CN1961943A - Pharmaceutical composition for treating cold, its preparation method and quality control method thereof - Google Patents
Pharmaceutical composition for treating cold, its preparation method and quality control method thereof Download PDFInfo
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- CN1961943A CN1961943A CN 200510200673 CN200510200673A CN1961943A CN 1961943 A CN1961943 A CN 1961943A CN 200510200673 CN200510200673 CN 200510200673 CN 200510200673 A CN200510200673 A CN 200510200673A CN 1961943 A CN1961943 A CN 1961943A
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Abstract
The invention discloses a medicinal composition which is prepared from honeysuckle flower, arctium fruit, capsule of weeping forsythia, root of ballon flower, mentha, bamboo leaves, Schizonepeta tenuifolia, licorice root, prepared soybean and acetaminopher. The composition can be used for treating common cold, fever and cephalalgia, dry mouth and cough, and throat pain. The invention also discloses the method for preparing the medicinal composition and its quality control method.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition, especially a kind of Chinese medicine composition that is used for the treatment of Common Cold belongs to the field of Chinese medicines.The invention still further relates to this preparation of drug combination method and method of quality control simultaneously.
Background technology
Respiratory system infection is a human class major disease of being faced always, outbreak repeatedly, and onset is rapid and changeful, and human beings'health is had the bigger danger side of body.Doctor trained in Western medicine distinguishes that the main method of controlling this type of disease is to select antibiotic for use, but the shortcoming that antibiotic treatment has that side effect is strong, bacterial strain easily develops immunity to drugs etc. to be difficult for overcoming.Chinese medicine cure cold then have effect comprehensively, outstanding feature such as stable curative effect, side effect be little, thereby Chinese medicine is becoming the main medication of treatment respiratory system disease.
Summary of the invention
Purpose of the present invention is exactly that a kind of pharmaceutical composition of more effectively treating respiratory system disease will be provided, especially a kind of Chinese medicine composition for the treatment of Common Cold; The preparation method and the method for quality control of this Chinese medicine composition also are provided simultaneously.
The raw material of this Chinese medicine composition consists of: Flos Lonicerae 5～15 weight portions, Fructus Arctii 3～9 weight portions, Fructus Forsythiae 5～15 weight portions, Radix Platycodonis 3～9 weight portions, Herba Menthae 4～8 weight portions, Herba Lophatheri 2～5 weight portions, Herba Schizonepetae 2～5 weight portions, Radix Glycyrrhizae 2～8 weight portions, Semen Sojae Preparatum 3～7 weight portions, acetaminophen 5～12 weight portions.
Consisting of after preferred: Flos Lonicerae 10 weight portions, Fructus Arctii 6 weight portions, Fructus Forsythiae 10 weight portions, Radix Platycodonis 6 weight portions, Herba Menthae 6 weight portions, Herba Lophatheri 4 weight portions, Herba Schizonepetae 4 weight portions, Radix Glycyrrhizae 5 weight portions, Semen Sojae Preparatum 5 weight portions, acetaminophen 10 weight portions.
In the prescription, be monarch drug more than with Flos Lonicerae, Fructus Forsythiae, the existing suffering table that cools completely, the effect of heat-clearing and toxic substances removing has the effect of repelling foulness with aromatics again, when Xie Wei divides pathogenic factor in the exterior thoroughly, has taken into account the characteristics that warm pathogenic factor is held foul gas under the arm more.Herba Menthae, Fructus Arctii acrid in the mouth and cool in nature, dispelling wind and heat pathogens, the clear sharp head, but and resolving toxin and disinhibiting the throat; Herba Schizonepetae, Semen Sojae Preparatum suffering and tepor, the principal drug assistance dispelling exopathogens from superficies of the body, diathermanous going out, hot and not strong though both belong to hot temperature these, temperature and not dry with the hot medicine of a cold nature compatibility of group, can increase the power of the hot expelling pathogenic factors from the exterior that looses, and all is ministerial drug.The Herba Lophatheri clearing away heat and promoting production of body fluid, Radix Platycodonis lung qi dispersing relieving cough and resolving phlegm is all adjuvant drug.But Radix Glycyrrhizae is coordinating the actions of various ingredients in a prescription both, protects the stomach regulating the spleen and stomach, can close the Radix Platycodonis clearing throat again, and the compatibility acetaminophen to strengthen full side's antipyretic effect, is to belong to assistant to make it to use.Relieving the exterior syndrome with drugs of pungent in flavor and cool in nature are played, heat-clearing and toxic substances removing, the effect of antipyretic-antalgic altogether by full side, be mainly used in Common Cold, fever and headache, xerostomia cough, have sore throat, such as influenza, acute tonsillitis, measles from the beginning of, and " encephalitis b ", " epidemic encephalitis ", parotitis etc. are defended branch wind heat patient from the beginning of genus.
This Chinese medicine composition can be made into multiple dosage form for making things convenient for clinical practice, comprises tablet, capsule, granule, soft capsule, pill etc.The inventor studies the preparation method of these dosage forms, and research emphasis is to extract FF.
Basic preparation process is: get crude drug, half balloonflower powder of measuring is broken into fine powder, sieve; Flos Lonicerae adds water temperature to be soaked, and leachate is standby; After Herba Menthae, Herba Schizonepetae added immersion, vapor distillation extracts volatile oil, and was standby; Aqueous solution after distillation device is in addition preserved, and medicinal residues and Fructus Arctii, Fructus Forsythiae, Herba Lophatheri, Radix Glycyrrhizae and residue Radix Platycodonis decoct with water, and collecting decoction filters; After Semen Sojae Preparatum adds water boil,, merge leachate, filter in 80 ℃ of warm macerating secondaries, standby; Merge above each medicinal liquid, be condensed into thick paste, spray drying gets extract powder, with Radix Platycodonis fine powder and acetaminophen, volatile oil mixing, makes required dosage form again.
Volatile oil in the above technology also can be used the betacyclodextrin inclusion earlier, is used further to preparation.
After the inventor has studied multiple dosage form, the preferred preparation method of capsule, process is as follows:
Get crude drug, will partly measure balloonflower powder and be broken into fine powder, sieve; Flos Lonicerae adds 80 ℃ of warm macerating secondaries of 15 times of water gagings, and each 2 hours, leachate was standby; Herba Menthae, Herba Schizonepetae add 10 times of water gagings, soak after 2 hours, extracted volatile oil 8 hours with steam distillation, volatile oil betacyclodextrin enclose, 40 ℃ of dryings of clathrate, pulverize, standby, the aqueous solution after distillation device is in addition preserved, medicinal residues and Fructus Arctii, Fructus Forsythiae, Herba Lophatheri, Radix Glycyrrhizae and residue Radix Platycodonis add 10 times of water gagings and decoct secondary, each 2 hours, collecting decoction filtered; After Semen Sojae Preparatum adds 8 times of water gagings and boils, in 80 ℃ of warm macerating secondaries, each 2 hours, merge leachate, filter; Merge above each medicinal liquid, be condensed into thick paste, spray drying gets extract powder, with Radix Platycodonis fine powder and acetaminophen, volatile oil clathrate compound fine powder mixing, crosses 100 mesh sieves again, incapsulates, promptly.
In the process of research pharmaceutical composition of the present invention and preparation method thereof, in order to control product quality, the inventor has also formulated method of quality control, thereby should belong to same inventive concept with pharmaceutical composition of the present invention and preparation method.This method of quality control contains qualitative identification and assay two parts, and division is as follows.
Qualitative identification:
A. get the medicated powder of drug combination preparation of the present invention, put microscopically and observe, as seen connect latex dust diameter 14～25 μ l, contain faint yellow granular substance;
B. get the medicated powder of the drug combination preparation of the present invention that is equivalent to acetaminophen 40mg, porphyrize is put in the 250ml measuring bottle, add 0.4% sodium hydroxide solution 50ml and water 50ml, jolting 15 minutes, thin up is to scale, shake up, filter, discard filtrate just with dry filter paper, precision is measured subsequent filtrate 5ml, puts in the 100ml measuring bottle, adds 0.4% sodium hydroxide solution 10ml, thin up is to scale, shake up, according to spectrophotometry, there is absorption maximum at the place at the 257nm wavelength;
C. get the medicated powder 2～5g of drug combination preparation of the present invention, add water 15ml and make dissolving, with ether extraction 3 times, each 15ml, extracting solution merges, and evaporate to dryness, residue add ethyl acetate 2ml makes dissolving, as need testing solution; Other gets the Mentholum reference substance, adds methanol and makes the solution that every 1ml contains 2mg, in contrast product solution; Get the Herba Schizonepetae oil reference substance again, add ethyl acetate and make the solution that every 1ml contains 0.05ml, in contrast product solution; Test according to thin layer chromatography, draw Mentholum, each 2 μ l of Herba Schizonepetae oil reference substance solution, need testing solution 4 μ l, putting respectively on same silica gel H lamellae, is developing solvent with cyclohexane extraction-ethyl acetates of 6: 1, launches, take out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to speckle colour developing at 105 ℃; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
Assay can be following any or two kinds of combinations:
A. spectrophotometry acetaminophen content
Get the medicated powder of drug combination preparation of the present invention, porphyrize, precision takes by weighing the amount that is equivalent to acetaminophen 40mg, put in the 250ml measuring bottle, add 0.4% sodium hydroxide solution 50ml and water 50ml, jolting 15 minutes, thin up is to scale, shake up, filter, discard filtrate just with dry filter paper, precision is measured subsequent filtrate 5ml, put in the 100ml measuring bottle, add 0.4% sodium hydroxide solution 10ml, thin up is to scale, shake up, with the reagent corresponding is blank, measures trap at 257nm wavelength place, presses acetaminophen C
8H
9NO
2Absorptance be 715 to calculate, promptly;
B. high effective liquid chromatography for measuring Flos Lonicerae
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; The phosphoric acid solution of 10: 90 acetonitrile-0.4% is a mobile phase; The detection wavelength is 327nm; Number of theoretical plate calculates by the chlorogenic acid peak should be not less than 1000;
It is an amount of that the preparation precision of reference substance solution takes by weighing the chlorogenic acid reference substance, adds 50% methanol and make the solution that every 1ml contains 30 μ g, promptly;
The medicated powder of drug combination preparation of the present invention is got in the preparation of need testing solution, and porphyrize is got 0.28～0.32g, the accurate title, decide, and puts in the tool plug conical flask, the accurate 50% methanol 50ml that adds, close plug claims to decide weight, supersound process 30 minutes, take out, put coldly, claim to decide weight again, supply the weight that subtracts mistake with 50% methanol, shake up, filter with 0.45 μ m microporous filter membrane, get subsequent filtrate, promptly;
Accurate respectively reference substance solution 5 μ l and the need testing solution 10 μ l of drawing inject chromatograph of liquid, measure, promptly.
So far, the inventor has finished its all technology contents, has reached its goal of the invention.Pharmaceutical composition of the present invention has relieving the exterior syndrome with drugs of pungent in flavor and cool in nature, heat-clearing and toxic substances removing, and the effect of antipyretic-antalgic can be used for treating Common Cold, fever and headache, xerostomia cough, disease such as have sore throat.For proving its therapeutic effect, the inventor has carried out randomized clinical trial, and used medicine is made by optimal proportion of the present invention, and process is as follows:
Picked at random clinic case 50 examples, each 25 example of men and women, 18～60 years old mean age, average 35.6 years old; All be diagnosed as Common Cold, wherein 36 examples have the fever and headache symptom, and 18 examples with have sore throat, 14 examples are with xerostomia cough, 2 example companion rhinorrhea with clear discharges; Other has 11 routine acomia heat symptom-complex shapes, but has sore throat; Also have 3 routine xerostomia coughs, headache.All case is all taken capsule of the present invention, every day 3 times, each 2, serve on 3 days.Beginning after 24 to observe from taking medicine, be effective with the sx, is healing with the symptom complete obiteration.
The results are shown in following table:
Annotate: 1, residue case symptom in the time of the 3rd day obviously alleviates, continue to take one day after, symptom also disappears substantially.
2, all cases are not all found any side effect.
By the result as seen, Chinese medicine composition of the present invention all has the obvious treatment effect to the various symptoms due to the Common Cold, and the generation that has no side effect.The inventor has reached its goal of the invention.
Below further specify technical scheme of the present invention with the specific embodiment, but protection scope of the present invention is not limited to these dosage forms.
The specific embodiment:
Embodiment 1:
(prescription): Flos Lonicerae 5kg, Fructus Arctii 3kg, Fructus Forsythiae 5kg, Radix Platycodonis 3kg, Herba Menthae 4kg, Herba Lophatheri 2kg, Herba Schizonepetae 2kg, Radix Glycyrrhizae 2kg, Semen Sojae Preparatum 3kg, acetaminophen 5kg.
(method for making): get the 1.5kg balloonflower powder and be broken into fine powder, sieve; Flos Lonicerae adds 70 ℃ of warm macerating of 20 times of water gagings 3 hours, and leachate is standby; Herba Menthae, Herba Schizonepetae add to be soaked after 1 hour, and vapor distillation extracts volatile oil and do not distillate to there being oil, and it is standby to collect volatile oil; Aqueous solution after distillation device is in addition preserved, and medicinal residues and Fructus Arctii, Fructus Forsythiae, Herba Lophatheri, Radix Glycyrrhizae and residue Radix Platycodonis add 10 times of water gagings and decocts 2 times, and each 1.5 hours, collecting decoction filtered; After Semen Sojae Preparatum adds 5 times of water gagings and boils, in 80 ℃ of warm macerating secondaries, each 1 hour, merge leachate, filter, standby; Merge above each medicinal liquid, be condensed into thick paste, spray drying gets extract powder, mixes with Radix Platycodonis fine powder and acetaminophen again, and with 80% alcohol granulation, oven dry, granulate spray into the alcoholic solution of volatile oil, hot blast drying, and compacting is in blocks, coating, promptly.
Embodiment 2:
(prescription): Flos Lonicerae 15kg, Fructus Arctii 9kg, Fructus Forsythiae 15kg, Radix Platycodonis 9kg, Herba Menthae 8kg, Herba Lophatheri 5kg, Herba Schizonepetae 5kg, Radix Glycyrrhizae 8kg, Semen Sojae Preparatum 7kg, acetaminophen 12kg.
(method for making): get crude drug, the 4.5kg balloonflower powder is broken into fine powder, sieve; Flos Lonicerae adds 80 ℃ of warm macerating secondaries of 15 times of water gagings, and each 2 hours, leachate was standby; Herba Menthae, Herba Schizonepetae add 10 times of water gagings, soak after 2 hours, extracted volatile oil 8 hours with steam distillation, volatile oil betacyclodextrin enclose, 40 ℃ of dryings of clathrate, pulverize, standby, the aqueous solution after distillation device is in addition preserved, medicinal residues and Fructus Arctii, Fructus Forsythiae, Herba Lophatheri, Radix Glycyrrhizae and residue Radix Platycodonis add 10 times of water gagings and decoct secondary, each 2 hours, collecting decoction filtered; After Semen Sojae Preparatum adds 8 times of water gagings and boils, in 80 ℃ of warm macerating secondaries, each 2 hours, merge leachate, filter; Merge above each medicinal liquid, be condensed into thick paste, spray drying gets extract powder, with Radix Platycodonis fine powder and acetaminophen, volatile oil clathrate compound fine powder mixing, crosses 100 mesh sieves again, incapsulates, promptly
Embodiment 3:
(prescription): Flos Lonicerae 10kg, Fructus Arctii 5kg, Fructus Forsythiae 10kg, Radix Platycodonis 9kg, Herba Menthae 4kg, Herba Lophatheri 4kg, Herba Schizonepetae 5kg, Radix Glycyrrhizae 2kg, Semen Sojae Preparatum 5kg, acetaminophen 8kg.
Method for making: get crude drug, the balloonflower powder of 4.5kg is broken into fine powder, sieve; Flos Lonicerae adds 80 ℃ of warm macerating of 10 times of water gagings 3 hours, and leachate is standby; Herba Menthae, Herba Schizonepetae add 10 times of water gagings and are dipped to, and vapor distillation extracted volatile oil 3 hours, and is standby; Aqueous solution after the distillation in addition device is preserved, and medicinal residues and Fructus Arctii, Fructus Forsythiae, Herba Lophatheri, Radix Glycyrrhizae and residue Radix Platycodonis add 15 times of water gagings and decocts three times, and 2 hours for the first time, for the second time, each 1.5 hours for the third time, collecting decoction, filtration; After Semen Sojae Preparatum adds 10 times of water gagings and boils,, merge leachate, filter in 80 ℃ of warm macerating secondaries, standby; Merge above each medicinal liquid, be condensed into thick paste, spray drying gets extract powder, again with Radix Platycodonis fine powder and acetaminophen mixing, sprays into the alcoholic solution of volatile oil, and hot blast drying is made granule, packing, promptly.
Embodiment 4:
(prescription): Flos Lonicerae 15kg, Fructus Arctii 3kg, Fructus Forsythiae 5kg, Radix Platycodonis 9kg, Herba Menthae 6kg, Herba Lophatheri 4kg, Herba Schizonepetae 5kg, Radix Glycyrrhizae 5kg, Semen Sojae Preparatum 4kg, acetaminophen 5kg.
(method for making): get crude drug, the 4.5kg balloonflower powder is broken into fine powder, sieve; Flos Lonicerae adds 70 ℃ of warm macerating of 8 times of water, and leachate is standby; Herba Menthae, Herba Schizonepetae add 10 times of water gagings to be soaked 2 hours, and vapor distillation extracted volatile oil 5 hours, and volatile oil is standby; Aqueous solution after distillation device is in addition preserved, and medicinal residues and Fructus Arctii, Fructus Forsythiae, Herba Lophatheri, Radix Glycyrrhizae and residue Radix Platycodonis add 10 times of water gagings of water and decocts three times, and each 1.5 hours, collecting decoction filtered; After Semen Sojae Preparatum adds 12 times of water gagings and boils,, merge leachate, filter in 80 ℃ of warm macerating secondaries, standby; Merge above each medicinal liquid, be condensed into thick paste, spray drying gets extract powder, again with Radix Platycodonis fine powder and acetaminophen mixing, is blended into the soybean oil and the volatile oil of 1.5 times of amounts, and mixing is pressed into soft capsule, promptly.
Embodiment 5:
The capsule that embodiment 2 is made carries out quality inspection:
This product content is got in [discriminating] (1), puts microscopically and observes: connect latex dust diameter 14～25 μ m, contain faint yellow granular substance.
(2) get the solution under [assay] item, according to spectrophotometry, there is absorption maximum at the place at the 257nm wavelength.
(3) get this product content 3g, add water 15ml and make dissolving, with ether extraction 3 times, each 15ml, extracting solution merges, and evaporate to dryness, residue add ethyl acetate 2ml makes dissolving, as need testing solution.Other gets the Mentholum reference substance, adds methanol and makes the solution that every 1ml contains 2mg, in contrast product solution; Get the Herba Schizonepetae oil reference substance again, add ethyl acetate and make the solution that every 1ml contains 0.05ml, in contrast product solution.Test according to thin layer chromatography, draw Mentholum, each 2 μ l of Herba Schizonepetae oil reference substance solution, need testing solution 4 μ l, putting respectively on same silica gel H lamellae, is developing solvent with cyclohexane extraction ethyl acetate (6: 1), launches, take out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
[assay] (1) is according to the spectrophotometry acetaminophen.
Get this product content under the content uniformity item, porphyrize, precision takes by weighing in right amount (being equivalent to acetaminophen 40mg approximately), put in the 250ml measuring bottle, add 0.4% sodium hydroxide solution 50ml and water 50ml, jolting 15 minutes, thin up is to scale, shake up, filter, discard filtrate just with dry filter paper, precision is measured subsequent filtrate 5ml, put in the 100ml measuring bottle, add 0.4% sodium hydroxide solution 10ml, thin up is to scale, shake up, with the reagent corresponding is blank, measures trap at 257nm wavelength place, presses acetaminophen (C
8H
9NO
2) absorptance (E1%1cm) be 715 to calculate, promptly.
Every of this product contains acetaminophen (C
8H
9NO
2) should be 180～220mg.
(2) according to the high effective liquid chromatography for measuring Flos Lonicerae.
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; The phosphoric acid solution of acetonitrile-0.4% (10: 90) is a mobile phase; The detection wavelength is 327nm.Number of theoretical plate calculates by the chlorogenic acid peak should be not less than 1000.
It is an amount of that the preparation precision of reference substance solution takes by weighing the chlorogenic acid reference substance, adds 50% methanol and make the solution that every 1ml contains 30 μ g, promptly gets (preserving below 10 ℃).
This product content under the content uniformity item is got in the preparation of need testing solution, and porphyrize is got about 0.3g, the accurate title, decide, and puts in the tool plug conical flask, the accurate 50% methanol 50ml that adds, close plug claims to decide weight, supersound process 30 minutes, take out, put coldly, claim to decide weight again, supply the weight that subtracts mistake with 50% methanol, shake up, filter with microporous filter membrane (0.45 μ m), get subsequent filtrate, promptly.
Accurate respectively reference substance solution 5 μ l and the need testing solution 10 μ l of drawing inject chromatograph of liquid, measure, promptly.
Every of this product contains Flos Lonicerae with chlorogenic acid (C
16H
18O
9) meter, must not be less than 0.4mg.
Claims (9)
1. a pharmaceutical composition is characterized in that this pharmaceutical composition is to be made by the crude drug of following weight ratio: Flos Lonicerae 5～15 weight portions, Fructus Arctii 3～9 weight portions, Fructus Forsythiae 5～15 weight portions, Radix Platycodonis 3～9 weight portions, Herba Menthae 4～8 weight portions, Herba Lophatheri 2～5 weight portions, Herba Schizonepetae 2～5 weight portions, Radix Glycyrrhizae 2～8 weight portions, Semen Sojae Preparatum 3～7 weight portions, acetaminophen 5～12 weight portions.
2. pharmaceutical composition according to claim 1 is characterized in that the optimal proportion of this drug regimen raw material: Flos Lonicerae 10 weight portions, Fructus Arctii 6 weight portions, Fructus Forsythiae 10 weight portions, Radix Platycodonis 6 weight portions, Herba Menthae 6 weight portions, Herba Lophatheri 4 weight portions, Herba Schizonepetae 4 weight portions, Radix Glycyrrhizae 5 weight portions, Semen Sojae Preparatum 5 weight portions, acetaminophen 10 weight portions.
3. pharmaceutical composition as claimed in claim 1 or 2 is characterized in that this pharmaceutical composition is made into any in tablet, capsule, granule, soft capsule, the pill.
4. as preparation of drug combination method as described in the claim 3, it is characterized in that this method is through following steps: get crude drug, the balloonflower powder of half amount is broken into fine powder, sieve; Flos Lonicerae adds water temperature to be soaked, and leachate is standby; After Herba Menthae, Herba Schizonepetae were soaked, vapor distillation extracts volatile oil, and was standby; Aqueous solution after distillation device is in addition preserved, and medicinal residues and Fructus Arctii, Fructus Forsythiae, Herba Lophatheri, Radix Glycyrrhizae and residue Radix Platycodonis decoct with water, and collecting decoction filters; After Semen Sojae Preparatum adds water boil,, merge leachate, filter in 80 ℃ of warm macerating secondaries, standby; Merge above each medicinal liquid, be condensed into thick paste, spray drying gets extract powder, with Radix Platycodonis fine powder and acetaminophen, volatile oil mixing, makes required dosage form again.
5. preparation of drug combination method as claimed in claim 4 after it is characterized in that making the volatile oil of Herba Menthae and Herba Schizonepetae, is used the betacyclodextrin inclusion earlier, is used further to preparation.
6. preparation of drug combination method as claimed in claim 5 is characterized in that the preparation process of capsule is:
Get crude drug, will partly measure balloonflower powder and be broken into fine powder, sieve; Flos Lonicerae adds 80 ℃ of warm macerating secondaries of 15 times of water gagings, and each 2 hours, leachate was standby; Herba Menthae, Herba Schizonepetae add 10 times of water gagings, soak after 2 hours, extracted volatile oil 8 hours with steam distillation, volatile oil betacyclodextrin enclose, 40 ℃ of dryings of clathrate, pulverize, standby, the aqueous solution after distillation device is in addition preserved, medicinal residues and Fructus Arctii, Fructus Forsythiae, Herba Lophatheri, Radix Glycyrrhizae and residue Radix Platycodonis add 10 times of water gagings and decoct secondary, each 2 hours, collecting decoction filtered; After Semen Sojae Preparatum adds 8 times of water gagings and boils, in 80 ℃ of warm macerating secondaries, each 2 hours, merge leachate, filter; Merge above each medicinal liquid, be condensed into thick paste, spray drying gets extract powder, with Radix Platycodonis fine powder and acetaminophen, volatile oil clathrate compound fine powder mixing, crosses 100 mesh sieves again, incapsulates, promptly.
7. as the method for quality control of pharmaceutical composition as described in the claim 3, comprise qualitative identification and assay two parts, it is characterized in that qualitative identification contains any one or more the combination in the following method:
A. get the medicated powder of drug combination preparation of the present invention, put microscopically and observe, as seen connect latex dust diameter 14～25 μ m, contain faint yellow granular substance;
B. get the medicated powder of the drug combination preparation of the present invention that is equivalent to acetaminophen 40mg, porphyrize is put in the 250ml measuring bottle, add 0.4% sodium hydroxide solution 50ml and water 50ml, jolting 15 minutes, thin up is to scale, shake up, filter, discard filtrate just with dry filter paper, precision is measured subsequent filtrate 5ml, puts in the 100ml measuring bottle, adds 0.4% sodium hydroxide solution 10ml, thin up is to scale, shake up, according to spectrophotometry, there is absorption maximum at the place at the 257nm wavelength;
C. get the medicated powder 2～5g of drug combination preparation of the present invention, add water 15ml and make dissolving, with ether extraction 3 times, each 15ml, extracting solution merges, and evaporate to dryness, residue add ethyl acetate 2ml makes dissolving, as need testing solution; Other gets the Mentholum reference substance, adds methanol and makes the solution that every 1ml contains 2mg, in contrast product solution; Get the Herba Schizonepetae oil reference substance again, add ethyl acetate and make the solution that every 1ml contains 0.05ml, in contrast product solution; Test according to thin layer chromatography, draw Mentholum, each 2 μ l of Herba Schizonepetae oil reference substance solution, need testing solution 4 μ l, putting respectively on same silica gel H lamellae, is developing solvent with cyclohexane extraction-ethyl acetates of 6: 1, launches, take out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to speckle colour developing at 105 ℃; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
8. the method for quality control of pharmaceutical composition as claimed in claim 7 is characterized in that wherein this method of assay can be following a kind of or two kinds:
A. spectrophotometry acetaminophen content
Get the medicated powder of drug combination preparation of the present invention, porphyrize, precision takes by weighing the amount that is equivalent to acetaminophen 40mg, puts in the 250ml measuring bottle, adds 0.4% sodium hydroxide solution 50ml and water 50ml, jolting 15 minutes, thin up shakes up to scale, filters with dry filter paper, discard filtrate just, precision is measured subsequent filtrate 5ml, puts in the 100ml measuring bottle, adds 0.4% sodium hydroxide solution 10ml, thin up is to scale, shaking up, is blank with the reagent corresponding, measures trap at 257nm wavelength place, absorptance by acetaminophen C8H9NO2 is 715 calculating, promptly;
B. high effective liquid chromatography for measuring Flos Lonicerae
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; The phosphoric acid solution of 10: 90 acetonitrile-0.4% is a mobile phase; The detection wavelength is 327nm; Number of theoretical plate calculates by the chlorogenic acid peak should be not less than 1000;
It is an amount of that the preparation precision of reference substance solution takes by weighing the chlorogenic acid reference substance, adds 50% methanol and make the solution that every 1ml contains 30 μ g, promptly.
The medicated powder of drug combination preparation of the present invention is got in the preparation of need testing solution, and porphyrize is got 0.28～0.32g, the accurate title, decide, and puts in the tool plug conical flask, the accurate 50% methanol 50ml that adds, close plug claims to decide weight, supersound process 30 minutes, take out, put coldly, claim to decide weight again, supply the weight that subtracts mistake with 50% methanol, shake up, filter with 0.45 μ l microporous filter membrane, get subsequent filtrate, promptly;
Accurate respectively reference substance solution 5 μ l and the need testing solution 10 μ l of drawing inject chromatograph of liquid, measure, promptly.
9. pharmaceutical composition is used for the treatment of the application in the medicine of disease such as cough, have sore throat of Common Cold, fever and headache, xerostomia in preparation as claimed in claim 1 or 2.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510200673 CN1961943A (en) | 2005-11-07 | 2005-11-07 | Pharmaceutical composition for treating cold, its preparation method and quality control method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510200673 CN1961943A (en) | 2005-11-07 | 2005-11-07 | Pharmaceutical composition for treating cold, its preparation method and quality control method thereof |
Publications (1)
| Publication Number | Publication Date |
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| CN1961943A true CN1961943A (en) | 2007-05-16 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101596231B (en) * | 2009-06-25 | 2012-05-02 | 王战云 | Medicinal composition for treating parotitis |
| CN102085311B (en) * | 2009-12-02 | 2013-06-12 | 广州青蒿医药科技有限公司 | Traditional Chinese medicinal composition for preventing or treating common cold and/or flu, method for preparing same and application thereof |
| CN110187044A (en) * | 2019-01-17 | 2019-08-30 | 山东省农业科学院家禽研究所 | A kind of quality determining method of Yinqiao Jiedu oral liquid |
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2005
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101596231B (en) * | 2009-06-25 | 2012-05-02 | 王战云 | Medicinal composition for treating parotitis |
| CN102085311B (en) * | 2009-12-02 | 2013-06-12 | 广州青蒿医药科技有限公司 | Traditional Chinese medicinal composition for preventing or treating common cold and/or flu, method for preparing same and application thereof |
| CN110187044A (en) * | 2019-01-17 | 2019-08-30 | 山东省农业科学院家禽研究所 | A kind of quality determining method of Yinqiao Jiedu oral liquid |
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