CN1315461C - Jaundice capillaris drip pill and its preparation method - Google Patents
Jaundice capillaris drip pill and its preparation method Download PDFInfo
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- CN1315461C CN1315461C CNB2005100633541A CN200510063354A CN1315461C CN 1315461 C CN1315461 C CN 1315461C CN B2005100633541 A CNB2005100633541 A CN B2005100633541A CN 200510063354 A CN200510063354 A CN 200510063354A CN 1315461 C CN1315461 C CN 1315461C
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Abstract
The present invention relates to a medicine composition which has the functions of clearing heat, promoting the function of gallbladder and treating jaundice and is used for curing the disease symptoms of acute icteric infectious hepatitis, chronic icteric infectious hepatitis, hepatochlic hygropyrexia symptoms, etc. The present invention aims to overcome the deficiencies of the existing oral medicine preparation for treating the disease symptoms and provides an icterus oriental wormwood drop pill which has the advantages of high biological utilization degree, rapid release of the medicine, rapid effect, small toxic and side effect, high content of the medicine, accurate dosage for taking, convenient use, low cost and no pollution during production. The icterus oriental wormwood drop pill of the present invention takes the traditional Chinese medicines of oriental wormwood, scutellaria, rhubarb, liquorice roots, etc. as raw materials, and the icterus oriental wormwood drop pill is formed by the preparation of a medicinal carrier used as a substrate and the raw materials together.
Description
Technical field
The present invention relates to a kind of clearing heat secreting bile that has, the effect of jaundice eliminating subcutaneous ulcer, be used for acute and chronic icteric infectious hepatitis, and the pharmaceutical composition that belongs to treatment for diseases such as syndrome of dampness-heat of liver and gallbladder, be a kind of drug composition oral preparation that feedstock production forms particularly to contain 4 flavor Chinese medicine active pharmaceutical ingredient extracts such as Herba Artemisiae Scopariae, Radix Scutellariae, Radix Et Rhizoma Rhei, Radix Glycyrrhizae.
Background technology
The jaundice capillaris granule that is prepared from according to the prescription that provides among the national drug standards WS-10442 (ZD-0442)-2002 and extraction process, it is a kind of clearing heat secreting bile that has, the effect of jaundice eliminating subcutaneous ulcer, be used for acute and chronic icteric infectious hepatitis, and the particulate species preparation that belongs to treatment for diseases such as syndrome of dampness-heat of liver and gallbladder, through clinical verification for many years, steady quality, determined curative effect is the common drug preparation that clinical and family is used for the treatment of above-mentioned disease.
Below be particulate prescription of jaundice capillaris and the extraction process that provides among the drug standard WS-10442 (ZD-0442)-2002:
Prescription: Herba Artemisiae Scopariae 699g, Radix Scutellariae 396g, Radix Et Rhizoma Rhei (system) 263.2g, Radix Glycyrrhizae 67.4g, sucrose 632g, dextrin 269g.
Method for making: above four Chinese medicine material, Herba Artemisiae Scopariae extract volatile oil, add behind the ethanol dilution standby; Three flavor medical materials such as medicinal residues and all the other Radix Scutellariaes decoct with water secondary, each 1 hour, collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.18 (80 ℃), put coldly, add equivalent ethanol, stir, left standstill 24 hours, and got the clear paste that supernatant concentration to relative density is 1.20 (80 ℃), with sucrose, dextrin, mixing, make granule, drying sprays into the alcoholic solution of above-mentioned volatile oil, mixing, promptly.Be explained as follows in the appended jaundice capillaris granule description:
Nomenclature of drug: jaundice capillaris granule:
Main component: Herba Artemisiae Scopariae, Radix Scutellariae, Radix Et Rhizoma Rhei (system), Radix Glycyrrhizae;
Character: be xanchromatic granule; Feeble QI perfume (or spice), it is sweet to distinguish the flavor of.
Function cures mainly: tool clearing heat secreting bile, jaundice eliminating subcutaneous ulcer.Be used for acute and chronic icteric infectious hepatitis.Belong to syndrome of dampness-heat of liver and gallbladder;
Usage: boiled water is taken after mixing it with water.
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.It is low that granule also exists medicament contg, measures inaccurately, takes defectives such as inconvenience.In addition, conventional peroral dosage form as tablet, capsule etc., because the technology of granulation is arranged, therefore can produce bigger dust pollution in preparation process, can staff's health be worked the mischief to a certain extent, also can cause certain pollution to environment simultaneously.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 acute and chronic icteric infectious hepatitis that is used for, and the deficiency that belongs to the oral drug preparation of syndrome of dampness-heat of liver and gallbladder, a kind of bioavailability height is provided, release fast, quick produce effects, toxic and side effects is little, and the medicament contg height, taking dose is accurate, taking convenience, cheap, and free of contamination aborning jaundice capillaris drip pill.Jaundice capillaris drip pill involved in the present invention is a raw material with Chinese medicines such as Herba Artemisiae Scopariae, Radix Scutellariae, Radix Et Rhizoma Rhei, Radix Glycyrrhizaes, is prepared from the pharmaceutically suitable carrier as substrate.Be prepared by the following technical solutions, can obtain jaundice capillaris drip pill involved in the present invention:
[preparation method]
1. raw material---contain the extract of 4 flavor Chinese medicine active pharmaceutical ingredients such as Herba Artemisiae Scopariae, Radix Scutellariae, Radix Et Rhizoma Rhei (system), Radix Glycyrrhizae;
2. substrate---one or more the mixture in pharmaceutically suitable carrier such as Polyethylene Glycol (1000～20000), 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 drug 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 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 drug extract and substrate, the adding Herba Artemisiae Scopariae volatile oil fully mixes to be made evenly, be placed in the water dropper jar of drop pill machine, splash in the condensing agent;
Condensing agent can be in liquid paraffin, methyl-silicone oil, vegetable oil, the water any one or multiple;
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.
[appendix: contain Herba Artemisiae Scopariae, Radix Scutellariae, Radix Et Rhizoma Rhei, Radix Glycyrrhizae active pharmaceutical ingredient preparation method of extract] gets Herba Artemisiae Scopariae 699g, Radix Scutellariae 396g, Radix Et Rhizoma Rhei (system) 263.2g, Radix Glycyrrhizae 67.4g, above four Chinese medicine material, and Herba Artemisiae Scopariae is extracted volatile oil, and is standby; Three flavor medical materials such as medicinal residues and all the other Radix Scutellariaes, decoct with water secondary, each 1 hour, collecting decoction, filter, filtrate is 1.15～1.20 clear paste in being concentrated into relative density below 80 ℃, puts coldly, adds equivalent ethanol, stir, left standstill 24 hours, getting supernatant is 1.20 clear paste in being concentrated into relative density below 80 ℃, mixing; Perhaps continue to be ground into dry powder, promptly dry below 80 ℃.
What provide above is a kind of common Herba Artemisiae Scopariae, Radix Scutellariae, Radix Et Rhizoma Rhei (system), Radix Glycyrrhizae active pharmaceutical ingredient preparation method of extract of containing, and under the same or analogous prerequisite of main active pharmaceutical ingredient of extract, is not limited to this a kind of method.
Beneficial effect
The jaundice capillaris granule that is prepared from according to the prescription that provides among the national drug standards WS-10442 (ZD-0442)-2002 and extraction process, it is a kind of clearing heat secreting bile that has, the effect of jaundice eliminating subcutaneous ulcer, be used for acute and chronic icteric infectious hepatitis, and the particulate species preparation that belongs to treatment for diseases such as syndrome of dampness-heat of liver and gallbladder, through clinical verification for many years, steady quality, determined curative effect is the common drug preparation 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.It is low that granule also exists medicament contg, measures inaccurately, takes defectives such as inconvenience.In addition, conventional peroral dosage form as tablet, capsule etc., because the technology of granulation is arranged, therefore can produce bigger dust pollution in preparation process, can staff's health be worked the mischief to a certain extent, also can cause certain pollution to environment simultaneously.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.
Jaundice capillaris drip pill involved in the present invention is compared with the jaundice capillaris granule, has following beneficial effect:
1. jaundice capillaris drip pill involved in the present invention; utilize surfactant etc. to be substrate; make solid dispersion with containing 4 flavor Chinese medicine active pharmaceutical ingredient extracts such as Herba Artemisiae Scopariae, Radix Scutellariae, Radix Et Rhizoma Rhei, Radix Glycyrrhizae; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases; 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. jaundice capillaris drip pill involved in the present invention contacts promptly with saliva and to dissolve rapidly, and is absorbed by oral mucosa, and is not only rapid-action, and the influence of not taken food, and promptly all can containing take after meal ante cibum, and local application's onset is faster.This has not only kept particulate advantage on the one hand, has more than granule again to be easy to absorb the bioavailability height.Can not produce any residual harmful substance yet, thereby make that patient's medication is safer, also have medication convenience, characteristic of accurate simultaneously at gastric.
3. jaundice capillaris 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 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 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 jaundice capillaris drip pill of the present invention.
First group: the test of single-matrix
1. raw material: make the dry powder that contains 4 flavor Chinese medicine active pharmaceutical ingredients such as Herba Artemisiae Scopariae, Radix Scutellariae, Radix Et Rhizoma Rhei, Radix Glycyrrhizae in advance according to [appendix], standby;
2. substrate: Polyethylene Glycol
(1000～20000), pharmaceutically suitable carrier such as 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. be prepared according to the process of [preparation method] 4～7 again, promptly can make the jaundice capillaris drip pill of all size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared jaundice capillaris drip pill in qualitative difference, according to 1: 1 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, 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 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning prepared jaundice capillaris drip pill in qualitative difference, according to 1: 3 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, 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 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared jaundice capillaris drip pill in qualitative difference, according to 1: 9 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, 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 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. raw material: make the dry powder that contains 4 flavor Chinese medicine active pharmaceutical ingredients such as Herba Artemisiae Scopariae, Radix Scutellariae, Radix Et Rhizoma Rhei, Radix Glycyrrhizae in advance according to [appendix], 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 one 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. (with g or kg is unit to proportioning, by weight)
3.1 the ratio of composite interstitial substance---polyoxyethylene stearate 40 esters: Polyethylene Glycol or poloxamer: Polyethylene Glycol or carboxymethyl starch sodium: Polyethylene Glycol or betacyclodextrin: Polyethylene Glycol=1: 1～1: 10,
3.2 hybrid medicine extract: mixed-matrix weight and=1: 1～1: 9.
[result of the test]
Test 4: for observe drug extract and mixed-matrix when 1: 1 the proportioning prepared jaundice capillaris drip pill in qualitative difference, 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 drug extract is mixed mutually with 4 kinds of different mixed-matrixes 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 experimental results and see Table 4.
Test 5: for observe drug extract and mixed-matrix when 1: 3 the proportioning prepared jaundice capillaris drip pill in qualitative difference, 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 drug extract is mixed mutually with 4 kinds of different mixed-matrixes 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 experimental results and see Table 5.
Test 6: for observe drug extract and mixed-matrix when 1: 9 the proportioning prepared jaundice capillaris drip pill in qualitative difference, 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 drug extract is mixed mutually with 4 kinds of different mixed-matrixes 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 experimental results and see Table 6.
Test 7: for observe drug extract and mixed-matrix when 1: 1 the proportioning prepared jaundice capillaris drip pill in qualitative difference, 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 drug extract is mixed mutually with 4 kinds of different mixed-matrixes 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 experimental results and see Table 7.
Test 8: for observe drug extract and mixed-matrix when 1: 3 the proportioning prepared jaundice capillaris drip pill in qualitative difference, 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 drug extract is mixed mutually with 4 kinds of different mixed-matrixes 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 experimental results and see Table 8.
Test 9: for observe drug extract and mixed-matrix when 1: 9 the proportioning prepared jaundice capillaris drip pill in qualitative difference, 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 drug extract is mixed mutually with 4 kinds of different mixed-matrixes 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 experimental results and see Table 9.
Test 10: in order to observe jaundice capillaris drip pill that drug extract and mixed-matrix make when 1: 1 the proportioning in qualitative difference, 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 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 experimental results and see Table 10.
Test 11: in order to observe jaundice capillaris drip pill that drug extract and mixed-matrix make when 1: 3 the proportioning in qualitative difference, 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 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 experimental results and see Table 11.
Test 12: in order to observe jaundice capillaris drip pill that drug extract and mixed-matrix make when 1: 9 the proportioning in qualitative difference, 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 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 experimental results and see 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 | 75 | ＜30 | ＞10 | + |
| Polyethylene Glycol 2000 | 50.0 | 87 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 50.0 | 76 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 6000 | 50.0 | 79 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 8000 | 50.0 | 79 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 10000 | 50.0 | 80 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 80 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 78 | ＜30 | ＞10 | ++ |
| Betacyclodextrin | 50.0 | 72 | ＜30 | ＞10. | + |
| Poloxamer | 50.0 | 79 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium | 50.0 | 73 | ＜30 | ＞10 | + |
| Sodium lauryl sulphate | 50.0 | 68 | ＞30 | ＞10 | ++ |
| Stearic acid | 50.0 | 55 | ＞30 | ＞10 | +++ |
| Sodium stearate | 50.0 | 54 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 50.0 | 55 | ＞30 | ＞10 | +++ |
| Lac | 50.0 | 52 | ＞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 | 63 | ＜30 | ＞10 | + |
| Polyethylene Glycol 2000 | 25.0 | 79 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 25.0 | 86 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 6000 | 25.0 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 25.0 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 91 | ＜30 | ＜10 | ++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 92 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 25.0 | 82 | ＜30 | ＞10 | ++ |
| Poloxamer | 25.0 | 89 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 25.0 | 80 | ＜30 | ＞10 | ++ |
| Sodium lauryl sulphate | 25.0 | 77 | ＜30 | ＞10 | ++ |
| Stearic acid | 25.0 | 73 | ＞30 | ＞10 | +++ |
| Sodium stearate | 25.0 | 72 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 25.0 | 71 | ＞30 | ＞10 | +++ |
| Lac | 25.0 | 72 | ＞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 | 77 | ＜30 | ＞10 | + |
| Polyethylene Glycol 2000 | 10.0 | 83 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 10.0 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 10.0 | 94 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 93 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 10.0 | 88 | ＜30 | ＜10 | ++ |
| Poloxamer | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 10.0 | 86 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 10.0 | 83 | ＜30 | ＞10 | +++ |
| Stearic acid | 10.0 | 76 | ＞30 | ＞10 | +++ |
| Sodium stearate | 10.0 | 77 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 10.0 | 74 | ＞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 | 85 | ＜30 | ＜10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 50 | 86 | ＜30 | ＜10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50 | 81 | ＜30 | ＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 50 | 78 | ＜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 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 25 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 25 | 86 | ＜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 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 10 | 92 | ＜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 | 94 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 50 | 94 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 50 | 83 | ＜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 | 94 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 25 | 95 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 92 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 25 | 89 | ＜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 | 95 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 10 | 94 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 10 | 91 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 10 | 88 | ＜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 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 50 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 50 | 82 | ＜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 | 94 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 25 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 25 | 87 | ＜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 | 94 | ＜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 | 90 | ＜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 only comparatively desirable, 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, though the rounding rate, the ball method of double differences is different and index such as hardness has raising, and is 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 jaundice capillaris drip pill that is used for the treatment of icterohepatitis is a raw material with Herba Artemisiae Scopariae, Radix Scutellariae, Radix et Rhizoma Rhei (processed), Radix Glycyrrhizae, be prepared from pharmaceutically suitable carrier as substrate, wherein:
(1) get Herba Artemisiae Scopariae 699g, Radix Scutellariae 396g, Radix Et Rhizoma Rhei (system) 263.2g, Radix Glycyrrhizae 67.4g, above four Chinese medicine material, Herba Artemisiae Scopariae is extracted volatile oil, and is standby; Three flavor medical materials such as medicinal residues and all the other Radix Scutellariaes, decoct with water secondary, each 1 hour, collecting decoction, filter, filtrate is 1.15～1.20 clear paste in being concentrated into relative density below 80 ℃, puts coldly, adds equivalent ethanol, stir, left standstill 24 hours, getting supernatant is 1.20 clear paste in being concentrated into relative density below 80 ℃, mixing; Perhaps continue to be ground into dry powder, promptly get the extract that contains pharmaceutically active ingredient in described four flavors dry below 80 ℃, standby;
(2) described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or carboxymethyl starch sodium, in weight portion, the mixed proportion of polyoxyethylene stearate 40 esters or carboxymethyl starch sodium and Polyethylene Glycol is 1: 1～1: 10, describedly contains that the extract of pharmaceutically active ingredient and the ratio of substrate are 1: 3 in four flavors;
(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 remains on 50 ℃～90 ℃, and the condensing agent cooling also remains on-5 ℃～40 ℃;
When (5) temperature for the treatment of dropping-pill machine head and condensing agent reaches described state respectively, will contain the fused solution of described extract and substrate and/or emulsion and/or suspension and place in the water dropper jar of drop pill machine, and splash into to shrink in the condensing agent and be shaped promptly.
2. jaundice capillaris 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.
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| CNB2005100633541A CN1315461C (en) | 2005-04-08 | 2005-04-08 | Jaundice capillaris drip pill and its preparation method |
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| CN112826850A (en) * | 2021-03-08 | 2021-05-25 | 中泓鑫海盐城生物技术有限公司 | Chinese herbal medicine preparation for preventing and treating hepatopancreas lesion of prawn in liver-turning period and application and preparation method thereof |
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Non-Patent Citations (3)
| Title |
|---|
| 中药药剂学，"滴丸" 范碧亭主编，380.383，上海科学技术出版社 1997 * |
| 国家药品监督管理局国家中成药标准汇编 中成药地方标准上升国家标准部分肝胆分册 国家药品监督管理局，211.212，国家药品监督管理局 2002 * |
| 国家药品监督管理局国家中成药标准汇编 中成药地方标准上升国家标准部分肝胆分册 国家药品监督管理局，211.212，国家药品监督管理局 2002;中药药剂学，"滴丸" 范碧亭主编，380.383，上海科学技术出版社 1997 * |
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