CN101190282B - Sugar-free compound traditional Chinese medicinal preparation for treating upper respiratory tract infection and quality control method thereof - Google Patents
Sugar-free compound traditional Chinese medicinal preparation for treating upper respiratory tract infection and quality control method thereof Download PDFInfo
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- CN101190282B CN101190282B CN2006101294830A CN200610129483A CN101190282B CN 101190282 B CN101190282 B CN 101190282B CN 2006101294830 A CN2006101294830 A CN 2006101294830A CN 200610129483 A CN200610129483 A CN 200610129483A CN 101190282 B CN101190282 B CN 101190282B
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Abstract
The invention relates to a sugar-free traditional Chinese preparation used for treating upper respiratory tract infection, the preparation method and quality control thereof. The components of the prescription are 10-50 parts of hogfennel root, platycodi, snakegourd, Thomson kudzu and dried plum (fruit) respectively, 3-20 parts of santal and 0.001-0.1 part of menthe-camphor. The menthe-camphor isdissolved with appropriate amount of ethanol; santal extracts volatile oil and the distilled water solution is filtered to get solution A; the rest drug is added with 6-12 times of water and is decocted for 1-3 times, 1-3 hours every time; water decoction solution is combined and filtered, then the water decoction solution; the santal filtrate A are merged, and concentrated into paste with a relative density of 1.0 to 1.3 at 60 DEG C, and then mixed with medicinal excipient to be prepared into various preparations. Proved by the clinical observation for many years, the Chinese medicine preparations of the invention, especial the Hanhuashangqing tablet, have significant curative effect on the patients with acute and chronic aryngitis, tonsillitis and upper respiratory tract infection.
Description
Technical field
The invention belongs to the Chinese medicine preparation technical field, relate to a kind of sugar-free Chinese medicine preparation for the treatment of upper respiratory tract infection and preparation method thereof and method of quality control.
Background technology
Respiratory tract infection is worldwide commonly encountered diseases, frequently-occurring disease, bigger to human beings'health harm, upper respiratory tract infection mainly comprises: influenza and flu, wherein influenza is to be caused by special influenza virus, and this virus is also in frequent variation, in case will send out on a large scale after new influenza virus comes out, and the difference of influenza and flu is exactly that it is heavier than the symptom of flu, harm is big, spread scope is wide at once.If it is very serious that influenza is not treated consequence, can becomes lower respiratory infection by upper respiratory tract infection and finally cause pneumonia, even can also cause a lot of complication, as myocarditis, nephritis, pleuritis etc.If diabetes, heart disease were arranged in the past, got influenza after these diseases all might recur, therefore in time treat.From present investigation, respiratory tract infection is modal disease, particularly respiratory tract chronic infection and repeated infection are contemporary clinical medical a great problems, and such disease patient accounts for internal medicine prescription on individual diagnosis patient sum more than 30% for a long time, and still lacks ideal Therapeutic Method at present.
Summary of the invention
Technical problem to be solved by this invention is, according to Chinese medical theory provide that a kind of quality of the pharmaceutical preparations is stable, determined curative effect, safe and effective, be convenient to deposit and (general containing supernatant sheet by name) Chinese traditional compound medicine of the treatment respiratory tract infection used, the preparation method of said preparation is provided simultaneously.
Another object of the present invention is to provide the method for quality control of containing supernatant sheet.
Chinese traditional compound medicine of the present invention, its prescription forms and scope is:
Radix Peucedani 10-50 part Radix Platycodonis 10-50 part Radix Trichosanthis 10-50 part
Radix Puerariae 10-50 part Fructus Mume (meat) 10-50 part Lignum Santali Albi 3-20 part
Mentholum 0.021-0.1 part.
The preferred Chinese traditional compound medicine of the present invention, its prescription forms and scope is
Radix Peucedani 15-40 part Radix Platycodonis 15-40 part Radix Trichosanthis 15-40 part
Radix Puerariae 15-40 part Fructus Mume (meat) 15-40 part Lignum Santali Albi 5-15 part
Mentholum 0.025-0.075 part.
The Chinese traditional compound medicine that the present invention is more preferably, its prescription consists of:
33 parts of 33 parts of Radix Trichosanthis of 33 parts of Radix Platycodoniss of Radix Peucedani
8 parts in 33 portions of Lignum Santali Albis of 33 portions of Fructus Mumes of Radix Puerariae (meat)
0.042 part of Mentholum.
In more than forming, every part of representative be weight portion.Weight is calculated with crude drug, easily, if be unit with the gram, more than forms and can be made into 100 doses of pharmaceutical preparatioies, described 1000 doses of fingers, the final drug preparation of making is as making 1000 of capsules, 1000 bags of granules, oral liquid 1000ml, 1000 in tablet or the like, specifically can be tablet, buccal, a 1-2 sheet, every heavy 0.3 gram, every day 4-8 time or containing at any time.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, can be unit with the kilogram or be unit as large-scale production with the ton, small-scale production can be that Unit Weight can increase or dwindle with the gram, but the constant rate of the raw medicinal herbs weight proportion between each composition.
Containing supernatant sheet of the present invention derives from clear that Chinese first Public Records Office records.Drive the pharmacy prescription, mainly be the treatment upper respiratory tract mucosa moistening dry sensation that brings out, acute/chronic pharyngitis, the flat upper respiratory tract infection such as adenitis of choosing, its above-mentioned weight proportion is to obtain through secular, a large amount of experimental science screenings, for special patient, can adjust the proportioning of the amount of composition accordingly, increase or reduce being no more than 100%, drug effect is constant.
The upper respiratory tract infection cause of disease, motherland's medical science thinks that lung loses the machine of logical accent, metabolism is abundant inadequately, violate event on the human body inner product heat, must ask its principle according to curing the disease, we have selected favourable lung qi for use, promote the secretory Radix Peucedani of respiratory mucus, Radix Platycodonis is from moistening respiratory tract and eliminating the phlegm, auxilliary on this basis from pollen, Radix Puerariae, Fructus Mume etc. are moisturized the product that the relieving restlessness of promoting the production of body fluid is quenched the thirst in a large number, purpose is to make its cooperation Radix Peucedani, Radix Platycodonis improves, enlarge, alleviate, moisten the effect of respiratory tract drying, join Lignum Santali Albi, Mentholum is in order that regulate the flow of vital energy except that full it, and is refrigerant analgesic dried to eliminate throat, the dry fullness in the chest of bringing of mouth and nose is not relaxed.It is appropriate to make a general survey of the shared seven flavor medicine compatibility of full side, has brought into play sharp lung jointly and has promoted the production of body fluid, and it is analgesic to regulate the flow of vital energy, and reaches above-mentioned effect.
Chinese medicine preparation of the present invention can be common oral formulations such as buccal tablet, granule, capsule, oral liquid, pill, powder or drop pill or the like.Preferably buccal tablet, granule, capsule, drop pill, more preferably buccal tablet.
Chinese medicine preparation of the present invention, when being prepared into medicament, can add the medicine acceptable auxiliary, described acceptable accessories, comprise diluent conventional in the preparation, filler is (as mannitol, lactose, Polyethylene Glycol), binding agent (starch, microcrystalline Cellulose), disintegrating agent is (as carboxymethyl cellulose, the low hydroxypropyl cellulose that replaces), lubricant is (as Pulvis Talci, magnesium stearate), wetting agent is (as propylene glycol, ethanol), stabilizing agent (EDTA-2Na, sodium thiosulfate, sodium pyrosulfite, sodium sulfite, ethanolamine, sodium bicarbonate, nicotiamide) or the like.
Wherein an amount of correctives refers to stevioside, citron sugar, xylitol or sorbitol, preferred xylitol.Xylitol be a kind ofly from materials such as corn cob, bagasse, extract, the novel sweetener and the senior treatment food of pure natural.Its flavor is sweet, the outward appearance crystal powder powder that is white in color, and sugariness is equivalent to sucrose.Xylitol not only without insulin, and can also promote secretion of insulin in the metabolism of the person, so xylitol good nutrient and the auxiliary therapeutical agent that be the diabetes patient.
Above-mentioned adjuvant can be a common dose, mixes with the main constituent extract with proportioning commonly used, and after main constituent extract consumption was determined, the proportioning between each pharmaceutic adjuvant can suitably be regulated as required.
Preparation of the present invention is determined usage and dosage according to patient's situation in use, but obeys 4-8 time every day, each 1-2 sheet, containing at any time.
Chinese medicine preparation of the present invention prepares by the following method.
(1) Lignum Santali Albi is adopted steam distillation, and it is standby to extract volatile oil, and the A medicinal residues that filter to get filtrate of the aqueous solution after the distillation are abandoned it;
(2) Radix Peucedani, Radix Platycodonis, Radix Trichosanthis, Radix Puerariae, Fructus Mume add 6-12 times of decocting and boil 1-3 time, and each 1-3 hour, merge decocting liquid, filter;
(3) decocting liquid and Lignum Santali Albi filtrate A merge, and 60 ℃ to be concentrated into 1.0～1.3 one-tenth cream of relative density standby;
(4) above-mentioned one-tenth cream is mixed with pharmaceutic adjuvant and an amount of correctives, with 60% ethanol system granule, drying; With an amount of dissolve with ethanol of Oleum Santali albi, Mentholum, add granule again, add pharmaceutic adjuvant, mix homogeneously is made oral formulations.
The present invention preferably containing supernatant sheet prepares by the following method.
(1) Lignum Santali Albi is adopted steam distillation, and it is standby to extract volatile oil, and the A medicinal residues that filter to get filtrate of the aqueous solution after the distillation are abandoned it;
(2) Radix Peucedani, Radix Platycodonis, Radix Trichosanthis, Radix Puerariae, Fructus Mume add 6-12 times of decocting and boil 1-3 time, and each 1-3 hour, merge decocting liquid, filter;
(3) decocting liquid and Lignum Santali Albi filtrate A merge, and 60 ℃ to be concentrated into 1.2～1.25 one-tenth cream of relative density standby;
(4), add starch 15-100g, mixing, drying with in the above-mentioned one-tenth cream.Other adds starch 15-100g, microcrystalline Cellulose 10-60g, xylitol 50-200g, and mix homogeneously is ground into fine powder, with 60% ethanol system granule, drying; Again with an amount of dissolve with ethanol of Oleum Santali albi, Mentholum, add granule, add aspartame 0.3-1g, magnesium stearate is an amount of, mix homogeneously is pressed into 1000.
The present invention also provide the method for quality control of Chinese medicine preparation concrete be: the discrimination method of containing supernatant sheet comprises to be differentiated and assay.
[inspection] this product is not except that checking disintegration, and other should meet every regulation relevant under the tablet item (appendix ID of Chinese Pharmacopoeia version in 2005).
Microbial limit: media dilution method (10 is adopted in count of bacteria
-1Diluent 0.2ml/ ware) measures; Mycete and yeast count are measured and are adopted conventional method (10
-1Diluent 1ml/ ware) measures; Escherichia coli adopts the conventional method inspection.
[discriminating] (1) Radix Peucedani is differentiated: get this product, remove film-coat, porphyrize is got powder 5g, the 10ml that adds diethyl ether, and reflux, extract, 1 hour leaves standstill, and filters, and filtrate evaporate to dryness, the residue 2ml that adds diethyl ether makes dissolving, as need testing solution.Other gets Radix Peucedani control medicinal material 0.5g, shines medical material solution in pairs with legal system.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with petroleum ether (60～90 ℃)-ethyl acetate (3: 1) is developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
(2) Radix Platycodonis is differentiated: get this product, remove film-coat, porphyrize is got powder 5g, adds water 30ml, chloroform 30ml, hydrochloric acid 6ml, reflux, extract, 1 hour leaves standstill, and puts cold, divide and get the chloroform layer, filter, evaporate to dryness, residue add ethanol 1ml makes dissolving, as need testing solution.Other gets Radix Platycodonis control medicinal material 0.5g, shines medical material solution in pairs with legal system.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with chloroform-ether (1: 1) is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the 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.
(3) Radix Puerariae is differentiated: get this product, remove film-coat, porphyrize is got powder 1g, adds methanol 10ml, and supersound extraction 30 minutes leaves standstill, and filters, and filtrate is concentrated into 1ml, as need testing solution.Other gets Radix Puerariae control medicinal material 0.8g, shines medical material solution in pairs with legal system.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw each 5 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel H lamellae of adhesive with the sodium carboxymethyl cellulose, with chloroform-methanol-water (7: 2.5: 0.25) is developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
[assay] photograph high performance liquid chromatography (" Chinese pharmacopoeia version-appendix VI D of portion in 2005) measure.
Chromatographic condition and system suitability test octadecylsilane chemically bonded silica are filler; Methanol-water-glacial acetic acid (30: 70: 0.5) is a mobile phase; The detection wavelength is 250nm.Number of theoretical plate calculates by puerarin peak should be not less than 3000, and the separating degree of puerarin peak and adjacent peak should requirement up to specification.
It is an amount of that the puerarin reference substance is got in the preparation of reference substance solution, and accurate the title decides, and adds 30% ethanol and makes the solution that every 1ml contains 6 μ g, promptly.
20 of this product are got in the preparation of need testing solution, remove film-coat, and accurate the title decides, porphyrize is got powder 0.5g, and accurate the title decides, put in the tool plug conical flask, the accurate 30% ethanol 25ml that adds claims to decide weight, supersound process 30 minutes is put coldly, claims to decide weight, supply the weight that subtracts mistake with 30% ethanol, shake up, filter, get subsequent filtrate, promptly.This product is a Film coated tablets, removes behind the coating to show light brown; Gas fragrance, little cold, sweet and sour.
The present invention further discloses Chinese traditional compound medicine, the particularly application of containing supernatant sheet in treatment acute/chronic pharyngitis, the flat upper respiratory tract infection medicine of choosing adenitis, mainly carried out clinical observation at Tianjin Chest Hospital's combination of Chinese and Western medicine Pneumology Department, its result is as follows:
Source of data: select to suffer from acute/chronic pharyngitis, flat patient's 50 examples of choosing adenitis and suffering from upper respiratory tract infection, major part is the out-patient, minority is an inpatient, and wherein the age reckling is 12 years old, and maximum patient is 69 years old, 40.5 years old mean age, male 18 people, women 32 people, every day 4-8 time, each containing of 1-2 sheet, 3-7 days continuously.Observation of curative effect; See Table 1
Containing supernatant sheet 50 routine observation of curative effect tables
The whole disappearance of symptom such as sign is produce effects in the table 1, and part or most of disappearance are for effective, and no change or carrying out property increase the weight of to invalid, and total effective rate is that produce effects adds effectively.Table 1 shows that this medicine is stifled to swallowing, the disappearing of sings and symptoms of dry pharynx, pharyngeal hyperemia, pharyngeal swelling pain, tonsillitis etc. has significant curative effect, all the other are all more than 78%, reference is only done in influence to pneumonia, because of the inpatient clothes expectorant that in this medicine of clothes, has, less because of routine number not as foundation to the influence of pulmonary's sign.
Typical case's case history
Example 1 Lee * *: women 27 years old.Diagnosis: bronchial asthma, chronic pharyngitis.Clinical manifestation: dry pharynx is arranged, pharyngalgia except that paroxysmal is breathed heavily.Have a medical check-up: the hyperemia of pharynx pod portion, two lungs are dispersed in does ring.August containing supernatant on the 16th sheet, each 2, every day 4 times, containing a week back dry pharynx, the pharyngalgia symptom all disappears.
Example 2 sand * *: male 59 years old.Diagnosis: bronchial asthma, emphysema, acute pharyngitis.Clinical manifestation: the stifled sense of pharynx and a spot of white expectorant are arranged except that paroxysmal is breathed heavily.Have a medical check-up: pharyngeal mild hyperaemia, two lungs are dispersed in dried moist rale.August containing supernatant on the 16th sheet, each 1, every day 8 times, the pharyngeal symptom in containing week back all disappears.
Example 3 Xiao * *: women 45 years old.Diagnosis: acute pharyngitis.Clinical manifestation: the stifled sense of pharynx, dry pharynx celostomia.Have a medical check-up: pharyngeal congestion, edema.JIUYUE containing supernatant on the 28th sheet, each 1,8 containing were promptly felt pharyngalgia and alleviate next day every day, celostomia takes a turn for the better, former speak to send out not speak can sound in second day, containing after the week pharyngeal symptom all disappear.
Chinese traditional compound medicine of the present invention, particularly containing supernatant sheet is compared with the Chinese medicine preparation of existing treatment upper respiratory tract infection and had following advantage: containing supernatant sheet of the present invention is remarkably productive to the patient treatment of suffering from upper respiratory tract infection, and effective percentage is up to more than 90%.The particularly development of sugar-free preparation, the patient who is more suitable for suffering from diabetes takes.
The specific embodiment
Embodiment 1
[prescription] Radix Peucedani 33g, Radix Platycodonis 33g, Radix Trichosanthis 33g, Radix Puerariae 33g, Fructus Mume (meat) 33g, Lignum Santali Albi 8g, Mentholum 0.042g.
[method for making] above seven flavors, it is standby that Lignum Santali Albi is extracted volatile oil, and the aqueous solution after the distillation filters.Radix Peucedani, Radix Platycodonis, Radix Trichosanthis, Radix Puerariae, Fructus Mume add 12 times of decoctings and boil secondary, and each 2 hours, merge decocting liquid, filter, be condensed into cream (surveying proportion 1.2 for 60 ℃) merging of filtrate and Lignum Santali Albi filtrate; Add starch 55g, mixing, drying.Other adds starch 85g, xylitol 125g, and aspartame 0.6g, mix homogeneously is ground into fine powder, with 60% ethanol system granule, drying; With an amount of dissolve with ethanol of Oleum Santali albi, Mentholum, add granule again, the adding magnesium stearate is an amount of, and mix homogeneously is pressed into 1000, every heavy 0.3g.
Embodiment 2
Prescription: Radix Peucedani 10g, Radix Platycodonis 10g, Radix Trichosanthis 10g, Radix Puerariae 10g, Fructus Mume (meat) 10g, Lignum Santali Albi 3g, Mentholum 0.021g.
Preparation method:
(1) Lignum Santali Albi 3g adopts steam distillation, and it is standby to extract volatile oil, the A that filters to get filtrate of the aqueous solution after the distillation;
(2) Radix Peucedani, Radix Platycodonis, Radix Trichosanthis, Radix Puerariae, each 10g of Fructus Mume add 12 times of decoctings and boil 3 times, and each 3 hours, merge decocting liquid, filter;
(3) decocting liquid and Lignum Santali Albi filtrate A merge, and 60 ℃ are concentrated into 1.20 one-tenth cream of relative density, add starch 35g, mixing, drying.Add starch 55g, mixing, drying.Other adds xylitol 210g, and mix homogeneously is ground into fine powder, Oleum Santali albi, Mentholum is added with an amount of dissolve with ethanol, with 60% ethanol system granule, drying again.Every packed 1g should go out 300 bags.
Embodiment 3
Prescription: Radix Peucedani 50g, Radix Platycodonis 50g, Radix Trichosanthis 50g, Radix Puerariae 50g, Fructus Mume 50g, Lignum Santali Albi 20g, Mentholum 0.1g.
Preparation method:
(1) Lignum Santali Albi 20g adopts steam distillation, and it is standby to extract volatile oil, and the A medicinal residues that filter to get filtrate of the aqueous solution after the distillation are abandoned it.
(2) Radix Peucedani, Radix Platycodonis, Radix Trichosanthis, Radix Puerariae, each 50g of Fructus Mume add 8 times of decoctings and boil 2 times, and each 3 hours, merge decocting liquid, filter;
(3) decocting liquid and Lignum Santali Albi filtrate A merge, and 60 ℃ are concentrated into 1.3 one-tenth cream of relative density, add starch 35g, mixing, drying.Other adds starch 100g, microcrystalline Cellulose 60g, citron sugar 175g, and mix homogeneously is ground into fine powder, with 60% ethanol system granule, drying; Again with an amount of dissolve with ethanol of Oleum Santali albi, Mentholum, add granule, add aspartame 1g, magnesium stearate is an amount of, mix homogeneously is pressed into 1000.
Embodiment 4:
Get main constituent extract 50.0g, add starch 55g, mixing, drying.Other adds starch 160g, and mix homogeneously is ground into fine powder, with 60% ethanol system granule, drying; With an amount of dissolve with ethanol of Oleum Santali albi, Mentholum, add granule again, mix homogeneously is adorned capsule No. 2, and every capsules dress 0.25g should go out 1000 of capsules.
Embodiment 5:
Get main constituent extract 50.0g, medical starch 100.0g, dextrin 30.0g, 50% ethanol is an amount of, above-mentioned raw materials is fully mixed make granule, again with an amount of dissolve with ethanol of Oleum Santali albi, Mentholum, add in the granule, 60～70 ℃ of dryings 2～4 hours, make 1000, every contains main constituent 0.5g.
Embodiment 6
Get main constituent extract 400g, Polyethylene Glycol-400020g, Polyethylene Glycol-600060g, sodium pyrosulfite is an amount of, and heating and melting temperature (40～90 ℃) makes raw material and adjuvant fully miscible, again with an amount of dissolve with ethanol of Oleum Santali albi, Mentholum, add miscible in, drip and to make 20000 drop pill, make every drop pill contain main constituent 1.0mg.
Embodiment 7
[prescription] Radix Peucedani 33g, Radix Platycodonis 33g, Radix Trichosanthis 33g, Radix Puerariae 33g, Fructus Mume (meat) 33g, Lignum Santali Albi 8g, Mentholum 0.042g.
[method for making] above seven flavors, it is standby that Lignum Santali Albi is extracted volatile oil, and the aqueous solution after the distillation filters.Radix Peucedani, Radix Platycodonis, Radix Trichosanthis, Radix Puerariae, Fructus Mume add 12 times of decoctings and boil secondary, and each 2 hours, merge decocting liquid, filter, the merging of filtrate and Lignum Santali Albi filtrate are concentrated into relative density 1.02～1.05 (60 ℃); Add Mentholum, Oleum Santali albi, add Mel 150g, add sodium benzoate 3g, add water to 1000ml, leave standstill, filter, embedding promptly gets containing supernatant oral liquid.
After the preferred embodiment that describes in detail, being familiar with this technology personage can be well understood to, can carry out various variations and modification not breaking away under above-mentioned claim and the spirit, all foundations technical spirit of the present invention all belongs to the scope of technical solution of the present invention to any simple modification, equivalent variations and modification that above embodiment did.And the embodiment that the present invention also is not subject in the description to be given an actual example.
Claims (10)
1. sugar-free compound Chinese medicine preparation for the treatment of upper respiratory tract infection is characterized in that it is made by the Chinese medicine of following component:
Radix Peucedani 10-50 part Radix Platycodonis 10-50 part Radix Trichosanthis 10-50 part
Radix Puerariae 10-50 part Fructus Mume 10-50 part Lignum Santali Albi 3-20 part
Mentholum 0.021-0.1 part.
2. the described sugar-free compound Chinese medicine preparation of claim 1 is characterized in that it is made by the Chinese medicine of following component:
Radix Peucedani 15-40 part Radix Platycodonis 15-40 part Radix Trichosanthis 15-40 part
Radix Puerariae 15-40 part Fructus Mume 15-40 part Lignum Santali Albi 5-15 part
Mentholum 0.025-0.075 part.
3. the described sugar-free compound Chinese medicine preparation of claim 1 is characterized in that it is made by the Chinese medicine of following component:
33 parts of 33 parts of Radix Trichosanthis of 33 parts of Radix Platycodoniss of Radix Peucedani
8 parts in 33 portions of Lignum Santali Albis of 33 parts of Fructus Mume of Radix Puerariae
0.042 part of Mentholum.
4. the described sugar-free compound Chinese medicine preparation of claim 1, Chinese medicine preparation wherein refers to tablet, granule, capsule, oral liquid, pill or powder.
5. the described sugar-free compound Chinese medicine preparation of claim 1, Chinese medicine preparation wherein refers to drop pill.
6. the described sugar-free compound Chinese medicine preparation of claim 1, Chinese medicine preparation wherein is a buccal tablet.
7. the application of the described sugar-free compound Chinese medicine preparation of claim 1 in preparation treatment acute/chronic pharyngitis, tonsillitic upper respiratory tract infection medicine.
8. method for preparing the described sugar-free compound Chinese medicine preparation of claim 1 is characterized in that through following steps:
(1) Lignum Santali Albi is adopted steam distillation, and it is standby to extract volatile oil, the A that filters to get filtrate of the aqueous solution after the distillation, and medicinal residues are abandoned it;
(2) Radix Peucedani, Radix Platycodonis, Radix Trichosanthis, Radix Puerariae, Fructus Mume add 6-12 times of decocting and boil 1-3 time, and each 1-3 hour, merge decocting liquid, filter;
(3) decocting liquid and Lignum Santali Albi filtrate A merge, and 60 ℃ to be concentrated into 1.0～1.3 one-tenth cream of relative density standby;
(4) above-mentioned one-tenth cream is mixed with pharmaceutic adjuvant and an amount of correctives, with 60% ethanol system granule, drying; With an amount of dissolve with ethanol of Oleum Santali albi, Mentholum, add granule again, add pharmaceutic adjuvant, mix homogeneously is made oral formulations; Wherein said an amount of correctives refers to stevioside, citron sugar, xylitol or sorbitol.
9. method for preparing claim 4 sugar-free compound Chinese medicine preparation is characterized in that through following steps:
(1) Lignum Santali Albi is adopted steam distillation, and it is standby to extract volatile oil, the A that filters to get filtrate of the aqueous solution after the distillation, and medicinal residues are abandoned it;
(2) Radix Peucedani, Radix Platycodonis, Radix Trichosanthis, Radix Puerariae, Fructus Mume add 6-12 times of decocting and boil 1-3 time, and each 1-3 hour, merge decocting liquid, filter;
(3) decocting liquid and Lignum Santali Albi filtrate A merge, and 60 ℃ to be concentrated into 1.2～1.25 one-tenth cream of relative density standby;
(4), add starch 15-100g, mixing, drying with in the above-mentioned one-tenth cream; Other adds starch 15-100g, xylitol 50-200g, aspartame 0.3-1g, and mix homogeneously is ground into fine powder, with 60% ethanol system granule, drying; With an amount of dissolve with ethanol of Oleum Santali albi, Mentholum, with granule, an amount of mix homogeneously of magnesium stearate, be pressed into 1000 then again, every heavy 0.3g.
10. the detection method of any sugar-free compound Chinese medicine preparation of claim 1-5 comprises discriminating and assay, and wherein the discrimination method step is as follows:
(1) Radix Peucedani is differentiated: get this product, remove film-coat, porphyrize is got powder 5g, the 10ml that adds diethyl ether, and reflux, extract, 1 hour leaves standstill, and filters, and filtrate evaporate to dryness, the residue 2ml that adds diethyl ether makes dissolving, as need testing solution; Other gets Radix Peucedani control medicinal material 0.5g, shines medical material solution in pairs with legal system.The thin layer chromatography test is according to appendix VIB of Chinese Pharmacopoeia version in 2005, draw each 10 μ l of above-mentioned two kinds of solution, putting respectively on same silica gel g thin-layer plate, is developing solvent with 3: 1 petroleum ether (60～90 ℃)-ethyl acetate, launches, take out, dry, put under the 365nm ultra-violet lamp and inspect, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color;
(2) Radix Platycodonis is differentiated: get this product, remove film-coat, porphyrize is got powder 5g, adds water 30ml, chloroform 30ml, hydrochloric acid 6ml, reflux, extract, 1 hour leaves standstill, and puts cold, divide and get the chloroform layer, filter, evaporate to dryness, residue add ethanol 1ml makes dissolving, as need testing solution; Other gets Radix Platycodonis control medicinal material 0.5g, shines medical material solution in pairs with legal system; The thin layer chromatography test is according to appendix VIB of Chinese Pharmacopoeia version in 2005, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with 1: 1 chloroform-ether was developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the 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;
(3) Radix Puerariae is differentiated: get this product, remove film-coat, porphyrize is got powder 1g, adds methanol 10ml, and supersound extraction 30 minutes leaves standstill, and filters, and filtrate is concentrated into 1ml, as need testing solution; Other gets Radix Puerariae control medicinal material 0.8g, shines medical material solution in pairs with legal system; The thin layer chromatography test is according to appendix VIB of Chinese Pharmacopoeia version in 2005, draw each 5 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel H lamellae of adhesive with the sodium carboxymethyl cellulose, with chloroform-methanol-water of 7: 2.5: 0.25 was developing solvent, launch, take out, dry, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color;
Content assaying method, step is as follows:
The preparation of need testing solution: get 20 of this product, remove film-coat, the accurate title, decide, porphyrize is got powder 0.5g, and accurate the title decides, put in the tool plug conical flask, the accurate 30% ethanol 25ml that adds claims to decide weight, supersound process 30 minutes is put coldly, claims to decide weight, supply the weight that subtracts mistake with 30% ethanol, shake up, filter, get subsequent filtrate, promptly;
The preparation of reference substance solution: it is an amount of to get the puerarin reference substance, and accurate the title decides, and adds 30% ethanol and makes the solution that every 1ml contains 6 μ g, promptly;
An appendix VID measures according to high performance liquid chromatography Chinese Pharmacopoeia version in 2005; Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; With methanol-water-glacial acetic acid of 30: 70: 0.5 was mobile phase; The detection wavelength is 250nm; Number of theoretical plate calculates by puerarin peak should be not less than 3000, and the separating degree of puerarin peak and adjacent peak is answered requirement up to specification;
Algoscopy: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure every of this product and contain puerarin C
21H
20O
9Must not be less than 0.05mg.
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Address after: 300380 Yumen Road, Xiqing District, Tianjin Patentee after: Lerentang Pharmaceutical Factory of Jinyao Darentang Group Co.,Ltd. Address before: 300380 Yumen Road, Xiqing District, Tianjin Patentee before: Letrentang pharmaceutical factory of Tianjin Zhongxin Pharmaceutical Group Co.,Ltd. |