CN102688435A - Preparation method of guiling preparation - Google Patents
Preparation method of guiling preparation Download PDFInfo
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- CN102688435A CN102688435A CN2012100744830A CN201210074483A CN102688435A CN 102688435 A CN102688435 A CN 102688435A CN 2012100744830 A CN2012100744830 A CN 2012100744830A CN 201210074483 A CN201210074483 A CN 201210074483A CN 102688435 A CN102688435 A CN 102688435A
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Abstract
The invention discloses a preparation method of a guiling preparation. The guiling preparation is prepared from ephedra, poppy capsule, semen armeniacae amarae (fried), semen juglandis, schisandra chinensis and round cardamom.. The invention is characterized in that the preparation method comprises the following steps of: extracting volatile oil by means of the steam distillation of the round cardamom, for later use; extracting for 2-3 times by adding medical dregs, ephedra, poppy capsule, semen juglandis and water, wherein each time is 2-4hours, merging extracting solutions, filtering, concentrating the filter liquor that each milliliter of the solution is equal to 0..8g-1.5g of crude drug, adding ethanol, so that the ethanol content reaches 35%-50%, standing, filtering, and concentrating the filter liquor to obtain thick paste, for later use; extracting the squeezed and oil-removed bitter almond and schisandra chinensis with 50%-85% ethanol for twice to three times, wherein each time is 1-3hours, merging the extracting solution, filtering, and concentrating the filter liquor to obtain thick paste, for later use; and merging the thick paste, and adding the pharmaceutically acceptable auxiliary materials, to prepare the particles, and adding the round cardamom volatile oil, to prepare the troche or the capsule, so that the guiling preparation can be prepared.
Description
Technical field
The present invention relates to the field of Chinese medicines, particularly a kind of method for preparing of Guiling preparation.
Background technology
Osmanthus spirit ball records in second in " the Sanitation Ministry medicine standard " Chinese traditional patent formulation preparation; It is processed by Six-element medical materials such as Herba Ephedrae, Pericarpium Papaveris, Semen Armeniacae Amarum (stir-fry), Semen Juglandis, Fructus Schisandrae Chinensis, Fructus Amomi Rotunduss; This product has the effect of convergence lung qi, relieving cough and relieving asthma, is used for treating the diseases such as work is breathed heavily, chronic cough of deficiency lung of suffering from a deficiency of the kidney.Spirit ball in osmanthus is directly pulverizing medicinal materials to be become fine powder, adds that refined honey processes again.Because spirit ball in osmanthus adopts full crude drug powder to be used as medicine, so dose is big, need take 6.5 grams at every turn, it is low also to have effective component content simultaneously, and the medicine stripping is slow, the shortcoming that bioavailability is not high, patient's poor compliance of taking medicine influences the performance of clinical drug curative effect.
Summary of the invention
The object of the present invention is to provide a kind of method for preparing of Guiling preparation, method for preparing provided by the invention is more scientific and reasonable, shows the Guiling preparation determined curative effect that the present invention makes through clinical verification.
The method for preparing of Guiling preparation provided by the invention is following:
Herba Ephedrae 400g Pericarpium Papaveris 300g Semen Armeniacae Amarum (stir-fry) 200g Semen Juglandis 200g
Fructus Schisandrae Chinensis 200g Fructus Amomi Rotundus 25g
Above Six-element medical material, Fructus Amomi Rotundus extracts volatile oil with vapor distillation, and the aqueous solution after isolating volatile oil and distilling is subsequent use; Medicinal residues are with Herba Ephedrae, Pericarpium Papaveris, Semen Juglandis extracting in water 2 ~ 3 times, each 2 ~ 4h, merge extractive liquid; Filter, the aqueous solution after filtrating and the distillation merges, and is concentrated into every ml soln and is equivalent to 0.8g ~ 1.5g crude drug; Add alcoholic solution, make to contain alcohol amount and reach 35% ~ 50%, leave standstill; Filter, filtrating concentrate the thick paste I, subsequent use; Semen Armeniacae Amarum squeezing is deoiled back and Fructus Schisandrae Chinensis with 50% ~ 85% ethanol extraction 2 ~ 3 times, each 1 ~ 3h, merge extractive liquid, filters, filtrating concentrated the thick paste II, subsequent use; Above-mentioned thick paste is merged, add acceptable auxiliary on the pharmaceutics, process granule, add Fructus Amomi Rotundus volatile oil again, process tablet or capsule, promptly get.
The relative density of said thick paste I in the time of 70 ℃ is preferably 1.20 ~ 1.40, and the relative density of thick paste II in the time of 70 ℃ is preferably 1.10 ~ 1.25.
Said adjuvant can be selected from one or more in starch, dextrin, mannitol, sorbitol, microcrystalline Cellulose, calcium carbonate, silicon dioxide, the magnesium stearate.
The adding method of said Fructus Amomi Rotundus volatile oil sprays into behind the dissolve with ethanol or with adding after the adsorbents adsorb, wherein adsorbent can be selected from one or more in silicon dioxide, Pulvis Talci, kaolin, calcium hydrogen phosphate, calcium sulfate, the calcium carbonate for adopting.
The present invention innovates part and is to have adopted different extraction processing methods to the different of medical material effective site and effective ingredient.
Fructus Amomi Rotundus among the present invention extracts volatile oil earlier, again with Herba Ephedrae, Pericarpium Papaveris, Semen Juglandis extracting in water, and with the alcohol precipitating method processing, reinstates ethanol extraction with Fructus Schisandrae Chinensis one after the Semen Armeniacae Amarum squeezing is deoiled.The method for preparing of method for preparing provided by the invention and osmanthus spirit ball compares, and not only removed suck tissue such as cellulosic, cork etc. a large amount of in the medical material, also optionally kept the effective ingredient in the medical material through different extraction processing methods.Show also that through clinical verification the Guilin preparation clinical efficacy that adopts method for preparing provided by the invention to make is definite.This shows that method for preparing of the present invention has improved content of effective in the medicine greatly under the prerequisite that guarantees curative effect.
The specific embodiment
Following embodiment is used to explain the present invention, but is not used for limiting scope of the present invention.
Embodiment 1
Herba Ephedrae 400g Pericarpium Papaveris 300g Semen Armeniacae Amarum (stir-fry) 200g Semen Juglandis 200g
Fructus Schisandrae Chinensis 200g Fructus Amomi Rotundus 25g
Above Six-element medical material, Fructus Amomi Rotundus extracts volatile oil with vapor distillation, and the aqueous solution after isolating volatile oil and distilling is subsequent use; Medicinal residues add 10 times of water gagings with Herba Ephedrae, Pericarpium Papaveris, Semen Juglandis and extract 2 times, 4h for the first time, 3h for the second time, merge extractive liquid; Filter, the aqueous solution after filtrating and the distillation merges, and is concentrated into every ml soln and is equivalent to the 1.0g crude drug; Add 80% alcoholic solution, make to contain alcohol amount and reach 45%, hold over night; Filter, filtrating is concentrated into the thick paste that relative density is 1.30 (70 ℃), and is subsequent use; The Semen Armeniacae Amarum squeezing back of deoiling adds 3 times of amount 80% alcohol reflux 2 times with Fructus Schisandrae Chinensis, 2h for the first time, and 1h for the second time, merge extractive liquid, filters, and filtrating is concentrated into the thick paste that relative density is 1.20 (70 ℃), and is subsequent use; Above-mentioned thick paste is merged, add the starch of thick paste weight 10%, mixing, drying is pulverized; Add 200g starch, mixing is used 75% alcohol granulation, drying, granulate; Fructus Amomi Rotundus volatile oil after adding is adsorbed with kaolin and an amount of magnesium stearate, mixing, fill becomes 1000 capsules, promptly gets.
Clinical verification:
1, case is included standard in
(1) meet doctor trained in Western medicine chronic bronchitis (type of panting) diagnosis, and Chinese medical discrimination is the syndrome of yin deficiency of lung and kidney person;
(2) age is in 18 ~ 65 one full year of life;
(3) course of disease≤3 day person;
(4) aspiration is tried, and can accept the checking medicine, keeps accomplishing person's course of treatment.
2, therapeutic scheme
(1) checking medicine
Checking medicine: the embodiment of the invention 1 capsule, every 0.35 gram;
The contrast medicine: osmanthus spirit ball, every ball weighs 6.5 grams.
(2) administrated method
Get into checking group or matched group at random according to table of random number.
The checking group: the embodiment of the invention 1 capsule, one time 4,2 times on the one, oral;
Matched group: osmanthus spirit ball, one time 1 ball, 2 times on the one, oral.
(3) course of treatment
10 days is a course of treatment.
3, therapeutic outcome
(1) comprehensive therapeutic effect
Table 1 liang group efficacy analysis
| Group | The example number | Face control | Produce effects | Effectively | Invalid | Obvious effective rate | Total effective rate |
| The checking group | 310 | 108 | 116 | 68 | 18 | 72.26% | 94.19% |
| Matched group | 105 | 35 | 40 | 23 | 7 | 71.43% | 93.33% |
Through rank test, two groups of comprehensive therapeutic effects compare P ﹥ 0.05, there was no significant difference.
(2) Clinical types curative effect
Table 2 liang group Clinical types efficacy analysis
| Type | Group | The example number | Face control | Produce effects | Effectively | Invalid | Obvious effective rate |
| Acute attack | The checking group | 184 | 71 | 70 | 33 | 10 | 76.63% |
| Acute attack | Matched group | 69 | 25 | 27 | 13 | 4 | 75.36% |
| Chronic delay | The checking group | 126 | 37 | 46 | 35 | 8 | 65.87% |
| Chronic delay | Matched group | 36 | 10 | 13 | 10 | 3 | 63.89% |
Through rank test, two groups of Clinical types curative effects compare P ﹥ 0.05, there was no significant difference.
(3) traditional Chinese medical science disease curative effect
Table 3 liang group traditional Chinese medical science disease efficacy analysis
| Group | The example number | Face control | Produce effects | Effectively | Invalid | Obvious effective rate |
| The checking group | 310 | 111 | 118 | 69 | 12 | 73.87% |
| Matched group | 105 | 36 | 42 | 22 | 5 | 74.29% |
Through rank test, two groups of traditional Chinese medical science disease curative effects compare P ﹥ 0.05, there was no significant difference.
(4) cardinal symptom, sign curative effect
Table 4 liang group individual event symptoms and therapeutic effect
| Cardinal symptom | Group | The example number | Face control | Produce effects | Effectively | Invalid | Obvious effective rate |
| Cough | The checking group | 310 | ?111 | ?118 | ?69 | ?12 | ?73.87% |
| Cough | Matched group | 105 | ?38 | 40? | ?21 | 6 | ?74.29% |
| Cough up phlegm | The checking group | 141 | ?45 | ?55 | ?34 | ?7 | ?70.92% |
| Cough up phlegm | Matched group | 47 | ?14 | ?19 | ?11 | ?3 | ?70.21% |
| Pant | The checking group | 310 | ?109 | ?117 | ?70 | ?14 | ?72.90% |
| Pant | Matched group | 105 | ?37 | ?39 | ?24 | ?5 | ?72.38% |
| Wheezing | The checking group | 310 | ?109 | ?115 | ?70 | ?16 | ?72.26% |
| Wheezing | Matched group | 105 | ?36 | ?39 | ?25 | ?5 | ?71.43% |
Through rank test, two groups of individual event symptom curative effects compare P ﹥ 0.05, there was no significant difference.
Table 5 liang group treatment back symptom and sign integration relatively
| Symptom and sign | The example number | The checking group (X ± S) | The example number | Matched group (X ± S) |
| Cough | 310 | 0.91±0.70 | 105 | 0.90±0.71 |
| Cough up phlegm | 310 | 0.22±0.38 | 105 | 0.21±0.38 |
| Pant | 310 | 0.90±0.70 | 105 | 0.89±0.70 |
| Wheezing | 310 | 0.91±0.70 | 105 | 0.87±0.69 |
| Heating | 310 | 0.20±0.29 | 105 | 0.19±0.28 |
| Dry mouth and throat | 310 | 0.82±0.68 | 105 | 0.83±0.68 |
| Spontaneous perspiration | 310 | 0.81±0.68 | 105 | 0.79±0.67 |
| Easy catching a cold | 310 | 0.74±0.64 | 105 | 0.72±0.65 |
| Breathe hard | 310 | 0.70±0.63 | 105 | 0.71±0.65 |
Through the t check, two groups of treatment back symptom and sign integrations compare P ﹥ 0.05, there was no significant difference.
(5) safety
During verifying, all do not find obvious adverse reaction for two groups, security inspection does not have yet to be treated normally preceding and case that the treatment back is unusual.
4, sum up
Clinical results shows: the embodiment of the invention 1 capsule for treating chronic bronchitis (type of panting) total effective rate is 94.19%, and obvious effective rate is 72.26%.Compare with matched group, through statistical procedures, there was no significant difference.Do not find obvious toxic and side effects and untoward reaction yet.
Embodiment 2
Herba Ephedrae 400g Pericarpium Papaveris 300g Semen Armeniacae Amarum (stir-fry) 200g Semen Juglandis 200g
Fructus Schisandrae Chinensis 200g Fructus Amomi Rotundus 25g
Above Six-element medical material, Fructus Amomi Rotundus extracts volatile oil with vapor distillation, and the aqueous solution after isolating volatile oil and distilling is subsequent use; Medicinal residues add 10 times of water gagings with Herba Ephedrae, Pericarpium Papaveris, Semen Juglandis and extract 2 times, 4h for the first time, 2h for the second time, merge extractive liquid; Filter, the aqueous solution after filtrating and the distillation merges, and is concentrated into every ml soln and is equivalent to the 0.8g crude drug; Add 95% alcoholic solution, make to contain alcohol amount and reach 35%, hold over night; Filter, filtrating is concentrated into the thick paste that relative density is 1.40 (70 ℃), and is subsequent use; The Semen Armeniacae Amarum squeezing back of deoiling adds 4 times of amount 85% alcohol reflux 2 times with Fructus Schisandrae Chinensis, 2h for the first time, and 1h for the second time, merge extractive liquid, filters, and filtrating is concentrated into the thick paste that relative density is 1.25 (70 ℃), and is subsequent use; Above-mentioned thick paste is merged, add 250g starch and 10g silicon dioxide, mixing, granulation, drying, granulate, Fructus Amomi Rotundus volatile oil spray into after with dissolve with ethanol, and mixing adds an amount of magnesium stearate, and mixing is pressed into 1000, and sugar coating or film-coat promptly get.
Embodiment 3
Herba Ephedrae 400g Pericarpium Papaveris 300g Semen Armeniacae Amarum (stir-fry) 200g Semen Juglandis 200g
Fructus Schisandrae Chinensis 200g Fructus Amomi Rotundus 25g
Above Six-element medical material, Fructus Amomi Rotundus extracts volatile oil with vapor distillation, and the aqueous solution after isolating volatile oil and distilling is subsequent use; Medicinal residues add 8 times of water gagings with Herba Ephedrae, Pericarpium Papaveris, Semen Juglandis and extract 3 times, each 2h, merge extractive liquid; Filter, the aqueous solution after filtrating and the distillation merges, and is concentrated into every ml soln and is equivalent to the 1.5g crude drug; Add 70% alcoholic solution, make to contain alcohol amount and reach 50%, hold over night; Filter, filtrating is concentrated into the thick paste that relative density is 1.20 (70 ℃), and is subsequent use; After deoiling, the Semen Armeniacae Amarum squeezing adds 3 times of amount 50% alcohol reflux 3 times with Fructus Schisandrae Chinensis, each 1h, and merge extractive liquid, filters, and filtrating is concentrated into the thick paste that relative density is 1.10 (70 ℃), and is subsequent use; Above-mentioned thick paste is merged, add the 100g dextrin, mixing, drying is pulverized, and adds 120g dextrin and 30g mannitol, uses 85% alcohol granulation, and drying adds with the Fructus Amomi Rotundus volatile oil after the silicon dioxide absorption, mixing, fill becomes 1000 capsules, promptly gets.
Embodiment 4
Herba Ephedrae 400g Pericarpium Papaveris 300g Semen Armeniacae Amarum (stir-fry) 200g Semen Juglandis 200g
Fructus Schisandrae Chinensis 200g Fructus Amomi Rotundus 25g
Above Six-element medical material, Fructus Amomi Rotundus extracts volatile oil with vapor distillation, and the aqueous solution after isolating volatile oil and distilling is subsequent use; Medicinal residues add 8 times of water gagings with Herba Ephedrae, Pericarpium Papaveris, Semen Juglandis and extract 3 times, each 2h, merge extractive liquid; Filter, the aqueous solution after filtrating and the distillation merges, and is concentrated into every ml soln and is equivalent to the 1.5g crude drug; Add 70% alcoholic solution, make to contain alcohol amount and reach 40%, hold over night; Filter, filtrating is concentrated into the thick paste that relative density is 1.40 (70 ℃), and is subsequent use; After deoiling, the Semen Armeniacae Amarum squeezing adds 2 times of amount 85% alcohol reflux 2 times with Fructus Schisandrae Chinensis, each 3h, and merge extractive liquid, filters, and filtrating is concentrated into the thick paste that relative density is 1.10 (70 ℃), and is subsequent use; Above-mentioned thick paste is merged, add 40g calcium carbonate, 200g starch and 5g silicon dioxide, mixing is granulated, drying, and granulate adds with Fructus Amomi Rotundus volatile oil after the calcium hydrogen phosphate absorption and an amount of Pulvis Talci, and mixing is pressed into 1000, and sugar coating or film-coat promptly get.
Claims (6)
1. the method for preparing of a Guiling preparation, described Guiling preparation is processed by Herba Ephedrae, Pericarpium Papaveris, Semen Armeniacae Amarum (stir-fry), Semen Juglandis, Fructus Schisandrae Chinensis, Fructus Amomi Rotundus, it is characterized in that method for preparing comprises the steps:
A, Fructus Amomi Rotundus adopt vapor distillation to extract volatile oil, and the aqueous solution after isolating volatile oil and distilling is subsequent use;
B, Fructus Amomi Rotundus medicinal residues are with Herba Ephedrae, Pericarpium Papaveris, Semen Juglandis extracting in water 2 ~ 3 times, each 2 ~ 4h, merge extractive liquid; Filter, the aqueous solution after filtrating is distilled with the A step merges, and is concentrated into every ml soln and is equivalent to 0.8g ~ 1.5g crude drug; Add alcoholic solution, make to contain alcohol amount and reach 35% ~ 50%, leave standstill; Filter, filtrating concentrate the thick paste I, subsequent use;
The squeezing of C, Semen Armeniacae Amarum is deoiled back and Fructus Schisandrae Chinensis with 50% ~ 85% ethanol extraction 2 ~ 3 times, each 1 ~ 3h, merge extractive liquid, filters, filtrating concentrated the thick paste II, subsequent use;
D, above-mentioned thick paste I and II are merged, add acceptable auxiliary on the pharmaceutics, process granule, add Fructus Amomi Rotundus volatile oil, process tablet or capsule, promptly get.
2. method for preparing as claimed in claim 1 is characterized in that the parts by weight of each medical material are respectively: 400 parts in Herba Ephedrae, 300 parts of Pericarpium Papaveriss, 200 parts of Semen Armeniacae Amarums (stir-fry), 200 parts of Semen Juglandis, 200 parts of Fructus Schisandrae Chinensis, 25 parts in Fructus Amomi Rotundus.
3. method for preparing as claimed in claim 1 is characterized in that: the relative density of thick paste I in the time of 70 ℃ is 1.20 ~ 1.40, and the relative density of thick paste II in the time of 70 ℃ is 1.10 ~ 1.25.
4. method for preparing as claimed in claim 1 is characterized in that said adjuvant is selected from one or more in starch, dextrin, mannitol, sorbitol, microcrystalline Cellulose, calcium carbonate, silicon dioxide, the magnesium stearate.
5. method for preparing as claimed in claim 1 is characterized in that: Fructus Amomi Rotundus volatile oil sprays into after with dissolve with ethanol or with adding after the adsorbents adsorb.
6. method for preparing as claimed in claim 5 is characterized in that described adsorbent is selected from one or more in silicon dioxide, Pulvis Talci, kaolin, calcium hydrogen phosphate, calcium sulfate, the calcium carbonate.
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| CN111317803A (en) * | 2018-12-14 | 2020-06-23 | 康普药业股份有限公司 | Adsorption method of Ganfule volatile oil |
| CN113509533A (en) * | 2020-04-09 | 2021-10-19 | 吉林省利华制药有限公司 | Guiling tablet medicine composition and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111317803A (en) * | 2018-12-14 | 2020-06-23 | 康普药业股份有限公司 | Adsorption method of Ganfule volatile oil |
| CN113509533A (en) * | 2020-04-09 | 2021-10-19 | 吉林省利华制药有限公司 | Guiling tablet medicine composition and preparation method thereof |
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Address after: 335200 north of national highway 320, Jiaotong North Road, Yujiang District, Yingtan City, Jiangxi Province Patentee after: Jiangxi Kangenbei tianshikang Pharmaceutical Co.,Ltd. Address before: Five industrial road, Yingtan Industrial Zone, Jiangxi 335000, China Patentee before: Jiangxi Herbi-Sky Co.,Ltd. |