CN100364509C - Compound drop pills of dahurian rhododendron leaf and preparation method - Google Patents
Compound drop pills of dahurian rhododendron leaf and preparation method Download PDFInfo
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- CN100364509C CN100364509C CNB2004101035540A CN200410103554A CN100364509C CN 100364509 C CN100364509 C CN 100364509C CN B2004101035540 A CNB2004101035540 A CN B2004101035540A CN 200410103554 A CN200410103554 A CN 200410103554A CN 100364509 C CN100364509 C CN 100364509C
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Abstract
The present invention discloses a medical composition which has the functions of cough relief, phlegm elimination and asthma relief and is used for treating bronchitis, cough, asthma, etc. The present invention aims to supply the insufficiency of the existing oral medicine preparation which is used for treating chronic cough, bronchitis, etc., and provides a medical composition oral preparation, namely compound dahurian rhododendron leaf dripping pills with the advantages of high living thing utilization, rapid medicine release, rapid effect taking, high medicine content, accurate metering, convenient admission, low cost, and no pollution in the process of production. The compound dahurian rhododendron leaf dripping pills of the present invention are prepared by using extracts of five traditional Chinese medicines of dahurian rhododendron leaf, stemona root, poppy capsule, balloon flower, thinleaf milkwort root, etc. as raw materials and using medicinal carriers as substrates.
Description
Technical field
The present invention relates to a kind of cough-relieving that has, eliminate the phlegm, antiasthmatic effect is used for the treatment of the pharmaceutical composition of diseases such as bronchitis and cough, asthma, being particularly related to the syrupy basic components of compound recipe Folium Rhododendri Daurici is reference, changes a social system a kind of drug composition oral dropping pill formulation that forms through dosage form.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The compound recipe Folium Rhododendri Daurici syrup that prescription that provides among-the B-0342-90 and extraction process are prepared from, it is a kind of cough-relieving that has, eliminate the phlegm, antiasthmatic effect, the liquid oral medicine that is used for the treatment of diseases such as bronchitis and cough, asthma, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of this type of disease.
Below be drug standard WS
3Prescription that provides among-the B-0342-90 and technology and brief description:
Prescription: Folium Rhododendri Daurici 200g, Radix Stemonae 100g, Pericarpium Papaveris 50g, Radix Platycodonis 100g, Radix Polygalae 100g;
Method for making: the above five tastes, be ground into coarse powder, with reference to percolation under Chinese Pharmacopoeia 13 pages of fluid extracts of 2000 editions appendix and the extractum item, make solvent with 18% ethanol, behind the dipping 24h, with the speed of per minute 1-3ml, slowly percolation, collect filtrate 700ml just, device is preserved in addition, continues percolation to reaching 4000ml, stop percolation and be concentrated into 80ml, merge, add sucrose 400g with first filtrate, boil heat of solution, adding preservative agent is an amount of, adds water to 1000ml, static, filter, promptly.
Function cures mainly: cough-relieving, eliminate the phlegm, and relieving asthma.Be used for bronchitis and cough, asthma etc.
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.And that the dosage form of oral liquid also exists medicament contg is low, and taking dose is big, and taking dose is inaccurate, takes inconvenient characteristics, also is not easy to go out to carry wait deficiency.
In addition, conventional peroral dosage form as tablet, capsule etc., because the technology of granulation is arranged, therefore can produce bigger dust pollution in preparation process, can staff's health be worked the mischief to a certain extent, also can cause certain pollution to environment simultaneously.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 chronic cough due to asthenia of viscera that is used for the treatment of, the deficiency of the oral drug preparation of diseases such as bronchitis, a kind of bioavailability height is provided, and has quick release, fast produce effects, taking dose is accurate, taking convenience, cheap, and free of contamination aborning drug composition oral preparation compound drop pills of dahurian rhododendron leaf.
Compound drop pills of dahurian rhododendron leaf involved in the present invention is a raw material with the extract (following general designation is made drug extract) of Chinese medicine of the five flavours such as Folium Rhododendri Daurici, the Radix Stemonae, Pericarpium Papaveris, Radix Platycodonis, Radix Polygalae, is prepared from the pharmaceutically suitable carrier as substrate.Be prepared by the following technical solutions, can obtain compound drop pills of dahurian rhododendron leaf involved in the present invention:
[preparation method]
1. the preparation of drug extract:
1.1 prescription: Folium Rhododendri Daurici 200g, Radix Stemonae 100g, Pericarpium Papaveris 50g, Radix Platycodonis 100g, Radix Polygalae 100g;
1.2 method for making: the above five tastes, be ground into coarse powder, with reference to percolation under Chinese Pharmacopoeia 13 pages of fluid extracts of 2000 editions appendix and the extractum item, make solvent with 18% ethanol, behind the dipping 24h, speed with per minute 1～3ml, slowly percolation is collected filtrate device preservation in addition just, continues percolation to there not being filtrate oozing out substantially, stop percolation and merge, be concentrated into relative density and be 1.2～1.4 thick paste promptly with first filtrate; Or, be ground into dry powder, promptly again through 60 ℃～80 ℃ dryings.
2. substrate: Polyethylene Glycol
(2000,4000,6000,8000,1000020000), one or more the mixture in pharmaceutically suitable carrier such as 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. treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively is in above the 2nd step during desired state of temperature, fused solution and/or the emulsion and/or the suspension that will contain drug extract and substrate, under the temperature conditions close, make evenly through fully stirring with the water dropper temperature, place in the water dropper jar of drop pill machine, splash in the condensing agent by water dropper;
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.
Beneficial effect
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The compound recipe Folium Rhododendri Daurici syrup that prescription that provides among-the B-0342-90 and extraction process are prepared from, it is a kind of cough-relieving that has, eliminate the phlegm, antiasthmatic effect, the liquid oral medicine that is used for the treatment of diseases such as bronchitis and cough, asthma, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of this type of 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.And that the dosage form of oral liquid also exists medicament contg is low, and taking dose is big, and taking dose is inaccurate, takes inconvenient characteristics, also is not easy to go out to carry wait deficiency.
In addition, conventional peroral dosage form as tablet, capsule etc., because the technology of granulation is arranged, therefore can produce bigger dust pollution in preparation process, can staff's health be worked the mischief to a certain extent, also can cause certain pollution to environment simultaneously.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.
Compound drop pills of dahurian rhododendron leaf involved in the present invention is compared with compound recipe Folium Rhododendri Daurici syrup has following beneficial effect:
1. compound drop pills of dahurian rhododendron leaf involved in the present invention; utilize surfactant to be substrate; extract with Chinese medicine of the five flavours such as Folium Rhododendri Daurici, the Radix Stemonae, Pericarpium Papaveris, Radix Platycodonis, Radix Polygalaes is made solid dispersion; making medicine be molecule, colloid or microcrystalline state is 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, brought into play efficient, quick-acting effects etc.
2. compound drop pills of dahurian rhododendron leaf 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. compound drop pills of dahurian rhododendron leaf 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 compound drop pills of dahurian rhododendron leaf of the present invention.
First group: the test of single-matrix
1. the preparation of drug extract:
1.1 prescription: Folium Rhododendri Daurici 200g, Radix Stemonae 100g, Pericarpium Papaveris 50g, Radix Platycodonis 100g, Radix Polygalae 100g;
1.2 method for making: the above five tastes, be ground into coarse powder, with reference to percolation under Chinese Pharmacopoeia 13 pages of fluid extracts of 2000 editions appendix and the extractum item, make solvent with 18% ethanol, behind the dipping 24h, speed with per minute 1～3ml, slowly percolation is collected filtrate device preservation in addition just, continues percolation to there not being filtrate oozing out substantially, stop percolation and merge, be concentrated into relative density and be 1.2～1.4 thick paste promptly with first filtrate; Or, be ground into dry powder, promptly again through 60 ℃～80 ℃ dryings.
2. substrate: Polyethylene Glycol
(2000,4000,6000,8000,10000,20000), one or more the mixture in pharmaceutically suitable carrier such as 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. the process that provides according to [preparation method] is prepared, and can obtain the compound drop pills of dahurian rhododendron leaf of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared compound drop pills of dahurian rhododendron leaf in qualitative difference, according to 1: 1 ratio, with drug extract respectively with Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning prepared compound drop pills of dahurian rhododendron leaf in qualitative difference, according to 1: 3 ratio, with drug extract respectively with Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared compound drop pills of dahurian rhododendron leaf in qualitative difference, according to 1: 9 ratio, with drug extract respectively with Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. the preparation of drug extract:
1.1 prescription: Folium Rhododendri Daurici 200g, Radix Stemonae 100g, Pericarpium Papaveris 50g, Radix Platycodonis 100g, Radix Polygalae 100g;
1.2 method for making: the above five tastes, be ground into coarse powder, with reference to percolation under Chinese Pharmacopoeia 13 pages of fluid extracts of 2000 editions appendix and the extractum item, make solvent with 18% ethanol, behind the dipping 24h, speed with per minute 1～3ml, slowly percolation is collected filtrate device preservation in addition just, continues percolation to there not being filtrate oozing out substantially, stop percolation and merge, be concentrated into relative density and be 1.2～1.4 thick paste promptly with first filtrate; Or, be ground into dry powder, promptly again through 60 ℃～80 ℃ dryings.
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 drug extract: substrate=1: 1～1: 9;
4. be prepared according to [preparation method] 4～7 again, promptly can make the compound drop pills of dahurian rhododendron leaf of various different sizes.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared compound drop pills of dahurian rhododendron leaf 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, adopt homemade drop pill machine, 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 experimental results and see Table 4.
Test 5: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared compound drop pills of dahurian rhododendron leaf 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, adopt homemade drop pill machine, 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 experimental results and see Table 5.
Test 6: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared compound drop pills of dahurian rhododendron leaf 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, adopt homemade drop pill machine, 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 experimental results and see Table 6.
Test 7: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared compound drop pills of dahurian rhododendron leaf 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, adopt homemade drop pill machine, 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 experimental results and see Table 7.
Test 8: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared compound drop pills of dahurian rhododendron leaf 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, adopt homemade drop pill machine, 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 experimental results and see Table 8.
Test 9: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared compound drop pills of dahurian rhododendron leaf 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, adopt homemade drop pill machine, 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 experimental results and see Table 9.
Test 10: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared compound drop pills of dahurian rhododendron leaf 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, adopt homemade drop pill machine, 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 experimental results and see Table 10.
Test 11: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared compound drop pills of dahurian rhododendron leaf 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, adopt homemade drop pill machine, 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 experimental results and see Table 11.
Test 12: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared compound drop pills of dahurian rhododendron leaf 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, adopt homemade drop pill machine, 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 experimental results and see 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 2000 | 50.0 | 61 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 50.0 | 78 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 6000 | 50.0 | 79 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 8000 | 50.0 | 78 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 10000 | 50.0 | 80 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 81 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 76 | ＜30 | ＞10 | ++ |
| Betacyclodextrin | 50.0 | 66 | ＜30 | ＞10 | + |
| Poloxamer | 50.0 | 73 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium | 50.0 | 71 | ＜30 | ＞10 | + |
| Sodium lauryl sulphate | 50.0 | 66 | ＞30 | ＞10 | ++ |
| Stearic acid | 50.0 | 53 | ＞30 | ＞10 | +++ |
| Sodium stearate | 50.0 | 54 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 50.0 | 54 | ＞30 | ＞10 | +++ |
| Lac | 50.0 | 50 | ＞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 2000 | 25.0 | 77 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 25.0 | 85 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 6000 | 25.0 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 25.0 | 90 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 90 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 91 | ＜30 | ＜10 | ++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 93 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 25.0 | 81 | ＜30 | ＞10 | ++ |
| Poloxamer | 25.0 | 88 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 25.0 | 82 | ＜30 | ＞10 | ++ |
| Sodium lauryl sulphate | 25.0 | 76 | ＜30 | ＞10 | ++ |
| Stearic acid | 25.0 | 70 | ＞30 | ＞10 | +++ |
| Sodium stearate | 25.0 | 71 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 25.0 | 69 | ＞30 | ＞10 | +++ |
| Lac | 25.0 | 68 | ＞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 2000 | 10.0 | 82 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 10.0 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 93 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 20000 | 10.0 | 94 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 89 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 10.0 | 87 | ＜30 | ＜10 | ++ |
| Poloxamer | 10.0 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 10.0 | 82 | ＜30 | ＞10 | +++ |
| Sodium lauryl sulphate | 10.0 | 82 | ＜30 | ＞10 | +++ |
| Stearic acid | 10.0 | 78 | ＞30 | ＞10 | +++ |
| Sodium stearate | 10.0 | 80 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 10.0 | 73 | ＞30 | ＞10 | +++ |
| Lac | 10.0 | 76 | ＞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 | 83 | ＜30 | ＞10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 50 | 82 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50 | 78 | ＜30 | ＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 50 | 73 | ＜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 | 89 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 25 | 90 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25 | 86 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 25 | 82 | ＜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 | 88 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 10 | 85 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10 | 82 | ＜30 | ＞10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 10 | 80 | ＜30 | ＞10 | +++ |
The group practices of table 7 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effectively become (%) | 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 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50 | 86 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 50 | 82 | ＜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 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 25 | 91 | ＜30 | ＜10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 25 | 86 | ＜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 | 95 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 10 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 10 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 10 | 88 | ＜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 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 50 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50 | 87 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 50 | 84 | ＜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 | 92 | ＜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 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 10 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10 | 91 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 10 | 91 | ＜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. a compound drop pills of dahurian rhododendron leaf for the treatment of bronchitis and cough, asthma is a raw material with Folium Rhododendri Daurici, the Radix Stemonae, Pericarpium Papaveris, Radix Platycodonis, Radix Polygalae, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
(1) preparation of drug extract: get Folium Rhododendri Daurici 200g, Radix Stemonae 100g, Pericarpium Papaveris 50g, Radix Platycodonis 100g, Radix Polygalae 100g; The above five tastes, be ground into coarse powder, with reference to percolation under Chinese Pharmacopoeia 13 pages of fluid extracts of 2000 editions appendix and the extractum item, make solvent with 18% ethanol, flood after 24 hours, speed with per minute 1ml～3ml, slowly percolation is collected filtrate device preservation in addition just, continues percolation to there not being filtrate oozing out substantially, stop percolation and merge with first filtrate, be concentrated into relative density and be 1.2～1.4 thick paste, or, be ground into dry powder again through 60 ℃～80 ℃ dryings, promptly get the extract that contains above-mentioned Chinese medicine of the five flavours effective ingredient, standby;
(2) described substrate is the mixture of Macrogol 2000 or Macrogol 4000 or polyethylene glycol 6000 or Polyethylene Glycol 8000 or cetomacrogol 1000 0 or Macrogol 2000 0 and polyoxyethylene stearate 40 esters or carboxymethyl starch sodium; By weight, the mixed proportion of polyoxyethylene stearate 40 esters or carboxymethyl starch sodium and described Polyethylene Glycol is 1: 1～1: 10, describedly contains the extract of above-mentioned Chinese medicine of the five flavours effective ingredient and the ratio of substrate is 1: 1～1: 3;
(3) according to aforementioned proportion, accurately take by weighing described extract and substrate, be placed in the heating container heating while stirring, standby until the fused solution that obtains containing described extract and substrate or emulsion or suspension;
(4) temperature control system of adjustment drop pill machine makes the water dropper temperature heating of drop pill machine and remains on 50 ℃～90 ℃, and the temperature cooling of condensing agent also remains on 40 ℃～-5 ℃;
When (5) treating that dropping-pill machine head and condensing agent temperature reach above-mentioned state respectively, will contain fused solution or the emulsion or the suspension of described extract and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent, shrink molding promptly.
2. compound drop pills of dahurian rhododendron leaf according to 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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| CN106729234A (en) * | 2016-12-13 | 2017-05-31 | 蓝莹 | A kind of Chinese medicine composition for treating cough |
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| Title |
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| 中华人民共和国卫生部药品标准 中药成方制剂 第2册. 172，中华人民共和国药典委员会. 1990 * |
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