CN1101689C - Anti-infectious antipyretic and antalgic medicine - Google Patents
Anti-infectious antipyretic and antalgic medicine Download PDFInfo
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- CN1101689C CN1101689C CN00112661A CN00112661A CN1101689C CN 1101689 C CN1101689 C CN 1101689C CN 00112661 A CN00112661 A CN 00112661A CN 00112661 A CN00112661 A CN 00112661A CN 1101689 C CN1101689 C CN 1101689C
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- medicine
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- baicalin
- andrographolide
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Abstract
The present invention relates to an anti-infectious antipyretic and antalgic medicine basically made from baicalin or corresponding water-solubility derivatives thereof and andrographolide or corresponding water-solubility derivatives thereof, wherein the proportion by weight of the baicalin to the andrographolide is (1 to 20): 1.
Description
What the present invention relates to is a kind of medicine with antibiotic, viral infection resisting and antipyretic effect.
It is existing many to be used for the treatment of infection that pathogenic microorganism such as antibacterial, virus cause and/or the medicine with antipyretic effect, and its indication, range of application and characteristics are respectively arranged.The medicine that is active component with natural medicinal raw material or its effective component extracts of single or mixed form is a big class wherein.For example, " the compound Radix Scutellariae sheet " that has been written in pharmaceutical standards or the preparation handbook as the typing medicine has a heat-clearing and toxic substances removing by what natural medicinal raw materials such as Radix Scutellariae, Rhizoma Polygoni Cuspidati, Herba Andrographis and Mahonia fortunei (Lindl.) Fedde were formed, removing heat from blood is subsided a swelling function and be can be used for treating laryngopharynx swelling and pain, aphtha of the mouth and tongue, cold, fever, damp-heat in the large intestine is had loose bowels, the puckery pain of pyretic stranguria, the oral type Chinese traditional patent formulation preparation of diseases such as carbuncle skin infection; " lotus sesame antiphlogistic capsule " has a heat clearing away by what the extract of total andrographolides and two kinds of natural medicinal raw materials of Radix Helicteris dry extractum was formed, detoxifcation, and antiinflammation can be used for gastroenteritis, bronchitis, tonsillitis, pharyngolaryngitis, the medicine of diseases such as pneumonia.These medicines by natural medicinal raw material or its extract component all are medicines of peroral dosage form, and occupation mode is comparatively single, and can make thus on administration patient's the object and be subjected to certain limitation.If directly use the natural drug raw material, remove the volume increased used preparation during pharmacy, say in a sense because of effective ingredient fully to discharge the waste that causes medicinal raw material.
At above-mentioned situation, it is more simple that purpose of the present invention at first provides a kind of composition, and the medicine that combines by the effective component extracts of the effective ingredient of natural medicinal raw material or its medicinal raw material with infection and antipyretic effect, make its active constituent content height, produce effects is fast, toxic and side effects is little, has better infection and antipyretic-antalgic effect.Further aim of the present invention provides a kind of medicine of oral agents with infection and antipyretic effect and the injection dosage form based on it.
The present invention has the medicine of infection and antipyretic effect, basically by baicalin or its corresponding soluble derivative, with andrographolide or its corresponding soluble derivative, be baicalin by weight: andrographolide=(1～20): 1 ratio is formed.The structure of baicalin is suc as formula shown in (I), R wherein
1=OH, R
2=glucuronic acid, R
3=H; The structure of andrographolide is suc as formula shown in (II).Baicalin and andrographolide, or its corresponding soluble derivative---the alkali metal salt compounds composition that allowed in pharmacopedics as the most frequently used potassium salt, sodium salt etc. is two kinds of active effective ingredient in the medicine of the present invention.Except that the composition form that can use its unification compound, according to its source, mode and/or the different needs in different preparations and process thereof, can allow also to contain other unavoidable impurity, complementary adding ingredient or can not cause adverse effect and/or interferential composition the drug action of this effective ingredient.
Said baicalin is faint yellow fine needle crystal in the mentioned component, and fusing point is 223-225 ℃.Known its has the pharmacological action of infection and antipyretic-antalgic, antiallergic action, antibiotic, hepatic cholagogic, blood pressure lowering, diuresis, calmness, aspect such as analgesic.This composition can be for by chemical complete synthesis mode, or the chemical compound that after chemical modification is transformed, is obtained by other related compound, also can be for by natural medicinal raw material---except that the root of the medicinal raw material Radix Scutellariae that generally can often adopt, can also be by other the natural medicinal raw material that equally also contains the baicalin composition, as and the Ye Hegen of head leather, leaf and the peel of stem of Bignoniaceae plant Semen Oroxyli, or the natural medicinal raw materials such as leaf of Plantaginaceae plant Big Semen Plantaginis, through extracting, this chemical compound composition that separates and obtain, even can also use the water extract of the various natural medicinal raw materials such as above-mentioned Radix Scutellariae of the baicalin that contains above-mentioned significant proportion amount to replace.Owing to itself have water solublity, except that having when needing especially, generally can make corresponding soluble derivative and use.When the water extract that directly uses natural medicinal raw material is replaced, difference with raw materials used kind and/or source, wherein can have other composition that ratio does not wait simultaneously inevitably, but as long as it meets not the requirement that the drug action to effective ingredient of the present invention has a negative impact, and the restriction of the requirement of different preparations and allowed band, can allow it to be present in the medicine.For example, in the water extract that is obtained by the medicinal raw material Radix Scutellariae, its main effective ingredient is a flavone compound, and has isolated the dozens of chromocor compound.Except that baicalin, as the baicalin (R in the formula (I) as main effective ingredient
1=OH, R
2=H, R
3=H), the wogonin (R in the formula (I)
1=H, R
2=H, R
3=OCH
3) and the wogonoside (R in the formula (I)
1=H, R
2=glucuronic acid, R
3=OCH
3) wait other composition can exist simultaneously inevitably.These compositions generally can not influence and disturb the drug action of baicalin, thereby under the prerequisite of the usage ratio that guarantees above-mentioned baicalin, according to the requirement of concrete pharmaceutical technology and preparation, can allow it to exist with suitable form and/or ratio.
Said andrographolide is the crystallization of colourless square, rectangle or prism-shaped in the mentioned component, odorless, and bitter in the mouth, fusing point are 224-230 ℃, and be water insoluble and be dissolved in the ethanol that boils, and slightly is dissolved in methanol or ethanol.Existing known this composition can have the pharmacologically active of aspects such as infection and antipyretic-antalgic, analgesia, analgesic, antiulcer, diuresis.This composition equally also can be for passing through the complete synthesis mode of chemistry, or the chemical compound that after chemical modification is transformed, is obtained by other related compound, this chemical compound composition that also can serve as reasons and obtain through ethanol extraction, separation as the Herba Andrographis of natural medicinal raw material, even can also use the ethanol extraction of the Herba Andrographis raw material of the andrographolide that contains the significant proportion amount to replace.When needs are made the water solublity dosage form, can use the soluble derivative commonly used of its corresponding potassium salt, sodium salt or other appropriate format that is prepared into according to a conventional method.When its ethanol extraction of direct use was replaced, this extract normally comprised this lactone and makes at interior total andrographolides.In like manner, as long as other wherein contained composition can not have a negative impact to the effect of effective ingredient in the said medicine of the present invention, and, also need not ask and its separation is removed and allow it to exist simultaneously with suitable form and/or ratio according to the requirement and the allowed band of different preparations.
Medicine of the present invention by after the said mixed, according to required dosage form, respectively by different dosage form preparation requirement, standard separately, and regulations such as processing, detection method, is made the medicine of corresponding dosage form with above-mentioned effective medicinal ingredient in the preparation.As: after adding the composition of suitable auxiliary, interpolation property, can be made into solid oral dosage forms such as corresponding tablet, pill, capsule, or the medicine of liquid oral dosage forms such as electuary, syrup, extractum.By the requirement and the processing method of injection routine, can make the medicine of corresponding intramuscular injection or intravenous form.
With said medicine of the present invention by baicalin: andrographolide is to be prepared into test specimen medicine at 4: 1, has carried out the toxicity test of animal:
Acute toxicity test: get 20 of mices, connect the dosage of 18.27 gram/kilograms (be equivalent to clinical consumption 725 times), every day, 2 gastric infusions were observed none animal dead continuously 8 days.Fail to record its median lethal dose(LD 50) LD
50
Long term toxicity test: get 22 of rat, by 1.26 gram/kilograms (be equivalent to clinical consumption 50 times) dosage, gastric infusion is 30 days continuously, except that the animal subject body weight gain shows slightly slowly, and organ no abnormality seens such as the heart, liver, spleen, lung, kidney.The result shows that medicine of the present invention does not have overt toxicity.
As follows with the part pharmacodynamics test that medicine of the present invention carries out:
With said medicine of the present invention respectively by Radix Scutellariae: Herba Andrographis is the test specimen medicine that 2: 1 (sample 1), 4: 1 (sample 2), 8: 1 (sample 3) and 16: 1 (sample 4) are prepared into four kinds of different proportion forms, carried out external antibacterial activity contrast test with the conventional medicine ciprofloxacin, the part test result of minimum inhibitory concentration (MIC) is as shown in table 1.
The test of table 1 antibacterial activity in vitro
| The test organisms kind | MIC (mg/ml) | ||||
| Sample 1 (2: 1) | Sample 2 (4: 1) | Sample 3 (8: 1) | Sample 4 (16: 1) | Ciprofloxacin (mcg/ml | |
| The gold bacterium 99-1 of Portugal | 0.38 | 0.78 | 0.39 | 0.32 | 16 |
| The gold bacterium 99-2 of Portugal | 0.38 | 0.39 | 0.39 | 0.32 | 16 |
| The gold ATCC25923 of Portugal | 0.56 | 0.56 | 0.39 | 0.39 | 0.5 |
| Escherichia coli 99-1 | ＞400 | ＞400 | ＞400 | ＞400 | 32 |
| Escherichia coli 99-2 | ＞400 | ＞400 | ＞400 | ＞400 | 8 |
| Bacillus cloacae 9894 | 1.56 | 1.56 | 1.56 | 1.54 | 1 |
| Bacillus cloacae 9896 | 1.56 | 1.56 | 1.56 | 1.56 | 1 |
| Bacillus pyocyaneus 9926 | 3.00 | 3.00 | 3.12 | 3.00 | 0.03 |
| Aerobacteria 9885 | 1.56 | 1.56 | 1.56 | 1.50 | 1 |
| Aerobacteria 9888 | 1.56 | 1.56 | 1.56 | 1.56 | 16 |
| Bacillus proteus 9936 | 1.56 | 1.56 | 3.12 | 3.10 | 0.06 |
| Streptococcus pneumoniae 1 | 0.78 | 0.78 | 0.78 | 0.79 | 0.5 |
| Streptococcus pneumoniae 4 | 1.56 | 1.56 | 1.56 | 1.56 | 2 |
| Bloodthirsty hemophilus influenza 1 | 3.12 | 1.56 | 1.56 | 1.58 | 0.25 |
| Bloodthirsty hemophilus influenza 4 | 6.25 | 6.25 | 12.5 | 11.0 | 1 |
| Ke Shi pneumobacillus 9863 | 1.56 | 3.10 | 3.12 | 3.10 | 2 |
| Ke Shi pneumobacillus 9864 | 1.78 | 1.78 | 1.56 | 1.50 | 0.25 |
| Hemolytic streptococcus 991 | 6.25 | 6.12 | 6.25 | 6.00 | 1 |
| Hemolytic streptococcus 992 | 6.12 | 6.12 | 6.25 | 6.30 | 0.5 |
The result of the test of table 1 clearlys show, and two of form kinds of drug study samples of the present invention that active component is formed in varing proportions all demonstrate clinical isolating common Gram-positive and negative pathogenic bacterium and to have certain antibacterial vigor.Show that through a large amount of experimental result statistics sample 1, sample 2, sample 3 and 4 four groups of effective ingredient of the sample example pharmaceuticals of form composition in varing proportions all have antibiotic preferably vigor to staphylococcus aureus, bacillus cloacae, bacillus pyocyaneus, aerobacteria, Bacillus proteus, Ke Shi pneumobacillus etc.; Antibacterial vigor to streptococcus pneumoniae, Hemolytic streptococcus is stronger.Bloodthirsty hemophilus influenza also there is certain antibacterial vigor.But to the escherichia coli DeGrain, all＞400.The result of table 1 also demonstrates, and the antibacterial activity in vitro of the laboratory sample medicine of three groups of different proportion forms is basic identical, but wherein sample 2, sample 3 and sample are better than 1 group in sample for 4 three groups slightly.Relevant test also shows, as Gram-positive, negative bacillus such as Gram-positives such as Diplococcus pneumoniae, meningococcus, negative cocci and dysentery bacterium, Bacillus typhi, Salmonella paratyphi, vibrio cholera, diphtheria corynebacterium, bordetella pertussis, and multiple pathogenic microorganism such as leptospira, Candida albicans, epidermophyton also all has bacteriostasis to said medicine of the present invention to other.
Antivirus test:
Above-mentioned experimental drug matter sample 3 is respectively 10 mg/ml (1 group) by total medicament contg, 5 mg/ml (2 groups), 2.5 mg/ml (3 groups) is four test group with the different dilution factors of 1.25 mg/ml (4 groups), the antivirus test result that done of four matched groups (1～4 group) that constituted with virazole medicine by the configuration of same dilution factor and blank group is as shown in table 2 respectively.
Table 2 antivirus test result
| Test specimen | Virus | The drug level group | The virus control group | The cell matched group | |||
| 1 group | 2 groups | 3 groups | 4 groups | ||||
| Medicine of the present invention | ADV3 | - | - | - | - | 3+ | - |
| ADV7 | - | - | - | 2+ | 3+ | - | |
| RSV | - | - | - | - | 3+ | - | |
| Virazole | ADV3 | - | 2+ | 2+ | 2+ | 3+ | - |
| ADV7 | 1+ | 2+ | 2+ | 2+ | 3+ | - | |
| RSV | - | - | - | 2+ | 3+ | - | |
| Blank | ADV3 | 3+ | 3+ | 3+ | 3+ | 3+ | - |
| ADV7 | 3+ | 3+ | 3+ | 3+ | 3+ | - | |
| RSV | 3+ | 3+ | 3+ | 3+ | 3+ | - | |
(annotate: no pathological changes in "-" expression cell in the table; How much "+" represents intracellular lesion degree.)
The experimental result of table 2 shows, each dilution group of experimental drug matter sample of the present invention all has in various degree inhibitory action to three kinds of viruses, and to ADV
3, ADV
7All be better than the control drug virazole with the inhibitory action of RSV.
Separate heat test:
With the SD rat is experimental animal, with the above-mentioned experimental drug matter sample 2 of the present invention, be the medicine positive controls with aspirin, with the negative matched group of carboxymethyl cellulose (CMC), all to irritate the administration of stomach mode, carry out the pharmacodynamics test to yeast powder pyrogenic action influence, the result is as shown in table 3.
Pyrogenic action influences result of the test to table 3 rat to yeast powder
| Group | Dosage (g/kg) | Number of animals (only) | Anus temperature difference meansigma methods after the administration (℃) | ||||
| 1 hour | 2 hours | 3 hours | 4 hours | 5 hours | |||
| Of the present invention group | 0.5 | 10 | 1.60 | 1.64 | 1.63 | 1.69* | 1.53** |
| Positive group | 0.6 | 11 | 0.77** | 0.16*** | 0.32*** | 0.56*** | 0.47*** |
| Negative group | Equivalent 1% | 11 | 2.26 | 2.51 | 2.11 | 2.42 | 2.45 |
The result of table 3 shows that aspirin can make the anus temperature of yeast powder pyrogenicity rat significantly reduce, and has tangible refrigeration function; Medicine of the present invention had tangible refrigeration function in 4～5 hours after with the test dose administration, learned by statistics and handled the two there was no significant difference, but significant difference is more all arranged with negative control group, wherein: * is P＜0.05, and * * is P＜0.01, and * * * is P＜0.001.
The clinical treatment test:
Adopt the above-mentioned experimental drug matter sample 2 of the present invention, with oral 420 milligrams/time, every day 3 times dosed administration, be used for the common diseases such as flu, acute bronchitis, pneumonia, gingivitis, pharyngolaryngitis, skin sore and furuncle and acute bacillary dysentery that cause by above-mentioned paathogenic factor, carry out therapeutic trial, 3～7 days is a course of treatment.Therapeutic trial patient's age 18～60 years old, average course of disease 8.19 days.By following standard the curative effect of test of cure is evaluated:
Recovery from illness; Remove the cause of disease in 3 days, all diseases are disappeared, and the tongue arteries and veins is normal, no longer recurrence;
Effectively: basic solution removes the cause of disease in 3 days, and cardinal symptom alleviates, and the tongue arteries and veins is normal, but occurs mild again after the drug withdrawal, reuse medicine may command symptom;
Invalid: symptom does not have any alleviation in 3 days;
Increase the weight of: 3～5 days symptoms of taking medicine increase the weight of on the contrary.
The observation of curative effect result of therapeutic trial is as shown in table 4.
Table 4 clinical observation on the therapeutic effect result
| The curative effect case load | Flu | Acute bronchitis | Pneumonia | Gingivitis | Pharyngolaryngitis | Skin sore and furuncle | Acute bacillary dysentery |
| Recovery from illness | 99 | 57 | 28 | 72 | 72 | 26 | 29 |
| Effectively | 20 | 11 | 4 | 22 | 30 | 20 | 5 |
| Invalid | 1 | 2 | 0 | 2 | 20 | 16 | 1 |
| Increase the weight of | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Total routine number | 120 | 70 | 32 | 96 | 122 | 62 | 35 |
More than every result of the test is clear shows that said medicine of the present invention can have clinical common pathogenic microorganisms such as various bacteria, viruses, even produces obvious and stronger inhibitory action; To also all producing the better and/or ideal curative effect of taking stopgap measures, effecting a permanent cure, particularly to having the obvious treatment effect as diseases such as common cold due to wind heat by the multiple common diseases such as inside and outside section that it caused.Said medicine decapacitation of the present invention increases the doctor when being used for infection and analgesic analgesia therapy outside more alternative variety range and the leeway, also be grouped into simply because of its one-tenth, effective ingredient is concentrated, and can be made into the several formulations form, thereby the use amount of medicine is reduced relatively, and reduced waste to natural medicinal raw material, reduced cost, and make the scope of its occupation mode and/or patient's object more extensive, help promoting the use of on a large scale.
Claims (10)
1. the medicine that has infection and antipyretic effect, it is characterized in that basically by baicalin or its corresponding soluble derivative, with andrographolide or its corresponding soluble derivative, be baicalin by weight: andrographolide=(1～20): 1 ratio is formed.
2. medicine as claimed in claim 1 is characterized in that the soluble derivative in the said composition is the alkali metal salt compounds that allows in the pharmacopedics.
3. medicine as claimed in claim 1 is characterized in that the baicalin in the said composition can be the extraction composition from natural medicinal raw material Radix Scutellariae.
4. medicine as claimed in claim 1 is characterized in that the baicalin in the said composition can be replaced with the water extract of the natural medicinal raw material of the baicalin that contains the significant proportion amount.
5. medicine as claimed in claim 1 is characterized in that the andrographolide in the said composition can be the ethanol extraction composition from natural medicinal raw material Herba Andrographis.
6. medicine as claimed in claim 1 is characterized in that the andrographolide in the said composition can be replaced with the Herba Andrographis feed ethanol extract of the andrographolide that contains the significant proportion amount.
7. as the described medicine of one of claim 1 to 6, it is characterized in that said medicine is the medicine of peroral dosage form.
8. as the described medicine of one of claim 1 to 6, it is characterized in that said medicine is the medicine of injection type.
9. medicine as claimed in claim 8 is characterized in that said medicine is an intramuscular injection type medicine.
10. medicine as claimed in claim 8 is characterized in that said medicine is an intravenous injection type medicine.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN00112661A CN1101689C (en) | 2000-01-28 | 2000-01-28 | Anti-infectious antipyretic and antalgic medicine |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN00112661A CN1101689C (en) | 2000-01-28 | 2000-01-28 | Anti-infectious antipyretic and antalgic medicine |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1266699A CN1266699A (en) | 2000-09-20 |
| CN1101689C true CN1101689C (en) | 2003-02-19 |
Family
ID=4582504
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN00112661A Expired - Lifetime CN1101689C (en) | 2000-01-28 | 2000-01-28 | Anti-infectious antipyretic and antalgic medicine |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1101689C (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103494831B (en) * | 2012-09-28 | 2015-10-28 | 成都中医药大学 | A kind of dispersible tablet for the treatment of acute respiratory infection and preparation method thereof |
| CN105326851A (en) * | 2015-12-01 | 2016-02-17 | 杨海娟 | Gankeshuangqing capsule drug composition and preparation method thereof |
| CN107648311B (en) * | 2017-08-30 | 2020-07-10 | 四川省中医药科学院 | Composition and medicine with antiviral and antiinflammatory effects |
-
2000
- 2000-01-28 CN CN00112661A patent/CN1101689C/en not_active Expired - Lifetime
Non-Patent Citations (3)
| Title |
|---|
| 中药药理学第一版 1992-08-31 李仪奎 姜名瑛中国中医药出版社出 * |
| 中药药理学第一版 1992-08-31 李仪奎 姜名瑛中国中医药出版社出;广东医学1987,8(4) 1987-04-30 复方黄芩片 * |
| 广东医学1987,8(4) 1987-04-30 复方黄芩片 * |
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| CN1266699A (en) | 2000-09-20 |
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