CN1739645A - Infant Kechuanling Chinese medicine prepn for treating dyspneic cough and its prepn - Google Patents
Infant Kechuanling Chinese medicine prepn for treating dyspneic cough and its prepn Download PDFInfo
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Abstract
The infant Cechuanling Chinese medicine preparation for treating dyspneic cough is prepared with seven kinds of Chinese medicinal materials, including ephedra, honeysuckle, almond, isatis root, gypsum, licorice and trichosanthes peel, and through extraction or other step to obtain active medicine matter, adding pharmaceutically acceptable carrier and conventional process to prepare oral liquid, ointment, syrup, etc.
Description
Technical field:
The present invention relates to a kind of XIAOER KECUANLING Chinese medicine preparation and preparation method thereof, relate in particular to oral liquid, soft extract, syrup preparation method.
Technical background:
XIAOER KECUANLING has lung qi dispersing, heat clearing away, cough-relieving, eliminate the phlegm, antiasthmatic effect.Be used for upper respiratory tract infection, tracheitis, pneumonia, cough etc.Because it is imperfect as yet that children's's immune organ is grown, antibody forming capacity is relatively poor, so very easily suffer from infectious disease.Children's compares with the adult absorption, distribution, metabolism and the drainage of medicine in addition also very big difference, and these factors have determined the dosage form of pediatric pharmaceuticals, and it is quite narrow and small to be convenient to the dosage form scope that pediatric patient selects.The XIAOER KECHUANLING CHONGJI and the preparation technology thereof that list in " the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation " the 4th, this extract drugs has adopted traditional handicraft, retain a large amount of impurity in the extract, used to medicine and brought side effect, limited the performance of drug effect thus.For this reason, the present invention proposes new extract drugs technology, on original technology basis, improve, the extract that uses this technology to obtain has simultaneously prepared multiple dosage form, has realized the variation of dosage form, being convenient to doctor and patient selects, improve quality standard simultaneously, thereby guaranteed curative effect, reached the purpose of invention.
Summary of the invention:
The invention provides a kind of XIAOER KECUANLING Chinese medicine preparation.
Chinese medicine preparation of the present invention, its prescription is composed as follows:
Herba Ephedrae 5-125 part Flos Lonicerae 50-1250 part Semen Armeniacae Amarum 25-625 part Radix Isatidis 50-1250 part
Gypsum Fibrosum 75-1875 part Radix Glycyrrhizae 25-625 part Fructus Trichosanthis 25-625 part
The above-mentioned raw materials weight ratio of preparation preparation of the present invention is preferably:
Herba Ephedrae 5-100 part Flos Lonicerae 100-900 part Semen Armeniacae Amarum 75-500 part Radix Isatidis 100-900 part
Gypsum Fibrosum 200-1545 part Radix Glycyrrhizae 75-500 part Fructus Trichosanthis 75-500 part
The raw material optimum weight ratio of preparation preparation of the present invention is preferably:
250 parts of 125 parts of Radix Isatidis of 250 portions of Semen Armeniacae Amarums of 25 portions of Flos Loniceraes of Herba Ephedrae
125 parts of 125 parts of Fructus Trichosanthis of 375 portions of Radix Glycyrrhizaes of Gypsum Fibrosum
In more than forming, the weight of medicine is calculated with crude drug, and this prescription composition can be made into 1000 doses of pharmaceutical preparatioies.Described 1000 doses of fingers, the final drug preparation of making, as make 1000 of capsule preparations, 1000 in tablet, granule 1000 grams, oral liquid 1000ml etc., also can make big packing as granule, as the 100-500 bag, specifically can be 100 bags, 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as taking dose 1-2 time.
More than form, can be made into the preparation of 50-1000 taking dose,, make 1000, make 1000 of capsules as tablet, each taking dose can be the 1-20 sheet/or, can take 50-1000 time altogether.As granule, make 125 bags, take the 1-2 bag at every turn, can take 62.5-125 time altogether.
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 ministerial drug and adjuvant drug in more than forming also can be replaced by the suitable Chinese medicine with identical property of medicine, 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.
The present invention also provides the preparation method of above-described pharmaceutically active substance, comprises the water extract-alcohol precipitation step.
The preparation method of preferred pharmaceutically active substance of the present invention is as follows:
1) by the said medicine prescription, gets Gypsum Fibrosum, Semen Armeniacae Amarum, Radix Glycyrrhizae, Radix Isatidis, Fructus Trichosanthis, Flos Lonicerae Six-element medicine, add 4-14 times of water, decocted 0.5-5 hour, filter.Medicinal residues add 6-10 times of decocting again and boiled 0.5-3 hour, filter merging filtrate, leave standstill, get supernatant, be condensed into the fluid extract of the about 1.05-1.20 of relative density (50 ℃), add ethanol and make the alcohol amount of containing reach 65-85%, stir evenly, cold preservation 12～48 hours, the leaching supernatant reclaims ethanol, be concentrated into the thick paste of the about 1.20-1.25 of relative density (60 ℃), standby.
2) Herba Ephedrae is pulverized, and adds 5-20 and doubly measures the hydrochloric acid solution that PH is 1-5, soak after 0.5-5 hour to decoct 1-10 time, and each 0.5-10 hour, filter, merging filtrate, medicinal liquid transfer PH to 6.0-8.0 standby;
It is active substance of the present invention that thick paste that more than obtains and medicinal liquid lump together, and these active substances can be the materials of extractum form, can be that dry extract also can be a fluid extract, makes different concentration according to the different needs decision of preparation.
Pharmaceutically active substance in the Chinese medicine preparation of the present invention, its shared percentage by weight in preparation can be 0.1-99.9%, all the other are the medicine acceptable carrier.Pharmaceutical preparation of the present invention exists with unit dosage form, and described unit dosage form is meant the unit of preparation, as every of tablet, capsular every capsules, every of injection etc., in the unit dose, the amount that contains active substance is 5-800mg, preferably 20-500mg.
Chinese medicine preparation of the present invention can be any pharmaceutically useful dosage form, these dosage forms comprise: tablet, capsule, oral liquid, syrup, granule, pill, powder, soft extract, sublimed preparation, injection, suppository, cream, spray, drop pill, patch, slow releasing preparation, controlled release preparation, preferably oral liquid, syrup, soft extract.
The preparation method of oral liquid of the present invention is as follows: 1) by prescription, get Gypsum Fibrosum, Semen Armeniacae Amarum, Radix Glycyrrhizae, Radix Isatidis, Fructus Trichosanthis, Flos Lonicerae Six-element medicine, add 4-14 times of water, decocted 0.5-5 hour, filter.Medicinal residues add 6-10 times of decocting again and boiled 0.5-3 hour, filter merging filtrate, leave standstill, get supernatant, be condensed into the fluid extract of the about 1.05-1.20 of relative density (50 ℃), add ethanol and make the alcohol amount of containing reach 65-85%, stir evenly, cold preservation 12～48 hours, the leaching supernatant reclaims ethanol, be concentrated into the thick paste of the about 1.20-1.25 of relative density (60 ℃), standby.
2) Herba Ephedrae is pulverized, and adds 5-20 and doubly measures the hydrochloric acid solution that PH is 1-5, soak after 0.5-5 hour to decoct 1-10 time, and each 0.5-10 hour, filter, merging filtrate, medicinal liquid transfer PH to 6.0-8.0 standby;
The above-mentioned raw materials medicine adds Mentholum, aspartame, and mix homogeneously is made oral liquid.
The preparation method of soft extract of the present invention is as follows: 1) by prescription, get Gypsum Fibrosum, Semen Armeniacae Amarum, Radix Glycyrrhizae, Radix Isatidis, Fructus Trichosanthis, Flos Lonicerae Six-element medicine, add 4-14 times of water, decocted 0.5-5 hour, filter.Medicinal residues add 6-10 times of decocting again and boiled 0.5-3 hour, filter merging filtrate, leave standstill, get supernatant, be condensed into the fluid extract of the about 1.05-1.20 of relative density (50 ℃), add ethanol and make the alcohol amount of containing reach 65-85%, stir evenly, cold preservation 12～48 hours, the leaching supernatant reclaims ethanol, be concentrated into the thick paste of the about 1.20-1.25 of relative density (60 ℃), standby.
2) Herba Ephedrae is pulverized, and adds 5-20 and doubly measures the hydrochloric acid solution that PH is 1-5, soak after 0.5-5 hour to decoct 1-10 time, and each 0.5-10 hour, filter, merging filtrate, medicinal liquid transfer PH to 6.0-8.0 standby;
3) get sucrose, add suitable quantity of water and be made into sucrose liquid and boil and dissolve, filter, tartarize is incubated 4 hours, makes it to become Nulomoline.Again with above-mentioned 1) 2) gained thick paste, extracting solution add in the Nulomoline, stirs, boil, during relative density 1.65 during cryoconcentration to 60 ℃, add the sodium benzoate mixing, cold slightly, in time place canned bucket, sealing is cooled to 80 ℃, promptly gets the XIAOER KECUANLING soft extract.
The preparation method of syrup of the present invention is as follows: 1) by prescription, get Gypsum Fibrosum, Semen Armeniacae Amarum, Radix Glycyrrhizae, Radix Isatidis, Fructus Trichosanthis, Flos Lonicerae Six-element medicine, add 4-14 times of water, decocted 0.5-5 hour, filter.Medicinal residues add 6-10 times of decocting again and boiled 0.5-3 hour, filter merging filtrate, leave standstill, get supernatant, be condensed into the fluid extract of the about 1.05-1.20 of relative density (50 ℃), add ethanol and make the alcohol amount of containing reach 65-85%, stir evenly, cold preservation 12～48 hours, the leaching supernatant reclaims ethanol, be concentrated into the thick paste of the about 1.20-1.25 of relative density (60 ℃), standby.
2) Herba Ephedrae is pulverized, and adds 5-20 and doubly measures the hydrochloric acid solution that PH is 1-5, soak after 0.5-5 hour to decoct 1-10 time, and each 0.5-10 hour, filter, merging filtrate, medicinal liquid transfer PH to 6.0-8.0 standby;
3) get sucrose in addition and add and to make dissolving in the water boil evenly, filter, make simple syrup.Simple syrup is added above-mentioned 1) 2) in the gained thick paste, extracting solution mixed liquor, add sodium benzoate simultaneously.About heating in water bath to 70 ℃, keep this temperature, stir and add 1% chitin hydrochloric acid solution down, continue to stir 50min, filter.Get supernatant and add water to ormal weight, fill promptly gets the XIAOER KECUANLING syrup.
XIAOER KECUANLING Chinese medicine preparation of the present invention compared with prior art, and is evident in efficacy, steady quality, bioavailability height.Realized the multiformity of dosage form, convenient drug administration is convenient to doctor and patient and is selected.Preparation method of the present invention is simple, be easy to control.
Study on extraction of the present invention:
One, Radix Glycyrrhizae, Gypsum Fibrosum, Semen Armeniacae Amarum, Radix Isatidis, Fructus Trichosanthis, Flos Lonicerae decocting process are investigated
1, with glycyrrhizic acid content, yield of extract as index.The factor level table sees the following form
| Level | Factor | |||||
| A | B | C | D | |||
| Amount of water | Decocting time | Be condensed into 50 ℃ of relative densities | Alcohol is sink to the alcohol amount that contains | |||
| 1 | 4 | 6 | 0.5 | 0.5 | 1.05 | 80％ |
| 2 | 9 | 8 | 2.5 | 1.5 | 1.20 | 85％ |
| 3 | 14 | 10 | 5 | 3 | 1.09 | 65％ |
2, orthogonal experiment design table and result
| Row number the experiment number | A | B | C | D | Yield of extract (%) | Glycyrrhizic acid content (mg/g) | Scoring |
| 1 | 1 | 1 | 1 | 1 | 14.9100 | 15.33 | 43.78 |
| 2 | 1 | 2 | 2 | 2 | 27.6305 | 20.96 | 73.86 |
| 3 | 1 | 3 | 3 | 3 | 28.3421 | 17.81 | 69.12 |
| 4 | 2 | 1 | 2 | 3 | 34.0150 | 17.64 | 78.31 |
| 5 | 2 | 2 | 3 | 1 | 43.4413 | 20.27 | 96.21 |
| 6 | 2 | 3 | 1 | 2 | 32.1008 | 18.05 | 75.65 |
| 7 | 3 | 1 | 3 | 2 | 12.9467 | 24.12 | 51.45 |
| 8 | 3 | 2 | 1 | 3 | 20.0090 | 14.70 | 51.44 |
| 9 | 3 | 3 | 2 | 1 | 26.2516 | 19.59 | 67.87 |
Above The results of analysis of variance optimised process as can be seen is A
2B
2C
3D
1Be Radix Glycyrrhizae, Radix Isatidis, Semen Armeniacae Amarum, Fructus Trichosanthis, Flos Lonicerae, Gypsum Fibrosum adds 9 times of water gagings together and decocted 2.5 hours, and medicinal residues add 8 times of decoctings again and boiled 1.5 hours, and supernatant concentration becomes the fluid extract of relative density about 1.09 (50 ℃), adds ethanol and makes and contain the alcohol amount to 80%.
Two, Herba Ephedrae Study on extraction
1, the factor level table sees the following form:
| Level | Factor | ||||
| A | B | C | D | ||
| Number of times | Decocting time | PH | Add solvent amount (doubly) | The pulverizing medicinal materials degree | |
| 1 | 2 | 1.5、1.5 | 1 | 5 | The Herba Ephedrae cutting |
| 2 | 1 | 10 | 2.8 | 10 | Fine powder |
| 3 | 10 | 2、1、1、0.5、0.5、0.5、 0.5、0.5、0.5、0.5 | 5 | 20 | Do not pulverize |
2, orthogonal experiment design table and the results are shown in following table:
| Row number the experiment number | A | B | C | D | Yield of extract (%) | Ephedrine hydrochloride content (mg/g) | Scoring |
| 1 | 1 | 1 | 1 | 1 | 19.518 | 4.6122 | 68.1 |
| 2 | 1 | 2 | 2 | 2 | 23.900 | 7.0391 | 83.7 |
| 3 | 1 | 3 | 3 | 3 | 18.806 | 4.9818 | 65.7 |
| 4 | 2 | 1 | 2 | 3 | 18.711 | 3.9833 | 65.5 |
| 5 | 2 | 2 | 3 | 1 | 28.590 | 4.7611 | 69.7 |
| 6 | 2 | 3 | 1 | 2 | 12.391 | 2.3318 | 43.2 |
| 7 | 3 | 1 | 3 | 2 | 19.550 | 2.5735 | 68.3 |
| 8 | 3 | 2 | 1 | 3 | 16.533 | 2.7694 | 57.9 |
| 9 | 3 | 3 | 2 | 1 | 17.160 | 2.4349 | 60.2 |
Above result optimised process as can be seen is A
1B
2C
2D
2, promptly Herba Ephedrae is ground into fine powder, adds the hydrochloric acid solution of 10 times of amount PH2.8, decocts twice, each 2 hours.But be ground into difficulty of fine powder filtration at the big epheday intermedia of producing, and the influence of D factor is not remarkable, adopts time good technology B
2C
2A
1D
1, promptly Herba Ephedrae is ground into fine powder, adds the hydrochloric acid solution of 10 times of amount PH2.8, decocts twice, each 2 hours.
In more than forming, every part of representative be weight portion. weight is calculated with crude drug, if be unit with the gram, more than form and can be made into 1000 doses of pharmaceutical preparatioies, described 1000 doses of fingers, the final drug preparation of making, as make oral liquid 1000ml, soft extract 1000ml, syrup 1000ml.
Following data declaration beneficial effect of the present invention by experiment:
Experimental example cures mainly relevant main pharmacodynamics research with function:
One, be subjected to the reagent thing:
Title: XIAOER KECHUANLING CHONGJI: according to " the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation " the 4th contained method preparation.Oral liquid for cough and asthma of children: according to method preparation of the present invention.
Two, laboratory animal: animal, strain, source: Cavia porcellus, kunming mouse, WISTER rat provide by Zunyi Medical College.
Feedstuff: test Mus full-valence pellet feed is provided by Guizhou Province's animal center.
Raise: the conventional raising, room temperature is controlled at 22-26 ℃.
Three, experimental technique and result
1, cough-relieving experiment: get 36 of kunming mouses, male and female half and half are divided into 3 groups at random, are respectively matched group, XIAOER KECHUANLING CHONGJI group, oral liquid for cough and asthma of children group.Each administration group is gastric infusion 20ml/kg according to dosage, and matched group gives the equal-volume distilled water, every day 1 time, 3d continuously.1h after the last administration puts into sprayer unit with mice and begins to accept spraying, the cough latent period of record mice, and calculate the cough-relieving rate:
Cough-relieving rate %=(administration group cough response time/matched group cough response time) * 100%
The result compares with the XIAOER KECHUANLING CHONGJI group, and significantly long, the also obviously rising of cough-relieving rate incubation period of oral liquid for cough and asthma of children group mouse cough is 190.15%.Compare P＜0.05 with matched group.The result sees following table for details.
| Group | Dosage g crude drug/kg | Cough latent period s | Cough-relieving rate % |
| Matched group | - | 18.77±4.31 | - |
| The XIAOER KECHUANLING CHONGJI group | 5.6 | 32.19±14.98 | 176.76 |
| The oral liquid for cough and asthma of children group | 5.6 | 35.94±13.03 | 190.15 |
2, the experiment of reducing phlegm: capillary glass-tube method, get 30 of WISTER rats, male and female half and half are divided into 3 groups at random, are respectively matched group, XIAOER KECHUANLING CHONGJI group, oral liquid for cough and asthma of children group.Water 12h is can't help in fasting before each group experiment, lignocaine 1g/kg intraperitoneal injection of anesthesia, it is fixing to face upward the position, cut off neck middle part skin, isolate trachea, hit exactly between two cartilages at thyroid cartilage lower edge and prick an aperture with sharp-pointed injection needle, insert one of internal diameter 0.8cm capillary glass tube then, make capillary tube just contact the trachea lower surface,, draw sputum length as the effect of reducing phlegm of estimating medicine with capillary tube so as to drawing the sputum at trachea rear portion.After the normal secretory volume of 1h, each administration group is gastric infusion 10ml/kg according to dosage before the record administration, and matched group gives the equal-volume distilled water, and record administration 1h respectively organizes the sputum secretory volume of rat.The results are shown in following table.
| Group | Dosage g/ crude drug/kg | The normal secretory volume cm of sputum | Secretory volume cm behind the sputum medicine |
| Matched group | - | 2.10±0.21 | 2.34±0.09 |
| The XIAOER KECHUANLING CHONGJI group | 5.4 | 2.11±0.22 | 2.72±0.23 2) |
| The oral liquid for cough and asthma of children group | 5.4 | 2.20±0.13 | 3.45±0.21 2) |
The result compares with the XIAOER KECHUANLING CHONGJI group, and the sputum secretory volume of oral liquid for cough and asthma of children group rat significantly increases, and compares P＜0.01 with matched group.
3, the experiment of relievining asthma: spraying causes the method for breathing heavily, and gets 30 of Cavia porcelluss, and male and female half and half are divided into 3 groups at random, are respectively matched group, XIAOER KECHUANLING CHONGJI group, oral liquid for cough and asthma of children.Each administration group is according to dosage irritated flavor administration 10ml/kg, and matched group gives the equal-volume distilled water, every day 1 time, 3d continuously.1h after the last administration by only Cavia porcellus being placed in the device case, starts the WH-96 ultrasound atomizer, sprays into the 1mg/ml histamine phosphate, pick up counting simultaneously, record from spraying begin to time that Cavia porcellus twitches as asthma incubation period, and calculate the asthma suppression ratio.The result compares with matched group, Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquidus is low, in two dosage group Cavia porcellus asthma obviously prolong P＜0.05 and P＜0.01 incubation period.The results are shown in following table.
| Group | Dosage g crude drug/kg | Asthma min incubation period | Asthma suppression ratio % |
| Matched group | - | 2.15±0.47 | - |
| The XIAOER KECHUANLING CHONGJI group | 5.4 | 2.50±0.65 | 109.5 |
| The oral liquid for cough and asthma of children group | 5.4 | 2.69±0.78 | 128.6 |
4, immunization experiment is got 36 of NIH mices, and male and female half and half are divided into 3 groups at random, are respectively matched group, XIAOER KECHUANLING CHONGJI group, oral liquid for cough and asthma of children group.Each administration group is gastric infusion 20ml/kg according to dosage, and matched group gives the equal-volume distilled water, every day 1 time, 7d continuously.1h after the last administration takes off cervical vertebra and puts to death mice, wins and respectively organizes mouse thymus and spleen, in BA61 type electronic-weighing, calculates mouse thymus exponential sum index and spleen index.The results are shown in following table:
| Group | Dosage g crude drug/kg | Thymus index mg/g | Index and spleen index mg/g |
| Matched group | - | 1.256±0.381 | 3.239±0.258 |
| The XIAOER KECHUANLING CHONGJI group | 5.4 | 1.746±0.465 | 3.664±1.354 |
| The oral liquid for cough and asthma of children group | 5.4 | 1.886±0.407 | 4.325±1.572 |
Result and oral liquid for cough and asthma of children group mouse thymus index and index and spleen index are compared with matched group all apparently higher than the XIAOER KECHUANLING CHONGJI group, thymus index P＜0.01, index and spleen index P＜0.05.
This experiment shows: oral liquid for cough and asthma of children and XIAOER KECHUANLING CHONGJI relatively more can prolong the incubation period of strong aqua ammonia inducing mouse cough, increase rat expectoration amount, prolong the incubation period of Cavia porcellus asthma due to the histamine phosphate.In addition, oral liquid for cough and asthma of children also has certain immunization.
Compared with prior art: preparation provided by the invention has lung qi dispersing, heat clearing away, and cough-relieving, the effect of relievining asthma, to upper respiratory tract infection, tracheitis, pneumonia, diseases such as cough have definite curative effect.The child cough and panting preparation of routine is made syrup, oral liquid, soft extract etc., take, can play a multiplier effect in exsiccant season.In addition, XIAOER KECUANLING soft extract of the present invention also has the function of tonification, particularly children's's immune organ is grown imperfect as yet, antibody forming capacity is relatively poor, asthma is because of eipathia asthenia, but take the soft extract health invigorating also with cough suppressing effect in the winter time, improve the immune disease-resistance ability of body, recurrence helps warding off disease.Soft extract, oral liquid and syrup also provide the compliance that the patient takes this medicine in addition, and the pediatric patient that convenient esophagus is narrower and small, gastrointestinal function is more weak is taken.And consider the medication in children situation of difficult especially, clothes are down smoothly, directly the through port transmucosal absorbs, and also can avoid the Degradation of first pass effect stomach function regulating, can play the effect that improves bioavailability to be convenient to pediatric patient.
The specific embodiment:
The present invention is further illustrated below in conjunction with fact Example, and following each fact Example only is used to illustrate the present invention, to the present invention and unrestricted.
Embodiment 1
Herba Ephedrae 5g, Flos Lonicerae 50g, Semen Armeniacae Amarum 25g, Radix Isatidis 50g, Gypsum Fibrosum 75g, Radix Glycyrrhizae 25g and Fructus Trichosanthis 25g, Mentholum 5g, aspartame 100g.
Method for making: 1) get Gypsum Fibrosum in the above prescription, Semen Armeniacae Amarum, Radix Glycyrrhizae, Radix Isatidis, Fructus Trichosanthis, Flos Lonicerae Six-element medicine, add 9 times of water, decocted 2.5 hours, filter.Medicinal residues add 8 times of decoctings again and boiled 1.5 hours, filter merging filtrate, leave standstill, get supernatant, be condensed into the fluid extract of relative density about 1.09 (50 ℃), add ethanol and make and contain alcohol amount and reach 80%, stir evenly, cold preservation 24 hours, the leaching supernatant reclaims ethanol, be concentrated into the thick paste of relative density about 1.22 (60 ℃), standby.
2) Herba Ephedrae is pulverized, and adds 10 times of amount PH and be 2.8 hydrochloric acid solution, soaks after 2 hours to decoct 2 times, and each 1.5 hours, filtration, merging filtrate, PH to 7.45 is standby for the medicinal liquid accent;
The above-mentioned raw materials medicine adds Mentholum, aspartame, and mix homogeneously is made oral liquid.
Embodiment 2
Herba Ephedrae 5g, Flos Lonicerae 50g, Semen Armeniacae Amarum 25g, Radix Isatidis 50g, Gypsum Fibrosum 75g, Radix Glycyrrhizae 25g and Fructus Trichosanthis 25g, sodium benzoate 8g, sucrose 1000g, tartaric acid 800g.
Method for making: 1) get Gypsum Fibrosum in the above prescription, Semen Armeniacae Amarum, Radix Glycyrrhizae, Radix Isatidis, Fructus Trichosanthis, Flos Lonicerae Six-element medicine, add 9 times of water, decocted 2.5 hours, filter.Medicinal residues add 8 times of decoctings again and boiled 1.5 hours, filter merging filtrate, leave standstill, get supernatant, be condensed into the fluid extract of relative density about 1.09 (50 ℃), add ethanol and make and contain alcohol amount and reach 80%, stir evenly, cold preservation 24 hours, the leaching supernatant reclaims ethanol, be concentrated into the thick paste of relative density about 1.22 (60 ℃), standby.
2) get Herba Ephedrae and pulverize, adds 10 times of amount PH and be 2.8 hydrochloric acid solution, soaks after 2 hours and decoct 2 times, each 1.5 hours, filtration, merging filtrate, PH to 7.45 is standby for the medicinal liquid accent;
3) get sucrose, add 10000ml water and be made into sucrose liquid and boil and dissolve, filter, tartarize is incubated 4 hours, makes it to become Nulomoline.Again with above-mentioned 1) 2) gained thick paste, extracting solution add in the Nulomoline, stirs, boil, during relative density 1.65 during cryoconcentration to 60 ℃, add the sodium benzoate mixing, cold slightly, in time place canned bucket, sealing is cooled to 80 ℃, promptly gets the XIAOER KECUANLING soft extract.
Embodiment 3
Herba Ephedrae 25g, Flos Lonicerae 250g, Semen Armeniacae Amarum 125g, Radix Isatidis 250g, Gypsum Fibrosum 375g, Radix Glycyrrhizae 125g, Fructus Trichosanthis 125g, sucrose 1000g, sodium benzoate 8g, 1% chitin hydrochloric acid solution 80ml.
Method for making: 1) get Gypsum Fibrosum in the above prescription, Semen Armeniacae Amarum, Radix Glycyrrhizae, Radix Isatidis, Fructus Trichosanthis, Flos Lonicerae Six-element medicine, add 9 times of water, decocted 2.5 hours, filter.Medicinal residues add 8 times of decoctings again and boiled 1.5 hours, filter merging filtrate, leave standstill, get supernatant, be condensed into the fluid extract of relative density about 1.09 (50 ℃), add ethanol and make and contain alcohol amount and reach 80%, stir evenly, cold preservation 24 hours, the leaching supernatant reclaims ethanol, be concentrated into the thick paste of relative density about 1.22 (60 ℃), standby.
2) get Herba Ephedrae and pulverize, adds 10 times of amount PH and be 2.8 hydrochloric acid solution, soaks after 2 hours and decoct 2 times, each 1.5 hours, filtration, merging filtrate, PH to 7.45 is standby for the medicinal liquid accent;
3) get sucrose in addition and add and to make dissolving in the water boil evenly, filter, make simple syrup.Simple syrup is added above-mentioned 1) 2) in the gained thick paste, extracting solution mixed liquor, add sodium benzoate simultaneously.About heating in water bath to 70 ℃, keep this temperature, stir and add 1% chitin hydrochloric acid solution down, continue to stir 50min, filter.Get supernatant and add water to 1000ml, fill promptly gets the XIAOER KECUANLING syrup.
Embodiment 4
The raw material weight ratio of preparation preparation of the present invention is preferably:
Herba Ephedrae 100g, Flos Lonicerae 900g, Semen Armeniacae Amarum 500g, Radix Isatidis 900g, Gypsum Fibrosum 1545g, Radix Glycyrrhizae 500g and Fructus Trichosanthis 500g, refined honey 1000g.
The above-mentioned raw materials medicine mixes to be pulverized, and crosses 100 mesh sieves, adds an amount of refined honey, makes honeyed pill.
Embodiment 5
Herba Ephedrae 125g, Flos Lonicerae 1250g, Semen Armeniacae Amarum 625g, Radix Isatidis 1250g, Gypsum Fibrosum 1875g, Radix Glycyrrhizae 625g and Fructus Trichosanthis 625g, medical starch 500g, Mentholum 10g
Press the extractum of embodiment 1 gained and the mixture of Herba Ephedrae extracting solution, add the Mentholum of medical starch and pulverizing, mix homogeneously, pelletize, tabletting is made tablet.
Embodiment 6
Herba Ephedrae 5g, Flos Lonicerae 100g, Semen Armeniacae Amarum 75g, Radix Isatidis 100g, Gypsum Fibrosum 200g, Radix Glycyrrhizae 75g and Fructus Trichosanthis 75g, sucrose 500g.
Press the extractum of embodiment 1 gained and the mixture of Herba Ephedrae extracting solution, add sucrose and appropriate amount of auxiliary materials and make granule.
Embodiment 7
Herba Ephedrae 5g, Flos Lonicerae 50g, Semen Armeniacae Amarum 25g, Radix Isatidis 1250g Gypsum Fibrosum 1875g, Radix Glycyrrhizae 625g, Fructus Trichosanthis 625g Mentholum 5g, aspartame 800g.
Method for making: 1) get Gypsum Fibrosum in the above prescription, Semen Armeniacae Amarum, Radix Glycyrrhizae, Radix Isatidis, Fructus Trichosanthis, Flos Lonicerae Six-element medicine, add 9 times of water, decocted 2.5 hours, filter.Medicinal residues add 8 times of decoctings again and boiled 1.5 hours, filter merging filtrate, leave standstill, get supernatant, be condensed into the fluid extract of relative density about 1.09 (50 ℃), add ethanol and make and contain alcohol amount and reach 80%, stir evenly, cold preservation 24 hours, the leaching supernatant reclaims ethanol, be concentrated into the thick paste of relative density about 1.22 (60 ℃), standby.
2) Herba Ephedrae is pulverized, and adds 10 times of amount PH and be 2.8 hydrochloric acid solution, soaks after 2 hours to decoct 2 times, and each 1.5 hours, filtration, merging filtrate, PH to 7.45 is standby for the medicinal liquid accent;
The above-mentioned raw materials medicine adds Mentholum, aspartame, and mix homogeneously is made oral liquid.
Embodiment 8
Herba Ephedrae 100g, Flos Lonicerae 900g, Semen Armeniacae Amarum 500g, Radix Isatidis 100g, Gypsum Fibrosum 1545g, Radix Glycyrrhizae 500g, Fructus Trichosanthis 500g sodium benzoate 10g, sucrose 1500g, tartaric acid 1000g.
Method for making: 1) get Gypsum Fibrosum in the above prescription, Semen Armeniacae Amarum, Radix Glycyrrhizae, Radix Isatidis, Fructus Trichosanthis, Flos Lonicerae Six-element medicine, add 9 times of water, decocted 2.5 hours, filter.Medicinal residues add 8 times of decoctings again and boiled 1.5 hours, filter merging filtrate, leave standstill, get supernatant, be condensed into the fluid extract of relative density about 1.09 (50 ℃), add ethanol and make and contain alcohol amount and reach 80%, stir evenly, cold preservation 24 hours, the leaching supernatant reclaims ethanol, be concentrated into the thick paste of relative density about 1.22 (60 ℃), standby.
2) get Herba Ephedrae and pulverize, adds 10 times of amount PH and be 2.8 hydrochloric acid solution, soaks after 2 hours and decoct 2 times, each 1.5 hours, filtration, merging filtrate, PH to 7.45 is standby for the medicinal liquid accent;
3) get sucrose, add 10000ml water and be made into sucrose liquid and boil and dissolve, filter, tartarize is incubated 4 hours, makes it to become Nulomoline.Again with above-mentioned 1) 2) gained thick paste, extracting solution add in the Nulomoline, stirs, boil, during relative density 1.65 during cryoconcentration to 60 ℃, add the sodium benzoate mixing, cold slightly, in time place canned bucket, sealing is cooled to 80 ℃, promptly gets the XIAOER KECUANLING soft extract.
Embodiment 9
Herba Ephedrae 100g, Flos Lonicerae 900g, Semen Armeniacae Amarum 125g, Radix Isatidis 1250g, Gypsum Fibrosum 375g, Radix Glycyrrhizae 625g, Fructus Trichosanthis 500g sucrose 2000g, sodium benzoate 12g, 1% chitin hydrochloric acid solution 100ml.
Method for making: 1) get Gypsum Fibrosum in the above prescription, Semen Armeniacae Amarum, Radix Glycyrrhizae, Radix Isatidis, Fructus Trichosanthis, Flos Lonicerae Six-element medicine, add 9 times of water, decocted 2.5 hours, filter.Medicinal residues add 8 times of decoctings again and boiled 1.5 hours, filter merging filtrate, leave standstill, get supernatant, be condensed into the fluid extract of relative density about 1.09 (50 ℃), add ethanol and make and contain alcohol amount and reach 80%, stir evenly, cold preservation 24 hours, the leaching supernatant reclaims ethanol, be concentrated into the thick paste of relative density about 1.22 (60 ℃), standby.
2) get Herba Ephedrae and pulverize, adds 10 times of amount PH and be 2.8 hydrochloric acid solution, soaks after 2 hours and decoct 2 times, each 1.5 hours, filtration, merging filtrate, PH to 7.45 is standby for the medicinal liquid accent;
3) get sucrose in addition and add and to make dissolving in the water boil evenly, filter, make simple syrup.Simple syrup is added above-mentioned 1) 2) in the gained thick paste, extracting solution mixed liquor, add sodium benzoate simultaneously.About heating in water bath to 70 ℃, keep this temperature, stir and add 1% chitin hydrochloric acid solution down, continue to stir 50min, filter.Get supernatant and add water to 1000ml, fill promptly gets the XIAOER KECUANLING syrup.
Claims (10)
1, a kind of XIAOER KECUANLING Chinese medicine preparation, make by following Chinese medicinal raw materials:
Herba Ephedrae 5-125 part Flos Lonicerae 50-1250 part Semen Armeniacae Amarum 25-625 part Radix Isatidis 50-1250 part
Gypsum Fibrosum 75-1875 part Radix Glycyrrhizae 25-625 part Fructus Trichosanthis 25-625 part.
2, a kind of XIAOER KECUANLING Chinese medicine preparation, make by following Chinese medicinal raw materials:
Herba Ephedrae 5-100 part Flos Lonicerae 100-900 part Semen Armeniacae Amarum 75-500 part Radix Isatidis 100-900 part
Gypsum Fibrosum 200-1545 part Radix Glycyrrhizae 75-500 part Fructus Trichosanthis 75-500 part.
3, a kind of XIAOER KECUANLING Chinese medicine preparation, make by following Chinese medicinal raw materials:
250 parts of 125 parts of Radix Isatidis of 250 portions of Semen Armeniacae Amarums of 25 portions of Flos Loniceraes of Herba Ephedrae
125 parts of 125 parts of Fructus Trichosanthis of 375 portions of Radix Glycyrrhizaes of Gypsum Fibrosum.
4, the Chinese medicine preparation of claim 1 is by raw material of Chinese medicine being processed through extraction or other modes, being made pharmaceutically active substance, is raw material with this pharmaceutically active substance, adds the medicine acceptable carrier in case of necessity, makes according to the routine techniques of galenic pharmacy.
5, the Chinese medicine preparation of claim 4, wherein said process extracts or other modes are processed, and makes pharmaceutically active substance, is through following steps:
1) by the said medicine prescription, gets Gypsum Fibrosum, Semen Armeniacae Amarum, Radix Glycyrrhizae, Radix Isatidis, Fructus Trichosanthis, Flos Lonicerae Six-element medicine, add 4-14 times of water, decocted 0.5-5 hour, filter.Medicinal residues add 6-10 times of decocting again and boiled 0.5-3 hour, filter, merging filtrate leaves standstill, get supernatant, be condensed into the fluid extract of the about 1.05-1.20 of relative density, add ethanol and make and contain alcohol amount and reach 65-85%, stir evenly, cold preservation 12～48 hours, the leaching supernatant reclaims ethanol, is concentrated into the thick paste of the about 1.20-1.25 of relative density;
2) Herba Ephedrae is pulverized, and adds 5-20 and doubly measures the hydrochloric acid solution that PH is 1-5, soak after 0.5-5 hour to decoct 1-10 time, and each 0.5-10 hour, filter, merging filtrate, medicinal liquid transfer PH to 6.0-8.0 standby;
It is active substance of the present invention that thick paste that more than obtains and medicinal liquid lump together.
6, the Chinese medicine preparation of claim 1 is tablet, capsule, oral liquid, syrup, granule, pill, powder, soft extract, sublimed preparation, injection, suppository, cream, spray, drop pill, patch, slow releasing preparation or controlled release preparation.
7, the Chinese medicine preparation of claim 6 is oral liquid, syrup or soft extract.
8, the preparation method of the Chinese medicine preparation of claim 1, it is characterized in that, process following steps: raw material of Chinese medicine is processed through extraction or other modes, make pharmaceutically active substance, with this pharmaceutically active substance is raw material, add the medicine acceptable carrier in case of necessity, according to the routine techniques preparation of galenic pharmacy.
9, the preparation method of claim 8, wherein said process extracts or other modes are processed, and makes pharmaceutically active substance, is through following steps:
1) by the said medicine prescription, gets Gypsum Fibrosum, Semen Armeniacae Amarum, Radix Glycyrrhizae, Radix Isatidis, Fructus Trichosanthis, Flos Lonicerae Six-element medicine, add 4-14 times of water, decocted 0.5-5 hour, filter.Medicinal residues add 6-10 times of decocting again and boiled 0.5-3 hour, filter, merging filtrate leaves standstill, get supernatant, be condensed into the fluid extract of the about 1.05-1.20 of relative density, add ethanol and make and contain alcohol amount and reach 65-85%, stir evenly, cold preservation 12～48 hours, the leaching supernatant reclaims ethanol, is concentrated into the thick paste of the about 1.20-1.25 of relative density;
2) Herba Ephedrae is pulverized, and adds 5-20 and doubly measures the hydrochloric acid solution that PH is 1-5, soak after 0.5-5 hour to decoct 1-10 time, and each 0.5-10 hour, filter, merging filtrate, medicinal liquid transfer PH to 6.0-8.0 standby;
It is active substance of the present invention that thick paste that more than obtains and medicinal liquid lump together.
10, the preparation method of claim 9 is characterized in that: the preparation method of oral liquid wherein is as follows:
1) by prescription, gets Gypsum Fibrosum, Semen Armeniacae Amarum, Radix Glycyrrhizae, Radix Isatidis, Fructus Trichosanthis, Flos Lonicerae Six-element medicine, add 4-14 times of water, decocted 0.5-5 hour, filter.Medicinal residues add 6-10 times of decocting again and boiled 0.5-3 hour, filter merging filtrate, leave standstill, get supernatant, be condensed into the fluid extract of the about 1.05-1.20 of relative density, add ethanol and make the alcohol amount of containing reach 65-85%, stir evenly, cold preservation 12～48 hours, the leaching supernatant reclaims ethanol, be concentrated into the thick paste of the about 1.20-1.25 of relative density, standby;
2) Herba Ephedrae is pulverized, and adds 5-20 and doubly measures the hydrochloric acid solution that PH is 1-5, soak after 0.5-5 hour to decoct 1-10 time, and each 0.5-10 hour, filter, merging filtrate, medicinal liquid transfer PH to 6.0-8.0 standby;
The above-mentioned raw materials medicine adds Mentholum, aspartame, and mix homogeneously is made oral liquid;
The preparation method of soft extract wherein is as follows:
1) by prescription, gets Gypsum Fibrosum, Semen Armeniacae Amarum, Radix Glycyrrhizae, Radix Isatidis, Fructus Trichosanthis, Flos Lonicerae Six-element medicine, add 4-14 times of water, decocted 0.5-5 hour, filter.Medicinal residues add 6-10 times of decocting again and boiled 0.5-3 hour, filter merging filtrate, leave standstill, get supernatant, be condensed into the fluid extract of the about 1.05-1.20 of relative density, add ethanol and make the alcohol amount of containing reach 65-85%, stir evenly, cold preservation 12～48 hours, the leaching supernatant reclaims ethanol, be concentrated into the thick paste of the about 1.20-1.25 of relative density, standby;
2) Herba Ephedrae is pulverized, and adds 5-20 and doubly measures the hydrochloric acid solution that PH is 1-5, soak after 0.5-5 hour to decoct 1-10 time, and each 0.5-10 hour, filter, merging filtrate, medicinal liquid transfer PH to 6.0-8.0 standby;
3) get sucrose, add suitable quantity of water and be made into sucrose liquid and boil and dissolve, filter, tartarize is incubated 4 hours, makes it to become Nulomoline.Again with above-mentioned 1) 2) gained thick paste, extracting solution add in the Nulomoline, stirs, boil, during relative density 1.65 during cryoconcentration to 60 ℃, add the sodium benzoate mixing, cold slightly, in time place canned bucket, sealing is cooled to 80 ℃, promptly gets the XIAOER KECUANLING soft extract;
The preparation method of syrup wherein is as follows:
1) by prescription, gets Gypsum Fibrosum, Semen Armeniacae Amarum, Radix Glycyrrhizae, Radix Isatidis, Fructus Trichosanthis, Flos Lonicerae Six-element medicine, add 4-14 times of water, decocted 0.5-5 hour, filter.Medicinal residues add 6-10 times of decocting again and boiled 0.5-3 hour, filter merging filtrate, leave standstill, get supernatant, be condensed into the fluid extract of the about 1.05-1.20 of relative density, add ethanol and make the alcohol amount of containing reach 65-85%, stir evenly, cold preservation 12～48 hours, the leaching supernatant reclaims ethanol, be concentrated into the thick paste of the about 1.20-1.25 of relative density, standby;
2) Herba Ephedrae is pulverized, and adds 5-20 and doubly measures the hydrochloric acid solution that PH is 1-5, soak after 0.5-5 hour to decoct 1-10 time, and each 0.5-10 hour, filter, merging filtrate, medicinal liquid transfer PH to 6.0-8.0 standby;
3) get sucrose in addition and add and to make dissolving in the water boil evenly, filter, make simple syrup.Simple syrup is added above-mentioned 1) 2) in the gained thick paste, extracting solution mixed liquor, add sodium benzoate simultaneously: about heating in water bath to 70 ℃, keep this temperature, stir and add 1% chitin hydrochloric acid solution down, continue to stir 50min, filter.Get supernatant and add water to ormal weight, fill promptly gets the XIAOER KECUANLING syrup.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103142989A (en) * | 2013-04-09 | 2013-06-12 | 杜京辉 | Traditional Chinese medicine composition for treating infantile cough and preparation method thereof |
| CN103977235A (en) * | 2014-04-25 | 2014-08-13 | 贵州三泓药业股份有限公司 | Pseudostellaria root lung-diffusing and cough-relieving oral liquid |
| CN104491059A (en) * | 2014-11-27 | 2015-04-08 | 哈尔滨市康隆药业有限责任公司 | Concentrated child kechuanling oral solution |
| EP2512444B1 (en) * | 2008-10-20 | 2017-03-22 | Monica Marzano Ancora | Mixtures of plants in spagyric mother tincture for dry cough in babies |
| CN107773592A (en) * | 2016-08-30 | 2018-03-09 | 北京盈科瑞创新医药股份有限公司 | A kind of child cough and panting Neulized inhalation pharmaceutical solutions and preparation method thereof |
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2005
- 2005-08-25 CN CNB200510003180XA patent/CN100477984C/en active Active
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2512444B1 (en) * | 2008-10-20 | 2017-03-22 | Monica Marzano Ancora | Mixtures of plants in spagyric mother tincture for dry cough in babies |
| CN103142989A (en) * | 2013-04-09 | 2013-06-12 | 杜京辉 | Traditional Chinese medicine composition for treating infantile cough and preparation method thereof |
| CN103142989B (en) * | 2013-04-09 | 2014-07-30 | 杜京辉 | Traditional Chinese medicine composition for treating infantile cough and preparation method thereof |
| CN103977235A (en) * | 2014-04-25 | 2014-08-13 | 贵州三泓药业股份有限公司 | Pseudostellaria root lung-diffusing and cough-relieving oral liquid |
| CN104491059A (en) * | 2014-11-27 | 2015-04-08 | 哈尔滨市康隆药业有限责任公司 | Concentrated child kechuanling oral solution |
| CN107773592A (en) * | 2016-08-30 | 2018-03-09 | 北京盈科瑞创新医药股份有限公司 | A kind of child cough and panting Neulized inhalation pharmaceutical solutions and preparation method thereof |
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| Publication number | Publication date |
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| CN100477984C (en) | 2009-04-15 |
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