls within protection scope of the present invention.
Claims (4)
1. treat the preparation method of the Chinese medicinal capsule of weakness of the spleen and stomach, it is characterized in that: this Chinese medicinal capsule makes by the following method:
Radix Pseudostellariae 240 ~ 270 weight portion Pericarpium Citri Reticulatae 24 ~ 27 weight portion Rhizoma Dioscoreae 180 ~ 200 weight portion
Fructus Hordei Germinatus 180 ~ 200 weight portion Fructus Crataegi 120 ~ 130 weight portion
The above five tastes, Radix Pseudostellariae and the Rhizoma Dioscoreae powder of getting half weight are broken into 18 ~ 30 order impalpable powders, sieve, mixing, for subsequent use; Remaining Radix Pseudostellariae and Pericarpium Citri Reticulatae, Fructus Hordei Germinatus, Fructus Crataegi decoct with water 1-3 time, each 1.5-2.5 hour, collecting decoction, and filter, filtrate concentrate under reduced pressure at low temperature is to paste, add above-mentioned fine powder, mixing, makes granule, dry, add right amount of auxiliary materials, mixing, incapsulates, to obtain final product.
2. the preparation method of the Chinese medicinal capsule for the treatment of weakness of the spleen and stomach according to claim 1, is characterized in that: this Chinese medicinal capsule makes by the following method:
Radix Pseudostellariae 252 weight portion Pericarpium Citri Reticulatae 24 weight portion Rhizoma Dioscoreae 184 weight portion
Fructus Hordei Germinatus 182 weight portion Fructus Crataegi 124 weight portion
The above five tastes, Radix Pseudostellariae and the Rhizoma Dioscoreae powder of getting 176 weight portions are broken into 18 ~ 30 order impalpable powders, sieve, mixing, for subsequent use; Remaining Radix Pseudostellariae and Pericarpium Citri Reticulatae, Fructus Hordei Germinatus, Fructus Crataegi decoct with water 2 times, each 2.5 hours, collecting decoction, and filter, filtrate concentrate under reduced pressure at low temperature, to paste, adds above-mentioned fine powder, and mixing, makes granule, dry, add right amount of auxiliary materials, and mixing, incapsulates, to obtain final product.
3. treat the method for quality control of the Chinese medicinal capsule of weakness of the spleen and stomach, it is characterized in that: this method of quality control contains one or more in following discrimination method:
A. get Chinese medicinal capsule thing, put basis of microscopic observation: needle-like calcium oxalate crystal bundle is present in myxocyte or is dispersed in, long 120 ~ 200 μm, needle diameter 3 ~ 4 μm; Calcium oxalate cluster crystal is present in parenchyma cell;
B. get Chinese medicinal capsule content 2g, add methanol 18ml, supersound process 12 minutes, filter, filtrate is concentrated into 1ml, as need testing solution; Separately get Radix Pseudostellariae control medicinal material 1g, be made in the same way of control medicinal material solution; Test according to thin layer chromatography, draw each 2 μ l of above-mentioned two kinds of solution, put respectively in same with sodium carboxymethyl cellulose be adhesive silica gel g thin-layer plate on, water-glacial acetic acid-n-butyl alcohol with 1: 1:5, for developing solvent, is put with in the developing solvent presaturation expansion cylinder of 16 minutes, is launched, take out, dry, spray with 0.22% ethanol solution of ninhydrin, be heated to spot development at 102 DEG C clear; In test sample chromatograph, on the position corresponding to control medicinal material chromatograph, the speckle of aobvious same color;
C. get Pericarpium Citri Reticulatae control medicinal material 0.2g, make control medicinal material solution by the need testing solution preparation method under B item; Get Hesperidin reference substance again, add methanol and make saturated solution, in contrast product solution; Test according to thin layer chromatography, draw the need testing solution under B item and each 5 μ l of above-mentioned two kinds of solution, put respectively in same take sodium carboxymethyl cellulose as the silica gel g thin-layer plate of adhesive, methanol-acetic acid ethyl ester-water with 4: 38: 6 is for developing solvent, launch, take out, dry, spray is with aluminum chloride test solution, and putting wavelength is inspect under 360nm ultra-violet lamp; In test sample chromatograph, on the position corresponding to control medicinal material chromatograph and reference substance chromatograph, the fluorescence speckle of aobvious same color;
Wherein, this Chinese medicinal capsule makes by the following method:
Radix Pseudostellariae 240 ~ 270 weight portion Pericarpium Citri Reticulatae 24 ~ 27 weight portion Rhizoma Dioscoreae 180 ~ 200 weight portion
Fructus Hordei Germinatus 180 ~ 200 weight portion Fructus Crataegi 120 ~ 130 weight portion
The above five tastes, Radix Pseudostellariae and the Rhizoma Dioscoreae powder of getting half weight are broken into 18 ~ 30 order impalpable powders, sieve, mixing, for subsequent use; Remaining Radix Pseudostellariae and Pericarpium Citri Reticulatae, Fructus Hordei Germinatus, Fructus Crataegi decoct with water 1-3 time, each 1.5-2.5 hour, collecting decoction, and filter, filtrate concentrate under reduced pressure at low temperature is to paste, add above-mentioned fine powder, mixing, makes granule, dry, add right amount of auxiliary materials, mixing, incapsulates, to obtain final product.
4. the method for quality control of the Chinese medicinal capsule for the treatment of weakness of the spleen and stomach according to claim 3, is characterized in that: the method is also containing, for example lower content assaying method:
Get Chinese medicinal capsule content, porphyrize, get 1g, weighed, put in apparatus,Soxhlet's, add methanol and make dissolving in right amount, reflux 4.5 ~ 5.5 hours in water-bath, extracting solution reclaims methanol to dry, and the residue 8ml that adds water makes dissolving, with water saturated n-butanol extraction 5 times, each 8ml, merge n-butanol extracting liquid, the 12ml that adds water washs, n-butyl alcohol liquid evaporate to dryness, residue adds methanol makes dissolving in right amount, is quantitatively transferred in 5ml measuring bottle, and be diluted to scale, shake up, as need testing solution; Separately get Hesperidin reference substance, weighed, add methanol and make the solution of every 1ml containing 0.2mg, product solution in contrast; Test according to thin layer chromatography, draw need testing solution 4 μ l, reference substance solution 2 μ l and 4 μ l, respectively cross point in same with sodium carboxymethyl cellulose be adhesive silica gel g thin-layer plate on, the methanol-acetic acid ethyl ester-water with 4: 38: 6, for developing solvent, launches, take out, dry, scan according to thin layer chromatography, wavelength: λ
s=281nm, λ
r=378nm, measures test sample trap integrated value and reference substance trap integrated value, calculates, to obtain final product;
Chinese medicinal capsule every in Hesperidin, must not be less than 0.42 ~ 0.48mg containing Pericarpium Citri Reticulatae.
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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CN105833240A (en) * | 2016-06-16 | 2016-08-10 | 亳州市永刚饮片厂有限公司 | Micro-fermented rhizoma dioscoreae decoction piece with functions of invigorating stomach, beautifying and moistening lung and preparation method of micro-fermented rhizoma dioscoreae decoction piece |
CN108287211A (en) * | 2018-01-25 | 2018-07-17 | 贵州广济堂药业有限公司 | A kind of quality determining method of radix pseudostellariae broken wall medicine materical crude slice |
CN109432373A (en) * | 2018-12-20 | 2019-03-08 | 韦德举 | A kind of hawthorn malt drinks and preparation method thereof adjusting taste |
CN110596105A (en) * | 2019-09-18 | 2019-12-20 | 贵州医科大学 | Quality standard detection method of wheat malt medicinal material |
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2016
- 2016-01-29 CN CN201610062625.XA patent/CN105521363A/en not_active Withdrawn
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105833240A (en) * | 2016-06-16 | 2016-08-10 | 亳州市永刚饮片厂有限公司 | Micro-fermented rhizoma dioscoreae decoction piece with functions of invigorating stomach, beautifying and moistening lung and preparation method of micro-fermented rhizoma dioscoreae decoction piece |
CN108287211A (en) * | 2018-01-25 | 2018-07-17 | 贵州广济堂药业有限公司 | A kind of quality determining method of radix pseudostellariae broken wall medicine materical crude slice |
CN109432373A (en) * | 2018-12-20 | 2019-03-08 | 韦德举 | A kind of hawthorn malt drinks and preparation method thereof adjusting taste |
CN110596105A (en) * | 2019-09-18 | 2019-12-20 | 贵州医科大学 | Quality standard detection method of wheat malt medicinal material |
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