CN1292779C - Chinese traditional medicine preparation for treating paediatric acute tonsillitis - Google Patents

Chinese traditional medicine preparation for treating paediatric acute tonsillitis Download PDF

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CN1292779C
CN1292779C CNB2005101049425A CN200510104942A CN1292779C CN 1292779 C CN1292779 C CN 1292779C CN B2005101049425 A CNB2005101049425 A CN B2005101049425A CN 200510104942 A CN200510104942 A CN 200510104942A CN 1292779 C CN1292779 C CN 1292779C
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CN1759878A (en
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韩志强
贾晓冬
安德清
曾杏雷
田英
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Taiyangshi (Tangshan) Pharm Ind Co., Ltd.
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TAIYANGSHI (TANGSHAN) PHARM IND CO Ltd
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Abstract

The present invention relates to a traditional Chinese medicine preparation for treating paediatric acute tonsillitis, a preparation method thereof, and the preparation of the present invention is prepared from honeysuckle, forsythia fruit, scutellaria roots, red peony roots, artemisia apiacea, burdock fruit, belamcanda rhizome, Zhe fritillariae and verbena.

Description

A kind of Chinese medicine preparation for the treatment of paediatric acute tonsillitis
Technical field:
The present invention relates to Chinese medicine preparation of a kind of children's's of treatment inflammation and preparation method thereof, particularly a kind of pharyngalgia that a variety of causes causes, scorching hot, dysphagia of being used for the treatment of, pharyngeal tonsils (tonsil) redness, heating, cough, expectorant is arranged, red tongue with yellow fur, Chinese medicine preparation of rapid pulse and preparation method thereof.
Background technology:
Tonsillitis is equivalent to the tonsillitis of western medicine, and tonsillitis and pharyngitis, acute laryngitis, acute rhinitis etc. are reached the same goal and upper respiratory tract infection.Again tonsillitis is divided into acute tonsillitis and chronic tonsillitis clinically.Acute tonsillitis is more common in children's more than 4 years old in department of pediatrics, all can fall ill throughout the year, and the pediatric patient symptom is heavy than adult patient, often with hyperpyrexia.If treatment is proper, general prognosis bona, but the course of disease of infant is longer, but protracted course of disease or generation repeatedly, as untimely appropriate treatment, in a single day it become focus, and antibacterial will breed at this, and produce toxin, enter human body with blood, make human body generation immunoreation, and this immunoreation is a kind of unusual allergic state, can further cause many internal organs to be fallen ill, as the long-term not amiable and compliant tonsillitis of morbidity repeatedly of nephritis, rheumatic fever or rheumatic heart disease, also can form recurrent respiratory tract infection, reduce children's's immunity of organisms, influence growing up healthy and sound of children's.Therefore,, can not adopt a casual attitude to it though tonsillitis is local disease, because the harm of above-mentioned complication is considerably beyond the harm of tonsillitis itself, therefore must active treatment.
The tonsillitis major part is caused that by viral infection minority is caused that by antibacterial and mycoplasma common virus is rhinovirus, respiratory syncytial virus, influenza virus, parainfluenza virus, Coxsackie virus etc.After bacterial infection is secondary to more.In the viral infection stage, use the antibiotic therapy poor effect.Present many heads of a family comprise that some doctor often uses antibiotic therapy when viral infection, cause abuse antibiotics, bring many toxic and side effects to infant.Therefore treatment by Chinese herbs is a direction.
In recent years, along with going deep into of clinical research, also occur the Chinese medicine preparation of some paediatric acute tonsillitis on the market, but existing medicine belongs to a bit and cures the symptoms, not the disease, some uses expensive composition, and some is cut and interrupt using owing to uncertain therapeutic efficacy in application process.
In view of this, the inventor develop a kind of taking convenience, effect steadily, determined curative effect, dosage form is stable, quality controllable and the pure Chinese medicinal preparation of the paediatric acute tonsillitis that has no side effect, to satisfy the demand of extensive patients.
Summary of the invention:
The invention provides a kind of Chinese medicine preparation of paediatric acute tonsillitis, said preparation is made by following Chinese medicine raw materials by weight proportion:
Flos Lonicerae 250-1000 weight portion, Fructus Forsythiae 250-1000 weight portion, Radix Scutellariae 150-600 weight portion, Radix Paeoniae Rubra 150-600 weight portion, Herba Artemisiae Annuae 150-600 weight portion, Fructus Arctii 100-400 weight portion, Rhizoma Belamcandae 100-400 weight portion, Bulbus Fritillariae Thunbergii 100-400 weight portion, Herba Verbenae 100-400 weight portion.
Preferably:
Flos Lonicerae 375-666 weight portion, Fructus Forsythiae 375-666 weight portion, Radix Scutellariae 225-400 weight portion, Radix Paeoniae Rubra 225-400 weight portion, Herba Artemisiae Annuae 225-400 weight portion, Fructus Arctii 150-266 weight portion, Rhizoma Belamcandae 150-266 weight portion, Bulbus Fritillariae Thunbergii 150-266 weight portion, Herba Verbenae 150-266 weight portion.
Most preferably:
Flos Lonicerae 500 weight portions, Fructus Forsythiae 500 weight portions, Radix Scutellariae 300 weight portions, Radix Paeoniae Rubra 300 weight portions, Herba Artemisiae Annuae 300 weight portions, Fructus Arctii 200 weight portions, Rhizoma Belamcandae 200 weight portions, Bulbus Fritillariae Thunbergii 200 weight portions, Herba Verbenae 200 weight portions.
In more than forming, the weight of each medicine of distinguishing the flavor of is calculated with crude drug, if per 1 weight portion is unit with the gram, above-mentioned prescription composition can be made into 1000 doses of pharmaceutical preparatioies.Described 1 dose of finger, the final drug preparation of making, as make 1000 of capsule preparations, 1000 in tablet, granule 1000 grams, oral liquid 1000ml etc.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be unit with the milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion obtains through science screening, for especial patient, and as serious symptom or light disease, fat or modest patient, the proportioning of the amount of can corresponding adjustment forming increases or reduces being no more than 100%, and drug effect is constant.
Raw material of Chinese medicine, especially adjuvant drug in more than forming can be replaced with the suitable Chinese medicine with identical property of medicine with messenger drug, and its drug effect of the Chinese medicine preparation after the replacement is constant.
Chinese medicine preparation of the present invention is to process through extraction or other modes by the raw material of Chinese medicine that above-mentioned prescription is formed, and makes pharmaceutically active substance, subsequently, with this material is raw material, adds the medicine acceptable carrier when needing, and makes according to the routine techniques of galenic pharmacy.Described active substance can obtain by extracting raw material of Chinese medicine respectively, also can obtain by the co-extracted raw material of Chinese medicine, also can obtain by other modes, as: by pulverize, squeeze, calcine, grind, sieve, percolation, extraction, water are carried, alcohol extraction, ester are carried, methods such as ketone is carried, chromatography obtain, these active substances can be the material of extractum form, can be that dry extract also can be a fluid extract, make different concentration according to the different needs decision of preparation.
Pharmaceutical preparation of the present invention, the pharmaceutical dosage forms of unit dose preferably, can make any pharmaceutically useful dosage form when making pharmaceutical preparation, these dosage forms are selected from: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, solution, injection, suppository, ointment, plaster, cream, spray, drop, patch.Preferably oral formulations form, most preferably granule.
Pharmaceutical preparation of the present invention, its pharmaceutically active substance makes through extracting processing, and processing method is as follows: Fructus Forsythiae, Herba Artemisiae Annuae, carry out vapor distillation, extract volatile oil, with standby after the beta-schardinger dextrin-grinding inclusion; The medicinal liquid of carrying behind the oil filters, and other puts; Add Flos Lonicerae, Radix Scutellariae, Fructus Arctii, Herba Verbenae in the medicinal residues, decoct with water merge extractive liquid,, filter, filtrate with carry oil back medicinal liquid and merge, concentrate clear paste; Radix Paeoniae Rubra, Rhizoma Belamcandae, Bulbus Fritillariae Thunbergii ethanol extraction, extracting solution is concentrated into clear paste; Above-mentioned clear paste merges the volatile oil with grind inclusion with beta-schardinger dextrin-after, forms pharmaceutically active substance of the present invention, and this active substance mixes with the medicine acceptable carrier, promptly can be made into Chinese medicine preparation of the present invention according to the galenic pharmacy routine techniques.
The preparation method of granule of the present invention can be:
More than nine flavors, Fructus Forsythiae, Herba Artemisiae Annuae are ground into coarse granule, add 20 times of water gagings, carry out vapor distillation, extract after 2 hours, collect volatile oil, measure beta-schardinger dextrin-s grinding enclose with 10 times, drying, porphyrize, standby; The medicinal liquid of carrying behind the oil filters, and other puts; Add medical materials such as Flos Lonicerae, Radix Scutellariae, Fructus Arctii, Herba Verbenae in the medicinal residues, decoct with water 3 times, each 10 times of water gagings, each 1 hour, merge extractive liquid, filtered, filtrate with carry oil back medicinal liquid and merge, be concentrated into the clear paste that relative density is about 1.05 (60 ℃); Radix Paeoniae Rubra, Rhizoma Belamcandae, Bulbus Fritillariae Thunbergii heating and refluxing extraction 3 times add 7 times of amount 70% ethanol at every turn, and each 3 hours, merge extractive liquid, filtered, and filtrate alkali pushes back receives ethanol to the greatest extent, continues to be concentrated into the clear paste that relative density is about 1.05 (60 ℃); Above-mentioned clear paste is merged, and mixing carries out spray drying, gets dry powder.Add volatile oil beta cyclodextrin inclusion complex, add an amount of protein sugar and dextrin, mix homogeneously with 80% ethanol moistening, is crossed 14 mesh sieves, and 40 ℃ of oven dry of wet granular become the 1000g granule behind the dried granule granulate, packing, and every bag of 5g, promptly.
Pharmaceutical preparation of the present invention can add some medicine acceptable carriers as required, can adopt the galenic pharmacy routine techniques to prepare this pharmaceutical preparation, as pharmaceutically active substance is mixed with the medicine acceptable carrier.Described medicine acceptable carrier is selected from: mannitol, sorbitol, sorbic acid or potassium salt, sodium pyrosulfite, sodium sulfite, sodium thiosulfate, cysteine hydrochloride, TGA, methionine, vitamin A, vitamin C, vitamin E, vitamin D, azone, the EDTA disodium, EDTA calcium sodium, the alkali-metal carbonate of monovalence, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulphuric acid, phosphoric acid, aminoacid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose and derivant thereof, alginate, gelatin, polyvinylpyrrolidone, glycerol, propylene glycol, ethanol, soil temperature 60-80, span-80, Cera Flava, lanoline, liquid paraffin, hexadecanol, gallate ester, agar, triethanolamine, basic amino acid, carbamide, allantoin, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, the phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc.
Pharmaceutical preparation of the present invention is determined usage and dosage according to patient's situation in use.
Chinese medicine preparation of the present invention, when making medicament, the medicament of unit dose can contain pharmaceutically active substance 0.1-1000mg of the present invention, and all the other are pharmaceutically acceptable carrier.Pharmaceutically acceptable carrier can be the 0.1-99.9% of total formulation weight amount by weight.
The most preferred prescription of the present invention is listed in the embodiment of the invention.
Chinese medicine preparation of the present invention has heat clearing away, detoxifcation, sore-throat relieving.Cure mainly paediatric acute tonsillitis from the beginning of, pathogenic heat are pented up card, card is seen: pharyngalgia, scorching hot, dysphagia, pharyngeal tonsils (tonsil) redness, the heating, the cough, expectorant is arranged, red tongue with yellow fur, rapid pulse.
Following data declaration beneficial effect of the present invention by experiment.
Observe the curative effect of Chinese medicine granules of the present invention (being called silver-colored cattle granule or children's Yin Niu granule) treatment paediatric acute tonsillitis by the preparation of embodiment 1 method.
One, refrigeration function:
1. to the refrigeration function of typhoid fever one paratyphoid fever, second triple vaccine pyrogenicity rabbit:
Get 50 of rabbit, experiment noon before that day and that morning, use electronic thermometer respectively, prediction anus temperature (＞0.6 ℃ of person of body temperature fluctuation rejects in surpassing 39 ℃ or one day) is got its meansigma methods as basal body temperature, by only weighing, through auricular vein, inject typhoid fever one paratyphoid fever, second triple vaccine 0.75ml/kg, survey its intensification degree after 1 hour, it is qualified to be considered as with 〉=0.8 ℃, is divided into the medicine height, in, low dose group, the APC group, quickly allaying infantile fever group and blank group, dosage is respectively 8.27g/kg, 4.13g/kg, 2.07g/kg, 0.0233g/kg and 3.06ml/kg, press the heavy volume of 5ml/kg rabbit and irritate stomach, blank group irritates stomach for isopyknic water.Respectively at administration 0.5h, 1.0h, 1.5h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h repetition measurement anus temperature, calculate the temperature difference more then then, and the result is organized a statistical procedures (seeing Table 1) with basal body temperature
Table 1. result shows that this product has tangible refrigeration function, gets final product onset behind high, the middle dosage medicine in 30 minutes, obvious antagonism 90-120 minute heating peak, sustainable 4 hours of refrigeration function; Sustainable 5 hours of high dose refrigeration function.Onset in 60 minutes behind the low dosage medicine, antagonism 90-120 minute heating peak effect is not obvious, sustainable 3 hours of refrigeration function.High dose is suitable with APC on 60--90 behind the medicine minute refrigeration function at high dose.
Aspect antagonism 90-120 minute heating peak,, with matched group in various degree significant difference is arranged more respectively in 6 hours the heating time-histories behind the medicine with the high dose best results; Prompting this product is to typhoid fever---and paratyphoid fever, the second triple vaccine causes rabbit fever models that therapeutical effect is preferably arranged.
To 2, the refrigeration function of 4-dinitrophenol pyrogenicity rat:
Get 60 of rats, experiment noon before that day and that morning are used electronic thermometer respectively, and prediction anus temperature (＞0.5 ℃ of person of body temperature fluctuation rejects in surpassing 39 ℃ or a day) is got its meansigma methods as basal body temperature, by only weighing.Percutaneous is injection 2,4-dinitrophenol 0.75ml/kg down, survey its intensification degree after 1 hour, it is qualified to be considered as with 〉=0.8 ℃, then rat is divided at random blank group, the high, medium and low dosage group of medicine, APC group and quickly allaying infantile fever group, dosage is respectively 15.95g/kg, 7.97g/kg, 3.99g/kg, 0.045g/kg and 5.91ml/kg, press the heavy volume of 1ml/100g Mus and irritate stomach, blank group irritates stomach for isopyknic water.Respectively at administration 0.5h, 1.0h, 1.5h, 2.0h, 3.0h, 4.0h, 5.0h repetition measurement anus temperature, calculate the temperature difference more then then, and the result is organized a statistical procedures (seeing Table 2) with basal body temperature.
Table 1 silver cattle granule refrigeration function (X ± s, n=10)
Group Dosage Before the mould 05h 1h 1.5h
Dosage group low dose group APC group RESUQING group in the normal group high dose group - 15.95 7.97 3.99 0.045 5.91 37.00±0.36 36.99±0.40 36.87±0.31 36.93±0.44 36.85±0.38 36.76±0.22 0.76±0.54 0.66±0.64 0.66±0.41 0.68±0.51 0.55±0.49 0.79±0.61 1.81±0.32 0.97±0.49 *** 1.21±0.40 ** 1.37±0.47 * 0.94±0.52 *** 1.28±0.57 * 2.39±0.29 1.50±0.40 *** 1.85±0.38 ** 1.84±0.50 ** 1.52±0.42 *** 1.66±0.52 **
Table 2. silver cattle granule refrigeration function (X ± s, n=10)
Group 2h 3h 4h 5h
Dosage group low dose group APC group RESUQING group in the normal group high dose group 2.90±0.24 2.02±0.50 *** 2.40±0.33 ** 2.50±0.41 *$& 2.06±0.48 *** 2.19±0.50 *** 2.84±0.34 2.34±0.47 * 2.55±0.24 * 2.52±0.40 2.21±0.50 ** 2.25±0.38 **@ 2.50±0.30 2.09±0.50 * 2.29±0.35 1.91±1.05 2.06±0.52 * 2.10±0.26 ** 2.16±0.27 1.74±0.49 * 1.99±0.38 2.08±0.46 1.80±0.48 1.83±0.29 *
Annotate: compare with normal group: *P＜0.05, *P＜0.01, * *P＜0.001; Compare: ﹠amp with the APC matched group; P＜0.05; Compare: $P＜0.05 with high dose group; With the RESUQING group relatively: @P＜0.05 result show: this product has tangible refrigeration function, gets final product onset behind the high, medium and low dosage medicine in 60 minutes, can be to some extent obvious antagonism 90-120 minute heating peak, the sustainable 2-5 of refrigeration function hour.Prompting this product to 2, the 4-dinitrophenol causes the rat fever model that therapeutical effect is preferably arranged.
Two, antiinflammatory action:
1. 2% compound Oleum Tiglii is caused the influence of mice ear:
Get 60 of healthy mices, male, body weight 18-22g, be divided into 5 groups at random, Chinese medicine preparation granule height of the present invention, in, low dose group, the diclofenac matched group, children's's QINGYAN CHONGJI group, the blank group, give Chinese medicine preparation granule 23.03g/kg of the present invention respectively, 11.52g/kg, 5.76g/kg, 9.75mg/kg, 10.24g/kg, the distilled water matched group irritates stomach for the equal-volume distilled water, all by the volume gastric infusion of 0.25ml/10g body weight, for three days on end, fasting is 12 hours before the last medicine, behind the medicine 1 hour, 2% compound Oleum Tiglii 0.1ml is evenly spread upon the mouse right ear two sides cause inflammation, be that the card punch of 9mm is on a left side with diameter after 4 hours, the same position of auris dextra is pounded down circular auricle, with smart its weight that claims of the accurate electronic balance of Mettler-Toledo, calculate its swelling degree and swelling rate and inhibitory rate of intumesce, organize a t check, the results are shown in Table 3.
Swelling degree=auris dextra weight-left ear is heavy
Swelling rate=(auris dextra heavy-left ear is heavy) ÷ left side ear heavy * 100%
Inhibitory rate of intumesce=(blank group swelling rate-medicine group swelling rate) the blank group of ÷ swelling rate * 100%
Table 3. Chinese medicine preparation granule of the present invention to 2% compound Oleum Tiglii cause mice ear influence (X ± s, n=10)
Group Dosage (g/kg) Swelling degree (g) Swelling rate (%) Inhibitory rate of intumesce (%)
Dosage low dosage diclofenac QINGYAN CHONGJI in the blank group high dose --- 23.03 11.52 5.76 0.00975 10.24 0.0091±0.0022 0.0038±0.0011 *** 0.0052±0.0016 ***$&& 0.0061±0.0017 **$$&&& 0.0033±0.0013 *** 0.0057±0.0029 **& 121.2±36.5 47.6±14.0 *** 62.6±17.9 ***& 77.6±22.0 **$$&& 43.6±16.9 *** 73.3±39.5 *& 60.8 48.3 35.9 64.1 39.5
Annotate: compare with the blank group *P＜0.05, *P＜0.01, * *P＜0.001
Compare: ﹠amp with the diclofenac matched group; P＜0.05 ﹠amp; ﹠amp; P＜0.01.&&&P＜0.001。
Compare: $P＜0.05 with high dose group.$$P＜0.01，$$$P＜0.001
Table 3 result is as seen: in the influence that 2% compound Oleum Tiglii is caused mice ear tangible antiinflammatory action is arranged, the high, medium and low dosage of Chinese medicine preparation granule of the present invention all can significantly suppress the mice ear effect due to the 2% compound Oleum Tiglii, reduce its swelling degree, improve its inhibitory rate of intumesce.High, medium and low dosage and blank group have utmost point significant difference, significant differences more respectively; Effect of high dosage intensity and diclofenac are suitable, and high, middle dosage obviously is better than children's's QINGYAN CHONGJI.The low dosage action intensity is suitable with children's's QINGYAN CHONGJI.
2. to the synthetic inhibitory action of PGE2 in the rat inflammation tissue
Get 50 of 160--180g left and right sides rats, male and female are regardless of and are divided into 5 groups at random, Chinese medicine preparation granule height of the present invention, in, low dosage, diclofenac matched group and blank group, every group 10, dosage is the same, successive administration three days, behind the last medicine 1 hour, right back sufficient subcutaneous injection 1% carrageenin 0.1ml, cause scorching back 4 hours, put to death rat, 0.5cm cuts at the place swelling foot on ankle joint, peeling, shred, normal saline 5ml soaked 1 hour, soak centrifugal (1500rpm) 10 minutes, draw supernatant 0.1ml, the KOH-MeOH solution 2.0ml that adds 0.5mol/L, 50 ℃ of constant temperature isomeries 20 minutes are diluted to 20.0ml with methanol, at wavelength 278nm place, measure its absorbance (A) value with the UV-2100 ultraviolet spectrophotometer, the result organizes a t check, the results are shown in Table 4.
Table 4. Chinese medicine preparation granule of the present invention to the influence of PGE2 content in the inflammation tissue (X ± s, n=10)
Group Dosage (g/kg) PGE 2Content (A value)
Dosage group low dose group diclofenac group in the blank group high dose group --- 15.95 7.97 3.99 0.00675 0.0662±0.0107 0.0382±0.0094 *** 0.048±0.0164 ** 0.0544±0.0091 *$& 0.0382±0.0104 ***
Annotate: with blank group ratio *P＜0.05, *P＜0.01, * *P＜0.001
With the diclofenac group than ﹠amp; P＜0.05 ， ﹠amp; ﹠amp; P＜0.01 ， ﹠amp; ﹠amp; ﹠amp; P＜0.001
With high dose group than $P＜0.05 ， $$P＜0.01 ， $$$P＜0.001
Table 4 result is as seen: high, medium and low dosage can suppress PGE in the rat inflammation tissue respectively to some extent 2Synthetic, high, medium and low dosage and blank group have utmost point significance, highly significant and significant difference more respectively; Point out through statistical procedures: its effect of high dosage intensity is suitable with diclofenac.
Three, 0.6%HAC is caused the analgesic activity of mice pain reaction:
It is some to get 18--20g male and healthy mice, be divided into 6 groups at random, Chinese medicine preparation granule height of the present invention, in, low dosage, the Voltaren group, children's's QINGYAN CHONGJI group and blank group, give Chinese medicine preparation granule 23.03g/kg of the present invention respectively, 11.52g/kg, 5.76g/kg, 10.24g/kg, Voltaren 9.75mg/kg, all by the volume gastric infusion of 0.25ml/10g body weight, the blank group is given isopyknic water gastric infusion, for three days on end, it is heavy to measure behind the last medicine 1 hour lumbar injection 0.6%HAC 0.1ml/10g Mus respectively, and record occurs turning round the body number of times in incubation period and 15 minutes of writhing response, and the result organizes a statistical procedures, by formula calculate pain suppression ratio (%), data see Table 5 respectively.
Pain suppression ratio=(the blank group is turned round body number of times-medicine group and turned round the body number of times) ÷ blank group is turned round body number of times * 100%
Table 5. Chinese medicine preparation granule of the present invention to 0.6%HAC cause the mice pain reaction influence (X ± s, n=10)
Group Dosage (g/kg) Turn round body incubation period (min) Turn round body number of times (inferior) Pain suppression ratio (%)
Dosage group low dose group diclofenac group QINGYAN CHONGJI in the blank high dose group --- 23.03 11.52 5.76 0.00975 10.24 3.56±0.69 5.30±1.40 ** 4.74±1.12 *&& 4.37±2.18& 6.91±2.09 *** 5.24±1.72 * 23.4±7.0 11.4±5.4 *** 13.7±6.8 ** 16.1±6.5 *& 10.3±3.6 ***** 14.9±4.9& 51.28 41.45 31.20 55.98 36.32
Annotate: with blank group ratio *P＜0.05, *P＜0.01, * *P＜0.001
With the diclofenac matched group than ﹠amp; P＜0.05 ， ﹠amp; ﹠amp; P＜0.01 ， ﹠amp; ﹠amp; ﹠amp; P＜0.001
With high dose group than $P＜0.05 ， $$P＜0.01 ， $$$P＜0.001
What by table 3 result as seen, high, middle dosage all can obviously suppress mice turns round body incubation period.With the water matched group in various degree significant difference is arranged relatively; What the high, medium and low dosage of Chinese medicine preparation granule of the present invention all can obviously reduce mice turns round the body number of times.With the water matched group in various degree significant difference is arranged relatively, point out Chinese medicine preparation granule of the present invention that analgesic activity is preferably arranged.From pain suppression ratio result: Chinese medicine preparation granule high dose of the present invention is suitable with diclofenac, is better than children's's QINGYAN CHONGJI.In the Chinese medicine preparation granule of the present invention, low dosage is suitable with children's's QINGYAN CHONGJI.
Four, disease-resistant source microbial action in the body
1. to bacteriostasis in the body of mice
(1). bacterium liquid preparation: test first three day and open strain, beta hemolytic streptococcus (02403), staphylococcus aureus (25923), hemophilus influenza (02006) quantitatively are inoculated in suitable MH meat soup respectively or contain in the MH meat soup of 10% Sanguis caprae seu ovis, 37 ℃ of temperature were incubated 6 hours, get bacterium liquid 0.1ml transferred species in 10mlMH meat soup or contain in the MH meat soup of 10% Sanguis caprae seu ovis, 37 ℃ of temperature were incubated 18 hours, transferred species is three times repeatedly, must test original bacteria liquid, and final concentration is 1 * 10 6-9CFU/ml.
(2) .MLD test: with normal saline bacterium liquid is suitably diluted, carry out successive with 0.5% gastric Mucin and dilute, get the test that minimum that above-mentioned mice carries out each bacterial strain causes 100% animal dead (MLD).The MLD that records staphylococcus aureus is 5 * 10 6CFU/ml, the MLD of hemophilus influenza are 5 * 10 7CFU/ml, the MLD of beta hemolytic streptococcus are 1 * 10 6CFU/ml.
(3). infecting mouse: get 150 of above-mentioned mices, be divided at random by body weight: water matched group, the high, medium and low dosage group of Chinese medicine preparation granule of the present invention, levofloxacin tablet group, water was can't help in fasting in 6 hours before the experiment, test pre-administration in preceding 24 hours 2 times, the 0.5ml MLD bacterium amount of every each strain bacterium of mice difference lumbar injection.Totally 10 of every group of mices, and respectively continued administration again in 1,6,12,24,48,72 hour by above-mentioned concentration in infecting the back; The accumulation death toll of observe, record infection back respectively being organized mice in 6,12,24,48,72 hours.Experimental result is organized an X 2Check and direct calculating probability the results are shown in Table 6.
Table 6. children's Yin Niu granule is to depression effect in the body of main pathogenic bacterium
Group Dosage (g/kg) Number of animals Death toll Mortality rate Gold Portugal bacterium Hemophilus influenza The second streptococcus
The X 2 test value Statistical significance Direct probability calculates Death toll Mortality rate The X 2 test value Statistical significance Direct probability calculates Death toll Mortality rate The X 2 test value Statistical significance Direct probability calculates
Dosage low dosage levofloxacin in the blank high dose --- 23.03 11.52 5.76 2.93 10 10 10 10 10 9 5 7 8 0 90 50 70 80 0 3.809 1.250 0.392 6.667 $$$ $$$ $ $$ **$$$ *** 9 2 5 7 1 90 20 50 70 10 9.899 3.809 1.250 12.800 ** $$ *** ** $$ *** 10 3 6 8 1 100 30 60 80 10 10.769 5.000 2.222 16.364 *** *$ $$ *** ** *$ $$ ***
Annotate: with blank group ratio *P＜0.05, *P＜0.01, * *P＜0.001, with the levofloxacin matched group than $P＜0.05 ， $$P＜0.01 ， $$$P＜0.001,
Table 6 is the result show: the water control animals infect behind above-mentioned three kinds of antibacterials occurred in 30 minutes idle moving, clinostatism, lethargy, rapid breathing appear then, most of death took place within 24 hours.Chinese medicine preparation granule treated animal of the present invention above-mentioned symptom also occurs after infecting; increase along with dosage; infection, death time postpone; but infect in the body that Chinese medicine preparation granule of the present invention causes staphylococcus aureus, beta hemolytic streptococcus and hemophilus influenza significant protective effect is arranged, its action intensity and levofloxacin tablet are suitable.Adopt staphylococcus aureus, beta hemolytic streptococcus, hemophilus influenza lumbar injection, observed the dead protective effect of Chinese medicine preparation granule of the present invention, kill the star sheet with left oxygen fluorine and make positive control mice.The result shows that Chinese medicine preparation granule high dose of the present invention has significant inhibitory effect to beta hemolytic streptococcus, also has certain inhibitory action to staphylococcus aureus.
2. to the interior resisting virus effect of mice
Influenza A virus A3/ capital is anti-/ 32/92, anti-/ 3/95 recovery in Influenza B virus B/ Shanghai is cultivated, and presses document [1]Method is carried out 10 times of serial dilutions (10 with virus -1～10 -8) each concentration is through 4 mices of rhinovaccination, observes for 2 weeks, record mouse invasion, death condition are calculated its minimal lethal dose (MLD).
Get 100 of mices, be divided into 10 groups at random, the high, medium and low dosage group of Chinese medicine preparation granule of the present invention, moroxydine group and distilled water matched group, the pre-administration of administration group 3 days, matched group is given the contrast of equal-volume distilled water, the shallow fiber crops of each mice ether, the bacterium liquid 0.2ml/ that per nasal splashes into minimal lethal dose only continues administration 3 days again after the inoculation, the record mouse infection death condition of falling ill in 14 days, observe its depression effect to virus, the result organizes an X 2 test and handles.(seeing Table 7)
Table 7. children's Yin Niu granule is to depression effect in the body of common virus
Group Dosage (g/kg) Number of animals Influenza B virus B Influenza A virus A3
Death toll Mortality rate The X 2 test value Statistical significance Direct probability calculates Death toll Mortality rate The X 2 test value Statistical significance Direct probability calculates
Dosage low dosage moroxydine group in the blank high dose --- 23.03 11.52 5.76 0.026 10 10 10 10 10 10 2 4 7 1 100 20 40 70 10 13.3333 8.5714 3.5294 16.3636 *** * $ *** *** ** $$ *** 9 2 4 5 0 90 20 40 50 0 9.8989 5.4945 3.8095 16.3636 ** *$ $ *** ** *$ $ ***
Annotate: with blank group ratio *P＜0.05, *P＜0.01, * *P＜0.001,
With the moroxydine matched group than $P＜0.05 ， $$P＜0.01 ， $$$P＜0.001,
Table 7 is the result show: behind the fatal dose virus infected mice, the animal of influenza A virus water matched group 90% falls ill dead in one day, and all the other animals also died off in 7 days.Chinese medicine preparation high dose of the present invention reaches 80% to the suppression ratio of lethal effect in the virion, and the suppression ratio of middle dosage is 60%, and the suppression ratio of low dosage is 50%, the suppression ratio of moroxydine sheet is 100%.Through X 2 test processing and direct probability calculate with the virus control group relatively, high, middle dosage has highly significant and significant difference respectively, the low dosage trend that has certain effect.
The present invention also comprises the method for quality control of preparation of the present invention, particularly granule, and this method comprises: contents such as character, discriminating, inspection, assay, specifically:
[character] this granule is the light brown granule, feeble QI perfume (or spice), and it is sweet to distinguish the flavor of.
This granule fine powder 2g is got in [discriminating] (1), add ether 20ml, heating extraction 0.5h, take off, put coldly, discard ether solution, volatilize solvent, add dehydrated alcohol 20ml, heating extraction 0.5h takes off, put cold, filtrate evaporate to dryness, residue dissolve with water 5ml, move to (internal diameter 1.5cm on the D101 type macroporous adsorptive resins, length 12cm), water 100ml eluting discards water liquid, with 3% ethanol 50ml eluting, discard, use 70% ethanol elution, collect eluent 50ml, evaporate to dryness, residue makes dissolving with ethanol 2ml, as need testing solution. and other gets the phillyrin reference substance, adds ethanol and makes the solution that every 1ml contains 1mg, product liquid in contrast, according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000) test, draw need testing solution 10ul, reference substance solution 5ul, put respectively on same silica gel g thin-layer plate, launch with chloroform-methanol-formic acid (9: 1.5: 0.1), take out, dry, spray is with 10% sulphuric acid ethanol liquid, 105 ℃ of heating colour developing in 5 minutes, in the test sample chromatograph, with reference substance chromatograph relevant position on show the speckle of same color.
(2) the need testing solution preparation is with differentiating (1). and other gets the peoniflorin reference substance, add ethanol and make the solution that every 1ml contains 1mg, product liquid in contrast, draw need testing solution 10ul according to thin layer chromatography (appendix VIB test of Chinese Pharmacopoeia version in 2000), reference substance solution 5ul, put respectively on same silica gel g thin-layer plate, launch with chloroform methanol (5: 1), take out, dry, spray is with the fragrant aldehyde test solution colour developing of eggplant, and 105 ℃ of heating developed the color in 5 minutes. in the test sample chromatograph, with reference substance chromatograph relevant position on, show the speckle of same color.
(3) get this granule 5g, be ground into fine powder, add 1ml ammonia and 50ml chloroform, water-bath reflux 1 hour is put coldly, filter, and the filtrate evaporate to dryness, residue is with chloroform 2ml dissolving, product solution in contrast.Other gets the peimine reference substance, and chlorination is copied into the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000) test, draw need testing solution 10ul, reference substance solution, 4ul puts respectively on same silica gel g thin-layer plate, launches with ethyl acetate-methanol-ammonia (17: 2: 1), take out, dry, spray is with the secret potassium liquid of rare iodine.Test sample with the corresponding position of reference substance chromatograph on show the mottle of same color.
(4) get this granule 2.5g, porphyrize adds ethanol 20ml, and supersound extraction 30 minutes filters, and filtrate evaporate to dryness, residue add ethanol makes dissolving, as need testing solution.Other gets the arctiin reference substance, adds ethanol and makes the solution that every 1ml contains 2mg, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw need testing solution 10ul, reference substance solution 4ul puts on same silica gel g thin-layer plate, is developing solvent with chloroform-methanol-water (40: 10: 1), launch, take out, dry, spray is with 10% sulphuric acid ethanol liquid, 105 ℃ of heating 5 minutes, the test sample chromatograph with the corresponding position of reference substance chromatograph on show the mottle of same color.
(5) get this granule 5g, porphyrize adds methanol 30ml, water-bath reflux, extract, 30 minutes filters the filtrate evaporate to dryness, residue makes dissolving with water 20ml, filters, and adds hydrochloric acid in the filtrate, transfer PH to 2, with ethyl acetate extraction 3 times, each 20ml, combined ethyl acetate liquid, evaporate to dryness, residue makes dissolving with methanol 5ml, and as need testing solution, other gets the baicalin reference substance, add methanol and make the solution that every 1ml contains 1mg, product solution according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000) test, is drawn need testing solution 10ul in contrast, reference substance solution 4ul, point is on same silica gel g thin-layer plate, with ethyl acetate-acetone-formic acid-water (5: 1: 1: 1) launch, take out, dry, spray is with 2% ferric chloride ethanol liquid.The test sample chromatograph with the reference substance chromatograph with the corresponding position of reference substance chromatograph on show the mottle of same color.
[inspection] should meet every regulation relevant under the granule item (" appendix of Chinese pharmacopoeia version in 2000).
[assay] measured according to high performance liquid chromatography (appendix VID).
It is filler that chromatographic condition and system suitability test contain silica gel with the octadecylsilane key: methanol-0.4% phosphate aqueous solution (20: 80) is mobile phase; The detection wavelength is 327nm.Theoretical cam curve is calculated 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, puts in the brown measuring bottle, adds 50% methanol and make the solution that every 1ml contains 50ug, promptly gets (preserving down for 10 ℃).
The about 1g of this product fine powder is got in the preparation of need testing solution, and accurate the title decides, and puts in the tool plug conical flask, precision adds 50% methanol 50ml, and supersound process 30 minutes is put cold, claim again to decide weight, supply the weight that subtracts mistake, shake up with 50% methanol, filter, precision is measured subsequent filtrate 5ml, puts in the brown measuring bottle of 10ml, adds 50% methanol to scale, shake up, promptly.Accurate respectively reference substance solution and the need testing solution 20ul of drawing of algoscopy injects chromatograph of liquid, measures, promptly.This granule whenever comprises Flos Lonicerae with chlorogenic acid (C 10H 1XO 9) meter, must not be less than 13mg.The Chinese medicine preparation of treatment paediatric acute tonsillitis of the present invention is guidance with the theory of Chinese medical science, has superioritys such as easy easy clothes, easy absorption, and then met by the sight of extensive patients.
Chinese medicine preparation of the present invention except that heat clearing function, can be taken into account dispelling wind, detoxifcation, sore-throat relieving three large effects simultaneously on the paediatric acute tonsillitis for the treatment of the genus wind-heat syndrome, acute pharyngitis, kind has very big novelty more in the past on function cures mainly.
The specific embodiment:
Further specify the present invention by the following examples, but not as limitation of the present invention.
Embodiment 1
Flos Lonicerae 500g, Fructus Forsythiae 499g, Radix Scutellariae 300g, Radix Paeoniae Rubra 300g, Herba Artemisiae Annuae 299g, Fructus Arctii 200g, Rhizoma Belamcandae 199g, Bulbus Fritillariae Thunbergii 200g, Herba Verbenae 199g.
More than nine flavors, Fructus Forsythiae, Herba Artemisiae Annuae are pulverized, and carry out vapor distillation, extract 1.5 hours, collect volatile oil, are encapsulated with for use with the beta-schardinger dextrin-grinding; The medicinal liquid of carrying behind the oil filters, and other puts; Add Flos Lonicerae, Radix Scutellariae, Fructus Arctii, Herba Verbenae in the medicinal residues, decoct with water 2 times, each 12 times of water gagings, each 1.5 hours, merge extractive liquid, filtered, filtrate with carry oil back medicinal liquid and merge, be evaporated to the clear paste that relative density is about 1.05 (60 ℃); Radix Paeoniae Rubra, Rhizoma Belamcandae, Bulbus Fritillariae Thunbergii heating and refluxing extraction 4 times add 8 times of amount 90% ethanol at every turn, and each 2 hours, merge extractive liquid, filtered, and decompression filtrate recycling ethanol continues to be concentrated into the clear paste that relative density is about 1.05 (60 ℃) to the greatest extent; Above-mentioned clear paste is merged, and mixing carries out spray drying, gets dry powder, adds Benexate Hydrochloride, adds suitable dextrin, mix homogeneously, and the system soft material, 50 ℃ of oven dry of wet granular behind the dried granule granulate, promptly get granule.Boiled water is taken after mixing it with water, one day three times; 1 year old with interior one time 5/3 gram, and 1-3 year is with interior one time 2.5 gram, and 3-7 year is with interior one time 5/3 gram, and 7-12 year is with interior one time 5 gram.
Embodiment 2
Flos Lonicerae 350g, Fructus Forsythiae 351g, Radix Scutellariae 200g, Radix Paeoniae Rubra 200g, Herba Artemisiae Annuae 199g, Fructus Arctii 100g, Rhizoma Belamcandae 99, Bulbus Fritillariae Thunbergii 10g, Herba Verbenae 101g.
Fructus Forsythiae, Herba Artemisiae Annuae carry out vapor distillation, extract volatile oil 3 hours, with standby after the beta-schardinger dextrin-grinding inclusion; The medicinal liquid of carrying behind the oil filters, and other puts; Add Flos Lonicerae, Radix Scutellariae, Fructus Arctii, Herba Verbenae in the medicinal residues, decoct with water 4 times, each 12 times of water gagings, each 1.5 hours, merge extractive liquid, filtered, filtrate with carry oil back medicinal liquid and merge, be concentrated into relative density and be about 1.05 clear paste; Radix Paeoniae Rubra, Rhizoma Belamcandae, Bulbus Fritillariae Thunbergii add 8 times of amount 50%% ethanol, extract 4 times, each 4 hours, are concentrated into relative density and are about 1.05 clear paste; Above-mentioned clear paste is merged, and mixing adds Benexate Hydrochloride, mix homogeneously, and the dry dry powder that gets adds appropriate amount of auxiliary materials, is pressed into tablet.One day three times; 1 year old with interior one time 1,1-3 year with interior one time 2,3-7 year with interior one time 3,7-12 year with interior one time 4.
Embodiment 3
Flos Lonicerae 1000g, Fructus Forsythiae 1000g, Radix Scutellariae 600g, Radix Paeoniae Rubra 600g, Herba Artemisiae Annuae 600g, Fructus Arctii 400g, Rhizoma Belamcandae 400g, Bulbus Fritillariae Thunbergii 400g, Herba Verbenae 400g.
Fructus Forsythiae, Herba Artemisiae Annuae carry out vapor distillation, extract volatile oil 3 hours, with standby after the beta-schardinger dextrin-grinding inclusion; The medicinal liquid of carrying behind the oil filters, and other puts; Add Flos Lonicerae, Radix Scutellariae, Fructus Arctii, Herba Verbenae in the medicinal residues, decoct with water 2 times, each 8 times of water gagings, each 1.5 hours, merge extractive liquid, filtered, filtrate with carry oil back medicinal liquid and merge, be concentrated into relative density and be about 1.05 clear paste; Radix Paeoniae Rubra, Rhizoma Belamcandae, Bulbus Fritillariae Thunbergii add 6 times of amount 90%% ethanol, extract 2 times, each 2 hours, are concentrated into relative density and are about 1.05 clear paste; Above-mentioned clear paste is merged, and mixing adds Benexate Hydrochloride, mix homogeneously, and the dry dry powder that gets adds appropriate amount of auxiliary materials, the system soft capsule.One day three times; 1 year old with interior one time 1,1-3 year with interior one time 2,3-7 year with interior one time 3,7-12 year with interior one time 4.
Embodiment 4
Flos Lonicerae 250g, Fructus Forsythiae 250g, Radix Scutellariae 150g, Radix Paeoniae Rubra 150g, Herba Artemisiae Annuae 150g, Fructus Arctii 100g, Rhizoma Belamcandae 100g, Bulbus Fritillariae Thunbergii 100g, Herba Verbenae 100g.
More than nine flavors, Fructus Forsythiae, Herba Artemisiae Annuae are ground into coarse granule, carry out vapor distillation, extract after 2 hours, collect volatile oil, doubly measure beta-schardinger dextrin-grinding inclusion, drying, porphyrize, standby; The medicinal liquid of carrying behind the oil filters, and other puts; Add medical materials such as Flos Lonicerae, Radix Scutellariae, Fructus Arctii, Herba Verbenae in the medicinal residues, decoct with water 3 times, each 10 times of water gagings, each 1 hour, merge extractive liquid, filtered, filtrate with carry oil back medicinal liquid and merge, be evaporated to the clear paste that relative density is about 1.05 (60 ℃); Radix Paeoniae Rubra, Rhizoma Belamcandae, Bulbus Fritillariae Thunbergii heating and refluxing extraction 3 times add 7 times of amount 70% ethanol at every turn, and each 3 hours, merge extractive liquid, filtered, and decompression filtrate recycling ethanol continues to be concentrated into the clear paste that relative density is about 1.05 (60 ℃) to the greatest extent; Above-mentioned clear paste is merged, and mixing carries out spray drying, gets dry powder, adds Benexate Hydrochloride, add an amount of protein sugar and dextrin, mix homogeneously with 80% ethanol moistening system soft material, is crossed 14 mesh sieves, 40 ℃ of oven dry of wet granular, encapsulated behind the dried granule granulate, promptly get capsule.One day three times; 1 year old with interior one time 1,1-3 year with interior one time 2,3-7 year with interior one time 3,7-12 year with interior one time 4.

Claims (10)

1, a kind of Chinese medicine preparation for the treatment of paediatric acute tonsillitis is characterized in that, said preparation is made by following Chinese medicine raw materials by weight proportion:
Flos Lonicerae 250-1000 weight portion, Fructus Forsythiae 250-1000 weight portion, Radix Scutellariae 150-600 weight portion, Radix Paeoniae Rubra 150-600 weight portion, Herba Artemisiae Annuae 150-600 weight portion, Fructus Arctii 100-400 weight portion, Rhizoma Belamcandae 100-400 weight portion, Bulbus Fritillariae Thunbergii 100-400 weight portion, Herba Verbenae 100-400 weight portion.
2, the Chinese medicine preparation of claim 1 is characterized in that, said preparation is made by following Chinese medicine raw materials by weight proportion:
Flos Lonicerae 375-666 weight portion, Fructus Forsythiae 375-666 weight portion, Radix Scutellariae 225-400 weight portion, Radix Paeoniae Rubra 225-400 weight portion, Herba Artemisiae Annuae 225-400 weight portion, Fructus Arctii 150-266 weight portion, Rhizoma Belamcandae 150-266 weight portion, Bulbus Fritillariae Thunbergii 150-266 weight portion, Herba Verbenae 150-266 weight portion.
3, the Chinese medicine preparation of claim 1 is characterized in that, said preparation is made by following Chinese medicine raw materials by weight proportion:
Flos Lonicerae 500 weight portions, Fructus Forsythiae 500 weight portions, Radix Scutellariae 300 weight portions, Radix Paeoniae Rubra 300 weight portions, Herba Artemisiae Annuae 300 weight portions, Fructus Arctii 200 weight portions, Rhizoma Belamcandae 200 weight portions, Bulbus Fritillariae Thunbergii 200 weight portions, Herba Verbenae 200 weight portions.
4. any one Chinese medicine preparation of claim 1-3 is selected from: tablet, capsule, soft capsule and granule.
5. the Chinese medicine preparation of claim 4 is granules.
6. the Chinese medicine preparation of claim 1 wherein also comprises the medicine acceptable carrier.
7. the application of the Chinese medicine preparation of claim 1 in the medicine of preparation treatment paediatric acute tonsillitis.
8, the preparation method of the Chinese medicine preparation of claim 1 is characterized in that, the process following steps: Fructus Forsythiae, Herba Artemisiae Annuae, carry out vapor distillation, and extract volatile oil, with standby after the beta-schardinger dextrin-grinding inclusion; The medicinal liquid of carrying behind the oil filters, and other puts; Add Flos Lonicerae, Radix Scutellariae, Fructus Arctii, Herba Verbenae in the medicinal residues, decoct with water merge extractive liquid,, filter, filtrate with carry oil back medicinal liquid and merge, concentrate clear paste; Radix Paeoniae Rubra, Rhizoma Belamcandae, Bulbus Fritillariae Thunbergii ethanol extraction, extracting solution is concentrated into clear paste; Above-mentioned clear paste merges the volatile oil with grind inclusion with beta-schardinger dextrin-after, forms pharmaceutically active substance of the present invention, and this active substance mixes with the medicine acceptable carrier, makes pharmaceutical preparation of the present invention according to the galenic pharmacy routine techniques.
9, preparation method according to Claim 8, it is characterized in that the preparation process following steps of granule dosage form wherein: Fructus Forsythiae, Herba Artemisiae Annuae are ground into coarse granule, add 20 times of water gagings, carry out vapor distillation, extract after 2 hours, collect volatile oil, grind enclose with 10 times of amount beta-schardinger dextrin-s, drying, porphyrize, standby; The medicinal liquid of carrying behind the oil filters, and other puts; Add medical materials such as Flos Lonicerae, Radix Scutellariae, Fructus Arctii, Herba Verbenae in the medicinal residues, decoct with water 3 times, each 10 times of water gagings, each 1 hour, merge extractive liquid, filtered, filtrate with carry oil back medicinal liquid and merge, be concentrated into relative density and be about 1.05 clear paste; Radix Paeoniae Rubra, Rhizoma Belamcandae, Bulbus Fritillariae Thunbergii heating and refluxing extraction 3 times add 7 times of amount 70% ethanol at every turn, and each 3 hours, merge extractive liquid, filtered, and filtrate alkali pushes back receives ethanol to the greatest extent, continues to be concentrated into relative density and is about 1.05 clear paste; Above-mentioned clear paste is merged, and mixing carries out spray drying, gets dry powder; Add volatile oil beta cyclodextrin inclusion complex, add an amount of protein sugar and dextrin, mix homogeneously with 80% ethanol moistening, is crossed 14 mesh sieves, and 40 ℃ of oven dry of wet granular become the 1000g granule behind the dried granule granulate, packing, and every bag of 5g, promptly.
10, the method for quality control of the pharmaceutical preparation of claim 5 is characterized in that, comprises following content, character, discriminating, inspection, assay, wherein
Theing contents are as follows of character
This granule is the light brown granule, feeble QI perfume (or spice), and it is sweet to distinguish the flavor of;
That differentiates thes contents are as follows:
(1) gets this granule fine powder 2g, add ether 20ml, heating extraction 0.5h, take off, put coldly, discard ether solution, volatilize solvent, add dehydrated alcohol 20ml, heating extraction 0.5h, take off, put cold, the filtrate evaporate to dryness, residue is with water 5ml, and dissolving moves on the D101 type macroporous adsorptive resins, water 100ml eluting discards water liquid, with 3% ethanol 50ml eluting, discard, use 70% ethanol elution, collect eluent 50ml, evaporate to dryness, residue makes dissolving with ethanol 2ml, as need testing solution. and other gets the phillyrin reference substance, add ethanol and make the solution that every 1ml contains 1mg, product liquid is tested according to thin layer chromatography in contrast, draw need testing solution 10ul, reference substance solution 5ul puts respectively on same silica gel g thin-layer plate, launches with chloroform-methanol-formic acid, take out, dry, spray is with 10% sulphuric acid ethanol liquid, and 105 ℃ of heating developed the color in 5 minutes, in the test sample chromatograph, with reference substance chromatograph relevant position on show the speckle of same color;
(2) the need testing solution preparation is with differentiating (1). and other gets the peoniflorin reference substance, adds ethanol and makes the solution that every 1ml contains 1mg, in contrast product liquid, draw need testing solution 10ul according to thin layer chromatography, reference substance solution 5ul puts respectively on same silica gel g thin-layer plate, launches with chloroform methanol, take out, dry, spray is with the fragrant aldehyde test solution colour developing of eggplant, and 105 ℃ of heating developed the color in 5 minutes. in the test sample chromatograph, with reference substance chromatograph relevant position on, show the speckle of same color;
(3) get this granule 5g, be ground into fine powder, add 1ml ammonia and 50ml chloroform, water-bath reflux 1 hour is put coldly, filter, and the filtrate evaporate to dryness, residue is with chloroform 2ml dissolving, product solution in contrast; Other gets the peimine reference substance, and chlorination is copied into the solution that every 1ml contains 1mg, in contrast product solution.According to the thin layer chromatography test, draw need testing solution 10ul, reference substance solution, 4ul puts respectively on same silica gel g thin-layer plate, launches with ethyl acetate-methanol-ammonia, takes out, and dries, and spray is with the secret potassium liquid of rare iodine; Test sample with the corresponding position of reference substance chromatograph on show the mottle of same color;
(4) get this granule 2.5g, porphyrize adds ethanol 20ml, and supersound extraction 30 minutes filters, and filtrate evaporate to dryness, residue add ethanol makes dissolving, as need testing solution; Other gets the arctiin reference substance, adds ethanol and makes the solution that every 1ml contains 2mg, in contrast product solution; Test according to thin layer chromatography, draw need testing solution 10ul, reference substance solution 4ul puts on same silica gel g thin-layer plate, is developing solvent with chloroform-methanol-water, launch, take out, dry, spray is with 10% sulphuric acid ethanol liquid, 105 ℃ of heating 5 minutes, the test sample chromatograph with the corresponding position of reference substance chromatograph on show the mottle of same color;
(5) get this granule 5g, porphyrize adds methanol 30ml, water-bath reflux, extract, 30 minutes filters the filtrate evaporate to dryness, residue makes dissolving with water 20ml, filters, and adds hydrochloric acid in the filtrate, transfer PH to 2, use ethyl acetate extraction 3 times, each 20ml, combined ethyl acetate liquid, evaporate to dryness, residue makes dissolving with methanol 5ml, as need testing solution, other gets the baicalin reference substance, adds methanol and makes the solution that every 1ml contains 1mg, product solution according to the thin layer chromatography test, is drawn need testing solution 10ul in contrast, reference substance solution 4ul, point launches with ethyl acetate-acetone-formic acid-water on same silica gel g thin-layer plate, takes out, dry, spray is with 2% ferric chloride ethanol liquid; The test sample chromatograph with the reference substance chromatograph with the corresponding position of reference substance chromatograph on show the mottle of same color;
That checks thes contents are as follows:
Should meet every regulation relevant under the granule item;
Theing contents are as follows of assay:
According to high effective liquid chromatography for measuring;
It is filler that chromatographic condition and system suitability test contain silica gel with the octadecylsilane key: methanol-0.4% phosphate aqueous solution is a mobile phase; The detection wavelength is 327nm; Theoretical cam curve is calculated 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, puts in the brown measuring bottle, adds 50% methanol and make the solution that every 1ml contains 50ug, promptly;
The about 1g of this product fine powder is got in the preparation of need testing solution, and accurate the title decides, and puts in the tool plug conical flask, precision adds 50% methanol 50ml, and supersound process 30 minutes is put cold, claim again to decide weight, supply the weight that subtracts mistake, shake up with 50% methanol, filter, precision is measured subsequent filtrate 5ml, puts in the brown measuring bottle of 10ml, adds 50% methanol to scale, shake up, promptly; Accurate respectively reference substance solution and the need testing solution 20ul of drawing of algoscopy injects chromatograph of liquid, measures, promptly; This granule whenever comprises Flos Lonicerae in chlorogenic acid, must not be less than 13mg.
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CN101204422B (en) * 2007-12-12 2011-04-13 李亚萍 Chinese traditional medicine preparation for acute tonsillitis
CN104083547B (en) * 2014-06-30 2017-09-29 成都中医药大学 A kind of pharmaceutical composition and preparation method and purposes for treating infant's respiration systemic disease
CN107621517B (en) * 2016-07-14 2020-02-21 天津同仁堂集团股份有限公司 Detection method of kechuanjing syrup
CN108815360B (en) * 2018-09-27 2021-05-18 西安碑林药业股份有限公司 A Chinese medicinal composition for treating infantile acute tonsillitis and acute pharyngitis, and its preparation method
CN110967441B (en) * 2019-12-23 2021-07-02 河北中医学院 Rapid thin-layer identification method for Jinshi Liyan granules

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CN1424084A (en) * 2002-12-19 2003-06-18 中国人民解放军第二军医大学 Honeysuckle flower and coptis root powder injection and its preparing method
CN1616002A (en) * 2004-09-14 2005-05-18 马耀茹 Oral administration or lozenge medicine for treating acute pharyngitis and acute tonsillitis

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Publication number Priority date Publication date Assignee Title
CN1424084A (en) * 2002-12-19 2003-06-18 中国人民解放军第二军医大学 Honeysuckle flower and coptis root powder injection and its preparing method
CN1616002A (en) * 2004-09-14 2005-05-18 马耀茹 Oral administration or lozenge medicine for treating acute pharyngitis and acute tonsillitis

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