CN1682923A - Body strengthening dripping pill for invigorating qi and refreshing and its preparing method - Google Patents
Body strengthening dripping pill for invigorating qi and refreshing and its preparing method Download PDFInfo
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- CN1682923A CN1682923A CN 200510051498 CN200510051498A CN1682923A CN 1682923 A CN1682923 A CN 1682923A CN 200510051498 CN200510051498 CN 200510051498 CN 200510051498 A CN200510051498 A CN 200510051498A CN 1682923 A CN1682923 A CN 1682923A
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Abstract
The present invention relates to a kind of medicine composition, body strengthening dripping pill, for treating weak health, heart palpitation, hard breath, sweating due to debility, hypodynamia and poor appetite, etc. The present invention has high bioavailability, fast medicine release, fast acting, high effective content, taking convenience and low cost. The body strengthening dripping pill is prepared with four kinds of Chinese medicinal materials of ginseng, ophiopogon root, schisandra and astragalus root and medicine carrier as matrix.
Description
Technical field
The present invention relates to a kind of invigorating qi and refreshing that has, strengthening superficial resistance to stop perspiration, the promoting the production of body fluid to quench thirst effect, be used to have a delicate constitution, shortness of breath and palpitation, sweating due to debility is thirsty, spiritlessness and weakness, the pharmaceutical composition of treatment for diseases such as inappetence is a kind of drug composition oral preparation that feedstock production forms to contain 4 flavor Chinese medicine active pharmaceutical ingredient extracts such as Radix Ginseng, Radix Ophiopogonis, the Radix Astragali, Fructus Schisandrae Chinensis particularly.
Background technology
Keep fit oral liquid according to what the preparation method that provides among the drug standard WS3-B-2630-97 promulgated by the ministries or commissions of the Central Government was prepared from, be a kind of invigorating qi and refreshing that has, strengthening superficial resistance to stop perspiration, promoting the production of body fluid to quench thirst effect, be used to have a delicate constitution, shortness of breath and palpitation, sweating due to debility is thirsty, spiritlessness and weakness, the syrups oral formulations of treatment for diseases such as inappetence, 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 in the WS3-B-2630-97 drug standard:
Prescription: Radix Ginseng 30, Radix Ophiopogonis 200, the Radix Astragali 300, Fructus Schisandrae Chinensis 100
Method for making: above four flavors, Radix Ginseng are with 50% alcohol reflux secondary, at every turn 2h, merge extractive liquid, is put coldly, filters, decompression filtrate recycling ethanol, residue and all the other wait three flavors, decoct with water three times, each 1.5h, collecting decoction filters, filtrate is concentrated into about 300ml, put cold, add 2 times the amount ethanol, leave standstill, filter, the liquid of filtering is evaporated to thick paste, adding water dilutes in right amount, filter, filtrate and Radix Ginseng extractive solution merge, cold preservation 24h, filter, it is an amount of to add simple syrup 500ml and antiseptic, makes 1000ml, promptly.
Function cures mainly: invigorating qi and refreshing, strengthening superficial resistance to stop perspiration, promoting the production of body fluid to quench thirst.Be used to have a delicate constitution, shortness of breath and palpitation, sweating due to debility is thirsty, spiritlessness and weakness, inappetence.
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.And the syrups oral formulations also exist medicament contg low, take metering and be difficult to accurately, take or carry shortcomings 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 is that additional having now is used to have a delicate constitution shortness of breath and palpitation, sweating due to debility is thirsty, spiritlessness and weakness, the deficiency of the oral drug preparation of treatment for diseases such as inappetence provides a kind of bioavailability height, and has a quick release, quick produce effects, the medicament contg height is taken accurate measurement, cheap, and portable drug composition oral preparation body strengthening dripping pill.
Body strengthening dripping pill involved in the present invention is a raw material with the extract that contains 4 flavor Chinese medicine active pharmaceutical ingredients such as Radix Ginseng, Radix Ophiopogonis, the Radix Astragali, Fructus Schisandrae Chinensis, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain body strengthening dripping pill involved in the present invention:
[preparation method]
1. raw material: the extract that contains 4 flavor Chinese medicine active pharmaceutical ingredients such as Radix Ginseng, Radix Ophiopogonis, the Radix Astragali, Fructus Schisandrae Chinensis;
2. substrate: Polyethylene Glycol
(1000～20000), one or more the mixture in 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. 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 that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and reaching desired state of temperature, fused solution and/or the emulsion and/or the suspension that will contain drug extract and substrate, place 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.
[appendix: a kind of 4 flavor active ingredient of Chinese herbs preparation method of extract such as Radix Ginseng that contain] is unit with g or kg, according to the weight portion meter, gets 3 parts of Radix Ginsengs, 20 parts of Radix Ophiopogonis, 30 parts of the Radixs Astragali, 10 parts of Fructus Schisandrae Chinensis; More than four flavors, Radix Ginseng was with 50% alcohol reflux 2 times, each 2 hours, merge extractive liquid, is put coldly, filters, decompression filtrate recycling ethanol, residue and all the other 3 flavors decoct with water 3 times, each 1.5 hours, collecting decoction filtered, filtrate and Radix Ginseng extractive solution merge, being decompressed to 0.1Mpa, is 1.3～1.35 thick paste being condensed into relative density below 60 ℃, promptly; Or continue to make drying under the same conditions, be ground into dry powder, promptly.
Beneficial effect
Keep fit oral liquid according to what the preparation method that provides among the drug standard WS3-B-2630-97 promulgated by the ministries or commissions of the Central Government was prepared from, be a kind of invigorating qi and refreshing that has, strengthening superficial resistance to stop perspiration, promoting the production of body fluid to quench thirst effect, be used to have a delicate constitution, shortness of breath and palpitation, sweating due to debility is thirsty, spiritlessness and weakness, the syrups oral formulations of treatment for diseases such as inappetence, 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 in the WS3-B-2630-97 drug standard:
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.And the syrups oral formulations also exist medicament contg low, take metering and be difficult to accurately, take or carry shortcomings 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.
Body strengthening dripping pill involved in the present invention with keep fit oral liquid and compare and have following beneficial effect:
1. body strengthening dripping pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion with the extract that contains 4 flavor Chinese medicine active pharmaceutical ingredients such as Radix Ginseng, Radix Ophiopogonis, the Radix Astragali, Fructus Schisandrae Chinensis; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases; and substrate is hydrophilic; medicine had wetting action; can make medicine molten microgranule or the solution of loosing into rapidly; thereby make the dissolving of medicine and absorb quickening; thereby improved bioavailability, brought into play efficient, quick-acting effects etc.
2. body strengthening dripping 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. body strengthening dripping pill involved in the present invention mixes the extract that contains active constituents of medicine mutually with molten matrix, splashes in the not miscible condensed fluid and makes.Therefore, the stability of drug height, not facile hydrolysis, oxidation, and the operation be under liquid state, to carry out, no dust pollution is not subject to the influence of crystal formation, thereby has guaranteed the quality of medicine, has increased stability.
4. production technology, the equipment of preparation drop pill are simple, easy to operate, the automaticity height, and labor intensity is low, the production efficiency height.Workshop does not have dust simultaneously, helps labor protection and environmental protection yet.
5. the production cost of preparation drop pill is usually with about 50% of other oral formulations of kind, and compares with oral liquid, and the dosage of drop pill is accurate, thereby makes the patient take metering control easily.
The specific embodiment
Now with several groups of specific embodiments, be described further with regard to the preparation method of body strengthening dripping 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 4 flavor active ingredient of Chinese herbs such as Radix Ginseng, Radix Ophiopogonis, the Radix Astragali, Fructus Schisandrae Chinensis earlier according to [appendix];
2. substrate: Polyethylene Glycol
(1000,2000,4000,6000,8000,10000,20000), 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. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the body strengthening dripping pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared body strengthening dripping 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 body strengthening dripping 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 body strengthening dripping 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 15 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: it is standby to make the extract dry powder that contains 4 flavor active ingredient of Chinese herbs such as Radix Ginseng, Radix Ophiopogonis, the Radix Astragali, Fructus Schisandrae Chinensis earlier according to [appendix];
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 body strengthening dripping pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared body strengthening dripping 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 body strengthening dripping 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 body strengthening dripping 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 body strengthening dripping 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 body strengthening dripping 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 body strengthening dripping 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 body strengthening dripping 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 body strengthening dripping 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 body strengthening dripping 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 | ??59 | ??＜30 | ＞10 | ??+ |
| Polyethylene Glycol 2000 | ??50.0 | ??68 | ??＜30 | ＞10 | ??+ |
| Polyethylene Glycol 4000 | ??50.0 | ??76 | ??＜30 | ＞10 | ??+ |
| Polyethylene Glycol 6000 | ??50.0 | ??84 | ??＜30 | ＞10 | ??++ |
| Polyethylene Glycol 8000 | ??50.0 | ??83 | ??＜30 | ＞10 | ??++ |
| Polyethylene Glycol 10000 | ??50.0 | ??85 | ??＜30 | ＞10 | ??++ |
| Polyethylene Glycol 20000 | ??50.0 | ??84 | ??＜30 | ＞10 | ??++ |
| Polyoxyethylene stearate 40 esters | ??50.0 | ??78 | ??＜30 | ＞10 | ??++ |
| Betacyclodextrin | ??50.0 | ??73 | ??＜30 | ＞10 | ??+ |
| Poloxamer | ??50.0 | ??78 | ??＜30 | ＞10 | ??++ |
| Carboxymethyl starch sodium | ??50.0 | ??72 | ??＜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 | ??53 | ??＞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 | ??68 | ??＜30 | ??＞10 | ??++ |
| Polyethylene Glycol 2000 | ??25.0 | ??78 | ??＜30 | ??＞10 | ??++ |
| Polyethylene Glycol 4000 | ??25.0 | ??87 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 6000 | ??25.0 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 8000 | ??25.0 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 10000 | ??25.0 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 20000 | ??25.0 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Polyoxyethylene stearate 40 esters | ??25.0 | ??93 | ??＜30 | ??＜10 | ??++ |
| Betacyclodextrin | ??25.0 | ??85 | ??＜30 | ??＞10 | ??++ |
| Poloxamer | ??25.0 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium | ??25.0 | ??87 | ??＜30 | ??＜10 | ??+++ |
| Sodium lauryl sulphate | ??25.0 | ??76 | ??＜30 | ??＞10 | ??++ |
| Stearic acid | ??25.0 | ??70 | ??＞30 | ??＞10 | ??+++ |
| Sodium stearate | ??25.0 | ??71 | ??＞30 | ??＞10 | ??+++ |
| Glycerin gelatine | ??25.0 | ??68 | ??＞30 | ??＞10 | ??+++ |
| Lac | ??25.0 | ??67 | ??＞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 | 75 | ??＜30 | ??＞10 | ??++ |
| Polyethylene Glycol 2000 | ??10.0 | 84 | ??＜30 | ??＞10 | ??++ |
| Polyethylene Glycol 4000 | ??10.0 | 88 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 6000 | ??10.0 | 93 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 8000 | ??10.0 | 93 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 10000 | ??10.0 | 93 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 20000 | ??10.0 | 93 | ??＜30 | ??＜10 | ??+++ |
| Polyoxyethylene stearate 40 esters | ??10.0 | 90 | ??＜30 | ??＜10 | ??++ |
| Betacyclodextrin | ??10.0 | 88 | ??＜30 | ??＜10 | ??++ |
| Poloxamer | ??10.0 | 92 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium | ??10.0 | 84 | ??＜30 | ??＞10 | ??+++ |
| Sodium lauryl sulphate | ??10.0 | 84 | ??＜30 | ??＞10 | ??+++ |
| Stearic acid | ??10.0 | 80 | ??＞30 | ??＞10 | ??+++ |
| Sodium stearate | ??10.0 | 76 | ??＞30 | ??＞10 | ??+++ |
| Glycerin gelatine | ??10.0 | 75 | ??＞30 | ??＞10 | ??+++ |
| Lac | ??10.0 | 75 | ??＞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 | ??84 | ??＜30 | ??＞10 | ??++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ??50 | ??82 | ??＜30 | ??＞10 | ??++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ??50 | ??79 | ??＜30 | ??＞10 | ??++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ??50 | ??73 | ??＜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 | ??89 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ??25 | ??88 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ??25 | ??83 | ??＜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 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ??10 | ??89 | ??＜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 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ??50 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ??50 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ??50 | ??87 | ??＜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 | ??94 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ??25 | ??92 | ??＜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 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ??10 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ??10 | ??92 | ??＜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 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ??50 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ??50 | ??88 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ??50 | ??85 | ??＜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 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ??25 | ??92 | ??＜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 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 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ??10 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ??10 | ??92 | ??＜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 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 (6)
1. one kind is used to have a delicate constitution, shortness of breath and palpitation, sweating due to debility is thirsty, spiritlessness and weakness, the pharmaceutical composition body strengthening dripping pill of treatment for diseases such as inappetence, with the extract that contains Radix Ginseng, Radix Ophiopogonis, the Radix Astragali, Fructus Schisandrae Chinensis etc. 4 flavor Chinese medicine active pharmaceutical ingredients is raw material, be prepared from pharmaceutically suitable carrier as substrate, wherein:
1.1 substrate: Polyethylene Glycol
(1000～20000), polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac, above-mentioned carrier one or more mixture wherein;
1.2 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9.
2. body strengthening dripping pill as claimed in claim 1, it is characterized in that the described extract that contains 4 flavor Chinese medicine active pharmaceutical ingredients such as Radix Ginseng, Radix Ophiopogonis, the Radix Astragali, Fructus Schisandrae Chinensis is made by following method: with g or kg is unit, according to the weight portion meter, get 3 parts of Radix Ginsengs, 20 parts of Radix Ophiopogonis, 30 parts of the Radixs Astragali, 10 parts of Fructus Schisandrae Chinensis; More than four flavors, Radix Ginseng was with 50% alcohol reflux 2 times, each 2 hours, merge extractive liquid, is put coldly, filters, decompression filtrate recycling ethanol, residue and all the other 3 flavors decoct with water 3 times, each 1.5 hours, collecting decoction filtered, filtrate and Radix Ginseng extractive solution merge, and are decompressed to 0.1Mpa, are 1.3～1.35 thick paste being condensed into relative density below 60 ℃, or continue to make drying under the same conditions, be ground into dry powder promptly.
3. body strengthening dripping pill as claimed in claim 1 is characterized in that: described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or Polyethylene Glycol and poloxamer or Polyethylene Glycol and carboxymethyl starch sodium or Polyethylene Glycol and betacyclodextrin; With g or kg is unit, and by weight, its mixed proportion is polyoxyethylene stearate 40 esters: Polyethylene Glycol or poloxamer: Polyethylene Glycol or carboxymethyl starch sodium: Polyethylene Glycol or betacyclodextrin: Polyethylene Glycol=1: 1～1: 10.
4. as claim 1 or 3 described any body strengthening dripping pills, it is characterized in that: the mixed proportion of described drug extract and substrate is 1: 1～1: 5.
5. the preparation method of a body strengthening dripping pill is characterized in that being made of following process:
5.1 raw material: the extract that contains 4 flavor Chinese medicine active pharmaceutical ingredients such as Radix Ginseng, Radix Ophiopogonis, the Radix Astragali, Fructus Schisandrae Chinensis;
5.2 substrate: Polyethylene Glycol
(1000～20000), 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;
5.3 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
5.4, accurately take by weighing drug extract 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 drug extract and substrate and/or emulsion and/or suspension;
5.5 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 ℃;
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, fused solution and/or the emulsion and/or the suspension that will contain drug extract and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent and shrink molding promptly.
6. as the preparation method of body strengthening dripping pill as described in the claim 5, 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 |
|---|---|---|---|
| CN 200510051498 CN1682923A (en) | 2005-03-08 | 2005-03-08 | Body strengthening dripping pill for invigorating qi and refreshing and its preparing method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510051498 CN1682923A (en) | 2005-03-08 | 2005-03-08 | Body strengthening dripping pill for invigorating qi and refreshing and its preparing method |
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|---|---|
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|---|---|---|---|
| CN 200510051498 Pending CN1682923A (en) | 2005-03-08 | 2005-03-08 | Body strengthening dripping pill for invigorating qi and refreshing and its preparing method |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1313133C (en) * | 2006-03-02 | 2007-05-02 | 浙江新光药业有限公司 | Medicine composition for treating coronary heart disease and its prepn process |
| CN1313132C (en) * | 2006-03-02 | 2007-05-02 | 浙江新光药业有限公司 | Medicine composition for treating coronary heart disease and its prepn process |
| CN102258679A (en) * | 2011-07-08 | 2011-11-30 | 史国兵 | Traditional Chinese medicine composition and preparation method and application thereof |
| CN107753733A (en) * | 2017-10-27 | 2018-03-06 | 南京多宝生物科技有限公司 | A kind of capsule for building up body for improving immunity and preparation method thereof |
-
2005
- 2005-03-08 CN CN 200510051498 patent/CN1682923A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1313133C (en) * | 2006-03-02 | 2007-05-02 | 浙江新光药业有限公司 | Medicine composition for treating coronary heart disease and its prepn process |
| CN1313132C (en) * | 2006-03-02 | 2007-05-02 | 浙江新光药业有限公司 | Medicine composition for treating coronary heart disease and its prepn process |
| CN102258679A (en) * | 2011-07-08 | 2011-11-30 | 史国兵 | Traditional Chinese medicine composition and preparation method and application thereof |
| CN102258679B (en) * | 2011-07-08 | 2013-08-28 | 史国兵 | Traditional Chinese medicine composition and preparation method and application thereof |
| CN107753733A (en) * | 2017-10-27 | 2018-03-06 | 南京多宝生物科技有限公司 | A kind of capsule for building up body for improving immunity and preparation method thereof |
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