CN105548454B - The quality determining method of children's helping digestion Chinese medicine preparation - Google Patents
The quality determining method of children's helping digestion Chinese medicine preparation Download PDFInfo
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- CN105548454B CN105548454B CN201610112717.4A CN201610112717A CN105548454B CN 105548454 B CN105548454 B CN 105548454B CN 201610112717 A CN201610112717 A CN 201610112717A CN 105548454 B CN105548454 B CN 105548454B
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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 present invention relates to a kind of quality determining method of children's helping digestion Chinese medicine preparation, children's helping digestion Chinese medicine preparation, its active ingredient to be mainly prepared by the raw material of following parts by weight：9 11 parts of hawthorn, 9 11 parts of malt, 9 11 parts of Medicated Leaven, 9 11 parts of rheum officinale, 19 21 parts of kaladana, 9 11 parts of betel nut, 46 parts of curcuma zedoary, 46 parts of Rhizoma Sparganii, the quality determining method are that the hawthorn, curcuma zedoary and Rhizoma Sparganii are detected using thin-layered chromatography.The quality determining method, by rationally controlling testing conditions, thin layer discriminating effectively has been carried out to the hawthorn in prescription, curcuma zedoary and Rhizoma Sparganii, can be on the basis of current standard, further the monarch drug in a prescription in prescription and ministerial drug are differentiated, improved, the perfect quality standard of children's helping digestion Chinese medicine preparations, and this method is easy to operate, high sensitivity, stability are good, the product quality in children's helping digestion Chinese medicine preparation production process can be effectively controlled, ensures product curative effect.
Description
Technical field
The present invention relates to the quality testing of Chinese medicine preparation, more particularly to the quality testing side of children's helping digestion Chinese medicine preparation
Method.
Background technology
The prescription of children's helping digestion oral liquid is by hawthorn (stir-bake to brown), malt (stir-fry), Medicated Leaven (stir-bake to brown), rheum officinale, kaladana
(stir-fry), betel nut (stir-bake to brown), curcuma zedoary (vinegar system), Rhizoma Sparganii (bran stir-fry) eight taste medicinal materials composition.Cure mainly relieving dyspepsia, purging intense heat defaecation.For
Infantile stomach heat is stopped eating, abdominal fullness and distention, nausea and vomiting, agitation, it is thirsty, be hard and dry.
The source of hawthorn is rosaceous plant large-fruited Chinese hawthorn Crataegus pinnatifida in children's helping digestion oral liquid
Bge.var.major N.E.Br. or hawthorn Crataegus pinnatifida Bge. dry mature fruit；Curcuma zedoary comes
Source is zingiberaceous plant zedoary Curcuma phaeocaulis Val., Guangxi zedoary CurcumaKwangsiensis
S.G.Lee et C.F.Liang or RADIX CURCUMAE Curcuma wenyujin Y.H.Chen et C.Ling dry rhizome；Three
The source of rib is Sparganiaceae plant rhizoma scirpi Sparganium stoloniferum Buch.-Ham. dry tuber.Fang Zhong
Take 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, in the tune that helps digestion, can energy dissipating mend, tool mark
This simultaneous effect controlled, malt reinforcing spleen to promote digestion, arrogates to oneself the rice and flour dyspepsia that disappears, charred FRUCTUS CRATAEGI, Divine Comedy, malt, it is monarch to be collectively referred to as Charred Triplet, can change all
Carnivorous rice and flour stagnate, make stomach Qi it is 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 mechanism of qi
It is not smooth, therefore using the Rhizoma Sparganii of gas consumption product, curcuma zedoary mutual reinforcement between to use, it is altogether ministerial drug, makes mechanism of qi transporting unobstructed, sick institute, often takes good in medicine
Effect；Rheum officinale attack product expel the heat-evil, dissolving stasis removing toxic substances, the heresy for letting out diet goes out from stool；Kaladana, betel nut Li Shui go stagnant by drink, laxation, lead
Fire-evil goes out from urine, and three medicines are adjutant altogether, solves constipation and anuresis, make all over the body evil product for two just, heresy has outlet, then accumulated heat from
Remove.
In clinical practice for many years, its curative effect is indubitable for this prescription, but for the Chinese medicine preparation matter of children's helping digestion oral liquid
Amount control, existing national standards have only carried out thin layer discriminating to rheum officinale, kaladana, the taste medicinal material of betel nut three, and for as prescription
In monarch drug in a prescription hawthorn, ministerial drug curcuma zedoary and Rhizoma Sparganii, but without any quality standard it is controllable.In addition, answered for what is be made up of eight taste medicines
Square preparation, only wherein three taste adjutant medicinal materials are detected, still had relative to the requirement of current tcm product quality control larger
Gap, it is impossible to it is fully effective control children's helping digestion oral liquid quality, so as to can influence product production and sales and quality protect
Card.
The content of the invention
Based on this, it is necessary to provide a kind of quality determining method of children's helping digestion Chinese medicine preparation.
A kind of quality determining method of children's helping digestion Chinese medicine preparation, the active ingredient of children's helping digestion Chinese medicine preparation are main
It is prepared by the raw material of following parts by weight：Hawthorn 9-11 parts, malt 9-11 parts, Medicated Leaven 9-11 parts, rheum officinale 9-11 parts, lead a cow
Sub- 19-21 parts, betel nut 9-11 parts, curcuma zedoary 4-6 parts, Rhizoma Sparganii 4-6 parts, the quality determining method are to institute using thin-layered chromatography
Hawthorn, curcuma zedoary and Rhizoma Sparganii is stated to be detected.
In one of the embodiments, the detection method of the hawthorn comprises the following steps：
(1) children's helping digestion Chinese medicine preparation is taken, adds ethyl acetate to be evaporated extract after extracting, residue solubilizer dissolves,
Obtain need testing solution；
(2) large-fruited Chinese hawthorn control medicinal material or hawthorn control medicinal material are taken, after adding water refluxing extraction, extract solution adds ethyl acetate to extract
Take, after gained extract is evaporated, the dissolving of residue solubilizer, obtain control medicinal material solution；
(3) the control medicinal material solution and need testing solution are drawn respectively, are put on same silica gel g thin-layer plate, with hexamethylene
The mixed liquor of alkane, chloroform and ethyl acetate deploys for solvent, takes out, dries after expansion, sprays with ethanol solution of sulfuric acid, add
The hot silica gel g thin-layer plate is clear to spot development, inspects.
In one of the embodiments, step (3) described solvent is that volume ratio is 3~5:0.5~3:1~4 hexamethylene,
Chloroform and ethyl acetate；Step (1) and (2) described solvent are methanol.
In one of the embodiments, the detection method of the curcuma zedoary comprises the following steps：
(1) children's helping digestion Chinese medicine preparation is taken, extract, residue are evaporated after adding the petroleum ether extraction of 60-90 DEG C of boiling range
Solubilizer dissolves, and obtains need testing solution；
(2) RADIX CURCUMAE control medicinal material or zedoary control medicinal material are taken, after adding water refluxing extraction, extract solution adds boiling range 60-90
DEG C petroleum ether extraction, after gained extract is evaporated, residue solubilizer dissolving, obtain control medicinal material solution；
(3) the control medicinal material solution and need testing solution are drawn respectively, are put on same silica gel g thin-layer plate, with oil
The mixed liquor of ether and ethyl acetate deploys for solvent, takes out, dries after expansion, spray with ethanol solution of sulfuric acid, heats the silica G
Lamellae is clear to spot development, inspects.
In one of the embodiments, step (3) described solvent is that volume ratio is 1~5:0.1~3 boiling range 60-90
DEG C petroleum ether and ethyl acetate；Step (1) and (2) described solvent are ethyl acetate.
In one of the embodiments, described plus water refluxing extraction time is 1~5 hour, the body of the sulfuric acid ethanol
Product concentration is 8~12%.
In one of the embodiments, the detection method of the Rhizoma Sparganii comprises the following steps：
(1) children's helping digestion Chinese medicine preparation is taken, extract, residue are evaporated after adding the petroleum ether extraction of 60-90 DEG C of boiling range
Solubilizer dissolves, and obtains need testing solution；
(2) Rhizoma Sparganii control medicinal material is taken, extract solution, residue solubilization are evaporated after adding the petroleum ether ultrasonic extraction of 60-90 DEG C of boiling range
Agent is dissolved, and obtains control medicinal material solution；
(3) the control medicinal material solution and need testing solution are drawn respectively, are put on same silica gel g thin-layer plate, with hexamethylene
The mixed liquor of alkane, ethyl acetate and formic acid deploys for solvent, takes out, dries after expansion, puts and inspected i.e. under uviol lamp 365nm
Can.
In one of the embodiments, step (3) described solvent is that volume ratio is 15~30:1~10:0.1~1 ring
Hexane, ethyl acetate and formic acid.
In one of the embodiments, step (2) the ultrasonic extraction time is 0.5~2 hour；Step (1) and (2) institute
It is ethyl acetate to state solvent.
In one of the embodiments, the quality determining method also includes using thin-layered chromatography to the rheum officinale, led
Niu Zi and betel nut are detected.
Compared with prior art, the invention has the advantages that：
The quality determining method of children's helping digestion Chinese medicine preparation of the present invention, by rationally controlling testing conditions, effectively
Thin layer discriminating has been carried out to the hawthorn in prescription, curcuma zedoary and Rhizoma Sparganii, can be on the basis of current standard, further to monarch in prescription
Medicine and ministerial drug differentiated, is improved, the perfect quality standard of children's helping digestion Chinese medicine preparations, and this method is easy to operate, sensitive
Degree is high, stability is good, can effectively control the product quality in children's helping digestion Chinese medicine preparation production process, ensures product curative effect.
Brief description of the drawings
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 of hawthorn under the conditions of different lamellaes：Qingdao silica G plate；Yantai plate：
Yantai silica G plate, Merck plate：Merck KGaA silica G plate, from making sheet：Make G plates by oneself)；
Fig. 3 is the indentification by TLC figure (normal temperature of hawthorn under normal temperature and low temperature environment：21.5 DEG C, low temperature：4.0℃；It is wet
Degree：52%)；
Fig. 4 is the indentification by TLC figure (humidity of hawthorn under different humidity environment：32%th, 72%, 88%；Temperature：21.5
℃)；
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 of curcuma zedoary under the conditions of different lamellaes：Qingdao silica G plate；Yantai plate：
Yantai silica G plate, Merck plate：Merck KGaA silica G plate, from making sheet：Make G plates by oneself)；
Fig. 7 is the indentification by TLC figure (normal temperature of curcuma zedoary under normal temperature and low temperature environment：22.0 DEG C, low temperature：5.0℃；It is wet
Degree：42%)；
Fig. 8 is that the thin layer of curcuma zedoary under different humidity environment differentiates figure (humidity：32%th, 72%, 88%；Temperature：22.0℃)；
Fig. 9 is the indentification by TLC figure of Rhizoma Sparganii in embodiment children's helping digestion oral liquid；
Figure 10 is thin layer discriminating figure (the Qingdao plate of Rhizoma Sparganii under the conditions of different lamellaes：Qingdao silica G plate；Yantai plate：Yantai
Silica G plate, Merck plate：Merck KGaA silica G plate, from making sheet：Make G plates by oneself)；
Figure 11 is that the thin layer of Rhizoma Sparganii under normal temperature and low temperature environment differentiates figure (normal temperature：21.5 DEG C, low temperature：5.0℃；Humidity：
47%)；
Figure 12 is that the thin layer of Rhizoma Sparganii under different humidity environment differentiates figure (humidity：32%th, 72%, 88%；Temperature：23.0
℃)。
Embodiment
The quality determining method of children's helping digestion Chinese medicine preparation of the present invention is made below in conjunction with specific embodiment further detailed
Thin explanation.
The medicine and reagent that the present invention uses：
Large-fruited Chinese hawthorn control medicinal material (National Institute for Food and Drugs Control 121138-201206)；Hawthorn control medicinal material (China
Food and medicine examines and determine research institute 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 (Chengdu
Rui Fensi bio tech ltd DZYC-S001).
Silica gel g thin-layer plate is (commercially available：Haiyang Chemical Plant, Qingdao, the imperial board of Yantai chemical industry research institute silver, Merck KGaA board；
Self-control：Silica G is produced (for thin-layer chromatography) by Haiyang Chemical Plant, Qingdao, 500 μm of thickness, and adhesive is that 0.5% carboxymethyl is fine
Tie up plain sodium)；Other reagents are that analysis is pure.
Children's helping digestion oral liquid is produced by Guangzhou Xiang Xue Pharmacy stock Co., Ltd, lot number is 201409003,
201409004、201409011；Children's helping digestion oral liquid preparation method is following, and (preparation method of each negative sample and children's helping digestion are oral
Liquid phase is same)：
【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.
【Preparation method】The taste of the above eight, is added water to cook three times, and 2 hours for the first time, second and third time each 1 hour, collecting decoction, filter
Cross, filtrate is concentrated into relative density 1.01~1.05 (60 DEG C), lets cool, and adds water to about 700mL, stands 24 hours, centrifugation, adds refining
Sweet 300g and sodium benzoate 0.8g (adding suitable quantity of water to boil, to filter), stirs evenly, stands, filtration, add water that 1000mL is made, embedding, go out
Bacterium, produce.
Embodiment
The present embodiment is the quality determining method of above-mentioned children's helping digestion oral liquid, rheum officinale in children's helping digestion oral liquid, is led
The detection method of Niu Zi and betel nut is according to existing national standards 2015 editions《Chinese Pharmacopoeia》Carry out, the inspection of hawthorn, curcuma zedoary and Rhizoma Sparganii
Survey comprises the following steps：
(1) hawthorn differentiates, specific method is as follows：
1st, the preparation of need testing solution：The children helping digestion oral liquid 50mL of lot number 201409004 is taken, is shaken with ethyl acetate
2 times (50mL/ times) is extracted, each acetic acid ethyl acetate extract is washed with water 50mL, discards aqueous, be evaporated extract, residue respectively
0.5~2mL of methanol is added to make its dissolving, as need testing solution；
2nd, the preparation of control medicinal material solution：Large-fruited Chinese hawthorn control medicinal material or hawthorn 0.5~4g of control medicinal material are taken, adds purified water
100mL, heating and refluxing extraction extract solution filtering, are concentrated into 50-60mL, with ethyl acetate shaking out 2 times after 4 hours
(50mL/ times), extract is evaporated, residue adds 0.5~2mL of methanol to make its dissolving, as control medicinal material solution；
3rd, the preparation of negative control solution：The negative sample 50mL of scarce hawthorn is taken, it is molten to be made in the same way of negative control by step 1
Liquid；
4th, thin-layer chromatography：According to 2015 editions《Chinese Pharmacopoeia》Four thin-layered chromatography of general rule 0502 experiments, draw comparison medicine
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, using volume ratio as 3~5:0.5~3:The mixed liquor of 1~4 hexamethylene-chloroform-ethyl acetate deploys for solvent, exhibition
Take out, dry after out, spray using volumetric concentration as 8~12% ethanol solution of sulfuric acid, heating blankets plate is clear to spot development, puts day
Inspected under light lamp.
As shown in figure 1, large-fruited Chinese hawthorn control medicinal material, hawthorn control medicinal material, lot number 201409004 are from left to right followed successively by figure
Test sample, hawthorn negative control solution, in test sample chromatogram, on position corresponding with control medicinal material chromatogram, show same color
Spot, and negative control solution immaculate.
The experiment of thin-layer chromatography durability is investigated during hawthorn differentiates：
(1) different thin layer slat elements are investigated：
The panel effect under Qingdao silica G plate, Yantai silica G plate, Merck KGaA silica G plate, self-control G slat elements is investigated
Fruit, as a result as shown in Fig. 2 each lamellae can be observed clearly the hawthorn characteristic point in each sample solution；
(2) normal temperature and cryogenic conditions are investigated：
The panel effect under normal temperature and cryogenic conditions is investigated, as a result as shown in figure 3, can under normal temperature and cryogenic conditions
Clearly the hawthorn characteristic point in each sample solution is observed；
(3) different humidity condition is investigated：
The panel effect under 32%, 72%, 88% damp condition has been investigated, as a result as shown in figure 4, under each damp condition
Clearly the hawthorn characteristic point in each sample solution can be observed；
(4) the Rf values under the conditions of each investigation are 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 differentiates, specific method is as follows：
1st, the preparation of need testing solution：The children helping digestion oral liquid 100mL of lot number 201409003 is taken, with 60-90 DEG C of boiling range
Petroleum ether shaking out 2 times (100mL/ times), each petroleum ether extraction liquid washs with water 100mL, discards aqueous, be evaporated respectively
Extract, residue adds 0.5~2mL of ethyl acetate to make its dissolving, as need testing solution；
2nd, the preparation of control medicinal material solution：RADIX CURCUMAE control medicinal material or zedoary 0.5~4g of control medicinal material are taken, adds purified water
50mL, heating and refluxing extraction is after 1 hour, extract solution filtering, with 60-90 DEG C 2 (50mL/ of petroleum ether shaking out of boiling range
It is secondary), each petroleum ether extraction liquid is washed with water 50mL respectively, discards aqueous, is evaporated extract, residue add ethyl acetate 0.5~
2mL makes its dissolving, as control medicinal material solution；
3rd, the preparation of negative control solution：The negative sample 100mL of scarce curcuma zedoary is taken, negative control is made in the same way of by step 1
Solution；
4th, thin-layer chromatography：According to 2015 editions《Chinese Pharmacopoeia》Four thin-layered chromatography of general rule 0502 experiments, draw comparison medicine
Material solution, need testing solution and negative control solution, for point sample on same silica gel g thin-layer plate, point sample volume is 2~20 respectively
μ L, using volume ratio as 1~5:The mixed liquor of the petroleum ether-ethyl acetate of 0.1~3 60-90 DEG C of boiling range is solvent, after expansion
Take out, dry, spray using volumetric concentration as 8~12% ethanol solution of sulfuric acid, heating blankets plate is clear to spot development, puts fluorescent lamp
Under inspect.
As shown in figure 5, RADIX CURCUMAE control medicinal material, zedoary control medicinal material, lot number are from left to right followed successively by figure
201409003 test samples, curcuma zedoary negative control solution, in test sample chromatogram, on position corresponding with control medicinal material chromatogram, show
The spot of same color, and negative control solution immaculate.
The experiment of thin-layer chromatography durability is investigated during curcuma zedoary differentiates：
(1) different thin layer slat elements are investigated：
The panel effect under Qingdao silica G plate, Yantai silica G plate, Merck KGaA silica G plate, self-control G slat elements is investigated
Fruit, as a result as shown in fig. 6, each lamellae more can be observed clearly the curcuma zedoary characteristic point in each sample solution；
(2) normal temperature and cryogenic conditions are investigated：
The panel effect under normal temperature and cryogenic conditions is investigated, as a result as shown in fig. 7, can under normal temperature and cryogenic conditions
Clearly the curcuma zedoary characteristic point in each sample solution is observed；
(3) different humidity condition is investigated：
The panel effect under 32%, 72%, 88% damp condition has been investigated, as a result as shown in figure 8, under each damp condition
Clearly the curcuma zedoary characteristic point in each sample solution can be observed；
(4) the Rf values under the conditions of each investigation are 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 differentiates, specific method is as follows：
1st, the preparation of need testing solution：The children helping digestion oral liquid 100mL of lot number 201409011 is taken, with 60-90 DEG C of boiling range
Petroleum ether shaking out 2 times (100mL/ times), each petroleum ether extraction liquid washs with water 100mL, discards aqueous, be evaporated respectively
Extract, residue adds 0.5~2mL of ethyl acetate to make its dissolving, as need testing solution；
2nd, the preparation of control medicinal material solution：Rhizoma Sparganii 0.5~4g of control medicinal material is taken, adds the petroleum ether 50mL of 60-90 DEG C of boiling range,
After ultrasonic extraction 1 hour, filter paper filtering, filtrate is evaporated, residue adds 0.5~2mL of ethyl acetate to make its dissolving, as control medicinal material
Solution；
3rd, the preparation of negative control solution：The negative sample 100mL of scarce Rhizoma Sparganii is taken, negative control is made in the same way of by step 1
Solution；
4th, thin-layer chromatography：According to 2015 editions《Chinese Pharmacopoeia》Four thin-layered chromatography of general rule 0502 experiments, draw comparison medicine
Material solution, need testing solution and negative control solution, for point sample on same silica gel g thin-layer plate, point sample volume is 2~20 respectively
μ L, using volume ratio as 15~30:1~10:The mixed liquor of 0.1~1 cyclohexane-ethyl acetate-formic acid is solvent, after expansion
Take out, dry, put and inspected under uviol lamp 365nm.
As shown in figure 9, it is negative that Rhizoma Sparganii control medicinal material, the test sample of lot number 201409011, Rhizoma Sparganii are from left to right followed successively by figure
Contrast solution, in test sample chromatogram, on position corresponding with control medicinal material chromatogram, show the fluorescence spot of same color, and it is cloudy
Property contrast solution immaculate.
The experiment of thin-layer chromatography durability is investigated during Rhizoma Sparganii differentiates：
(1) different thin layer slat elements are investigated：
The panel effect under Qingdao silica G plate, Yantai silica G plate, Merck KGaA silica G plate, self-control G slat elements is investigated
Fruit, as a result as shown in Figure 10, each lamellae clearly can be observed the Rhizoma Sparganii characteristic point in each sample solution；
(2) normal temperature and cryogenic conditions are investigated：
The panel effect under normal temperature and cryogenic conditions has been investigated, as a result as shown in figure 11, equal energy under normal temperature and cryogenic conditions
It is enough that clearly the Rhizoma Sparganii characteristic point in each sample solution is observed；
(3) different humidity condition is investigated：
The panel effect under 32%, 72%, 88% damp condition is investigated, as a result as shown in figure 12, under each damp condition
Clearly the Rhizoma Sparganii characteristic point in each sample solution can be observed；
(4) the Rf values under the conditions of each investigation are 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 embodiment described above can be combined arbitrarily, to make description succinct, not to above-mentioned reality
Apply all possible combination of each technical characteristic in example to be all described, as long as however, the combination of these technical characteristics is not deposited
In contradiction, the scope that this specification is recorded all is considered to be.
Embodiment described above only expresses the several embodiments of the present invention, and its description is more specific and detailed, but simultaneously
Can not therefore it be construed as limiting the scope of the patent.It should be pointed out that come for one of ordinary skill in the art
Say, without departing from the inventive concept of the premise, various modifications and improvements can be made, these belong to the protection of the present invention
Scope.Therefore, the protection domain of patent of the present invention should be determined by the appended claims.
Claims (4)
1. a kind of detection method of children's helping digestion Chinese medicine preparation, the active ingredient of children's helping digestion Chinese medicine preparation is mainly by as follows
The raw material of parts by weight is prepared：Hawthorn 9-11 parts, malt 9-11 parts, Medicated Leaven 9-11 parts, rheum officinale 9-11 parts, kaladana 19-
21 parts, betel nut 9-11 parts, curcuma zedoary 4-6 parts, Rhizoma Sparganii 4-6 parts, it is characterised in that children's helping digestion Chinese medicine preparation is children's helping digestion
Oral liquid, the detection method are that the hawthorn, curcuma zedoary and Rhizoma Sparganii are detected using thin-layered chromatography；
Wherein, the detection method of the Rhizoma Sparganii comprises the following steps：
(1) children's helping digestion Chinese medicine preparation is taken, is evaporated extract after adding the petroleum ether extraction of 60-90 DEG C of boiling range, residue adds second
Acetoacetic ester dissolves, and obtains need testing solution；
(2) Rhizoma Sparganii control medicinal material is taken, is evaporated extract solution after adding the petroleum ether ultrasonic extraction of 60-90 DEG C of boiling range, residue adds acetic acid second
Ester dissolves, and obtains control medicinal material solution；
(3) the control medicinal material solution and need testing solution are drawn respectively, is put on same silica gel g thin-layer plate, using volume ratio as
15~30:1~10:0.1~1 hexamethylene, ethyl acetate and formic acid deploys for solvent, takes out, dries after expansion, puts ultraviolet
Inspected under lamp 365nm；
The detection method of the hawthorn comprises the following steps：
(1) children's helping digestion Chinese medicine preparation is taken, adds ethyl acetate to be evaporated extract after extracting, residue adds methanol to dissolve, and obtains confession
Test sample solution；
(2) large-fruited Chinese hawthorn control medicinal material or hawthorn control medicinal material are taken, after adding water refluxing extraction, extract solution adds ethyl acetate to extract, institute
After extract is evaporated, residue adds methanol to dissolve, and obtains control medicinal material solution；
(3) the control medicinal material solution and need testing solution are drawn respectively, are put on same silica gel g thin-layer plate, using volume ratio as 3
~5:0.5~3:1~4 hexamethylene, chloroform and ethyl acetate deploy for solvent, take out, dry after expansion, spray with sulfuric acid
Ethanol solution, it is clear to spot development to heat the silica gel g thin-layer plate, inspects；
The detection method of the curcuma zedoary comprises the following steps：
(1) children's helping digestion Chinese medicine preparation is taken, is evaporated extract after adding the petroleum ether extraction of 60-90 DEG C of boiling range, residue adds second
Acetoacetic ester dissolves, and obtains need testing solution；
(2) RADIX CURCUMAE control medicinal material or zedoary control medicinal material are taken, after adding water refluxing extraction, extract solution adds 60-90 DEG C of boiling range
Petroleum ether extraction, after gained extract is evaporated, residue adds ethyl acetate to dissolve, and obtains control medicinal material solution；
(3) the control medicinal material solution and need testing solution are drawn respectively, are put on same silica gel g thin-layer plate, using volume ratio as 1
~5:The petroleum ether and ethyl acetate of 0.1~3 60-90 DEG C of boiling range deploy for solvent, take out, dry after expansion, spray with sulphur
Sour ethanol solution, it is clear to spot development to heat the silica gel g thin-layer plate, inspects.
2. the detection method of children's helping digestion Chinese medicine preparation according to claim 1, it is characterised in that the backflow of described plus water carries
The time taken is 1~5 hour, and the volumetric concentration of the sulfuric acid ethanol is 8~12%.
3. the detection method of children's helping digestion Chinese medicine preparation according to claim 1, it is characterised in that in the inspection of the Rhizoma Sparganii
In survey method, the time of step (2) described ultrasonic extraction is 0.5~2 hour.
4. the detection method of children's helping digestion Chinese medicine preparation according to claim any one of 1-3, it is characterised in that the inspection
Survey method also includes detecting the rheum officinale, kaladana and betel nut using thin-layered chromatography.
Priority Applications (1)
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| CN109596768B (en) * | 2018-12-31 | 2020-03-20 | 海南葫芦娃药业集团股份有限公司 | Detection method of infantile indigestion removing granules |
| CN111693641B (en) * | 2020-07-20 | 2023-03-17 | 江苏弘典中药产业研究院有限公司 | Thin-layer identification method for Renshujianwei granules |
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