CN104013755A - Extract product for preparation of lung ventilating and regulating preparation - Google Patents
Extract product for preparation of lung ventilating and regulating preparation Download PDFInfo
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Abstract
The invention discloses an extract product for preparation of a lung ventilating and regulating tablet/capsule/particle/ pill, the extract product is obtained by an improved extraction process, the improved extraction process improves the content of ephedrine and other effective components in the preparation per unit, and residues on ignition can be decreased significantly.
Description
Technical field:
The invention belongs to field of medicaments, relate to a kind of extraction process of Chinese crude drug of improved diffusing-freeing lung rectifying medicinal preparation.
Background technology: tongxuan lifei pills, the cold expelling that induces sweat, lung qi dispersing antitussive.For the cough due to anemofrigid cold, fever with chills, nasal obstruction watery nasal discharge, has a headache lossless, limb aching pain.Prescription consists of: Pericarpium Citri Reticulatae 96g, Rhizoma Pinelliae (processed) 72g, Poria 96g, Fructus Aurantii (parched) 96g, Radix Scutellariae 96g, Folium Perillae 144g, Radix Peucedani 96g, Radix Platycodonis 96g, Semen Armeniacae Amarum 72g, Herba Ephedrae 96g, Radix Glycyrrhizae 72g, above ten simply, be ground into fine powder, sieve, mix, with refined honey, add the city water-honeyed pill of appropriate water.Along with the development technical staff of Chinese medicine extraction technology separately extracts part medical material, and according to the tall design of carrying out extraction scheme of property of its medicinal ingredient, and made granule, Tablet and Capsula agent, current disclosed technique is as follows:
[prescription] Folium Perillae 180g Radix Peucedani 120g Radix Platycodonis 120g Semen Armeniacae Amarum 90g Herba Ephedrae 120g Radix Glycyrrhizae 90g Pericarpium Citri Reticulatae 120g Rhizoma Pinelliae (processed) 90 Poria 120g Fructus Aurantii (parched) 120g Radix Scutellariae 120g
Make 1000 slices/
Simply, get common pulverizing of Rhizoma Pinelliae Preparata and Fructus Aurantii 48g is fine powder to [method for making] above ten; Folium Perillae, Pericarpium Citri Reticulatae extraction by steam distillation volatile oil, separates volatile oil → 2, standby; Medicinal liquid filters, and medicinal residues decoct with water 2 hours again, filter, and merging filtrate, water cooking liquid is standby; Semen Armeniacae Amarum squeezing is deoiled, and gets its slag and remaining Fructus Aurantii, with 85% alcohol heating reflux, extracts secondary, and each 2 hours, merge ethanol extract, filter, filtrate recycling ethanol is also concentrated into the thick paste that relative density is 1.36 (50 ℃), standby; The Six-elements such as all the other Radix Peucedanis decoct with water secondary, and each 2 hours, collecting decoction, filtered, and decocting liquid is standby; Merge above-mentioned decocting liquid, be evaporated to the thick paste of relative density 1.34～1.38 (50 ℃), add above-mentioned Rhizoma Pinelliae Preparata, Fructus Aurantii fine powder and Semen Armeniacae Amarum, Fructus Aurantii thick paste, mix, granulation, dry, (1) sprays into above-mentioned volatile oil, mix tabletting, sugar coating or film-coat; (2) filled capsules; (3) be distributed into granule.The manufacturer of domestic production Tongxuanlifei tablet, capsule, granule generally adopts above-mentioned technique to produce at present.
My technical staff of unit is when studying the production technology of Tongxuanlifei sheet, through test repeatedly, invented a kind of improved extraction process, this extraction process is maintaining former technique substantially constant in the situation that, by regulating pH value, increase the means such as time of soaking and make the Content of Ephedrine With in unit formulation have significantly lifting, average increase rate is more than 70%.
Summary of the invention:
Current disclosed technique is as follows:
[prescription] Folium Perillae 180g Radix Peucedani 120g Radix Platycodonis 120g Semen Armeniacae Amarum 90g Herba Ephedrae 120g Radix Glycyrrhizae 90g Pericarpium Citri Reticulatae 120g Rhizoma Pinelliae (processed) 90g Poria 120g Fructus Aurantii (parched) 120g Radix Scutellariae 120g
Make 1000 slices/
(1) above ten simply, and getting common pulverizing of Rhizoma Pinelliae Preparata and Fructus Aurantii 48g is fine powder; Folium Perillae, Pericarpium Citri Reticulatae extraction by steam distillation volatile oil, separates volatile oil, standby;
(2) medicinal liquid filters, and medicinal residues decoct with water 2 hours again, filter, and merging filtrate, water cooking liquid is standby; Semen Armeniacae Amarum squeezing is deoiled, and gets its slag and remaining Fructus Aurantii, with 85% alcohol heating reflux, extracts secondary, and each 2 hours, merge ethanol extract, filter, filtrate recycling ethanol is also concentrated into the thick paste that relative density is 1.36 (50 ℃), standby;
(3) Six-element such as all the other Radix Peucedanis decocts with water secondary, and each 2 hours, collecting decoction, filtered, and decocting liquid is standby; Merge above-mentioned decocting liquid, be evaporated to the thick paste of relative density 1.34～1.38 (50 ℃), add above-mentioned Rhizoma Pinelliae Preparata, Fructus Aurantii fine powder and Semen Armeniacae Amarum, Fructus Aurantii thick paste, mix, granulation, dry, spray into above-mentioned volatile oil, mix;
(4) (1) tabletting, sugar coating or film-coat; (2) filled capsules; (3) be distributed into granule.
The main improvement of the present invention is in (3) above-mentioned step, and the complete process after improvement is as follows:
[prescription] Folium Perillae 180g Radix Peucedani 120g Radix Platycodonis 120 Semen Armeniacae Amarum 90g Herba Ephedrae 120g Radix Glycyrrhizae 90g Pericarpium Citri Reticulatae 120g Rhizoma Pinelliae (processed) 90g Poria 120g Fructus Aurantii (parched) 120g Radix Scutellariae 120g
Make 1000 slices/
(1) above ten simply, and getting common pulverizing of Rhizoma Pinelliae Preparata and Fructus Aurantii 48g is fine powder; Folium Perillae, Pericarpium Citri Reticulatae extraction by steam distillation volatile oil, separates volatile oil, standby;
(2) medicinal liquid filters, and medicinal residues decoct with water 2 hours again, filter, and merging filtrate, water cooking liquid is standby; Semen Armeniacae Amarum squeezing is deoiled, and gets its slag and remaining Fructus Aurantii, with 85% alcohol heating reflux, extracts secondary, and each 2 hours, merge ethanol extract, filter, filtrate recycling ethanol is also concentrated into the thick paste that relative density is 1.36 (50 ℃), standby;
(3) Six-element such as all the other Radix Peucedanis adds the water that medical material 4-6 doubly measures, and regulates pH value to 3-4, soaks 4-6 hour, and reflux, extract, 2-3 hour, filters and separate extracting solution; Medicinal residues continue the water that adds 4-6 doubly to measure, and regulate pH value to 3-4, soak 4-6 hour, and reflux, extract, 2-3 hour, crosses leaching extracting solution; The decocting liquid that merges (1) and (2), regulates pH value to 7-9, at 50 ± 5 ℃, is evaporated to relative density 1.34～1.38.Add above-mentioned Rhizoma Pinelliae Preparata, Fructus Aurantii fine powder and Semen Armeniacae Amarum, Fructus Aurantii thick paste, mix, granulation, dry, spray into above-mentioned volatile oil, mix;
(4) 1. tabletting, sugar coating or film-coat; 2. filled capsules; 3. be distributed into granule.
By to the improvement of (3) step process, the content of unit formulation Ephedrine having been improved more than 70%, and residue on ignition has had significant reduction.
As everyone knows, change due to extraction process, the change of parameter, can cause the material base of extract to change, thereby cause the effective ingredient in extract to improve or reduce, the present invention, by changing the physicochemical property of solvent and the parameter of extraction process, gets a promotion the content of effective ingredient, and the impurity that contains inorganic salt, heavy metal is reduced.
Adopt the extraction process after improving, produce three batches of tablets, lot number is respectively 0601A, 0602A, 0603A, adopt traditional handicraft same size to carry out three batches of confirmatory productions, lot number is respectively 0601B, 0602B, 0603B, carry out the assay of ephedrine and the mensuration of residue on ignition of unit formulation, the content of the ephedrine in the preparation that the extraction process after employing improves is made is significantly higher than the preparation that traditional handicraft is produced, and the preparation that residue on ignition is significantly produced lower than traditional processing technology.
Specific embodiment:
Embodiment 1: the preparation of the Tongxuanlifei tablet after improvement
[prescription] Folium Perillae 180g, Radix Peucedani 120g, Radix Platycodonis 120g, Semen Armeniacae Amarum 90g, Herba Ephedrae 120g, Radix Glycyrrhizae 90g, Pericarpium Citri Reticulatae 120g, Rhizoma Pinelliae (processed) 90g, Poria 120g, Fructus Aurantii (parched) 120g, Radix Scutellariae 120g
Make 1000
(1) above ten simply, and getting common pulverizing of Rhizoma Pinelliae Preparata and Fructus Aurantii 48g is fine powder; Folium Perillae, Pericarpium Citri Reticulatae extraction by steam distillation volatile oil, separates volatile oil, standby;
(2) medicinal liquid filters, and medicinal residues decoct with water 2 hours again, filter, and merging filtrate, water cooking liquid is standby; Semen Armeniacae Amarum squeezing is deoiled, and gets its slag and remaining Fructus Aurantii, with 85% alcohol heating reflux, extracts secondary, and each 2 hours, merge ethanol extract, filter, filtrate recycling ethanol is also concentrated into the thick paste that relative density is 1.36 (50 ℃), standby;
(3) Six-element such as all the other Radix Peucedanis adds the water that medical material 4-6 doubly measures, and regulates pH value to 3-4, soaks 4-6 hour, and reflux, extract, 2-3 hour, filters and separate extracting solution; Medicinal residues continue the water that adds 4-6 doubly to measure, and regulate pH value to 3-4, soak 4-6 hour, and reflux, extract, 2-3 hour, crosses leaching extracting solution; The decocting liquid that merges (1) and (2), regulates pH value to 7-9, at 50 ± 5 ℃, is evaporated to relative density 1.34～1.38.Add above-mentioned Rhizoma Pinelliae Preparata, Fructus Aurantii fine powder and Semen Armeniacae Amarum, Fructus Aurantii thick paste, mix, granulation, dry, spray into above-mentioned volatile oil, mix;
(4) tabletting is made 1000.
Produce 3 batches continuously, lot number is respectively: 0601A, 0602A, 0603A.
Embodiment 2: the preparation of the Tongxuanlifei sheet of the same scale of employing traditional handicraft:
[prescription] Folium Perillae 180g, Radix Peucedani 120g, Radix Platycodonis 120g, Semen Armeniacae Amarum 90g, Herba Ephedrae 120g, Radix Glycyrrhizae 90g, Pericarpium Citri Reticulatae 120g, Rhizoma Pinelliae (processed) 90g, Poria 120g, Fructus Aurantii (parched) 120g, Radix Scutellariae 120g
Make 1000
(1) above ten simply, and getting common pulverizing of Rhizoma Pinelliae Preparata and Fructus Aurantii 48g is fine powder; Folium Perillae, Pericarpium Citri Reticulatae extraction by steam distillation volatile oil, separates volatile oil, standby;
(2) medicinal liquid filters, and medicinal residues decoct with water 2 hours again, filter, and merging filtrate, water cooking liquid is standby; Semen Armeniacae Amarum squeezing is deoiled, and gets its slag and remaining Fructus Aurantii, with 85% alcohol heating reflux, extracts secondary, and each 2 hours, merge ethanol extract, filter, filtrate recycling ethanol is also concentrated into the thick paste that relative density is 1.36 (50 ℃), standby;
(3) Six-element such as all the other Radix Peucedanis decocts with water secondary, and each 2 hours, collecting decoction, filtered, and decocting liquid is standby; Merge above-mentioned decocting liquid, be evaporated to the thick paste of relative density 1.34～1.38 (50 ℃), add above-mentioned Rhizoma Pinelliae Preparata, Fructus Aurantii fine powder and Semen Armeniacae Amarum, Fructus Aurantii thick paste, mix, granulation, dry, spray into above-mentioned volatile oil, mix;
(4) tabletting, produces three batches continuously, and lot number is respectively: 0601B, 0602B, 0603B.
The comparison of the assay result of 3: the two kinds of prepared Tongxuanlifei sheet of various processes Ephedrines of embodiment:
(1), the content assaying method of ephedrine: get 20, accurately weighed, add water 20ml and dissolve, put in separatory funnel, with Petroleum ether extraction 4 times (20,15,15,15ml), n-butanol extraction 4 times for water layer (25,20,20,20ml), merge extractive liquid,, with after anhydrous sodium sulfate dehydration, n-butyl alcohol is removed in decompression, residue adds dissolve with methanol and is settled to 2ml, as need testing solution.Separately get astragaloside reference substance, add methanol and make every 1ml containing the solution of 1mg, in contrast product solution.According to thin layer chromatography (appendix VI B), test, draw each 5 μ 1 of need testing solution and reference substance solution, cross point is on same silica gel g thin-layer plate respectively, chloroform-methanol-the water (30: 10: 1) of take is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, 105 ℃ of bakings, within approximately 5 minutes, to speckle, develop the color clear, take out, on lamellae, cover onesize glass plate, use immobilization with adhesive tape around, according to thin layer chromatography (appendix VIB thin layer chromatography scanning), scan, wavelength X <[s] >=530nm, measure test sample trap integrated value and reference substance trap integrated value, calculate the content of every contained ephedrine, get the meansigma methods of 20.
The assay method of residue on ignition: get 20 of test samples, put in the crucible of ignition to constant weight, accurately weighed, slowly blazing to carbonization completely, let cool; Add sulphuric acid 0.5～1ml make moistening, after low-temperature heat to sulfuric acid vapor eliminates, at 700～800 ℃ of ignition to constant weight, calculating mean value.
(3), measurement result is as in the table below:
| Lot number | The content of ephedrine (mg) | Residue on ignition (mg) |
| 0601A | 0.99 | 0.11 |
| 0601B | 0.61 | 0.21 |
| 0602A | 1.10 | 0.14 |
| 0602B | 0.68 | 0.35 |
| 0603A | 1.15 | 0.10 |
| 0603B | 0.62 | 0.33 |
Result shows the Tongxuanlifei sheet that the content of Tongxuanlifei sheet Ephedrine prepared by the extraction process after employing improves is all prepared apparently higher than traditional handicraft, the tablet that residue on ignition is significantly produced lower than traditional handicraft.
Embodiment 4: the preparation of the Tongxuanlifei capsule after improvement
[prescription] Folium Perillae 180g, Radix Peucedani 120g, Radix Platycodonis 120g, Semen Armeniacae Amarum 90g, Herba Ephedrae 120g, Radix Glycyrrhizae 90g, Pericarpium Citri Reticulatae 120g, Rhizoma Pinelliae (processed) 90g, Poria 120g, Fructus Aurantii (parched) 120g, Radix Scutellariae 120g
Make 1000 capsules
(1) above ten simply, and getting common pulverizing of Rhizoma Pinelliae Preparata and Fructus Aurantii 48g is fine powder; Folium Perillae, Pericarpium Citri Reticulatae extraction by steam distillation volatile oil, separates volatile oil, standby;
(2) medicinal liquid filters, and medicinal residues decoct with water 2 hours again, filter, and merging filtrate, water cooking liquid is standby; Semen Armeniacae Amarum squeezing is deoiled, and gets its slag and remaining Fructus Aurantii, with 85% alcohol heating reflux, extracts secondary, and each 2 hours, merge ethanol extract, filter, filtrate recycling ethanol is also concentrated into the thick paste that relative density is 1.36 (50 ℃), standby;
(3) Six-element such as all the other Radix Peucedanis adds the water that medical material 4-6 doubly measures, and regulates pH value to 3-4, soaks 4-6 hour, and reflux, extract, 2-3 hour, filters and separate extracting solution; Medicinal residues continue the water that adds 4-6 doubly to measure, and regulate pH value to 3-4, soak 4-6 hour, and reflux, extract, 2-3 hour, crosses leaching extracting solution; The decocting liquid that merges (1) and (2), regulates pH value to 7-9, at 50 ± 5 ℃, is evaporated to relative density 1.34～1.38.Add above-mentioned Rhizoma Pinelliae Preparata, Fructus Aurantii fine powder and Semen Armeniacae Amarum, Fructus Aurantii thick paste, mix, granulation, dry, spray into above-mentioned volatile oil, mix;
(4) be filled to 1000 of capsules.
Claims (2)
1. for the preparation of an extract for Tongxuanlifei tablets/capsules/pellets/granules, this extract is extracted and is obtained by following steps:
(1) Radix Peucedani 120 parts ± 20%, Radix Platycodonis 120 parts ± 20%, Herba Ephedrae 120 parts ± 20%, Radix Glycyrrhizae 90 parts ± 20%, Poria 120 parts ± 20%, Radix Scutellariae 120 parts ± 20%, add the water that medical material 4-6 doubly measures, regulate pH value to 3-4, soak 4-6 hour, reflux, extract, 2-3 hour, filters and separates extracting solution;
(2) medicinal residues continue the water that adds 4-6 doubly to measure, and regulate pH value to 3-4, soak 4-6 hour, and reflux, extract, 2-3 hour, crosses leaching extracting solution;
(3) merge the decocting liquid of (1) and (2), regulate pH value to 7-9, at 50 ± 5 ℃, be evaporated to relative density 1.34～1.38.
2. tablets/capsules/granule/the pill of the Tongxuanlifei that described in employing claim 1 prepared by extract.
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| CN201410233866.7A CN104013755A (en) | 2014-05-28 | 2014-05-28 | Extract product for preparation of lung ventilating and regulating preparation |
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| CN201410233866.7A CN104013755A (en) | 2014-05-28 | 2014-05-28 | Extract product for preparation of lung ventilating and regulating preparation |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108310124A (en) * | 2018-03-21 | 2018-07-24 | 江西济民可信药业有限公司 | A kind of hot children heat-cough oral liquid of clearing lung-heat and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108310124A (en) * | 2018-03-21 | 2018-07-24 | 江西济民可信药业有限公司 | A kind of hot children heat-cough oral liquid of clearing lung-heat and preparation method thereof |
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Application publication date: 20140903 |