CN1709468A - Pulmonary-toxin-clearing dropping pill using hop extract as raw material, and its preparing method - Google Patents
Pulmonary-toxin-clearing dropping pill using hop extract as raw material, and its preparing method Download PDFInfo
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- CN1709468A CN1709468A CN 200510085277 CN200510085277A CN1709468A CN 1709468 A CN1709468 A CN 1709468A CN 200510085277 CN200510085277 CN 200510085277 CN 200510085277 A CN200510085277 A CN 200510085277A CN 1709468 A CN1709468 A CN 1709468A
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Abstract
The present invention relates to a Chinese medicine composition prepared by using hop extract as raw material. In particular, it relates to a Chinese medicine composition oral preparation--Feiduqing dripping pills for curing poor stomach intake, unquiet sleep and auxiliary therapy of pulmonary tuberculosis. Said invention also provides its preparation process and concrete steps.
Description
Technical field
The present invention relates to a kind of is the pharmaceutical composition that feedstock production forms with the Flos lupuli extractum, particularly a kind of infantile anorexia that is used for, the drug composition oral preparation of sleep disorder and pulmonary tuberculosis auxiliary treatment.
Background technology
The clear sheet of toxic swelling that is prepared from according to the preparation method that provides among the national drug standards WS-11286 (ZD-1286)-2002, a kind of is that feedstock production forms with the Flos lupuli extractum, be used for infantile anorexia, the drug composition oral tablet of sleep disorder and pulmonary tuberculosis auxiliary treatment, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
Below be the brief description among the drug standard WS-11286 (ZD-1286)-2002:
Nomenclature of drug: the clear sheet of lung poison
Prescription: Flos lupuli extractum 111g (containing Flos lupuli (Flos Humuli Lupuli) barras 50g), dextrin 178g, carboxymethyl starch sodium 11g, magnesium stearate 2.5g
Method for making: get Flos lupuli extractum, add dextrin, carboxymethyl starch sodium, mixing is made granule, and drying adds magnesium stearate, mixing, and tabletting, promptly.
Function cures mainly: invigorating the stomach and promoting digestion, the diuresis of calming the nerves.Be used for infantile anorexia, the phthisical auxiliary treatment of sleep disorder.
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 infantile anorexia that is used for, the deficiency of the oral drug preparation of sleep disorder and pulmonary tuberculosis auxiliary treatment provides a kind of bioavailability height, takes hindgut gastric noresidue material, and has a quick release, quick produce effects, medicament contg height, taking convenience, cheap, and free of contamination aborning oral formulations pulmonary-toxin-clearing dropping pill.Pulmonary-toxin-clearing dropping pill involved in the present invention is a raw material with the Chinese medicine extract Flos lupuli extractum, is prepared from the pharmaceutically suitable carrier as substrate.Be prepared by the following technical solutions, can obtain pulmonary-toxin-clearing dropping pill involved in the present invention:
[preparation method]
1. raw material: Flos lupuli extractum
2. substrate: the mixture of one or more in pharmaceutically suitable carrier such as polyethylene glycols, sorbitol anhydride class, polyoxyethylene sorbitol acid anhydride class, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, Flos lupuli extractum: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing Flos lupuli extractum and substrate, base is placed heating while stirring in the heating container, standby until the fused solution that obtains containing Flos lupuli extractum 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 Flos lupuli extractum and substrate and/or emulsion and/or suspension places in the dropping-pill machine head jar, 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 clear sheet of lung poison that is prepared from according to the preparation method that provides among the national drug standards WS-11286 (ZD-1286)-2002, a kind of is that feedstock production forms with the Flos lupuli extractum, be used for infantile anorexia, the drug composition oral tablet of sleep disorder and pulmonary tuberculosis auxiliary treatment, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.
In addition, conventional peroral dosage form is as tablet, capsule, granule (electuary) etc., in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Pulmonary-toxin-clearing dropping pill involved in the present invention, compare with the clear sheet of lung poison and to have following beneficial effect:
1. pulmonary-toxin-clearing dropping pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion with Flos lupuli extractum, 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. pulmonary-toxin-clearing 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. pulmonary-toxin-clearing dropping pill involved in the present invention mixes the Flos lupuli extractum that contains active pharmaceutical ingredient 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 pulmonary-toxin-clearing dropping pill of the present invention.
[first group: the test of single-matrix]
1. raw material: Flos lupuli extractum
2. substrate: Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and Flos lupuli extractum: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can get the pulmonary-toxin-clearing dropping pill of different size.
[result of the test]
Test 1: for observe Flos lupuli extractum and different substrates when 1: 1 the proportioning prepared pulmonary-toxin-clearing dropping pill in qualitative difference, according to 1: 1 ratio, with Flos lupuli extractum 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 the pharmaceutical composition experiment of 13 Flos lupuli extractums and different substrates, and obtain 13 groups of different experimental results and see Table 1.
Test 2: for observe Flos lupuli extractum and different substrates when 1: 3 the proportioning prepared pulmonary-toxin-clearing dropping pill in qualitative difference, according to 1: 3 ratio, with Flos lupuli extractum 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 the pharmaceutical composition experiment of 13 Flos lupuli extractums and different substrates, and obtain 13 groups of different experimental results and see Table 2.
Test 3: for observe Flos lupuli extractum and different substrates when 1: 9 the proportioning prepared pulmonary-toxin-clearing dropping pill in qualitative difference, according to 1: 9 ratio, with Flos lupuli extractum 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 the pharmaceutical composition experiment of 13 Flos lupuli extractums 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: Flos lupuli extractum
2. substrate:
2.1 Polyethylene Glycol---English name Macrogol,
2.2 polyoxyethylene stearate 40 esters---English name Polyoxyl (40) Stearate, molecular formula is with C
17H
35COO (CH
2CH
2O)
nH represents that n is about 40,
2.3 poloxamer---English name Poloxamer, polyoxyethylene poly-oxygen propylene aether, molecular formula HO (C
2H
4O)
a(C
3H
6O)
b(C
2H
4O)
cH,
The sodium salt of the starch carboxymethyl ester that 2.4 carboxymethyl starch sodium---English name Carboxymethylstach Sodium, starch generates with the monoxone effect under alkali condition,
2.5 betacyclodextrin---English name Betacyclodextrin, molecular formula C
6H
10O
5, this product is that ring dextrin glucosyl transferase acts on 7 glucoses that starch generates with α-1, the bonded cyclic oligosaccharide of 4-glycosidic bond;
3. proportioning: with g or kg is unit, Flos lupuli extractum: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can get the pulmonary-toxin-clearing dropping pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of Flos lupuli extractum and mixed-matrix prepared pulmonary-toxin-clearing dropping pill when 1: 1 the proportioning, with g or kg is unit, 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 Flos lupuli extractum 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 Flos lupuli extractum 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 Flos lupuli extractum and mixed-matrix prepared pulmonary-toxin-clearing dropping pill when 1: 3 the proportioning, with g or kg is unit, 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 Flos lupuli extractum 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 Flos lupuli extractum 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 Flos lupuli extractum and mixed-matrix prepared pulmonary-toxin-clearing dropping pill when 1: 9 the proportioning, with g or kg is unit, 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 Flos lupuli extractum 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 Flos lupuli extractum 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 Flos lupuli extractum and mixed-matrix prepared pulmonary-toxin-clearing dropping pill when 1: 1 the proportioning, with g or kg is unit, 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 Flos lupuli extractum 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 Flos lupuli extractum 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 Flos lupuli extractum and mixed-matrix prepared pulmonary-toxin-clearing dropping pill when 1: 3 the proportioning, with g or kg is unit, 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 Flos lupuli extractum 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 Flos lupuli extractum 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 Flos lupuli extractum and mixed-matrix prepared pulmonary-toxin-clearing dropping pill when 1: 3 the proportioning, with g or kg is unit, 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 Flos lupuli extractum 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 Flos lupuli extractum 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 Flos lupuli extractum and mixed-matrix prepared pulmonary-toxin-clearing dropping pill when 1: 1 the proportioning, with g or kg is unit, 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 Flos lupuli extractum 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 Flos lupuli extractum 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 Flos lupuli extractum and mixed-matrix prepared toxic swelling clearing dropping pill when 1: 3 the proportioning, with g or kg is unit, 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 Flos lupuli extractum 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 Flos lupuli extractum 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 Flos lupuli extractum and mixed-matrix prepared pulmonary-toxin-clearing dropping pill when 1: 3 the proportioning, with g or kg is unit, 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 Flos lupuli extractum 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 Flos lupuli extractum 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 Flos lupuli extractum and single-matrix
(Flos lupuli extractum: 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 | ??72 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 4000 | ??50.0 | ??84 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 6000 | ??50.0 | ??84 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 10000 | ??50.0 | ??84 | ??＜30 | ??＞10 | ??++ |
| Polyethylene Glycol 20000 | ??50.0 | ??84 | ??＜30 | ??＞10 | ??++ |
| Span 40 | ??50.0 | ??69 | ??＜30 | ??＞10 | ??++ |
| Polyoxyethylene stearate 40 esters | ??50.0 | ??77 | ??＜30 | ??＞10 | ??++ |
| Poloxamer | ??50.0 | ??80 | ??＜30 | ??＞10 | ??++ |
| Sodium lauryl sulphate | ??50.0 | ??78 | ??＞30 | ??＞10 | ??++ |
| Stearic acid | ??50.0 | ??74 | ??＞30 | ??＞10 | ??++ |
| Sodium stearate | ??50.0 | ??69 | ??＞30 | ??＞10 | ??++ |
| Glycerin gelatine | ??50.0 | ??68 | ??＞30 | ??＞10 | ??+ |
| Lac | ??50.0 | ??66 | ??＞30 | ??＞10 | ??+ |
The group practices of table 2 Flos lupuli extractum and single-matrix
(Flos lupuli extractum: 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 | ??80 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 4000 | ??25.0 | ??90 | ??＜30 | ??＜10 | ??++ |
| Polyethylene Glycol 6000 | ??25.0 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 10000 | ??25.0 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 20000 | ??25.0 | ??89 | ??＜30 | ??＜10 | ??+++ |
| Span 40 | ??25.0 | ??77 | ??＜30 | ??＞10 | ??+++ |
| Polyoxyethylene stearate 40 esters | ??25.0 | ??89 | ??＜30 | ??＜10 | ??++ |
| Poloxamer | ??25.0 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Sodium lauryl sulphate | ??25.0 | ??76 | ??＜30 | ??＞10 | ??++ |
| Stearic acid | ??25.0 | ??78 | ??＞30 | ??＞10 | ??+++ |
| Sodium stearate | ??25.0 | ??74 | ??＞30 | ??＞10 | ??+++ |
| Glycerin gelatine | ??25.0 | ??74 | ??＞30 | ??＞10 | ??+++ |
| Lac | ??25.0 | ??73 | ??＞30 | ??＞10 | ??+++ |
The group practices of table 3 Flos lupuli extractum and single-matrix
(Flos lupuli extractum: 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 | ??85 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 4000 | ??10.0 | ??90 | ??＜30 | ??＜10 | ??++ |
| Polyethylene Glycol 6000 | ??10.0 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 10000 | ??10.0 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 20000 | ??10.0 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Span 40 | ??10.0 | ??79 | ??＜30 | ??＜10 | ??+++ |
| Polyoxyethylene stearate 40 esters | ??10.0 | ??90 | ??＜30 | ??＜10 | ??++ |
| Poloxamer | ??10.0 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Sodium lauryl sulphate | ??10.0 | ??82 | ??＜30 | ??＞10 | ??+++ |
| Stearic acid | ??10.0 | ??81 | ??＞30 | ??＞10 | ??+++ |
| Sodium stearate | ??10.0 | ??77 | ??＞30 | ??＞10 | ??+++ |
| Glycerin gelatine | ??10.0 | ??76 | ??＞30 | ??＞10 | ??+++ |
| Lac | ??10.0 | ??75 | ??＞30 | ??＞10 | ??+++ |
The group practices of table 4 Flos lupuli extractum and mixed-matrix
(Flos lupuli extractum: 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 | ??85 | ??＜30 | ??＞10 | ??++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ??50 | ??85 | ??＜30 | ??＞10 | ??++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ??50 | ??83 | ??＜30 | ??＞10 | ??++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ??50 | ??81 | ??＜30 | ??＞10 | ??+ |
The group practices of table 5 Flos lupuli extractum and mixed-matrix
(Flos lupuli extractum: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | ??25 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ??25 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ??25 | ??87 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ??25 | ??85 | ??＜30 | ??＞10 | ??++ |
The group practices of table 6 Flos lupuli extractum and mixed-matrix
(Flos lupuli extractum: 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 | ??89 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ??10 | ??85 | ??＜30 | ??＞10 | ??+++ |
The group practices of table 7 Flos lupuli extractum and mixed-matrix
(Flos lupuli extractum: 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 | ??90 | ??＜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 | ??87 | ??＜30 | ??＜10 | ??++ |
The group practices of table 8 Flos lupuli extractum and mixed-matrix
(Flos lupuli extractum: 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 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ??25 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ??25 | ??88 | ??＜30 | ??＜10 | ??+++ |
The group practices of table 9 Flos lupuli extractum and mixed-matrix
(Flos lupuli extractum: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | ??10 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ??10 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ??10 | ??88 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ??10 | ??88 | ??＜30 | ??＜10 | ??+++ |
The group practices of table 10 Flos lupuli extractum and mixed-matrix
(Flos lupuli extractum: 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 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ??50 | ??87 | ??＜30 | ??＞10 | ??+++ |
The group practices of table 11 Flos lupuli extractum and mixed-matrix
(Flos lupuli extractum: 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 | ??87 | ??＜30 | ??＜10 | ??+++ |
The group practices of table 12 Flos lupuli extractum and mixed-matrix
(Flos lupuli extractum: 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 | ??91 | ??＜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 Flos lupuli extractum 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 Flos lupuli extractum 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 Flos lupuli extractum 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 infantile anorexia, and the pharmaceutical composition pulmonary-toxin-clearing dropping pill of sleep disorder and pulmonary tuberculosis auxiliary treatment is a raw material with the Chinese medicine extract Flos lupuli extractum, 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, Flos lupuli extractum: substrate=1: 1～1: 9.
2. pulmonary-toxin-clearing 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 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 pulmonary-toxin-clearing dropping pill as claimed in claim 1 or 2 is characterized in that: the mixed proportion of described Flos lupuli extractum and substrate is 1: 1～1: 5.
4. the preparation method of a pulmonary-toxin-clearing dropping pill is characterized in that being made of following process:
4.1 raw material: Flos lupuli extractum
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, Flos lupuli extractum: substrate=1: 1～1: 9;
4.4, accurately take by weighing Flos lupuli extractum 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 Flos lupuli extractum 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 Flos lupuli extractum 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 pulmonary-toxin-clearing 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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB200510085277XA CN100542519C (en) | 2005-07-22 | 2005-07-22 | It with the Flos lupuli extractum pulmonary-toxin-clearing dropping pill of raw material and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB200510085277XA CN100542519C (en) | 2005-07-22 | 2005-07-22 | It with the Flos lupuli extractum pulmonary-toxin-clearing dropping pill of raw material and preparation method thereof |
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| Publication Number | Publication Date |
|---|---|
| CN1709468A true CN1709468A (en) | 2005-12-21 |
| CN100542519C CN100542519C (en) | 2009-09-23 |
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| CNB200510085277XA Expired - Fee Related CN100542519C (en) | 2005-07-22 | 2005-07-22 | It with the Flos lupuli extractum pulmonary-toxin-clearing dropping pill of raw material and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104606294A (en) * | 2013-11-04 | 2015-05-13 | 吉林吉春制药股份有限公司 | Medicine used for strengthening stomach and promoting digestion, and calming nerves and increasing urine, and used for adjuvant therapy of poor appetite, instable sleeping, and phthisis |
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2005
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104606294A (en) * | 2013-11-04 | 2015-05-13 | 吉林吉春制药股份有限公司 | Medicine used for strengthening stomach and promoting digestion, and calming nerves and increasing urine, and used for adjuvant therapy of poor appetite, instable sleeping, and phthisis |
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| CN100542519C (en) | 2009-09-23 |
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