CN1231242C - Medication composition for children 's virus pneumonia and its preparation method - Google Patents
Medication composition for children 's virus pneumonia and its preparation method Download PDFInfo
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- CN1231242C CN1231242C CN 02138175 CN02138175A CN1231242C CN 1231242 C CN1231242 C CN 1231242C CN 02138175 CN02138175 CN 02138175 CN 02138175 A CN02138175 A CN 02138175A CN 1231242 C CN1231242 C CN 1231242C
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Abstract
The present invention relates to a compound Chinese medicinal preparation, particularly to a medicinal composition for infantile virus pneumonia and a preparation method thereof. The medicinal composition is prepared from eleven traditional Chinese medicines of ephedra, bitter apricot seed, gypsum, liquorice, peucedanum root, stiff silkworm, red sage root, giant knotweed rhizome, bistort rhizome, semen and white mulberry bark. The medicinal composition has obvious functions of resisting viruses and bacteria, clearing away heat, diminishing inflammation, relieving cough and eliminating phlegm and has good curative effect on infantile virus pneumonia and no adverse reaction.
Description
The present invention relates to a kind of compound Chinese medicinal preparation, be meant a kind of pharmaceutical composition for the treatment of infantile viral pneumonia and preparation method thereof especially.
Clinical viral pneumonia for seeing, is clinical commonly encountered diseases of department of pediatrics and frequently-occurring disease with children's more.The patient generally has heating, cough, asthma, and there is rale in pulmonary; Crisis such as hyperpyrexia, cardiopalmus infantile malnutrition out of breath, purple, extreme exhaustion, shock appear continuing in weight person.At present doctor trained in Western medicine does not still have effective antiviral property pneumonia medicine, and antibiotics in the chemicals, antiviral agents are unreliable to the viral pneumonia curative effect, the course of treatment long, the state of an illness easily repeatedly.And the traditional Chinese medical science often obtains significant curative effect according to its pathological characters combination drug.
Pharmaceutical composition of the present invention prescription comes from Zhang Zhongjing name side, Han dynasty " MAXINGSHIGAN TANG ", adds flavor according to clinical experience for many years and forms.MAXINGSHIGAN TANG is led lung-heat, relieving cough and asthma off, is usually used in treating pneumonia, chronic bronchitis, bronchial asthma, measles, diseases such as pertussis the present age.At present report is that the Chinese patent medicine that the basis can be used for treating infantile viral pneumonia has: child's oral liquid for clearing away lung-heat, infantile lung clearing phlegm transforming oral liquid, the sweet electuary of little infantile paralysis (national nonprescription drugs medicine catalogue) with the MAXINGSHIGAN TANG, the numb brave mixture＜Shaanxi traditional Chinese medical science 2001 of Hanzhong city institute of traditional Chinese medicine, (5) 〉, also have " treatment infantile pneumonia medicine production method " (Chinese patent CN92109826) etc. in addition, but do not retrieve and the identical medicine of pharmaceutical composition prescription of the present invention.
Pharmaceutical composition of the present invention has increased by seven flavor Chinese medicines, prescription uniqueness on the basis of MAXINGSHIGAN TANG.Radix Peucedani a surname opens lung qi, lowering the adverse-rising QI to resolve phlegm in the side, Bombyx Batryticatus dispelling wind pathogens, drying dampness to eliminate phlegm, Radix Salviae Miltiorrhizae, Rhizoma Polygoni Cuspidati, Rhizoma Bistortae three medicines are used lung-heat flourishing together, heap soil or fertilizer over and around the roots blood is that the pneumonia of the stasis of blood has certain dissipation role, Radix Glycyrrhizae is used for coordinating the actions of various ingredients in a prescription, especially to preventing the hot rhythm of the heart quickening of loosing and too causing of Herba Ephedrae, certain preventive effect that the cold and cool untoward reaction such as gastric abscess that cause of Gypsum Fibrosum can rise.Full side has a surname's bundle lung qi, clearing and dissipating phlegm-heat, and the effect that detoxifcation is invigorated blood circulation, it is remarkable to cure mainly the infantile viral pneumonia clinical efficacy, especially heating is not moved back, and it is more than repeatedly to cough, and pulmonary's moist rale does not disappear etc. good therapeutic effect.
The object of the present invention is to provide a kind of to infantile viral pneumonia the good curing effect is arranged, the pharmaceutical composition that has no adverse reaction and preparation method thereof.
The objective of the invention is to realize by following measure:
Consisting of of pharmaceutical composition of the present invention: Herba Ephedrae, Semen Armeniacae Amarum, Gypsum Fibrosum, Radix Glycyrrhizae, Radix Peucedani, Bombyx Batryticatus, Radix Salviae Miltiorrhizae, Rhizoma Polygoni Cuspidati, Rhizoma Bistortae, Semen Lepidii (Semen Descurainiae), Cortex Mori.
Adopt suitable method to extract above-mentioned ten Herba indigoferae Pseudotinctoriae waters, organic solvent or water-containing organic solvent,, make pharmaceutical composition of the present invention through concentrating or dry or mix with pharmaceutically acceptable various additives.
The extracting method of pharmaceutical composition of the present invention can be: earlier with contain the medical material of volatile oil such as Herba Ephedrae in the pharmaceutical formulation of the present invention, Semen Armeniacae Amarum extracts volatile oil; To carry volatile oil residue medicinal residues and Aromatic water and all the other medical material Gypsum Fibrosum, Semen Lepidii (Semen Descurainiae), Cortex Mori, Radix Peucedani, Bombyx Batryticatus, Radix Salviae Miltiorrhizae, Rhizoma Polygoni Cuspidati, Rhizoma Bistortae, Radix Glycyrrhizae water, organic solvent or water-containing organic solvent again extracts; Also can not extract volatile oil, with ten Herba indigoferae Pseudotinctoriae of pharmaceutical composition of the present invention: Herba Ephedrae, Semen Armeniacae Amarum, Gypsum Fibrosum, Radix Glycyrrhizae, Radix Peucedani, Bombyx Batryticatus, Radix Salviae Miltiorrhizae, Rhizoma Polygoni Cuspidati, Rhizoma Bistortae, Semen Lepidii (Semen Descurainiae), the direct water of Cortex Mori, organic solvent or water-containing organic solvent extract.Organic solvent can be alcohols or acetone such as ethanol, methanol, propanol, also can be halo alkanes or esters such as ethyl acetate, butyl acetate such as dichloromethane, chloroform.
Pharmaceutical composition of the present invention can contain pharmaceutically acceptable various additives, these additives comprise filler, diluent, inclusion agent, solvent, correctives, antiseptic, cosolvent, stabilizing agent, pH regulator agent, dispersant, disintegrating agent, lubricant, emulsifying agent, binding agent, surfactant and pigment etc., or their mixture.
The dosage form of pharmaceutical composition of the present invention can be granule, syrup, capsule, tablet, oral liquid, soft capsule, pill, Emulsion, spray, drop, suppository, injection.
Pharmaceutically acceptable additives can be dextrin, sucrose, starch, cyclodextrin, microcrystalline Cellulose, carboxymethyl cellulose, carboxymethyl starch, hydroxypropyl emthylcellulose, hydroxypropyl cellulose, ethyl cellulose, water, ethanol, propylene glycol, glycerol, Polyethylene Glycol, polyvidone, vegetable oil, magnesium stearate, Pulvis Talci, sorbitol, nipalgin, tween etc. specifically, but are not limited to raise variety.
Pharmaceutical composition of the present invention is through biological activity test, shows good antiviral, antibiotic, antipyretic and anti-inflammatory, Antitussive and Expectorant Effect, do not measure toxicity, specifically sees following test example.
Test example 1: interior resisting virus test
10 every group of mices, irritate respectively stomach give pharmaceutical composition of the present invention little, in, heavy dose of, and contrast, administration is mice intranasal vaccination influenza virus liquid after 3 hours, later administration every day 2 times, totally 5 days.Calculate the average life natural law in the mice 15 days and prolong vital rates.The results are shown in following table:
| Group | Number of animals (only) | Average life natural law (my god) | Prolong vital rates (%) |
| The heavy dose of group of dosage group in the contrast small dose group | 10 10 10 10 | 4.2 6.5 * 6.8 * 7.9 ** | 54.8 61.9 88.1 |
Compare with matched group,
*P＜0.05,
*P＜0.01.
The result shows that each dosage group of pharmaceutical composition of the present invention can make influenza infection mice The average survival time natural law prolong, and prolongs the vital rates maximum and can prolong 88.1%, illustrates that it has significant antivirus action.
Test example 2: anti-streptococcus pneumoniae test in the body
15 every group of mices, lumbar injection culture of streptococcus pneumonia liquid 0.1ml/ only, irritate respectively immediately after the infection stomach give pharmaceutical composition of the present invention little, in, heavy dose of and contrast, every day 3 times, administration 3 days.Observe the death toll of mice in 7 days.The results are shown in following table:
| Group | Number of animals (only) | Death toll (only) | Mortality rate (%) |
| The heavy dose of group of dosage group in the matched group small dose group | 15 15 15 15 | 15 13 9 8 | 100.0 86.7 60.0 * 53.3 ** |
Compare with matched group,
*P＜0.05,
*P＜0.01.
The result shows, in the pharmaceutical composition of the present invention, heavy dose of group all can reduce the streptococcus pneumoniae infection mouse death rate, the mice of streptococcus pneumoniae infection had obvious protective effect.
Test example 3: separate heat test
10 every group of rats, in right side foot plantar subcutaneous injection 1% carrageenin 0.1ml/ only, irritate respectively immediately after the administration stomach give pharmaceutical composition of the present invention little, in, heavy dose of and contrast, the injection back was measured rat anus temperature in 0.5,1,2,3 hour.Calculate rat anus temperature rise value, the results are shown in accompanying drawing:
The rat fever reaction all has certain inhibitory action due to the above-mentioned result of the test demonstration, each dosage group on Carrageenan of pharmaceutical composition of the present invention, and administration got final product onset in 1 hour, and suppression ratio is 51%, illustrates that it has certain refrigeration function.
Test example 4: antitussive test
10 every group of mices, irritate respectively stomach give pharmaceutical composition of the present invention little, in, heavy dose of and contrast, after the administration 1 hour, mice is put into the 1000ml beaker of inverted Sheng anhydrous sodium sulfite 0.35g and 50% sulphuric acid 5ml rapidly, observe the number of times of coughing in mouse cough incubation period and 2 minutes.The results are shown in following table:
| Group | Cough latent time (S) | Cough number of times (inferior) |
| Dosage group small dose group in the heavy dose of group of matched group | 48.8±9.5 58.4±8.4* 57.8±9.4* 47.7±10.6 | 50.2±15.5 36.7±12.3* 36.0±10.7* 49.0±13.7 |
Annotate: compare with matched group,
*P＜0.05.
Result of the test shows that the big or middle dosage group of pharmaceutical composition of the present invention is to SO
2Induced mice cough reaction all has certain inhibitory action, can make cough latent time significant prolongation, and the cough number of times significantly reduces, and shows that it has good antitussive effect.
Test example 5: expectorant test
10 every group of mices, irritate respectively stomach give pharmaceutical composition of the present invention little, in, heavy dose of and contrast, after the administration 1 hour, lumbar injection 5% phenol red solution 0.1ml/10g, put to death mice after 30 minutes, the flushing trachea is measured the cleaning mixture optical density value, finds corresponding phenol red concentration on phenol red standard curve.The results are shown in following table:
| Group | Phenol red output (μ g/ml) | Increase percentage rate (%) |
| The heavy dose of group of dosage group in the matched group small dose group | 0.54±0.21 0.75±0.23 * 0.82±0.30 * 0.91±0.27 ** | 38.9 51.9 68.5 |
Compare with matched group,
*P＜0.01,
*P＜0.01.
The result shows that each dosage group of pharmaceutical composition of the present invention all can obviously promote the phenol red discharge of mice trachea, and the maximum rate of growth can reach 68.5%, illustrates that it has phlegm-dispelling functions preferably.
Test example 6: antiinflammatory test
10 every group of mices, irritate respectively stomach give pharmaceutical composition of the present invention little, in, heavy dose of and contrast.Administration every day 3 times, continuous 2 days, after the last administration 1 hour, only evenly be applied in two sides before and after the ear of a mice left side with dimethylbenzene 0.02ml/, auris dextra is in contrast.After 1 hour mice being put to death, lay auricle at the same position of two ears and weigh with the 9mm card punch, is auricle swelling degree with the difference of two ear weight.The results are shown in following table:
| Group | Auricle swelling degree (mg) | Auricle edema rate (%) | Suppression ratio (%) |
| The heavy dose of group of dosage group in the matched group small dose group | 10.8±1.7 9.7±2.6 9.0±2.0 * 8.8±2.2 * | 164.6±33.4 140.0±42.1 134.5±39.4 * 128.8±42.2 * | 14.9 18.3 21.7 |
Compare with matched group,
*P＜0.05.
The result shows, in the pharmaceutical composition of the present invention, heavy dose of group all can significantly suppress the Mice Auricle inflammation due to the dimethylbenzene, the suppression ratio maximum can be 21.7%, illustrates that it has certain antiinflammatory action.
Test example 7: toxicity test
Pharmaceutical composition its mouse oral of the present invention administration fails to measure LD
50, peroral administration mtd test shows that all no abnormal situation took place after 20 mices were pressed 735g crude drug/Kg/ day administration, did not also have dead in 1 week.This dosage is 58.4 times of clinical day for human beings oral dose.
The present invention is further elaborated by the following examples:
Take by weighing Herba Ephedrae 150g, Semen Armeniacae Amarum 320g, Gypsum Fibrosum 600g, Radix Glycyrrhizae 350g, Radix Peucedani 250g, Bombyx Batryticatus 200g, Radix Salviae Miltiorrhizae 300g, Rhizoma Polygoni Cuspidati 350g, Rhizoma Bistortae 400g, Semen Lepidii (Semen Descurainiae) 240g, Cortex Mori 400g, Herba Ephedrae and Semen Armeniacae Amarum distillation extraction are gone out volatile oil; The Gypsum Fibrosum crushing and water-adding was decocted first 10 minutes, will extract volatile oil residual medicine dreg and Aromatic water and Radix Glycyrrhizae, Radix Peucedani, Bombyx Batryticatus, Radix Salviae Miltiorrhizae, Rhizoma Polygoni Cuspidati, Rhizoma Bistortae, Semen Lepidii (Semen Descurainiae), Cortex Mori adding again, merged to decoct twice, and each half an hour, decocting liquid merges filtration.Filtrate decompression is concentrated into relative density the be 1.20 extractum liquid of (90 ℃ of heat are surveyed), puts and is chilled to room temperature, adds ethanol and is adjusted to and contains alcohol amount 70% (w/w), leaves standstill 15 hours.Get supernatant, being evaporated to relative density is the extractum of 1.31 (90 ℃ of heat are surveyed), merges volatile oil and extractum, adds oral liquid excipient commonly used, adopts the conventional preparation technology of oral liquid, makes oral liquid.
Embodiment 2
According to method volatile oil and the extractum of embodiment 1, add granule excipient commonly used, adopt the conventional preparation technology of granule, make granule.
Embodiment 3
Method according to embodiment 1 is extracted volatile oil and extractum, the spray-dried granule of making.
Embodiment 4
Method according to embodiment 1 is extracted volatile oil and extractum, adds syrup excipient commonly used, adopts the conventional preparation technology of syrup, makes syrup.
Embodiment 5
Method according to embodiment 1 is extracted volatile oil and extractum, the spray-dried dried particles of making, and the Capsules of packing into is made capsule.
Embodiment 6
Method according to embodiment 1 is extracted volatile oil and extractum, adds tablet excipient commonly used, adopts the conventional preparation technology of tablet, makes tablet.
Embodiment 7
Method according to embodiment 1 is extracted volatile oil and extractum, concentrates the conventional preparation technology that soft capsule is adopted in the back, makes soft capsule.
Embodiment 8
Method according to embodiment 1 is extracted volatile oil and extractum, adds spray excipient commonly used, adopts the conventional preparation technology of spray, makes spray.
Claims (3)
1. pharmaceutical composition for the treatment of infantile viral pneumonia is characterized in that it is made by following materials of weight proportions medical material: Herba Ephedrae 150g, Semen Armeniacae Amarum 320g, Gypsum Fibrosum 600g, Radix Glycyrrhizae 350g, Radix Peucedani 250g, Bombyx Batryticatus 200g, Radix Salviae Miltiorrhizae 300g, Rhizoma Polygoni Cuspidati 350g, Rhizoma Bistortae 400g, Semen Lepidii (Semen Descurainiae) 240g, Cortex Mori 400g.
2. pharmaceutical composition according to claim 1 is characterized in that: the dosage form of pharmaceutical composition can be granule, oral liquid, syrup, capsule, tablet, soft capsule, pill, Emulsion, spray, drop.
3. preparation of drug combination method as claimed in claim 1, it is characterized in that: with ten Herba indigoferae Pseudotinctoriae of drug regimen of the present invention: Herba Ephedrae, Semen Armeniacae Amarum, Gypsum Fibrosum, Radix Glycyrrhizae, Radix Peucedani, Bombyx Batryticatus, Radix Salviae Miltiorrhizae, Rhizoma Polygoni Cuspidati, Rhizoma Bistortae, Semen Lepidii (Semen Descurainiae), Cortex Mori, take by weighing by described weight proportion, water, organic solvent or aqueous organic solvent extraction, through concentrating or dry or mix, make pharmaceutical composition of the present invention with pharmaceutically acceptable additives.
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| CN 02138175 CN1231242C (en) | 2002-08-26 | 2002-08-26 | Medication composition for children 's virus pneumonia and its preparation method |
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| CN 02138175 CN1231242C (en) | 2002-08-26 | 2002-08-26 | Medication composition for children 's virus pneumonia and its preparation method |
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| CN1231242C true CN1231242C (en) | 2005-12-14 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN100435817C (en) * | 2005-09-28 | 2008-11-26 | 大连美罗中药厂有限公司 | Medicine for treating rheumatism and rheumatoid diseases and preparing method |
| CN102429972A (en) * | 2010-12-23 | 2012-05-02 | 河南天方药业中药有限公司 | Oral liquid for treating virus bronchopneumonia of children and preparation process thereof |
| MX2015010473A (en) | 2013-02-12 | 2016-02-09 | Uriel Kesler | Non-dairy formulae. |
| CN107281333A (en) * | 2017-08-21 | 2017-10-24 | 北京煜煌科技有限公司 | A kind of paediatrics oral capsule and preparation method thereof |
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