CN1279094A - Oral medicine 'Feishu' and its preparing process - Google Patents
Oral medicine 'Feishu' and its preparing process Download PDFInfo
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- CN1279094A CN1279094A CN 99113049 CN99113049A CN1279094A CN 1279094 A CN1279094 A CN 1279094A CN 99113049 CN99113049 CN 99113049 CN 99113049 A CN99113049 A CN 99113049A CN 1279094 A CN1279094 A CN 1279094A
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Abstract
An oral-applied Chinese medicine in the form of oral liquid, tablet, or capsule for treating chronic tracheitis, pneumonectasis and cor pulmonale is prepared from 18 Chinese-medicinal materials including astragalus root, cistanche, stemone root, white atractylodes rhizome, red sage root, liquorice root, etc through immersing, squeezing, filtering, vacuum distillating, pulverizing, mixing with extract and granulating, tabletting, or loading in capsules. Its advantages include high curative effect and no toxic by-effect.
Description
The present invention relates to A61K 9/00 class, be used for the treatment of the oral medicine ' Feishu ' and the preparation method of chronic tracheitis, emphysema, pulmonary heart disease.
Chronic tracheitis is a kind of commonly encountered diseases, frequently-occurring disease, is pursuing the growth at age, and sickness rate is also improving constantly.Because outbreak exceedes to prolong and do not heal repeatedly, finally causes chronic obstructive emphysema, causes pulmonary heart disease, its mortality rate also is (1) first of other disease death rate.
Because the life-time service antibiotic, cause easily that body develops immunity to drugs, antibacterial has produced drug resistance, curative effect obviously descends, and cures difficulty more.Therefore, reduce the M ﹠ M of chronic obstructive emphysema, pulmonary heart disease, effective method is the morbidity of prevention chronic tracheitis or thoroughly cures chronic tracheitis.
Motherland's medical science early has clear understanding to the pathogenesis of chronic tracheitis, thinks that the morbidity machine of chronic tracheitis is relevant with the functional disorder of lung, spleen, kidney.Insufficiency of lung-QI, unable outside defending, deficiency of spleen and stomach with influence and lung, causes the outbreak repeatedly of primary disease, exceedes to prolong and does not heal.Chronic tracheitis mostly is the card (2) of deficiency in origin and excess in superficiality.Prevent or the radical cure medicine and still inefficacy is significant at present.
The purpose of this invention is to provide a kind of oral medicine ' Feishu ' and preparation method, proved recipe is done to revise and prepare with modern extraction process, be used for the treatment of chronic tracheitis, chronic obstructive emphysema, pulmonary heart disease (compensatory phase).
Oral medicine ' Feishu ', be used for the treatment of chronic tracheitis, emphysema, pulmonary heart disease, it is characterized in that component and weight ratio are: Radix Astragali 90g, Herba Cistanches 90g, Radix Stemonae 90g, Bulbus Fritillariae Uninbracteatae 90g, Rhizoma Atractylodis Macrocephalae 60g, Fructus Schisandrae Chinensis 60g, Radix Salviae Miltiorrhizae 60g, Rhizoma Pinelliae Preparatum 60g, Radix Platycodonis 60g, Pericarpium Citri Reticulatae 60g, Radix Glycyrrhizae 60g, Radix Angelicae Sinensis 60g, Radix Ginseng 30g, Gecko 30g, Radix Asparagi 30g, Poria 30g, Cortex Eucommiae 30g, Rhizoma Dioscoreae 30g.
The method for preparing oral medicine ' Feishu ', with the herbal decoction piece is raw material, the peroral dosage form of making comprises oral liquid, sheet and capsule, comprise immersion, squeeze the juice, filter, distill, pulverize, granulate, it is characterized in that the ethanol with 35-40% concentration is the raw material that solvent soaking is weighed 1 described component, solvent and raw material ratio are 4: 1, after soaking 7 days at ambient temperature, fully squeeze the juice, precipitate, filter, with the cleaner liquid distilling under reduced pressure, concentrated solution, concentration is for containing crude drug in whole 0.5g/ml; The part component only need be pulverized, and is used for film-making agent or capsule.
Embodiment:
Oral medicine ' Feishu ', with treatment chronic tracheitis, emphysema, pulmonary heart disease, it is characterized in that component and weight ratio are: Radix Astragali 90g, Herba Cistanches 90g, Radix Stemonae 90g, Bulbus Fritillariae Uninbracteatae 90g, Rhizoma Atractylodis Macrocephalae 60g, Fructus Schisandrae Chinensis 60g, Radix Salviae Miltiorrhizae 60g, Rhizoma Pinelliae Preparatum 60g, Radix Platycodonis 60g, Pericarpium Citri Reticulatae 60g, Radix Glycyrrhizae 60g, Radix Angelicae Sinensis 60g, Radix Ginseng 30g, Gecko 30g, Radix Asparagi 30g, Poria 30g, Cortex Eucommiae 30g, Rhizoma Dioscoreae 30g, Radix Rehmanniae Preparata 30g, Rhizoma Atractylodis 30g.
Do not become preceding topic with above-mentioned full side's total amount, the Poria in its Chinese crude drug component, Rhizoma Dioscoreae, the Cortex Eucommiae, Radix Ginseng,
Do not become preceding topic with above-mentioned full side's total amount, the Poria in its Chinese crude drug component, Rhizoma Dioscoreae, the Cortex Eucommiae, Radix Ginseng, Gecko, Radix Asparagi can be replaced by Radix Rehmanniae Preparata, Rhizoma Atractylodis, Fructus Lycii difference equivalent.For example, replace the Cortex Eucommiae, replace Poria or Radix Asparagi, replace Rhizoma Dioscoreae etc. with Fructus Lycii with Rhizoma Atractylodis with Radix Rehmanniae Preparata.
The method for preparing oral medicine ' Feishu ', with the herbal decoction piece is that raw material is made oral liquid, tablet, capsule, comprise equipment such as adopting heater, vacuum pump, condensing tower, reactor, soak, squeeze the juice, filter, distill, processing such as pulverizing, granulation, it is characterized in that the ethanol with 35-40% concentration is the raw material of the above-mentioned component of solvent soaking, solvent and raw material ratio are 4: 1, after soaking 7 days at ambient temperature, fully squeeze the juice, precipitate, filter, with the cleaner liquid distilling under reduced pressure,-0.5-1 atmospheric pressure, get concentrated solution, concentration is for containing crude drug in whole 0.5g/ml.
The preparation method of oral liquid: get above-mentioned concentrated solution and add flavoring agents such as an amount of Mel, crystal sugar, keep oral liquid to contain crude drug in whole 0.5g/ml.
Oral tablet, capsular preparation method: get the Radix Astragali, Herba Cistanches, the Radix Stemonae, Bulbus Fritillariae Uninbracteatae, the Rhizoma Atractylodis Macrocephalae, Fructus Schisandrae Chinensis, Rhizoma Pinelliae Preparatum, Radix Platycodonis, Pericarpium Citri Reticulatae, Radix Glycyrrhizae, Radix Angelicae Sinensis, Radix Asparagi, the Cortex Eucommiae in the above-mentioned component, weight ratio is identical, make extractum by above-mentioned technology, standby; Decoction pieces Radix Salviae Miltiorrhizae, Radix Ginseng, Gecko, Poria, the Rhizoma Dioscoreae of above-mentioned weight ratio were pulverized 100 mesh sieves, and fine powder is standby; With extractum and the abundant mixing of fine powder, add appropriate amount of auxiliary materials, cross 60 mesh sieves, make wet grain, the grain that will wet is dry under decompression, 50 ± 2 ℃ of conditions, sieve, granulate, adding adjuvant tabletting or incapsulate, and makes oral tablet or capsule.
Oral tablet, capsular preparation also can be when soaking operation the Radix Rehmanniae Preparata with equivalent replace the Cortex Eucommiae, replace Poria, Rhizoma Dioscoreae with Rhizoma Atractylodis, Fructus Lycii during at pulverizing process.
Usage, consumption:
Each 4/sheet, twice of every day is oral, and 4 weeks were a course of treatment.
1, the clinical observation of oral medicine ' Feishu ' curative effect:
1.1 127 examples are organized in the treatment of patient's situation, man, 72 examples, woman, 55 examples.In age 35-68 year, wherein there are 26 examples in 35-40 year, 41-50 year, 29 examples, 43 examples in 51-60 year, 19 examples more than 61 years old.What the course of disease was short is 3 years, the longest nearly 30 years.Acute attack person's 29 examples wherein, chronic author's 98 examples of sending out repeatedly.The above-mentioned age course of disease is learned processing (P＜0.05) by statistics, have the comparability on the curative effect.
1.2 usage, consumption:
Each 4/sheet, twice of every day is oral, and 4 weeks were a course of treatment.
1.3 diagnostic criteria: all case all meets the diagnostic criteria (3) of national chronic bronchitis specialized conference revision in 1979.
1.4 the state of an illness is judged severe: be associated with chronic obstructive emphysema, pulmonary heart disease.
Moderate: be associated with chronic obstructive emphysema.
Slightly: do not have the chronic obstructive emphysema of merging pulmonary heart disease.
1.5 criterion of therapeutical effect: with reference to the clinical research guiding principle of treatment by Chinese herbs chronic bronchitis
(4), with cough, expectorant, breathe heavily, 4 symptoms of wheezing sound evaluation curative effect.Produce effects: cough, expectorant, asthma shape and pulmonary's wheezing sound obviously all or alleviate or asymptomatic.Effectively: expectoration, asthma shape and pulmonary's wheezing sound partly alleviate.Invalid: as to cough, expectorant, asthma shape glue pulmonary wheezing sound do not have change.
2, therapeutic effect
Produce effects: 78 examples (61.4%) are effective: 39 examples (30.9%) invalid 10 (7.9%) see table (1), table (2) for details.
Table 1 age and pharmacodynamic change
Each age group p＜O.01 there were significant differences.Table 2 course of disease and pharmacodynamic change
| Age | The example number | Produce effects | Effectively | Invalid | |||
| 35-40 | 26 | 21 | 80％ | 5 | 20％ | ||
| 41-50 51-60 is more than 61 | 39 43 19 | 27 | 69％ 53.5％ 36.8％ | 9 17 8 | 23％ 39.5％ 42.2％ | 3 3 4 | 8％ 7％ 21％ |
| The course of disease time | The example number | Produce effects | Effectively | Invalid | |||
| Below 5 years | 42 | 37 | 88％ | 5 | 12％ | ||
| 6-10 11-15 is more than 16 years old | 38 25 22 | 27 11 3 | 71％ 44％ 13.7％ | 10 11 13 | 26.4％ 44％ 59％ | 1 3 6 | 2.6％ 12％ 27.3％ |
Each course of disease section curative effect has notable difference P＜0.01
Model case: Zhao, 49 years old, go to a doctor on November 21st, 1989 end, readme recurrent cough, expectoration, tachypnea 11 years.Annual winter-spring season morbidity, nearly 2 years morbidity back sxs, the work of can not having gone to work.Two weeks, preceding suffering from cold because of climate change fallen ill, and cough with asthma increases the weight of, and coughs white foam shape expectorant.Health check-up: the thin refreshing epidemic disease of shape, two lung audible asthma sounds.The X line is taken the photograph sheet, and emphysema, lung marking strengthen.Blood phase WBC 11.5 * 16
5/ L NO.75 LO.25 takes three courses of treatment continuously, the complete obiteration of cough with asthma symptom, and the X line is taken the photograph sheet: emphysema, lung marking are clear.Take two courses of treatment before going into the winter later in every year, continuous 5 years, and follow the trail of observation in 5 years, there are not recurrence and energy operate as normal.
3, toxicity trial
3.1 acute toxicity test materials and methods
Animal: get 50 of kunming mices, male and female half and half, body weight 20 ± 2g is divided into 5 groups at random.
Administration: the lung oral liquid for relaxation, intragastric administration every day twice, dosage sees Table 3.Observed general state in 24 hours, the counting death toll.
Table 3 medicine acute toxicity animal experiment
Result of the test shows that oral medicine ' Feishu ' does not produce any toxic reaction to body, and maximum dosage 35.2g/Kg.d is 160 times of the effective oral dose 0.17g/Kg.d of human, so oral medicine ' Feishu ' is nontoxic.
| The death in 24 hours of group number of elements dosage general state |
| ????1 ????2 ????3 ????4 ????5 | ????10 ????10 ????10 ????10 ????10 | ?1．7g／Kg．d ?3．4g／Kg．d ?6．8g／Kg．d 17．6g／Kg．d 35．2g／KG．d | Normal normal | Do not have |
3.2 chronic toxicity test materials and methods
Animal: get 90 of Wistor kind rat, male and female half and half, body weight 200 ± 20g is divided into test group (60) at random, matched group (30).
Administration: the lung oral liquid for relaxation, intragastric administration every day twice, every day dosage 6.8g/Kg.d.
Test method: test group administration every day, matched group is normally watched foster.In the time of the 1st, 2,3 month, respectively test group, matched group are put to death, carry out the hematology, serum biochemistry is learned and the histopathology check, and data are taken statistics to learn handle.
Respectively organize white, the red blood cell count(RBC) of blood in the table 4 chronic toxicity animal experiment
| Project | Moon time | Number of elements | Sex | Group | ||||
| Test | Contrast | |||||||
| 1 | ?10 ?10 | ?M ?F | ?12．5±2．51 ?12．88±3．86 | ?12．72±3．92 ?13．41±3．71 | ||||
| Leukocyte | 2 | ?10 ?10 | ?M ?F | ?13．80±2．54 ?13．78±2．16 | ?13．86±1．96 ?13．22±1．37 | |||
| 3 | ?10 ?10 | ?M ?F | ?11．79±2．46 ?12．90±2．10 | ?12．25±2．37 ?12．39±3．12 | ||||
| 1 | ?10 ?10 | ?M ?F | ?6．96±0．89 ?7．26±0．72 | ?7．27±0.59 ?6．98±0．84 | ||||
| Erythrocyte | 2 | ?10 ?10 | ?M ?F | ?7．22±0．23 ?7．36±0．15 | ?7．18±0．17 ?7．33±0．17 | |||
| 3 | ?10 ?10 | ?M ?F | ?7．82±0．16 ?7．76±0．17 | ?7．34±0．18 ?7．74±0．11 | ||||
(P＞0.05) table 5 serum biochemistry index relatively
| Between month | Number | Not | Test | Contrast | |
| Glutamate pyruvate transaminase | 1 | ?10 ?10 | ????M ????F | 32．4±4．7 31．2±6．9 | 31．7±5．9 32．1±5．7 |
| ?2 | ?10 ?10 | ????M ????F | 28±4．1 29．8±6．4 | 29±7．1 31．7±5．9 | |
| ?3 | ?10 ?10 | ????M ????F | 32．5±8．6 31．8±7．2 | 32．0±7．8 30．6±6．3 | |
| Blood urea nitrogen | 1 | ?10 ?10 | ????M ????F | 9．53±0．85 9．62±0．91 | 9．45±0．79 9．71±0．96 |
| ?2 | ?10 ?10 | ????M ????F | 9．10±0．11 9．36±0．28 | 9．25±0．23 9．41±0．34 | |
| ?3 | ?10 ?10 | ????M ????F | 9．57±0．89 9．25±0．25 | 9．42±0．38 9．34±0．32 |
(P＞0.05) interpretation of result: animal experiment proves that oral agents of the present invention is without any side effects, and therefore experimental animal proves that this medicine is to the human body avirulence with 40 times of being adult dosage 0.17g/Kg.d of dosage 6.8g/Kg.d.
Claims (6)
1, a kind of oral medicine ' Feishu ', be used for the treatment of chronic tracheitis, emphysema, pulmonary heart disease, it is characterized in that component and weight ratio are: Radix Astragali 90g, Herba Cistanches 90g, Radix Stemonae 90g, Bulbus Fritillariae Uninbracteatae 90g, Rhizoma Atractylodis Macrocephalae 60g Fructus Schisandrae Chinensis 60g, Radix Salviae Miltiorrhizae 60g, Rhizoma Pinelliae Preparatum 60g, Radix Platycodonis 60g, Pericarpium Citri Reticulatae 60g, Radix Glycyrrhizae 60g, Radix Angelicae Sinensis 60g, Radix Ginseng 30g, Gecko 30g, Radix Asparagi 30g, Poria 30g, Cortex Eucommiae 30g, Rhizoma Dioscoreae 30g.
2, oral medicine ' Feishu ' according to claim 1 is characterized in that not becoming preceding topic with above-mentioned full side's total amount, and the Poria in its Chinese crude drug component, Rhizoma Dioscoreae, the Cortex Eucommiae, Radix Ginseng, Gecko, Radix Asparagi can be replaced by Radix Rehmanniae Preparata, Rhizoma Atractylodis, Fructus Lycii difference equivalent.
3, a kind of method for preparing oral medicine ' Feishu ', with the herbal decoction piece is raw material, the dosage form of making oral agents comprises oral liquid, tablet, capsule, comprise immersion, squeeze the juice, filter, distill, pulverize, granulate, it is characterized in that the ethanol with 35-40% concentration is the raw material that solvent soaking is weighed 1 described component, solvent and raw material ratio are 4: 1, after soaking 7 days at ambient temperature, fully squeeze the juice, precipitate, filter, with the cleaner liquid distilling under reduced pressure, concentrated solution, concentration is for containing crude drug in whole 0.5g/ml; The part component only need be pulverized, and is used for film-making agent or capsule.
4, the method for preparing oral medicine ' Feishu ' according to claim 2, the preparation method that it is characterized in that oral liquid are to get the concentrated solution of above-mentioned technology gained, add crystal sugar, Mel is an amount of, and oral liquid contains crude drug in whole 0.5g/ml.
5, the method for preparing oral medicine ' Feishu ' according to claim 3, it is characterized in that oral tablet, capsular preparation method: the Radix Astragali, Herba Cistanches, the Radix Stemonae, Bulbus Fritillariae Uninbracteatae, the Rhizoma Atractylodis Macrocephalae, Fructus Schisandrae Chinensis, Rhizoma Pinelliae Preparatum, Radix Platycodonis, Pericarpium Citri Reticulatae, Radix Glycyrrhizae, Radix Angelicae Sinensis, Radix Asparagi, the Cortex Eucommiae in the weighting 1 described component, weight ratio is identical, make extractum by power 3 described technologies, standby; Decoction pieces Radix Salviae Miltiorrhizae, Radix Ginseng, Gecko, Poria, the Rhizoma Dioscoreae of power 1 described weight ratio were pulverized 100 mesh sieves, and fine powder is standby; With extractum and the abundant mixing of fine powder, add appropriate amount of auxiliary materials, cross 60 mesh sieves, make wet grain, the grain that will wet is dry under decompression, 50 ± 2 ℃ of conditions, sieve, granulate, adding adjuvant tabletting or incapsulate, and makes oral tablet or capsule.
6, the method for preparing oral medicine ' Feishu ' according to claim 5 is characterized in that oral tablet, the also available right 2 described Radix Rehmanniaes Preparata of capsular preparation are replaced the Cortex Eucommiae when soaking operation, replacement Poria, Rhizoma Dioscoreae when using Rhizoma Atractylodis, Fructus Lycii at pulverizing process.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 99113049 CN1279094A (en) | 1999-06-28 | 1999-06-28 | Oral medicine 'Feishu' and its preparing process |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 99113049 CN1279094A (en) | 1999-06-28 | 1999-06-28 | Oral medicine 'Feishu' and its preparing process |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102125669A (en) * | 2010-10-27 | 2011-07-20 | 宋爱民 | Chinese medicinal preparation for treating chronic bronchitis of phlegm-dampness accumulation in lung |
| CN103550594A (en) * | 2013-11-13 | 2014-02-05 | 张笑飞 | Lung clearing traditional Chinese medicine for children |
| CN105250849A (en) * | 2015-11-20 | 2016-01-20 | 文永忠 | Chuangen Duanmi pills |
| CN105327273A (en) * | 2015-11-10 | 2016-02-17 | 张蓓 | Chinese patent medicine for treating lung distension and preparing method thereof |
| CN111920892A (en) * | 2020-08-20 | 2020-11-13 | 成都中医药大学附属医院 | A Chinese medicinal composition for preventing and treating chronic obstructive pulmonary disease and cardiovascular and cerebrovascular diseases |
-
1999
- 1999-06-28 CN CN 99113049 patent/CN1279094A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102125669A (en) * | 2010-10-27 | 2011-07-20 | 宋爱民 | Chinese medicinal preparation for treating chronic bronchitis of phlegm-dampness accumulation in lung |
| CN102125669B (en) * | 2010-10-27 | 2012-05-30 | 宋爱民 | Chinese medicinal preparation for treating chronic bronchitis of phlegm-dampness accumulation in lung |
| CN103550594A (en) * | 2013-11-13 | 2014-02-05 | 张笑飞 | Lung clearing traditional Chinese medicine for children |
| CN103550594B (en) * | 2013-11-13 | 2016-03-30 | 张笑飞 | Child's lung heat clearing Chinese medicine |
| CN105327273A (en) * | 2015-11-10 | 2016-02-17 | 张蓓 | Chinese patent medicine for treating lung distension and preparing method thereof |
| CN105250849A (en) * | 2015-11-20 | 2016-01-20 | 文永忠 | Chuangen Duanmi pills |
| CN111920892A (en) * | 2020-08-20 | 2020-11-13 | 成都中医药大学附属医院 | A Chinese medicinal composition for preventing and treating chronic obstructive pulmonary disease and cardiovascular and cerebrovascular diseases |
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