CN100382785C - Cough suppressing phlegm transforming drip pill and its preparation method - Google Patents
Cough suppressing phlegm transforming drip pill and its preparation method Download PDFInfo
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- CN100382785C CN100382785C CNB2005100711112A CN200510071111A CN100382785C CN 100382785 C CN100382785 C CN 100382785C CN B2005100711112 A CNB2005100711112 A CN B2005100711112A CN 200510071111 A CN200510071111 A CN 200510071111A CN 100382785 C CN100382785 C CN 100382785C
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Abstract
The present invention discloses a medicinal composition having the functions of moistening the lung, eliminating phlegm, relieving coughs and relieving asthma and used for treating common cold with coughs, chronic bronchitis, bronchial asthma, etc. The present invention aims to overcome the defects of the existing oral medicinal preparation for treating the diseases and provide an oral preparation, namely a cough relieving and phlegm eliminating drop pill, which has the advantages of high bioavailability, quick medicine release, quick effect, high medicine content, convenient administration, low price and no pollution during production. The cough relieving and phlegm eliminating drop pill of the present invention is prepared by using extract containing active ingredients of three traditional Chinese medicines such as platycodon root, stemona root and bitter apricot seed, and mixing medicinal extract of ephedrine hydrochloride as raw materials and by using a medicinal vector as a matrix.
Description
Technical field
The present invention relates to a kind ofly have lung moistening and eliminate the phlegm, the relieving cough and relieving asthma effect, be used for the cough due to common cold, the pharmaceutical composition of treatment for diseases such as chronic bronchitis and bronchial asthma is a kind of drug composition oral preparation that feedstock production forms with the extract that contains Radix Platycodonis, the Radix Stemonae, Semen Armeniacae Amarum etc. 3 flavor active ingredient of Chinese herbs and the hybrid medicine extract of ephedrine hydrochloride particularly.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The eliminating phlegm and stopping cough granule that the preparation method that provides among-the B-3565-98 is prepared from, be a kind ofly to have lung moistening and eliminate the phlegm, the relieving cough and relieving asthma effect, be used for the cough due to common cold, the oral granular formulation of treatment for diseases such as chronic bronchitis and bronchial asthma, 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 drug standard WS
3Prescription that provides among-the B-3565-98 and technology and brief description:
Prescription: Radix Platycodonis 100g, Radix Stemonae 100g, Semen Armeniacae Amarum 28g, ephedrine hydrochloride 0.6g
Method for making: above four flavors, Radix Platycodonis, the Radix Stemonae, Semen Armeniacae Amarum decoct 2 times, when boiling (Semen Armeniacae Amarum treat that water is little add), each 2h, collecting decoction filters, and filtrate decompression is concentrated into the thick paste that relative density is 1.30-1.40 (85), adds sodium citrate, ephedrine hydrochloride, other adds starch, each 150g of dextrin, mixes, stir,, be ground into fine powder in 55 drying under reduced pressure 4-6h, add citric acid powder and fine powder 20g and an amount of cane sugar powder, mixing is granulated, vacuum drying 4h makes 1000g, promptly.
Function cures mainly: lung moistening is eliminated the phlegm, relieving cough and relieving asthma.Be used for the cough due to common cold, chronic bronchitis and bronchial asthma.
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 cough due to common cold that is used for, the deficiency of the oral drug preparation of treatment for diseases such as chronic bronchitis and bronchial asthma, a kind of bioavailability height is provided, and has quick release, fast produce effects, the medicament contg height, taking convenience, cheap, and free of contamination aborning oral formulations cough suppressing phlegm transforming drip pill.Cough suppressing phlegm transforming drip pill involved in the present invention is a raw material with the extract that contains Radix Platycodonis, the Radix Stemonae, Semen Armeniacae Amarum etc. 3 flavor active ingredient of Chinese herbs and the hybrid medicine extract of ephedrine hydrochloride, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain cough suppressing phlegm transforming drip pill involved in the present invention:
[preparation method]
1. the preparation of hybrid medicine extract: get Radix Platycodonis 100g, Radix Stemonae 100g, Semen Armeniacae Amarum 28g, ephedrine hydrochloride 0.6g, more than four flavors, Radix Platycodonis, the Radix Stemonae, Semen Armeniacae Amarum decoct 2 times, add when wherein Semen Armeniacae Amarum is treated that water is little and boiled, each 2 hours, collecting decoction filters, and to be concentrated into relative density under the 0.1MPa condition be 1.30～1.40 thick paste to filtrate being decompressed to, add ephedrine hydrochloride, mix, stir, promptly get hybrid medicine extract thick paste; Or be decompressed under 0.1MPa, the 55 ℃ of conditions drying under reduced pressure 4 hours～6 hours, and be ground into dry powder, promptly get hybrid medicine extract dry powder;
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 hybrid medicine extract: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing hybrid medicine extract and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing hybrid medicine 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 hybrid medicine 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.
[beneficial effect]
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The eliminating phlegm and stopping cough granule that the preparation method that provides among-the B-3565-98 is prepared from, be a kind ofly to have lung moistening and eliminate the phlegm, the relieving cough and relieving asthma effect, be used for the cough due to common cold, the oral granular formulation of treatment for diseases such as chronic bronchitis and bronchial asthma, 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.
Cough suppressing phlegm transforming drip pill involved in the present invention is compared with the eliminating phlegm and stopping cough granule has following beneficial effect:
1. cough suppressing phlegm transforming drip pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion with the extract that contains 3 flavor active ingredient of Chinese herbs such as Radix Platycodonis, the Radix Stemonae, Semen Armeniacae Amarum and the hybrid medicine extract of ephedrine hydrochloride; 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. cough suppressing phlegm transforming 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 suppressing phlegm transforming 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 suppressing phlegm transforming drip pill of the present invention.
[first group: the test of single-matrix]
1. raw material: the hybrid medicine extract dry powder that makes the extract that contains 3 flavor active ingredient of Chinese herbs such as Radix Platycodonis, the Radix Stemonae, Semen Armeniacae Amarum and ephedrine hydrochloride according to [preparation method 1] earlier is standby;
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 hybrid medicine extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method 4～7] is prepared, and can obtain the cough suppressing phlegm transforming drip pill of different size.
[result of the test]
Test 1: for observe hybrid medicine extract and different substrates when 1: 1 the proportioning prepared cough suppressing phlegm transforming drip pill in qualitative difference, according to 1: 1 ratio, with the hybrid medicine 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 hybrid medicine extract and different substrates, and obtain 16 groups of different experimental results and see Table 1.
Test 2: for observe hybrid medicine extract and different substrates when 1: 3 the proportioning prepared cough suppressing phlegm transforming drip pill in qualitative difference, according to 1: 3 ratio, with the hybrid medicine 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 hybrid medicine extract and different substrates, and obtain 16 groups of different experimental results and see Table 2.
Test 3: for observe hybrid medicine extract and different substrates when 1: 9 the proportioning prepared cough suppressing phlegm transforming drip pill in qualitative difference, according to 1: 9 ratio, with the hybrid medicine 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 hybrid medicine 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: the hybrid medicine extract dry powder that makes the extract that contains 3 flavor active ingredient of Chinese herbs such as Radix Platycodonis, the Radix Stemonae, Semen Armeniacae Amarum and ephedrine hydrochloride according to [preparation method 1] earlier is standby;
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 hybrid medicine extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the cough suppressing phlegm transforming drip pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of hybrid medicine extract and mixed-matrix prepared cough suppressing phlegm transforming 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 hybrid medicine extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines extract and mixed-matrixes are 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 hybrid medicine extract and mixed-matrix prepared cough suppressing phlegm transforming 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 hybrid medicine extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines extract and mixed-matrixes are 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 hybrid medicine extract and mixed-matrix prepared cough suppressing phlegm transforming 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 hybrid medicine extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines extract and mixed-matrixes are 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 hybrid medicine extract and mixed-matrix prepared cough suppressing phlegm transforming 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 hybrid medicine extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines extract and mixed-matrixes are 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 hybrid medicine extract and mixed-matrix prepared cough suppressing phlegm transforming 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 hybrid medicine extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines extract and mixed-matrixes are 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 hybrid medicine extract and mixed-matrix prepared cough suppressing phlegm transforming 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 hybrid medicine extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines extract and mixed-matrixes are 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 hybrid medicine extract and mixed-matrix prepared cough suppressing phlegm transforming 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 the hybrid medicine 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 pharmaceutical composition experiment that 4 hybrid medicines extract and mixed-matrixes are 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 hybrid medicine extract and mixed-matrix prepared cough suppressing phlegm transforming 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 the hybrid medicine 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 pharmaceutical composition experiment that 4 hybrid medicines extract and mixed-matrixes are 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 hybrid medicine extract and mixed-matrix prepared cough suppressing phlegm transforming 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 the hybrid medicine 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 pharmaceutical composition experiment that 4 hybrid medicines extract and mixed-matrixes are constituted, and obtain 4 groups of different experiments and the results are shown in Table 12.
The group practices of table 1 hybrid medicine extract and single-matrix (hybrid medicine 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 | 65 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 50.0 | 82 | ＜30 | ＞10 | + |
| Polyethylene Glycol 6000 | 50.0 | 82 | ＜30 | ＞10 | + |
| Polyethylene Glycol 10000 | 50.0 | 83 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 83 | ＜30 | ＞10 | ++ |
| Span 40 | 50.0 | 64 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 76 | ＜30 | ＞10 | ++ |
| Poloxamer | 50.0 | 76 | ＜30 | ＞10 | ++ |
| Sodium lauryl sulphate | 50.0 | 73 | ＞30 | ＞10 | ++ |
| Stearic acid | 50.0 | 63 | ＞30 | ＞10 | ++ |
| Sodium stearate | 50.0 | 62 | ＞30 | ＞10 | ++ |
| Glycerin gelatine | 50.0 | 61 | ＞30 | ＞10 | + |
| Lac | 50.0 | 62 | ＞30 | ＞10 | + |
The group practices of table 2 hybrid medicine extract and single-matrix (hybrid medicine 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 | 71 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 25.0 | 86 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 6000 | 25.0 | 87 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 88 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 87 | ＜30 | ＜10 | +++ |
| Span 40 | 25.0 | 75 | ＜30 | ＞10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 86 | ＜30 | ＜10 | ++ |
| Poloxamer | 25.0 | 89 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 25.0 | 76 | ＜30 | ＞10 | ++ |
| Stearic acid | 25.0 | 76 | ＞30 | ＞10 | +++ |
| Sodium stearate | 25.0 | 75 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 25.0 | 73 | ＞30 | ＞10 | +++ |
| Lac | 25.0 | 73 | ＞30 | ＞10 | +++ |
The group practices of table 3 hybrid medicine extract and single-matrix (hybrid medicine 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 | 82 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 10.0 | 90 | ＜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 | 78 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 90 | ＜30 | ＜10 | ++ |
| Poloxamer | 10.0 | 90 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 10.0 | 76 | ＜30 | ＞10 | +++ |
| Stearic acid | 10.0 | 76 | ＞30 | ＞10 | +++ |
| Sodium stearate | 10.0 | 75 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 10.0 | 73 | ＞30 | ＞10 | +++ |
| Lac | 10.0 | 72 | ＞30 | ＞10 | +++ |
The group practices of table 4 hybrid medicine extract and mixed-matrix (hybrid medicine 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 | 82 | ＜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 | 79 | ＜30 | ＞10 | + |
The group practices of table 5 hybrid medicine extract and mixed-matrix (hybrid medicine 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 | 87 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 25 | 84 | ＜30 | ＞10 | ++ |
The group practices of table 6 hybrid medicine extract and mixed-matrix (hybrid medicine 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 | 90 | ＜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 hybrid medicine extract and mixed-matrix (hybrid medicine 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 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 50 | 91 | ＜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 hybrid medicine extract and mixed-matrix (hybrid medicine 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 | 90 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 25 | 88 | ＜30 | ＜10 | +++ |
The group practices of table 9 hybrid medicine extract and mixed-matrix (hybrid medicine 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 | 89 | ＜30 | ＜10 | +++ |
The group practices of table 10 hybrid medicine extract and mixed-matrix (hybrid medicine 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 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 50 | 89 | ＜30 | ＞10 | +++ |
The group practices of table 11 hybrid medicine extract and mixed-matrix (hybrid medicine 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 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 25 | 88 | ＜30 | ＜10 | +++ |
The group practices of table 12 hybrid medicine extract and mixed-matrix (hybrid medicine 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 | 89 | ＜30 | ＜10 | +++ |
1. can be seen by the result in the table: when the ratio of hybrid medicine 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 hybrid medicine 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 hybrid medicine 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 (6)
1. one kind is used for the cough due to common cold, the pharmaceutical composition cough suppressing phlegm transforming drip pill of treatment for diseases such as chronic bronchitis and bronchial asthma, with Radix Platycodonis, the Radix Stemonae, the extract of Semen Armeniacae Amarum 3 flavor active ingredient of Chinese herbs and the hybrid medicine extract of ephedrine hydrochloride is raw material, be prepared from pharmaceutically suitable carrier as substrate, wherein:
1.1 the preparation of hybrid medicine extract: get Radix Platycodonis 100g, Radix Stemonae 100g, Semen Armeniacae Amarum 28g, ephedrine hydrochloride 0.6g, more than four flavors, Radix Platycodonis, the Radix Stemonae, Semen Armeniacae Amarum decoct 2 times, add when wherein Semen Armeniacae Amarum is treated that water is little and boiled, each 2 hours, collecting decoction filters, and to be concentrated into relative density under the 0.1MPa condition be 1.30～1.40 thick paste to filtrate being decompressed to, add ephedrine hydrochloride, mix, stir, promptly get hybrid medicine extract thick paste; Or be decompressed under 0.1MPa, the 55 ℃ of conditions drying under reduced pressure 4 hours～6 hours, and be ground into dry powder, promptly get hybrid medicine extract dry powder, standby;
1.2 substrate: Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, polyoxyethylene stearate 40 esters, poloxamer, above-mentioned carrier one or more mixture wherein;
1.3 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 3.
2. cough suppressing phlegm transforming drip pill as claimed in claim 1, it is characterized in that: described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or poloxamer, by weight, the ratio of polyoxyethylene stearate 40 esters or poloxamer and Polyethylene Glycol is 1: 1～1: 10, and the ratio of described drug extract and described substrate is 1: 1～1: 3;
3. according to the given formula proportion of claim 1, accurately take by weighing hybrid medicine extract and substrate, be placed in the heating container heating while stirring, standby until the fused solution that obtains containing hybrid medicine extract and substrate and/or emulsion and/or suspension;
4. adjust the temperature control system of 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 ℃;
5. when treating in dropping-pill machine head and the condensation column that the temperature of condensing agent reaches desired state of temperature respectively, the fused solution that contains hybrid medicine extract and substrate and/or emulsion and/or the suspension that make by claim 3, place in the water dropper jar of drop pill machine, splash in the condensing agent and shrink molding promptly.
6. as the preparation method of cough suppressing phlegm transforming drip pill as described in the claim 4, it is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
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| CN101385833B (en) * | 2008-10-27 | 2011-05-04 | 余健民 | Eucalyptus leaf cough syrup and preparation method thereof |
| CN104547813A (en) * | 2015-01-13 | 2015-04-29 | 青岛市中心医院 | Traditional Chinese medicine for treating asthma and preparation method thereof |
| CN105267810A (en) * | 2015-08-28 | 2016-01-27 | 周香玲 | Traditional Chinese medicine composition for treating trachitis |
| CN105395879A (en) * | 2015-12-23 | 2016-03-16 | 徐枫 | Traditional Chinese medicine used for treating senile chronic bronchitis |
| CN110251629B (en) * | 2019-08-08 | 2021-09-28 | 胡锡基 | Traditional Chinese medicine composition for treating asthma and preparation method thereof |
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| 国家药品标准中药成方制剂19册. 卫生部药典委员会，48页. 1998 * |
| 滴丸剂的研究进展. 胡向青等.药学进展，第28卷第12期. 2004 * |
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