CN101239103A - Clearing heat and detoxication traditional Chinese medicine preparation and preparation thereof - Google Patents
Clearing heat and detoxication traditional Chinese medicine preparation and preparation thereof Download PDFInfo
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Abstract
The invention provides a traditional Chinese medicine preparation for clearing heat and detoxication and the preparation method, which is prepared by raw materials like honeysuckle, forsythia and southernwood, etc. the raw materials are all extracted by a supercritical carbon dioxide extraction method to get a naphtha; the residue of the extraction is extracted by water, is carried on condensation, alcohol precipitation, and decompression dry to get a water extraction dry powder which can be made into the troche, the granule, the hard capsule agent and the soft capsule agent of the traditional Chinese medicine preparation for clearing heat and detoxication by a conventional pharmaceutical method. The medicine of the invention has functions of dispelling wind-heat and clearing heat and detoxication, has good treatment effects on wind-heat cold, and on the fevers caused by a plurality of diseases.
Description
Technical field
The invention belongs to field of medicaments, more particularly, relating to Chinese medicine is Chinese medicine preparation of a kind of heat-clearing and toxic substances removing of making of raw material and preparation method thereof.
Technical background
Flu is a kind of commonly encountered diseases, frequently-occurring disease, but cause that the factor of flu is numerous, Therapeutic Method ought be different to some extent.Distinguish the flu that different factors cause, symptomatic treatment can be received the effect of getting twice the result with half the effort.
The traditional Chinese medical science thinks that flu is because six climate exopathogens, the time row virus attack human body and causing a disease, be main cause with the ailment said due to cold or exposure.Though ailment said due to cold or exposure is first of the six climate exopathogens, in Various Seasonal, often with other in season in gas phase close and hurt sb.'s feelings, as the wind and cold that belong in winter more, spring, the wind heat that belong to were pressed from both sides heat-damp in summer summer more more, the dryness of holding concurrently autumn more, and plum rain season presss from both sides damp more, a little less than outside defending, lung is defended careless and sluggish, and exopathogen is taken advantage of when attacking, then easily impression morbidity.As abrupt change of climate, cold temperature is not normal, and the six climate exopathogens in time heresy of row are wreaked havoc, and the invasion and attack human body is defended outer gas and can not be regulated strain, then every sickness rate rising of seeing primary disease.
Anemopyretic cold, wind heat belongs to pathogenic warmth, is subjected to attacking the lung first on its heresy, the lung master meter is defended, and the evil wound table of wind heat is defended, and aversion to cold promptly occurs, exterior syndromes such as heating, but wind heat is a YANG pathogen, and from the easy impairment of YIN Tianjin of cremating, so heating is heavy, aversion to cold is light, thirst with desire to drink, wind-heat invading the lung, its key is stopped up by wind heat, then nose cold current turbid nasal discharge, cough expectorant Huang is violated on the wind heat in head, then headache, on violate then pharyngalgia of throat, fever without sweat system is due to space between skin and muscles closes by excess of pathogen, the tongue fur BOHUANG, and floating and rapid pulse is all wind heat levying at table.
Coldrex major part common in the existing market is the mixture of Chinese medicine and chemical medicine, and is drowsiness easily behind the clothes, and heating is difficult to lower, and patient's course of disease is prolonged, and sense of discomfort is difficult to alleviate; For anemopyretic cold, still lack eutherapeutic symptomatic treatment medicine on the market.
Summary of the invention
The present invention be directed to the less present situation of anemopyretic cold medicine, develop a kind of Chinese medicine preparation for the treatment of anemopyretic cold, medicine of the present invention also has better therapeutic effect to the heating that multiple disease causes simultaneously.
The Chinese medicine preparation that the purpose of this invention is to provide a kind of heat-clearing and toxic substances removing.
Another object of the present invention provides a kind of preparation method of Chinese medicine preparation of heat-clearing and toxic substances removing.
The objective of the invention is to be achieved through the following technical solutions:
The Chinese medicine preparation of a kind of heat-clearing and toxic substances removing of the present invention is to be made by following raw materials in part by weight: Flos Lonicerae 15--17, Fructus Forsythiae 12--14, Herba Artemisiae Annuae 9-11.
The Chinese medicine preparation of preferred a kind of heat-clearing and toxic substances removing of the present invention is by comprising that following optimum weight part raw material makes: Flos Lonicerae 16, Fructus Forsythiae 13, Herba Artemisiae Annuae 10.
In the medicine of the present invention, Flos Lonicerae, sweet in the mouth is cold in nature, and wind-heat dissipating is arranged, and the merit of heat-clearing and toxic substances removing is with being monarch drug; Fructus Forsythiae, bitter, be slightly cold, have dispelling wind and heat pathogens, the merit of a surname's expelling pathogenic factors from the exterior heresy, Fang Zhongyong is a ministerial drug; Herba Artemisiae Annuae hardship, suffering, the cold merit that clearing away the hectic fever is arranged, the heating that multiple disease is caused all has good effect, and Fang Zhongyong is an adjuvant drug, and three medicines share, and are total to the diffusing wind heat of long memorial, the effect of heat-clearing and toxic substances removing.
The preparation method of the Chinese medicine preparation active component of a kind of heat-clearing and toxic substances removing of the present invention comprises the steps:
(1) three flavor medical materials such as extracting honeysuckle, Fructus Forsythiae, Herba Artemisiae Annuae mix in proportion, use the carbon dioxide supercritical fluid extraction method at pressure 30MPa, 40 ℃ of temperature, extraction time 3-5h, CO
2Extract under the condition of flow 1.5--3L/Kg medical material h, obtain volatile oil, medicinal residues are used in addition;
(2) will extract medicinal residues behind the volatile oil decocts with water and extracts each 1 hour 3 times; Add for the first time 12 times of water extraction, add 10 times of water extraction for the second time, add 8 times of water extraction for the third time, merge extractive liquid, filters, and being condensed into relative density is the clear paste of 1.14～1.16 (80 ℃);
(3) add ethanol in the clear paste after concentrating, making the ethanol final concentration is 75--85%, and the precipitate with ethanol time is 24h, filters behind the precipitate with ethanol, and filtrate concentrates, and reclaims ethanol, and drying under reduced pressure is pulverized, and gets water and promotes powder, standby;
The preparation method of the Chinese medicine preparation of a kind of heat-clearing and toxic substances removing of the present invention comprises the steps:
(1) solid orally ingestible preparation
A. get the water of step (3) gained and promote powder, add conventional pharmaceutic adjuvant, mix, resulting volatile oil is sprayed in the mixed powder, and mixing is granulated with pharmacy conventional method system, pack promptly gets a kind of oral formulations such as granule, hard capsule of Chinese medicine preparation of heat-clearing and toxic substances removing;
B. get the water of step (3) gained and promote powder, add conventional pharmaceutic adjuvant, mix, granulate with pharmacy conventional method system, drying, cooling sprays into resulting volatile oil in the granule, and is encapsulated, promptly gets a kind of hard capsule of Chinese medicine preparation of heat-clearing and toxic substances removing;
C. get the water promotion powder of step (3) gained, add conventional pharmaceutic adjuvant, mix, granulate with pharmacy conventional method system, drying, cooling sprays into resulting volatile oil in the granule, and tabletting wraps film-coat, promptly gets a kind of tablet of Chinese medicine preparation of heat-clearing and toxic substances removing;
(2) soft capsule preparation
A. get 1 part in gelatin, add 0.6 part of 1 part in water and glycerol, 70～80 ℃ melt glue after, move into 55～65 ℃ of heat preservation for standby use in the insulation jar;
B. it is an amount of to get the adjuvant soybean oil, with colloid mill at first with gained volatile oil mix homogeneously, promote the powder mix homogeneously with the water of gained again, and in mixed process, carry out quantitatively,
C. the medicinal liquid for preparing is added in the feed tank, carry out pelleting, make soft capsule, and at 25 ℃, 30% time typing of relative humidity after 20 hours,
D. the soft capsule after will finalizing the design moves into drying machine and carries out drying, the drying condition of soft capsule is that 30 ± 2 ℃, relative humidity are that 18%--22%, wind speed are 0.5--0.7m/s, time is 6--10 hour, dried soft capsule is washed ball, pack after choosing ball, promptly get a kind of soft capsule of Chinese medicine preparation of heat-clearing and toxic substances removing.
The Chinese medicine preparation of a kind of heat-clearing and toxic substances removing of the present invention, the chlorogenic acid content of every soft capsule, tablet, hard capsule is not less than 10mg; Chlorogenic acid content is not less than 20mg/g in the granule.
The Chinese medicine preparation of a kind of heat-clearing and toxic substances removing of the present invention can be in the application in the preparation treatment anemopyretic cold medicine.
The Chinese medicine preparation of a kind of heat-clearing and toxic substances removing of the present invention can be in the application in the medicine of preparation treatment heating.
The Chinese medicine preparation of a kind of heat-clearing and toxic substances removing of the present invention, Flos Lonicerae in the side, sweet in the mouth is cold in nature, and wind-heat dissipating is arranged, and the merit of heat-clearing and toxic substances removing is with being monarch drug.Fructus Forsythiae, bitter, be slightly cold, " Records of Tradition Chinese and Western Medicine in Combination " meaning: " can saturating flesh table, heat clearing away is by wind, for controlling the wind heat key medicine, and can the eliminating the toxic material out by tonification, again for delivering the rash key medicine ".Dispelling wind and heat pathogens is arranged, the merit of a surname's expelling pathogenic factors from the exterior heresy, Fang Zhongyong is a ministerial drug.Herba Artemisiae Annuae hardship, suffering, the cold merit that clearing away the hectic fever is arranged, " book on Chinese herbal medicine justice " cloud: " wind-fire that can loose, the abnormal smells from the patient delicate fragrance, then suitable sharp stasis, and clearing away heat from blood has speciality especially ".The heating that multiple disease is caused all has good effect, and Fang Zhongyong is an adjuvant drug, and three medicines share, and is total to the diffusing wind heat of long memorial, the effect of heat-clearing and toxic substances removing.
Below be representative with the soft capsule, by technical study, quality control index and pharmacodynamic study, pharmaceutical research is described further the Chinese medicine preparation of a kind of heat-clearing and toxic substances removing of the present invention.
One. Study on Preparation
Because the volatile oil of Flos Lonicerae, Fructus Forsythiae, Herba Artemisiae Annuae three flavor Chinese crude drugs is all relevant with its drug effect with water soluble ingredient, so the present invention at first utilizes the volatile oil component in three kinds of medical materials of carbon dioxide supercritical fluid extraction, residual residue water heating extraction.
1. volatile oil Study on extraction
Equipment: 5 liters of CO
2Supercritical extraction equipment (HA221-50-06 type) is manufactured and designed by Nantong Huaan Overcritical Extraction Co., Ltd..150 liters of CO
2Supercritical extraction equipment (type of production) is formed consistent with 5 liters of supercritical extraction equipment.
Apparatus and process flow process: CO
2Steel cylinder → high-pressure pump → extraction kettle → extraction-container → storage tank → circulation
The extraction process condition
We select to adopt L to the condition of extraction process
9(3
4) orthogonal array tests, and is performance assessment criteria with the yield (%) of volatile oil.Obtaining optimum process condition is pressure 30MPa, 40 ℃ of temperature, extraction time 4h, CO
2Flow 2L/Kg medical material h.
Supercritical extraction volatile oil is through three batches of pilot experiments (every crowd of inventory 87.5kg), and the result shows: the average yield of volatile oil is 2.56%.
2. water soluble ingredient Study on extraction
The extraction process condition is selected
The design of test level
The water-soluble portion extraction efficiency mainly is subjected to the influence of the water yield (A), extraction time (B), extraction time (C) three factors, adopts orthonormal design of experiments that extraction process is optimized.At above-mentioned three factors, adopt three levels of each factor design in the experiment, utilize L
9(3
4) orthogonal table tests.Its factor level, testing program and experimental result see Table 1, table 2, table 3.
Table 1 extraction factor water-glass (four factors, three levels)
Performance assessment criteria:
With the yield of chlorogenic acid and the yield of extractum is performance assessment criteria.
The condition selection result
Accurately take by weighing residue 100g, test by the factor level of table 1 through three kinds of medical material mix homogeneously of supercritical extraction.Shown by table 3 The results of analysis of variance: accounting for the medical material percentage by weight with extracted extractum is that performance assessment criteria is found, extraction time B, extraction time C all have the significance meaning, its factor affecting is C＞B＞A in proper order, and intuitive analysis shows that the optimum process condition that the extractum yield is minimum should be C
1, B
1, A
1With gained chlorogenic acid yield is performance assessment criteria, and extraction time C, water consumption A all have the significance meaning, and its factor affecting is in proper order
C＞A＞B, intuitive analysis shows that optimum process condition should be C
3, A
3, B
1Considering down that the step adopts the precipitate with ethanol purification, is main performance assessment criteria with the chlorogenic acid yield therefore, in conjunction with suitability for industrialized production save time, energy-conservation, the purpose that reduces cost, the extraction process scheme is defined as A
3B
1C
3The basis on, can reduce the adding water yield gradually during back extracted twice, be about to three kinds of medical materials and decoct with water and extract 3 times, each 1 hour, add 12 times of water extraction for the first time, add 10 times of water extraction for the second time, add 8 times of water extraction for the third time, merge extractive liquid, filters promptly.
Table 2 extraction process orthogonal experiments
The variance analysis of table 3 yield of extract
F
1-0.1(2，2)＝9
Table 4 water is proposed the yield variance analysis of chlorogenic acid
F
1-0.05(2，2)＝19.0，F
1-0.1(2，2)＝9
Three crowdes of pilot experiment results of water extract:
Three crowdes of pilot experiment results of table 5 water extract
3. alcohol precipitation process research
Herbal extract also contains a lot of impurity of Denging except that containing effective ingredient such as required chlorogenic acid, phillyrin, adopt ethanol precipitation to remove above-mentioned impurity usually.In the ethanol precipitation, consider that concentration of alcohol (A), multiple (B), precipitate with ethanol time (C) can influence to some extent to sedimentation effect, therefore adopt positive quadraturing design test that alcohol precipitation process has been carried out preferably.At above-mentioned three factors, adopt three levels of each factor design, the percentage ratio that accounts for total solid with pure hypostasis is performance assessment criteria, utilizes L
9(3
4) orthogonal table tests.
Result of the test shows: optimum process condition is that pure final concentration is 80%, and the alcohol amount is 8 times of clear paste, and the precipitate with ethanol time is 24h.Filter behind the precipitate with ethanol, filtrate concentrates, drying under reduced pressure, pulverize water extract dry powder, standby.
4. three crowdes of pilot experiment results of soft capsule:
Result of study according to above technology.Carry out pilot plant test, inventory is undertaken by 20 times of recipe quantity, and lot number is respectively.Result of the test sees Table 6:
Three batches of result of the tests of table 6 pilot scale
Result of study shows, the quality control index of the Chinese medicine preparation of a kind of heat-clearing and toxic substances removing of the present invention: it is 14.1mg-18.7mg that every soft capsule contains chlorogenic acid, and every soft capsule that conformance with standard requires contains chlorogenic acid and must not be less than 10.0mg.
Two. pharmacodynamic study
Function at the Chinese medicine preparation of a kind of heat-clearing and toxic substances removing of the present invention cures mainly, we carried out antiviral, antibiotic, bring down a fever, pharmacodynamics test such as antiinflammatory.Result of the test is as follows:
(1) the extracorporeal antivirus effect test shows: medicine 6.25g of the present invention (crude drug)/L can effectively suppress herpes simplex virus type 1, influenza virus A 3 types and acute laryngo-tracheo-bronchitis virus in intracellular propagation, and three's therapeutic index is respectively 3.74,2.72 and 3.
(2) the interior resisting virus test shows: medicine 20g of the present invention (crude drug)/kg has protective effect to the death of influenza virus infection, herpes simplex virus type 1 in the mice body.
(3) the in-vitro antibacterial test shows: medicine of the present invention has significant bacteriostasis to staphylococcus aureus, escherichia coli, bacillus pyocyaneus, hemophilus influenza, streptococcus pneumoniae, group B streptococcus.Its minimal inhibitory concentration MIC (mg crude drug/m1) be respectively 63,125,125,250,125,125 to bacterial strains such as staphylococcus aureuses.
(4) test of bringing down a fever shows that medicine of the present invention sends out model brimful of tears to White Rabbit due to rat fever model, the endotoxin due to the fresh yeast antipyretic effect is preferably all arranged.Compare with matched group, through the t check, difference is extremely remarkable.
(5) the antiinflammatory test shows that medicine of the present invention has antiinflammatory action preferably.Can resist dimethylbenzene induced mice ear swelling, certain antiinflammatory action is arranged.
(6) can obviously reduce mouse writhing number of times due to the lumbar injection acetic acid, analgesic activity preferably has been described.
Three. pharmaceutical research
5 of the rats of trial test: 100～120g, medicine of the present invention is with the dosage of 9.0g/kg, the administration volume of 2ml/100g, gastric infusion, once a day, continuous 5 days, compare with the normal saline matched group, do not find rat by the change of coarse, the general activity situation of hair, and other toxic reaction symptom.
With reference to " Western medicine new drug research guide (pharmacy, pharmacology, toxicology) " regulation, " as the toxic oral administration dosage of chmice acute greater than 5g/kg; drug administration by injection dosage can be considered only to do one and be higher than the dosage group of intending using 50 times of clinical dosages greater than 2g/kg toxigenicity reaction and dead or only during the toxic reaction of individual animal not yet.”
The observation of 1 mice maximum dosage-feeding
1.1 the animal grouping: get 40 of healthy mices, male and female half and half are divided into 2 groups at random, are respectively normal saline matched group and medicine group, 20 every group.
1.2 medication: the mice fasting be can't help water 12 hours, after weighing, pressed the dosage of 22.5g/kg and the administration volume of 1ml/20g and irritated stomach, and matched group is irritated the stomach normal saline after the same method.
1.3 observation index: toxic reaction and the death condition of close observation mice behind the filling stomach.After 4 hours, change into and observe once continuous 14 days every day.Weigh weekly 1 time.Poor to ordinary circumstance, body weight reduces or the tangible mice that raises is dissected the pathological changes of perusal main organs.If do not see dead mouse, then calculate maximum dosage-feeding.
1.4 result: irritate after stomach gives medicine of the present invention, show no obvious abnormalities in 4 hours.In 14 days, mice hair color light, diet, activity and body weight all do not have significant difference (table 7) with matched group.Calculating the oral maximum dosage-feeding of mice is 22.5g/kg.
Variation (the unit: g) of the oral acute toxicity body weight of table 7 medicine mice of the present invention
Test group and matched group compare, no statistical significant difference.
The observation of the oral medicine maximum dosage-feeding of the present invention of 2 rats
2.1 animal grouping: get 40 of healthy rats, male and female half and half.Be divided into 2 groups at random, be respectively normal saline matched group and medicine group, 20 every group.
2.2 medication: the rat fasting be can't help water 12 hours, after weighing, pressed the dosage of 9.0g/kg and the administration volume of 2ml/100g and irritated stomach, and in 8:00 and 16:00 administration, matched group gives normal saline after the same method respectively.
2.3 observation index: toxic reaction of close observation rat and death condition after the administration after 4 hours, change into and observe once continuous 14 days every day.Claim body weight weekly 1 time.Poor to ordinary circumstance, body weight reduces or the tangible rat that raises is dissected the pathological changes of perusal main organs.If do not see rats death, then calculate maximum dosage-feeding.
2.4 result: give virus carefree after, activities in rats is normal, shows no obvious abnormalities reaction.In 14 days, the rat good bloom, diet, activity and body weight all do not have significant difference (table 8) with matched group.Calculating the oral maximum dosage-feeding of medicine rat of the present invention is: 9.0g/kg+9.0g/kg=18.0g/kg.
Variation (the unit: g) of the oral acute toxicity body weight of table 8 medicine rat of the present invention;
Test group and matched group compare, no statistical significant difference.
Conclusion:
The maximum dosage-feeding that oral administration every day of medicine mice of the present invention is 1 time is 22.5g/kg, the maximum dosage-feeding 18.0g/kg that oral administration every day of rat is 2 times.Be equivalent to the clinical plan of people 375 times and 300 times respectively with dosage.
3. to the malicious result of study of the length of medicine of the present invention
Observe rat and irritated the toxic reaction that stomach produces for medicine of the present invention in continuous 30 days, be the reference data for clinical drug use of medicine of the present invention.Method: with 2.0ml/100g administration volume, give the administration of Wistar rat oral gavage every day with medicine 9.0g/kg of the present invention (high dose group), 3.0g/kg (middle dosage group), 1.0g/kg (low dose group) and normal saline (matched group) respectively, continuous 30 days, observe the general toxicity reaction of rat.
The result shows:
(1) 1～2 week after the administration, the high dose activities in rats reduces, and coarse by hair, male rat is more obvious.From the 3rd week of administration, the basic recovery normally.
(2) the 1st～2 week after the administration, high, middle dosage group rats eating amount reduces than matched group, and the food-intake that is administered to the 3rd each administration group of all backs returns to the matched group level.
(3) high dose group self administration of medication the 1st week～the 4th all weight ratio matched groups obviously reduce.In, body weight and the matched group of low dose group rat relatively change not quite; The body weight of high dose group male rat still reduces than matched group to convalescent period, but the rate of increase of body weight is apparently higher than matched group.
(4) 30 days each administration group blood glucose of administration reduces than matched group, and the blood glucose of middle dosage group and matched group be P＜0.05 relatively, and drug withdrawal is after 21 days, in, the blood glucose value of low dose group still reduces than matched group, its meaning awaits further research.
(5) administration 30 days and drug withdrawal are 21 days, and each internal organs visual examination of animal shows no obvious abnormalities.Microscopically is observed and is found that 30 days high dose group of administration have 10/10 example that duodenal chronic inflammatory disease is arranged, 21 days basic recoveries normally of drug withdrawal.Other internal organs are not found tangible pathological change.
Research conclusion:
Medicine 9g/kg (high dose group of the present invention; Be equivalent to the clinical plan of people 150 times with dosage) to take continuously and duodenal mucosa had certain stimulation in 30 days, 3 weeks of drug withdrawal can recover substantially;
The dosage of 3g/kg (middle dosage group; Be equivalent to the clinical plan of people 50 times with dosage) find no the change of obvious clinical meaning.
Below by preparation embodiment technical solution of the present invention is described further, but technical scheme of the present invention is not limited to embodiment.
Embodiment 1:
Crude drug prescription: Flos Lonicerae 1200g Fructus Forsythiae 975g Herba Artemisiae Annuae 750g
Preparation technology:
(1) extraction of volatile oil:
Get above three flavor medical materials by prescription and mix, utilize carbon dioxide supercritical fluid extraction volatile oil, extraction conditions: pressure 30MPa, 40 ℃ of temperature, extraction time 5h, CO
2Flow 1.5L/Kg medical material h; Get volatile oil 74.9g, yield is 2.56%
(2) water-soluble active ingredient extracts:
More than carrying oil back medicinal residues water extracts.Condition: decoct with water and extract 3 times, each 1 hour, add 12 times of water extraction for the first time, add 10 times of water extraction for the second time, add 8 times of water extraction for the third time, merge extractive liquid, filters, and being condensed into relative density is the clear paste of 1.14～1.16 (80 ℃);
With gained clear paste precipitate with ethanol, the precipitate with ethanol condition: pure final concentration is 85%, and the alcohol amount is 8 times of clear paste, and the precipitate with ethanol time is 24h.Filter behind the precipitate with ethanol, filtrate concentrates, and reclaims ethanol, and drying under reduced pressure is pulverized, and it is standby to get water-soluble dry powder 220g.
(3) formulation preparation: the gained water-soluble active ingredient is added an amount of lactose, mix, spray into volatile oil, mixing is made granule 500g, pack, and every bag 2 gram promptly makes 250 bags of the Chinese medicine preparation granules of a kind of heat-clearing and toxic substances removing of the present invention.
Embodiment 2:
Crude drug prescription: Flos Lonicerae 1200g Fructus Forsythiae 975g Herba Artemisiae Annuae 750g
Preparation technology:
(1) extraction of volatile oil:
Get above three flavor medical materials by prescription and mix, utilize carbon dioxide supercritical fluid extraction volatile oil, extraction conditions: pressure 30MPa, 40 ℃ of temperature, extraction time 4h, CO
2Flow 2L/Kg medical material h; Get volatile oil 75g, yield is 2.56%
(2) water-soluble active ingredient extracts:
More than carrying oil back medicinal residues water extracts.Condition: decoct with water and extract 3 times, each 1 hour, add 12 times of water extraction for the first time, add 10 times of water extraction for the second time, add 8 times of water extraction for the third time, merge extractive liquid, filters, and being condensed into relative density is the clear paste of 1.14～1.16 (80 ℃);
With gained clear paste precipitate with ethanol, the precipitate with ethanol condition: pure final concentration is 80%, and the alcohol amount is 8 times of clear paste, and the precipitate with ethanol time is 24h.Filter behind the precipitate with ethanol, filtrate concentrates, and reclaims ethanol, and drying under reduced pressure is pulverized, and it is standby to get water-soluble dry powder 220g.
(3) preparation of soft capsule: get 1 part in gelatin, add 0.6 part of 1 part in water and glycerol, 70～80 ℃ melt glue after, move into 55～65 ℃ of heat preservation for standby use in the insulation jar.It is an amount of to get the adjuvant soybean oil, utilize colloid mill at first with the volatile oil mix homogeneously, promote the powder mix homogeneously with water again, its process is carried out quantitatively, the total amount of volatile oil+water promotion powder+soybean oil is 500g.The medicinal liquid for preparing is added in the feed tank, carry out pelleting, make 1000.Soft capsule, moves into drying machine and carries out drying after 20 hours in 30% time typing of 25 ℃, relative humidity, and drying condition is that 30 ± 2 ℃, relative humidity are that 18--22%, wind speed are 0.6m/s, and the time is 8 hours.Dried soft capsule is washed ball, packs after choosing ball, promptly makes 985 of the Chinese medicine preparation soft capsules of a kind of heat-clearing and toxic substances removing of the present invention, and yield is 98.5%.
Embodiment 3:
Crude drug prescription: Flos Lonicerae 4386g Fructus Forsythiae 4094g Herba Artemisiae Annuae 3216g
Preparation technology:
(1) extraction of volatile oil:
Get above three flavor medical materials by prescription and mix, utilize carbon dioxide supercritical fluid extraction volatile oil, extraction conditions: pressure 30MPa, 40 ℃ of temperature, extraction time 3h, CO
2Flow 2.5L/Kg medical material h; Get volatile oil 298g, yield is 2.55%
(2) water-soluble active ingredient extracts:
To carry oil back medicinal residues water extracts.Condition: decoct with water and extract 3 times, each 1 hour, add 12 times of water extraction for the first time, add 10 times of water extraction for the second time, add 8 times of water extraction for the third time, merge extractive liquid, filters, and being condensed into relative density is the clear paste of 1.14～1.16 (80 ℃);
With gained clear paste precipitate with ethanol, the precipitate with ethanol condition: pure final concentration is 75%, and the alcohol amount is 8 times of clear paste, and the precipitate with ethanol time is 24h.Filter behind the precipitate with ethanol, filtrate concentrates, and reclaims ethanol, and drying under reduced pressure is pulverized, and it is standby to get water-soluble dry powder 885g.
(3) formulation preparation: the gained water-soluble active ingredient is added an amount of conventional adjuvant, granulate by the pharmacy conventional method, spray into volatile oil, mixing is pressed into 4000, and conventional method bag film-coat promptly makes the tablet of the Chinese medicine preparation of a kind of heat-clearing and toxic substances removing of the present invention.
Embodiment 4:
Crude drug prescription: Flos Lonicerae 2618g Fructus Forsythiae 1848g Herba Artemisiae Annuae 1386g
Preparation technology:
(1) extraction of volatile oil:
Get above three flavor medical materials by prescription and mix, utilize carbon dioxide supercritical fluid extraction volatile oil, extraction conditions: pressure 30MPa, 40 ℃ of temperature, extraction time 3h, CO
2Flow 3L/Kg medical material h; Get volatile oil 140g, yield is 2.39%
(2) water-soluble active ingredient extracts:
More than carrying oil back medicinal residues water extracts.Condition: decoct with water and extract 3 times, each 1 hour, add 12 times of water extraction for the first time, add 10 times of water extraction for the second time, add 8 times of water extraction for the third time, merge extractive liquid, filters, and being condensed into relative density is the clear paste of 1.14～1.16 (80 ℃);
With gained clear paste precipitate with ethanol, the precipitate with ethanol condition: pure final concentration is 85%, and the alcohol amount is 8.5 times of clear paste, and the precipitate with ethanol time is 24h.Filter behind the precipitate with ethanol, filtrate concentrates, and reclaims ethanol, and drying under reduced pressure is pulverized, and it is standby to get water-soluble active ingredient 445g.
(3) formulation preparation: the gained water-soluble active ingredient is added an amount of conventional adjuvant, mix, granulate by the pharmacy conventional method, drying, Fang Leng sprays into volatile oil, mixing incapsulates, and promptly makes 2000 of the capsules of the Chinese medicine preparation of a kind of heat-clearing and toxic substances removing of the present invention.
Embodiment 5:
Crude drug prescription: Flos Lonicerae 2400g Fructus Forsythiae 1950g Herba Artemisiae Annuae 1500g
Preparation technology:
(1) extraction of volatile oil:
Get above three flavor medical materials by prescription and mix, utilize carbon dioxide supercritical fluid extraction volatile oil, extraction conditions: pressure 30MPa, 40 ℃ of temperature, extraction time 5h, CO
2Flow 1.5L/Kg medical material h; Get volatile oil 150g, yield is 2.56%
(2) water-soluble active ingredient extracts:
More than carrying oil back medicinal residues water extracts.Condition: decoct with water and extract 3 times, each 1 hour, add 12 times of water extraction for the first time, add 10 times of water extraction for the second time, add 8 times of water extraction for the third time, merge extractive liquid, filters, and being condensed into relative density is the clear paste of 1.14～1.16 (80 ℃);
With gained clear paste precipitate with ethanol, the precipitate with ethanol condition: pure final concentration is 75%, and the alcohol amount is 8 times of clear paste, and the precipitate with ethanol time is 24h.Filter behind the precipitate with ethanol, filtrate concentrates, and reclaims ethanol, and drying under reduced pressure is pulverized, and it is standby to get water-soluble active ingredient 440g.
(3) preparation of soft capsule: get 1 part in gelatin, add 0.6 part of 1 part in water and glycerol, 70～80 ℃ melt glue after, move into 55～65 ℃ of heat preservation for standby use in the insulation jar.It is an amount of to get the adjuvant soybean oil, utilize colloid mill at first with the volatile oil mix homogeneously, promote the powder mix homogeneously with water again, its process is carried out quantitatively, the total amount of volatile oil+water promotion powder+soybean oil is 1000g.The medicinal liquid for preparing is added in the feed tank, carry out pelleting, make 2000.Soft capsule, moves into drying machine and carries out drying after 20 hours in 30% time typing of 25 ℃, relative humidity, and drying condition is that 30 ± 2 ℃, relative humidity are that 18--22%, wind speed are 0.5m/s, and the time is 10 hours.Dried soft capsule is washed ball, packs after choosing ball, promptly makes 1960 of the Chinese medicine preparation soft capsules of a kind of heat-clearing and toxic substances removing of the present invention, and yield is 98%.
Embodiment 6:
Crude drug prescription: Flos Lonicerae 2400g Fructus Forsythiae 1950g Herba Artemisiae Annuae 1500g
Preparation technology:
(1) extraction of volatile oil:
Get above three flavor medical materials by prescription and mix, utilize carbon dioxide supercritical fluid extraction volatile oil, extraction conditions: pressure 30MPa, 40 ℃ of temperature, extraction time 4h, CO
2Flow 2L/Kg medical material h; Get volatile oil 150g, yield is 2.56%
(2) water-soluble active ingredient extracts:
More than carrying oil back medicinal residues water extracts.Condition: decoct with water and extract 3 times, each 1 hour, add 12 times of water extraction for the first time, add 10 times of water extraction for the second time, add 8 times of water extraction for the third time, merge extractive liquid, filters, and being condensed into relative density is the clear paste of 1.14～1.16 (80 ℃);
With gained clear paste precipitate with ethanol, the precipitate with ethanol condition: pure final concentration is 80%, and the alcohol amount is 8 times of clear paste, and the precipitate with ethanol time is 24h.Filter behind the precipitate with ethanol, filtrate concentrates, and reclaims ethanol, and drying under reduced pressure is pulverized, and it is standby to get water-soluble active ingredient 440g.
(3) preparation of soft capsule: get 1 part in gelatin, add 0.6 part of 1 part in water and glycerol, 70～80 ℃ melt glue after, move into 55～65 ℃ of heat preservation for standby use in the insulation jar.It is an amount of to get the adjuvant soybean oil, utilize colloid mill at first with the volatile oil mix homogeneously, promote the powder mix homogeneously with water again, its process is carried out quantitatively, the total amount of volatile oil+water promotion powder+soybean oil is 1000g.The medicinal liquid for preparing is added in the feed tank, carry out pelleting, make 2000.Soft capsule, moves into drying machine and carries out drying after 20 hours in 30% time typing of 25 ℃, relative humidity, and drying condition is that 30 ℃, relative humidity are 20%, wind speed is 0.6m/s, and the time is 8 hours.Dried soft capsule is washed ball, packs after choosing ball, promptly makes 1940 of the Chinese medicine preparation soft capsules of a kind of heat-clearing and toxic substances removing of the present invention, and yield is 97%.
Claims (5)
1. the Chinese medicine preparation of a heat-clearing and toxic substances removing is characterized in that it is to be made by following raw materials in part by weight: Flos Lonicerae 15--17, Fructus Forsythiae 12--14, Herba Artemisiae Annuae 9-11; Its feature is that also its dosage form is tablet, granule, hard capsule and the soft capsule of oral formulations.
2. the Chinese medicine preparation of a kind of heat-clearing and toxic substances removing as claimed in claim 1 is characterized in that it is by comprising that following optimum weight part raw material makes: Flos Lonicerae 16, Fructus Forsythiae 13, Herba Artemisiae Annuae 10.
3. as the Chinese medicine preparation of a kind of heat-clearing and toxic substances removing of claim 1 and/or 2, it is characterized in that its preparation method may further comprise the steps:
(1) three flavor medical materials such as extracting honeysuckle, Fructus Forsythiae, Herba Artemisiae Annuae mix in proportion, use the carbon dioxide supercritical fluid extraction method at pressure 30MPa, 40 ℃ of temperature, extraction time 3-5h, CO
2Extract under the condition of flow 1.5--3L/Kg medical material h, obtain volatile oil, medicinal residues are used in addition;
(2) will extract medicinal residues behind the volatile oil decocts with water and extracts each 1 hour 3 times; Add for the first time 12 times of water extraction, add 10 times of water extraction for the second time, add 8 times of water extraction for the third time, merge extractive liquid, filters, and relative density is 1.14～1.16 clear paste when being condensed into 80 ℃;
(3) add ethanol in the clear paste after concentrating, making the ethanol final concentration is 75--85%, and the precipitate with ethanol time is 24h, filters behind the precipitate with ethanol, and filtrate concentrates, and reclaims ethanol, and drying under reduced pressure is pulverized, and gets water and promotes powder, standby;
(4) water of getting step (3) gained is promoted powder, adds conventional pharmaceutic adjuvant, mixes, and resulting volatile oil is sprayed in the mixed powder, and mixing is granulated with pharmacy conventional method system, packs, and promptly gets a kind of granule of Chinese medicine preparation of heat-clearing and toxic substances removing;
(5) water of getting step (3) gained is promoted powder, adds conventional pharmaceutic adjuvant, mixes, granulate with pharmacy conventional method system, and drying, cooling sprays into resulting volatile oil in the granule, and is encapsulated, promptly gets a kind of hard capsule of Chinese medicine preparation of heat-clearing and toxic substances removing;
(6) water of getting step (3) gained is promoted powder, adds conventional pharmaceutic adjuvant, mixes, granulate with pharmacy conventional method system, and drying, cooling sprays into resulting volatile oil in the granule, tabletting, the bag film-coat promptly gets a kind of tablet of Chinese medicine preparation of heat-clearing and toxic substances removing;
(7) soft capsule preparation
A. get 1 part in gelatin, add 0.6 part of 1 part in water and glycerol, 70～80 ℃ melt glue after, move into 55～65 ℃ of heat preservation for standby use in the insulation jar;
B. it is an amount of to get the adjuvant soybean oil, with colloid mill at first with gained volatile oil mix homogeneously, promote the powder mix homogeneously with the water of gained again, and in mixed process, carry out quantitatively;
C. the medicinal liquid for preparing is added in the feed tank, carry out pelleting, make soft capsule, and 25 ℃, 30% time typing of relative humidity 20 hours;
D. the soft capsule after will finalizing the design moves into drying machine and carries out drying, drying condition is that 30 ± 2 ℃, relative humidity are that 18%--22%, wind speed are 0.5--0.7m/s, time is 6--10 hour, dried soft capsule is through washing ball, pack after choosing ball, promptly get a kind of soft capsule of Chinese medicine preparation of heat-clearing and toxic substances removing.
4. as the Chinese medicine preparation of a kind of heat-clearing and toxic substances removing of claim 1 and/or 2, it is characterized in that its application in preparation treatment anemopyretic cold medicine.
5. as the Chinese medicine preparation of a kind of heat-clearing and toxic substances removing of claim 1 and/or 2, it is characterized in that its application in the medicine of preparation treatment heating.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104306712A (en) * | 2014-09-25 | 2015-01-28 | 苏州市天灵中药饮片有限公司 | Heat clearing and detoxifying tea and preparation method thereof |
| CN104435093A (en) * | 2014-06-23 | 2015-03-25 | 南京华宽信息咨询中心 | Anti-influenza virus soft capsules as well as preparation method and application thereof |
-
2008
- 2008-03-24 CN CNA2008100844480A patent/CN101239103A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104435093A (en) * | 2014-06-23 | 2015-03-25 | 南京华宽信息咨询中心 | Anti-influenza virus soft capsules as well as preparation method and application thereof |
| CN104306712A (en) * | 2014-09-25 | 2015-01-28 | 苏州市天灵中药饮片有限公司 | Heat clearing and detoxifying tea and preparation method thereof |
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