CN1316963C - Yunnan begonia herb drip pill and its preparation method - Google Patents
Yunnan begonia herb drip pill and its preparation method Download PDFInfo
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- CN1316963C CN1316963C CN 200510068273 CN200510068273A CN1316963C CN 1316963 C CN1316963 C CN 1316963C CN 200510068273 CN200510068273 CN 200510068273 CN 200510068273 A CN200510068273 A CN 200510068273A CN 1316963 C CN1316963 C CN 1316963C
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Abstract
The present invention relates to a medical composition which has the functions of dispelling wind, eliminating dampness, activating collateral flows and clearing away heat and toxic materials and is used for treating diseases, such as rheumatic arthritis, rheumatoid arthritis, chronic arthritis, lupus erythematosus, etc. The present invention has the purpose of supplementing the insufficiency of existing oral medicine preparations for treating the diseases and provides an oral preparation, namely a Yunnan begonia herb drop pill, which has the advantages of high biological availability, quick medicine releasing, obvious effect, high medicine content, convenient taking, low price and no pollution in the process of manufacture. The present invention is prepared by using a traditional Chinese medicine, namely a Yunnan begonia herb as a raw material and a medicinal carrier which is used as a basal substance together.
Description
Technical field
The present invention relates to a kind of expelling wind and removing dampness that has, collaterals activating, antipyretic and antidote functions, be used for rheumatic arthritis, rheumatoid arthritis, the pharmaceutical composition of treatment for diseases such as chronic arthritis and lupus erythematosus is a kind of drug composition oral preparation that feedstock production forms with the Chinese crude drug Herba Begoniae Yunnanensis particularly.
Background technology
The Herba Begoniae Yunnanensis sheet that is prepared from according to the preparation method that provides among the drug standard WS3-B-0755-91 promulgated by the ministries or commissions of the Central Government, it is a kind of expelling wind and removing dampness that has, collaterals activating, antipyretic and antidote functions is used for rheumatic arthritis, rheumatoid arthritis, the oral tablet of treatment for diseases such as chronic arthritis and lupus erythematosus, 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 WS3-B-0755-91:
Prescription: Herba Begoniae Yunnanensis
Method for making: get Tripterygium hypoglaucum, be cut into fragment, add 50% soak with ethanol 1h after, reflux 3 times, each 1h, merging filtrate, decompression recycling ethanol is condensed into thick paste, vacuum is in dry one-tenth dry extract.Get 250g, make granule, add adjuvant, make 1000.
Function cures mainly: expelling wind and removing dampness, collaterals activating, heat-clearing and toxic substances removing; Be used for rheumatic arthritis, rheumatoid arthritis also can be used for chronic arthritis and lupus erythematosus.
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 rheumatic arthritis that is used for, rheumatoid arthritis, the deficiency of the oral drug preparation of treatment for diseases such as chronic arthritis and lupus erythematosus provides a kind of bioavailability height, and has a quick release, quick produce effects, medicament contg height, taking convenience, cheap, and free of contamination aborning oral formulations Yunnan begonia herb drip pill.Yunnan begonia herb drip pill involved in the present invention is a raw material with the Chinese medicine Herba Begoniae Yunnanensis, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain Yunnan begonia herb drip pill involved in the present invention:
[preparation method]
1. the preparation of drug extract: with g or kg is unit, get Tripterygium hypoglaucum, be cut into fragment, add 50% soak with ethanol after 1 hour, reflux 3 times, each 1 hour, merging filtrate, decompression recycling ethanol, be condensed into the thick paste that relative density is 1.25-1.35, or make and be dried to dry extract, be ground into dry powder, promptly;
2. substrate: the mixture of one or more in pharmaceutically suitable carrier such as polyethylene glycols, sorbitol anhydride class, polyoxyethylene sorbitol acid anhydride class, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing drug extract and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing Radix Astragali extract and substrate and/or emulsion and/or suspension;
5. adopt homemade or general drop pill machine (as the TZDW-1 type drop pill machine of Changzheng Tianmin High Science ﹠ Technology Co., Ltd., Beijing's production), and the temperature control system of adjustment drop pill machine, make the water dropper temperature heating of drop pill machine and remain on (50～90) ℃, the temperature cooling of condensing agent also remains on (40～-5) ℃;
6. when treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and reaching desired state of temperature, to contain the fused solution of stilbene, Radix Saposhnikoviae, the Rhizoma Atractylodis Macrocephalae, Rhizoma Zingiberis Recens etc. 4 flavor active ingredient of Chinese herbs extracts and substrate and/or emulsion and/or suspension places in the water dropper jar of drop pill machine, splash in the condensing agent, condensing agent can be any one in liquid paraffin, methyl-silicone oil, the vegetable oil;
7. will shrink the drop pill taking-up of molding by the outlet of drop pill machine, remove the surface condensation agent, be drying to obtain.
[beneficial effect]
The Tripterygium Hypoglaucum Hutch Tablet that is prepared from according to the preparation method that provides among the drug standard WS3-B-0755-91 promulgated by the ministries or commissions of the Central Government, it is a kind of expelling wind and removing dampness that has, collaterals activating, antipyretic and antidote functions is used for rheumatic arthritis, rheumatoid arthritis, the oral tablet of treatment for diseases such as chronic arthritis and lupus erythematosus, 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.
Yunnan begonia herb drip pill involved in the present invention is compared with Tripterygium Hypoglaucum Hutch Tablet has following beneficial effect:
1. the disease treating drop pills of coughing involved in the present invention; utilize surfactant to be substrate; make solid dispersion with the extract that contains Chinese medicine Herba Begoniae Yunnanensis active pharmaceutical ingredient, 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. Yunnan begonia herb drip pill involved in the present invention, contact promptly with saliva and to dissolve rapidly, and absorb by oral mucosa, not only rapid-action, and the influence of not taken food, promptly all can containing take after meal ante cibum, can not produce any residual harmful substance at gastric yet, thereby make that patient's medication is safer, also have medication convenience, characteristic of accurate simultaneously.
3. Yunnan begonia herb drip pill involved in the present invention mixes the extract that contains active constituents of medicine mutually with molten matrix, splashes in the not miscible condensed fluid and makes.Therefore, the stability of drug height, not facile hydrolysis, oxidation, and the operation be under liquid state, to carry out, no dust pollution is not subject to the influence of crystal formation, thereby has guaranteed the quality of medicine, has increased stability.
4. production worker sesame, 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 Yunnan begonia herb drip pill of the present invention.
[first group: the test of single-matrix]
1: raw material: it is standby to make the extract dry powder that contains Chinese medicine Herba Begoniae Yunnanensis active pharmaceutical ingredient earlier according to [preparation method 1];
2. substrate: Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the Yunnan begonia herb drip pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared Yunnan begonia herb drip pill in qualitative difference, according to 1: 1 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 13 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning prepared Yunnan begonia herb drip pill in qualitative difference, according to 1: 3 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 13 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared Yunnan begonia herb drip pill in qualitative difference, according to 1: 9 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain drug extract 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: it is standby to make the extract dry powder that contains Chinese medicine Herba Begoniae Yunnanensis active pharmaceutical ingredient earlier according to [preparation method 1];
2. substrate:
2.1 Polyethylene Glycol---English name Macrogol,
2.2 polyoxyethylene stearate 40 esters---English name Polyoxyl (40) Stearate,
Molecular formula is with C
17H
35COO (CH
2CH
2O)
nH represents that n is about 40,
2.3 poloxamer---English name Poloxamer, polyoxyethylene poly-oxygen propylene aether,
Molecular formula HO (C
2H
4O)
a(C
3H
6O)
b(C
2H
4O)
cH,
The sodium salt of the starch carboxymethyl ester that 2.4 carboxymethyl starch sodium---English name Carboxymethylstach Sodium, starch generates with the monoxone effect under alkali condition,
2.5 betacyclodextrin---English name Betacyclodextrin, molecular formula C
6H
10O
5, this product is that ring dextrin glucosyl transferase acts on 7 glucoses that starch generates with α-1, the bonded cyclic oligosaccharide of 4-glycosidic bond;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the Yunnan begonia herb drip pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared Yunnan begonia herb drip pill when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 1 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 4.
Test 5: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared Yunnan begonia herb drip pill when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 3 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 5.
Test 6: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared Yunnan begonia herb drip pill when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 9 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 6.
Test 7: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared Yunnan begonia herb drip pill when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 1 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 7.
Test 8: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared Yunnan begonia herb drip pill when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 3 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 8.
Test 9: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared Yunnan begonia herb drip pill when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 9 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 9.
Test 10: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared Yunnan begonia herb drip pill when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 1 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 10.
Test 11: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared Yunnan begonia herb drip pill when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 3 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 11.
Test 12: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared Yunnan begonia herb drip pill when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 9 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 12.
The group practices of table 1 drug extract and single-matrix
(drug extract: substrate=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 50.0 | 67 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 50.0 | 84 | ＜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 | 75 | ＜30 | ＞10 | ++ |
| Poloxamer | 50.0 | 78 | ＜30 | ＞10 | ++ |
| Sodium lauryl sulphate | 50.0 | 74 | ＞30 | ＞10 | ++ |
| Stearic acid | 50.0 | 60 | ＞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 drug extract and single-matrix
(drug extract: substrate=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 25.0 | 71 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 25.0 | 86 | ＜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 | 87 | ＜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 drug extract and single-matrix
(drug extract: substrate=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 10.0 | 84 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 10.0 | 91 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 6000 | 10.0 | 90 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 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 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 50 | 83 | ＜30 | ＞10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 50 | 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 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 25 | 90 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 25 | 90 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 25 | 84 | ＜30 | ＞10 | ++ |
The group practices of table 6 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 10 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 10 | 90 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 10 | 84 | ＜30 | ＞10 | +++ |
The group practices of table 7 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 50 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 50 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50 | 91 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 50 | 86 | ＜30 | ＜10 | ++ |
The group practices of table 8 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 25 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 25 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 25 | 88 | ＜30 | ＜10 | +++ |
The group practices of table 9 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 10 | 92 | ＜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 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 50 | 92 | ＜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 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 25 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 25 | 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 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 10 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 10 | 93 | ＜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 (2)
1. a Yunnan begonia herb drip pill that is used for arthritis and lupus erythematosus zhiliao is a raw material with the Chinese medicine Herba Begoniae Yunnanensis, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
(1) is unit with g or kg, gets Tripterygium hypoglaucum, be cut into fragment, add 50% soak with ethanol after 1 hour, reflux 3 times, each 1 hour, merging filtrate, decompression recycling ethanol, be condensed into relative density and be 1.25～1.35 thick paste, or make and be dried to dry extract, be ground into dry powder, promptly get the extract that contains the Herba Begoniae Yunnanensis effective ingredient, standby;
(2) described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or carboxymethyl starch sodium, by weight, the mixed proportion of polyoxyethylene stearate 40 esters or carboxymethyl starch sodium and Polyethylene Glycol is 1: 1～1: 10, describedly contains the extract of Herba Begoniae Yunnanensis effective ingredient and the ratio of substrate is 1: 3;
(3) according to aforementioned proportion, accurately take by weighing described extract and substrate, be placed in the heating container heating while stirring, standby until the fused solution that obtains containing described extract and substrate and/or emulsion and/or suspension;
(4) temperature control system of adjustment drop pill machine makes the water dropper heating of drop pill machine and maintains the temperature at 50 ℃～90 ℃, and the condensing agent cooling also maintains the temperature at 40 ℃～-5 ℃;
When (5) temperature for the treatment of dropping-pill machine head and condensing agent reaches described state respectively, will contain fused solution and/or the emulsion and/or the suspension of described extract and substrate, place in the water dropper jar of drop pill machine, and splash in the condensing agent and shrink molding promptly.
2. Yunnan begonia herb drip pill as claimed in claim 1 is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510068273 CN1316963C (en) | 2005-05-08 | 2005-05-08 | Yunnan begonia herb drip pill and its preparation method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510068273 CN1316963C (en) | 2005-05-08 | 2005-05-08 | Yunnan begonia herb drip pill and its preparation method |
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| CN1686440A CN1686440A (en) | 2005-10-26 |
| CN1316963C true CN1316963C (en) | 2007-05-23 |
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| CN102935160B (en) * | 2012-09-04 | 2014-02-26 | 辽宁大学 | Traditional Chinese medicine cataplasm for improving intestines and stomach functions and preparation method thereof |
| CN112842906A (en) * | 2020-12-31 | 2021-05-28 | 重庆市药研院制药有限公司 | Ficus pumila root straight powder forming process and vacuum drying equipment |
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