CN102247521A - Preparation containing in-vitro cultivated calculus bovis for treating children cough, and preparation method thereof - Google Patents
Preparation containing in-vitro cultivated calculus bovis for treating children cough, and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a preparation containing in-vitro cultivated calculus bovis for treating children cough, and a preparation method thereof. The preparation is characterized in that: the preparation is prepared from materials of, by weight: 2 to 4 parts of in-vitro cultivated calculus bovis, 20 to 40 parts of purple perilla leaf, 20 to 40 parts of mulberry leaf, 40 to 80 parts of radix peucedani, 20 to 40 parts of Chekiang fritillary bulb, 20 to 40 parts of ephedra stem, 20 to 40 parts of balloonflower root, 40 to 80 parts of arisaema erubescens (wall.) schott (prepared), 20 to 40 parts of tangerine peel, 40 to 80 parts of bitter apricot kernel (stir-fried), 40 to 80 parts of baikal skullcap root, 14 to 28 parts of natural indigo, 40 to 80 parts of trichosanthes root, 40 to 80 parts of submature bitter orange (stir fried with bran), 30 to 60 parts of chinese hawthorn fruit (stir-fried), 10 to 20 parts of licorice, a proper amount of cane sugar, and a proper amount of dextrin. According to the invention, artificial bovis is substituted by in-vitro cultivated calculus bovis, such that problems of preparation safety and preparation efficiency are solved. With crushing and mixing methods aimed at valuable material in-vitro cultivated calculus bovis, dispersion uniformity of in-vitro cultivated calculus bovis can be ensured.
Description
Technical field
The present invention relates to a kind of preparation and preparation method that contains the treatment infantile cough of In vitro cultured Calculus Bovis, belong to the technical field that medicine is made.
Background technology
Child's common cold and influenza are modal children diseases, and regular meeting causes that headache body burning, cough with profuse sputum, tachypnea are done to breathe heavily, laryngopharynx swelling and pain, dysphoria or the like symptom.
Belong to syndrome of superficies cold and interior heat in the classification of traditional Chinese medical science disease, onset often has upper respiratory tract infection symptoms earlier, and the cough beginning is not heavy, be zest, expectorant is few, cough aggravation after 1～2 day, and expectorant transfers the mucus purulence to by viscosity, heavier case often rises in morning, sleep evening, after Body Position Change, suction cold air or the physical exertion, the paroxysmal cough is arranged, cough sometimes even all day, wheezing sound and out of breath can be arranged, or thick dry rale is arranged, or base of lung portion hears moist rale.
Should clearing away heat and expelling pathogen in the exterior on the method for treatment, antitussive reduces phlegm.It is that the numerous doctors and the patient head of a family are selected that a kind of preparation of being made by artificial Calculus Bovis, Folium Perillae, Folium Mori, Radix Peucedani, Bulbus Fritillariae Thunbergii, Herba Ephedrae, Radix Platycodonis, Rhizoma Arisaematis (system), Pericarpium Citri Reticulatae, Semen Armeniacae Amarum (stir-fry), Radix Scutellariae, Indigo Naturalis, Radix Trichosanthis, Fructus Aurantii (parched with bran), Fructus Crataegi (stir-fry), Radix Glycyrrhizae (common name: treasured is coughed peaceful granule) is arranged; but this product exists two problems not have fine solution, and quality is unstable and cause this product side reaction to take place often.Reason one: use the artificial Calculus Bovis in the prescription, limit owing to the oxious component unconjugated bilirubin is not carried out content in the working standard, the untoward reaction report is a lot; Reason two: artificial Calculus Bovis's amount is much smaller than the amount of other drug and adjuvant (by weight, artificial Calculus Bovis: other drug and adjuvant=1: 300) in the prescription, and original mixed method the uniformity often occurs and can not finely solve.Original mixed method is: the material of getting it filled extracts clear paste, adds suitable amount of sucrose and dextrin, and goes into worker's Calculus Bovis fine powder and directly mixes, and makes granule.Below these two kinds of reasons are described in detail and illustrate:
One; the treasured that present infant is taken is coughed peaceful granule and is contained the artificial Calculus Bovis; in artificial Calculus Bovis's the quality standard not the content to unconjugated bilirubin limit; unconjugated bilirubin content wherein is than natural Calculus Bovis; many (Chinese Pharmacopoeia has strict restriction to the middle content of the unconjugated bilirubin in natural Calculus Bovis and the In vitro cultured Calculus Bovis) that the content of In vitro cultured Calculus Bovis is high; it can be by the blood brain barrier system that affects the nerves when unconjugated bilirubin surpassed finite concentration; the free too high jaundice that causes easily of content of bilirubin in the blood; take the present treasured that contains the artificial Calculus Bovis for the age less than 3 years old child and cough peaceful granule; often there is child vomiting to occur; anorexia; the untoward reaction of jaundice is especially adopted the treasured of original mixed method preparation to cough peaceful granule and is caused the artificial Calculus Bovis to disperse in medicine when inhomogeneous more very.
The In vitro cultured Calculus Bovis that the present invention uses is the crude drug that obtains State Food and Drug Administration's approval registration, has perfect quality standard.In vitro cultured Calculus Bovis is the lithogenous biochemical process of mock bull body inner bag; the Calculus Bovis of in external Fel Bovis seu Bubali, developing; its character, surface structure, microstructure, composition, content are all consistent with the high-quality natural Calculus Bovis; steady quality, controlled; do not contain Hyodeoxycholic Acid; can carry out suitability for industrialized production, just in time remedy the deficiency of natural Calculus Bovis.The one-tenth stone process of In vitro cultured Calculus Bovis is Biochemical processes, is the process that various effective ingredient, effective group make up naturally.1997, In vitro cultured Calculus Bovis obtained national Chinese medicine one kind new medicine certificate, and 2002, the research achievement obtained national technological invention second prize.Expert through Chinese Pharmacopoeia Commission's tissue repeatedly proves: the shape of In vitro cultured Calculus Bovis, structure, composition, content are all similar to natural Calculus Bovis; pharmacodynamics, toxicologic study result prove safety; clinical efficacy is consistent with natural Calculus Bovis; and being higher than natural Calculus Bovis for some sick curative effect of planting, is the ideal substitute of natural Calculus Bovis.The quality standard of In vitro cultured Calculus Bovis is by " Chinese pharmacopoeia version in 2005 is recorded.
State Food and Drug Administration successively holds expert discussion on Wuhan, Beijing and other places, and whether alternative natural Calculus Bovis has carried out discussing again and again with Calculus Bovis cultivating to In vitro cultured Calculus Bovis.Detection to the multiple one-tenth such as content of bilirubin of In vitro cultured Calculus Bovis shows; In vitro cultured Calculus Bovis can substitute natural Calculus Bovis fully; State Food and Drug Administration is according to expert's conclusion, and decision can use 41 kinds of emergency and severe disease medications such as cow-bezoar bolus for resurrections In vitro cultured Calculus Bovis, Calculus Bovis cultivating to substitute.To solve this problem of Calculus Bovis insufficient raw material.The cultivation success of In vitro cultured Calculus Bovis will make more common people can benefit from the medicinal efficacy of Calculus Bovis.
On January 31st, 2004, State Food and Drug Administration sends " about the notice of Calculus Bovis and succedaneum use problem thereof ": for the new drug that contains Calculus Bovis of clinical anxious severe disease disease medicine variety that contains Calculus Bovis in the national drug standards prescription and the approval of national drug supervisory and management department, Calculus Bovis in the prescription can be substituted uses that feed intake of Calculus Bovis equivalent with Calculus Bovis cultivating, In vitro cultured Calculus Bovis, but it is alternative not to be able to the artificial Calculus Bovis; Other kinds that contain Calculus Bovis can substitute the use that feeds intake of Calculus Bovis equivalent with Calculus Bovis cultivating, In vitro cultured Calculus Bovis or artificial Calculus Bovis with the Calculus Bovis in the prescription.The scope of application to the artificial Calculus Bovis of this document limits, and can be equal to use with natural Calculus Bovis to In vitro cultured Calculus Bovis, also is the affirming of quality, drug effect, clinical efficacy to In vitro cultured Calculus Bovis.
The present invention uses In vitro cultured Calculus Bovis to replace the precious artificial Calculus Bovis who coughs in the peaceful granule, has scientific basis and policy support.With regard to active ingredient; in existing statutory standards; the bilirubin that the artificial Calculus Bovis is contained (active ingredient) must not be less than 0.63%; bilirubinicly must not be less than 35.0% and In vitro cultured Calculus Bovis and natural Calculus Bovis contain; show according to existing data; the effective ingredient of In vitro cultured Calculus Bovis and natural Calculus Bovis is effective ingredient such as compound calcium bilirubinate, cholic acid; and the content of compound calcium bilirubinate is very low among the artificial Calculus Bovis; mainly be made up of unconjugated bilirubin, clinical efficacy and natural Calculus Bovis and In vitro cultured Calculus Bovis are more too wide in the gap.
Two, existing treasured is coughed peaceful granule and is made by artificial Calculus Bovis and all the other 15 flavor vegetable drugs, because artificial Calculus Bovis's use amount and other drug and adjuvant use amount difference are big, (that is: the material of getting it filled extracts clear paste to original mixed method, add suitable amount of sucrose and dextrin, with go into worker's Calculus Bovis fine powder and directly mix, make granule) can't guarantee artificial Calculus Bovis's dispersed uniform degree in medicine; In vitro cultured Calculus Bovis belongs to expensive thin medical material, is used as medicine with its alternative artificial Calculus Bovis, if continue to prepare granule according to original mixed method, then causes expensive thin medical material to disperse the inhomogeneous direct curative effect of medication that influences.Improvement mixed method and process technology scheme that the present invention uses can finely address this problem.
Summary of the invention
The present invention has provided a kind of preparation and preparation method that contains the treatment infantile cough of In vitro cultured Calculus Bovis.
Prescription provided by the invention and preparation, verify through clinical experiment: to children's exogenous wind and cold, interior-heat stop eating that the headache body burning that causes, cough with profuse sputum, tachypnea are done to breathe heavily, laryngopharynx swelling and pain, dysphoria, have clearing away heat and expelling pathogen in the exterior, antitussive expectorant good efficacy, can significantly improve the above-mentioned symptom and the sign of infant.
In vitro cultured Calculus Bovis in the preparation provided by the invention is pulverized mixed method can guarantee In vitro cultured Calculus Bovis dispersed uniform in medicine effectively.
A kind of preparation that contains the treatment infantile cough of In vitro cultured Calculus Bovis; it is characterized in that: calculating according to composition by weight, is by 2～4 parts of In vitro cultured Calculus Boviss; 20～40 parts of Folium Perillaes; 20～40 parts on Folium Mori; 40～80 parts of Radix Peucedanis; 20～40 parts of Bulbus Fritillariae Thunbergiis; 20～40 parts in Herba Ephedrae; 20～40 parts of Radix Platycodoniss; 40～80 parts of Rhizoma Arisaematiss (system); 20～40 parts of Pericarpium Citri Reticulataes; 40～80 parts of Semen Armeniacae Amarums (stir-fry); 40～80 parts of Radix Scutellariaes; 14～28 parts of Indigo Naturaliss; 40～80 parts of Radix Trichosanthis; 40～80 parts of Fructus Aurantiis (parched with bran); 30～60 parts of Fructus Crataegis (stir-fry); 10～20 parts in Radix Glycyrrhizae adds suitable amount of sucrose and dextrin is made.
Calculate according to composition by weight, select for use the concrete numerical value ratio of above-mentioned raw materials to be: 15 parts of 3 parts of In vitro cultured Calculus Boviss, 30 parts of Folium Perillaes, 30 parts on Folium Mori, 60 parts of Radix Peucedanis, 30 parts of Bulbus Fritillariae Thunbergiis, 30 parts in Herba Ephedrae, 30 parts of Radix Platycodoniss, 60 parts of Rhizoma Arisaematiss (system), 30 parts of Pericarpium Citri Reticulataes, 60 parts of Semen Armeniacae Amarums (stir-fry), 60 parts of Radix Scutellariaes, 21 parts of Indigo Naturaliss, 60 parts of Radix Trichosanthis, 60 parts of Fructus Aurantiis (parched with bran), 45 parts of Fructus Crataegis (stir-fry), Radix Glycyrrhizae add suitable amount of sucrose and dextrin is made.
Technical scheme of the present invention is:
The first step: get In vitro cultured Calculus Bovis earlier and be ground into impalpable powder, cross 150 mesh sieves, standby;
Second step: Folium Perillae, Pericarpium Citri Reticulatae extract volatile oil, and the aqueous solution after distillation device is in addition collected; 13 flavors such as Folium Mori, Radix Peucedani, Bulbus Fritillariae Thunbergii, Herba Ephedrae, Radix Platycodonis, Rhizoma Arisaematis (system), Semen Armeniacae Amarum (stir-fry), Radix Scutellariae, Indigo Naturalis, Radix Trichosanthis, Fructus Aurantii (parched with bran), Fructus Crataegi (stir-fry), Radix Glycyrrhizae decoct with water secondary, 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction, filter, filtrate and above-mentioned aqueous solution merge, are condensed into the clear paste that relative density is 1.32～1.35 (50 ℃).And by the weight ratio of clear paste, sucrose and dextrin be take by weighing sucrose at 1: 3: 2, dextrin is standby.
The 3rd step: get the method that impalpable powder that the first step obtains increases progressively with equivalent and join in the dextrin, grind well, cross 120 mesh sieves, standby;
The 4th step: get cane sugar powder and be broken into fine powder, cross 100 mesh sieves, the mixed powder that obtains with the 3rd step mixes according to the method that equivalent increases progressively, and crosses 100 mesh sieves.
The 5th step: qinghuo reagent, join in the mixed powder of the 4th step acquisition, mixed 30 minutes, extruding is sieved and is made wet granular;
The 6th step:, remove and promptly to obtain finished particle by the coarse grain and the fine powder that can pass through 80 mesh sieves of 10 mesh sieves with 10 mesh sieves and 80 mesh sieves with the 80 ℃ of oven dry of wet granular (water content is less than 5%) that make;
The 7th step: the Folium Perillae of second step acquisition and the volatile oil of Pericarpium Citri Reticulatae are injected in the dried particles, and mixing after airtight 24 hours, is distributed into bag.
The innovative point of the present invention on prescription is: select for use In vitro cultured Calculus Bovis to replace the artificial Calculus Bovis.The artificial Calculus Bovis is the succedaneum of seeking under the very rare situation of China's Calculus Bovis resource; be directly allotment after the Fel Bovis seu Bubali drying to be formed; because unconjugated bilirubin content is higher; the content of compound calcium bilirubinate is on the low side; the clinical report side reaction is a lot; in the medicine of a lot of child's preparations and treatment cardio-cerebral diseases; the artificial Calculus Bovis can not substitute natural Calculus Bovis and use, and In vitro cultured Calculus Bovis be State Food and Drug Administration's approval can be by the Calculus Bovis succedaneum that uses with the natural Calculus Bovis Isodose.
The innovative point of the present invention on preparation technology is: adopt the pulverizing and the mixing of improving one's methods and carrying out In vitro cultured Calculus Bovis; amount is little; the big In vitro cultured Calculus Bovis of curative effect contribution is ground into impalpable powder; cross 150 mesh sieves (particle diameter=90 μ m ± 4.6 μ m); and the mixed method that adopts equivalent to increase progressively is mixed with 150 purpose dextrin (particle diameter=90 μ m ± 4.6 μ m); the gained mixture mixes according to the method that equivalent increases progressively with 100 purpose cane sugar powders (particle diameter=150 μ m ± 6.6 μ m) again, can avoid In vitro cultured Calculus Bovis to disperse uneven situation to take place fully.
Because original mixed method is: the material of getting it filled extracts clear paste, adds suitable amount of sucrose and dextrin, and goes into worker's Calculus Bovis fine powder and directly mixes, and makes granule.Artificial Calculus Bovis's amount is much smaller than the amount (by weight, artificial Calculus Bovis: other drug and adjuvant ≈ 1: 300) of other drug and adjuvant in the prescription, so that disperseing often appears in original mixed method is inhomogeneous.And improved mixed method can address this problem well among the present invention.
The pulverizing mixed method of In vitro cultured Calculus Bovis is among the present invention:
1, gets In vitro cultured Calculus Bovis earlier and be ground into impalpable powder (crossing 150 mesh sieves);
2, the method that increases progressively with equivalent of In vitro cultured Calculus Bovis impalpable powder joins in the dextrin, grinds well, and crosses 120 mesh sieves;
3, cane sugar powder is broken into fine powder, crosses 100 mesh sieves, the mixed powder that obtains with the 2nd step mixes according to the method that equivalent increases progressively, and crosses 100 mesh sieves;
4, get remaining vegetable medicinal material extract gained clear paste, join in the mixed powder of the 3rd step acquisition, mixed 30 minutes, extruding is sieved and is made granule.
Experimentation 1: improve the dispersing uniformity of pulverizing mixed method and original pulverizing mixed method and compare
(Chinese Medicine science and technology publishing house) tests with reference to " pharmaceutical production checking guide " version in 2003,
1. test arrangement: 1. pulverize: get In vitro cultured Calculus Bovis 0.2g (bilirubin C
33H
36N
4O
6Content is: 36.82%), 2 parts, a pulverizing by improving one's methods is impalpable powder (crossing 150 mesh sieves), and another part is by original method porphyrize (crossing 80 mesh sieves); 2. mix: get 2 parts in dextrin, every part of 20kg, respectively by improve one's methods and original method with after In vitro cultured Calculus Bovis mixes; 3. sampling rule: final mixture divides the upper, middle and lower three level sampling, 3 (sample point uniform distribution) of every layer of sampling; 4. independently carry out three tests respectively, write down the content of bilirubin result of each part sampling, calculate the RSD (%) of each time test.
2. content of bilirubin is measured
2.1 the about 10mg of bilirubin reference substance is got in the preparation of reference substance solution, the accurate title, decide, and puts in the brown measuring bottle of 100ml, adds the chloroform dissolving and be diluted to scale, shake up, precision is measured 5ml, puts in the brown measuring bottle of 50ml, add ethanol to scale, shake up, promptly get (containing bilirubin 10 μ g among every 1ml).
2.2 the preparation precision of standard curve is measured reference substance solution 1ml, 2ml, 3ml, 4ml, 5ml, put in the tool plug test tube, add ethanol respectively to 9ml, each precision adds diazotising solution (first liquid: get p-anilinesulfonic acid. 0.1g, add hydrochloric acid 1.5ml and make into 100ml in right amount with water; Second liquid: get sodium nitrite 0.5g, add water and make and be dissolved into 100ml, put in the refrigerator and preserve.Time spent is got first liquid 10ml and second liquid 0.3ml, mixing) 1ml, shake up, placing 1 hour in 15～20 ℃ of dark places, is blank with the reagent corresponding, according to ultraviolet visible spectrophotometry (appendix VA), measure absorbance at 533nm wavelength place, with the absorbance is vertical coordinate, and concentration is abscissa, the drawing standard curve.
2.3 algoscopy is got mixed medicated powder 1.0g, accurate claims surely, puts in the conical flask, adds 1 of mixed solution 60ml, the hydrochloric acid of chloroform and ethanol (7: 3), shakes up, and puts in the water-bath reflux about 30 minutes, puts coldly, moves in the brown measuring bottle of 100ml.Container mixed with little amount solution washing is incorporated in the same measuring bottle, adds above-mentioned mixed solution to scale, shakes up.Precision is measured supernatant 10ml, puts in the brown measuring bottle of 50ml, adds ethanol to scale, shakes up.Precision is measured 3ml, puts in the tool plug test tube, and the method under the preparation of sighting target directrix curve from " adding ethanol to 9ml ", is measured absorbance in accordance with the law, reads from standard curve to contain bilirubinic weight (mg) the need testing solution, calculates, promptly.The results are shown in Table 1
Table 1 content of bilirubin measurement result table
Three times the independent trials result shows: (1) improves one's methods RSD far below original method, and the mixed powder principal agent that makes of improving one's methods is uniformly dispersed degree far above original method; (2) original method RSD is all above 2%, and this does not meet the prescribed limit (requiring RSD to surpass 2%) of content relative standard deviation in the checking of solid preparation hybrid technique, and this is the defective place of original method just; And improve one's methods the RSD that tests for three times all in 2%, proving improves one's methods can remedy this defective well.
Experimentation 2: the determining of the optimal proportion of clear paste, sucrose and dextrin
1, contains more bitter principle in the preparation of the present invention, need to add adjuvants such as suitable amount of sucrose and dextrin.The sucrose proportion is crossed conference and is caused the easy moisture absorption of granule, caking and rotten, the too small then granule of ratio heavy bitter taste, and the infant refusal is taken; The dextrin ratio is crossed conference influences particulate melting, the too small effect that then can not play the reduction moisture absorption of ratio.
2, it is a collection of to make clear paste by prescription, gets 5kg, and totally 5 parts, every part of according to the form below adds the adjuvant of ormal weight, the back 80 ℃ of dryings of granulating 5 hours.Check melting, mouthfeel; Get the dried granule 2.0g of each part again and put respectively in the weighing botle of 5 dry constant weights, expose 5 hours down in room temperature condition simultaneously, measure each duplicate samples moisture.See Table 2:
Table 2 adjuvant ratio investigation table
| Clear paste (kg) | Sucrose: dextrin | Sucrose (kg) | Dextrin (kg) | Mouthfeel | Melting | Moisture (%) before exposing | Expose back moisture (%) |
| 5 | 1∶2 | 8.33 | 16.67 | Extremely bitter | Dissolving not exclusively | 4.6％ | 5.9％ |
| 5 | 2∶3 | 10.00 | 15.00 | Bitterness is obvious | Muddy | 4.6％ | 6.5％ |
| 5 | 1∶1 | 12.50 | 12.50 | Little hardship | Slight haze | 4.6％ | 7.2％ |
| 5 | 3∶2 | 15.00 | 10.00 | Sweet taste | Dissolving fully | 4.6％ | 7.7％ |
| 5 | 2∶1 | 16.67 | 8.33 | Extremely sweet | Dissolving fully | 4.6％ | 10.8％ |
The result shows: the ratio of sucrose and dextrin is 3: 2 o'clock, and granule mouthfeel flavor is sweet, and melting is good, and has certain anti-wettability power, is the adjuvant ratio of the best, and can get best ratio thus and be: clear paste, sucrose and dextrin are 1: 3: 2 according to weight ratio.
Experimentation 3: the quality standard research of preparation of the present invention
It is that existing " Chinese pharmacopoeia one one of version in 2005 is recorded kind that the treasured that contains the artificial Calculus Bovis is coughed peaceful granule; preparation of the present invention is to substitute the artificial Calculus Bovis with In vitro cultured Calculus Bovis; so with reference to " relevant standard code in one one of the Chinese pharmacopoeia version in 2005; according to State Food and Drug Administration " specification requirement of study of tcm new drug "; the treasured that contains In vitro cultured Calculus Bovis is coughed peaceful granule (preparation of the present invention) carry out the research of quality standard, carried out the checking of test method simultaneously.Result of study: the specificity that thin layer is differentiated, results such as the specificity of assay, precision, repeatability and application of sample recovery test all comply with relevant regulations.Test shows; the use In vitro cultured Calculus Bovis replaces the treasured behind the artificial Calculus Bovis to cough peaceful granule; the quality standard of preparation of the present invention meets the " regulation of Chinese pharmacopoeia current edition relevant criterion, and " in the Chinese pharmacopoeia current edition treasured that contains the artificial Calculus Bovis is coughed peaceful granular mass standard and the method for inspection similarly is applicable to preparation of the present invention (treasured that contains In vitro cultured Calculus Bovis is coughed peaceful granule) fully.
Experimentation 4: the clinical efficacy research of preparation of the present invention
Preparation of the present invention is that the treasured that contains In vitro cultured Calculus Bovis is coughed peaceful granule; by Dazhou City, Sichuan Province central hospital is responsible department; Affiliated Hospital of Sichuan Institute of Tradition Chinese Medicine; second the People's Hospital, Shuangliu County, Sichuan Province is a participant; coughing peaceful granule with the treasured that contains the artificial Calculus Bovis is the contrast medicine; with reference to " new Chinese medicine clinical research guideline "; " TCM Pediatrics disease diagnosis criterion of therapeutical effect "; " Pediatrics of Chinese Medicine "; the related content of " Clinical Researches of New Drugs design and statistical analysis "; carried out the clinical observation of this product treatment infantile cough syndrome of superficies cold and interior heat (acute tracheobronchitis), and preparation clinical efficacy of the present invention and safety have been made objective appraisal.Clinical observation result is as follows:
1. test exercise question: the treasured that contains In vitro cultured Calculus Bovis is coughed peaceful granule therapy infantile cough syndrome of superficies cold and interior heat (acute tracheobronchitis) clinical trial, and coughing peaceful granule with the treasured that contains the artificial Calculus Bovis is the multicenter clinical observation research that treasured that contrast evaluation contains In vitro cultured Calculus Bovis is coughed the safety of peaceful granule therapy cough syndrome of superficies cold and interior heat, effectiveness.
The treatment group: the treasured that contains In vitro cultured Calculus Bovis is coughed peaceful granule, one-year-oldly once obeys 1.25 grams (1/4 bag) to two years old, once obeys 2.5 grams (1/2 bag) in three years old to five years old, once obeys 5 grams (1 bag) in six years old to 14 years old, and every day 2 times, boiled water is taken after mixing it with water.
Matched group: the treasured that contains the artificial Calculus Bovis is coughed peaceful granule,, one-year-oldly once obeyed 1.25 grams (1/4 bag) to two years old, once obeyed 2.5 grams (1/2 bag) in three years old to five years old, once obeyed 5 grams (1 bag) in six years old to 14 years old, every day 2 times, boiled water is taken after mixing it with water.
2. physical data
2.1 the case source: this test case derives from Dazhou City central hospital and observes qualified case 159 examples of being tried altogether, Affiliated Hospital of Sichuan Institute of Tradition Chinese Medicine 158 examples, second the People's Hospital, Shuangliu County, 160 examples, the person that includes the statistical analysis in is totally 477 examples, wherein test group 358 examples, matched group 119 examples.
2.1.1 the age: two groups of infant age ratios: in the 477 routine infants, the oldest 13 years old, minimum 1 years old.Two groups of infant age distribution and mean age are relatively shown in table 1, table 2:
Table 1 liang group infant age distribution relatively
X is compared in two groups of infant age distribution
2=0.15, P=0.928, the difference not statistically significant illustrates between two groups to have comparability.
The table 2 liang group infant mean age (year) relatively
Two groups of infant age ratios, its average significance test of difference is t=0.079 as a result, p=0.938, P＞0.05, the difference not statistically significant illustrates between two groups to have comparability.
2.1.2 sex: in the 477 routine infants, male's 245 examples, women's 232 examples, man: woman=1: 0.95.Two groups of infant sex ratios are more as shown in table 3.
Table 3 liang group infant sex ratio
Two groups of infant sex ratios, by analysis, X
2=0.035, p=0.852, the difference not statistically significant illustrates between two groups to have comparability.
2.1.3 the course of disease: in the 477 routine infants, the course of disease is the longest 27 days, and is the shortest 1 day.Two groups of infant courses of disease distribute and the average course of disease comparison shown in table 4, table 5.
Table 4 a liang group infant course of disease distributes relatively
Two groups of infant courses of disease distribute relatively, X2=0.601, and P=0.741, the difference not statistically significant illustrates between two groups to have comparability.
Table 5 liang group infant average course of disease (my god) relatively
Two groups of infant courses of disease compare, and its average significance test of difference is t=0.871 as a result, p=0.385, and P＞0.05, the difference not statistically significant illustrates between two groups to have comparability.
2.1.4 treat preceding two groups of severity extents relatively: as shown in table 6
The preceding two groups of infant severity extents of table 6 treatment relatively
Treat preceding two groups of infant severity extents relatively, X
2=0.369, P=0.543, the difference not statistically significant illustrates between two groups to have comparability.
2.1.5 tcm symptom is relatively before two groups of case treatments: tcm symptom is more as shown in table 7 before two groups of case treatments:
Tcm symptom relatively before the table 7 liang group infant treatment
Treat each tcm symptom of preceding two groups of infants relatively, it is heavier than the matched group state of an illness to remove the group treatment group of having sore throat, and all the other symptom P are equal＞and 0.05, the difference not statistically significant illustrates between two groups to have comparability.
2.1.6 picture of the tongue, pulse condition are relatively before two groups of infant treatments: as shown in table 8
Picture of the tongue, pulse condition are relatively before the table 8 liang group infant treatment
Treat preceding two groups of infant picture of the tongues, pulse condition relatively, through the four fold table analysis, P all＞0.05, the difference not statistically significant illustrates between two groups to have comparability.
2.1.7 tcm syndrome integration and comparison before two groups of infant treatments: as shown in table 9
Tcm syndrome integration and comparison before the table 9 liang group infant treatment
Two groups of infant tcm syndrome integrations and comparison, through the t check, two distribution variances equate, its average significance test of difference, P＞0.05, the difference not statistically significant illustrates between two groups to have comparability.
2.1.8 treat preceding two groups of infant doctor trained in Western medicine signs (pulmonary rale) relatively: as shown in table 10
The preceding two groups of infant pulmonary rales of table 10 treatment relatively
Treat preceding two groups of infant pulmonary rale situations relatively, P＞0.05, the difference not statistically significant illustrates between two groups to have comparability.
2.1.9 treat preceding two groups of infant hemogram relatively: as shown in table 11.
The preceding two groups of infant hemogram of table 11 treatment relatively
Treat preceding two groups of infant hemogram situations relatively, by analysis, P all＞0.05, the difference not statistically significant illustrates between two groups to have comparability.
2.1.10 treat preceding two groups of infant chest film inspections relatively: as shown in table 12.
The preceding two groups of infant rabats of table 12 treatment relatively
| Group | The example number | Positive common practice number | Unusual routine number | Unusual rate % |
| The treatment group | 358 | 246 | 112 | 31.28 |
| Matched group | 119 | 84 | 35 | 29.41 |
Treat preceding two groups of infant rabats relatively, by analysis, X
2=0.147, p=0.701, P＞0.05, the difference not statistically significant illustrates between two groups to have comparability.
3. therapeutic outcome
3.1 the two groups of infant curative effects in treatment back are relatively: as shown in table 13:
The two groups of infant curative effects in table 13 treatment back relatively
Two groups of curative effects are analyzed through Ridit, wherein R treatment (more showing)=0.487, and R contrast (more showing)=0.540, U=2.112, P=0.035, P＜0.05 illustrates that treatment group cure-remarkable-effectiveness rate is apparently higher than matched group; R treats (effectively)=0.487, and R contrasts (effectively)=0.541, U=1.870, and P=0.062, P＞0.05, the difference not statistically significant illustrates that the total effects of treatment group and matched group is suitable.
3.2 the two groups of infant tcm syndrome curative effects in treatment back are relatively: the result is as shown in table 14:
The two groups of infant tcm syndrome curative effects in table 14 treatment back relatively
Two groups of curative effects are analyzed through Ridit, wherein R treatment (more showing)=0.487, and R contrast (more showing)=0.540, U=2.13, P=0.033, P＜0.05, the cure-remarkable-effectiveness rate that treatment group curative effect is described is apparently higher than matched group; R treats (effectively)=0.486, and R contrasts (effectively)=0.542, U=1.929, and P=0.053, P＞0.05, the difference not statistically significant illustrates the therapeutic equivalence that treatment group and matched group are total.
Onset time and remission time comparison 3.3 two groups of infants are coughed: see Table 15
Table 15 liang group infant cough onset time and remission time are relatively
Cough onset time relatively for two groups, through the t check, t=1.39, P＞0.05, difference does not have significance;
Two groups of cough remission times are relatively checked through t, t=1.73, and P＜0.05, difference does not have significance.
3.4 traditional Chinese medical science primary symptom curative effect:
3.4.1 two groups of treatment back cough curative effects relatively: the result is shown in table 16,17.
The two groups of infant coughs in table 16 treatment back curative effect relatively
Two groups of infant cough curative effects are analyzed through Ridit, wherein R treatment (more showing)=0.486, and R contrast (more showing)=0.541, U=2.275, P=0.023, P＜0.05, the cure-remarkable-effectiveness rate of treatment group cough curative effect is apparently higher than matched group; R treats (effectively)=0.487, and R contrasts (effectively)=0.538, U=1.737, and P=0.083, P＞0.05, the difference not statistically significant illustrates that the total effects and the matched group of treatment group cough is suitable.
3.4.2 cough up phlegm after two groups of treatments, expectorant chromaticness curative effect relatively: the result is shown in table 18, table 19.
The two groups of infants in table 18 treatment back are coughed up phlegm curative effect relatively
Two groups of infants curative effect of coughing up phlegm is analyzed through rank test or Ridit, R treatment=0.496, and R contrast=0.515, U=0.612, P=0.540, P＞0.05, the difference not statistically significant illustrates treatment group cough up phlegm curative effect and matched group therapeutic equivalence.
The two groups of infant expectorant chromaticness curative effects in table 19 treatment back relatively
Two groups of infant expectorant chromaticness curative effects are analyzed through rank test or Ridit, R treatment=0.496, and R contrast=0.514, U=0.566, P=0.572, P＞0.05, the difference not statistically significant illustrates treatment group cough up phlegm curative effect and matched group therapeutic equivalence.
3.4.3 pant curative effect relatively after two groups of treatments: the result is shown in table 20.
The two groups of infants in table 20 treatment back are panted curative effect relatively
Two groups of infants curative effect of panting is analyzed R treatment=0.491, R contrast through rank test or Ridit)=0.526, U=1.219, P=0.223, P＞0.05, the difference not statistically significant illustrates treatment group pant curative effect and matched group therapeutic equivalence.
3.5 the two groups of treatment back traditional Chinese medical science time disease curative effects are relatively: the result is shown in table 21:
Table 21 treatment back two groups of infant traditional Chinese medical science time disease curative effect relatively
Two groups of infants treatment back is for the effect that all has clear improvement of all symptoms in the traditional Chinese medical science minor symptom, but compare between group, treatment group and matched group are for the improvement of heating, pharyngalgia, learn by statistics and handle, P＞0.05 not statistically significant, but compare for two groups for symptom headache, dysphoria, P＜0.05 illustrates that the treatment group obviously is better than matched group for the curative effect of headache, dysphoric improvement.
3.6 two groups of infant tongues, pulse condition curative effects compare: the result is shown in table 22.
Table 22 liang group infant treatment back picture of the tongue, pulse condition curative effect are relatively
Two groups of infants are treated forward and backward picture of the tongue, pulse condition curative effect relatively, and two groups all have significant curative effect to infant picture of the tongue, pulse condition.Two groups tongue, pulse condition curative effect are through the contingency table X 2 test, and P is all greater than 0.05, and the difference not statistically significant illustrates two groups of infant picture of the tongues, pulse condition therapeutic equivalence.
3.7 tcm syndrome integration and curative effect are relatively after two groups of infant treatments: shown in table 23.
Table 23 liang group treatment back tcm syndrome integration and curative effect are relatively
By table 23 as seen: when syndrome integration and each sample data were matched before and after the treatment of treatment group infant, through the t check, its average significance test of difference is t=13.392 as a result, p=0.000, and difference has remarkable statistical significance; When two each sample datas of processing are matched before and after the treatment of control group, through the t check, its average significance test of difference is t=15.229 as a result, p=0.000, difference has remarkable statistical significance, illustrates that curative and contrast medicine all can significantly improve the tcm symptom integration of cough syndrome of superficies cold and interior heat.
Two groups of differences are relatively checked through t, and two handle homogeneities of variance, its average significance test of difference result, and t=0.0800, p=0.9364 illustrates two groups of therapeutic equivalences.
3.8 two groups of infant treatment back doctor trained in Western medicine signs (pulmonary rale) relatively: shown in table 24.
The two groups of infant pulmonary rale curative effects in table 24 treatment back relatively
Two groups of infants are panted curative effect through rank test or Ridit analysis, and P＜0.05 illustrates that two groups all can obviously be improved panting of infant; Relatively, R treats=0.497 between group, R contrast=0.511, and U=0.432, P=0.666, P＞0.05, the difference not statistically significant illustrates treatment group pulmonary rale curative effect and matched group therapeutic equivalence.
3.9 two groups of infant hemogram checkings relatively before and after the treatment: as shown in Table 25.
The forward and backward two groups of infant hemogram of table 25 treatment relatively
By table 17 as seen: the average own control of two groups of patient treatment front and back WBC differences is relatively checked through t, t=0.913, and P=0.389, difference does not have significance; Before and after two groups of treatments the averages of WBC differences relatively, through the t check, t=0.869, P=0.421, difference does not have significance, and the therapeutic equivalence that improves for hemogram is described after two groups of Drug therapys.
3.10 two groups of infant rabats in treatment back curative effect as a result compare: shown in table 26.
Table 26 treatment two groups of infant chest film inspection results in back relatively
By table 26 as seen, two groups of rabat curative effects of infant are through the contingency table X 2 test, P＞0.05, and the difference not statistically significant, illustrating two groups, that the infant rabat is improved curative effect is similar.
4 safety analysiss:
4.1 safety indexes changes before and after the treatment: shown in table 27.
The influence of table 27 pair hepatic and renal function, electrocardiogram, routine blood test
Shown in table 27, by to vicissitudinous each index of safety indexes before and after the treatment, organize contingency table X 2 test between interior x2 test of paired comparison of enumeration data, group respectively, P illustrates all greater than 0.05 as a result:
1. to the influence of liver function: curative and contrast medicine do not have toxicity to liver.
2. to the influence of renal function: curative and contrast medicine do not have toxicity to kidney.
3. to Electrocardiographic influence: curative and contrast medicine do not have influence to electrocardiogram, illustrate that curative and contrast medicine do not have toxicity to heart.
4. to the influence of routine blood test: curative and contrast medicine have no adverse reaction to platelet, erythrocyte, hemoglobin.
5. to large and small just conventional influence: same liver function.
Two groups of influences to safety index are similar.
5. analysis of adverse reactions
In the process of the test, do not see that untoward reaction takes place.
6. model case
Example one: Liu * *, man, 3 years old
Because of heating, cough were gone to a doctor in 3 days.Disease is seen: heating, and body temperature fluctuates between 38 ℃-38.5 ℃, the cough slight asthma, the nocturnal cough is heavier, and the expectorant yellow skin is difficult for bringing up, and inappetence is hard and dry.Have a medical check-up and see: acute heat sickly complexion, pharyngeal hyperemia, both tonsils I ° enlargement, no exudate.Heart rate 102 times/minute, hear sounds is strong, the tiny rale of two fullness of the lung cloth, abdomen is soft, does not touch under the liver spleen rib.Red tongue, thick, yellow and greasy fur, slippery and rapid pulse.The laboratory is checked: blood leukocytes 9.6 * 109/L, neutrality 78%, lymph 22%.Chest x-ray prompting: two lung no abnormality seens.The Western medicine diagnose bronchitis.Tcm diagnosis is cough, exterior cold and interior heat type.The treasured that contains In vitro cultured Calculus Bovis is coughed peaceful particulate oral; each 2.5 grams, every day three times is after taking medicine 1 day; infant body temperature is normal; cough is clearly better, and wheezing sound in the throat alleviates, and appetite increases to some extent; stool day 1 row; the treasured that contains In vitro cultured Calculus Bovis continue clothes is coughed peaceful granule all transference cures after four days, and hemogram is normal, treat after seven days and fully recovers.(Dazhou City central hospital)
Example two: thunder * *, woman, 3 years old
The paroxysm of cough first quarter moon, dry cough is coughed up phlegm not well, cough very and stridulate for very night, the decreased food intake of receiving is few, be hard and dry, every other day delegation.Coughing after repeatedly all kinds of Chinese and western drugses are taken in diagnosis and treatment in the outer court after being ill slightly alleviates, but still cough is frequent, difficulty falling asleep.Check: no out of breath, body temperature 37.70C (anus), pharyngeal congestion (+), the heart is no abnormal, and two pulmonary respiration sounds are owed freely, respiratory harshness, abdomen is soft.Chemical examination: blood leukocytes: total 7.4x109/L, neutrality 72%, lymph 28%.Rabat: two lung marking increase deeply and increase.White and thin fur, red tip of the tongue, rolling pulse.Be diagnosed as the cough of exterior cold and interior heat type; the treatment clearing lung, eliminating phlegm, relieving cough ﹠ asthma; the treasured that contains In vitro cultured Calculus Bovis is coughed peaceful particulate oral; each 2.5 grams, every day three times is after taking medicine 2 days; cough is clearly better; the treasured that contains In vitro cultured Calculus Bovis continue clothes is coughed peaceful granule all transference cures after three days, and hemogram, rabat are normal, treats after seven days and fully recover.(Sichuan Chinese medicine academy Affiliated Hospital)
Example three: poplar * *, man, 2 years old
Because of fever, cough were gone to a doctor in 6 days, because of heating (T39.5C) appears in the Changes in weather back of suffering from cold, the back body temperature of oneself taking medicine reduces infant before 7 days, cough obviously then, rale sound is arranged in the larynx, little tachypnea, appetite reduces, angel, cry when sleep night, big dry stool, urine still can, the red tongue white and thin fur, the little purple of fingerprint sees FENGGUAN.Pulmonary is dispersed in tiny rale, and the T:37.50C routine blood test shows: WBC7.6X109/L, Hb100g/L, N85%; Rabat shows: two lung marking increase deeply, AD cough, exterior cold and interior heat type; adopt the cold expelling lung qi dispersing, the method for removing heat-phlegm, the treasured that contains In vitro cultured Calculus Bovis is coughed peaceful particulate oral; each 2.5 grams, every day three times is after taking medicine 2 days; infant body temperature is normal; cough is clearly better, and the treasured that contains In vitro cultured Calculus Bovis continue clothes is coughed peaceful granule all transference cures after five days, and pulmonary rale disappears; hemogram, rabat recover normal, treat recovery from illness after seven days.(second the People's Hospital, Shuangliu County)
7 discuss
(wherein 358 examples are organized in treatment, matched group 119 examples by the clinical trial to 477 example cough syndrome of superficies cold and interior heat patients; ) result shows: the cure-remarkable-effectiveness rate of treatment group is 69.27%, and total effective rate is 92.46%; The cure-remarkable-effectiveness rate of matched group is 59.66%, and total effective rate is 86.55%.Two groups of curative effects relatively, credit is analysed by statistics, the cure-remarkable-effectiveness rate of curative effect has notable statistics difference (P＜0.05), illustrates that curative (treasured that contains In vitro cultured Calculus Bovis is coughed peaceful granule) treatment cough syndrome of superficies cold and interior heat cure-remarkable-effectiveness rate obviously is better than contrasting medicine (treasured that contains the artificial Calculus Bovis is coughed peaceful granule); Total effective rate does not relatively have significant difference (P＞0.05), and curative and the total therapeutic equivalence of contrast medicine are described.Illustrate that the treasured that contains In vitro cultured Calculus Bovis coughs the curative effect of peaceful granule therapy infantile cough syndrome of superficies cold and interior heat and slightly be better than contrasting the treasured that medicine contains the artificial Calculus Bovis and cough peaceful granule.
Clinical trial shows, the treasured that contains In vitro cultured Calculus Bovis is coughed peaceful granule and can significantly be improved the tcm syndrome of cough syndrome of superficies cold and interior heat infant.The tcm syndrome cure-remarkable-effectiveness rate of treatment group (treasured that contains In vitro cultured Calculus Bovis is coughed peaceful granule) is 72.07%, and total effective rate is 93.58%; The cure-remarkable-effectiveness rate of matched group (treasured that contains the artificial Calculus Bovis is coughed peaceful granule) tcm syndrome is 62.18%, and total effective rate is 89.08%.Two groups of curative effects are relatively analyzed through Ridit, and cure-remarkable-effectiveness rate has significant difference (P＜0.05), and total effective rate does not have significant difference (P＞0.05), and the traditional Chinese medical science disease therapeutic equivalence of treatment group and matched group is described.Illustrating that the treasured that contains In vitro cultured Calculus Bovis is coughed slightly is better than contrasting the treasured that medicine contains the artificial Calculus Bovis and coughs peaceful granule on the tcm syndrome curative effect of peaceful granule therapy cough syndrome of superficies cold and interior heat.
Clinical trial also shows, the treasured that contains In vitro cultured Calculus Bovis is coughed peaceful granule and all can significantly be improved the cardinal symptom and the sign of cough syndrome of superficies cold and interior heat infant, and its obvious effective rate and total effective rate are respectively: cough: 73.46%, 93.29%; Cough up phlegm: 68.20%, 86.21%; Expectorant chromaticness: 66.28%, 85.06%; Pant: 77.06%, 91.74%; Pulmonary rale: 77.05%, 85.79%.Compare with matched group (treasured that contains the artificial Calculus Bovis is coughed peaceful granule), learn by statistics and handle, obvious curative effects is all arranged, but treatment group and matched group compare therapeutic equivalence (P＞0.05).
Simultaneously; the treasured that contains In vitro cultured Calculus Bovis is coughed unusual main tongue, the pulse condition of peaceful granule to cough syndrome of superficies cold and interior heat infant: red tongue; white or yellow thin fur and floating and rapid pulse or superficially and silly all can significantly improve are to matched group (treasured that contains the artificial Calculus Bovis is coughed peaceful granule) curative effect similar (P＞0.05).
Cough onset time and cough remission time all had obvious curative effects after two groups of infants were taken medicine, but two groups are compared there was no significant difference.
The treasured that contains In vitro cultured Calculus Bovis is coughed in the peaceful granule clinical trial process, and not finding has obvious toxic-side effects to safety indexes (blood, urine, just routine and the heart, liver, renal function), and the description of adverse events and untoward reaction does not take place in the process of the test.
8. conclusion
The treasured that contains In vitro cultured Calculus Bovis is coughed the pure Chinese medicinal preparation of peaceful granule for treatment infantile cough syndrome of superficies cold and interior heat, has the cold expelling lung qi dispersing, removing heat-phlegm, the merit of relieving cough and asthma, determined curative effect.In the clinical trial process, do not see the toxic and side effects and the untoward reaction of drug-induced.
The specific embodiment:
Embodiments of the invention 1:
In vitro cultured Calculus Bovis 3g, Folium Perillae 30g, Folium Mori 30g, Radix Peucedani 60g, Bulbus Fritillariae Thunbergii 30g, Herba Ephedrae 30g; Radix Platycodonis 30g, Rhizoma Arisaematis (system) 60g, Pericarpium Citri Reticulatae 30g, Semen Armeniacae Amarum (stir-fry) 60g, Radix Scutellariae 60g; Indigo Naturalis 21g, Radix Trichosanthis 60g, Fructus Aurantii (parched with bran) 60g, Fructus Crataegi (stir-fry) 45g, Radix Glycyrrhizae 15g
More than ten Six-elements, be prepared into granule according to the following steps.
The first step: get In vitro cultured Calculus Bovis earlier and be ground into impalpable powder, cross 150 mesh sieves, standby;
Second step: Folium Perillae, Pericarpium Citri Reticulatae extract volatile oil, and the aqueous solution after distillation device is in addition collected; 13 flavors such as Folium Mori, Radix Peucedani, Bulbus Fritillariae Thunbergii, Herba Ephedrae, Radix Platycodonis, Rhizoma Arisaematis (system), Semen Armeniacae Amarum (stir-fry), Radix Scutellariae, Indigo Naturalis, Radix Trichosanthis, Fructus Aurantii (parched with bran), Fructus Crataegi (stir-fry), Radix Glycyrrhizae decoct with water secondary, 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction, filter, filtrate and above-mentioned aqueous solution merge, are condensed into the clear paste that relative density is 1.32～1.35 (50 ℃).(sucrose consumption=clear paste weight * 3; Dextrin consumption=clear paste weight * 2).
The 3rd step: get the method that impalpable powder that the first step obtains increases progressively with equivalent and join in the dextrin, grind well, cross 120 mesh sieves, standby;
The 4th step: get cane sugar powder and be broken into fine powder, cross 100 mesh sieves, the mixed powder that obtains with the 3rd step mixes according to the method that equivalent increases progressively, and crosses 100 mesh sieves.
The 5th step: qinghuo reagent, join in the mixed powder of the 4th step acquisition, mixed 30 minutes, extruding is sieved and is made wet granular;
The 6th step:, remove and promptly to obtain finished particle by the coarse grain and the fine powder that can pass through 80 mesh sieves of 10 mesh sieves with 10 mesh sieves and 80 mesh sieves with the 80 ℃ of oven dry of wet granular (water content is less than 5%) that make;
The 7th step: the Folium Perillae of second step acquisition and the volatile oil of Pericarpium Citri Reticulatae are injected in the dried particles, and mixing after airtight 24 hours, is distributed into bag.
Embodiments of the invention 2:
In vitro cultured Calculus Bovis 0.3kg, Folium Perillae 3kg, Folium Mori 3kg, Radix Peucedani 6kg, Bulbus Fritillariae Thunbergii 3kg, Herba Ephedrae 3kg; Radix Platycodonis 3kg, Rhizoma Arisaematis (system) 6kg, Pericarpium Citri Reticulatae 3kg, Semen Armeniacae Amarum (stir-fry) 6kg, Radix Scutellariae 6kg; Indigo Naturalis 2.1kg, Radix Trichosanthis 6kg, Fructus Aurantii (parched with bran) 6kg, Fructus Crataegi (stir-fry) 4.5kg, Radix Glycyrrhizae 1.5kg
More than ten Six-elements, be prepared into granule according to the following steps.
The first step: get In vitro cultured Calculus Bovis earlier and be ground into impalpable powder, cross 150 mesh sieves, standby;
Second step: Folium Perillae, Pericarpium Citri Reticulatae extract volatile oil, and the aqueous solution after distillation device is in addition collected; 13 flavors such as Folium Mori, Radix Peucedani, Bulbus Fritillariae Thunbergii, Herba Ephedrae, Radix Platycodonis, Rhizoma Arisaematis (system), Semen Armeniacae Amarum (stir-fry), Radix Scutellariae, Indigo Naturalis, Radix Trichosanthis, Fructus Aurantii (parched with bran), Fructus Crataegi (stir-fry), Radix Glycyrrhizae decoct with water secondary, 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction, filter, filtrate and above-mentioned aqueous solution merge, are condensed into the clear paste that relative density is 1.32～1.35 (50 ℃).(sucrose consumption=clear paste weight * 3; Dextrin consumption=clear paste weight * 2).
The 3rd step: get the method that impalpable powder that the first step obtains increases progressively with equivalent and join in the dextrin, grind well, cross 120 mesh sieves, standby;
The 4th step: get cane sugar powder and be broken into fine powder, cross 100 mesh sieves, the mixed powder that obtains with the 3rd step mixes according to the method that equivalent increases progressively, and crosses 100 mesh sieves.
The 5th step: qinghuo reagent, join in the mixed powder that the 4th step obtained, and add an amount of 90～95% ethanol and do binding agent, mixed 30 minutes, extruding is sieved and is made wet granular;
The 6th step:, remove and promptly to obtain finished particle by the coarse grain and the fine powder that can pass through 80 mesh sieves of 10 mesh sieves with 10 mesh sieves and 80 mesh sieves with the 80 ℃ of oven dry of wet granular (water content is less than 5%) that make;
The 7th step: the Folium Perillae of second step acquisition and the volatile oil of Pericarpium Citri Reticulatae are injected in the dried particles, and mixing after airtight 24 hours, is distributed into bag.
Claims (5)
1. preparation that contains the treatment infantile cough of In vitro cultured Calculus Bovis; it is characterized in that: calculating according to composition by weight, is by 2～4 parts of In vitro cultured Calculus Boviss; 20～40 parts of Folium Perillaes; 20～40 parts on Folium Mori; 40～80 parts of Radix Peucedanis; 20～40 parts of Bulbus Fritillariae Thunbergiis; 20～40 parts in Herba Ephedrae; 20～40 parts of Radix Platycodoniss; 40～80 parts of Rhizoma Arisaematiss (system); 20～40 parts of Pericarpium Citri Reticulataes; 40～80 parts of Semen Armeniacae Amarums (stir-fry); 40～80 parts of Radix Scutellariaes; 14～28 parts of Indigo Naturaliss; 40～80 parts of Radix Trichosanthis; 40～80 parts of Fructus Aurantiis (parched with bran); 30～60 parts of Fructus Crataegis (stir-fry); 10～20 parts in Radix Glycyrrhizae adds suitable amount of sucrose and dextrin is made.
2. according to the described preparation of claim 1; it is characterized in that: calculating according to composition by weight, is to add suitable amount of sucrose and dextrin is made by 15 parts of 3 parts of In vitro cultured Calculus Boviss, 30 parts of Folium Perillaes, 30 parts on Folium Mori, 60 parts of Radix Peucedanis, 30 parts of Bulbus Fritillariae Thunbergiis, 30 parts in Herba Ephedrae, 30 parts of Radix Platycodoniss, 60 parts of Rhizoma Arisaematiss (system), 30 parts of Pericarpium Citri Reticulataes, 60 parts of Semen Armeniacae Amarums (stir-fry), 60 parts of Radix Scutellariaes, 21 parts of Indigo Naturaliss, 60 parts of Radix Trichosanthis, 60 parts of Fructus Aurantiis (parched with bran), 45 parts of Fructus Crataegis (stir-fry), Radix Glycyrrhizae.
3. according to claim 1 or 2 described preparations, it is characterized in that: described preparation is a granule.
4. according to the preparation method of the arbitrary described preparation of claim 1～3, it is characterized in that:
The first step: get In vitro cultured Calculus Bovis earlier and be ground into impalpable powder, cross 150 mesh sieves, standby;
Second step: Folium Perillae, Pericarpium Citri Reticulatae extract volatile oil, and the aqueous solution after distillation device is in addition collected; 13 flavors such as Folium Mori, Radix Peucedani, Bulbus Fritillariae Thunbergii, Herba Ephedrae, Radix Platycodonis, Rhizoma Arisaematis (system), Semen Armeniacae Amarum (stir-fry), Radix Scutellariae, Indigo Naturalis, Radix Trichosanthis, Fructus Aurantii (parched with bran), Fructus Crataegi (stir-fry), Radix Glycyrrhizae decoct with water secondary, 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction, filter, filtrate and above-mentioned aqueous solution merge, are condensed into the clear paste that relative density is 1.32～1.35 (50 ℃).
The 3rd step: get the method that impalpable powder that the first step obtains increases progressively with equivalent and join in the dextrin, grind well, cross 120 mesh sieves, standby;
The 4th step: get cane sugar powder and be broken into fine powder, cross 100 mesh sieves, the mixed powder that obtains with the 3rd step mixes according to the method that equivalent increases progressively, and crosses 100 mesh sieves.
The 5th step: qinghuo reagent, join in the mixed powder that the 4th step obtained, and add an amount of 90～95% ethanol and do binding agent, mixed 30 minutes, extruding is sieved and is made wet granular;
The 6th step:, remove and promptly to obtain finished particle by the coarse grain and the fine powder that can pass through 80 mesh sieves of 10 mesh sieves with 10 mesh sieves and 80 mesh sieves with the 80 ℃ of oven dry of wet granular (water content is less than 5%) that make;
The 7th step: the Folium Perillae of second step acquisition and the volatile oil of Pericarpium Citri Reticulatae are injected in the dried particles, and mixing after airtight 24 hours, is distributed into bag.
5. according to claim 1 or 2 described preparations, it is characterized in that: by weight, the weight ratio of clear paste, sucrose and dextrin is 1: 3: 2.
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| CN104027642A (en) * | 2014-06-06 | 2014-09-10 | 黄艳梅 | Traditional Chinese medicine composition for protecting lung and relieving cough for infants |
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2010
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Non-Patent Citations (2)
| Title |
|---|
| 国家药典委员会: "《中华人民共和国药典》", 31 December 2005 * |
| 王莉萍: "《体外培育牛黄研究概况》", 《医药导报》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104027642A (en) * | 2014-06-06 | 2014-09-10 | 黄艳梅 | Traditional Chinese medicine composition for protecting lung and relieving cough for infants |
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Application publication date: 20111123 |