CN1709414A - Compound liver-benefiting dropping pill for treating hepatitis and its preparing method - Google Patents
Compound liver-benefiting dropping pill for treating hepatitis and its preparing method Download PDFInfo
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- CN1709414A CN1709414A CN 200510075167 CN200510075167A CN1709414A CN 1709414 A CN1709414 A CN 1709414A CN 200510075167 CN200510075167 CN 200510075167 CN 200510075167 A CN200510075167 A CN 200510075167A CN 1709414 A CN1709414 A CN 1709414A
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Abstract
The present invention discloses a Chinese medicine composition with the actions of boosting liver, enriching kidney, removing toxic material and dispelling dampness for curing the diseases of hypochondriac pain, reduced food intake, obdominal distention, aching lumbus, lack of strength and yellow urine, etc. due to deficiency of liver-yin and kidney-yin and noxious dampness. Said Chinese medicine composition can be made into compound Yiganling dripping pills, and is made up by using Chinese medicine Yiganling powder and Wurenchun extract as raw material and medicinal carrier as matrix through a certain preparation process.
Description
Technical field
The present invention relates to a kind of liver-benefiting kidney-nourishing that has, the detoxifying, removing dampness effect, be used for the hepatic and renal YIN deficiency, noxious dampness does not cause hypochondriac pain clearly, poor appetite, abdominal distention, the soreness of waist is weak, the pharmaceutical composition of treatment for diseases such as yellowish urine is a kind of drug composition oral preparation that feedstock production forms with Chinese medicine silymarin and schizandrol extractum particularly.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The compound liver-benepitino remedy sheet that the preparation method that provides among-the B-2380-97 is prepared from, be a kind of liver-benefiting kidney-nourishing that has, the detoxifying, removing dampness effect is used for the hepatic and renal YIN deficiency, noxious dampness does not cause hypochondriac pain clearly, poor appetite, abdominal distention, the soreness of waist is weak, the oral tablet of treatment for diseases such as yellowish urine, 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-2380-97 and technology and brief description:
Prescription: silymarin 30g, schizandrol extractum 80g
Method for making: above two flavors, silybin powder and starch, dextrin mixing add schizandrol extractum, make granule, and drying is pressed into 1000, sugar coating, promptly.
Function cures mainly: liver-benefiting kidney-nourishing, detoxifying, removing dampness.Be used for the hepatic and renal YIN deficiency, noxious dampness does not cause hypochondriac pain clearly, poor appetite, and abdominal distention, the soreness of waist is weak, diseases such as yellowish urine; Or the chronic hepatitis transaminase person of increasing.
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 that additional having now is used for the hepatic and renal YIN deficiency, and noxious dampness does not cause hypochondriac pain clearly, poor appetite, abdominal distention, the soreness of waist is weak, the deficiency of the oral drug preparation of treatment for diseases such as yellowish urine, 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 compound liver-benefiting dropping pill.Compound liver-benefiting dropping pill involved in the present invention is a raw material with Chinese medicine silymarin and schizandrol extractum, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain compound liver-benefiting dropping pill involved in the present invention:
[preparation method]
1. hybrid medicine raw material: with g or kg is unit, gets 3 parts of silybin powder and 8 parts of schizandrol extractum mixings, standby;
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 raw material: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing hybrid medicine raw material and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing hybrid medicine raw material 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 raw 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]
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The compound liver-benepitino remedy sheet that the preparation method that provides among-the B-2380-97 is prepared from, be a kind of liver-benefiting kidney-nourishing that has, the detoxifying, removing dampness effect is used for the hepatic and renal YIN deficiency, noxious dampness does not cause hypochondriac pain clearly, poor appetite, abdominal distention, the soreness of waist is weak, the oral tablet of treatment for diseases such as yellowish urine, 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.
Compound liver-benefiting dropping pill involved in the present invention is compared with the compound liver-benepitino remedy sheet has following beneficial effect:
1. compound liver-benefiting dropping pill involved in the present invention; utilize surfactant to be substrate; hybrid medicine raw material with silybin powder and schizandrol extractum is made solid dispersion; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases; and substrate is hydrophilic; medicine had wetting action; can make medicine molten microgranule or the solution of loosing into rapidly; thereby make the dissolving of medicine and absorb quickening; thereby improved bioavailability, brought into play efficient, quick-acting effects etc.
2. compound liver-benefiting dropping 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. compound liver-benefiting dropping 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 compound liver-benefiting dropping pill of the present invention.
[first group: the test of single-matrix]
1. hybrid medicine raw material: with g or kg is unit, gets 3 parts of silybin powder and 8 parts of schizandrol extractum mixings, 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 raw material: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the compound liver-benefiting dropping pill of different size.
[result of the test]
Test 1: for observe hybrid medicine raw material and different substrates when 1: 1 the proportioning prepared compound liver-benefiting dropping pill in qualitative difference, according to 1: 1 ratio, with the hybrid medicine raw 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 hybrid medicine raw material and different substrates, and obtain 13 groups of different experimental results and see Table 1.
Test 2: for observe hybrid medicine raw material and different substrates when 1: 3 the proportioning prepared compound liver-benefiting dropping pill in qualitative difference, according to 1: 1 ratio, with the hybrid medicine raw 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 hybrid medicine raw material and different substrates, and obtain 13 groups of different experimental results and see Table 2.
Test 3: for observe hybrid medicine raw material and different substrates when 1: 9 the proportioning prepared compound liver-benefiting dropping pill in qualitative difference, according to 1: 1 ratio, with the hybrid medicine raw 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 hybrid medicine raw material and different substrates, and obtain 13 groups of different experimental results and see Table 3.
[second group: the test of mixed-matrix]
1. hybrid medicine raw material: with g or kg is unit, gets 3 parts of silybin powder and 8 parts of schizandrol extractum mixings, 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 raw material: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the compound liver-benefiting dropping pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of hybrid medicine raw material and mixed-matrix prepared compound liver-benefiting dropping 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 raw material 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 raw material 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 raw material and mixed-matrix prepared compound liver-benefiting dropping 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 raw material 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 raw material 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 raw material and mixed-matrix prepared compound liver-benefiting dropping 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 raw material 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 raw material 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 raw material and mixed-matrix prepared compound liver-benefiting dropping 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 raw material 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 raw material 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 raw material and mixed-matrix prepared compound liver-benefiting dropping 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 raw material 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 raw material 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 raw material and mixed-matrix prepared compound liver-benefiting dropping 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 raw material 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 raw material 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 raw material and mixed-matrix prepared compound liver-benefiting dropping 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 different with the 4 kinds respectively mixing matrix phases of hybrid medicine raw material 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 raw material 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 raw material and mixed-matrix prepared compound liver-benefiting dropping 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 different with the 4 kinds respectively mixing matrix phases of hybrid medicine raw material 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 raw material 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 raw material and mixed-matrix prepared compound liver-benefiting dropping 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 different with the 4 kinds respectively mixing matrix phases of hybrid medicine raw material 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 raw material 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 raw material and single-matrix
(hybrid medicine raw 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 | ????83 | ????＜30 | ????＞10 | ++ |
| Span 40 | ????50.0 | ????61 | ????＜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 hybrid medicine raw material and single-matrix
(hybrid medicine raw 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 | ????72 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 4000 | ????25.0 | ????87 | ????＜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 | ????77 | ????＞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 hybrid medicine raw material and single-matrix
(hybrid medicine raw 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 | ????83 | ????＜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 | ????90 | ????＜30 | ????＜10 | +++ |
| Span 40 | ????10.0 | ????73 | ????＜30 | ????＜10 | +++ |
| Polyoxyethylene stearate 40 esters | ????10.0 | ????87 | ????＜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 hybrid medicine raw material and single-matrix
(hybrid medicine raw 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 hybrid medicine raw material and single-matrix
(hybrid medicine raw 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 | ????90 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????25 | ????90 | ????＜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 hybrid medicine raw material and single-matrix
(hybrid medicine raw 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 | ????90 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????10 | ????90 | ????＜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 hybrid medicine raw material and single-matrix
(hybrid medicine raw 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: 5 | ????50 | ????91 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????50 | ????91 | ????＜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 hybrid medicine raw material and single-matrix
(hybrid medicine raw 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 | ????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 hybrid medicine raw material and single-matrix
(hybrid medicine raw 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 | ????91 | ????＜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 hybrid medicine raw material and single-matrix
(hybrid medicine raw 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 | ????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 hybrid medicine raw material and single-matrix
(hybrid medicine raw 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 | ????92 | ????＜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 hybrid medicine raw material and single-matrix
(hybrid medicine raw 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 drug extract and substrate was 1: 1, its rounding rate, the ball method of double differences was different and index such as hardness is all undesirable, and dissolve scattered time limit influenced not obvious.
2. when the ratio of drug extract and substrate is 1: 3, the rounding rate, the ball method of double differences is different and index such as hardness slightly all begins to enter preferable state.
3. when the ratio of drug extract and substrate is 1: 9, the rounding rate, the ball method of double differences is different and index such as hardness improves not obvious.
4. the general effect of composite interstitial substance is better than single-matrix.
5. the hardness method for expressing in the subordinate list adopts drop pill is placed on the glass plate, press...withes one's finger it, observes its metamorphosis."+" expression flicking promptly is out of shape, " ++ " expression distortion of firmly pressing, and " +++" expression is indeformable by it.
Claims (5)
1. one kind is used for the hepatic and renal YIN deficiency, and noxious dampness does not cause hypochondriac pain, poor appetite clearly, abdominal distention, the soreness of waist is weak, the pharmaceutical composition compound liver-benefiting dropping pill of treatment for diseases such as yellowish urine, with Chinese medicine silybin powder and schizandrol extractum is raw material, be prepared from pharmaceutically suitable carrier as substrate, wherein:
1.1 hybrid medicine raw material: with g or kg is unit, gets 3 parts of silybin powder and 8 parts of schizandrol extractum mixings, standby;
1.2 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;
1.3 proportioning: with g or kg is unit, by weight, and hybrid medicine raw material: substrate=1: 1～1: 9.
2. compound liver-benefiting dropping pill 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 compound liver-benefiting dropping pill 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 compound liver-benefiting dropping pill is characterized in that being made of following process:
4.1 hybrid medicine raw material: with g or kg is unit, gets 3 parts of silybin powder and 8 parts of schizandrol extractum mixings, standby;
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 hybrid medicine raw material: substrate=1: 1～1: 9;
4.4, accurately take by weighing hybrid medicine raw 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 hybrid medicine raw 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 hybrid medicine raw 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 compound liver-benefiting dropping 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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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100751675A CN1315470C (en) | 2005-06-10 | 2005-06-10 | Compound liver-benefiting dropping pill for treating hepatitis and its preparing method |
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|---|---|---|---|
| CNB2005100751675A CN1315470C (en) | 2005-06-10 | 2005-06-10 | Compound liver-benefiting dropping pill for treating hepatitis and its preparing method |
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| CN1315470C CN1315470C (en) | 2007-05-16 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100409838C (en) * | 2006-09-04 | 2008-08-13 | 南昌弘益科技有限公司 | Method for producing medicine Yigan dipping-pills for tonifying liver |
| CN101856393A (en) * | 2010-06-06 | 2010-10-13 | 林秀连 | Application of compound Yiganling composition in aspect of auxiliary treatment of chemotherapy of tumors |
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2005
- 2005-06-10 CN CNB2005100751675A patent/CN1315470C/en not_active Expired - Fee Related
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100409838C (en) * | 2006-09-04 | 2008-08-13 | 南昌弘益科技有限公司 | Method for producing medicine Yigan dipping-pills for tonifying liver |
| CN101856393A (en) * | 2010-06-06 | 2010-10-13 | 林秀连 | Application of compound Yiganling composition in aspect of auxiliary treatment of chemotherapy of tumors |
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| CN1315470C (en) | 2007-05-16 |
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