CN106053706A - Production quality control method of three-snake-gall fritillariae cirrhosae bulbus syrup - Google Patents
Production quality control method of three-snake-gall fritillariae cirrhosae bulbus syrup Download PDFInfo
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Abstract
The invention discloses a production quality control method of three-snake-gall fritillariae cirrhosae bulbus syrup. The method comprises a production control method and a quality control method. By controlling the production of the three-snake-gall fritillariae cirrhosae bulbus syrup, and qualitatively identifying and quantitatively detecting active ingredients, the product quality is effectively controlled, the quality stability and safety and efficiency in use can be guaranteed.
Description
Technical field
The present invention relates to the quality of production control method field for phlegm-heat cough medicine, be specifically related to a kind of three Fel Serpentis rivers
The quality of production control method of shellfish syrup.
Background technology
Triple fluorescent labeling energy clearing heat and moistening lung, preventing phlegm from forming and stopping coughing, it is used for phlegm-heat cough, its active ingredient has hydrochloric acid Herba Ephedrae
Alkali, Folium Eriobotryae fermented product, isofraxidin.Ephedrine hydrochloride is adrenomimetic, energy exciting sympathetic nerves, can be used for bronchus
Asthma, pertussis, pollinosis and other anaphylactic diseases；Its cold nature of Folium Eriobotryae, bitter in the mouth, have clearing away lung-heat to relieve cough, stopping nausea and vomiting by lowering the adverse flow of QI
Effect, is usually used in treating cough due to lung-heat, QI rising in reverse order dyspnea with rapid respiration, gastric heat vomiting, the diseases such as dysphoria with smothery sensation is thirsty；Isofraxidin has enhancing to be resisted
Disease ability, resisting fatigue and regain one's vigor, stimulate the effects such as immunity of organisms.
At present for the quality of production control method of triple fluorescent labeling, it mostly is discriminating or the detection of single component, and
Operating condition parameter mostly is broadly to be summarized, it is difficult to it is carried out evaluation all sidedly.Therefore, it is necessary to set up a comprehensive mirror
Not, the quality of production control method of triple fluorescent labeling effective ingredient is detected.
Summary of the invention
For solving above-mentioned technical problem, the invention provides the quality of production control method of a kind of triple fluorescent labeling.
The present invention is achieved by the following technical programs:
The quality of production control method of a kind of triple fluorescent labeling, the method includes production control method, quality control
Method；
Production control method:
Take Bulbus Fritillariae Cirrhosae 30g, be ground into middle powder, according to fluid extract and the percolation under extractum item, make molten with 70% ethanol
Agent, carries out percolation after dipping 18h, collects the another device of liquid 20ml of just filtering and preserves, continues percolation, to liquid inanimate object alkali reaction of filtering,
Collect continuous liquid of filtering, reclaim ethanol and be concentrated into appropriate, adding just filter liquid and Fel Serpentis 2g, mixing, stand, filter, from filter
Add 70% ethanol, make into 32ml, the Oleum menthae 0.24g that addition is dissolved with appropriate amount of ethanol, mixing, standby；Take Cortex Mori 15g, fiber crops
Yellow 15g, Folium Eriobotryae 140g, Radix Platycodonis 12g, Caulis et Folium hedyotis hedyotideae 90g, Radix Cynanchi Atrati 40g, Herba Sarcandrae 100g, Radix Stemonae 30g boiling three times, often
Secondary 1.5h, collecting decoction, filter, filtrate is concentrated into about 400ml, adds citric acid 1g and preservative, mixing, stands, filters, standby
With.Separately take sucrose 800g to add water and boil dissolving in right amount, filter, let cool, merge with above-mentioned each reserve liquid, add water to 2000ml, stir
Even, to obtain final product；
Method of quality control:
1) discriminating of ephedrine hydrochloride:
Prepared by a, need testing solution: take triple fluorescent labeling 30mL, adds liquor ammoniae fortis 2mL, shakes extraction two with ether
Secondary, each 20mL, merge ether extracted liquid, add ethanol solution hydrochloride and shake up, water-bath is evaporated, residue adds methanol 1mL to be made molten
Solve；
Prepared by b, reference substance solution: take ephedrine hydrochloride appropriate, adds methanol and shakes up, makes every 1mL solution hydrochloric acid Han 1mg
Ephedrine；
C, point sample: according to thin layer chromatography (one annex VIB of " Chinese Pharmacopoeia " version in 2010) test, draw above-mentioned for examination
The each 5 μ L of product solution, reference substance solution, put respectively on same silica gel g thin-layer plate, with chloroform-methanol-liquor ammoniae fortis for exhibition
Open agent, launch, take out, dry；
D, develop the color and inspect: on silica gel g thin-layer plate, spraying ninhydrin solution, be heated to spot development at 105 DEG C clear；
E, discriminating: in test sample chromatograph, on position corresponding with reference substance chromatograph, show identical punctation, then
Test sample contains ephedrine hydrochloride；
2), the discriminating of Folium Eriobotryae fermented product:
Prepared by a, confession trial work product solution: take triple fluorescent labeling 25mL, is 10 with sodium hydroxide solution regulation pH, then uses
Ethyl acetate shaking is extracted 3 times, each 25mL, and combined ethyl acetate solution is evaporated, and residue adds methanol 1mL makes dissolving, as confession
Test sample solution；
Prepared by b, control medicinal material solution: take Folium Eriobotryae control medicinal material 2g, shred, boiling 2h, filters, and filtrate is concentrated into
20mL；
C, point sample: according to thin layer chromatography (one annex VIB of " Chinese Pharmacopoeia " version in 2010) test, draw above-mentioned for examination
The each 10 μ L of product solution, reference substance solution, put respectively on same silica gel g thin-layer plate, with cyclohexane-ethyl acetate-glacial acetic acid are
Developing solvent, launches, takes out, dries；
D, develop the color and inspect: on silica gel g thin-layer plate, spraying 5% vanillin-sulfuric acid solution, be heated to spot development at 105 DEG C
Clearly；
E, discriminating: in test sample chromatograph, on position corresponding with control medicinal material chromatograph, the speckle of display same color,
Then contain Folium Eriobotryae fermented product；
3) mensuration of isofraxidin
A, testing conditions: measure according to high performance liquid chromatography (one annex VI D of " Chinese Pharmacopoeia " version in 2010), with ten
Eight alkyl silane bonded silica gels are filler, and acetonitrile-0.1% phosphoric acid solution with volume ratio as 15:85 is flowing phase, detects ripple
A length of 344nm；
Prepared by b, need testing solution: precision measures triple fluorescent labeling 10mL, is placed in separatory funnel, adds chloroform
Shaking is extracted, and extracting solution is evaporated, and residue adds methanol and dissolves, and is transferred in 10mL measuring bottle, adds methanol to scale, shakes up, filters；
Prepared by c, reference substance solution: accurately weighed isofraxidin reference substance is appropriate, adds methanol, shakes up, make every 1mL molten
Liquid determines isofraxidin containing 20 μ g；
D, mensuration: accurate absorption reference substance solution, each 10 μ L of need testing solution, be injected separately into high performance liquid chromatograph and carry out
Measure.
Described step 1) ethanol solution hydrochloride concentration is 5% in a, addition is 1.5mL.
Described step 1) a is evaporated into water bath method, bath temperature is 55-80 DEG C.
Described step 1) volume ratio of chloroform-methanol-liquor ammoniae fortis is 8:1.4:0.2 in c.
Described step 2) volume ratio of c cyclohexane-ethyl acetate-glacial acetic acid solution is 4:8:0.05.
Described step 3) number of theoretical plate is pressed isofraxidin peak and is calculated >=4000 in a.
Described step 3) b adds chloroform shaking extract 5 times, each 20mL.
Described step 3) chloroform extraction liquid is evaporated in b temperature is 50-65 DEG C.
The every 1mL of described triple fluorescent labeling contains Herba Sarcandrae with isofraxidin (C11H10O5) meter >=15 μ g.
The beneficial effects of the present invention is: use the present invention tingle to the active ingredient salt in triple fluorescent labeling respectively
Yellow alkali, Folium Eriobotryae fermented product differentiate, then are measured the content of isofraxidin, during specify that discriminating, mensuration
Conditional parameter, effectively overcomes deficiency of the prior art.The thin layer chromatography using the present invention is easy and simple to handle, quick, easily
In judging discriminating；And use High Performance Liquid Chromatographv to pass through the control of conditional parameter, the result drawn more accuracy, and have good
Repeatability, precision and the response rate, can effectively control the quality of triple fluorescent labeling, it is ensured that the effect of product.At mirror
Use Folium Eriobotryae to make reference substance in not and also there is easily acquisition, the advantage of low cost.
Detailed description of the invention
Technical scheme is further described by following example, but claimed scope is not limited to institute
State.
The quality of production control method of a kind of triple fluorescent labeling, the method includes production control method, quality control
Method；
Production control method:
Take Bulbus Fritillariae Cirrhosae 30g, be ground into middle powder, according to fluid extract and the percolation under extractum item, make molten with 70% ethanol
Agent, carries out percolation after dipping 18h, collects the another device of liquid 20ml of just filtering and preserves, continues percolation, to liquid inanimate object alkali reaction of filtering,
Collect continuous liquid of filtering, reclaim ethanol and be concentrated into appropriate, adding just filter liquid and Fel Serpentis 2g, mixing, stand, filter, from filter
Add 70% ethanol, make into 32ml, the Oleum menthae 0.24g that addition is dissolved with appropriate amount of ethanol, mixing, standby；Take Cortex Mori 15g, fiber crops
Yellow 15g, Folium Eriobotryae 140g, Radix Platycodonis 12g, Caulis et Folium hedyotis hedyotideae 90g, Radix Cynanchi Atrati 40g, Herba Sarcandrae 100g, Radix Stemonae 30g boiling three times, often
Secondary 1.5h, collecting decoction, filter, filtrate is concentrated into about 400ml, adds citric acid 1g and preservative, mixing, stands, filters, standby
With.Separately take sucrose 800g to add water and boil dissolving in right amount, filter, let cool, merge with above-mentioned each reserve liquid, add water to 2000ml, stir
Even, to obtain final product；
Method of quality control:
1) discriminating of ephedrine hydrochloride:
Take triple fluorescent labeling 30mL, add liquor ammoniae fortis 2mL, extract secondary, each 20mL with ether shaking, merge second
Ether extracting solution, adds the ethanol solution hydrochloride 1.5mL that concentration is 5%, shakes up, be evaporated in the water-bath of 65 DEG C, and residue adds methanol 1mL
Make dissolving as need testing solution；Take ephedrine hydrochloride appropriate, add methanol and shake up, make every 1mL solution hydrochloric acid Herba Ephedrae Han 1mg
Alkali is as reference substance solution；According to thin layer chromatography (one annex VIB of " Chinese Pharmacopoeia " version in 2010) test, draw above-mentioned confession
The each 5 μ L of test sample solution, reference substance solution, put the trichlorine on same silica gel g thin-layer plate, with volume ratio as 8:1.4:0.2 respectively
Methane-methanol-liquor ammoniae fortis makees developing solvent, launches, takes out, dries；Silica gel g thin-layer plate sprays ninhydrin solution, at 105 DEG C
It is heated to spot development clear；In test sample chromatograph, on position corresponding with reference substance chromatograph, show identical red grouper
Point, test sample contains ephedrine hydrochloride；
2), the discriminating of Folium Eriobotryae fermented product:
Take triple fluorescent labeling 25mL, be 10 with sodium hydroxide solution regulation pH, then shake extraction 3 by ethyl acetate
Secondary, each 25mL, combined ethyl acetate solution, it is evaporated, residue adds methanol 1mL makes dissolving as need testing solution；Take Folium Eriobotryae
Control medicinal material 2g, shreds, boiling 2h, filters, and filtrate is concentrated into 20mL as control medicinal material solution；According to thin layer chromatography
(one annex VIB of " Chinese Pharmacopoeia " version in 2010) tests, and draws above-mentioned need testing solution, each 10 μ L of reference substance solution, respectively
Point is on same silica gel g thin-layer plate, and the cyclohexane-ethyl acetate-glacial acetic acid solution with volume ratio as 4:8:0.05 makees developing solvent,
Launch, take out, dry；Silica gel g thin-layer plate sprays 5% vanillin-sulfuric acid solution, is heated to spot development at 105 DEG C clear；
In test sample chromatograph, on position corresponding with control medicinal material chromatograph, the speckle of display same color, test sample contains Folium Eriobotryae
Extract；
3) mensuration of isofraxidin
Measure according to high performance liquid chromatography (one annex VI D of " Chinese Pharmacopoeia " version in 2010), with octadecylsilane
Bonded silica gel is filler, and acetonitrile-0.1% phosphoric acid solution with volume ratio as 15:85 is flowing phase, and detection wavelength is 344nm,
Number of theoretical plate is calculated as 5000 by isofraxidin peak；Precision measures triple fluorescent labeling 10mL, is placed in separatory funnel, adds
Chloroform shaking is extracted 5 times, each 20mL, and extracting solution is evaporated at 57 DEG C, and residue adds methanol and dissolves, and is transferred to 10mL measuring bottle
In, adding methanol to scale, shake up, filter, filtrate is as need testing solution；Accurately weighed isofraxidin reference substance is appropriate, adds
Methanol, shakes up, and makes every 1mL solution and determines isofraxidin as reference substance solution containing 20 μ g；Precision draws reference substance solution, for examination
The each 10 μ L of product solution, are injected separately into high performance liquid chromatograph and are measured.
The every 1mL of described triple fluorescent labeling contains Herba Sarcandrae with isofraxidin (C11H10O5) it is calculated as 15.8 μ g.
Claims (9)
1. the quality of production control method of a triple fluorescent labeling, it is characterised in that: the method include production control method,
Method of quality control；
Production control method:
Take Bulbus Fritillariae Cirrhosae 30g, be ground into middle powder, according to fluid extract and the percolation under extractum item, use 70% ethanol as solvent, leaching
Carry out percolation after stain 18h, collect the another device of liquid 20ml of just filtering and preserve, continue percolation, to liquid inanimate object alkali reaction of filtering, collect continuous
Filter liquid, reclaim ethanol and be also concentrated into appropriate, add just filter liquid and Fel Serpentis 2g, mixing, stand, filter, from filter, add 70%
Ethanol, makes into 32ml, the Oleum menthae 0.24g that addition is dissolved with appropriate amount of ethanol, mixing, standby；Take Cortex Mori 15g, Herba Ephedrae 15g,
Folium Eriobotryae 140g, Radix Platycodonis 12g, Caulis et Folium hedyotis hedyotideae 90g, Radix Cynanchi Atrati 40g, Herba Sarcandrae 100g, Radix Stemonae 30g boiling three times, each 1.5h,
Collecting decoction, filters, and filtrate is concentrated into about 400ml, adds citric acid 1g and preservative, mixing, stands, filters, standby.Separately take
Sucrose 800g adds water and boils dissolving in right amount, filters, lets cool, merge with above-mentioned each reserve liquid, add water to 2000ml, stir evenly, to obtain final product；
Method of quality control:
1) discriminating of ephedrine hydrochloride:
Prepared by a, need testing solution: take triple fluorescent labeling 30mL, adds liquor ammoniae fortis 2mL, extracts secondary with ether shaking, often
Secondary 20mL, merges ether extracted liquid, adds ethanol solution hydrochloride and shake up, be evaporated in water-bath, and residue adds methanol 1mL makes dissolving；
Prepared by b, reference substance solution: take ephedrine hydrochloride appropriate, adds methanol and shakes up, makes every 1mL solution hydrochloric acid Herba Ephedrae Han 1mg
Alkali；
C, point sample: test according to thin layer chromatography, draw above-mentioned need testing solution, each 5 μ L of reference substance solution, put respectively in same
On silica gel g thin-layer plate, with chloroform-methanol-liquor ammoniae fortis as developing solvent, launch, take out, dry；
D, develop the color and inspect: on silica gel g thin-layer plate, spraying ninhydrin solution, be heated to spot development at 105 DEG C clear；
E, discriminating: in test sample chromatograph, on position corresponding with reference substance chromatograph, show identical punctation, then for examination
Product contain ephedrine hydrochloride；
2), the discriminating of Folium Eriobotryae fermented product:
Prepared by a, confession trial work product solution: take triple fluorescent labeling 25mL, is 10 with sodium hydroxide solution regulation pH, then uses acetic acid
Ethyl ester shaking is extracted 3 times, each 25mL, and combined ethyl acetate solution is evaporated, and residue adds methanol 1mL makes dissolving, as test sample
Solution；
Prepared by b, control medicinal material solution: take Folium Eriobotryae control medicinal material 2g, shred, boiling 2h, filters, and filtrate is concentrated into
20mL；
C, point sample: test according to thin layer chromatography, draw above-mentioned need testing solution, each 10 μ L of reference substance solution, put respectively in same
On one silica gel g thin-layer plate, with cyclohexane-ethyl acetate-glacial acetic acid as developing solvent, launch, take out, dry；
D, develop the color and inspect: on silica gel g thin-layer plate, spraying 5% vanillin-sulfuric acid solution, be heated to spot development at 105 DEG C clear
Clear；
E, discriminating: in test sample chromatograph, on position corresponding with control medicinal material chromatograph, the speckle of display same color, then contain
There is Folium Eriobotryae fermented product；
3) mensuration of isofraxidin
A, testing conditions: according to high effective liquid chromatography for measuring, with octadecylsilane chemically bonded silica as filler, with volume ratio
Acetonitrile-0.1% phosphoric acid solution for 15:85 is flowing phase, and detection wavelength is 344nm；
Prepared by b, need testing solution: precision measures triple fluorescent labeling 10mL, is placed in separatory funnel, adds chloroform shaking
Extracting, extracting solution is evaporated, and residue adds methanol and dissolves, and is transferred in 10mL measuring bottle, adds methanol to scale, shakes up, filters；
Prepared by c, reference substance solution: accurately weighed isofraxidin reference substance is appropriate, adds methanol, shakes up, make every 1mL solution and contain
20 μ g determine isofraxidin；
D, mensuration: accurate absorption reference substance solution, each 10 μ L of need testing solution, be injected separately into high performance liquid chromatograph and survey
Fixed.
The quality of production control method of a kind of triple fluorescent labeling the most according to claim 1, it is characterised in that described
Step 1) ethanol solution hydrochloride concentration is 5% in a, addition is 1.5mL.
The quality of production control method of a kind of triple fluorescent labeling the most according to claim 1, it is characterised in that described
Step 1) a is evaporated into water bath method, bath temperature is 55-80 DEG C.
The quality of production control method of a kind of triple fluorescent labeling the most according to claim 1, it is characterised in that described
Step 1) volume ratio of chloroform-methanol-liquor ammoniae fortis is 8:1.4:0.2 in c.
The quality of production control method of a kind of triple fluorescent labeling the most according to claim 1, it is characterised in that described
Step 2) volume ratio of c cyclohexane-ethyl acetate-glacial acetic acid solution is 4:8:0.05.
The quality of production control method of a kind of triple fluorescent labeling the most according to claim 1, it is characterised in that described
Step 3) in a number of theoretical plate based on isofraxidin peak >=in 4000.
The quality of production control method of a kind of triple fluorescent labeling the most according to claim 1, it is characterised in that described
Step 3) chloroform adds shaking and extracts 5 times in b, each 20mL.
The quality of production control method of a kind of triple fluorescent labeling the most according to claim 1, it is characterised in that described
Step 3) chloroform extraction liquid is evaporated in b temperature is 50-65 DEG C.
9. according to the quality of production control method of a kind of triple fluorescent labeling described in claim 1-9, it is characterised in that institute
State the every 1mL of triple fluorescent labeling containing Herba Sarcandrae with isofraxidin (C11H10O5) meter >=15 μ g.
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Application publication date: 20161026 |