CN101310735A - Traditional Chinese drug pelletized granule for reducing fever, detoxifying, diminishing inflammation and preparation method thereof - Google Patents
Traditional Chinese drug pelletized granule for reducing fever, detoxifying, diminishing inflammation and preparation method thereof Download PDFInfo
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Abstract
The invention provides a traditional Chinese medicine sugar-free granule for treating acute and chronic tonsillitis, acute and chronic pharyngitis and upper respiratory tract infection and a preparation method thereof, and the granules are prepared by honeysuckle flower extract and baical skullcap root extract according to a certain proportion. The granules of the invention are applicable to various people groups, and the clinical efficacy is significantly improved.
Description
Technical field
The present invention relates to treat the acute and chronic tonsillitis, acute and chronic pharyngitis, preparation method of the Chinese medicine granules of upper respiratory tract infection disease and products thereof belongs to technical field of Chinese medicines.
Background technology
Acute and chronic tonsillitis, acute and chronic pharyngitis, upper respiratory tract infection are many to be caused by flu, belongs to common susceptible disease, especially in stage occurred frequently of this type of respiratory system disease especially autumn and winter season.The medicine for the treatment of this type of disease is innumerable especially, and western medicine is many based on Tri-Biocin, antipyretic-antalgic class medicine and antiviral class medicine, though the Western medicine instant effect is easy to generate drug resistance, and too much use also can cause other diseases of human body.Use this type of disease of treatment by Chinese herbs then can avoid the shortcoming of above-mentioned Western medicine, but it is uneven to treat the Chinese patent medicine curative effect of this type of disease at present, many medicines all can not reach the advantage of instant effect.
Silver yellow class preparation is exactly to treat acute and chronic tonsillitis, acute and chronic pharyngitis, a upper respiratory tract infection effect class medicine preferably in the market.National standards such as YINHUANG CHONGJI, oral liquid, capsule, tablet have all been carried out for many years, its standard of silver yellow granule is recorded in the 6th of ministry standard, prescription is made up of Flos Lonicerae extract 100g, Radix Scutellariae extract 40g, method for making is above two flavors, and is an amount of with sucrose 800g and starch, stirs, make granule, dry below 60 ℃, make 1000g, promptly.Wherein the preparation method of Flos Lonicerae extract is an extracting honeysuckle, decocts with water secondary, each 2 hours, collecting decoction filters, and filtrate adds lime cream and is adjusted to pH value to 10～12, leave standstill, the leaching precipitation adds suitable quantity of water, adds sulphuric acid and regulates pH value to 6～7, stir evenly, filter, filtrate is concentrated into the thick paste shape, promptly.The preparation method of Radix Scutellariae extract adds to and decocts secondary in the boiling water for getting Radix Scutellariae, and each 1 hour, collecting decoction filtered filtrate and adds sulphuric acid adjusting pH value to 2, leave standstill, and the leaching precipitation, after an amount of washing of ethanol, drying, promptly.Though the silver yellow granule have dissolving absorb fast, bioavailability is high, mouthfeel is good, is convenient to take advantage such as carry, but added a large amount of sucrose in this granule, taking dose is strengthened, and be unwell to some and be difficult for taking sacchariferous patient, for example diabetics.Moreover because what use is conventional granulation in this technology, and sucrose plays an important role in granulation, if change other adjuvants into, the unsuitable molding of granule should not be granulated.Be applicable to that any patient takes, the curative effect height so provide a kind of, and the medicine that is easy to granulate and preparation method thereof is practicable.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of any patient of being fit to take, the curative effect of medication height, and the granule that is easy to granulate and preparation method thereof.
The medicine of treatment acute and chronic tonsillitis provided by the invention, acute and chronic pharyngitis, upper respiratory tract infection is prepared from by following steps:
1) extracting honeysuckle decocts with water secondary, and each 2 hours, collecting decoction filtered, filtrate adds lime cream and regulates pH value to 10～12, leaves standstill, and the leaching precipitation adds suitable quantity of water, adds sulphuric acid and regulates pH value to 6～7, stir evenly, filter, filtrate is concentrated into the thick paste shape, gets Flos Lonicerae extract;
2) get Radix Scutellariae, add to and decoct secondary in the boiling water, each 1 hour, collecting decoction, filtration, filtrate adds sulphuric acid and regulates pH value to 2, leaves standstill, the leaching precipitation, after an amount of washing of ethanol, drying gets Radix Scutellariae extract;
3) take by weighing the Flos Lonicerae extract and the step 2 of step 1) in 5: 2 ratios) Radix Scutellariae extract, add the adjuvant except that sucrose after, stir, make granule, promptly.
Adjuvant in the above step 3) except that the sugarcane candy is one or more the compositions in pharmaceutic adjuvant tangerine sugar, xylitol, fructose, mannitol, sorbitol, lactose, starch, the dextrin, the mixture of preferred tangerine sugar and dextrin; Selected method of granulating is spray granulation method, boiling granulating method and extrusion granulator method in the step 3), is preferably the boiling granulating method; The granule that application the present invention makes is a sugar-free granule.
Process conditions preferred:
1) selection of method of granulating
To spray granulation method, boiling granulating method, the prepared granule of extrusion granulator method that adopts in the technology, press commercially available back, adopt the water isolation type electro-heating standing-temperature cultivator,, and can monitor true temperature and humidity at 40 ± 2 ℃ of temperature, relative humidity 75 ± 5%.Take a sample respectively once 1st month, 2 months, 3 months, 6 the end of month at duration of test, press the study on the stability project and detect.
Below be several method of granulating gained drug quality study on the stability results' comparison, the results are shown in following table:
3 kinds of method of granulating medicine stabilities are investigated the result
"+" expression meets quality of the pharmaceutical preparations requirement.
Above result shows: the method for granulating technology stability is followed successively by boiling granulating method＞spray granulation method＞extrusion granulator method.The boiling granulating method is to utilize air-flow powder suspension, is fluidization, sprays into adhesive liquid again, makes the powder granulating that condenses.Feeding gas flow temperature can regulate according to producing needs.Flos Lonicerae extract in the medicine of the present invention, its active ingredient chlorogenic acid is poor stability under higher temperature, easily decomposes.After adopting the boiling granulating method in the preparation method, its dry and step of granulating is finished, baking temperature be effectively controlled (40 ℃～55 ℃), effective ingredient is difficult for loss, make in the preparation active constituent content obtain significance and improve, and the granule melting that this method makes is good, epigranular, storage for a long time are difficult for hardening.In line with the factor of aspects such as constant product quality, evident in efficacy and energy savings, select for use the boiling granulating method to carry out particulate preparation.
2) selection of adjuvant
The selection of the supplementary product kind of granule and usage ratio, the quality of the pharmaceutical preparations and curative effect to medicine have the significance influence, in order to find out the optimum amount ratio of best supplementary product kind and raw material and adjuvant, the inventor has carried out a large amount of tests, below is the part test of being implemented:
Take by weighing Flos Lonicerae extract and Radix Scutellariae extract in proportion, the adjuvant that adds variety classes and ratio is respectively granulated with the boiling granulating method, investigates from the complexity of granulating, particulate appearance character and three aspects of particulate hygroscopicity, determine the selection percentage of adjuvant, the results are shown in following table:
The selection of adjuvant
As can be seen from the above table, when medicine, dextrin, when the tangerine sugar proportioning is 7: 18: 0.125, not only granulate easily, and the particle appearance character that makes is good, measures the moisture content change minimum after three months through fuchsin(e)test.
The specific embodiment
Further describe the preparation method with Chinese medicine sugar-free granule of heat clearing away, detoxifcation, inflammation-diminishing function of the present invention below, but therefore the present invention is not subjected to any restriction.
[embodiment 1] takes by weighing Flos Lonicerae extract 100 weight portions, baicalin extract 40 weight portions, adds dextrin 360 weight portions and tangerine sugar 5 ‰ weight portions, and mix homogeneously is granulated with the boiling granulating method, promptly.
[embodiment 2] take by weighing Flos Lonicerae extract 200 weight portions, baicalin extract 80 weight portions, add dextrin 720 weight portions and tangerine sugar 5 ‰ weight portions, and mix homogeneously is granulated with the boiling granulating method, promptly.
[embodiment 3] take by weighing Flos Lonicerae extract 100 weight portions, baicalin extract 40 weight portions, add dextrin 360 weight portions and tangerine sugar 5 ‰ weight portions, and mix homogeneously is granulated with the extrusion granulator method, promptly.
[embodiment 4] take by weighing Flos Lonicerae extract 100 weight portions, baicalin extract 40 weight portions, add dextrin 360 weight portions and tangerine sugar 5 ‰ weight portions, and mix homogeneously is granulated with the spray granulation method, promptly.
[embodiment 5] take by weighing Flos Lonicerae extract 100 weight portions, baicalin extract 40 weight portions, add starch 360 weight portions and tangerine sugar 5 ‰ weight portions, and mix homogeneously is granulated with the boiling granulating method, promptly.
[embodiment 6] take by weighing Flos Lonicerae extract 100 weight portions, baicalin extract 40 weight portions, add lactose 360 weight portions and tangerine sugar 2.5 ‰ weight portions, and mix homogeneously is granulated with the boiling granulating method, promptly.
[embodiment 7] take by weighing Flos Lonicerae extract 100 weight portions, baicalin extract 40 weight portions, add dextrin 360 weight portions and mannitol 5 ‰ weight portions, and mix homogeneously is granulated with the boiling granulating method, promptly.
[embodiment 8] take by weighing Flos Lonicerae extract 100 weight portions, baicalin extract 40 weight portions, add xylitol 360 weight portions, and mix homogeneously is granulated with the boiling granulating method, promptly.
[embodiment 9] take by weighing Flos Lonicerae extract 100 weight portions, baicalin extract 40 weight portions, add sorbitol 360 weight portions, and mix homogeneously is granulated with the boiling granulating method, promptly.
[embodiment 10] take by weighing Flos Lonicerae extract 100 weight portions, baicalin extract 40 weight portions, add fructose 360 weight portions and tangerine sugar 2.5 ‰ weight portions, and mix homogeneously is granulated with the boiling granulating method, promptly.
[embodiment 11] take by weighing Flos Lonicerae extract 100 weight portions, baicalin extract 40 weight portions, add fructose 360 weight portions and mannitol 2.5 ‰ weight portions, and mix homogeneously is granulated with the boiling granulating method, promptly.
One, pharmacodynamics test:
1, trial drug: the positive controls medicine, produce by Jiahe, Guangzhou pharmaceutical factory;
Medicine group medicine of the present invention is according to the prepared sugar-free granule of embodiment 1;
The negative control group medicine is normal saline solution.
2, test method:
1) heat clearing away effect:
Get the white big ear rabbit of body weight at 2.0～3.0kg, male and female have concurrently, experiment the previous day choose body temperature at 38.0～39.4 ℃, and body temperature changed the rabbit be no more than 0.4 ℃ and used rabbit as experiment the same day.The same day, measure the preceding basal body temperature of modeling, oneself rabbit ear vein bacterial injection endotoxin normal saline solution, dosage is 7.5g, observation body temperature changes, per 0.5 hour record once, choose injection 1h after body temperature rise surpass 0.5 ℃ rabbit, be divided into 5 groups at random, 8 every group: the large, medium and small dosage group of medicine of the present invention, positive controls.Irritate stomach to rabbit, after the administration, continue to observe rabbit body temperature and change, per 1 hour record once, continuous record 5h is an observation index with the animal heat of every 1h and the difference of basal body temperature, the results are shown in following table.
Table 3 rabbit pyrogenic test result
Annotate: compare * P＜0.05 with negative control group, * * P＜0.01, medicine group of the present invention and positive controls be Δ P＜0.05 relatively.
The result shows: medicine of the present invention and silver yellow granule matched group relatively have the significance inhibitory action to fever in rabbits due to the bacterial endotoxin, have the effect of heat clearing away.
2) Detoxication:
Experiment was surveyed body temperature 3 in advance with rat, experiment measured value on the same day is the rat basal body temperature, the variation of screening body temperature is no more than 0.3 ℃ animal, be divided into 5 groups at random, every group 13: silver yellow granule positive controls, the large, medium and small dosage of medicine of the present invention, behind the gastric infusion, inject 1% carrageenin solution 0.1ml under the rat right hind leg sole immediately, record causes before the inflammation and causes scorching back 1～6h rat foot volume, and calculating swelling rate.
Table 4 rat foot is to scorching result of the test
Annotate: compare * P＜0.05 with negative control group, * * P＜0.01, medicine group of the present invention and positive controls be Δ P＜0.05 relatively.
The result shows: medicine group of the present invention and the comparison of silver yellow granule matched group can significantly suppress the volume of rat swelling sole, have antibacterial antidotal effect.
Two, clinical trial
1.1 case is selected early stage, light-duty acute pharyngitis patient 300 examples, male 153 examples, women 147 examples, 13～69 years old age, average 38.4 years old.With severe cases: (1) hyperpyrexia (body temperature 〉=40 ℃); (2) course of disease 〉=3d companion body temperature＞39 ℃; (3) purulence angina patient all gives and forgoing.Except causing that in addition for having used antibiotic before examining, and by general disease (as hematopathy etc.) pharyngeal the infected also.
1.2 the test grouping is divided into 2 groups at random with 300 routine patients
Medicine group 200 examples of the present invention, male 102 examples, women 98 examples.Take the granule of the embodiment of the invention 1 preparation, every day 2 times, each 4g avoids maror.
Matched group 100 examples, male 51 examples, women 49 examples.Silver yellow granule every day of taking that Jiahe, Guangzhou pharmaceutical factory produces 2 times, each 8g avoids maror.
1.3 clinical observation project and efficacy assessment standard
1.3.1 observation item comprises symptom pharyngalgia, dry pharynx sense, dysphagia, pharynx foreign body sensation, cough and expectoration, heating etc.Sign: pharyngeal mucous membrane hyperemia, the congested swelling of lateral pharyngeal band, pharyngeal exudate, submandibular lymph nodes enlargement and tenderness etc.Check behind the medication 3d.
1.3.2 judge grade scale (1) produce effects of curative effect: subjective symptoms and positive sign disappear or complete obiteration substantially; (2) effective: subjective symptoms and positive sign alleviate; (3) invalid: symptom and sign do not have and alleviate.Total effective rate=produce effects+effectively/total routine number * 100%.
2 results
2.1 treatment acute pharyngitis doing well,improving situation, the back acute pharyngitis patient's that takes medicine various symptoms all have the different improvement of degree, are improved as outstanding with pharyngalgia, pharynx foreign body sensation, cough and expectoration and heating etc. especially.The results are shown in Table 1.
Table 1 a treatment acute pharyngitis doing well,improving situation (example)
* medicine group of the present invention and matched group P＜0.05
As can be seen from the above table, medicine group of the present invention and the matched group preceding clinical symptoms there was no significant difference of taking medicine, the back medicine group clinical symptoms improvement ratio of the present invention of taking medicine is significantly higher than matched group.
2.2 treatment acute pharyngitis sign is improved situation, the back acute pharyngitis patient's that takes medicine various signs all have improvement, and are wherein particularly evident with pharyngeal mucous membrane hyperemia and lateral pharyngeal band hyperemia, swelling.The results are shown in Table 2.
Table 2 treatment acute pharyngitis sign is improved situation (example)
* medicine group of the present invention and matched group P＜0.05
As can be seen from the above table, medicine group of the present invention and the matched group preceding clinical sign there was no significant difference of taking medicine, the back medicine group clinical sign improvement ratio of the present invention of taking medicine is significantly higher than matched group.
2.3 the curative effect of treatment acute pharyngitis the results are shown in Table 3.
The curative effect (example) of table 3 treatment acute pharyngitis
| Total routine number | Produce effects | Effectively | Invalid | Total effective rate | |
| Medicine group of the present invention | 200 | 117 | 51 | 32 | 94％* |
| Matched group | 100 | 66 | 19 | 15 | 85％ |
* medicine group of the present invention and matched group P＜0.05
As can be seen from the above table, of the present invention group of medicine to the total effective rate of treatment acute pharyngitis apparently higher than matched group.Drug therapy of the present invention reaches light-duty acute pharyngitis effective percentage in early days and reaches 94%, and does not have obvious toxic-side effects, and 200 routine patients do not find any untoward reaction at period in a medicine.
Claims (6)
1, a kind ofly be used for the acute and chronic tonsillitis, acute and chronic pharyngitis, the Chinese medicine granules of upper respiratory tract infection is prepared from according to following steps:
1) extracting honeysuckle decocts with water secondary, and each 2 hours, collecting decoction filtered, filtrate adds lime cream and regulates p H-number to 10～12, leaves standstill, and the leaching precipitation adds suitable quantity of water, adds sulfur acid for adjusting pH value to 6～7, stir evenly, filter, filtrate is concentrated into the thick paste shape, gets Flos Lonicerae extract;
2) get Radix Scutellariae, add to and decoct secondary in the boiling water, each 1 hour, collecting decoction, filtration, filtrate adds sulphuric acid and regulates pH value to 2, leaves standstill, the leaching precipitation, after an amount of washing of ethanol, drying gets Radix Scutellariae extract;
3) take by weighing the Flos Lonicerae extract and the step 2 of step 1) in 5: 2 ratios) Radix Scutellariae extract, add the adjuvant except that sucrose after, stir, make granule, promptly.
2, described according to claim 1, it is characterized in that the adjuvant that adds in the step 3) is the pharmaceutic adjuvant except that sucrose;
3, described according to claim 2, pharmaceutic adjuvant is preferably tangerine sugar, xylitol, fructose, mannitol, sorbitol, lactose, dextrin, starch;
4, described according to claim 1, it is characterized in that the step 3) method of granulating is spray granulation method, boiling granulating method, extrusion granulator method;
5, described according to claim 4, method of granulating is preferably the boiling granulating method;
6, a kind ofly be used for acute and chronic tonsillitis, the Chinese medicine sugar-free granule of acute and chronic pharyngitis, upper respiratory tract infection by what each described method among the claim 1-5 prepared.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101744883B (en) * | 2008-12-19 | 2011-12-07 | 北京亚东生物制药有限公司 | Chinese medicinal composition preparation and preparation method thereof and quality control method |
| CN105497133A (en) * | 2015-12-19 | 2016-04-20 | 昆明赛诺制药有限公司 | Periplaneta Americana medicine composition for treating pharyngitis and tonsillitis and preparation method thereof |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1069881A (en) * | 1992-09-08 | 1993-03-17 | 四川省中药厂 | The preparation method of antivirus powder without sugar |
| CN1565585A (en) * | 2003-06-30 | 2005-01-19 | 浙江大德制药有限公司 | Preparing method of sugar free medicinal granule |
| CN1582972A (en) * | 2003-08-19 | 2005-02-23 | 武汉健民集团随州药业有限公司 | Sugarless Xiasangju granules |
| CN1297277C (en) * | 2004-02-21 | 2007-01-31 | 李文东 | Laminaran granule and its preparation technology |
-
2007
- 2007-05-23 CN CN2007100995077A patent/CN101310735B/en active Active
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101744883B (en) * | 2008-12-19 | 2011-12-07 | 北京亚东生物制药有限公司 | Chinese medicinal composition preparation and preparation method thereof and quality control method |
| CN105497133A (en) * | 2015-12-19 | 2016-04-20 | 昆明赛诺制药有限公司 | Periplaneta Americana medicine composition for treating pharyngitis and tonsillitis and preparation method thereof |
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