CN1698633A - Glycyrrhizin drop pills and preparation method thereof - Google Patents
Glycyrrhizin drop pills and preparation method thereof Download PDFInfo
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- CN1698633A CN1698633A CN 200510075168 CN200510075168A CN1698633A CN 1698633 A CN1698633 A CN 1698633A CN 200510075168 CN200510075168 CN 200510075168 CN 200510075168 A CN200510075168 A CN 200510075168A CN 1698633 A CN1698633 A CN 1698633A
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Abstract
The invention discloses a glycyrrhizin drop pills and preparation process, which is aimed at providing a hepatitis-treating medicinal composition having the advantages of high biological availability, quick-speed medicine release, quick-speed effect, higher medicinal content, easy administration and low price. The glycyrrhizin drop pill is prepared from the effective compositions of the Chinese herbal licorice root as raw material and medicinal carrying agent as the base material.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of hepatitis, is a kind of drug composition oral preparation that feedstock production forms with monopotassium glycyrrhizunate or ammonium glycyrrhizinate particularly.
Background technology---17-64 promulgated by the ministries or commissions of the Central Government
The glycyrrhizin tablet that is prepared from according to the preparation method that provides among the drug standard WS-11396 promulgated by the ministries or commissions of the Central Government (ZD-1396)-2002, it is a kind of oral tablet for the treatment of hepatitis, 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-11396 (ZD-1396)-2002:
Prescription: monopotassium glycyrrhizunate
Method for making: extracting liquorice acid monopotassium salt 150g and starch 90g, partial starch is added water furnishing starch slurry, remaining starch and monopotassium glycyrrhizunate mixing are granulated with starch slurry, and drying is pressed into 1000 or 2000, sugar coating or film-coat, promptly.
Function cures mainly: treatment hepatitis medicine; Be used for chronic hepatitis B.
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 is to replenish the existing deficiency that is used for the treatment of the oral drug preparation of hepatitis, and a kind of bioavailability height is provided, and has a quick release, produce effects fast, medicament contg height, taking convenience, cheap, and free of contamination aborning oral formulations glycyrrhiza edulcorant drip ball.Glycyrrhiza edulcorant drip ball involved in the present invention is a raw material with effective ingredient monopotassium glycyrrhizunate or the ammonium glycyrrhizinate of Chinese medicine Radix Glycyrrhizae, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain glycyrrhiza edulcorant drip ball involved in the present invention:
[preparation method]
1. raw material: monopotassium glycyrrhizunate or ammonium glycyrrhizinate
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 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-adopts 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 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 glycyrrhizin tablet that is prepared from according to the preparation method that provides among the drug standard WS-11396 promulgated by the ministries or commissions of the Central Government (ZD-1396)-2002, it is a kind of oral tablet for the treatment of hepatitis, 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-11396 (ZD-1396)-2002:
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.
Glycyrrhiza edulcorant drip ball involved in the present invention is compared with glycyrrhizin tablet has following beneficial effect:
1. glycyrrhiza edulcorant drip ball involved in the present invention; utilize surfactant to be substrate; make solid dispersion with monopotassium glycyrrhizunate or ammonium glycyrrhizinate, 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. glycyrrhiza edulcorant drip ball 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. glycyrrhiza edulcorant drip ball involved in the present invention mixes monopotassium glycyrrhizunate or ammonium glycyrrhizinate 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 glycyrrhiza edulcorant drip ball of the present invention.
[first group: the test of single-matrix]
1. raw material: monopotassium glycyrrhizunate or ammonium glycyrrhizinate
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 raw material: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the glycyrrhiza edulcorant drip ball of different size.
[result of the test]
Test 1: for observe medicine material and different substrates when 1: 1 the proportioning prepared glycyrrhiza edulcorant drip ball in qualitative difference, according to 1: 1 ratio, with medicine material respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain 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 glycyrrhiza edulcorant drip ball in qualitative difference, according to 1: 3 ratio, with medicine material respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain 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 glycyrrhiza edulcorant drip ball in qualitative difference, according to 1: 9 ratio, with medicine material respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain 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. raw material: monopotassium glycyrrhizunate or ammonium glycyrrhizinate
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 medicine material: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the glycyrrhiza edulcorant drip ball of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of medicine material and mixed-matrix prepared glycyrrhiza edulcorant drip ball 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 is in order to observe the mass discrepancy of medicine material and mixed-matrix prepared glycyrrhiza edulcorant drip ball 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 glycyrrhiza edulcorant drip ball 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 glycyrrhiza edulcorant drip ball 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 glycyrrhiza edulcorant drip ball 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 glycyrrhiza edulcorant drip ball 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 glycyrrhiza edulcorant drip ball 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 medicine material 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 medicine material and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 10.
Test 11: in order to observe the mass discrepancy of medicine material and mixed-matrix prepared glycyrrhiza edulcorant drip ball 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 medicine material 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 medicine material and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 10.
Test 12: in order to observe the mass discrepancy of medicine material and mixed-matrix prepared glycyrrhiza edulcorant drip ball 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 medicine material 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 medicine material and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 10.
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 | ????69 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 4000 | ????50.0 | ????85 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 6000 | ????50.0 | ????85 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 10000 | ????50.0 | ????84 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 20000 | ????50.0 | ????83 | ????＜30 | ????＞10 | ++ |
| Span 40 | ????50.0 | ????63 | ????＜30 | ????＞10 | ++ |
| Polyoxyethylene stearate 40 esters | ????50.0 | ????77 | ????＜30 | ????＞10 | ++ |
| Poloxamer | ????50.0 | ????78 | ????＜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 | ????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 | ????75 | ????＜30 | ????＞10 | +++ |
| Polyoxyethylene stearate 40 esters | ????25.0 | ????88 | ????＜30 | ????＜10 | ++ |
| Poloxamer | ????25.0 | ????89 | ????＜30 | ????＜10 | +++ |
| Sodium lauryl sulphate | ????25.0 | ????73 | ????＜30 | ????＞10 | ++ |
| Stearic acid | ????25.0 | ????74 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????25.0 | ????73 | ????＞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 | ????90 | ????＜30 | ????＜10 | +++ |
| Span 40 | ????10.0 | ????73 | ????＜30 | ????＜10 | +++ |
| Polyoxyethylene stearate 40 esters | ????10.0 | ????89 | ????＜30 | ????＜10 | ++ |
| Poloxamer | ????10.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Sodium lauryl sulphate | ????10.0 | ????78 | ????＜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 mixed-matrix
(medicine material: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | ????50 | ????83 | ????＜30 | ????＞10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????50 | ????82 | ????＜30 | ????＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????50 | ????81 | ????＜30 | ????＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????50 | ????77 | ????＜30 | ????＞10 | + |
The group practices of table 5 medicine material and mixed-matrix
(medicine material: 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 | ????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 mixed-matrix
(medicine material: 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 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????10 | ????90 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????10 | ????84 | ????＜30 | ????＞10 | +++ |
The group practices of table 7 medicine material and mixed-matrix
(medicine material: 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 | ????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 mixed-matrix
(medicine material: 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 | ????90 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????25 | ????91 | ????＜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 mixed-matrix
(medicine material: 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 | ????90 | ????＜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 medicine material and mixed-matrix
(medicine material: 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 | ????91 | ????＜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 mixed-matrix
(medicine material: 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 | ????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 mixed-matrix
(medicine material: 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 | ????91 | ????＜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 (5)
1. a pharmaceutical composition glycyrrhiza edulcorant drip ball that is used for the treatment of hepatitis is a raw material with monopotassium glycyrrhizunate or ammonium glycyrrhizinate, be prepared from pharmaceutically suitable carrier as substrate, wherein:
1.1 substrate: 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, above-mentioned carrier one or more mixture wherein;
1.2 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9.
2. glycyrrhiza edulcorant drip ball as claimed in claim 1 is characterized in that: described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or Polyethylene Glycol and poloxamer or Polyethylene Glycol and carboxymethyl starch sodium or Polyethylene Glycol and betacyclodextrin; With g or kg is unit, and by weight, its mixed proportion is polyoxyethylene stearate 40 esters: Polyethylene Glycol or poloxamer: Polyethylene Glycol or carboxymethyl starch sodium: Polyethylene Glycol or betacyclodextrin: Polyethylene Glycol=1: 1～1: 10.
3. any glycyrrhiza edulcorant drip ball as claimed in claim 1 or 2 is characterized in that: the mixed proportion of described drug extract and substrate is 1: 1～1: 5.
4. the preparation method of a glycyrrhiza edulcorant drip ball is characterized in that being made of following process:
4.1 medicine material: monopotassium glycyrrhizunate or ammonium glycyrrhizinate
4.2 substrate: 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, above-mentioned carrier one or more mixture wherein;
4.3 proportioning: with g or kg is unit, by weight, and medicine material: substrate=1: 1～1: 9;
4.4, accurately take by weighing medicine material and substrate according to the given ratio of prescription, 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;
4.5 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 ℃;
4.6 when treating in dropping-pill machine head and the condensation column that the temperature of condensing agent reaches desired state of temperature respectively, fused solution and/or the emulsion and/or the suspension that will contain medicine material and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent and shrink molding promptly.
5. as the preparation method of glycyrrhiza edulcorant drip ball 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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| CNB200510075168XA CN100358531C (en) | 2005-06-10 | 2005-06-10 | Glycyrrhizin drop pills and preparation method thereof |
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| CNB200510075168XA CN100358531C (en) | 2005-06-10 | 2005-06-10 | Glycyrrhizin drop pills and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100341515C (en) * | 2006-03-31 | 2007-10-10 | 山东山大康诺制药有限公司 | Film-coated tablet of glycyrrhizinic acid monopotassiium salt and method for preparing the same |
| CN102526082A (en) * | 2011-12-16 | 2012-07-04 | 南京农业大学 | Compound glycyrrhizin soluble powder for livestock and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP3344005B2 (en) * | 1993-06-30 | 2002-11-11 | 不二製油株式会社 | Manufacturing method of aseptic flower paste |
| CN1066627C (en) * | 1997-10-13 | 2001-06-06 | 贵州黄果村立爽药业有限公司 | Throat disease curing drop and its preparation |
| CN1579404A (en) * | 2003-08-06 | 2005-02-16 | 孙明杰 | Novel preparation of glycyrrhizin |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100341515C (en) * | 2006-03-31 | 2007-10-10 | 山东山大康诺制药有限公司 | Film-coated tablet of glycyrrhizinic acid monopotassiium salt and method for preparing the same |
| CN102526082A (en) * | 2011-12-16 | 2012-07-04 | 南京农业大学 | Compound glycyrrhizin soluble powder for livestock and preparation method thereof |
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| CN100358531C (en) | 2008-01-02 |
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