CN100375613C - Schizandrol dripping pills for decreasing aminopherase and method for preparing the same - Google Patents
Schizandrol dripping pills for decreasing aminopherase and method for preparing the same Download PDFInfo
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- CN100375613C CN100375613C CNB2005100751622A CN200510075162A CN100375613C CN 100375613 C CN100375613 C CN 100375613C CN B2005100751622 A CNB2005100751622 A CN B2005100751622A CN 200510075162 A CN200510075162 A CN 200510075162A CN 100375613 C CN100375613 C CN 100375613C
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Abstract
The present invention discloses a medicine composition used for the reduction of serum glutamic pyruvic transaminase. The present invention has the purpose of complementing the deficiency of existing oral medicine preparations used for the treatment of the disease, providing pentagonal ester dripping pills having high bioavailability, quick medicine release, rapid effect, high medicine content, convenient administration, low price and no pollution during production. The pentagonal ester dripping pills of the present invention are prepared from the raw material of kadsura longepedunculata alcohol extract and medicinal carriers serving as matrixes.
Description
Technical field
The present invention relates to a kind ofly can reduce serum glutamic pyruvic transminase, can be used for pharmaceutical composition chronic, chronic persistent hepatitis Glutamate pyruvate transaminase rises person treatment, is a kind of oral formulations that feedstock production forms with Chinese medicine Fructus Schisandrae Sphenantherae ethanol extractum particularly.
Background technology
The five-ester sheet that is prepared from according to the preparation method that provides among the national drug standards WS-10557 (ZD-0557)-2002, be a kind ofly can reduce serum glutamic pyruvic transminase, can be used for oral tablet chronic, chronic persistent hepatitis Glutamate pyruvate transaminase rises person treatment, 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-10557 (ZD-0557)-2002:
Prescription: the 7.5g of Fructus Schisandrae Sphenantherae ethanol extractum's (in schisantherin A), calcium hydrogen phosphate 125g, starch 20g, Sodium Hydroxymethyl Stalcs 7.5g, magnesium stearate 1.5g
Method for making: get Fructus Schisandrae Sphenantherae ethanol extractum, add the calcium hydrogen phosphate mixing, drying is pulverized, and adds starch, carboxymethyl starch sodium, magnesium stearate, and mixing is made granule, dry, tabletting, and coating, promptly.
Function cures mainly: can reduce serum glutamic pyruvic transminase.Can be used for chronic, chronic persistent hepatitis Glutamate pyruvate transaminase rises person.
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.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 chronic, that chronic persistent hepatitis Glutamate pyruvate transaminase rises person treats, 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 WUZHI DIWAN.WUZHI DIWAN involved in the present invention is a raw material with Chinese medicine Fructus Schisandrae Sphenantherae ethanol extractum, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain WUZHI DIWAN involved in the present invention:
[preparation method]
1. medicine material: Fructus Schisandrae Sphenantherae ethanol extractum
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, Fructus Schisandrae Sphenantherae ethanol extractum's (in schisantherin A): substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing medicine material and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing medicine material and substrate and/or emulsion and/or suspension;
5. adopt homemade or general drop pill machine (as the TZDW-l 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 medicine material 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]
The five-ester sheet that is prepared from according to the preparation method that provides among the national drug standards WS-10557 (ZD-0557)-2002, be a kind ofly can reduce serum glutamic pyruvic transminase, can be used for oral tablet chronic, chronic persistent hepatitis Glutamate pyruvate transaminase rises person treatment, 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.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.
WUZHI DIWAN involved in the present invention is compared with the five-ester sheet has following beneficial effect:
1. WUZHI DIWAN involved in the present invention; utilize surfactant to be substrate; make solid dispersion with medicine material, make medicine be molecule, colloid or microcrystalline state and be scattered in the substrate, the total surface area of medicine increases; and substrate is hydrophilic; medicine is had wetting action, can make that medicine is rapidly molten to loose into microgranule or solution, thereby make the dissolving of medicine and absorb and accelerate; thereby improved bioavailability, brought into play efficient, quick-acting effects etc.
2. WUZHI DIWAN 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. WUZHI DIWAN involved in the present invention is mixed 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 WUZHI DIWAN of the present invention.
[first group: the test of single-matrix]
1. medicine material: Fructus Schisandrae Sphenantherae ethanol extractum
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, Fructus Schisandrae Sphenantherae ethanol extractum's (in schisantherin A): substrate=1: 1～1: 9;
4. according to preparation method] 4～7 processes that provide are prepared, and can obtain the WUZHI DIWAN of different size.
[result of the test]
Test 1: for observe medicine material and different substrates when 1: 1 the proportioning prepared WUZHI DIWAN in qualitative difference, according to 1: 1 ratio, with medicine material respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
5000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain medicine material and different substrates, and obtain 13 groups of different experimental results and see Table 1.
Test 2: for observe medicine material and different substrates when 1: 3 the proportioning prepared WUZHI DIWAN in qualitative difference, according to 1: 1 ratio, with medicine material respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol 5
000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain medicine material and different substrates, and obtain 13 groups of different experimental results and see Table 2.
Test 3: for observe medicine material and different substrates when 1: 9 the proportioning prepared WUZHI DIWAN in qualitative difference, according to 1: 1 ratio, with medicine material respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain medicine material and different substrates, and obtain 13 groups of different experimental results and see Table 3.
[second group: the test of mixed-matrix]
1. medicine material: Fructus Schisandrae Sphenantherae ethanol extractum
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, Fructus Schisandrae Sphenantherae ethanol extractum's (in schisantherin A): substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the WUZHI DIWAN of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of medicine material and mixed-matrix prepared WUZHI DIWAN 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 medicine material 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 medicine material and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 4.
Test 5: in order to observe the mass discrepancy of medicine material and mixed-matrix prepared WUZHI DIWAN 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 medicine material 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 medicine material and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 5.
Test 6: in order to observe the mass discrepancy of medicine material and mixed-matrix prepared WUZHI DIWAN 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 medicine material 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 medicine material and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 6.
Test 7: in order to observe the mass discrepancy of medicine material and mixed-matrix prepared WUZHI DIWAN 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 medicine material 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 medicine material and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 7.
Test 8: in order to observe the mass discrepancy of medicine material and mixed-matrix prepared WUZHI DIWAN 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 medicine material 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 medicine material and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 7.
Test 9: in order to observe the mass discrepancy of medicine material and mixed-matrix prepared WUZHI DIWAN 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 medicine material 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 medicine material and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 7.
Test 10: in order to observe the mass discrepancy of medicine material and mixed-matrix prepared WUZHI DIWAN 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 different with the 4 kinds respectively mixing matrix phases of medicine material 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 medicine material and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 4.
Test 11: in order to observe the mass discrepancy of medicine material and mixed-matrix prepared WUZHI DIWAN 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 different with the 4 kinds respectively mixing matrix phases of medicine material 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 medicine material and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 4.
Test 12: in order to observe the mass discrepancy of medicine material and mixed-matrix prepared WUZHI DIWAN 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 different with the 4 kinds respectively mixing matrix phases of medicine material 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 medicine material and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 4.
The group practices of table 1 medicine material and single-matrix
(medicine material: 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 | 66 | <30 | >10 | + |
| Polyethylene Glycol 4000 | 50.0 | 84 | <30 | >10 | + |
| Polyethylene Glycol 6000 | 50.0 | 85 | <30 | >10 | + |
| Polyethylene Glycol 10000 | 50.0 | 85 | <30 | >10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 84 | <30 | >10 | ++ |
| Span 40 | 50.0 | 62 | <30 | >10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 78 | <30 | >10 | ++ |
| Poloxamer | 50.0 | 78 | <30 | >10 | ++ |
| Sodium lauryl sulphate | 50.0 | 74 | >30 | >10 | ++ |
| Stearic acid | 50.0 | 62 | >30 | >10 | ++ |
| Sodium stearate | 50.0 | 62 | >30 | >10 | ++ |
| Glycerin gelatine | 50.0 | 60 | >30 | >10 | + |
| Lac | 50.0 | 60 | >30 | >10 | + |
The group practices of table 2 medicine material and single-matrix
(medicine material: 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 | 73 | <30 | >10 | + |
| Polyethylene Glycol 4000 | 25.0 | 88 | <30 | <10 | ++ |
| Polyethylene Glycol 6000 | 25.0 | 88 | <30 | <10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 88 | <30 | <10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 87 | <30 | <10 | +++ |
| Span 40 | 25.0 | 76 | <30 | >10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 89 | <30 | <10 | ++ |
| Poloxamer | 25.0 | 89 | <30 | <10 | +++ |
| Sodium lauryl sulphate | 25.0 | 74 | <30 | >10 | ++ |
| Stearic acid | 25.0 | 77 | >30 | >10 | +++ |
| Sodium stearate | 25.0 | 74 | >30 | >10 | +++ |
| Glycerin gelatine | 25.0 | 73 | >30 | >10 | +++ |
| Lac | 25.0 | 73 | >30 | >10 | +++ |
The group practices of table 3 medicine material and single-matrix
(medicine material: substrate=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 10.0 | 84 | <30 | >10 | + |
| Polyethylene Glycol 4000 | 10.0 | 90 | <30 | <10 | ++ |
| Polyethylene Glycol 6000 | 10.0 | 90 | <30 | <10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 90 | <30 | <10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 91 | <30 | <10 | +++ |
| Span 40 | 10.0 | 73 | <30 | <10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 88 | <30 | <10 | ++ |
| Poloxamer | 10.0 | 90 | <30 | <10 | +++ |
| Sodium lauryl sulphate | 10.0 | 77 | <30 | >10 | +++ |
| Stearic acid | 10.0 | 77 | >30 | >10 | +++ |
| Sodium stearate | 10.0 | 74 | >30 | >10 | +++ |
| Glycerin gelatine | 10.0 | 73 | >30 | >10 | +++ |
| Lac | 10.0 | 73 | >30 | >10 | +++ |
The group practices of table 4 medicine material and single-matrix
(medicine material: substrate=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 | 84 | <30 | >10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 50 | 84 | <30 | >10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50 | 83 | <30 | >10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 50 | 77 | <30 | >10 | + |
The group practices of table 5 medicine material and single-matrix
(medicine material: substrate=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 | 88 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 25 | 89 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25 | 88 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 25 | 84 | <30 | >10 | ++ |
The group practices of table 6 medicine material and single-matrix
(medicine material: substrate=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 | 89 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 10 | 89 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10 | 88 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 10 | 84 | <30 | >10 | +++ |
The group practices of table 7 medicine material and single-matrix
(medicine material: substrate=1: 11
| 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 | 90 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50 | 90 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 50 | 86 | <30 | <10 | ++ |
The group practices of table 8 medicine material and single-matrix
(medicine material: substrate=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 medicine material and single-matrix
(medicine material: substrate=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 | 90 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 10 | 90 | <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 medicine material and single-matrix
(medicine material: substrate=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 | 90 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 50 | 91 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50 | 91 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 50 | 87 | <30 | >10 | +++ |
The group practices of table 11 medicine material and single-matrix
(medicine material: substrate=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 | 91 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 25 | 91 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25 | 89 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 25 | 86 | <30 | <10 | +++ |
The group practices of table 12 medicine material and single-matrix
(medicine material: substrate=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 medicine material 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 medicine material 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 medicine material 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 WUZHI DIWAN that is used to reduce serum glutamic pyruvic transminase is a raw material with Chinese medicine Fructus Schisandrae Sphenantherae ethanol extractum, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
(1) 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 Fructus Schisandrae Sphenantherae ethanol extractum and substrate is 1: 3;
(2) according to aforementioned proportion, accurately take by weighing Fructus Schisandrae Sphenantherae ethanol extractum and substrate, be placed in the heating container heating while stirring, standby until the fused solution that obtains containing Fructus Schisandrae Sphenantherae ethanol extractum and substrate and/or emulsion and/or suspension;
(3) 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 (4) temperature for the treatment of dropping-pill machine head and condensing agent reaches desired state of temperature respectively, fused solution and/or the emulsion and/or the suspension that will contain Fructus Schisandrae Sphenantherae ethanol extractum and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent, shrink molding promptly.
2. WUZHI DIWAN as claimed in claim 1 is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
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| CNB2005100751622A CN100375613C (en) | 2005-06-10 | 2005-06-10 | Schizandrol dripping pills for decreasing aminopherase and method for preparing the same |
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Non-Patent Citations (4)
| Title |
|---|
| 中药药剂学. 上海科学技术出版社，380-381. 1997 * |
| 中药药剂学. 范碧亭，380381，上海科学技术出版社. 1997 * |
| 国家中成药标准汇编（中成药地方标准上升国家标准部分）内科 肝胆分册. 国家药品监督管理局，62-63，国家药品监督管理局. 2002 * |
| 药品标准中成药方制剂. 90，中华人民共和国***药典委员会. 1991 * |
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Assignee: Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd. Assignor: Beijing Zhengda Oasis Medicine Technology Co., Ltd. Contract record no.: 2011320000177 Denomination of invention: Schizandrol dripping pills for decreasing aminopherase and method for preparing the same Granted publication date: 20080319 License type: Exclusive License Open date: 20051123 Record date: 20110308 |
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