CN105548454A - Quality detecting method of traditional Chinese medicine preparation for helping digestion of children - Google Patents
Quality detecting method of traditional Chinese medicine preparation for helping digestion of children Download PDFInfo
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- CN105548454A CN105548454A CN201610112717.4A CN201610112717A CN105548454A CN 105548454 A CN105548454 A CN 105548454A CN 201610112717 A CN201610112717 A CN 201610112717A CN 105548454 A CN105548454 A CN 105548454A
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/90—Plate chromatography, e.g. thin layer or paper chromatography
Abstract
The invention relates to a quality detecting method of a traditional Chinese medicine preparation for helping digestion of children. Effective components of the traditional Chinese medicine preparation for helping digestion of the children are mainly prepared from raw materials in parts by weight as follows: 9-11 parts of hawthorn fruits, 9-11 parts of malt, 9-11 parts of medicated leaven, 9-11 parts of Chinese rhubarb, 19-21 parts of semen pharbitidis, 9-11 parts of areca seeds, 4-6 parts of curcuma zedoary and 4-6 parts of common burreed rhizomes. According to the quality detection method, the hawthorn fruits, the curcuma zedoary and the common burreed rhizomes are detected through thin-layer chromatography; the hawthorn fruits, the curcuma zedoary and the common burreed rhizomes in a prescription are subjected to thin-layer identification effectively through reasonable control on detection conditions, monarch drugs and ministerial drugs in the prescription can be further identified on the basis of a current standard, the quality standard of the traditional Chinese medicine preparation for helping digestion of the children is enhanced and perfected, further, the method is simple and convenient to operate, high in sensitivity and good in stability, product quality of the traditional Chinese medicine preparation for helping the digestion of the children in a production process can be effectively controlled, and the curative effect of a product is guaranteed.
Description
Technical field
The present invention relates to the quality testing of Chinese medicine preparation, particularly relate to the quality determining method of children's's helping digestion Chinese medicine preparation.
Background technology
The prescription of children's's helping digestion oral liquid is made up of hawthorn (stir-bake to brown), Fructus Hordei Germinatus (stir-fry), Medicated Leaven (stir-bake to brown), rheum officinale, kaladana's (stir-fry), betel nut (stir-bake to brown), curcuma zedoary (vinegar system), Rhizoma Sparganii (bran stir-fry) eight taste medicinal materials.Cure mainly relieving dyspepsia, purging intense heat defaecation.Stop eating for infantile stomach heat, abdominal fullness and distention, n and V, agitation, thirsty, be hard and dry.
In children's's helping digestion oral liquid, the source of hawthorn is the dry mature fruit of rosaceous plant large-fruited Chinese hawthorn CrataeguspinnatifidaBge.var.majorN.E.Br. or hawthorn CrataeguspinnatifidaBge.; The source of curcuma zedoary is the dry rhizome of zingiberaceous plant zedoary CurcumaphaeocaulisVal., Guangxi zedoary CurcumaKwangsiensisS.G.LeeetC.F.Liang or RADIX CURCUMAE CurcumawenyujinY.H.ChenetC.Ling; The source of Rhizoma Sparganii is the dry tuber of Sparganiaceae plant rhizoma scirpi SparganiumstoloniferumBuch.-Ham..Get in side hawthorn digesting appetizing, promoting blood circulation and removing blood stasis, arrogate to oneself the meat dyspepsia that disappears, Divine Comedy function strengthening the spleen and stomach, help digestion in adjusting, can energy dissipating mend, the effect that tool is treated both principal and secondary aspect of disease, Fructus Hordei Germinatus reinforcing spleen to promote digestion, arrogate to oneself the rice and flour dyspepsia that disappears, charred FRUCTUS CRATAEGI, Divine Comedy, Fructus Hordei Germinatus, be collectively referred to as Charred Triplet for monarch, can change all carnivorous rice and flour and stagnate, making stomach Qi, logical to fall behavior suitable, to dredge stomach internal organs; Diet internal injury blocks in stomach internal organs, and stomach arteries and veins is obstructed, then functional activity of QI being not smooth, thus with promoting the circulation of qi disappear long-pending Rhizoma Sparganii, curcuma zedoary mutual reinforcement between for, be ministerial drug altogether, make mechanism of qi transporting unobstructed, in medicine, sick institute, often gets good effect; Rheum officinale attack long-pending to expel the heat-evil, the stasis of blood of dispelling removing toxic substances, the heresy of letting out diet goes out from stool; Kaladana, betel nut Li Shui go stagnant by drink, laxation, and lead fire-evil and go out from urine, three medicines are adjutant altogether, separate constipation and anuresis, and make evil all over the body amassing for two just, heresy has outlet, then accumulated heat is from removing.
This prescription in clinical practice for many years, its curative effect is indubitable, but for the Chinese medicine preparation quality control of children's's helping digestion oral liquid, existing national standards has only carried out TLC distinguish to rheum officinale, kaladana, betel nut three taste medicinal material, and for as the monarch drug in a prescription hawthorn in prescription, ministerial drug curcuma zedoary and Rhizoma Sparganii, but controlled without any quality standard.In addition, for the compound preparation be made up of eight taste medicines, only wherein three taste adjutant medicinal materials are detected, larger gap is still had relative to the requirement of current tcm product quality control, can not the quality of fully effective control children's helping digestion oral liquid, thus production and sales and the quality assurance of product can be affected.
Summary of the invention
Based on this, be necessary the quality determining method that a kind of children's's helping digestion Chinese medicine preparation is provided.
A kind of quality determining method of children's's helping digestion Chinese medicine preparation, the effective constituent of described children's's helping digestion Chinese medicine preparation is prepared from primarily of the raw material of following weight portion: hawthorn 9-11 part, Fructus Hordei Germinatus 9-11 part, Medicated Leaven 9-11 part, rheum officinale 9-11 part, kaladana 19-21 part, betel nut 9-11 part, curcuma zedoary 4-6 part, Rhizoma Sparganii 4-6 part, and described quality determining method adopts thin-layered chromatography to detect described hawthorn, curcuma zedoary and Rhizoma Sparganii.
Wherein in an embodiment, the detection method of described hawthorn comprises the steps:
(1) get described children's's helping digestion Chinese medicine preparation, add evaporate to dryness extract after extraction into ethyl acetate, residue solubilizer dissolves, and obtains need testing solution;
(2) get large-fruited Chinese hawthorn control medicinal material or hawthorn control medicinal material, after the refluxing extraction that adds water, extract adds extraction into ethyl acetate, and after gained extract evaporate to dryness, residue solubilizer dissolves, and obtains control medicinal material solution;
(3) described control medicinal material solution and need testing solution is drawn respectively, point is on same silica gel g thin-layer plate, with the mixed liquor of cyclohexane, methenyl choloride and ethyl acetate for developping agent launches, take out after expansion, dry, spray is with ethanol solution of sulfuric acid, heat this silica gel g thin-layer plate clear to spot development, inspect.
Wherein in an embodiment, step (3) described developping agent is volume ratio is 3 ~ 5:0.5 ~ 3:1 ~ 4 cyclohexane, methenyl choloride and ethyl acetate; Step (1) and (2) described solvent are methyl alcohol.
Wherein in an embodiment, the detection method of described curcuma zedoary comprises the steps:
(1) get described children's's helping digestion Chinese medicine preparation, add evaporate to dryness extract after the petroleum ether extraction of boiling range 60-90 DEG C, residue solubilizer dissolves, and obtains need testing solution;
(2) get RADIX CURCUMAE control medicinal material or zedoary control medicinal material, after the refluxing extraction that adds water, extract adds the petroleum ether extraction of boiling range 60-90 DEG C, and after gained extract evaporate to dryness, residue solubilizer dissolves, and obtains control medicinal material solution;
(3) described control medicinal material solution and need testing solution is drawn respectively, point is on same silica gel g thin-layer plate, with the mixed liquor of sherwood oil and ethyl acetate for developping agent launches, take out after expansion, dry, spray is with ethanol solution of sulfuric acid, heat this silica gel g thin-layer plate clear to spot development, inspect.
Wherein in an embodiment, sherwood oil and the ethyl acetate of step (3) described developping agent to be volume ratio be boiling range 60-90 DEG C of 1 ~ 5:0.1 ~ 3; Step (1) and (2) described solvent are ethyl acetate.
Wherein in an embodiment, described in add water time of refluxing extraction be 1 ~ 5 hour, the volumetric concentration of described sulfuric acid ethanol is 8 ~ 12%.
Wherein in an embodiment, the detection method of described Rhizoma Sparganii comprises the steps:
(1) get described children's's helping digestion Chinese medicine preparation, add evaporate to dryness extract after the petroleum ether extraction of boiling range 60-90 DEG C, residue solubilizer dissolves, and obtains need testing solution;
(2) get Rhizoma Sparganii control medicinal material, add evaporate to dryness extract after the ultrasonic extraction of sherwood oil of boiling range 60-90 DEG C, residue solubilizer dissolves, and obtains control medicinal material solution;
(3) draw described control medicinal material solution and need testing solution respectively, put on same silica gel g thin-layer plate, launch for developping agent with the mixed liquor of cyclohexane, ethyl acetate and formic acid, take out after expansion, dry, inspect under putting uviol lamp 365nm.
Wherein in an embodiment, the cyclohexane of step (3) described developping agent to be volume ratio be 15 ~ 30:1 ~ 10:0.1 ~ 1, ethyl acetate and formic acid.
Wherein in an embodiment, step (2) described ultrasonic extraction time is 0.5 ~ 2 hour; Step (1) and (2) described solvent are ethyl acetate.
Wherein in an embodiment, described quality determining method also comprises employing thin-layered chromatography and detects described rheum officinale, kaladana and betel nut.
Compared with prior art, the present invention has following beneficial effect:
The quality determining method of children's's helping digestion Chinese medicine preparation of the present invention, by conservative control testing conditions, effectively TLC distinguish is carried out to the hawthorn in prescription, curcuma zedoary and Rhizoma Sparganii, can on the basis of act.std, further monarch drug in a prescription in prescription and ministerial drug are differentiated, improve, the perfect quality standard of children's's helping digestion Chinese medicine preparation, and the method is easy and simple to handle, highly sensitive, good stability, effectively can control the product quality in children's's helping digestion Chinese medicine preparation production run, ensure product curative effect.
Accompanying drawing explanation
Fig. 1 is the indentification by TLC figure of hawthorn in embodiment children's helping digestion oral liquid;
Fig. 2 is indentification by TLC figure (the Qingdao plate: Qingdao silica G plate of hawthorn under different thin layer plate condition; Yantai plate: Yantai silica G plate, Merck plate: Merck KGaA silica G plate, from making sheet: self-control G plate);
Fig. 3 is indentification by TLC figure (normal temperature: 21.5 DEG C, the low temperature: 4.0 DEG C of hawthorn under normal temperature and low temperature environment; Humidity: 52%);
Fig. 4 is the indentification by TLC figure (humidity: 32%, 72%, 88% of hawthorn under different humidity environment; Temperature: 21.5 DEG C);
Fig. 5 is the indentification by TLC figure of curcuma zedoary in embodiment children's helping digestion oral liquid;
Fig. 6 is indentification by TLC figure (the Qingdao plate: Qingdao silica G plate of curcuma zedoary under different thin layer plate condition; Yantai plate: Yantai silica G plate, Merck plate: Merck KGaA silica G plate, from making sheet: self-control G plate);
Fig. 7 is indentification by TLC figure (normal temperature: 22.0 DEG C, the low temperature: 5.0 DEG C of curcuma zedoary under normal temperature and low temperature environment; Humidity: 42%);
Fig. 8 is the TLC distinguish figure (humidity: 32%, 72%, 88% of curcuma zedoary under different humidity environment; Temperature: 22.0 DEG C);
Fig. 9 is the indentification by TLC figure of Rhizoma Sparganii in embodiment children's helping digestion oral liquid;
Figure 10 is TLC distinguish figure (the Qingdao plate: Qingdao silica G plate of Rhizoma Sparganii under different thin layer plate condition; Yantai plate: Yantai silica G plate, Merck plate: Merck KGaA silica G plate, from making sheet: self-control G plate);
Figure 11 is TLC distinguish figure (normal temperature: 21.5 DEG C, the low temperature: 5.0 DEG C of Rhizoma Sparganii under normal temperature and low temperature environment; Humidity: 47%);
Figure 12 is the TLC distinguish figure (humidity: 32%, 72%, 88% of Rhizoma Sparganii under different humidity environment; Temperature: 23.0 DEG C).
Embodiment
Be described in further detail below in conjunction with the quality determining method of specific embodiment to children's's helping digestion Chinese medicine preparation of the present invention.
The medicine that the present invention adopts and reagent:
Large-fruited Chinese hawthorn control medicinal material (National Institute for Food and Drugs Control 121138-201206); Hawthorn control medicinal material (National Institute for Food and Drugs Control 121626-201402); RADIX CURCUMAE control medicinal material (National Institute for Food and Drugs Control 121304-201303); Zedoary control medicinal material (National Institute for Food and Drugs Control 120973-201304); Rhizoma Sparganii control medicinal material (Rui Fensi bio tech ltd, Chengdu DZYC-S001).
Silica gel g thin-layer plate is (commercially available: Haiyang Chemical Plant, Qingdao, Yantai chemical industry research institute silver imperial board, Merck KGaA board; Self-control: silica G produces (for thin-layer chromatography) by Haiyang Chemical Plant, Qingdao, thickness 500 μm, and bonding agent is 0.5% sodium carboxymethyl cellulose); It is pure that other reagent are analysis.
Children's's helping digestion oral liquid is produced by Guangzhou Xiang Xue Pharmacy stock Co., Ltd, and lot number is 201409003,201409004,201409011; This children's's helping digestion oral liquid method for making following (method for making of each negative sample is identical with this children's's helping digestion oral liquid):
[prescription] charred FRUCTUS CRATAEGI: 10g, Medicated Leaven (stir-bake to brown): 10g, coloured malt: 10g, charred SEMEN ARECAE: 10g, Rhizoma Sparganii (bran stir-fry): 5g, rheum officinale: 10g, stir-baked RHIIZOMA CURCUMAE with vinegar: 5g, stir-baked SEMEN PHARBITIDIS: 20g.
Eight tastes more than [method for making], boiling three times, 2 hours first times, second and third time is each 1 hour, collecting decoction, filter, filtrate is concentrated into relative density 1.01 ~ 1.05 (60 DEG C), lets cool, add water to about 700mL, leave standstill 24 hours, centrifugal, add refined honey 300g and Sodium Benzoate 0.8g (add suitable quantity of water to boil, filter), stir evenly, leave standstill, filter, add water and make 1000mL, embedding, sterilizing, to obtain final product.
Embodiment
The present embodiment is the quality determining method of above-mentioned children's's helping digestion oral liquid, the detection method of rheum officinale in this children's's helping digestion oral liquid, kaladana and betel nut is carried out according to existing national standards 2015 editions " Chinese Pharmacopoeias ", and the detection of hawthorn, curcuma zedoary and Rhizoma Sparganii comprises the steps:
(1) hawthorn is differentiated, concrete grammar is as follows:
1, the preparation of need testing solution: the children's's helping digestion oral liquid 50mL getting lot number 201409004, with ethyl acetate shaking out 2 times (50mL/ time), each acetic acid ethyl acetate extract is respectively with water 50mL washing, discard water liquid, evaporate to dryness extract, residue adds methyl alcohol 0.5 ~ 2mL makes it dissolve, as need testing solution;
2, the preparation of control medicinal material solution: get large-fruited Chinese hawthorn control medicinal material or hawthorn control medicinal material 0.5 ~ 4g, add purified water 100mL, heating and refluxing extraction is after 4 hours, extracting liquid filtering, be concentrated into 50-60mL, with ethyl acetate shaking out 2 times (50mL/ time), evaporate to dryness extract, residue adds methyl alcohol 0.5 ~ 2mL makes it dissolve, medicinal material solution in contrast;
3, the preparation of negative control solution: the negative sample 50mL getting scarce hawthorn, is made in the same way of negative control solution by step 1;
4, thin-layer chromatography: according to 2015 editions " Chinese Pharmacopoeias " four general rule 0502 thin-layered chromatography tests, draw control medicinal material solution, need testing solution and negative control solution, put respectively on same silica gel g thin-layer plate, point sample volume is 2 ~ 20 μ L, be that the mixed liquor of the cyclohexane-methenyl choloride-ethyl acetate of 3 ~ 5:0.5 ~ 3:1 ~ 4 launches for developping agent with volume ratio, take out after expansion, dry, spray is 8 ~ 12% ethanol solution of sulfuric acid with volumetric concentration, heating blankets plate is clear to spot development, inspects under putting daylight lamp.
As shown in Figure 1, large-fruited Chinese hawthorn control medicinal material, hawthorn control medicinal material, lot number 201409004 test sample, hawthorn negative control solution is from left to right followed successively by, in test sample chromatogram, on the position corresponding to control medicinal material chromatogram in figure, the spot of aobvious same color, and negative control solution immaculate.
In hawthorn discriminating, the experiment of thin-layer chromatography durability is investigated:
(1) different thin layer plate condition is investigated:
Investigated the panel effect under Qingdao silica G plate, Yantai silica G plate, Merck KGaA silica G plate, self-control G slat element, result as shown in Figure 2, all can observe the hawthorn unique point in each sample solution clearly by each thin layer plate;
(2) normal temperature and cryogenic conditions is investigated:
Investigated the panel effect under normal temperature and cryogenic conditions, result as shown in Figure 3, all can be observed the hawthorn unique point in each sample solution under normal temperature and cryogenic conditions clearly;
(3) different humidity condition is investigated:
Investigated the panel effect under 32%, 72%, 88% damp condition, result as shown in Figure 4, all can be observed the hawthorn unique point in each sample solution under each damp condition clearly;
(4) the Rf value under each investigation condition is as shown in table 1.
Table 1
| Qingdao plate | Yantai plate | Merck plate | From making sheet | Normal temperature |
| 0.256 | 0.240 | 0.308 | 0.304 | 0.256 |
| Low temperature | 32% humidity | 72% humidity | 88% humidity | |
| 0.225 | 0.249 | 0.256 | 0.250 |
(2) curcuma zedoary is differentiated, concrete grammar is as follows:
1, the preparation of need testing solution: the children's's helping digestion oral liquid 100mL getting lot number 201409003, with the sherwood oil shaking out 2 times (100mL/ time) of boiling range 60-90 DEG C, each petroleum ether extraction liquid is respectively with water 100mL washing, discard water liquid, evaporate to dryness extract, residue adds ethyl acetate 0.5 ~ 2mL makes it dissolve, as need testing solution;
2, the preparation of control medicinal material solution: get RADIX CURCUMAE control medicinal material or zedoary control medicinal material 0.5 ~ 4g, add purified water 50mL, heating and refluxing extraction is after 1 hour, extracting liquid filtering, with the sherwood oil shaking out 2 times (50mL/ time) of boiling range 60-90 DEG C, each petroleum ether extraction liquid is respectively with water 50mL washing, discard water liquid, evaporate to dryness extract, residue adds ethyl acetate 0.5 ~ 2mL makes it dissolve, medicinal material solution in contrast;
3, the preparation of negative control solution: the negative sample 100mL getting scarce curcuma zedoary, is made in the same way of negative control solution by step 1;
4, thin-layer chromatography: according to 2015 editions " Chinese Pharmacopoeias " four general rule 0502 thin-layered chromatography tests, draw control medicinal material solution, need testing solution and negative control solution, point sample is on same silica gel g thin-layer plate respectively, point sample volume is 2 ~ 20 μ L, be that the mixed liquor of the petroleum ether-ethyl acetate of boiling range 60-90 DEG C of 1 ~ 5:0.1 ~ 3 is for developping agent with volume ratio, take out after expansion, dry, spray is 8 ~ 12% ethanol solution of sulfuric acid with volumetric concentration, heating blankets plate is clear to spot development, inspects under putting daylight lamp.
As shown in Figure 5, RADIX CURCUMAE control medicinal material, zedoary control medicinal material, lot number 201409003 test sample, curcuma zedoary negative control solution is from left to right followed successively by, in test sample chromatogram, on the position corresponding to control medicinal material chromatogram in figure, the spot of aobvious same color, and negative control solution immaculate.
In curcuma zedoary discriminating, the experiment of thin-layer chromatography durability is investigated:
(1) different thin layer plate condition is investigated:
Investigated the panel effect under Qingdao silica G plate, Yantai silica G plate, Merck KGaA silica G plate, self-control G slat element, result as shown in Figure 6, all can observe the curcuma zedoary unique point in each sample solution comparatively clearly by each thin layer plate;
(2) normal temperature and cryogenic conditions is investigated:
Investigated the panel effect under normal temperature and cryogenic conditions, result as shown in Figure 7, all can be observed the curcuma zedoary unique point in each sample solution under normal temperature and cryogenic conditions clearly;
(3) different humidity condition is investigated:
Investigated the panel effect under 32%, 72%, 88% damp condition, result as shown in Figure 8, all can be observed the curcuma zedoary unique point in each sample solution under each damp condition clearly;
(4) the Rf value under each investigation condition is as shown in table 2.
Table 2
| Qingdao plate | Yantai plate | Merck plate | From making sheet | Normal temperature |
| 0.344 | 0.335 | 0.370 | 0.385 | 0.344 |
| Low temperature | 32% humidity | 72% humidity | 88% humidity | |
| 0.276 | 0.250 | 0.331 | 0.337 |
(3) Rhizoma Sparganii is differentiated, concrete grammar is as follows:
1, the preparation of need testing solution: the children's's helping digestion oral liquid 100mL getting lot number 201409011, with the sherwood oil shaking out 2 times (100mL/ time) of boiling range 60-90 DEG C, each petroleum ether extraction liquid is respectively with water 100mL washing, discard water liquid, evaporate to dryness extract, residue adds ethyl acetate 0.5 ~ 2mL makes it dissolve, as need testing solution;
2, the preparation of control medicinal material solution: get Rhizoma Sparganii control medicinal material 0.5 ~ 4g, adds the sherwood oil 50mL of boiling range 60-90 DEG C, and ultrasonic extraction is after 1 hour, Filter paper filtering, evaporate to dryness filtrate, and residue adds ethyl acetate 0.5 ~ 2mL makes it dissolve, medicinal material solution in contrast;
3, the preparation of negative control solution: the negative sample 100mL getting scarce Rhizoma Sparganii, is made in the same way of negative control solution by step 1;
4, thin-layer chromatography: according to 2015 editions " Chinese Pharmacopoeias " four general rule 0502 thin-layered chromatography tests, draw control medicinal material solution, need testing solution and negative control solution, point sample is on same silica gel g thin-layer plate respectively, point sample volume is 2 ~ 20 μ L, be that the mixed liquor of the cyclohexane-ethyl acetate-formic acid of 15 ~ 30:1 ~ 10:0.1 ~ 1 is for developping agent with volume ratio, take out after expansion, dry, inspect under putting uviol lamp 365nm.
As shown in Figure 9, Rhizoma Sparganii control medicinal material, lot number 201409011 test sample, Rhizoma Sparganii negative control solution is from left to right followed successively by, in test sample chromatogram, on the position corresponding to control medicinal material chromatogram in figure, the fluorescence spot of aobvious same color, and negative control solution immaculate.
In Rhizoma Sparganii discriminating, the experiment of thin-layer chromatography durability is investigated:
(1) different thin layer plate condition is investigated:
Investigated the panel effect under Qingdao silica G plate, Yantai silica G plate, Merck KGaA silica G plate, self-control G slat element, result as shown in Figure 10, all can observe the Rhizoma Sparganii unique point in each sample solution clearly by each thin layer plate;
(2) normal temperature and cryogenic conditions is investigated:
Investigated the panel effect under normal temperature and cryogenic conditions, result as shown in figure 11, all can be observed the Rhizoma Sparganii unique point in each sample solution under normal temperature and cryogenic conditions clearly;
(3) different humidity condition is investigated:
Investigated the panel effect under 32%, 72%, 88% damp condition, result as shown in figure 12, all can be observed the Rhizoma Sparganii unique point in each sample solution under each damp condition clearly;
(4) the Rf value under each investigation condition is as shown in table 3.
Table 3
| Qingdao plate | Yantai plate | Merck plate | From making sheet | Normal temperature |
| 0.328 | 0.312 | 0.375 | 0.344 | 0.328 |
| Low temperature | 32% humidity | 72% humidity | 88% humidity | |
| 0.281 | 0.250 | 0.281 | 0.234 |
Each technical characteristic of the above embodiment can combine arbitrarily, for making description succinct, the all possible combination of each technical characteristic in above-described embodiment is not all described, but, as long as the combination of these technical characteristics does not exist contradiction, be all considered to be the scope that this instructions is recorded.
The above embodiment only have expressed several embodiment of the present invention, and it describes comparatively concrete and detailed, but can not therefore be construed as limiting the scope of the patent.It should be pointed out that for the person of ordinary skill of the art, without departing from the inventive concept of the premise, can also make some distortion and improvement, these all belong to protection scope of the present invention.Therefore, the protection domain of patent of the present invention should be as the criterion with claims.
Claims (10)
1. the quality determining method of children's's helping digestion Chinese medicine preparation, the effective constituent of described children's's helping digestion Chinese medicine preparation is prepared from primarily of the raw material of following weight portion: hawthorn 9-11 part, Fructus Hordei Germinatus 9-11 part, Medicated Leaven 9-11 part, rheum officinale 9-11 part, kaladana 19-21 part, betel nut 9-11 part, curcuma zedoary 4-6 part, Rhizoma Sparganii 4-6 part, it is characterized in that, described quality determining method adopts thin-layered chromatography to detect described hawthorn, curcuma zedoary and Rhizoma Sparganii.
2. the quality determining method of children's's helping digestion Chinese medicine preparation according to claim 1, it is characterized in that, the detection method of described hawthorn comprises the steps:
(1) get described children's's helping digestion Chinese medicine preparation, add evaporate to dryness extract after extraction into ethyl acetate, residue solubilizer dissolves, and obtains need testing solution;
(2) get large-fruited Chinese hawthorn control medicinal material or hawthorn control medicinal material, after the refluxing extraction that adds water, extract adds extraction into ethyl acetate, and after gained extract evaporate to dryness, residue solubilizer dissolves, and obtains control medicinal material solution;
(3) described control medicinal material solution and need testing solution is drawn respectively, point is on same silica gel g thin-layer plate, with the mixed liquor of cyclohexane, methenyl choloride and ethyl acetate for developping agent launches, take out after expansion, dry, spray is with ethanol solution of sulfuric acid, heat this silica gel g thin-layer plate clear to spot development, inspect.
3. the quality determining method of children's's helping digestion Chinese medicine preparation according to claim 2, is characterized in that, step (3) described developping agent is volume ratio is 3 ~ 5:0.5 ~ 3:1 ~ 4 cyclohexane, methenyl choloride and ethyl acetate; Step (1) and (2) described solvent are methyl alcohol.
4. the quality determining method of children's's helping digestion Chinese medicine preparation according to claim 1, it is characterized in that, the detection method of described curcuma zedoary comprises the steps:
(1) get described children's's helping digestion Chinese medicine preparation, add evaporate to dryness extract after the petroleum ether extraction of boiling range 60-90 DEG C, residue solubilizer dissolves, and obtains need testing solution;
(2) get RADIX CURCUMAE control medicinal material or zedoary control medicinal material, after the refluxing extraction that adds water, extract adds the petroleum ether extraction of boiling range 60-90 DEG C, and after gained extract evaporate to dryness, residue solubilizer dissolves, and obtains control medicinal material solution;
(3) described control medicinal material solution and need testing solution is drawn respectively, point is on same silica gel g thin-layer plate, with the mixed liquor of sherwood oil and ethyl acetate for developping agent launches, take out after expansion, dry, spray is with ethanol solution of sulfuric acid, heat this silica gel g thin-layer plate clear to spot development, inspect.
5. want the quality determining method of the children's's helping digestion Chinese medicine preparation described in 4 according to right, it is characterized in that, sherwood oil and the ethyl acetate of step (3) described developping agent to be volume ratio be boiling range 60-90 DEG C of 1 ~ 5:0.1 ~ 3; Step (1) and (2) described solvent are ethyl acetate.
6. the quality determining method of the children's's helping digestion Chinese medicine preparation according to claim 2 or 4, is characterized in that, described in add water time of refluxing extraction be 1 ~ 5 hour, the volumetric concentration of described sulfuric acid ethanol is 8 ~ 12%.
7. the quality determining method of children's's helping digestion Chinese medicine preparation according to claim 1, it is characterized in that, the detection method of described Rhizoma Sparganii comprises the steps:
(1) get described children's's helping digestion Chinese medicine preparation, add evaporate to dryness extract after the petroleum ether extraction of boiling range 60-90 DEG C, residue solubilizer dissolves, and obtains need testing solution;
(2) get Rhizoma Sparganii control medicinal material, add evaporate to dryness extract after the ultrasonic extraction of sherwood oil of boiling range 60-90 DEG C, residue solubilizer dissolves, and obtains control medicinal material solution;
(3) draw described control medicinal material solution and need testing solution respectively, put on same silica gel g thin-layer plate, launch for developping agent with the mixed liquor of cyclohexane, ethyl acetate and formic acid, take out after expansion, dry, inspect under putting uviol lamp 365nm.
8. want the quality determining method of the children's's helping digestion Chinese medicine preparation described in 7 according to right, it is characterized in that, the cyclohexane of step (3) described developping agent to be volume ratio be 15 ~ 30:1 ~ 10:0.1 ~ 1, ethyl acetate and formic acid.
9. want the quality determining method of the children's's helping digestion Chinese medicine preparation described in 7 according to right, it is characterized in that, the time of the described ultrasonic extraction of step (2) is 0.5 ~ 2 hour; Step (1) and (2) described solvent are ethyl acetate.
10. the quality determining method of the children's's helping digestion Chinese medicine preparation according to claim 1-5 or any one of 7-9, is characterized in that, described quality determining method also comprises employing thin-layered chromatography and detects described rheum officinale, kaladana and betel nut.
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| CN201610112717.4A CN105548454B (en) | 2016-02-29 | 2016-02-29 | The quality determining method of children's helping digestion Chinese medicine preparation |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107064324A (en) * | 2016-12-06 | 2017-08-18 | 山东省中医药研究院 | A kind of authentication method and content assaying method of the HPLC finger-prints of Rhizoma Sparganii polyphenol components |
| WO2020140670A1 (en) * | 2018-12-31 | 2020-07-09 | 海南葫芦娃药业集团股份有限公司 | Method for detecting infantile accumulation-eliminating granules |
| CN111693641A (en) * | 2020-07-20 | 2020-09-22 | 江苏弘典中药产业研究院有限公司 | Thin-layer identification method for renshu stomach-invigorating granules |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1876139A (en) * | 2005-06-03 | 2006-12-13 | 贵阳云岩西创药物科技开发有限公司 | Medicinal preparation for treating children's fastidium, its preparation process and quality control method |
| CN101002905A (en) * | 2007-01-12 | 2007-07-25 | 广东众生药业股份有限公司 | Medicine for treating infantile anorexia, its preparing method and quality control method |
| CN101444604A (en) * | 2009-01-06 | 2009-06-03 | 贵州本草堂药业有限公司 | Chinese medicine granular formulation to therapy children anorexia and preparation method thereof and detection method |
| CN102038902A (en) * | 2009-10-26 | 2011-05-04 | 天津中新药业集团股份有限公司达仁堂制药厂 | Quality control method of traditional Chinese medicine preparation xiaoerbaishou pill |
-
2016
- 2016-02-29 CN CN201610112717.4A patent/CN105548454B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1876139A (en) * | 2005-06-03 | 2006-12-13 | 贵阳云岩西创药物科技开发有限公司 | Medicinal preparation for treating children's fastidium, its preparation process and quality control method |
| CN101002905A (en) * | 2007-01-12 | 2007-07-25 | 广东众生药业股份有限公司 | Medicine for treating infantile anorexia, its preparing method and quality control method |
| CN101444604A (en) * | 2009-01-06 | 2009-06-03 | 贵州本草堂药业有限公司 | Chinese medicine granular formulation to therapy children anorexia and preparation method thereof and detection method |
| CN102038902A (en) * | 2009-10-26 | 2011-05-04 | 天津中新药业集团股份有限公司达仁堂制药厂 | Quality control method of traditional Chinese medicine preparation xiaoerbaishou pill |
Non-Patent Citations (3)
| Title |
|---|
| 国家药典委员会: "《中华人民共和国药典2010版 一部》", 31 January 2010 * |
| 李其凤等: "莪术药材质量控制方法的研究", 《中药材》 * |
| 邓世容: "三棱饮片炮制工艺及质量标准研究", 《中国优秀博硕士学位论文全文数据库 医药卫生科技辑》 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107064324A (en) * | 2016-12-06 | 2017-08-18 | 山东省中医药研究院 | A kind of authentication method and content assaying method of the HPLC finger-prints of Rhizoma Sparganii polyphenol components |
| CN107064324B (en) * | 2016-12-06 | 2019-07-30 | 山东省中医药研究院 | A kind of identification method and content assaying method of the HPLC finger-print of trigone polyphenol components |
| WO2020140670A1 (en) * | 2018-12-31 | 2020-07-09 | 海南葫芦娃药业集团股份有限公司 | Method for detecting infantile accumulation-eliminating granules |
| CN111693641A (en) * | 2020-07-20 | 2020-09-22 | 江苏弘典中药产业研究院有限公司 | Thin-layer identification method for renshu stomach-invigorating granules |
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