CN1316962C - Cough panting quieting drip pill and its preparation method - Google Patents
Cough panting quieting drip pill and its preparation method Download PDFInfo
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- CN1316962C CN1316962C CNB2005100682707A CN200510068270A CN1316962C CN 1316962 C CN1316962 C CN 1316962C CN B2005100682707 A CNB2005100682707 A CN B2005100682707A CN 200510068270 A CN200510068270 A CN 200510068270A CN 1316962 C CN1316962 C CN 1316962C
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Abstract
The present invention relates to a medical composition which has the functions of cough relief, phlegm elimination and asthma relief and is used for treating diseases, such as acute and chronic bronchitis, upper respiratory tract infection, etc. The present invention aims to supply the insufficiency of oral drug preparations used for treating the acute and chronic bronchitis and the upper respiratory tract infection, and provides an oral preparation cough and asthma relieving dripping pill with the advantages of high bioavailability, rapid medicine release, rapid effect taking, high medicine content, accurate metering, convenient admission, low cost and no pollution in the process of production. The cough and asthma relieving dripping pill is prepared by using the extracts of active components of 13 kinds of traditional Chinese medicine of ephedra, bitter apricot seed, balloon flower, hogfenneL root, perilla fruit, radish seed, dried orange peel, aucklandia root, curcuma root, trogopterus dung, stemona root (fried with honey), earthworm, ammonium chloride, etc. as raw materials and using medicinal carriers as substrates.
Description
Technical field
The present invention relates to a kind ofly have cough-relieving, eliminate the phlegm, antiasthmatic effect, be used for acute and chronic bronchitis, the pharmaceutical composition of treatment for diseases such as upper respiratory tract infection is a kind of drug composition oral preparation that feedstock production forms with the extract that contains 13 flavor active ingredient of Chinese herbs such as Herba Ephedrae, Semen Armeniacae Amarum, Radix Platycodonis, Radix Peucedani, Fructus Perillae, Semen Raphani, Pericarpium Citri Reticulatae, the Radix Aucklandiae, Radix Curcumae, Oletum Trogopterori, the Radix Stemonae (processing), Pheretima, ammonium chloride particularly.
Background technology
Pacify oral liquid according to the cough with asthma that the preparation method that provides among the national drug standards WS-11258 (ZD-1258)-2002 is prepared from, be a kind ofly have cough-relieving, eliminate the phlegm, antiasthmatic effect, be used for acute and chronic bronchitis, the oral granular formulation of treatment for diseases such as upper respiratory tract infection, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
Below be prescription and technology and the brief description that provides in WS-11258 (ZD-1258)-2002 drug standard;
Prescription: Herba Ephedrae 15g, Semen Armeniacae Amarum 15g, Radix Platycodonis 15g, Radix Peucedani 22.5g, Fructus Perillae 22.5g, Semen Raphani 22.5g, Pericarpium Citri Reticulatae 15g, Radix Aucklandiae 22.5g, Radix Curcumae 25g, Oletum Trogopterori 25g, the Radix Stemonae (processing) 22.5g, Pheretima 22.5g, ammonium chloride 165g, Mel 3000ml, potassium sorbate 2g
Method for making: above 13 flavor medicines, the Radix Aucklandiae, Herba Ephedrae, Radix Peucedani, Semen Raphani, Pericarpium Citri Reticulatae extract volatile oil with the way of distillation, and be standby; Aqueous solution after medicinal residues and distillation device is in addition collected.Other gets Radix Platycodonis, the Radix Stemonae (moxibustion), Pheretima, Semen Armeniacae Amarum, Fructus Perillae, Radix Curcumae, Oletum Trogopterori, decoct with water three times, 2 hours for the first time, second and third time (adding medicinal residues such as the Radix Aucklandiae) was respectively 1.5 hours and 1 hour, aqueous solution after three decocting liquids and the distillation merges, filter, filtrate decompression is concentrated into about 160ml, adds ethanol and makes and contain alcohol and measure and reach 70%, left standstill 48 hours, filter, decompression filtrate recycling ethanol adds the suitable quantity of water dilution and is afraid of to there not being the alcohol flavor, add ammonium chloride, volatile oil, Mel and potassium sorbate successively, filter, add water to ormal weight, promptly.
Function cures mainly: cough-relieving, eliminate the phlegm, relieving asthma; Be used for acute and chronic bronchitis, upper respiratory tract infection.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.It is low that oral liquid also has a medicament contg, and dose is not accurate enough and take inconvenient shortcoming.
In addition, conventional peroral dosage form is as tablet, capsule, granule (electuary) etc., in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Summary of the invention
Purpose of the present invention, be to replenish the existing acute and chronic bronchitis that is used for, the deficiency of the oral drug preparation of treatment for diseases such as upper respiratory tract infection, a kind of bioavailability height is provided, and has quick release, fast produce effects, the medicament contg height, accurate measurement, taking convenience, cheap, and free of contamination aborning oral formulations cough panting quieting drip pill.Cough panting quieting drip pill involved in the present invention, with the extract that contains Herba Ephedrae, Semen Armeniacae Amarum, Radix Platycodonis, Radix Peucedani, Fructus Perillae, Semen Raphani, Pericarpium Citri Reticulatae, the Radix Aucklandiae, Radix Curcumae, Oletum Trogopterori, the Radix Stemonae (processing), Pheretima, ammonium chloride etc. 13 flavor active ingredient of Chinese herbs is raw material, is prepared from the pharmaceutically suitable carrier as substrate.Be prepared by the following technical solutions, can obtain cough panting quieting drip pill involved in the present invention:
[preparation method]
1. raw material: the extract that contains 13 flavor active ingredient of Chinese herbs such as Herba Ephedrae, Semen Armeniacae Amarum, Radix Platycodonis, Radix Peucedani, Fructus Perillae, Semen Raphani, Pericarpium Citri Reticulatae, the Radix Aucklandiae, Radix Curcumae, Oletum Trogopterori, the Radix Stemonae (processing), Pheretima, ammonium chloride;
2. substrate: the mixture of one or more in pharmaceutically suitable carrier such as polyethylene glycols, sorbitol anhydride class, polyoxyethylene sorbitol acid anhydride class, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing drug extract and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing drug extract and substrate and/or emulsion and/or suspension;
5. adopt homemade or general drop pill machine (as the TZDW-1 type drop pill machine of Changzheng Tianmin High Science ﹠ Technology Co., Ltd., Beijing's production), and the temperature control system of adjustment drop pill machine, make the water dropper temperature heating of drop pill machine and remain on (50～90) ℃, the temperature cooling of condensing agent also remains on (40～-5) ℃;
6. when treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and reaching desired state of temperature, to contain the fused solution of drug extract and substrate and/or emulsion and/or suspension places in the water dropper jar of drop pill machine, splash in the condensing agent, condensing agent can be any one in liquid paraffin, methyl-silicone oil, the vegetable oil;
7. will shrink the drop pill taking-up of molding by the outlet of drop pill machine, remove the surface condensation agent, be drying to obtain.
[appendix: a kind of 13 flavor active ingredient of Chinese herbs preparation method of extract such as Herba Ephedrae that contain] gets Herba Ephedrae 15g, Semen Armeniacae Amarum 15g, Radix Platycodonis 15g, Radix Peucedani 22.5g, Fructus Perillae 22.5g, Semen Raphani 22.5g, Pericarpium Citri Reticulatae 15g, Radix Aucklandiae 22.5g, Radix Curcumae 25g, Oletum Trogopterori 25g, the Radix Stemonae (processing) 22.5g, Pheretima 22.5g, ammonium chloride 165g, more than 13 the flavor medicines, the Radix Aucklandiae, Herba Ephedrae, Radix Peucedani, Semen Raphani, Pericarpium Citri Reticulatae, extract volatile oil with the way of distillation, standby; Aqueous solution after medicinal residues and distillation device is in addition collected; Other gets Radix Platycodonis, the Radix Stemonae (moxibustion), Pheretima, Semen Armeniacae Amarum, Fructus Perillae, Radix Curcumae, Oletum Trogopterori, decoct with water three times, 2 hours for the first time, second and third time adds medicinal residues such as the Radix Aucklandiae and aqueous solution decocts together, be respectively 1.5 hours, 1 hour, aqueous solution after three decocting liquids and the distillation merges, filter, filtrate decompression is concentrated into flowing soaking paste, adds ammonium chloride, volatile oil, being decompressed to 0.1MPa, being condensed into relative density below 60 ℃ is 1.3～1.35 thick paste, or continue to make drying, be ground into dry powder, promptly.
What provide above is a kind of preparation method of common drug extract, under the same or analogous prerequisite of main active pharmaceutical ingredient of extract, is not limited to this a kind of method.
[beneficial effect]
Pacify oral liquid according to the cough with asthma that the preparation method that provides among the national drug standards WS-11258 (ZD-1258)-2002 is prepared from, be a kind ofly have cough-relieving, eliminate the phlegm, antiasthmatic effect, be used for acute and chronic bronchitis, the oral granular formulation of treatment for diseases such as upper respiratory tract infection, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.It is low that oral liquid also has a medicament contg, and dose is not accurate enough and take inconvenient shortcoming.
In addition, conventional peroral dosage form is as tablet, capsule, granule (electuary) etc., in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Cough panting quieting drip pill involved in the present invention is compared with cough with asthma peace oral liquid has following beneficial effect:
1. cough panting quieting drip pill involved in the present invention; utilize surfactant to be substrate; with contain Herba Ephedrae; Semen Armeniacae Amarum; Radix Platycodonis; Radix Peucedani; Fructus Perillae; Semen Raphani; Pericarpium Citri Reticulatae; the Radix Aucklandiae; Radix Curcumae; Oletum Trogopterori; the Radix Stemonae (processing); Pheretima; the extract of 13 flavor active ingredient of Chinese herbs such as ammonium chloride is made solid dispersion together; make medicine be molecule; colloid or microcrystalline state are scattered in the substrate; the total surface area of medicine increases; and substrate is hydrophilic; medicine had wetting action; can make medicine molten microgranule or the solution of loosing into rapidly; thereby make the dissolving of medicine and absorb quickening; thereby improved bioavailability, performance is efficient; quick-acting effects etc.
2. cough panting quieting drip pill involved in the present invention, contact promptly with saliva and to dissolve rapidly, and absorb by oral mucosa, not only rapid-action, and the influence of not taken food, promptly all can containing take after meal ante cibum, can not produce any residual harmful substance at gastric yet, thereby make that patient's medication is safer, also have medication convenience, characteristic of accurate simultaneously.
3. cough panting quieting drip pill involved in the present invention mixes the extract that contains active constituents of medicine mutually with molten matrix, splashes in the not miscible condensed fluid and makes.Therefore, the stability of drug height, not facile hydrolysis, oxidation, and the operation be under liquid state, to carry out, no dust pollution is not subject to the influence of crystal formation, thereby has guaranteed the quality of medicine, has increased stability.
4. production technology, the equipment of preparation drop pill are simple, easy to operate, the automaticity height, and labor intensity is low, the production efficiency height.Workshop does not have dust simultaneously, helps labor protection and environmental protection yet.
5. the production cost of preparation drop pill is usually with about 50% of other oral formulations of kind, and compares with oral liquid, and the dosage of drop pill is accurate, thereby makes the patient take metering control easily.
The specific embodiment
Now with several groups of specific embodiments, be described further with regard to the preparation method of cough panting quieting drip pill of the present invention.
First group: the test of single-matrix
1. raw material: it is standby in powder to make the extract that contains 13 flavor Chinese medicine active pharmaceutical ingredients such as Herba Ephedrae, Semen Armeniacae Amarum, Radix Platycodonis, Radix Peucedani, Fructus Perillae, Semen Raphani, Pericarpium Citri Reticulatae, the Radix Aucklandiae, Radix Curcumae, Oletum Trogopterori, the Radix Stemonae (processing), Pheretima, ammonium chloride earlier according to [appendix];
2. substrate: Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and Radix Astragali extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the cough panting quieting drip pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared cough panting quieting drip pill in qualitative difference, according to 1: 1 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 13 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning prepared cough panting quieting drip pill in qualitative difference, according to 1: 3 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 13 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared cough panting quieting drip pill in qualitative difference, according to 1: 9 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 13 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. raw material: it is standby to make the extract dry powder that contains 13 flavor Chinese medicine active pharmaceutical ingredients such as Herba Ephedrae, Semen Armeniacae Amarum, Radix Platycodonis, Radix Peucedani, Fructus Perillae, Semen Raphani, Pericarpium Citri Reticulatae, the Radix Aucklandiae, Radix Curcumae, Oletum Trogopterori, the Radix Stemonae (processing), Pheretima, ammonium chloride earlier according to [appendix];
2. substrate:
2.1 Polyethylene Glycol---English name Macrogol,
2.2 polyoxyethylene stearate 40 esters---English name Polyoxyl (40) Stearate,
Molecular formula is with C
17H
35COO (CH
2CH
2O)
nH represents that n is about 40,
2.3 poloxamer---English name Poloxamer, polyoxyethylene poly-oxygen propylene aether,
Molecular formula HO (C
2H
4O)
a(C
3H
6O)
b(C
2H
4O)
cH,
The sodium salt of the starch carboxymethyl ester that 2.4 carboxymethyl starch sodium---English name Carboxymethylstach Sodium, starch generates with the monoxone effect under alkali condition,
2.5 betacyclodextrin---English name Betacyclodextrin, molecular formula C
6H
10O
5, this product is that ring dextrin glucosyl transferase acts on 7 glucoses that starch generates with α-1, the bonded cyclic oligosaccharide of 4-glycosidic bond;
3. proportioning: with g or kg is unit, by weight, and Radix Astragali extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the cough panting quieting drip pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared cough panting quieting drip pill when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 1 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 4.
Test 5: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared cough panting quieting drip pill when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 3 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 5.
Test 6: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared cough panting quieting drip pill when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 9 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 6.
Test 7: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared cough panting quieting drip pill when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 1 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 7.
Test 8: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared cough panting quieting drip pill when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 3 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 8.
Test 9: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared cough panting quieting drip pill when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 9 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 9.
Test 10: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared cough panting quieting drip pill when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 1 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 10.
Test 11: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared cough panting quieting drip pill when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 3 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 11.
Test 12: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared cough panting quieting drip pill when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 9 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 12.
The group practices of table 1 drug extract and single-matrix
(drug extract: substrate=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 50.0 | 67 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 50.0 | 86 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 6000 | 50.0 | 88 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 10000 | 50.0 | 88 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 87 | ＜30 | ＜10 | ++ |
| Span 40 | 50.0 | 61 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 88 | ＜30 | ＜10 | + |
| Poloxamer | 50.0 | 89 | ＜30 | ＜10 | ++ |
| Sodium lauryl sulphate | 50.0 | 73 | ＞30 | ＞10 | ++ |
| Stearic acid | 50.0 | 60 | ＞30 | ＞10 | ++ |
| Sodium stearate | 50.0 | 61 | ＞30 | ＞10 | ++ |
| Glycerin gelatine | 50.0 | 61 | ＞30 | ＞10 | + |
| Lac | 50.0 | 62 | ＞30 | ＞10 | + |
The group practices of table 2 drug extract and single-matrix
(drug extract: substrate=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 25.0 | 67 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 25.0 | 91 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 6000 | 25.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 91 | ＜30 | ＜10 | +++ |
| Span 40 | 25.0 | 68 | ＜30 | ＞10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 91 | ＜30 | ＜10 | ++ |
| Poloxamer | 25.0 | 92 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 25.0 | 78 | ＜30 | ＞10 | ++ |
| Stearic acid | 25.0 | 77 | ＞30 | ＞10 | +++ |
| Sodium stearate | 25.0 | 74 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 25.0 | 74 | ＞30 | ＞10 | +++ |
| Lac | 25.0 | 73 | ＞30 | ＞10 | +++ |
The group practices of table 3 drug extract and single-matrix
(drug extract: substrate=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 10.0 | 84 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 10.0 | 92 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 6000 | 10.0 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 93 | ＜30 | ＜10 | +++ |
| Span 40 | 10.0 | 78 | ＜30 | ＞10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 92 | ＜30 | ＜10 | ++ |
| Poloxamer | 10.0 | 91 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 10.0 | 79 | ＜30 | ＞10 | +++ |
| Stearic acid | 10.0 | 77 | ＞30 | ＞10 | +++ |
| Sodium stearate | 10.0 | 74 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 10.0 | 73 | ＞30 | ＞10 | +++ |
| Lac | 10.0 | 74 | ＞30 | ＞10 | +++ |
The group practices of table 4 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 50 | 85 | ＜30 | ＞10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 50 | 84 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50 | 82 | ＜30 | ＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 50 | 76 | ＜30 | ＞10 | + |
The group practices of table 5 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 25 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 25 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25 | 88 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 25 | 84 | ＜30 | ＞10 | ++ |
The group practices of table 6 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 10 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 10 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10 | 89 | ＜30 | ＞10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 10 | 83 | ＜30 | ＞10 | +++ |
The group practices of table 7 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 50 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 50 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50 | 91 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 50 | 87 | ＜30 | ＜10 | ++ |
The group practices of table 8 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 25 | 93 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 25 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 91 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 25 | 88 | ＜30 | ＜10 | +++ |
The group practices of table 9 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 10 | 93 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 10 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 10 | 92 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 10 | 89 | ＜30 | ＜10 | +++ |
The group practices of table 10 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 50 | 93 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 50 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50 | 91 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 50 | 89 | ＜30 | ＞10 | +++ |
The group practices of table 11 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 25 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 25 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 25 | 87 | ＜30 | ＜10 | +++ |
The group practices of table 12 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 10 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 10 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10 | 91 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 10 | 89 | ＜30 | ＜10 | +++ |
1. can be seen by the result in the table: when the ratio of drug extract and substrate was 1: 1, its rounding rate, the ball method of double differences was different and index such as hardness is all undesirable, and dissolve scattered time limit influenced not obvious.
2. when the ratio of drug extract and substrate is 1: 3, the rounding rate, the ball method of double differences is different and index such as hardness slightly all begins to enter preferable state.
3. when the ratio of drug extract and substrate is 1: 9, the rounding rate, the ball method of double differences is different and index such as hardness improves not obvious.
4. the general effect of composite interstitial substance is better than single-matrix.
5. the hardness method for expressing in the subordinate list adopts drop pill is placed on the glass plate, press...withes one's finger it, observes its metamorphosis."+" expression flicking promptly is out of shape, " ++ " expression distortion of firmly pressing, and " +++" expression is indeformable by it.
Claims (2)
1. treat bronchitic cough panting quieting drip pill for one kind, with Herba Ephedrae, Semen Armeniacae Amarum, Radix Platycodonis, Radix Peucedani, Fructus Perillae, Semen Raphani, Pericarpium Citri Reticulatae, the Radix Aucklandiae, Radix Curcumae, Oletum Trogopterori, Radix Stemonae (processed), Pheretima, ammonium chloride is raw material, be prepared from pharmaceutically suitable carrier, it is characterized in that as substrate:
(1) gets Herba Ephedrae 15g, Semen Armeniacae Amarum 15g, Radix Platycodonis 15g, Radix Peucedani 22.5g, Fructus Perillae 22.5g, Semen Raphani 22.5g, Pericarpium Citri Reticulatae 15g, Radix Aucklandiae 22.5g, Radix Curcumae 25g, Oletum Trogopterori 25g, the Radix Stemonae (processing) 22.5g, Pheretima 22.5g, ammonium chloride 165g, more than 13 the flavor medicines, the Radix Aucklandiae, Herba Ephedrae, Radix Peucedani, Semen Raphani, Pericarpium Citri Reticulatae, extract volatile oil with the way of distillation, standby; Aqueous solution after medicinal residues and distillation device is in addition collected; Other gets Radix Platycodonis, the Radix Stemonae (moxibustion), Pheretima, Semen Armeniacae Amarum, Fructus Perillae, Radix Curcumae, Oletum Trogopterori, decoct with water three times, 2 hours for the first time, second, adding medicinal residues such as the Radix Aucklandiae and aqueous solution for three times decocts together, be respectively 1.5 hours, 1 hour, aqueous solution after three decocting liquids and the distillation merges, filter, filtrate decompression is concentrated into flowing soaking paste, add ammonium chloride, volatile oil, be decompressed to 0.1MPa, be condensed into relative density below 60 ℃ and be 1.3～1.35 thick paste, or continue to make drying, be ground into dry powder, promptly get and contain Herba Ephedrae, Semen Armeniacae Amarum, Radix Platycodonis, Radix Peucedani, Fructus Perillae, Semen Raphani, Pericarpium Citri Reticulatae, the Radix Aucklandiae, Radix Curcumae, Oletum Trogopterori, Radix Stemonae (processed), Pheretima, the extract of ammonium chloride effective ingredient, standby;
(2) described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or carboxymethyl starch sodium, by weight, the mixed proportion of polyoxyethylene stearate 40 esters or carboxymethyl starch sodium and Polyethylene Glycol is 1: 1～1: 10, describedly contains the extract of Herba Ephedrae, Semen Armeniacae Amarum, Radix Platycodonis, Radix Peucedani, Fructus Perillae, Semen Raphani, Pericarpium Citri Reticulatae, the Radix Aucklandiae, Radix Curcumae, Oletum Trogopterori, Radix Stemonae (processed), Pheretima, ammonium chloride effective ingredient and the ratio of substrate is 1: 3;
(3) according to aforementioned proportion, accurately take by weighing drug extract and substrate, be placed in the heating container heating while stirring, standby until the fused solution that obtains containing described extract and substrate and/or emulsion and/or suspension;
(4) temperature control system of adjustment drop pill machine makes the water dropper heating of drop pill machine and maintains the temperature at 50 ℃～90 ℃, and the condensing agent cooling also maintains the temperature at 40 ℃～-5 ℃;
When (5) temperature for the treatment of dropping-pill machine head and condensing agent reaches described state respectively, will contain fused solution and/or the emulsion and/or the suspension of described extract and substrate, place in the water dropper jar of drop pill machine, and splash in the condensing agent and shrink molding promptly.
2. cough panting quieting drip pill as claimed in claim 1 is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
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Non-Patent Citations (5)
| Title |
|---|
| 中药药剂学 范碧亭，380.383，上海科学技术出版社 1997 * |
| 固体分散体在缓控释制剂中的应用 胡道德等，中国医药工业杂志，第33卷第5期 2002 * |
| 国家中成药标准汇编肺系 国家药品监督管理局，68，国家药品监督管理局 2002 * |
| 葛根素固体分散体的制备及其体外研究 周毅生 贾永艳 申小清 朱新成 高松 武爱玲，中国药学杂志，第38卷第1期 2003 * |
| 葛根素固体分散体的制备及其体外研究 周毅生 贾永艳 申小清 朱新成 高松 武爱玲，中国药学杂志，第38卷第1期 2003;固体分散体在缓控释制剂中的应用 胡道德等，中国医药工业杂志，第33卷第5期 2002;国家中成药标准汇编肺系 国家药品监督管理局，68，国家药品监督管理局 2002;中药药剂学 范碧亭，380.383，上海科学技术出版社 1997 * |
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