CN105770074A - Traditional Chinese medicine composition for treating wind-heat common cold and preparation method thereof - Google Patents

Traditional Chinese medicine composition for treating wind-heat common cold and preparation method thereof Download PDF

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CN105770074A
CN105770074A CN201610247425.1A CN201610247425A CN105770074A CN 105770074 A CN105770074 A CN 105770074A CN 201610247425 A CN201610247425 A CN 201610247425A CN 105770074 A CN105770074 A CN 105770074A
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parts
radix
chinese medicine
prepares
distillation
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吴世德
徐传彬
吴维群
刘杰
陈俊亮
龙玉波
徐吉军
王艳梅
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SHANDONG MINGREN FURUIDA PHARMACEUTICAL Co Ltd
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SHANDONG MINGREN FURUIDA PHARMACEUTICAL Co Ltd
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Abstract

The invention relates to a traditional Chinese medicine composition for treating wind-heat common cold and a preparation method thereof. The traditional Chinese medicine composition is prepared from radix puerariae, radix puerariae, honeysuckle flowers, fructus forsythiae, herba artemisiae annuae, radix scutellariae, folium mori, radix peucedani, radix platycodonis, bitter apricot seeds and menthol. The invention further relates to application of the traditional Chinese medicine composition in preparing medicine for treating wind-heat common cold. Pungent dispersing and cool relieving is mainly adopted in the traditional Chinese medicine composition, and heat clearing, and exterior syndrome relieving and antipyretic detoxification are supplemented; the traditional Chinese medicine is an effective prescription for treating wind-heat common cold and hyperthermia epidemic toxin and can also relieve cough and reduce sputum. Pharmacodynamic experiments show that the traditional Chinese medicine preparation has obvious antibacterial and antiviral effects in in-vitro experiments, animal experiments show that the traditional Chinese medicine preparation has the effects of bringing down a fever, relieving a cough, enhancing organism nonspecific immunity and resisting inflammation, the defects that similar products are single in function and have large toxic and side effects are overcome, and the curative effect of treating complications of the wind-heat type common cold is definite.

Description

A kind of Chinese medicine composition treating anemopyretic cold and preparation method thereof
Technical field
The present invention relates to a kind of Chinese medicine composition treating anemopyretic cold and preparation method thereof, belong to technical field of Chinese medicine.
Background technology
Anemopyretic cold is one of most common disease of the mankind, serious harm human health, multiple is born in spring, summer.Spring is windy, and weather turns temperature, therefore wind is heterogeneous double pathogenic with the heresy of warm;Summer, outdoor was sultry, and indoor are comparatively nice and cool again, the indoor and outdoor fluctuation of temperature, also easily ill.The heresy invasion and attack lung of wind heat is defended, and causes and defends table discord, impairment of purifying function of the lung and cause anemopyretic cold, Symptoms is heating weight, micro evil wind, distending pain in the head, have antiperspirant, red swelling and pain of throat, cough, expectorant is glutinous or yellow, yellow thick nasal discharge of having a stuffy nose, thirst and liking drink, the tip of the tongue limit are red, the micro-Huang of white and thin fur." General Treatise on the Cause and Symptoms of Diseases wind heat time ": " wind heat patient, the gas of wind heat first enter lung also from fur.Lung is the five internal organs upper cover, waits the fur of body, if the skin natural fibre line of meat is empty, then and the gas of wind heat, first hinder fur, be into lung also.Its shape makes people's aversion to wind shiver with cold, and order is intended to de-, and tears saliva goes out." control suitable relieving the exterior syndrome with drugs of pungent in flavor and cool in nature, disperse wind heat."Nei Jing" point out the disease to wind heat treatment " wind is excessive in interior, controls with pungent cool, help with hardship sweet;Heat is excessive in interior, controls with salty-cold, and assistant is with sweetness and bitterness "; we's card is that heresy of wind heat is outer attacks, and distemper heresy poison occupy flesh table therefore heating, evil poison is altered, has a headache; evil drug-pedlar's lung, impairment of dispersing and descending function of the lung are then had a stuffy nose, coughed, stop up in swallowing then laryngopharynx swelling and pain in the heresy of wind heat, and heresy is strongly fragrant in skin, and strongly fragrant resistance venation then extremity are indolent and listless.We follow old maxim, and treatment wind heat diseases caused by exogenous pathogenic factor, with pungent and cold medicine for relieving the exterior syndrome, are that Xin Liang is equipped with the sweet cold of heat-clearing and toxic substances removing, and play the merit of clearing away heat and expelling pathogen in the exterior altogether.
In correlation technique, the medicine used by treatment flu is chemical drugs and antibiotic mostly, although its curative effect is very fast, but toxic and side effects is big, and long-term taking body is easily generated drug resistance.At the Chinese prescription of existing treatment wind heat disease flu, such as decoction for dispelling pathogens from superficial muscles, Yinqiao Mixture etc..Generally only having bacteriostasis or anti-virus ability in street drug, when treatment anemopyretic cold, therapeutical effect is single, lacks harmony, and a series of complication that anemopyretic cold is brought do not have clear and definite effect.
Chinese patent literature CN1425449A (application number 03100188.2) discloses a kind of Chinese medicine composition treating anemopyretic cold and preparation method thereof.Said composition is made up of Radix Bupleuri, Flos Lonicerae, Radix Scutellariae, Radix Puerariae, Herba Schizonepetae, Herba Artemisiae Annuae, Fructus Forsythiae, Radix Platycodonis, Semen Armeniacae Amarum, Herba Menthae, Herba Houttuyniae.Although the party is with Radix Bupleuri, Flos Lonicerae for monarch drug, being aided with Radix Scutellariae, Radix Puerariae etc. is ministerial drug, but other all medicine sending down the abnormal ascending QI dispersing lung-QI and dissipating phlegm are not enough, thus have impact on curative effect.
Summary of the invention
It is an object of the invention to provide a kind of Chinese medicine composition treating anemopyretic cold and preparation method thereof, overcome existing treatment coldrex above shortcomings.
Chinese medicine composition of the present invention has the advantages such as rapid-action, evident in efficacy, therapeutical effect scope wide, has no side effect, and has the advantages such as efficient, energy-conservation, effective ingredient destruction is few according to constitutive property in conjunction with the preparation method that lot of documents is established.
A kind of Chinese medicine composition treating anemopyretic cold, raw material medicines in portions by weight is composed as follows:
Radix Puerariae 10-50 part, Radix Bupleuri 10-50 part, Flos Lonicerae 10-40 part, Fructus Forsythiae 5-40 part, Herba Artemisiae Annuae 5-40 part, Radix Scutellariae 5-40 part, Folium Mori 5-50 part, Radix Peucedani 10-50 part, Radix Platycodonis 5-30 part, Semen Armeniacae Amarum 5-30 part, Mentholum 0.01-1 part.
Preferably, raw material medicines in portions by weight is composed as follows:
Radix Puerariae 10-30 part, Radix Bupleuri 15-40 part, Flos Lonicerae 10-20 part, Fructus Forsythiae 10-30 part, Herba Artemisiae Annuae 10-30 part, Radix Scutellariae 10-30 part, Folium Mori 10-30 part, Radix Peucedani 10-40 part, Radix Platycodonis 10-20 part, Semen Armeniacae Amarum 10-20 part, Mentholum 0.01-0.5 part.
Further, providing a preferred embodiment here, raw material medicines in portions by weight is composed as follows:
Radix Puerariae 20 parts, Radix Bupleuri 20 parts, Flos Lonicerae 15 parts, Fructus Forsythiae 15 parts, Herba Artemisiae Annuae 15 parts, Radix Scutellariae 15 parts, 10 parts of Folium Mori, Radix Peucedani 15 parts, Radix Platycodonis 10 parts, Semen Armeniacae Amarum 10 parts, Mentholum 0.03 part.
Further, providing another preferred embodiment here, raw material medicines in portions by weight is composed as follows:
Radix Puerariae 16 parts, Radix Bupleuri 24 parts, Flos Lonicerae 12 parts, Fructus Forsythiae 10 parts, Herba Artemisiae Annuae 16 parts, Radix Scutellariae 20 parts, 15 parts of Folium Mori, Radix Peucedani 12 parts, Radix Platycodonis 15 parts, Semen Armeniacae Amarum 10 parts, Mentholum 0.02 part.
Further, providing the 3rd preferred embodiment here, raw material medicines in portions by weight is composed as follows:
Radix Puerariae 20 parts, Radix Bupleuri 18 parts, Flos Lonicerae 16 parts, Fructus Forsythiae 16 parts, Herba Artemisiae Annuae 16 parts, Radix Scutellariae 12 parts, 12 parts of Folium Mori, Radix Peucedani 12 parts, Radix Platycodonis 10 parts, Semen Armeniacae Amarum 12 parts, Mentholum 0.04 part.
In above-mentioned each component:
Radix Puerariae, for the dry root of legume pueraria lobata Puerarialobata (willd) Ohwi or Radix Puerariae rattan PuerariathomsoniiBenth..Effect expelling pathogenic factors from muscles for reducing heat, delivers rash, promoting the production of body fluid to quench thirst, yang invigorating antidiarrheal.Curing mainly fever caused by exogenous pathogens, pain of the head and nape is strong, and measles without adequate eruption, epidemic febrile disease is thirsty, quenches one's thirst, and has loose bowels, dysentery, alcoholism, obstruction of qi in the chest and cardialgia.
Radix Bupleuri, for the dry root of umbelliferae bupleurum BupleurumchinenseDC. or Radix Bupeuri Scorzonerfolii. BupleurumscorzonerifoliumWilld..Effect clearing away heat and expelling pathogen in the exterior, treating SHAO YANG disease by mediation, dispersing the stagnated live-QI to relieve the stagnation of QI, ascending up spleen-Qi and Yang.Cure mainly fever caused by exogenous pathogens, alternate attack of chill and fever, malaria, jaundice, distending pain in the chest and hypochondrium, conjunctival congestion of having a headache, deaf bitter taste, have through uncomfortable, visceroptosis, the proctoptosis prolapse of the uterus.
Flos Lonicerae, for dry flower or the first flower opened of band of caprifoliaceae plant Radix Ophiopogonis (LonicerajaponicaThunb.), Flos Lonicerae (LonicerahypoglaucaMiq.), Flos Lonicerae (LoniceraconfusaDC.) or hair style Radix Ophiopogonis (LoniceradasystylaRehd.).Effect heat-clearing and toxic substances removing, dispelling wind and heat pathogens.For carbuncle furuncle, sore throat, erysipelas, toxic-heat and blood stasis, anemopyretic cold, the disease such as epidemic febrile disease heating, laryngopharynx swelling and pain.
Fructus Forsythiae, for the dry fruit of Oleaceae plants Fructus Forsythiae (Forsythiasuspense (Thunb.) Vahl).Effect heat-clearing and toxic substances removing, dispersing swelling and dissipating binds.Curing mainly affection due to external wind and heat, epidemic febrile disease epidemic disease, carbuncle sore tumefacting virus, scrofula goiter, sore throat swells and ache, stranguria with urinary obstruction, deaf.
Herba Artemisiae Annuae, for the dry aerial parts of feverfew Herba Artemisiae annuae ArtemisiaannuaL..Effect clearing deficient heat, clearing away summer-heat preventing the attack (or recurrence) of malaria, dehumidify parasite killing.Curing mainly deficiency of YIN hectic fever hectic fever due to YIN-deficiency, outer temperature-sensing thermal heat-damp in summer, the head swoons, malaria, jaundice, dysentery, scabies, skin pruritus.
Radix Scutellariae, for the dry root of labiate Radix Scutellariae ScutellariabaicalensisGeorgi.Heat clearing and damp drying, eliminating fire and detoxication, hemostasis, antiabortive.Curing mainly retention of damp-heat in the interior, vomiting, dysentery, jaundice, pyretic stranguria, cough due to lung-heat coughs up phlegm, epidemic febrile disease heating excessive thirst, liver-fire headache conjunctival congestion, and carbuncle furuncle is told nosebleed and had blood in stool, metrostaxis, excessive fetal movement due to heat in pregnancy.
Folium Mori, for the dried leaves of moraceae plants Mulberry MorusalbaL..Effect dispelling wind and heat pathogens, clearing away lung-heat and moistening for dryness, liver heat removing and eyesight improving.Curing mainly anemopyretic cold, lung-heat type cough, dizziness headache, conjunctival congestion is dim-sighted.
Radix Peucedani, for the dry root of samphire Peucedanum praeruptorum DUNN PeucedanumpraeruptorumDunn.Effect lowering the adverse-rising QI to resolve phlegm, dissipates wind heat clearing away.Curing mainly expectorant dyspnea of heat type full, slightly expectorant Huang is thick, cough due to pathogenic wind-heat's abundant expectoration.
Radix Platycodonis, for the dry root of Campanulaceae Platycodongrandiflorum (Jacq.) A.DC.Effect lung qi dispersing eliminates the phlegm, therapeutic method to keep the adverse QI flowing downwards sore-throat relieving, eliminating carbuncle evacuation of pus.Curing mainly cough with copious phlegm, laryngopharynx swelling and pain, aphonia, fullness in the chest and hypochondriac pain, dysentery is suffered from abdominal pain, uroschesis, lung abscess vomiting pus.
Semen Armeniacae Amarum, for the dry mature seed of rosaceous plant Prunus armeniaca L.var.ansu Maxim. PrunusarmeniacaL.var.ansumaxim Siberia Fructus Pruni PrunussibiricaL., prunus mandshuricaKoehne Prunusmandshurica (Maxim) Koehne or Fructus Pruni PrunusarmeniacaL..Effect lung qi dispersing cough-relieving, lowering the adverse-rising QI to subdue asthma, loosening bowel to relieve constipation, parasite killing detoxifies.Cure mainly cough, dyspnea with rapid and short breath fullness in the chest, sore throat pharyngalgia, dryness of the intestine constipation, insect poison skin infection.
Mentholum, for a kind of saturated cyclic alcohol that fresh stem and Ye Jing steam distillation, freezing, the recrystallization of labiate Herba Menthae menthehaplocalyxBriq. obtains.
The prescription of the present invention is made up of Radix Puerariae, Radix Bupleuri, Flos Lonicerae, Fructus Forsythiae, Herba Artemisiae Annuae, Radix Scutellariae, Folium Mori, Radix Peucedani, Radix Platycodonis, Semen Armeniacae Amarum, Mentholum.
With Radix Puerariae, Radix Bupleuri pungent and cool drugs can disperse, dispelling wind to relieve the exterior syndrome in side, bring down a fever for monarch drug.It is aided with Flos Lonicerae, Fructus Forsythiae heat-clearing and toxic substances removing, gently declares expelling pathogenic factors from the exterior to be ministerial drug.Induce sweat with Antifebrile Action of Herba Artemisiae, Radix Scutellariae clearing away lung-heat, Herba Menthae Folium Mori relieving sore-throat by clearing away heat, dispersing lung-QI and dissipating phlegm, Radix Peucedani lowering the adverse-rising QI to resolve phlegm, dispelling wind-heat, Semen Armeniacae Amarum lung qi dispersing cough-relieving, and it is adjuvant drug, Radix Platycodonis resolving toxin and disinhibiting the throat, priming up and for making medicine, full side is equipped with heat-clearing and toxic substances removing, sore-throat relieving, cough-relieving with pungent scattered pathogenic factor in the exterior medicine.Play clearing away heat and expelling pathogen in the exterior, relieving cough and resolving phlegm altogether.
Full side dissipates cool solution for main specially with clearing away heat and expelling pathogen in the exterior with pungent, antipyretic and detoxicated, and for controlling effective good recipe of affection due to external wind and heat, warm epidemic disease poison, also holding concurrently can relieving cough and resolving phlegm.
The application in preparation treatment anemopyretic cold medicine of the Chinese medicine composition of above-mentioned treatment anemopyretic cold.
According to currently preferred, the dosage form of above-mentioned treatment anemopyretic cold medicine is tablet, granule, capsule, oral liquid or mixture.
The preparation method of a kind of oral liquid treating anemopyretic cold, comprises the steps:
(1) take Semen Armeniacae Amarum in proportion and pulverize, then after mixing with Radix Bupleuri, Flos Lonicerae, Fructus Forsythiae, Herba Artemisiae Annuae, Folium Mori, soak, reheat distillation, collect distillate and carry out redistillation, prepare re-distilled liquid and redistillation raffinate, the remaining mixture after distillation is carried out solid-liquid separation, prepare the medicinal residues after distillation and remaining distillate;
(2), after the medicinal residues after distillation step (1) prepared mix with Radix Puerariae, Radix Scutellariae, Radix Peucedani, Radix Platycodonis, boiling, after solid-liquid separation; the remaining distillate that liquid prepares with step (1) merges; filter, concentration, prepare condensed cream;
(3) condensed cream that step (2) prepares is mixed with ethanol, stir evenly, cold preservation, take supernatant, reclaim ethanol, concentration, prepare precipitate with ethanol condensed cream;
(4) re-distilled liquid that precipitate with ethanol condensed cream step (3) prepared prepares with step (1) mixes, and adds Mentholum, to obtain final product.
According to currently preferred, after described step (4) adds Mentholum, also include adding correctives and preservative, add the redistillation raffinate constant volume that step (1) prepares, stir evenly, cold preservation, filter, adjust pH value, fill, sterilizing, lamp inspection, packaging step.
According to currently preferred, the preparation method of described oral liquid, step is as follows:
(1) take Semen Armeniacae Amarum in proportion and pulverize, then after mixing with Radix Bupleuri, Flos Lonicerae, Fructus Forsythiae, Herba Artemisiae Annuae, Folium Mori, soak, reheat distillation, the distillate collecting 3-5 times of quality of crude drug carries out redistillation, prepare re-distilled liquid and the redistillation raffinate of 2 times of quality of crude drug, the remaining mixture after distillation is carried out solid-liquid separation, prepare the medicinal residues after distillation and remaining distillate;
(2) after the medicinal residues after distillation step (1) prepared mix with Radix Puerariae, Radix Scutellariae, Radix Peucedani, Radix Platycodonis; boiling secondary; 1-4 hour first time; second time 0.5-4 hour; after solid-liquid separation, the remaining distillate that liquid prepares with step (1) merges, and filters; concentrating under reduced pressure, prepares condensed cream;
(3) condensed cream that step (2) prepares is mixed with ethanol, stir evenly, cold preservation 24 hours, take supernatant, decompression recycling ethanol, concentrating under reduced pressure, prepare precipitate with ethanol condensed cream;
(4) re-distilled liquid that precipitate with ethanol condensed cream step (3) prepared prepares with step (1) mixes, add Mentholum, correctives and preservative, add the redistillation raffinate constant volume that step (1) prepares, stir evenly, cold preservation 24 hours, filter, adjust pH value, fill, sterilizing, lamp inspection, packs and get final product.
According to currently preferred, in described step (1), the amount of water soaked is 10 times of the weight of the crude drug soaked, and soak time is 1 hour;When adding thermal distillation, the distillate collecting 4 times of quality of crude drug carries out redistillation.
According to currently preferred, in described step (2), boiling secondary, first time adds the water of 10 times of quality, decocts 2 hours, and second time adds the water of 8 times of quality, decocts 1 hour;Being evaporated to relative density is 1.12~1.13, and reference density is water, and detection temperature is 50~60 DEG C;
According to currently preferred, in described step (3), amount of alcohol added is 2 times of condensed cream quality;Being evaporated to relative density is 1.13~1.14, and reference density is water, and detection temperature is 50~60 DEG C.
According to currently preferred, in described step (4), correctives is steviosin, and addition is 1.5~2.5mg/ml, and preservative is sodium benzoate, and addition is 2~4mg/ml, and adjusting pH value is 6.0~7.5.
Above-mentioned preparation process all can adopt the usual operating conditions of this area as vapo(u)rizing temperature etc. does not add the condition of restriction.
The technical characterstic of preparation method:
The extraction of volatile ingredient: owing to the volatile ingredient (HCN such as trace) in some component is dissolved in water, therefore adopt distilling with water method to extract this some volatile compounds, collect a certain amount of distillate.For fully distilling out the volatile ingredient in the medical material tissues such as Radix Bupleuri, first medical material is added 10 times amount water soaking 1 hour, so as to thoroughly run through, then begin to warm up distillation.Liquid volume collection to be distilled is to when being approximately equivalent to crude drug 4 times amount, and distillate only has faint abnormal smells from the patient, therefore distillate carries out redistillation, collects the re-distilled liquid being equivalent to crude drug 2 times amount, and remaining distillate uses when remaining dosing.
Decocting time and concentration: by with paste-forming rate for index, comparing the different decocting time impact on extraction effect by experiment, portion presses component parts by weight, and add water 10 times amount for the first time, and add water 8 times amount for the second time, decocts 4 hours respectively, merges twice decocting liquid;Another part of first time adds water 10 times amount, decocts 2 hours, and second time adds water 8 times amount, decocts 1 hour, merges twice decocting liquid;Decocting liquid filters, and takes equivalent, puts and be evaporated in water-bath, puts and be dried to constant weight in baking oven, calculates paste-forming rate.The paste-forming rate respectively 29.76%, 28.86% of result two parts experiment, both are more or less the same, and illustrate that extraction effect is suitable.The extracting method of second part, had both shortened man-hour, had improve production efficiency, decreases again energy consumption, and does not affect decoction effect.Water boiling and extraction liquid selects concentrating under reduced pressure, and alcohol deposit fluid selects concentrating under reduced pressure, and thickening temperature is low, and effective ingredient destroys few, at utmost retains effective ingredient, improves again production efficiency simultaneously, shortens man-hour, decrease energy consumption, reached the beneficial effect achieved many things at one stroke.
The determination of alcohol adding amount during precipitate with ethanol: while with each component effective ingredient of water boiling and extraction, also extracted inert matter, such as starch, fatty oil, resin, tannin etc., also have a large amount of particle suspensions in medicinal liquid, remove these compositions, with purification medicinal liquid, reduce dose.We have investigated the different alcohol adding amounts action effect on removing these invalid components and the impact on index components content by experiment, determine ethanol consumption most widely suited with 2 times of concentrated solution volume, now index components content is the highest, and medicinal liquid clarity is best.
Dosing and Cryoprecipitation: take precipitate with ethanol condensed cream and add above-mentioned re-distilled liquid, Mentholum (dissolving with a small amount of ethanol), correctives and preservative, adjust medicinal liquid total amount to enough with remaining distillate after redistillation, stir evenly.The amount being divided into due to volatility is relatively fewer, and it can be had the molten effect of certain rib by other compositions in medicinal liquid, so not finding oil-water separation phenomenon, therefore need not add cosolvent and can be prepared by uniformly for medicinal liquid.For ensureing the clarity of product, therefore by the medicinal liquid deepfreeze 24 hours after preparation, filter.
The adjustment of medicinal liquid pH value: record the pH value of medicinal liquid after dosing about 5.0, owing to this product contains more flavones ingredient, when pH value is relatively low, dissolubility reduces, and is long placed in easily Precipitation from medicinal liquid, affect clarity and the drug effect of finished product, thus the pH value of reply this product is adjusted, preferably.Test result indicate that: medicinal liquid pH value before sterilization adjusts between 6.0-7.5, after sterilizing, clarity is good, meets the requirements.
The selection of correctives: the preparation bitterness that this product component is made is heavier, should add sweeting agent and correct its taste.Owing to steviosin has the advantages such as consumption is few, sugariness is big, calorific value is low compared with sucrose, according to result of the test, select appropriate steviosin so that composition more palatable sweetness and bitterness is moderate, easy for patients to accept.
The selection of preservative: for preventing growing of microorganism, it is ensured that the quality of formulation products, should adding appropriate preservative, we have selected sodium benzoate, investigates through the room temperatures of 6 months, and result is respond well.
The invention have the benefit that
1, Chinese medicine composition of the present invention dissipates cool solution based on pungent, and specially with clearing away heat and expelling pathogen in the exterior, antipyretic and detoxicated, for controlling effective good recipe of affection due to external wind and heat, warm epidemic disease poison, also holding concurrently can relieving cough and resolving phlegm.Pharmacodynamics test shows: the Chinese medicine preparation experiment in vitro of the present invention all presents significantly antibacterial, antivirus action, zoopery show this product also have bring down a fever, cough-relieving, enhancing body nonspecific immunity and antiinflammatory action, overcome the shortcoming that like product effect is single, toxic and side effects is big, and to the complication determined curative effect that treatment anemopyretic cold brings.
2, oral liquid prepared by the present invention is adopted, grope to obtain by the production experience that inventor is long-term, take into full account the effective ingredient of each component, subsequently through substantial amounts of experimental study, at utmost to retain effective ingredient, both improve production efficiency, shortened man-hour, reduce again energy consumption, achieve the combination of comprehensive Social benefit and economic benefit.
Detailed description of the invention
Below in conjunction with embodiment, technical scheme is described further, but institute of the present invention protection domain is not limited to this.
Embodiment 1
A kind of Chinese medicine composition treating anemopyretic cold, raw material medicines in portions by weight is composed as follows:
Radix Puerariae 20 parts, Radix Bupleuri 20 parts, Flos Lonicerae 15 parts, Fructus Forsythiae 15 parts, Herba Artemisiae Annuae 15 parts, Radix Scutellariae 15 parts, 10 parts of Folium Mori, Radix Peucedani 15 parts, Radix Platycodonis 10 parts, Semen Armeniacae Amarum 10 parts, Mentholum 0.03 part.
The preparation method of the oral liquid of the Chinese medicine composition of described treatment anemopyretic cold, step is as follows:
(1) take Semen Armeniacae Amarum in proportion and pulverize, then after mixing with Radix Bupleuri, Flos Lonicerae, Fructus Forsythiae, Herba Artemisiae Annuae, Folium Mori, add the water soaking 1 hour of 10 times of quality, boil again and add thermal distillation, the distillate collecting 4 times of quality of crude drug carries out boiling redistillation, prepare re-distilled liquid and the redistillation raffinate of 2 times of quality of crude drug, the remaining mixture after distillation is carried out solid-liquid separation, prepare the medicinal residues after distillation and remaining distillate;
(2) after the medicinal residues after distillation step (1) prepared mix with Radix Puerariae, Radix Scutellariae, Radix Peucedani, Radix Platycodonis, boiling secondary, first time adds 10 times amount water; decoct 2 hours; second time adds 8 times amount water, decocts 1 hour, after solid-liquid separation; the remaining distillate that liquid prepares with step (1) merges; filter, be evaporated to relative density and be 1.12 (detection temperature is 50~60 DEG C, and reference density is water; lower same), prepare condensed cream;
(3) condensed cream step (2) prepared and the ethanol mixing of 2 times of quality, stir evenly, cold preservation 24 hours, take supernatant, decompression recycling ethanol, and being evaporated to relative density is 1.13, prepares precipitate with ethanol condensed cream;
(4) re-distilled liquid that precipitate with ethanol condensed cream step (3) prepared prepares with step (1) mixes, and adds Mentholum, steviosin and sodium benzoate, and steviosin addition is 2mg/ml, sodium benzoate addition is 3mg/ml, add the redistillation raffinate constant volume that step (1) prepares, stir evenly, cold preservation 24 hours, filter, adjusting pH value is 6.5, fill, sterilizing, lamp inspection, packs and get final product.
Embodiment 2
A kind of Chinese medicine composition treating anemopyretic cold, raw material medicines in portions by weight is composed as follows:
Radix Puerariae 16 parts, Radix Bupleuri 24 parts, Flos Lonicerae 12 parts, Fructus Forsythiae 10 parts, Herba Artemisiae Annuae 16 parts, Radix Scutellariae 20 parts, 15 parts of Folium Mori, Radix Peucedani 12 parts, Radix Platycodonis 15 parts, Semen Armeniacae Amarum 10 parts, Mentholum 0.02 part.
The preparation method of the granule of the Chinese medicine composition of described treatment anemopyretic cold, step is as follows:
(1) take Semen Armeniacae Amarum in proportion and pulverize, then after mixing with Radix Bupleuri, Flos Lonicerae, Fructus Forsythiae, Herba Artemisiae Annuae, Folium Mori, add the water soaking 1 hour of 6 times of quality, boil again and add thermal distillation, the distillate collecting 3 times of quality of crude drug carries out boiling redistillation, prepare re-distilled liquid and the redistillation raffinate of 1 times of quality of crude drug, the remaining mixture after distillation is carried out solid-liquid separation, prepare the medicinal residues after distillation and remaining distillate;
(2) after the medicinal residues after distillation step (1) prepared mix with Radix Puerariae, Radix Scutellariae, Radix Peucedani, Radix Platycodonis; boiling secondary; first time adds 8 times amount water, decocts 4 hours, and second time adds 6 times amount water; decoct 2 hours; after solid-liquid separation, the remaining distillate that liquid prepares with step (1) merges, and filters; being evaporated to relative density is 1.13, prepares condensed cream;
(3) condensed cream step (2) prepared and the ethanol mixing of 1.5 times of quality, stir evenly, cold preservation 24 hours, take supernatant, decompression recycling ethanol, and being evaporated to relative density is 1.14, prepares precipitate with ethanol condensed cream;
(4) re-distilled liquid that precipitate with ethanol condensed cream step (3) prepared prepares with step (1) mixes, and adds Mentholum, is directly processed into granule through normal process steps.
Embodiment 3
A kind of Chinese medicine composition treating anemopyretic cold, raw material medicines in portions by weight is composed as follows:
Radix Puerariae 20 parts, Radix Bupleuri 18 parts, Flos Lonicerae 16 parts, Fructus Forsythiae 16 parts, Herba Artemisiae Annuae 16 parts, Radix Scutellariae 12 parts, 12 parts of Folium Mori, Radix Peucedani 12 parts, Radix Platycodonis 10 parts, Semen Armeniacae Amarum 12 parts, Mentholum 0.04 part.
The preparation method of the hard capsule of the Chinese medicine composition of described treatment anemopyretic cold, step is as follows:
(1) take Semen Armeniacae Amarum in proportion and pulverize, then after mixing with Radix Bupleuri, Flos Lonicerae, Fructus Forsythiae, Herba Artemisiae Annuae, Folium Mori, add the water soaking 0.5 hour of 8 times of quality, boil again and add thermal distillation, the distillate collecting 4 times of quality of crude drug carries out boiling redistillation, prepare re-distilled liquid and the redistillation raffinate of 1.5 times of quality of crude drug, the remaining mixture after distillation is carried out solid-liquid separation, prepare the medicinal residues after distillation and remaining distillate;
(2) after the medicinal residues after distillation step (1) prepared mix with Radix Puerariae, Radix Scutellariae, Radix Peucedani, Radix Platycodonis; boiling secondary; first time adds 10 times amount water, decocts 3 hours, and second time adds 8 times amount water; decoct 1.5 hours; after solid-liquid separation, the remaining distillate that liquid prepares with step (1) merges, and filters; being evaporated to relative density is 1.13, prepares condensed cream;
(3) condensed cream step (2) prepared and the ethanol mixing of 2 times of quality, stir evenly, cold preservation 24 hours, take supernatant, decompression recycling ethanol, and being evaporated to relative density is 1.14, prepares precipitate with ethanol condensed cream;
(4) re-distilled liquid that precipitate with ethanol condensed cream step (3) prepared prepares with step (1) mixes, and adds Mentholum, is directly processed into hard capsule through normal process steps.
Comparative example
A kind of Chinese medicine composition treating anemopyretic cold, raw material medicines in portions by weight is composed as follows: (in Chinese patent literature CN1425449A shown in embodiment)
Radix Bupleuri 100 parts, Flos Lonicerae 75 parts, Radix Scutellariae 60 parts, Radix Puerariae 50 parts, Herba Schizonepetae 50 parts, Herba Artemisiae Annuae 75 parts, Fructus Forsythiae 75 parts, Semen Armeniacae Amarum 50 parts, Herba Menthae 75 parts, Herba Houttuyniae 75 parts, Radix Platycodonis 50 parts.
(1) take Semen Armeniacae Amarum in proportion and pulverize, then after mixing with Radix Bupleuri, Flos Lonicerae, Herba Artemisiae Annuae, Fructus Forsythiae, Herba Schizonepetae, Herba Menthae, Herba Houttuyniae, add the water soaking 1 hour of 10 times of quality, boil again and add thermal distillation, the distillate collecting 4 times of quality of crude drug carries out boiling redistillation, prepare re-distilled liquid and the redistillation raffinate of 2 times of quality of crude drug, the remaining mixture after distillation is carried out solid-liquid separation, prepare the medicinal residues after distillation and remaining distillate;
(2) after the medicinal residues after distillation step (1) prepared mix with Radix Scutellariae, Radix Puerariae, Radix Platycodonis; boiling secondary; first time adds 10 times amount water, decocts 2 hours, and second time adds 8 times amount water; decoct 1 hour; after solid-liquid separation, the remaining distillate that liquid prepares with step (1) merges, and filters; being evaporated to relative density is 1.12, prepares condensed cream;
(3) condensed cream step (2) prepared and the ethanol mixing of 2 times of quality, stir evenly, cold preservation 24 hours, take supernatant, decompression recycling ethanol, and being evaporated to relative density is 1.13, prepares precipitate with ethanol condensed cream;
(4) re-distilled liquid that precipitate with ethanol condensed cream step (3) prepared prepares with step (1) mixes, and adds Mentholum, steviosin and sodium benzoate, and steviosin addition is 2mg/ml, sodium benzoate addition is 3mg/ml, add the redistillation raffinate constant volume that step (1) prepares, stir evenly, cold preservation 24 hours, filter, adjusting pH value is 6.5, fill, sterilizing, lamp inspection, packs and get final product.
Experimental example clinical trial
One, diagnostic criteria (reference " new Chinese medicine guideline of clinical investigations " first volume)
1, tcm diagnosis standard
(1) heating, aversion to cold, watery nasal discharge, sneeze.
All have when (2) four, more than winter, often fall ill because of weather cataclysm.
(3) have cough, laryngopharynx swelling and pain concurrently more.
(4) General Symptoms is heavier, in popularity person, for time row diseases caused by exogenous pathogenic factor.
Possess above-mentioned (1) or (4) item, in conjunction with (2) and (3) item, can make a definite diagnosis.
2, Standards of Chinese Medical Syndrome Differentiation
Wind-heat syndrome: heating weight, aversion to cold is light, have antiperspirant, headache, nasal obstruction, the turbid tears of stream, sneeze, cough, yellow thick, red swelling of the pharynx pain, the xerostomia of spitting and thirsty, red tongue or limit point are red, white and thin fur or BOHUANG, floating and rapid pulse.
3, cardinal symptom weight classification:
By cardinal symptom by heavy, medium and light, nothing (or disappearance) 3 points respectively, 2 points, 1 point, 0 point.
(1) heating: weight (3 points): fever of the body is obvious, and body temperature is more than 39.1 DEG C;
In (2 points): fever of the body is heavier, and body temperature is more than 38.1~39 DEG C;
Gently (1 point): fever of the body is slight, and body temperature is less than 38 DEG C;
(2) aversion to cold: weight (3 points): aversion to cold is obvious, or shiver with cold;
In (2 points): micro evil wind tremble with fear;
Gently (1 point): slight aversion to wind and cold of suddenly feeling;
(3) sweating: weight (3 points): whole body sweating;
In (2 points): micro-have sweating;
Gently (1 point): even have sweating;
(4) headache: weight (3 points): headache is as split, it is difficult to stand;
In (2 points): distending pain in the head;
Gently (1 point): slight headache, or two temple pain;
(5) whole body is uncomfortable: weight (3 points): whole-body muscle joint aches, lazy dynamic;
In (2 points): limbs joint is ached;
Gently (1 point): podomere is micro-aching and limp discomfort;
(6) nasal obstruction watery nasal discharge: weight (3 points): have a stuffy nose obstructed, flow turbid tears sticky;
In (2 points): BITONG gas is smooth, time flow turbid tears;
Gently (1 point): mild nasal congestion, ventilating micro-has smooth, occasionally has turbid tears;
(7) cough: weight (3 points): cough frequency is acute, coughs sound loud, high-pitched sound mute, coughs up phlegm, yellow viscous;
In (2 points): cough constantly;
Gently (1 point): even have cough, cough up phlegm few;
(8) pharyngalgia: weight (3 points): throat tonsillitis congestion and swelling pain is obvious, swallows even swallow to increase the weight of to hinder;
In (2 points): throat tonsillitis is swollen and ache, breast I ° of enlargement, diet is harmless;
Gently (1 point): the micro-sense pain of throat, or sense of discomfort, tonsillitis is without enlargement;
4, Western medicine diagnose standard and typing:
Primary disease will easily make diagnosis according to the primary symptom such as heating, cough, nasal obstruction, watery nasal discharge, sneeze.Its state of an illness weight is divided into three types:
Light-duty: heating, body temperature lower than 38 DEG C, wake tears, sneeze, headache, can have slight cough, hoarseness, pharyngalgia, pharyngeal hyperemia, tonsil silght enlargement, hyperemia.
Medium-sized: to generate heat 38~39 DEG C, wake tears, sneeze, nasal obstruction, headache, can there be Mild cough, hoarseness, pharyngeal hyperemia, antiadoncus, retropharyneal folliculosis, general malaise, loss of appetite.
Heavy: to generate heat more than 39 DEG C, companion's general malaise, spirit is poor, inappetence, aversion to cold, headache, cough and sniffle are heavier, can have hoarseness, pharyngalgia, pharyngeal hyperemia substantially, antiadoncus, soft palate, visible canescence bubble rash or ulcer on staphyleus mucosa, it is seen that conjunctival congestion, edema or folliculus etc..
Two, test case standard:
1, case standard is included in:
Meet above-mentioned Chinese and western medicine diagnostic criteria and Standards of Chinese Medical Syndrome Differentiation.The course of disease is less than 3.Select light medium-sized patient.
2, queuing case standard:
(1) there is complication and with the severe total disease patients such as other cardiovascular, liver, kidney and hemopoietic system, psychotic, those who are allergic to this drug.
(2) patient such as suppurative tonsillitis, bronchitis, bronchiolitis, pneumonia.
(3) age is under-18s, over-65s person.
(4) once disappearance person was started by antibiotic, antipyretic, sign before treatment.
(5) do not meet inclusive criteria, do not adhere to taking medicine, dosing is changed dressings in midway, it is impossible to judge that curative effect or data are not congruent and affect the treatment or safety judgement person.
Three, Therapeutic Method:
1, adopt random table packet, set up treatment group and matched group;
2, medication:
(1) treatment group: the oral liquid of the oral embodiment 1 of patient, 10ml of dose, 3 times on the one, serve on 5 days;
(2) matched group: the oral liquid of patient's oral contrast example, 20ml of dose, 3 times on the one, it serve on 5 days;
(3), during Ureteral Calculus, antibiotic must not be applied and other move back medicine medicine etc..
Four, observation index:
1, safety observation
(1) general health check-up project;
(2) blood, routine urinalysis, urine three gallbladder are chemically examined;
2, health giving quality observation
(1) symptom: heating, aversion to cold, sniffle, cough, pharyngeal symptom, systemic conditions;
(2) sign: body temperature, pharynx, tonsil inspection, picture of the tongue, pulse condition etc..
(3) laboratory routine examination: total hemocytes count and differential counting.
Five, curative effect determinate standard:
1, anemopyretic cold curative effect determinate standard
(1) recovery from illness: take medicine in 24~48 hours, temperature recovery normal (axil temperature drop, to less than 37 DEG C, no longer gos up), syndrome disappears, and abnormal physical and chemical index recovers normal;
(2) effective: taking medicine in 24~48 hours, temperature recovery is normal;Main syndromes major part disappears, and abnormal physical and chemical index is close to normal;
(3) effective: taking medicine in 48~72 hours, temperature recovery is normal;Main syndromes partial disappearance, abnormal physical and chemical index makes moderate progress;
(4) invalid: not meet above standard person.
2, cardinal symptom curative effect determinate standard
(1) disappear: Sx disappears;
(2) improve: Sx score reduces by more than 1 point (containing 1 point);
(3) unchanged: Sx score is unchanged;
(4) increase the weight of: Sx score increases by more than 1 point;
Six, clinical trial:
1. treatment group: the Chinese medicinal composition preparation treatment anemopyretic cold of the application embodiment of the present invention 1, oral test medicine, treatment cycle is 5 days.Treating in 242 example anemopyretic cold patients altogether, male patient 136 example, female patient 106 example, the age is between 18 years old~65 years old.Fully recover 46 examples, cure rate 19.0%;Effective 95 examples, obvious effective rate 39.3%;Effective 85 examples, effective percentage 35.1%;Invalid 16 examples, inefficiency 6.6%.Total effective rate is 93.4%.
2. matched group: applying the Chinese medicinal composition preparation treatment anemopyretic cold of comparative example of the present invention, oral comparison medicine, treatment cycle is 5 days.Treating in 155 example anemopyretic cold patients altogether, male patient 86 example, female patient 69 example, the age is between 18 years old~65 years old.Fully recover 23 examples, cure rate 14.8%;Effective 50 examples, obvious effective rate 32.3%;Effective 62 examples, effective percentage 40.0%;Invalid 20 examples, inefficiency 12.9%.Total effective rate is 87.1%.
Statistical result shows: treatment group and matched group significant difference.Clinical trial shows: Chinese medicine composition of the present invention is that one has clearing away heat and expelling pathogen in the exterior, the Chinese medicine preparation of relieving cough and resolving phlegm, this medicine reasonable compatibility, complementary collaborative, dialectical treatment, can be used for the anemopyretic cold caused by affection due to external wind and heat, disease sees fever and aversion to wind, headache nasal obstruction, laryngopharynx swelling and pain, cough, the whole body is uncomfortable, and effect is notable.
It should be noted that above-mentioned specific embodiment is illustrative of, under the above-mentioned instruction of the present invention, those skilled in the art can carry out various improvement and deformation on the basis of above-described embodiment, and these improve or deformation is within the scope of the present invention.
It will be understood by those skilled in the art that specific descriptions above are intended merely to the explanation purpose of the present invention, be not intended to limit the present invention.Protection scope of the present invention is limited by claim and equivalent thereof.

Claims (10)

1. treating a Chinese medicine composition for anemopyretic cold, raw material medicines in portions by weight is composed as follows:
Radix Puerariae 10-50 part, Radix Bupleuri 10-50 part, Flos Lonicerae 10-40 part, Fructus Forsythiae 5-40 part, Herba Artemisiae Annuae 5-40 part, Radix Scutellariae 5-40 part, Folium Mori 5-50 part, Radix Peucedani 10-50 part, Radix Platycodonis 5-30 part, Semen Armeniacae Amarum 5-30 part, Mentholum 0.01-1 part.
2. Chinese medicine composition as claimed in claim 1, it is characterised in that raw material medicines in portions by weight is composed as follows:
Radix Puerariae 10-30 part, Radix Bupleuri 15-40 part, Flos Lonicerae 10-20 part, Fructus Forsythiae 10-30 part, Herba Artemisiae Annuae 10-30 part, Radix Scutellariae 10-30 part, Folium Mori 10-30 part, Radix Peucedani 10-40 part, Radix Platycodonis 10-20 part, Semen Armeniacae Amarum 10-20 part, Mentholum 0.01-0.5 part.
3. Chinese medicine composition as claimed in claim 2, it is characterised in that raw material medicines in portions by weight is composed as follows:
Radix Puerariae 20 parts, Radix Bupleuri 20 parts, Flos Lonicerae 15 parts, Fructus Forsythiae 15 parts, Herba Artemisiae Annuae 15 parts, Radix Scutellariae 15 parts, 10 parts of Folium Mori, Radix Peucedani 15 parts, Radix Platycodonis 10 parts, Semen Armeniacae Amarum 10 parts, Mentholum 0.03 part;
Preferably, raw material medicines in portions by weight is composed as follows:
Radix Puerariae 16 parts, Radix Bupleuri 24 parts, Flos Lonicerae 12 parts, Fructus Forsythiae 10 parts, Herba Artemisiae Annuae 16 parts, Radix Scutellariae 20 parts, 15 parts of Folium Mori, Radix Peucedani 12 parts, Radix Platycodonis 15 parts, Semen Armeniacae Amarum 10 parts, Mentholum 0.02 part;
Preferably, raw material medicines in portions by weight is composed as follows:
Radix Puerariae 20 parts, Radix Bupleuri 18 parts, Flos Lonicerae 16 parts, Fructus Forsythiae 16 parts, Herba Artemisiae Annuae 16 parts, Radix Scutellariae 12 parts, 12 parts of Folium Mori, Radix Peucedani 12 parts, Radix Platycodonis 10 parts, Semen Armeniacae Amarum 12 parts, Mentholum 0.04 part.
4. the Chinese medicine composition treating anemopyretic cold described in claim 1 treats the application in anemopyretic cold medicine in preparation.
5. apply as claimed in claim 4, it is characterised in that the dosage form of described treatment anemopyretic cold medicine is tablet, granule, capsule, oral liquid or mixture.
6. the preparation method of the oral liquid treating anemopyretic cold, it is characterised in that comprise the steps:
(1) take Semen Armeniacae Amarum in the ratio described in claim 1 and pulverize, then after mixing with Radix Bupleuri, Flos Lonicerae, Fructus Forsythiae, Herba Artemisiae Annuae, Folium Mori, soak, reheat distillation, collect distillate and carry out redistillation, prepare re-distilled liquid and redistillation raffinate, the remaining mixture after distillation is carried out solid-liquid separation, prepare the medicinal residues after distillation and remaining distillate;
(2), after the medicinal residues after distillation step (1) prepared mix with Radix Puerariae, Radix Scutellariae, Radix Peucedani, Radix Platycodonis, boiling, after solid-liquid separation; the remaining distillate that liquid prepares with step (1) merges; filter, concentration, prepare condensed cream;
(3) condensed cream that step (2) prepares is mixed with ethanol, stir evenly, cold preservation, take supernatant, reclaim ethanol, concentration, prepare precipitate with ethanol condensed cream;
(4) re-distilled liquid that precipitate with ethanol condensed cream step (3) prepared prepares with step (1) mixes, and adds Mentholum, to obtain final product.
7. preparation method as claimed in claim 6, it is characterised in that after described step (4) adds Mentholum, also include adding correctives and preservative, add the redistillation raffinate constant volume that step (1) prepares, stir evenly, cold preservation, filter, adjust pH value, fill, sterilizing, lamp inspection, packaging step.
8. preparation method as claimed in claims 6 or 7, it is characterised in that step is as follows:
(1) take Semen Armeniacae Amarum in proportion and pulverize, then after mixing with Radix Bupleuri, Flos Lonicerae, Fructus Forsythiae, Herba Artemisiae Annuae, Folium Mori, soak, reheat distillation, the distillate collecting 3-5 times of quality of crude drug carries out redistillation, prepare re-distilled liquid and the redistillation raffinate of 2 times of quality of crude drug, the remaining mixture after distillation is carried out solid-liquid separation, prepare the medicinal residues after distillation and remaining distillate;
(2) after the medicinal residues after distillation step (1) prepared mix with Radix Puerariae, Radix Scutellariae, Radix Peucedani, Radix Platycodonis; boiling secondary; 1-4 hour first time; second time 0.5-4 hour; after solid-liquid separation, the remaining distillate that liquid prepares with step (1) merges, and filters; concentrating under reduced pressure, prepares condensed cream;
(3) condensed cream that step (2) prepares is mixed with ethanol, stir evenly, cold preservation 24 hours, take supernatant, decompression recycling ethanol, concentrating under reduced pressure, prepare precipitate with ethanol condensed cream;
(4) re-distilled liquid that precipitate with ethanol condensed cream step (3) prepared prepares with step (1) mixes, add Mentholum, correctives and preservative, add the redistillation raffinate constant volume that step (1) prepares, stir evenly, cold preservation 24 hours, filter, adjust pH value, fill, sterilizing, lamp inspection, packs and get final product.
9. the preparation method as described in claim 6-8 any one, it is characterised in that in described step (1), the amount of water soaked is 10 times of the weight of the crude drug soaked, and soak time is 1 hour;When adding thermal distillation, the distillate collecting 4 times of quality of crude drug carries out redistillation;
Preferably, in described step (2), boiling secondary, first time adds the water of 10 times of quality, decocts 2 hours, and second time adds the water of 8 times of quality, decocts 1 hour;Being evaporated to relative density is 1.12~1.13, and reference density is water, and detection temperature is 50~60 DEG C;
Preferably, in described step (3), amount of alcohol added is 2 times of condensed cream quality;Being evaporated to relative density is 1.13~1.14, and reference density is water, and detection temperature is 50~60 DEG C.
10. the preparation method as described in claim 6-8 any one, it is characterised in that in described step (4), correctives is steviosin, and addition is 1.5~2.5mg/ml, and preservative is sodium benzoate, addition is 2~4mg/ml, and adjusting pH value is 6.0~7.5.
CN201610247425.1A 2016-04-20 2016-04-20 Traditional Chinese medicine composition for treating wind-heat common cold and preparation method thereof Pending CN105770074A (en)

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