CN1237983C - Compound rhizome of Cyrtomium aspirin tablet - Google Patents
Compound rhizome of Cyrtomium aspirin tablet Download PDFInfo
- Publication number
- CN1237983C CN1237983C CN 03108749 CN03108749A CN1237983C CN 1237983 C CN1237983 C CN 1237983C CN 03108749 CN03108749 CN 03108749 CN 03108749 A CN03108749 A CN 03108749A CN 1237983 C CN1237983 C CN 1237983C
- Authority
- CN
- China
- Prior art keywords
- aspirin
- compound recipe
- rhizoma osmundae
- percolation
- tablet
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
Landscapes
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention relates to a compound cyrtomin aspirin tablet for treating a cold and influenza, which is prepared by raw material medicines having the following weight percentages: 30 to 42% of basket fern rhizome, 20 to 30% of isatis roots, 20 to 30% of wild chrysanthemum flowers, 8 to 16% of vietnamese sophora roots, 1 to 4% of aspirin and 0.01 to 0.1% of chlorpheniramine maleate. The prescription can be prepared into anyy general oral medicine. The medicine of the present invention is a product organically combining traditional Chinese medicines and western medicines, wherein western medicine constituents relieve heat and symptoms, and eliminate pain; the traditional Chinese medicine constituents kill viruses and aim at reasons of diseases; the traditional Chinese medicines and the western medicines are combined to take the effect on treating both manifestation and root reasons of diseases. The present invention has the advantages of obvious treatment effect, convenient oral utilization, short course of treatment, obvious effect, no obvious poison side effect, and safe and reliable clinic use. The present invention adopts sandwich tablet preparation technology to effectively prevent the hydrolysis phenomenon of aspirin in the process of storage.
Description
Technical field the present invention relates to a kind of Chinese medicine and western medicine compound preparation for oral administration---compound recipe Rhizoma Osmundae Genprin and preparation method thereof that is used for the treatment of human body flu and influenza.
Background technology is more various to the types of drugs of treatment flu and influenza now, therapeutic domain is more single, how, because being virus, the special influenzas of most flu cause, so the curative effect of most coldrexs is not very good with antipyretic analgesic and relief of symptoms medicine compatibility.
At present, contain the Chinese medicine and western medicine compound preparation that the aspirin composition is used for the treatment of flu and anti-sense, all adopt the tablet that the method for tabletting makes behind the mixing granulation, because aspirin character instability, the influence of Chinese medicine ingredients in addition can be quickened the hydrolysis of aspirin, generates by-product, influence pharmaceutical effectiveness, increase the toxicity of medicine.
Summary of the invention the object of the present invention is to provide a kind of Chinese and western medicinal composition compound recipe Rhizoma Osmundae Genprin that human body flu and influenza is had significant curative effect.
Another object of the present invention is to provide a kind of preparation method that can solve this medicine aspirin stability problem in storage process preferably.
For achieving the above object, the technical scheme that the present invention takes is: medicament selection Rhizoma Dryopteris Crassirhizomatis of the present invention, Radix Isatidis, Flos Chrysanthemi Indici, Radix Sophorae Tonkinensis, aspirin, chlorphenamine maleate make up, make each efficacy of drugs produce synergism these drug regimens, thereby can effectively treat flu and influenza.Be the effect that monarch drug has heat-clearing and toxic substances removing with the Rhizoma Dryopteris Crassirhizomatis in the side, influenza virus is had very strong inhibitory action; Radix Isatidis, Flos Chrysanthemi Indici, Radix Sophorae Tonkinensis all have the effect of heat-clearing and toxic substances removing, pharynx-clearing throat-benefiting, and collaborative monarch drug is strengthened the effect of heat-clearing and toxic substances removing, is ministerial drug altogether.Wherein: but the main component of Rhizoma Dryopteris Crassirhizomatis is pannol, trident Embryo Gallus domesticus such as phenol, the chlorogenic acid test strong inhibition influenza virus of fainting, and certain antibacterial action is arranged; That the Radix Isatidis master contains is indigo, indirubin, qingdainone etc., various bacteria is had effect, and have Detoxication, has showed tangible refrigeration function during low dosage; Flos Chrysanthemi Indici contains volatile oil, is main component with Camphora, and contains australene, yejuhua lactone, Eucarvone etc., and hemolytic staphylococcus aureus, diphtheria corynebacterium, dysentery bacterium and bacillus pyocyaneus are all had inhibitory action; The Radix Sophorae Tonkinensis master contains alkaloid and chromocor compound, alkaloid has sophocarpine, matrine, oxymatrine, dauricine etc., flavone comprises sophoranone, sophoradin etc., can suppress delayed hypersensitivity, serum IgM and IgG antibody also show a rising trend, and its contained Radix Sophorae Flavescentis total alkaloids has inhibition and killing action to tubercule bacillus, vibrio cholera, leprosy bacillus, leptospira etc.; Aspirin is the salicylic acid antipyretic analgesic, the body temperature of fever patient is reduced to normally, but normal body temperature is not had influence, and it is synthetic and produce analgesic effect to suppress PG, no addiction die be widely used in clinical; Chlorphenamine maleate is a histamine H 1 receptor antagonist, is characterized in that antihistamine effect is stronger, and consumption is little, a little less than the central inhibitory action, is used to the early treatment that catches a cold with the aspirin compatibility, can alleviate the early symptom of flu.
The consumption of drug component of the present invention also draws through groping in a large number to sum up, and each component percentages content is: Rhizoma Dryopteris Crassirhizomatis 30-42%, Radix Isatidis 20-30%, Flos Chrysanthemi Indici 20-30%, Radix Sophorae Tonkinensis 8-16%, aspirin 1-4%, chlorphenamine maleate 0.01-0.1%.
Be preferably: Rhizoma Dryopteris Crassirhizomatis 750g, Radix Isatidis 500g, Flos Chrysanthemi Indici 500g, Radix Sophorae Tonkinensis 250g, aspirin 50g, chlorphenamine maleate 1g.
Medicine of the present invention can adopt the conventional method of Chinese medicine preparation to be prepared into any conventional oral preparations.For example: dissolved granule, capsule etc., still bring into play drug effect better, especially in order to solve this medicine aspirin stability problem in storage process, preferred sandwich tablet for each raw material that makes this medicine.But these can not be used to limit protection scope of the present invention.
Medicine of the present invention can obtain sandwich tablet by following method:
1. take by weighing Rhizoma Dryopteris Crassirhizomatis, Radix Isatidis, Flos Chrysanthemi Indici, Radix Sophorae Tonkinensis and pulverize separately by described percentage ratio consumption and become coarse powder;
2. get Flos Chrysanthemi Indici, Radix Sophorae Tonkinensis is made solvent with 80% ethanol, the percolation (appendix IO of Chinese Pharmacopoeia version in 2000) according under fluid extract and the extractum item carries out percolation 2-3ml/kg.min, the collection liquid of filtering;
3. get Rhizoma Dryopteris Crassirhizomatis, Radix Isatidis is made solvent with 60% ethanol, the percolation (appendix IO of Chinese Pharmacopoeia version in 2000) according under fluid extract and the extractum item carries out percolation 2-3ml/kg.min, the collection liquid of filtering;
4. merge percolate, reclaim ethanol, and fluid temperature concentrating under reduced pressure under 60-70 ℃, vacuum 0.02-0.04Mpa is become thick paste, spray drying is pulverized, and makes granule;
5. get aspirin and be ground into fine powder,, make granule, be pressed into chip with the chlorphenamine maleate mixing;
6. extract granule and chip are pressed into sandwich, the bag film-coat gets finished product.
Medicine of the present invention is the product that Chinese medicine and western medicine organically combines, western medicine composition antipyretic-antalgic wherein, relief of symptoms; The Chinese medicine ingredients kill virus is at the cause of disease.The Chinese medicine and western medicine synergism, treating both the principal and secondary aspects of a disease brings out the best in each other.Therapeutic effect is remarkable, has convenient oral, short treating period, instant effect, does not see obvious toxicity, clinical safe and reliable advantage.Medicine of the present invention takes sandwich tablet producing technology effectively to prevent the hydrolysis phenomenon of aspirin in storage process.
Below further set forth the beneficial effect of medicine of the present invention by test example, these test examples comprise aspirin stability accelerated test in animal acute toxicity test, pharmacodynamics test, clinical observation on the therapeutic effect test and the sandwich tablet of the sandwich tablet of a kind of dosage form (to call compound recipe Rhizoma Osmundae aspirin tablet in the following text) of medicine of the present invention.
Test example one: compound recipe Rhizoma Osmundae aspirin tablet animal acute toxicity test
Materials and methods
Animal: Kunming mouse, body weight are 19.90 ± 1.06, male and female half and half.Buy from Lanzhou Inst. of Biological Products, Ministry of Public Health.
Medicine: compound recipe Rhizoma Osmundae aspirin tablet is provided by LanZhou FoCi Pharmacy Co., Ltd.Prepare with distilled water.
The animal experiment chamber quality certification number: the general 004-01 of Gansu Province's experimental animal administration committee.
(1) mice LD
50Measure
60 of mices, random packet are 6 groups, 10 every group, and the intragastrically administration, dosage and concentration see table 8-1 for details, and agent was apart from 1: 3, and mice is normal behind the single administration, observes continuously 7 days, and mice all survives, and can't record LD
50
Compound recipe Rhizoma Osmundae aspirin tablet is pressed 0.5g/ml (maximum suspendible concentration), can't measure LD
50Value is so do maximum resistance test again by " provisions for new drugs approval ".
(2) mtd test
Get 20 of mices, observe and test after three days, water is can't help in test fasting the previous day, under the condition of 20 ± 2 ℃ of room temperatures, irritate stomach once, liquor strength is 0.5g/ml (a maximum suspendible concentration), dosage is 1ml/20g (maximum volume), administration accumulative total is 25g/kg in one day, after the administration, and two weeks of breeding observing.
The result is viewing duration after administration, and mice diet, feces, fur are normal, do not see the behavior change of mice outward appearance and poisoning symptom occurs, and vegetative activity is all right, none animal dead, and naked eyes cut open inspection, the main organs no abnormality seen.
Table 1-1: compound recipe Rhizoma Osmundae aspirin tablet LD
50Measure
| Group | Number of animals | Drug level | Dosage | The administration volume | Suitable clinical dosage | The dead mouse number | The survival mice situation |
| 1 2 3 4 5 6 | 10 10 10 10 10 10 | 0.16 0.20 0.27 0.32 0.40 0.50 | 4.00 5.00 6.00 8.00 10.00 12.50 | 0.5 0.5 0.5 0.5 0.5 0.5 | 66.7 83.3 100.0 133.3 166.7 208.3 | 0 0 0 0 0 0 | Normal normal |
Discuss and brief summary
At the LD that explores compound recipe Rhizoma Osmundae aspirin tablet
50During dosage, press the 12.5kg/kg gastric infusion, can't measure LD
50So, replenishing requirement according to the new drug toxicological study, the maximum volume under the Cmax that mice can be accepted carries out determination of acute toxicity, mainly observes the untoward reaction in two weeks of administration.The result is 416.6 times of corresponding clinical dosages when the mice dosage is 25kg/kg, and viewing duration does not see that mice has untoward reaction, and the postmortem naked eyes also do not see that main organs has ANOMALOUS VARIATIONS, and the basic avirulence of this medicine of results suggest is clinical safe in utilization.
Annotate: dosage all is meant and is equivalent to tablet weight in the test.
Test example two: compound recipe Rhizoma Osmundae aspirin tablet pharmacodynamics test
1. test material
1.1 medicine: compound recipe Rhizoma Osmundae aspirin tablet.Every contains Chinese medicine and is equivalent to the 2g crude drug, contains Western medicine 0.051g; Western medicine composition tablet (hereinafter to be referred as western medicine composition) contains Western medicine 0.051g; Above tablet is produced by LanZhou FoCi Pharmacy Co., Ltd.
1.2 experimental animal: KM kind mice, the male and female dual-purpose, body weight 14-22g is provided by Lanzhou Institute of Biological Products, the quality certification number: moving word 14-001 number of doctor.Wistar kind rat, male and female dual-purpose, body weight 180-200g.Animal housing provides by the Lanzhou medical college, the quality certification number: moving word 14-006 number of doctor.
2. test method and result
2.1 influence to influenza virus infecting mouse lung weight
Get 55 of the mices of 14-16g, be divided into 4 groups at random by body weight, normal down knot is according to 10 of groups, and all the other each groups are 15, and self-infection plays administration the previous day, wherein irritates stomach compound recipe Rhizoma Osmundae aspirin tablet 4.1g/g and western medicine composition 0.1g/kg respectively for 2 groups.Morning and afternoon every day, each administration was 1 time, and administration is 5 days altogether.Normal control group and virus control group are all irritated appearance normal saline such as stomach.After the administration in second day, except that the normal control group, all the other respectively organize mice under the slight anesthesia of ether, with influenza virus Mus lung adapted strain FM1 collunarium 15LD
50Infect, the normal control group replaces viral drop nose with reason saline under identical conditions.After the last administration, respectively organize the mice fasting and prohibited water 12 hours, after weighing mice is fixed, cut off skin of chest, cut off oxter, left side arterial blood letting and put to death, open the thoracic cavity, take out full lung and wash 2 times with clear water, extract tissues such as trachea and lymph node, use the filter paper suck dry moisture, precision balance is weighed, and is calculated as follows lung exponential sum suppression ratio.The results are shown in Table 2-1:
Table 2-1 compound recipe Rhizoma Osmundae aspirin tablet is to the influence of influenza virus Lung Index of mice infected by Influenza virus
| Group | Dosage (g/kg) | Number of animals | Lung index (%) | Lung index suppression ratio (%) |
| Normal control papova matched group compound recipe Rhizoma Osmundae aspirin tablet western medicine composition | Deng capacity such as capacity 4.1 0.1 | 10 11 15 14 | 0.82±0.09 ** 1.57±0.29 1.16±0.15 ** 1.29±0.18 *# | 26.11 21.70 |
Annotate: compare with the virus control group
*P＜0.01,
*#P＜0.05 is compared with compound recipe Rhizoma Osmundae aspirin tablet in P＜0.05
2.2 protective effect to the death of influenza virus infecting mouse
Get 70 of the mices of 11-16g, be divided into 4 groups at random, 10 of normal control groups, all the other each groups are 20, infect and play gastric infusion the previous day, wherein irritate stomach compound recipe Rhizoma Osmundae aspirin tablet 4.1g/kg western medicine composition 0.1g/kg respectively for 3 groups, respectively be administered once morning and afternoon every day, and administration is 5 days altogether.Normal control group and virus control group are all irritated capacity normal saline such as stomach, and after the administration in second day, except that the normal control group, all the other respectively organize mice under the slight anesthesia of ether, with influenza virus lung adapted strain FM1 collunarium 2LD
50Infect, the normal control group is used physiologic saline for substitute virus collunarium under identical conditions.Self-infection played observation 14 days the same day, and mouse diing time and death toll respectively organized in record, and carry out statistical procedures.The results are shown in Table 2-2
Table 2-2 compound recipe Rhizoma Osmundae aspirin tablet is to the protective effect of influenza virus infecting mouse death
| Group | Drug dose (g/kg) | Infective dose (10-6) | Number of animals (only) | Death toll (only) | Mortality rate (%) | Dead protective rate (%) | Average survival natural law (d) |
| Normal control virus control compound recipe Rhizoma Osmundae aspirin tablet western medicine composition | Deng capacity such as capacity 4.1 0.1 | 0.05 0.05 0.05 | 10 20 20 20 | 0 18 14 **# 17 | 0 90 70 85 | 30 15 | ＞14 6.5 9.8 **# 7.2 |
Annotate: compare with the virus control group
*#P＜0.05 is compared with compound recipe Rhizoma Osmundae aspirin tablet in P＜0.01
2.3 yeast is caused the refrigeration function of heating rat
Get dry yeast 10g, place mortar, adding distil water grinds to form outstanding uniformly slurry, and standardize solution is 50ml (20%) in the 50mL volumetric flask, gets 30 of rats, is divided into 3 groups at random, tests preceding 3 day every day and tests so that rat adapts to clinical thermometer.The same day was surveyed 2 anus temperature (1 hour at interval) with digital body thermometer (OMRON, MC---3 types) in test, get 2 meansigma methodss as administration before normal body temperature.Each organize rat irritate respectively stomach compound recipe Rhizoma Osmundae aspirin tablet 4.1g/kg, western medicine composition 0.1g/kg and etc. the capacity normal saline.Each Mus in back subcutaneous injection 20% sterilised yeast suspension 10ml/kg, was respectively surveyed body temperature once in 2,4,6 and 8 hours immediately then after the administration, after the off-test, carried out statistical procedures, the results are shown in Table 2-3:
Table 2-3 compound recipe Rhizoma Osmundae aspirin tablet is to the influence of heating rat temperature due to the yeast
| Group | Dosage (g/kg) | Rat temperature | ||||
| Before the administration | 2h | 4h | 6h | 8h | ||
| Normal control compound recipe Rhizoma Osmundae aspirin tablet western medicine composition | Deng capacity 4.1 0.1 | 37.84±0.20 37.81±0.23 37.76±0.23 | 37.73±0.23 37.58±0.19 37.64±0.22 | 38.27±0.13 37.58±0.1 9 ** 37.83±0.23 ** | 38.16±0.18 37.99±0.20 ** 38.01±0.24 ** | 38.45±0.34 38.11±0.22 * 38.31±0.23 |
Annotate: compare with the normal control group
*P＜0.05
*P＜0.01
2.4 the influence of xylol induced mice cutaneous permeability
Get 30 of body weight 18-20g mices, be divided into 3 groups at random, mouse web portion is lost hair or feathers with depilatory, respectively organized in second day mice irritate respectively stomach compound recipe Rhizoma Osmundae aspirin tablet 4.1g/kg, western medicine composition 0.1g/kg and etc. the normal saline of capacity.Respectively organized mouse tail vein injection 0.5% Azo-Blue normal saline 0.1ml/10g after the administration in 1 hour, only drip dimethylbenzene 0.03ml/ in mouse web portion depilation position immediately, behind the 20min dislocation of mice cervical vertebra is put to death, cut abdominal part indigo plant and dye skin, put into the test tube that adds acetone-metabisulfite solution 10ml after shredding, jumping a queue places the dark place to place the centrifugal 10min of 2000rpm behind the 72h, get supernatant and measure OD value (7220 type spectrophotometer) in the 590nm place, with acetone-metabisulfite solution school zero.The results are shown in Table 2-4
The influence of table 2-4 compound recipe Rhizoma Osmundae aspirin tablet xylol induced mice capillary of skin permeability
| Group | Dosage (g/kg) | Number of animals | The OD letter (X ± S) |
| Normal control compound recipe Rhizoma Osmundae aspirin tablet western medicine composition | Deng capacity 4.1 0.1 | 10 10 10 | 0.446±0.089 0.325±0.048 ** 0.334±0.061 ** |
Annotate: compare with the normal control group
*P＜0.01
2.5 the influence of Dichlorodiphenyl Acetate induced mice writhing response
Get 30 of mice body weight 18-20g mices, be divided into 3 groups at random, each organize mice irritate respectively stomach compound recipe Rhizoma Osmundae aspirin tablet 4.1g/kg, western medicine composition 0.1g/kg and etc. the normal saline of capacity.40min after the administration respectively organizes the mouse writhing number of times according to writhing method mensuration, carries out statistical procedures, the results are shown in Table 2-5:
The influence of table 2-5 compound recipe Rhizoma Osmundae aspirin tablet Dichlorodiphenyl Acetate induced mice writhing response
| Group | Dosage (g/kg) | Number of animals | Turn round the body number of times |
| Normal control compound recipe Rhizoma Osmundae aspirin tablet western medicine composition | Deng capacity 4.1 0.1 | 10 10 10 | 31.3±4.6 19.6±5.1 ** 20.2±6.5 ** |
Annotate: compare with the normal control group
*P＜0.01
3. conclusion
Result of the test shows that compound recipe Rhizoma Osmundae aspirin tablet and western medicine composition all can obviously reduce influenza infection mouse lung index, and exponential reduction effect is better than western medicine composition to compound recipe Rhizoma Osmundae aspirin tablet to lung, compares significant difference with western medicine composition.The dead mouse quantity that compound recipe Rhizoma Osmundae aspirin tablet can make influenza virus cause reduces, and makes influenza virus cause dead mice prolonged survival period, compares significance with western medicine composition.Yeast is caused the heating rat, and compound recipe Rhizoma Osmundae aspirin tablet and western medicine composition all have refrigeration function, and compound recipe Rhizoma Osmundae aspirin tablet and western medicine composition relatively have enhanced trend.Compound recipe Rhizoma Osmundae aspirin tablet and increasing of western medicine composition xylol induced mice capillary of skin permeability have tangible reduction effect, with the matched group comparing difference significance is arranged, compound recipe Rhizoma Osmundae aspirin tablet and western medicine composition comparing difference do not have significance, but the effect of compound recipe Rhizoma Osmundae aspirin tablet group has enhanced trend.To lumbar injection acetic acid induced mice writhing response, compound recipe Rhizoma Osmundae aspirin tablet and western medicine composition all have the obvious suppression effect, but two group differences do not have significance.
In sum; the compound recipe Rhizoma Osmundae aspirin tablet of being made up of Chinese medicine ingredients and western medicine composition has significant protective effect to influenza virus infecting mouse pulmonary; this effect is better than western medicine composition, and compound recipe Rhizoma Osmundae aspirin tablet causes that to influenza virus the protective effect of dead mouse also is better than western medicine composition.Yeast is caused the cooling effect of heating rat, the inhibitory action that increases of xylol induced mice skin capillary permeability and Dichlorodiphenyl Acetate cause the inhibitory action of the writhing response due to the mouse peritoneal pain, compound recipe Rhizoma Osmundae aspirin tablet and western medicine composition are relatively, two group difference nonsignificances, but enhanced trend is arranged with the effect of western medicine composition comparison compound recipe Rhizoma Osmundae aspirin tablet.
Test example three: the clinical observation on the therapeutic effect test of compound recipe Rhizoma Osmundae aspirin tablet treatment influenza, flu
Affiliated Hospital No.1, Lanzhou Medical College, Gansu Provincial Hospital of Traditional Chinese Medicine, three tame hospitals of Gansu Province's building worker's hospital in November, 1998-1998 year December compound recipe Rhizoma Osmundae aspirin tablet has been carried out clinical verification, patient's 120 examples (60 examples of catching a cold, influenza 60 examples) have been observed altogether, western medicine composition matched group 90 examples.Now result of the test is reported as follows.
1. data and method
1.1 diagnostic criteria
Flu: diagnosis upper respiratory tract infection is mainly by there being the popular contact history of catching a cold, clinical manifestation, and X line finding and numeration of leukocyte, and to the reaction of antibiotic therapy.
(1) clinical manifestation: the dry pharynx pharyngalgia, nasal obstruction sneeze, watery nasal discharge, cough, heating, headache, systemic pain, weak, poor appetite etc.
(2) numeration of leukocyte is normal or on the low side.
Influenza:
(1) epidemiology contact history.
(2) clinical manifestation onset is hurried, based on General Symptoms: fear of cold, heating, general malaise, aching pain in waist and back, headache, nasal obstruction, the few expectorant of cough, chest pain, Blushing, eye conjunctiva and pharyngeal congestion.
1.2 include, get rid of the case standard in
Include the case standard in
Meet flu diagnostic criteria, influenza diagnostic criteria, body temperature is more than 38 ℃, and the course of disease is the person within 48 hours, can include the test case in.
Get rid of the case standard
(1) used other to treat the medicine person of influenza, flu.
(2) age is at under-18s or over-65s, gestation and women breast-feeding their children, allergic constitution and may allergy sufferers to this medicine.
(3) merge serious primary disease persons such as cardiovascular, cerebrovascular, liver, kidney, hemopoietic system, psychotic.
(4) do not meet the standard of including in, not medication in accordance with regulations can't be judged curative effect, or data is not congruent affects the treatment or safety judgement person.
1.3 physical data is selected outpatient service and inpatient 60 examples of catching a cold, influenza 60 examples, western medicine composition matched group catch a cold 45 examples, influenza 45 examples.Difference that each organizes sex, the age, there are no significant (P＞0.01).
2. Therapeutic Method
This test adopts single at random blind method to observe.The treatment group is taken compound recipe Rhizoma Osmundae aspirin tablet, (oral, each 4, every day 3 times) provide by LanZhou FoCi Pharmacy Co., Ltd.The western medicine composition matched group take have only aspirin, tablet that chlorphenamine maleate is made (contain Western medicine 0.051g, oral, each 4, every day 3 times), provide by LanZhou FoCi Pharmacy Co., Ltd.Treatment was a course of treatment with 3 days all.
3. result
Curative effect determinate standard
Flu: formulate according to " Western medicine new drug treatment flu clinical research guideline ".The recovery from illness: treat 3 days normal with interior temperature recovery, cold symptoms all disappears.Produce effects: treat 3 days normal with interior body temperature, most of transference cure of flu.Effectively: treat and reduced than before with interior body temperature in 3 days, the cardinal symptom of flu partly disappears.Invalid: treat and do not reduce with interior body temperature or raise in 3 days, the cardinal symptom of flu does not have improvement.
Influenza: formulate according to " Western medicine new drug treatment flu clinical research guideline ".Recovery from illness: treat in 3 days, body temperature is normal, transference cure, and do not have repeatedly.Produce effects: treat 3 days normal substantially with interior body temperature, cardinal symptom disappears.Effectively: treated 3 days, body temperature descends, but still has repeatedly, and cardinal symptom partly disappears.Invalid: treated 3 days, body temperature does not fall, and symptom does not have obvious improvement.
3.1 efficacy analysis sees Table 3-1,3-2:
Table 3-1 flu comprehensive therapeutic effect relatively
| Group | The example number | Recovery from illness (%) | Produce effects (%) | Effectively (%) | Total effective rate (%) |
| Compound recipe Rhizoma Osmundae aspirin tablet western medicine composition | 60 45 | 48.5 19.7 | 29.6 17.4 | 13.4 20.8 | 91.5 57.9 |
Comprehensive therapeutic effect compares, P＞0.01, and there were significant differences.
Table 3-2 influenza comprehensive therapeutic effect relatively
| Group | The example number | Recovery from illness (%) | Produce effects (%) | Effectively (%) | Total effective rate (%) |
| Compound recipe Rhizoma Osmundae aspirin tablet western medicine composition | 60 45 | 44.9 16.6 | 28.5 20.2 | 17.1 15.0 | 90.5 51.8 |
Comprehensive therapeutic effect compares, and there is highly significant difference P＞0.01, and compound recipe Rhizoma Osmundae aspirin tablet group is better than the western medicine composition group.
3.2 symptom, sign curative effect are relatively, see Table 3-3,3-4:
Table 3-3 cold symptoms sign curative effect relatively
| Sequence number | Symptom | Compound recipe Rhizoma Osmundae aspirin tablet group | The western medicine composition group | ||||
| Treat precedent number (n) | Cure rate (%) | Total effective rate (%) | Treat precedent number (n) | Cure rate (%) | Total effective rate (%) | ||
| A B C D E F G H | The yellow tears headache of fever and aversion to wind nasal obstruction stream bodily pain cough dry throat pain | 54 48 48 45 48 35 33 26 | 55.6 46.7 42.9 61.5 48.2 48.5 40.0 37.5 | 100.0 94.3 85.7 92.3 89.2 90.0 90.8 90.0 | 44 36 38 37 27 28 22 19 | 46.7 14.3 7.8 22.2 20.2 12.5 16.7 14.3 | 100.0 50.0 54.5 45.5 75.5 81.8 58.2 50.0 |
Annotate: A, E, F＞0.05 B, C, D, G, H＜0.001
Table 3-4 flu-like symptom sign curative effect relatively
| Sequence number | Symptom | Compound recipe Rhizoma Osmundae aspirin tablet group | The western medicine composition group | ||||
| Treat precedent number (n) | Cure rate (%) | Total effective rate (%) | Treat precedent number (n) | Cure rate (%) | Total effective rate (%) | ||
| A B C D E F G H I J | The asthma of fever with chilliness nasal obstruction runny nose headache bodily pain dry cough pharyngalgia is coughed up phlegm | 55 49 52 42 46 49 40 34 42 34 | 55.6 46.7 44.4 50.0 40.0 38.9 41.7 50.0 45.7 46.6 | 100.0 93.3 94.4 92.9 78.8 78.6 88.3 92.0 93.0 92.0 | 42 36 31 29 42 34 30 27 30 17 | 50.0 16.7 20.0 12.5 12.5 16.7 9.1 11.0 8.3 8.3 | 92.9 41.7 54.5 45.0 62.3 68.7 38.0 36.0 40.5 28.6 |
Annotate: A, E, F＞0.05 B, C, D, G, H, I, J＜0.001
4. safety detects
In the clinical verification of compound recipe Rhizoma Osmundae aspirin tablet, carried out blood, urine, just safeties detections such as routine, electrocardiogram, liver, kidney, function before and after treatment organized 120 routine patient treatments, do not seen obvious toxicity, clinical take safe and reliable.
5. untoward reaction
Treatment is organized 120 routine patients in the clinical verification process, and removing 3 routine patients has slight drowsiness sense, slight digestive tract reaction place, and other have no adverse reaction, and transference cure behind the adjustment dose.
6. sum up
Compound recipe Rhizoma Osmundae aspirin tablet is the product that Chinese medicine and western medicine organically combines, and its effect is better, has convenient oral, short treating period, instant effect, the little advantage of side effect.From table 1,2 comprehensive curative effects relatively, the individual event cure rate relatively has significant difference (P＞0.01), and treatment group curative effect is better than matched group.In table 3, alleviate heating, headache, the no significant difference of general pain symptom (P＞0.05), and there were significant differences to symptom cure rates (P＞0.01) such as aversion to wind, nasal obstruction, stream yellow thick nasal discharge, cough, dry pharynx pains.Alleviate heating, headache, the no significant difference of general pain symptom (P＞0.05) in the table 4, and to aversion to cold, nasal obstruction, watery nasal discharge, dry cough, pharyngalgia, pant, cough up phlegm etc. that there were significant differences for symptom cure rate (P＞0.01).
Test example four: compound recipe Rhizoma Osmundae aspirin tablet stability accelerated test
1. test method is got three batches of compound recipe Rhizoma Osmundae aspirin tablets, press commercially available back,, place under the condition of relative humidity 75% ± 5% 40 ℃ ± 2 ℃ of temperature, in duration of test sampling respectively in 0th month, the 1st month, 2 months, 3 months, 6 months, investigate by the stability test requirement.
2. investigate project character, discriminating, tablet weight variation, disintegration, health examination, assay.
3. investigate and the results are shown in Table 4-1, table 4-2, table 4-3:
Table 4-1 lot number 010101
Table 4-2 lot number 010102
Table 4-3 lot number 010103
4. investigate conclusion reserved sample observing result and show, compound recipe Rhizoma Osmundae aspirin tablet is placed under relative humidity 75% ± 5% condition after six months 40 ℃ ± 2 ℃ of temperature, and it is all up to specification that its character, discriminating assay etc. detects index.Test shows that this sandwich blade technolgy can effectively prevent aspirin hydrolysis phenomenon in storage process.
Appended drawings is preparation technology's flow chart of the sandwich tablet form of the present invention.
With embodiment the present invention is described in further detail below the specific embodiment:
Rhizoma Dryopteris Crassirhizomatis 750g, Radix Isatidis 500g, Flos Chrysanthemi Indici 500g, Radix Sophorae Tonkinensis 250g, aspirin 50g, chlorphenamine maleate 1g.
Embodiment one: the sandwich method for preparing tablet thereof of medicine of the present invention:
1. take by weighing Rhizoma Dryopteris Crassirhizomatis, Radix Isatidis, Flos Chrysanthemi Indici, Radix Sophorae Tonkinensis and pulverize separately by recipe quantity and become coarse powder;
2. get Flos Chrysanthemi Indici, Radix Sophorae Tonkinensis is made solvent with 80% ethanol, the percolation (appendix IO of Chinese Pharmacopoeia version in 2000) according under fluid extract and the extractum item carries out percolation 2-3ml/kg.min, the collection liquid of filtering;
3. get Rhizoma Dryopteris Crassirhizomatis, Radix Isatidis is made solvent with 60% ethanol, the percolation (appendix IO of Chinese Pharmacopoeia version in 2000) according under fluid extract and the extractum item carries out percolation 2-3ml/kg.min, the collection liquid of filtering;
4. merge percolate, reclaim ethanol, and fluid temperature concentrating under reduced pressure under 60-70 ℃, vacuum 0.02-0.04Mpa is become thick paste, spray drying is pulverized, and makes granule;
5. get aspirin and be ground into fine powder,, make granule, be pressed into chip with the chlorphenamine maleate mixing;
6. extract granule and chip are pressed into 1000 sandwich, the bag film-coat, packing inspection promptly gets compound recipe Rhizoma Osmundae aspirin tablet finished product.
7. sandwich of this medicine is a Film coated tablets, remove the peplos clothing after, be Chinese traditional medicine layer, show brown or sepia; Inner core is that Western medicine is white in color, distinguish the flavor of little acid, hardship.
Embodiment two: the capsule preparation method thereof of medicine of the present invention:
Step is 1. extremely 4. with embodiment one;
5. get aspirin and be ground into fine powder,, make granule with the chlorphenamine maleate mixing;
6. with extract granule with after the western medicine composition granule fully mixes, incapsulate, finished product.
Embodiment three: the preparation method of medicine instant of the present invention:
1. extremely 3. with embodiment one;
4. merge percolate, reclaim ethanol, and fluid temperature concentrating under reduced pressure under 60-70 ℃, vacuum 0.02-0.04Mpa is become thick paste, spray drying is pulverized, extract powder;
5. get aspirin, chlorphenamine maleate pulverize separately, get fine powder;
6. get Chinese medical concrete fine powder and Western medicine fine powder, add a small amount of Icing Sugar and soluble starch, fully granulate behind the mixing, get finished product after the packing.
Claims (8)
1, a kind of medicaments compound Rhizoma Osmundae Genprin for the treatment of flu and influenza is characterized in that the medicament that it is made by the following raw materials by weight percent medicine: Rhizoma Dryopteris Crassirhizomatis 30-42%, Radix Isatidis 20-30%, Flos Chrysanthemi Indici 20-30%, Radix Sophorae Tonkinensis 8-16%, aspirin 1-4%, chlorphenamine maleate 0.01-0.1%.
2, compound recipe Rhizoma Osmundae Genprin according to claim 1 is characterized in that the consumption of each crude drug is: Rhizoma Dryopteris Crassirhizomatis 750g, Radix Isatidis 500g, Flos Chrysanthemi Indici 500g, Radix Sophorae Tonkinensis 250g, aspirin 50g, chlorphenamine maleate 1g.
3, compound recipe Rhizoma Osmundae Genprin according to claim 1 and 2 is characterized in that said medicament can also be a said dosage form for oral administration on any pharmaceutics.
4, compound recipe Rhizoma Osmundae Genprin according to claim 3 is characterized in that said medicament can be dissolved granule, capsule or sandwich tablet.
5, compound recipe Rhizoma Osmundae Genprin according to claim 4 is characterized in that sandwich of described medicine is Film coated tablets, remove the peplos clothing after, be Chinese traditional medicine layer, show brown or sepia; Inner core is a Western medicine, is white in color, distinguish the flavor of little acid, hardship.
6, the preparation method of compound recipe Rhizoma Osmundae Genprin according to claim 5 is characterized in that and can obtain sandwich tablet by following method:
1. take by weighing Rhizoma Dryopteris Crassirhizomatis, Radix Isatidis, Flos Chrysanthemi Indici, Radix Sophorae Tonkinensis and pulverize separately by described percentage ratio consumption and become coarse powder;
2. get Flos Chrysanthemi Indici, Radix Sophorae Tonkinensis is made solvent with 80% ethanol, the percolation according under fluid extract and the extractum item carries out percolation 2-3ml/kg.min, the collection liquid of filtering;
3. get Rhizoma Dryopteris Crassirhizomatis, Radix Isatidis is made solvent with 60% ethanol, the percolation according under fluid extract and the extractum item carries out percolation 2-3ml/kg.min, the collection liquid of filtering;
4. merge percolate, reclaim ethanol, and fluid temperature concentrating under reduced pressure under 60-70 ℃, vacuum 0.02-0.04Mpa is become thick paste, spray drying is pulverized, and makes granule;
5. get aspirin and be ground into fine powder,, make granule, be pressed into chip with the chlorphenamine maleate mixing;
6. extract granule and chip are pressed into sandwich, the bag film-coat gets sandwich tablet finished product.
7, the preparation method of compound recipe Rhizoma Osmundae Genprin according to claim 4 is characterized in that and can obtain capsule by following method:
1. take by weighing Rhizoma Dryopteris Crassirhizomatis, Radix Isatidis, Flos Chrysanthemi Indici, Radix Sophorae Tonkinensis and pulverize separately by described percentage ratio consumption and become coarse powder;
2. get Flos Chrysanthemi Indici, Radix Sophorae Tonkinensis is made solvent with 80% ethanol, the percolation according under fluid extract and the extractum item carries out percolation 2-3ml/kg.min, the collection liquid of filtering;
3. get Rhizoma Dryopteris Crassirhizomatis, Radix Isatidis is made solvent with 60% ethanol, the percolation according under fluid extract and the extractum item carries out percolation 2-3ml/kg.min, the collection liquid of filtering;
4. merge percolate, reclaim ethanol, and fluid temperature concentrating under reduced pressure under 60-70 ℃, vacuum 0.02-0.04Mpa is become thick paste, spray drying is pulverized, and makes granule;
5. get aspirin and be ground into fine powder,, make granule with the chlorphenamine maleate mixing;
6. with extract granule with after the western medicine composition granule fully mixes, incapsulate, the capsule finished product.
8, the preparation method of compound recipe Rhizoma Osmundae Genprin according to claim 4 is characterized in that and can obtain electuary by following method:
1. take by weighing Rhizoma Dryopteris Crassirhizomatis, Radix Isatidis, Flos Chrysanthemi Indici, Radix Sophorae Tonkinensis and pulverize separately by described percentage ratio consumption and become coarse powder;
2. get Flos Chrysanthemi Indici, Radix Sophorae Tonkinensis is made solvent with 80% ethanol, the percolation according under fluid extract and the extractum item carries out percolation 2-3ml/kg.min, the collection liquid of filtering;
3. get Rhizoma Dryopteris Crassirhizomatis, Radix Isatidis is made solvent with 60% ethanol, the percolation according under fluid extract and the extractum item carries out percolation 2-3ml/kg.min, the collection liquid of filtering;
4. merge percolate, reclaim ethanol, and fluid temperature concentrating under reduced pressure under 60-70 ℃, vacuum 0.02-0.04Mpa is become thick paste, spray drying is pulverized, extract powder;
5. get aspirin, chlorphenamine maleate pulverize separately, get fine powder;
6. get Chinese medical concrete fine powder and Western medicine fine powder, add a small amount of Icing Sugar and soluble starch, fully granulate behind the mixing, get the electuary finished product after the packing.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03108749 CN1237983C (en) | 2003-03-26 | 2003-03-26 | Compound rhizome of Cyrtomium aspirin tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03108749 CN1237983C (en) | 2003-03-26 | 2003-03-26 | Compound rhizome of Cyrtomium aspirin tablet |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1466981A CN1466981A (en) | 2004-01-14 |
| CN1237983C true CN1237983C (en) | 2006-01-25 |
Family
ID=34152331
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 03108749 Expired - Lifetime CN1237983C (en) | 2003-03-26 | 2003-03-26 | Compound rhizome of Cyrtomium aspirin tablet |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1237983C (en) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100417393C (en) * | 2004-07-16 | 2008-09-10 | 福建三爱药业有限公司 | Compound asket fern and aspirin preparation for treating cold and its preparation process |
| CN101134035B (en) * | 2004-12-10 | 2010-06-09 | 上海第二医科大学附属仁济医院 | Application of sophocarpine in the preparing of medicament for treating inflammation caused by influenza B virus |
| CN103520632B (en) * | 2013-08-06 | 2016-01-06 | 河南科技大学 | One is used for the treatment of grippal Chinese medicine composition and preparation method thereof |
| CN115669811A (en) * | 2022-11-07 | 2023-02-03 | 江苏海枫达生物科技有限公司 | Production and use method and production equipment of moistureproof premixed sheet containing gamma amino acid additive |
-
2003
- 2003-03-26 CN CN 03108749 patent/CN1237983C/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| CN1466981A (en) | 2004-01-14 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1210047C (en) | Medicine for treating cold and preparation method thereof | |
| CN104352552A (en) | Food, health care product or medicine composition | |
| CN101703684B (en) | Medicament for treating allergic purpura and preparation method thereof | |
| CN1403138A (en) | Compound Chinese medicine prepn for treating urinary system infection and prostatitis and its prepn process | |
| CN106974952A (en) | Application of the fresh ginseng activity extract in treatment oral cavity and digestive tract ulcer medicine is prepared | |
| CN1682843A (en) | A kind of traditional Chinese medicine composition for preventing bird flu | |
| CN1237983C (en) | Compound rhizome of Cyrtomium aspirin tablet | |
| CN102139051B (en) | Application of soft capsule capable of clearing heat and eliminating toxin in preparation of medicament for treating viral pneumonia | |
| CN106511740B (en) | A kind of product and preparation method thereof comprising ginseng | |
| CN102198192B (en) | Traditional Chinese medicine composition for treating HINI and application thereof | |
| CN100563680C (en) | Chinese medicine preparation and the method for making and the application thereof of prevention and treatment intestinal adhesion after abdominal cavity operation | |
| CN103316103B (en) | Coccidian-expelling and dysentery-stopping mixture for livestock and preparation method thereof | |
| CN101721437B (en) | Preparation method of pharmaceutical composition for treating chronic pharyngitis | |
| CN116036188B (en) | Traditional Chinese medicine composition for preventing and treating chicken coccidiosis as well as preparation method and application thereof | |
| CN104436022A (en) | Hemsleya-macrosperma-containing traditional Chinese medicine composition for treating diabetes mellitus | |
| CN104435931B (en) | One kind analgesic patch and preparation method thereof | |
| CN109663012A (en) | Dispelling wind and heat, removing toxic substances relieving sore-throat Chinese medicine composition and the preparation method and application thereof | |
| CN109200108B (en) | Traditional Chinese medicine composition for treating depression and preparation method and application thereof | |
| CN104042928A (en) | Pharmaceutical composition for treating diabetes and its preparation method and use | |
| CN1957997A (en) | Animal use compound medicament with effects of relieving the muscles and skin, clearing away heat, relieving darrhea, and relieving dysentery, and preparation method | |
| CN103893512B (en) | A kind of Chinese medicine composition for treating urarthritis | |
| CN102552440A (en) | Anti-asthmatic and anti-inflammatory medicament and preparation method and application thereof | |
| CN107137621A (en) | It is a kind of to treat Chinese medicine composition of high fat of blood and its preparation method and application | |
| CN101045116A (en) | Traditional Chinese medicine for treating cholecystitis | |
| CN106924448A (en) | Treat pharmaceutical composition of anemopyretic cold and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CX01 | Expiry of patent term | ||
| CX01 | Expiry of patent term |
Granted publication date: 20060125 |