CN102008557A - Anti-influenza detoxifying capsules and preparation method thereof - Google Patents
Anti-influenza detoxifying capsules and preparation method thereof Download PDFInfo
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Abstract
The invention discloses anti-influenza detoxifying capsules. The capsules are mainly prepared from the following raw materials in part by weight: 10 to 30 parts of indigowoad leaf, 15 to 30 parts of honeysuckle flower, 10 to 30 parts of indigowoad root, 5 to 15 parts of weeping forsythia, 5 to 15 parts of male fern rhizome, 5 to 15 parts of bistort rhizome and 15 to 25 parts of red paeony root. The capsules have reasonable formula, simple compatibility and exact curative effect, are suitable for treating anemopyretic cold, are mainly used for treating and combine treatment and fitness, have the effects of clearing away heat and toxic material, dissipating the superficial and relieving sore throat and can eliminate syndromes of surface wind-heat evil, dry and sore throat, cough and the like. The invention also provides a preparation method of the anti-influenza detoxifying capsules.
Description
Technical field
The invention belongs to the field of Chinese medicines, be specifically related to anti-sense detoxicating capsule of a kind of treatment anemopyretic cold with heat-clearing and toxic substances removing, relieving the exterior syndrome sore-throat relieving function and preparation method thereof.
Background technology
Anemopyretic cold is common flu type, and anemopyretic cold is due to evil criminal's table, the lung qi of wind heat become estranged.Symptom shows as heating weight, micro evil wind, distending pain in the head, antiperspirant, red swelling and pain of throat, cough, expectorant sticking or yellow, have a stuffy nose yellow thick nasal discharge, thirst and liking drink, red, the little Huang of white and thin fur in the tip of the tongue limit is arranged.Cause of disease diseases caused by exogenous pathogenic factor six climate exopathogens, the time row virus, function weakens outside human body is defended, and can not regulate in the strain, from fur, mouth and nose invasion, the evil lung of violating is defended, and defends the table discord and causes a disease.In general, flu seldom has the situation that the change of disease takes place, and the course of disease is lacked and being easy to recover.But time sense serious symptom, old man, baby children, weak patients, also variable sometimes sick he.In addition, flu has certain infectiousness, and is very high at susceptible sickness rate in season, people ' s health and work production often brought bigger influence, therefore actively control.
From the traditional medicine theory: flu is a kind of common exogenous diseases that ailment said due to cold or exposure caused of catching a cold.Method of treatment should be based on relieving the exterior syndrome with drugs of pungent in flavor and cool in nature.Have recognized that promptly that as far back as Huangdi's Internal Classics flu mainly is due to the diseases caused by exogenous pathogenic factor ailment said due to cold or exposure." element is asked a bone empty talk piece of writing " cloud: " wind from outside go into, make us cold with shivering, sweating headache, heavy sensation of the body aversion to cold ".Also there be " time row disease " with its meaning in ancient doctor family, Qingxu spirit tire " medical science source and course opinion cold refractory opinion " cloud: " ordinary person feels wind and cold, has a headache and fever, and the tears of coughing go out, the cold of common saying meaning, the random thoughts of row are also when being ".As for the name of flu, then get instant result in the Northern Song Dynasty " all wind of Renzhai Zhi Zhi Fang, Effective Recipes from Renzhai House ", in its cold side's opinion, introduce and control " the flu ailment said due to cold or exposure is had a headache and fever, and it is low voice speaking to cough, and tears saliva is sticky " with shensu drink.
At present, in the treatment of doctor trained in Western medicine, have one-sidedness, and side effect is big, has anaphylactoid patient may cause shock to cause death.Utilization Chinese herbal treatment flu is the work of always studying, but present curative effect of medication can not be satisfactory.Chinese patent CN200610111509.9 discloses a kind of compound medicine for the treatment of anemopyretic cold, its raw material medicines in portions by weight proportioning is: 280～380 parts of Fructus Arctiis, 780～880 parts of Flos Loniceraes, 450～550 parts of Fructus Forsythiaes, 280～380 parts of Herba Menthaes, 280～380 parts of Herba Schizonepetaes, 450～550 parts of Radix Isatidiss, 280～380 parts of Rhizoma Et Radix Notopterygiis, 450～550 parts of Folium Isatidiss, Radix Glycyrrhizae 110-210 part.Chinese patent CN200710054104.0 discloses a kind of Chinese medicine for the treatment of diseases caused by exogenous pathogenic factor epidemic disease, anemopyretic cold, make by following each the component raw material medicine that with the weight portion is unit: 150～800 parts of Radix Scutellariaes, 100～800 parts of Rhizoma Coptidis, 50～360 parts of Fructus Forsythiaes, 30～260 parts of Fructus Arctiis, 180～900 parts of Rhizoma Et Radix Notopterygiis, 200～850 parts of Radix Saposhnikoviaes, 150～800 parts of Herba Schizonepetae, 60～450 parts in Gypsum Fibrosum, 50～500 parts of Radix Platycodoniss, 30～300 parts in Radix Glycyrrhizae.Chinese patent CN200610035588.X discloses a kind of Chinese medicine composition for the treatment of anemopyretic cold, it is characterized in that the medicament of being made by the raw material of following weight parts: Radix Bupleuri 315～630, Radix Scutellariae 315～630, Gypsum Fibrosum 630～1260, Herba Artemisiae Annuae 252～504, Radix Isatidis 315～630, Flos Lonicerae 315～630, Radix Et Rhizoma Rhei 210～420, Herba Taraxaci 315～630, the Rhizoma Anemarrhenae 210～420, Fructus Forsythiae 210～420.
The Chinese medicine product of above-mentioned treatment anemopyretic cold, used taste of Chinese medicine number is too much, has reduced the medicine proportion of a therapeutical effect relatively, has influenced the pharmic function performance, so effect is slow, the course of treatment is long, effect is undesirable.
Summary of the invention
The objective of the invention is to overcome the defective that prior art exists, provide that a kind of reasonable recipe, compatibility are simplified, the anti-sense detoxicating capsule of the treatment anemopyretic cold of determined curative effect, to control, control foster combination, have thermal detoxification, the effect of relieving the exterior syndrome sore-throat relieving, but syndromes such as pathogenic wind-heat at table, elimination parched throat laryngalgia, cough are evacuated in removing summer-heat simultaneously.
A kind of anti-sense detoxicating capsule is characterized in that mainly being made by following bulk drugs: Folium Isatidis 10-30 part, Flos Lonicerae 15-30 part, Radix Isatidis 10-30 part, Fructus Forsythiae 5-15 part, Rhizoma Dryopteris Crassirhizomatis 5-15 part, Rhizoma Bistortae 5-15 part, Radix Paeoniae Rubra 15-25 part.
Further, described anti-sense detoxicating capsule is mainly made by following bulk drugs: Folium Isatidis 15-25 part, Flos Lonicerae 18-23 part, Radix Isatidis 15-25 part, Fructus Forsythiae 8-12 part, Rhizoma Dryopteris Crassirhizomatis 5-10 part, Rhizoma Bistortae 8-12 part, Radix Paeoniae Rubra 18-23 part.
Further, described anti-sense detoxicating capsule is mainly made by following bulk drugs: 20 parts of Folium Isatidiss, 21 parts of Flos Loniceraes, 20 parts of Radix Isatidis, 10 parts of Fructus Forsythiaes, 7 parts of Rhizoma Dryopteris Crassirhizomatiss, 10 parts of Rhizoma Bistortaes, 21 parts of Radix Paeoniae Rubra.
The dosage form of above-mentioned Chinese medicine also can be tablet, granule or oral solutions.
Another object of the present invention is to provide above-mentioned anti-sense detoxicating capsular preparation method, it is characterized in that comprising the following steps:
A) take by weighing Folium Isatidis, Flos Lonicerae, Radix Isatidis, Fructus Forsythiae, Rhizoma Dryopteris Crassirhizomatis, Rhizoma Bistortae and the Radix Paeoniae Rubra of described weight proportion, add 6-14 times of water gaging, dipping spends the night under the room temperature;
B) heating decocted 1-3 hour, and A filters to get filtrate; Add 6-14 times of water gaging in filtering residue, decocted 1-3 hour, B filters to get filtrate;
C) merging filtrate A and liquor B, concentrating under reduced pressure gets clear paste, and adding ethanol to ethanol content is 40%-85%, standing over night, leaching supernatant;
D) reclaim ethanol in the supernatant, concentrating under reduced pressure gets clear paste, and adding ethanol to ethanol content once more is 40%-85%, standing over night, leaching supernatant;
E) reclaim ethanol in the supernatant, concentrate extractum;
F) the extractum vacuum drying makes extract powder;
G) extract powder mixes with adjuvant, makes granule, and particle packing makes anti-sense detoxicating capsule in capsule.
Further, among the step c filtrate to be concentrated into relative density be 1.05～1.15.
Supernatant concentration to relative density is preferably 1.10～1.20 in the steps d.
The particulate method of system is a dry granulation in the step g.
The particulate method of system is a wet granulation in the step g.
The present invention is directed to the characteristics of anemopyretic cold, select for use Folium Isatidis, Flos Lonicerae, Radix Isatidis, Fructus Forsythiae, Rhizoma Dryopteris Crassirhizomatis, Rhizoma Bistortae and Radix Paeoniae Rubra to make Chinese medicine preparation.Employing is controlled and is supported bonded method to control, and the medicine of making is a kind of reasonable recipe, and compatibility is simplified, the anti-sense detoxicating capsule of the treatment anemopyretic cold of determined curative effect.
The leaf of Folium Isatidis leaf system cruciferae isatis, its root is a Radix Isatidis, has heat-clearing and toxic substances removing, blood cooling and ecchymoses removing, is used for pathogenic warmth and joins the army, sore throat, carbuncle etc.Mainly contain compositions such as tryptophan, indirubin, indigo, cupreol, couroupitine A.Modern pharmacology proof Folium Isatidis has broad-spectrum antibacterial action.Its decoct all has certain inhibitory action to staphylococcus aureus, alpha streptococcus, meningococcus, Diplococcus pneumoniae, hemophilus influenza.Folium Isatidis also has inhibitory action to encephalitis b virus, mumps virus, influenza virus etc. in addition, and influenza virus induced mice pneumonia is had depression effect.Folium Isatidis has the obvious anti-inflammatory and anti refrigeration function with fashion, and its decoct 10g/kg gavages to rabbit can suppress the local skin inflammatory reaction that dimethylbenzene causes, reduces capillary permeability.Under dosage, can make cholera, typhoid fever mixed vaccine cause that the rabbit body temperature of heating obviously descends.
Flos Lonicerae is the dry flower of caprifoliaceae plant Radix Ophiopogonis, Flos Lonicerae etc. or the flower that band is just opened, and has the function of heat-clearing and toxic substances removing, wind-heat dissipating, is used for anemopyretic cold, epidemic febrile disease heating.It mainly contains antibacterial activity composition chlorogenic acid and isochlorogenic acid, and modern pharmacology studies confirm that Flos Lonicerae decocting liquid has stronger antibacterial activity, simultaneously influenza virus, Orphan virus, herpesvirus is also had the obvious suppression effect.The Flos Lonicerae decoct also can promote leukocytic phagocytic function, has antiinflammatory and refrigeration function.
Fructus Forsythiae is the dry fruit of Oleaceae plant Fructus Forsythiae, has the function of heat-clearing and toxic substances removing, dispersing swelling and dissipating binds, be used for anemopyretic cold, epidemic febrile disease from the beginning of etc. disease.Mainly contain compositions such as phillyrin with strong antibacterial activity, Fructus Forsythiae ester glycoside, forsythol, oleanolic acid.Modern pharmacological research shows that the Fructus Forsythiae decoct all has inhibitory action to multiple Gram-positive and negative bacteria, also proves that Fructus Forsythiae has obvious inhibitory action to Asia influenza A virus, rhinovirus-17 simultaneously.The Fructus Forsythiae decoct also has antipyretic and anti-inflammatory and anti-allergic effects.
Radix Paeoniae Rubra is the root of cohosh river Radix Paeoniae Rubra, has the function of clearing away heat and cooling blood, eliminating stasis to stop pain, is used for maculae caused by violent heat pathogen.Mainly contain relatively large peoniflorin, contain compositions such as paeonol, peony lactone, benzoylpaeoniflorin simultaneously.Modern pharmacology studies show that the Radix Paeoniae Rubra action range, has calmness, analgesia and cooling effect; Radix Paeoniae Rubra decocting liquid has stronger inhibitory action to multiple pathogenic microorganism, as to dysentery bacterium, typhoid fever, paratyphoid fever, green pus, large intestine, distortion etc.The antiviral experiment shows that the Radix Paeoniae Rubra decoct has inhibitory action to the 68-1 of capital section virus, herpesvirus, influenza virus, parainfluenza virus and enterovirus.
Rhizoma Dryopteris Crassirhizomatis is rhizome and petiole bases such as Dryopteridaceae plant shield-fern, has parasite killing, heat-clearing and toxic substances removing, hemostatic function.Be usually used in diseases such as anemopyretic cold, warm macule, mumps clinically.Modern pharmacology studies confirm that Rhizoma Dryopteris Crassirhizomatis all has stronger inhibitory action to multiple virus.The Embryo Gallus domesticus experimental result shows that the Rhizoma Osmundae decoct all has a significant inhibitory effect to influenza virus, herpes simplex virus, influenza virus are B-mode.The Rhizoma Dryopteris Crassirhizomatis decoct still has bacteriostasis to a certain degree.Modern clinical Rhizoma Osmundae commonly used and compound treatment pneumonia thereof, encephalitis B, prevention and treatment flu and influenza etc.
Rhizoma Bistortae is the dry rhizome of polygonaceae plant Rhizoma Bistortae, has heat clearing away cooling down, inducing diuresis and reducing edema function.Be used for diseases such as cough due to lung-heat, diarrhea of heat type clinically.Mainly contain compositions such as tannin, gallic acid, benzoaric acid and D catechol.Modern pharmacology studies confirm that, this product has antibiotic, antivirus action.
The anti-sense detoxicating capsule of treatment anemopyretic cold of the present invention has the function of heat-clearing and toxic substances removing, relieving the exterior syndrome sore-throat relieving, is mainly used in the diseases such as fever of the body, micro evil wind, distending pain in the head, nasal obstruction stream turbid nasal discharge, cough, parched throat or red swelling and pain of throat that cold anemopyretic syndrome causes.Prove that through pharmacological experiment this product has the antiinflammatory action of significantly bringing down a fever.The in-vitro antibacterial experiment shows that this product has tangible antibacterial action to escherichia coli and staphylococcus aureus.Antiviral experiment shows that this product is external, all have certain antivirus action in the body.Folium Isatidis in the side, bitter Great Cold, heat-clearing and toxic substances removing, " treating the seasonal epidemic pathogens headache " " not Lu ", " controlling the pestilence cold and heat " " property of medicine book on Chinese herbal medicine "; Flos Lonicerae, sweet trembling with fear into lung meridian, heat-clearing and toxic substances removing, also Chang Yu " heat radiation " Compendium of Material Medica of inducing sweat can " wind-fire be damp and hot in the clear network, separates the dirty filthy heresy of temperature ".Two medicines are combined into monarch drug, play heat-clearing and toxic substances removing altogether, the merit of dispelling wind and heat pathogens.Radix Isatidis, Fructus Forsythiae are ministerial drug.Radix Isatidis, bitter cold is gone into lung meridian, heat-clearing and toxic substances removing, throat is everlasting with the monarch drug Folium Isatidis and is used the product be all heat-clearing and toxic substances removing, and Folium Isatidis is longer than detoxifcation, the outstanding throat of Radix Isatidis.Fructus Forsythiae, hardship is slightly cold, heat-clearing and toxic substances removing, dispersing swelling and dissipating binds." main cold and heat " " herbal classic ", " going all heat of the part of the body cavity above the diaphragm housing the heart and lungs " " pearl sac ".Also often close with the monarch drug Flos Lonicerae and be usefulness, the effect of heat-clearing and toxic substances removing is all arranged, the right Flos Lonicerae wind heat of loosing of holding concurrently, rising looses reach thoroughly act as excellent, the Re Yousheng during Fructus Forsythiae then purifies the blood.Rhizoma Dryopteris Crassirhizomatis, hardship is slightly cold, and " can separate the poison of pathogenic heat " essentials of Matea Medica also is a ministerial drug.Assist monarch drug to increase heat-clearing and toxic substances removing, the power of wind-dispelling heat-dissipating sore-throat relieving with Radix Isatidis, Fructus Forsythiae.Rhizoma Bistortae, hardship is slightly cold, the heat-clearing and toxic substances removing removing heat from blood; Radix Paeoniae Rubra, hardship is slightly cold, removing heat from blood and promoting blood circulation, " the red meaning that the strange blood that looses is then arranged " " book on Chinese herbal medicine is looked for the truth ".Two medicines are adjuvant altogether, and the medicine promoting the circulation of blood of assisting a ruler in governing a country the monarch and his subjects is diffusing evil, dispelling wind and heat pathogens.More than all medicines coordinate mutually, complement each other, bring into play heat-clearing and toxic substances removing jointly, the effect of relieving the exterior syndrome sore-throat relieving.
The present invention is except that amount of water, and proportioning that other relate to and percentage composition thereof are all by weight.
Below by concrete experimental data capsular curative effect of anti-sense detoxicating of the present invention etc. is described further.
This test adopt multicenter, at random, positive drug contrast, two groups of parallel test methods, the A group is matched group, uses the Yinqiao detoxification capsule, oral one time 3, three times on the one, serious symptom person adds once, 3 days is a course of treatment.B group is test group, uses the anti-sense of the present invention detoxicating capsule, oral one time 3, three times on the one, serious symptom person adds once.Treat sex between preceding two groups, wedding not, age, body weight, height, body temperature, respiratory frequency, pulse, systolic pressure, diastolic pressure, the course of disease, the state of an illness and the tcm symptom sign is kept the score, total mark, tongue fur, pulse condition, body temperature, difference that relatively there are no significant in twos between group, hematology, the inspection of urine stool routine, hepatic and renal function, Electrocardioscopy and Chest X-rays aspect have good comparability.
Xiyuan Hospital, Chinese Medicine Academy of China: go into to organize case load totally 60 examples, wherein A organizes 30 examples, and B organizes 30 examples.The A group is finished 28 examples, and 0 example that comes off is rejected 2 examples; The B group is finished 27 examples, and 1 example that comes off is rejected 2 examples.Efficacy analysis: (1) curative effect of disease (doctor judges that PP analyzes), two groups of curative effect comparing difference no statistical significances (P＞0.05); (2) tcm syndrome curative effect (computer judges that ITT analyzes), two groups of curative effect comparing difference no statistical significances (P＞0.05); (3) body temperature curative effect: body temperature onset time and analgesic time ratio, two groups of comparing difference no statistical significances (P＞0.05).Treatment back urine stool routine no abnormality seen.Treat after 3 days, two groups have all that routine blood test appears in the part experimenter, hepatic and renal function is unusual.Going into to organize case is 60 examples, adverse events all do not occur.
Longhua hospital of Shanghai Univ. of Traditional Chinese Medicine: go into to organize case load totally 60 examples, wherein A organizes 30 examples, and B organizes 30 examples.The A group is finished 29 examples, and 0 example that comes off is rejected 1 example; The B group is finished 28 examples, and 0 example that comes off is rejected 2 examples.Efficacy analysis: (1) curative effect of disease (doctor judges that PP analyzes), comparing difference no statistical significance between two groups of curative effect groups (P＞0.05); (2) tcm syndrome curative effect (computer judges that ITT analyzes), two groups of curative effect comparing difference no statistical significances (P＞0.05); (3) body temperature curative effect: body temperature onset time, relatively two groups of comparing differences had statistical significance (P＜0.05), analgesic time ratio, two groups of comparing difference no statistical significances (P＞0.05).Treatment back urine stool routine no abnormality seen.Treat after 3 days, two groups have all that routine blood test appears in the part experimenter, hepatic and renal function is unusual.Going into to organize case is 60 examples, adverse events all do not occur.
The Zhejiang Prov. Hospital of Traditional Chinese Medicine: go into to organize case load totally 60 examples, wherein A organizes 30 examples, and B organizes 30 examples.The A group is finished 26 examples, and 2 examples that come off are rejected 2 examples; The B group is finished 23 examples, and 1 example that comes off is rejected 6 examples.Efficacy analysis: (1) curative effect of disease (doctor judges that PP analyzes), two groups of curative effect comparing difference no statistical significances (P＞0.05); (2) tcm syndrome curative effect (computer judges that ITT analyzes), two groups of curative effect comparing differences have statistical significance (P＜0.05); (3) body temperature curative effect: body temperature onset time and analgesic time ratio, two groups of comparing difference no statistical significances (P＞0.05).Treatment back urine stool routine no abnormality seen.Treat after 3 days, two groups have all that routine blood test appears in the part experimenter, hepatic and renal function is unusual.Going into to organize case is 60 examples, and A organizes 1 example and adverse events occurs, is untoward reaction.
Guang-amen Hospital, China Traditional Chinese Medicine Instl: go into to organize case load totally 60 examples, wherein A organizes 30 examples, and B organizes 30 examples.The A group is finished 26 examples, and 2 examples that come off are rejected 2 examples; The B group is finished 24 examples, and 3 examples that come off are rejected 3 examples.Efficacy analysis: (1) curative effect of disease (doctor judges that PP analyzes), two groups of comparing difference no statistical significances (P＞0.05); (2) tcm syndrome curative effect (computer judges that ITT analyzes), two groups of curative effect comparing difference no statistical significances (P＞0.05); (3) body temperature curative effect: body temperature onset time and analgesic time ratio, two groups of comparing difference no statistical significances (P＞0.05).Treatment back urine stool routine no abnormality seen.Treat after 3 days, two groups have all that routine blood test appears in the part experimenter, hepatic and renal function is unusual.Going into to organize case is 60 examples, adverse events all do not occur.
In JIUYUE, 2003 to 2004 year June is in Xiyuan Hospital, Chinese Medicine Academy of China, Longhua hospital of Shanghai Univ. of Traditional Chinese Medicine, Zhejiang Prov. Hospital of Traditional Chinese Medicine and Guang-amen Hospital, China Traditional Chinese Medicine Instl, adopt the demixing zone group at random, the safety and the effectiveness of double blinding, positive drug parallel control, multiple center trial antagonism sense detoxicating capsule for treating wind-heat cold estimate.
Test adopt multicenter, at random, positive drug contrast, two groups of parallel test methods, the A group is matched group, uses the Yinqiao detoxification capsule, the B group is test group, uses the capsule of 1,2 or 3 arbitrary groups of anemopyretic cold that make of embodiment.The test group medicine is the capsule of 1,2 or 3 arbitrary groups of anemopyretic cold that make of embodiment, oral one time 3, three times on the one, serious symptom person adds once; The matched group medicine is the Yinqiao detoxification capsule, oral one time 3, three times on the one, serious symptom person adds once, 3 days is a course of treatment.
Result of the test
1. case distributional analysis
Case load totally 240 examples are gone into to organize in 4 tame research centers, matched group 120 examples wherein, test group 120 examples.Matched group is finished 109 examples, and 4 examples that come off are rejected 7 examples; Test group is finished 102 examples, and 5 examples that come off are rejected 13 examples.Two groups of expulsion rates, rejecting rate comparing difference no statistical significance (P＞0.05).
2, analysis of comparable
2.1 demographic characteristics and general inspection before the treatment
Before the treatment, two groups of differences of respiratory frequency comparison have statistical significance (P＜0.05), sex between two groups, wedding not, age, body weight, height, body temperature, pulse, systolic pressure, diastolic pressure, the course of disease, the state of an illness, the equal no statistical significance of comparing difference (P＞0.05) between group.
2.2 treatment tcm symptom sign
Tcm symptom sign and tcm symptom total mark before the treatment, two groups of comparing difference no statistical significances (P＞0.05) see Table 2-14～2-22, treatment anterior pharynx mucous hyperemia, picture of the tongue and pulse condition inspection, two groups of comparing difference no statistical significances (P＞0.05).
2.3 the related experiment chamber is checked before the treatment
Hematology, Chest X-rays and throat swab are identified before the treatment, two groups of equal no statistical significances of comparing difference (P＞0.05),
3, compliance analysis:
Compliance is good, and except that coming off, reject the case, 211 routine experimenter's compliances are 100%.
By above analysis as seen: before the treatment, two groups of differences of respiratory frequency comparison have statistical significance (P＜0.05=, sex between two groups, wedding not, age, body weight, height, body temperature, pulse, systolic pressure, diastolic pressure, the course of disease, the state of an illness, the equal no statistical significance of comparing difference between group.Tcm symptom sign and tcm symptom total mark before the treatment, two groups of comparing difference no statistical significances (P＞0.05), treatment anterior pharynx mucous hyperemia, picture of the tongue and pulse condition inspection, two groups of comparing difference no statistical significances (P＞0.05).Hematology, Chest X-rays and throat swab are identified before the treatment, and comparability was good before two groups of cases of two groups of equal no statistical significances of comparing difference (P＞0.05) were treated.
4, efficacy analysis
4.1 curative effect of disease is judged
Curative effect of disease is judged (doctor judges that PP analyzes), and the matched group cure rate is 37.615%, and cure-remarkable-effectiveness rate is 79.817%; The test group cure rate is 30.392%, and cure-remarkable-effectiveness rate is 73.529%.Two groups of comparing difference no statistical significances (P＞0.05).Cure rate, cure-remarkable-effectiveness rate be two groups of equal no statistical significances of difference (P＞0.05) relatively, see Table 4-1.Behind the deduction center effect, conclusion is identical with it, sees Table 4-2.
Table 4-1 curative effect of disease (doctor judges that PP analyzes):
| Matched group | (％) | Test group | (％) | Q-value | The P value | Judge | |
| Clinical recovery | 41 | 37.615 | 31 | 30.392 | |||
| Produce effects | 46 | 42.202 | 44 | 43.137 | |||
| Effectively | 19 | 17.431 | 24 | 23.529 | |||
| Invalid | 3 | 2.752 | 3 | 2.941 | |||
| Add up to | 109 | 102 | 1.509 | 0.219 | Not remarkable | ||
| Cure rate | 37.615 | 30.392 | 0.923 | 0.337 | Not remarkable | ||
| Cure-remarkable-effectiveness rate | 79.817 | 73.529 | 0.842 | 0.359 | Not remarkable |
Table 4-2 curative effect of disease (doctor judges that PP analyzes, the deduction center effect):
| Add up to | Clinical recovery | Produce effects | Effectively | Invalid | |
| Center 1 | |||||
| Matched group | 28 | 12 | 13 | 2 | 1 |
| Test group | 27 | 12 | 11 | 4 | 0 |
| Center 2 | |||||
| Matched group | 29 | 5 | 14 | 10 | 0 |
| Test group | 28 | 4 | 17 | 6 | 1 |
| Center 3 | |||||
| Matched group | 26 | 15 | 7 | 4 | 0 |
| Test group | 23 | 6 | 11 | 6 | 0 |
| Center 4 | |||||
| Matched group | 26 | 9 | 12 | 3 | 2 |
| Test group | 24 | 9 | 5 | 8 | 2 |
| The CMH method: | Q＝1.526 | P＝0.217 | Not remarkable |
4.2 tcm syndrome is judged:
Tcm syndrome is judged (computer judges that ITT analyzes), and the matched group cure rate is 34.513%, and cure-remarkable-effectiveness rate is 76.991%; The test group cure rate is 28.037%, and cure-remarkable-effectiveness rate is 68.224% (cure-remarkable-effectiveness rate=(clinical recovery+produce effects)/total).Two groups of comparing difference no statistical significances (P＞0.05).Cure rate, cure-remarkable-effectiveness rate be two groups of equal no statistical significances of difference (P＞0.05) relatively, see Table 4-3.Behind the deduction center effect, conclusion is identical with it, sees Table 4-5.Tcm syndrome judges that (computer judges that PP analyzes) conclusion is identical with it, sees Table 4-4, table 4-6.Tcm syndrome judges that (doctor judges that PP analyzes) conclusion is identical with it, sees Table 4-7.
4.3 body temperature curative effect
Body temperature onset time comparison, two groups of comparing difference no statistical significances (P＞0.05).
Analgesic time ratio, two groups of comparing difference no statistical significances (P＞0.05).
4.4 disease treatment process
Descend two groups of equal no statistical significances of comparing difference (P＞0.05) after the medication of body temperature mean gradually.
4.5 tcm syndrome individual event curative effect
Behind the administration 3d, Syndrome in TCM marquis's individual event curative effect, picture of the tongue and pulse condition inspection are compared, two groups of difference no statistical significances (P＞0.05).
Result of the test: this test adopt multicenter, double blinding, at random, the test method of positive drug parallel control, matched group uses the Yinqiao detoxification capsule, test group is used anti-sense detoxicating capsule.Case load totally 240 examples are gone into to organize in 4 tame research centers, matched group 120 examples wherein, test group 120 examples.Matched group is finished 109 examples, and 4 examples that come off are rejected 7 examples; Test group is finished 102 examples, and 5 examples that come off are rejected 13 examples.Compliance is good, and except that coming off, reject the case, 211 routine experimenter's compliances are 100%.
Efficacy analysis: (1) curative effect of disease: curative effect of disease is judged (doctor judges that PP analyzes), and the matched group cure rate is 37.615%, and cure-remarkable-effectiveness rate is 79.817%; The test group cure rate is 30.392%, and cure-remarkable-effectiveness rate is 73.529%.Two groups of comparing difference no statistical significances (P＞0.05).Cure rate, cure-remarkable-effectiveness rate be two groups of equal no statistical significances of difference (P＞0.05) relatively; (2) tcm syndrome curative effect: tcm syndrome is judged (computer judges that ITT analyzes), and the matched group cure rate is 34.513%, and cure-remarkable-effectiveness rate is 76.991%; The test group cure rate is 28.037%, and cure-remarkable-effectiveness rate is 68.224%.Two groups of comparing difference no statistical significances (P＞0.05).Cure rate, cure-remarkable-effectiveness rate be two groups of equal no statistical significances of difference (P＞0.05) relatively; (3) body temperature curative effect: body temperature onset time and analgesic time ratio, two groups of comparing difference no statistical significances (P＞0.05).
Treatment back urine stool routine no abnormality seen.Treat after 3 days, two groups have all that routine blood test appears in the part experimenter, hepatic and renal function is unusual.Go into to organize case 240 and be example, adverse events appears in 1 example, all has no adverse reaction.
The specific embodiment
Embodiment 1
Take by weighing Folium Isatidis 800 grams, Flos Lonicerae 840 grams, Radix Isatidis 800 grams, Fructus Forsythiae 400 grams, Rhizoma Dryopteris Crassirhizomatis 280 grams, Rhizoma Bistortae 400 grams, Radix Paeoniae Rubra 840 grams.
Preparation method is as follows:
1) extract: add 6 times of water gaging dippings and spend the night, heating decocted after 1 hour, the isolated by filtration medicinal liquid; Medicinal residues add 14 times of water gagings and decoct after 2 hours, separate medicinal liquid, abandon medicinal residues.Merge medicinal liquid twice.
2) concentrate: it is 1.05～1.15 extractum that the medicinal liquid that merges is concentrated into relative density.
3) precipitate with ethanol: in refrigerative extractum, add ethanol, adjust concentration of alcohol to 50%, standing over night.Separation of supernatant is abandoned precipitate.
4) concentrate: after the supernatant after a precipitate with ethanol is separated reclaims ethanol, be condensed into relative density and be 1.10～1.20 extractum.
5) secondary precipitate with ethanol: in refrigerative extractum, add ethanol, adjust concentration of alcohol to 75%, standing over night.Separation of supernatant is abandoned precipitate.
6) concentrate: the supernatant after the secondary precipitate with ethanol is separated reclaims ethanol to there not being the alcohol flavor.
7) drying: vacuum degree control-0.06～-0.1Mpa, the drying baker temperature is controlled at 55 ℃ ± 5 ℃.Dry 6 hours, be advisable when clear-cut to extractum is loose, dry extract.
8) pulverize: dry extract with 16 order stainless steel mesh crushing screenings, is got extract powder.
9) granulate: take by weighing the silicon dioxide of extract powder, magnesium stearate, Pulvis Talci and 1/3 recipe quantity by recipe quantity, and add appropriate amount of starch and reach 98% of the total input amount of prescription, mixed 10 minutes.
10) compacting: with the material compacting of above-mentioned mixing.
11) granulate: granule is pulverized and made to the material of compacting with 14 order stainless (steel) wires.
12) total mixing: granule in the mixer chamber, is added the silicon dioxide of 2/3 recipe quantity simultaneously, mixed 10 minutes.
13) encapsulated: in No. 0 capsule, its filling is controlled at every 0.5g ± 7%, promptly gets the anti-sense detoxicating capsule for the treatment of anemopyretic cold with the particle packing for preparing, and yield is 95%
Embodiment 2
Take by weighing Folium Isatidis 400 grams, Flos Lonicerae 1200 grams, Radix Isatidis 400 grams, Fructus Forsythiae 600 grams, Rhizoma Dryopteris Crassirhizomatis 200 grams, Rhizoma Bistortae 600 grams, Radix Paeoniae Rubra 600 grams.
1) extract: add 8 times of water gaging dippings 14 hours, heating decocted after 1.5 hours, the isolated by filtration medicinal liquid; Medicinal residues add 12 times of water gagings and decoct after 2 hours, separate medicinal liquid, abandon medicinal residues.Merge medicinal liquid twice.
2) concentrate: it is 1.05～1.15 extractum that the medicinal liquid that merges is concentrated into relative density.
3) precipitate with ethanol: add ethanol in refrigerative extractum, adjust concentration of alcohol to 75%, placement is spent the night.Separation of supernatant is abandoned precipitate.
4) concentrate: after the supernatant after a precipitate with ethanol is separated reclaims ethanol, be concentrated into relative density and be 1.10～1.20 extractum.
5) secondary precipitate with ethanol: add ethanol in refrigerative extractum, adjust concentration of alcohol to 50%, placement is spent the night.Separation of supernatant is abandoned precipitate.
6) concentrate: the supernatant after the secondary precipitate with ethanol is separated reclaims ethanol to there not being the alcohol flavor.
7) drying: vacuum degree control-0.06～-0.1Mpa, the drying baker temperature is controlled at 60 ℃ ± 5 ℃.5 hours drying times, get dry extract.
8) pulverize: dry extract with 16 order stainless steel mesh crushing screenings, is got extract powder.
9) granulate: take by weighing the Pulvis Talci of extract powder, magnesium stearate, 1/3 recipe quantity and the silicon dioxide of 2/3 recipe quantity by recipe quantity, and add appropriate amount of starch and reach 98% of the total input amount of prescription, mixed 10 minutes.
10) compacting: with the material compacting of above-mentioned mixing.
11) granulate: granule is pulverized and made to the material of compacting with 14 order stainless (steel) wires.
12) total mixing: granule in the mixer chamber, is added 1/3 place's silicon dioxide of remaining 2/3 recipe quantity simultaneously, mixed 10 minutes.
13) encapsulated: in No. 0 capsule, its filling is controlled at every 0.5g ± 7%, promptly gets the anti-sense detoxicating capsule for the treatment of anemopyretic cold with the particle packing for preparing, and yield is 97%
Embodiment 3
Take by weighing Folium Isatidis 1200 grams, Flos Lonicerae 600 grams, Radix Isatidis 800 grams, Fructus Forsythiae 200 grams, Rhizoma Dryopteris Crassirhizomatis 600 grams, Rhizoma Bistortae 200 grams, Radix Paeoniae Rubra 1000 grams.
1) extract: add 10 times of water gaging dippings and spend the night, heating decocted after 1.5 hours, the isolated by filtration medicinal liquid; Medicinal residues add 10 times of water gagings and decoct after 1.5 hours, separate medicinal liquid.Merge medicinal liquid twice, medicinal residues discard.
2) concentrate: it is 1.05～1.15 extractum that the medicinal liquid that merges is concentrated into relative density.Use the container packing, the cooling back is standby.
3) precipitate with ethanol: add ethanol in refrigerative extractum, adjust concentration of alcohol to 50%, placement is spent the night.Separation of supernatant is abandoned precipitate.
4) concentrate: after the supernatant after a precipitate with ethanol is separated reclaims ethanol, be concentrated into relative density and be 1.10～1.20 extractum.
5) secondary precipitate with ethanol: add ethanol in refrigerative extractum, adjust concentration of alcohol to 75%, placement is spent the night.Separation of supernatant is abandoned precipitate.
6) concentrate: the supernatant after the secondary precipitate with ethanol is separated reclaims ethanol to there not being the alcohol flavor.
7) drying: vacuum degree control-0.06～-0.0.1Mpa, the drying baker temperature is controlled at 65 ℃ ± 5 ℃.4 hours drying times, get dry extract.
8) pulverize: dry extract with 16 order stainless steel mesh crushing screenings, is got extract powder.
9) granulate: take by weighing 2/3 silicon dioxide of extract powder, magnesium stearate, Pulvis Talci and 1/2 recipe quantity by recipe quantity, and add appropriate amount of starch and reach 98% of the total input amount of prescription, mixed 20 minutes.
10) compacting: with the material compacting of above-mentioned mixing.
11) granulate: granule is pulverized and made to sheet with 14 order stainless (steel) wires.
12) total mixing: granule in the mixer chamber, is added 1/3 silicon dioxide of 1/2 recipe quantity simultaneously,, mixed 10 minutes.
13) encapsulated: in No. 0 capsule, its filling is controlled at every 0.5g ± 7%, promptly gets the anti-sense detoxicating capsule for the treatment of anemopyretic cold with the particle packing for preparing.Yield is 97%.
Embodiment 4
Take by weighing Folium Isatidis 600 grams, Flos Lonicerae 1200 grams, Radix Isatidis 400 grams, Fructus Forsythiae 800 grams, Rhizoma Dryopteris Crassirhizomatis 400 grams, Rhizoma Bistortae 280 grams, Radix Paeoniae Rubra 600 grams.
1) extract: add 12 times of water gaging dippings and spend the night, heating decocted after 2 hours, the isolated by filtration medicinal liquid; Medicinal residues add 8 times of water gagings and decoct after 1.5 hours, separate medicinal liquid.Merge medicinal liquid twice, medicinal residues discard.
2) concentrate: it is 1.05～1.15 extractum that the medicinal liquid that merges is concentrated into relative density.Use the container packing, the cooling back is standby.
3) precipitate with ethanol: add ethanol in refrigerative extractum, adjust concentration of alcohol to 50%, placement is spent the night.Separation of supernatant is abandoned precipitate.
4) concentrate: after the supernatant after a precipitate with ethanol is separated reclaims ethanol, be concentrated into relative density and be 1.10～1.20 extractum.
5) secondary precipitate with ethanol: add ethanol in refrigerative extractum, adjust concentration of alcohol to 50%, placement is spent the night.Separation of supernatant is abandoned precipitate.
6) concentrate: the supernatant after the secondary precipitate with ethanol is separated reclaims ethanol to there not being the alcohol flavor.
7) drying: vacuum degree control-0.06～-0.1Mpa, the drying baker temperature is controlled at 70 ℃ ± 5 ℃.3 hours drying times, get dry extract.
8) pulverize: dry extract with 16 order stainless steel mesh crushing screenings, is got extract powder
9) granulate: take by weighing extract powder and add appropriate amount of starch by recipe quantity and reach 95% of the total input amount of prescription, mixed 20 minutes.
10) compacting: with the material compacting of above-mentioned mixing.
11) granulate: granule is pulverized and made to the compacting material with 14 order stainless (steel) wires.
12) total mixing: granule in the mixer chamber, is added magnesium stearate, Pulvis Talci and silicon dioxide, mixed 10 minutes.
13) encapsulated: in No. 0 capsule, its filling is controlled at every 0.5g ± 7% with the particle packing for preparing.Promptly get the anti-sense detoxicating capsule for the treatment of anemopyretic cold, yield is 98%.
Embodiment 5
Take by weighing Folium Isatidis 800 grams, Flos Lonicerae 1000 grams, Radix Isatidis 600 grams, Fructus Forsythiae 600 grams, Rhizoma Dryopteris Crassirhizomatis 600 grams, Rhizoma Bistortae 400 grams, Radix Paeoniae Rubra 800 grams.
1) extract: add 14 times of water gaging dippings and spend the night, heating decocted after 2 hours, the isolated by filtration medicinal liquid; Medicinal residues add 6 times of water gagings and decoct after 1 hour, separate medicinal liquid.Merge medicinal liquid twice, medicinal residues discard.
2) concentrate: it is 1.05～1.15 extractum that the medicinal liquid that merges is concentrated into relative density.Use the container packing, the cooling back is standby.
3) precipitate with ethanol: add ethanol in refrigerative extractum, adjust concentration of alcohol to 50%, placement is spent the night.Separation of supernatant is abandoned precipitate.
4) concentrate: after the supernatant after a precipitate with ethanol is separated reclaims ethanol, be concentrated into relative density and be 1.10～1.20 extractum.
5) secondary precipitate with ethanol: add ethanol in refrigerative extractum, adjust concentration of alcohol to 50%, placement is spent the night.Separate, precipitate discards.
6) concentrate: the supernatant after the secondary precipitate with ethanol is separated reclaims ethanol to there not being the alcohol flavor.
7) drying: vacuum degree control-0.06～-0.1Mpa, the drying baker temperature is controlled at 65 ℃ ± 5 ℃.4 hours drying times, get dry extract.
8) granulate: with dry extract, carry out granulate with 14 purpose rustless steel mesh screens.
9) mix: the extract granule that granulate is good adds, 1/2 Pulvis Talci of starch, recipe quantity and 1/3 silicon dioxide, and add an amount of 5% starch slurry and granulate.Mixed 10 minutes.
10) drying: wet granular is carried out 65 ℃ ± 5 ℃.2 hours drying times.
11) total mixing: granule in the mixer chamber, is added magnesium stearate and recipe quantity 1/2 Pulvis Talci and 2/3 silicon dioxide, mixed 10 minutes.
12) encapsulated: in No. 0 capsule, its filling is controlled at every 0.5g ± 7% with the particle packing for preparing.Promptly get the anti-sense detoxicating capsule for the treatment of anemopyretic cold, yield is 95%.
Claims (8)
1. an anti-sense detoxicating capsule is characterized in that mainly being made by following bulk drugs: Folium Isatidis 10-30 part, Flos Lonicerae 15-30 part, Radix Isatidis 10-30 part, Fructus Forsythiae 5-15 part, Rhizoma Dryopteris Crassirhizomatis 5-15 part, Rhizoma Bistortae 5-15 part, Radix Paeoniae Rubra 15-25 part.
2. anti-sense detoxicating capsule as claimed in claim 1 is characterized in that mainly being made by following bulk drugs: Folium Isatidis 15-25 part, Flos Lonicerae 18-23 part, Radix Isatidis 15-25 part, Fructus Forsythiae 8-12 part, Rhizoma Dryopteris Crassirhizomatis 5-10 part, Rhizoma Bistortae 8-12 part, Radix Paeoniae Rubra 18-23 part.
3. anti-sense detoxicating capsule as claimed in claim 2 is characterized in that mainly being made by following bulk drugs: 20 parts of Folium Isatidiss, 21 parts of Flos Loniceraes, 20 parts of Radix Isatidis, 10 parts of Fructus Forsythiaes, 7 parts of Rhizoma Dryopteris Crassirhizomatiss, 10 parts of Rhizoma Bistortaes, 21 parts of Radix Paeoniae Rubra.
4. the capsular preparation method of the described anti-sense detoxicating of claim 1 is characterized in that comprising the following steps:
A) take by weighing Folium Isatidis, Flos Lonicerae, Radix Isatidis, Fructus Forsythiae, Rhizoma Dryopteris Crassirhizomatis, Rhizoma Bistortae and the Radix Paeoniae Rubra of described weight proportion, add 6-14 times of water gaging, dipping spends the night under the room temperature;
B) heating decocted 1-3 hour, and A filters to get filtrate; Add 6-14 times of water gaging in filtering residue, decocted 1-3 hour, B filters to get filtrate;
C) merging filtrate A and liquor B, concentrating under reduced pressure gets clear paste, and adding ethanol to ethanol content is 40%-85%, standing over night, leaching supernatant;
D) reclaim ethanol in the supernatant, concentrating under reduced pressure gets clear paste, and adding ethanol to ethanol content once more is 40%-85%, standing over night, leaching supernatant;
E) reclaim ethanol in the supernatant, concentrate extractum;
F) the extractum vacuum drying makes extract powder;
G) extract powder mixes with adjuvant, makes granule, and particle packing makes anti-sense detoxicating capsule in capsule.
5. preparation method as claimed in claim 4 is characterized in that, among the step c filtrate to be concentrated into relative density be 1.05～1.15.
6. preparation method as claimed in claim 4 is characterized in that, supernatant concentration to relative density is 1.10～1.20 in the steps d.
7. preparation method as claimed in claim 4 is characterized in that, the particulate method of system is a dry granulation in the step g.
8. preparation method as claimed in claim 4 is characterized in that, the particulate method of system is a wet granulation in the step g.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103638122A (en) * | 2013-11-21 | 2014-03-19 | 宁夏多维药业有限公司 | Anti-common cold capsule preparation method |
| CN105920387A (en) * | 2016-04-27 | 2016-09-07 | 朱增伟 | Traditional Chinese medicine for treating viral cold |
| CN112493587A (en) * | 2020-12-18 | 2021-03-16 | 鲁南制药集团股份有限公司 | Separated anti-virus health mask |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1895410A (en) * | 2006-06-23 | 2007-01-17 | 徐新盛 | Medicinal composition for treating cough and its preparation |
| CN1943656A (en) * | 2005-10-08 | 2007-04-11 | 曾雄辉 | A kind of medicine for preventing and treating diseases of common cold, epidemic cold and parotitis |
| CN101780248A (en) * | 2010-03-04 | 2010-07-21 | 胡荣光 | Chinese herbal medicine compound for preventing flu |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1943656A (en) * | 2005-10-08 | 2007-04-11 | 曾雄辉 | A kind of medicine for preventing and treating diseases of common cold, epidemic cold and parotitis |
| CN1895410A (en) * | 2006-06-23 | 2007-01-17 | 徐新盛 | Medicinal composition for treating cough and its preparation |
| CN101780248A (en) * | 2010-03-04 | 2010-07-21 | 胡荣光 | Chinese herbal medicine compound for preventing flu |
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| 《中兽医医药杂志》 20050610 张晓菊等 浅论中药抗流感病毒研究概况 , 第03期 2 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103638122A (en) * | 2013-11-21 | 2014-03-19 | 宁夏多维药业有限公司 | Anti-common cold capsule preparation method |
| CN105920387A (en) * | 2016-04-27 | 2016-09-07 | 朱增伟 | Traditional Chinese medicine for treating viral cold |
| CN112493587A (en) * | 2020-12-18 | 2021-03-16 | 鲁南制药集团股份有限公司 | Separated anti-virus health mask |
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| CN102008557B (en) | 2011-11-16 |
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Address after: 310000 No. 12, No. 258, Hangzhou economic and Technological Development Zone, Hangzhou, Zhejiang Patentee after: Hangzhou Guoguang pharmaceutical Limited by Share Ltd Address before: 310018, No. 258, No. 12, Xiasha Road, Jianggan District economic and Technological Development Zone, Hangzhou, Zhejiang Patentee before: Hangzhou Guoguang Pharmaceutical Co., Ltd. |