CN1322857C - Xiaoke drip pill used for suppressing cough and transforming phlegm and its preparation method - Google Patents
Xiaoke drip pill used for suppressing cough and transforming phlegm and its preparation method Download PDFInfo
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- CN1322857C CN1322857C CNB200510069303XA CN200510069303A CN1322857C CN 1322857 C CN1322857 C CN 1322857C CN B200510069303X A CNB200510069303X A CN B200510069303XA CN 200510069303 A CN200510069303 A CN 200510069303A CN 1322857 C CN1322857 C CN 1322857C
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Abstract
The present invention relates to a medical composition which has functions of relief cough, dispersing of phlegm and relief of asthma for curing diseases of cough, cough with dyspnea, expectoration, etc. caused by acute and chronic bronchitis. The present invention aims to replenish the insufficiency of the existing oral medicine preparation for treating diseases of cough, cough with dyspnea, expectoration, etc. caused by acute and chronic bronchitis. The present invention provides a cough relief dripping pill which has the advantages of high biologic utilization rate, fast release of medicine, fast excellence, high medicine content, convenient administration, low cost and no pollution in a production process. The cough relief dripping pill of the present invention is formed by the preparation of the extract of the active ingredients of six kinds of traditional Chinese medicine of loquat leaf, poppy shell, stemona, ephedrae, platycodon root and menthol together with medicinal carriers which serve as base materials.
Description
Technical field
The present invention relates to a kind of relieving cough and resolving phlegm that has, antiasthmatic effect, being used for the pharmaceutical composition of treatment for diseases such as cough that acute and chronic bronchitis causes, cough with asthma, expectoration, is a kind of drug composition oral preparation that feedstock production forms with the extract that contains 6 flavor active ingredient of Chinese herbs such as Folium Eriobotryae, Pericarpium Papaveris, the Radix Stemonae, Herba Ephedrae, Radix Platycodonis, Mentholum particularly.
Background technology
The cough relieving granule that is prepared from according to the preparation method that provides among the national drug standards WS-11495 (ZD-1495)-2002, it is a kind of relieving cough and resolving phlegm that has, antiasthmatic effect, the oral granular formulation that is used for treatment for diseases such as cough that acute and chronic bronchitis causes, cough with asthma, expectoration, 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 among the drug standard WS-11495 (ZD-1495)-2002:
Prescription: Folium Eriobotryae 110g, Pericarpium Papaveris 80g, Radix Stemonae 30g, Herba Ephedrae 30g, Radix Platycodonis 20g, Mentholum 0.3g, sucrose 950g
Method for making: above Six-element medical material, except that Mentholum, five tastes medical materials such as all the other Folium Eriobotryaes decoct with water secondary, each 2 hours, collecting decoction filtered, and filtrate decompression is concentrated into the clear paste that relative density is 1.26～1.30 (20 ℃), add sucrose, mixing is made granule, drying; With a little anhydrous alcohol solution of Mentholum, spray in the granule in addition, mixing, promptly.
Function cures mainly: relieving cough and resolving phlegm, relieving asthma; The cough, cough with asthma, the expectoration that cause in acute and chronic bronchitis are arranged.
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.The medicament contg of granule is also lower, takes inconvenience.
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 deficiency that is used for the oral drug preparation of treatment for diseases such as cough that acute and chronic bronchitis causes, cough with asthma, expectoration, a kind of bioavailability height is provided, and has a quick release, quick produce effects, medicament contg height, taking convenience, cheap, and free of contamination aborning oral formulations disappears and coughs drop pill.Drop pill is coughed in involved in the present invention disappearing, and is raw material with the extract that contains 6 flavor active ingredient of Chinese herbs such as Folium Eriobotryae, Pericarpium Papaveris, the Radix Stemonae, Herba Ephedrae, Radix Platycodonis, Mentholum, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain involved in the present invention disappearing and cough drop pill:
[preparation method]
1. raw material: the extract that contains 6 flavor active ingredient of Chinese herbs such as Folium Eriobotryae, Pericarpium Papaveris, the Radix Stemonae, Herba Ephedrae, Radix Platycodonis, Mentholum;
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 stilbene, Radix Saposhnikoviae, the Rhizoma Atractylodis Macrocephalae, Rhizoma Zingiberis Recens etc. 4 flavor active ingredient of Chinese herbs extracts 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 6 flavor active ingredient of Chinese herbs preparation method of extract such as Folium Eriobotryae that contain] gets Folium Eriobotryae 110g, Pericarpium Papaveris 80g, Radix Stemonae 30g, Herba Ephedrae 30g, Radix Platycodonis 20g, Mentholum 0.3g, above Six-element medical material, except that Mentholum, five tastes medical materials such as all the other Folium Eriobotryaes, decoct with water secondary, each 2 hours, collecting decoction, filter, filtrate decompression is condensed into relative density to 0.1MPa, below 60 ℃ be 1.3～1.35 thick paste, add Mentholum, and fully stirring makes evenly, promptly gets the drug extract thick paste; Maybe the thick paste that will concentrate makes drying under the same conditions, is ground into dry powder, in addition with a little anhydrous alcohol solution of Mentholum, sprays in the dry powder, and mixing promptly gets drug extract dry powder.
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]
The cough relieving granule that is prepared from according to the preparation method that provides among the national drug standards WS-11495 (ZD-1495)-2002, it is a kind of relieving cough and resolving phlegm that has, antiasthmatic effect, the oral granular formulation that is used for treatment for diseases such as cough that acute and chronic bronchitis causes, cough with asthma, expectoration, 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.The medicament contg of granule is also lower, takes inconvenience.
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.
Involved in the present invention disappearing coughed drop pill and compared with cough relieving granule and have following beneficial effect:
1. drop pill is coughed in involved in the present invention disappearing; utilize surfactant to be substrate; make solid dispersion with the extract that contains 6 flavor Chinese medicine active pharmaceutical ingredients such as Folium Eriobotryae, Pericarpium Papaveris, the Radix Stemonae, Herba Ephedrae, Radix Platycodonis, Mentholum; 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. drop pill is coughed in involved in the present invention disappearing, 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. involved in the present invention disappearing coughed drop pill the extract that contains active constituents of medicine mixed 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, be described further with regard to the preparation method of coughing drop pill that disappears of the present invention with several groups of specific embodiments.
First group: the test of single-matrix
1. raw material: it is standby to make the extract dry powder that contains 6 flavor Chinese medicine active pharmaceutical ingredients such as Folium Eriobotryae, Pericarpium Papaveris, the Radix Stemonae, Herba Ephedrae, Radix Platycodonis, Mentholum 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 drug extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain disappearing of different size and cough drop pill.
[result of the test]
Test 1: cough drop pill in qualitative difference in order to observe drug extract and different substrates prepared disappearing when 1: 1 the proportioning, 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 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 1.
Test 2: cough drop pill in qualitative difference in order to observe drug extract and different substrates prepared disappearing when 1: 3 the proportioning, 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 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 2.
Test 3: cough drop pill in qualitative difference in order to observe drug extract and different substrates prepared disappearing when 1: 9 the proportioning, 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 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 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 6 flavor Chinese medicine active pharmaceutical ingredients such as Folium Eriobotryae, Pericarpium Papaveris, the Radix Stemonae, Herba Ephedrae, Radix Platycodonis, Mentholum 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 drug extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain disappearing of different size and cough drop pill.
[result of the test]
Test 4: cough the mass discrepancy of drop pill in order to observe drug extract and mixed-matrix prepared disappearing 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: cough the mass discrepancy of drop pill in order to observe drug extract and mixed-matrix prepared disappearing 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: cough the mass discrepancy of drop pill in order to observe drug extract and mixed-matrix prepared disappearing 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: cough the mass discrepancy of drop pill in order to observe drug extract and mixed-matrix prepared disappearing 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: cough the mass discrepancy of drop pill in order to observe drug extract and mixed-matrix prepared disappearing 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: cough the mass discrepancy of drop pill in order to observe drug extract and mixed-matrix prepared disappearing 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: cough the mass discrepancy of drop pill in order to observe drug extract and mixed-matrix prepared disappearing 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: cough the mass discrepancy of drop pill in order to observe drug extract and mixed-matrix prepared disappearing 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: cough the mass discrepancy of drop pill in order to observe drug extract and mixed-matrix prepared disappearing 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 | 62 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 50.0 | 80 | ＜30 | ＞10 | + |
| Polyethylene Glycol 6000 | 50.0 | 83 | ＜30 | ＞10 | + |
| Polyethylene Glycol 10000 | 50.0 | 84 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 84 | ＜30 | ＞10 | ++ |
| Span 40 | 50.0 | 60 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 74 | ＜30 | ＞10 | ++ |
| Poloxamer | 50.0 | 77 | ＜30 | ＞10 | ++ |
| Sodium lauryl sulphate | 50.0 | 74 | ＞30 | ＞10 | ++ |
| Stearic acid | 50.0 | 61 | ＞30 | ＞10 | ++ |
| Sodium stearate | 50.0 | 61 | ＞30 | ＞10 | ++ |
| Glycerin gelatine | 50.0 | 60 | ＞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 | 69 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 25.0 | 89 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 6000 | 25.0 | 89 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 90 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 91 | ＜30 | ＜10 | +++ |
| Span 40 | 25.0 | 73 | ＜30 | ＞10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 90 | ＜30 | ＜10 | ++ |
| Poloxamer | 25.0 | 90 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 25.0 | 79 | ＜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 | 80 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 10.0 | 91 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 6000 | 10.0 | 90 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 91 | ＜30 | ＜10 | +++ |
| Span 40 | 10.0 | 75 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 89 | ＜30 | ＜10 | ++ |
| Poloxamer | 10.0 | 90 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 10.0 | 77 | ＜30 | ＞10 | +++ |
| Stearic acid | 10.0 | 76 | ＞30 | ＞10 | +++ |
| Sodium stearate | 10.0 | 73 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 10.0 | 73 | ＞30 | ＞10 | +++ |
| Lac | 10.0 | 72 | ＞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 | 83 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50 | 82 | ＜30 | ＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 50 | 75 | ＜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 | 90 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 25 | 90 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 25 | 85 | ＜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 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 10 | 90 | ＜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 | 90 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 50 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 50 | 88 | ＜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 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 25 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 25 | 89 | ＜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 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 10 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 10 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 10 | 87 | ＜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 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=I: 10 | 25 | 86 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1O | 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 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10 | 91 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 10 | 88 | ＜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. acute and chronic bronchitic the disappearing of treatment coughed drop pill, is raw material with Folium Eriobotryae, Pericarpium Papaveris, the Radix Stemonae, Herba Ephedrae, Radix Platycodonis, Mentholum, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
(1) gets Folium Eriobotryae 110g, Pericarpium Papaveris 80g, Radix Stemonae 30g, Herba Ephedrae 30g, Radix Platycodonis 20g, Mentholum 0.3g, above Six-element medical material, except that Mentholum, five tastes medical materials such as all the other Folium Eriobotryaes, decoct with water secondary, each 2 hours, collecting decoction filtered, filtrate decompression is condensed into relative density to 0.1MPa, below 60 ℃ be 1.3～1.35 thick paste, add Mentholum, and fully stirring makes evenly, promptly gets the drug extract thick paste; Maybe the thick paste that will concentrate makes drying under the same conditions, is ground into dry powder, in addition with a little anhydrous alcohol solution of Mentholum, sprays in the dry powder, and mixing promptly gets the extract that contains pharmaceutically active ingredient in the above-mentioned Six-element, and is 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, and the ratio of described extract and substrate is 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 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) treating that dropping-pill machine head and condensing agent reach described state of temperature 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. as claimed in claim 1 disappearing coughed drop pill, it is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
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| CNB200510069303XA CN1322857C (en) | 2005-05-13 | 2005-05-13 | Xiaoke drip pill used for suppressing cough and transforming phlegm and its preparation method |
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| CN105816837A (en) * | 2016-04-26 | 2016-08-03 | 铜陵市佘家贡姜厂 | Raw ginger dropping pill preparation for relieving cough and asthma and preparation method thereof |
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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 * |
| 固体分散体中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）2册 国家***药典委员会，412，国家***药典委员会 2002 * |
| 葛根素固体分散体的制备及其体外研究 周毅生等，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 周毅生等，中国药学杂志，第38卷第1期 2003;固体分散体中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）2册 国家***药典委员会，412，国家***药典委员会 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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