CN1682804A - Oral administration dripping pill for nourishing heart to calm mind and its preparing method - Google Patents
Oral administration dripping pill for nourishing heart to calm mind and its preparing method Download PDFInfo
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- CN1682804A CN1682804A CNA2005100074203A CN200510007420A CN1682804A CN 1682804 A CN1682804 A CN 1682804A CN A2005100074203 A CNA2005100074203 A CN A2005100074203A CN 200510007420 A CN200510007420 A CN 200510007420A CN 1682804 A CN1682804 A CN 1682804A
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Abstract
The orally taken dripping pill has the functions of benefiting vital energy, consolidating superficial resistance, nourishing heart, tranquilizing, invigorating spleen, regulating the function of the stomach, and is used in treating heart and spleen deficiency, poor appetite, lacking in strength, insomnia, etc. The orally taken dripping pill is prepared with astragalus root, ginseng, fragrant solomonseal rhizome and royal jelly as main material as well as matrix carrier, and has high bioavailability, fast acting, high effective content, taking convenience and low cost.
Description
Technical field
The present invention relates to a kind of benefiting QI for strengthening the superficies that has, tranquilizing by nourishing the heart, the invigorating the spleen and regulating the stomach effect, it is all empty to be used for the treatment of heart spleen, and diet is thought less, the abdominal distention abdominal distention, weak breath is weak, nervous cardiopalmus, tired mind, the pharmaceutical composition of diseases such as insomnia is a kind of drug composition oral preparation that feedstock production forms with 4 flavor Chinese medicines such as the Radix Astragali, Radix Ginseng, Rhizoma Polygonati Odorati, Lac regis apis particularly.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The rehabilitation spring oral liquid that the preparation method that provides among-the B-3987-98 is prepared from, it is a kind of benefiting QI for strengthening the superficies that has, tranquilizing by nourishing the heart, the invigorating the spleen and regulating the stomach effect, it is all empty to be used for heart spleen, diet is thought less, the abdominal distention abdominal distention, weak breath is weak, nervous cardiopalmus, tired mind, the syrups oral formulations of disease treatments such as insomnia.This product to coronary heart disease cause uncomfortable in chest pained, the hyperhidrosis of breathing hard, the left ventricle contractile function goes down, and to hyperlipemia, the Glutamate pyruvate transaminase rises that acute and chronic active hepatitis causes all has the auxiliary treatment effect, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.Below be drug standard WS
3Prescription that provides among-the B-3987-98 and technology and brief description:
Prescription: Radix Astragali 200g, Radix Ginseng 7.5g, Rhizoma Polygonati Odorati 10g, Lac regis apis 25g
Method for making: above four flavors, the Radix Astragali, Radix Ginseng, Rhizoma Polygonati Odorati are given as one thinks fit cataclasm, add water logging after 2 hours, decoct three times, each 1～1.5 hour, collecting decoction filtered, filtrate decompression is concentrated into 2 times of amounts of medical material, adds ethanol and makes and contain the alcohol amount and reach 70%, fully stirs, cold preservation 24 hours filters, and filtrate recycling ethanol is to there not being the alcohol flavor, add Lac regis apis diluent and correctives, antiseptic is an amount of, regulates pH value to 3.5～5.0, add water and adjust total amount to 1000ml, filter, embedding, promptly.
Function cures mainly: benefiting QI for strengthening the superficies, tranquilizing by nourishing the heart, invigorating the spleen and regulating the stomach.It is all empty to be used for heart spleen, and diet is thought less, the abdominal distention abdominal distention, and weak breath is weak, nervous cardiopalmus, tired mind, insomnia.This product to coronary heart disease cause uncomfortable in chest pained, the hyperhidrosis of breathing hard, the left ventricle contractile function goes down, and to hyperlipemia, the Glutamate pyruvate transaminase rises that acute and chronic active hepatitis causes all has the auxiliary treatment effect.
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 to replenish the existing all void of heart spleen that is used for the treatment of, and diet is thought less, the abdominal distention abdominal distention, weak breath is weak, nervous cardiopalmus, tired mind, the deficiency of the oral drug preparation of diseases such as insomnia 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 rehabilitation spring drop pill.
Rehabilitation spring drop pill involved in the present invention is a raw material with 4 flavor Chinese medicines such as the Radix Astragali, Radix Ginseng, Rhizoma Polygonati Odorati, Lac regis apis, after extraction obtains containing the extract of pharmaceutically active ingredient in above 4 flavors, is prepared from the pharmaceutically suitable carrier as substrate again.Be prepared by the following technical solutions, can obtain rehabilitation spring drop pill involved in the present invention:
[preparation method]
1. active pharmaceutical ingredient: the extract that contains pharmaceutically active ingredient in 4 flavors such as the Radix Astragali, Radix Ginseng, Rhizoma Polygonati Odorati, Lac regis apis;
2. substrate: Polyethylene Glycol
(2000～20000), 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 preparation method of drug extract] is unit with g, get Radix Astragali 200g, Radix Ginseng 7.5g, Rhizoma Polygonati Odorati 10g, Lac regis apis 25g, more than four the flavor, with the Radix Astragali, Radix Ginseng, Rhizoma Polygonati Odorati is given as one thinks fit cataclasm, adds water logging after 2 hours, decoct three times, each 1～1.5 hour, collecting decoction filtered, filtrate decompression is concentrated into 2 times of amounts of medical material, add ethanol and make and contain the alcohol amount and reach 70%, fully stir cold preservation 24 hours, filter, filtrate recycling ethanol adds Lac regis apis to there not being the alcohol flavor, decompression (0.1MPa), be condensed into relative density under low temperature (60 ℃) condition and be 1.3～1.35 thick paste, perhaps continue to make drying, be ground into dry powder, promptly.
Beneficial effect
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The rehabilitation spring oral liquid that the preparation method that provides among-the B-3987-98 is prepared from, it is a kind of benefiting QI for strengthening the superficies that has, tranquilizing by nourishing the heart, the invigorating the spleen and regulating the stomach effect, it is all empty to be used for heart spleen, diet is thought less, the abdominal distention abdominal distention, weak breath is weak, nervous cardiopalmus, tired mind, the syrups oral formulations of disease treatments such as insomnia.This product to coronary heart disease cause uncomfortable in chest pained, the hyperhidrosis of breathing hard, the left ventricle contractile function goes down, and to hyperlipemia, the Glutamate pyruvate transaminase rises that acute and chronic active hepatitis causes all has the auxiliary treatment effect, 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.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.
Rehabilitation spring drop pill involved in the present invention is compared with rehabilitation spring oral liquid has following beneficial effect:
1. rehabilitation spring drop pill involved in the present invention; utilize surfactant to be substrate; the extract of pharmaceutically active ingredient is made solid dispersion in containing 4 flavors such as the Radix Astragali, Radix Ginseng, Rhizoma Polygonati Odorati, Lac regis apis; 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. rehabilitation spring drop 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. rehabilitation spring drop 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 product type, 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, the preparation method of drop pill is described further with regard to the rehabilitation of the present invention spring.
First group: the test of single-matrix
1. the preparation of drug extract: be prepared according to [appendix: a kind of preparation method of drug extract], the extract dry powder that obtains containing pharmaceutically active ingredient in 4 flavors such as the Radix Astragali, Radix Ginseng, Rhizoma Polygonati Odorati, Royal Jelly is standby;
2. substrate: Polyethylene Glycol
(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 etc.;
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 rehabilitation spring drop pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared rehabilitation spring drop pill in qualitative difference, according to 1: 1 ratio, with drug extract respectively with 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, adopt homemade drop pill machine, 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 15 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning prepared rehabilitation spring drop pill in qualitative difference, according to 1: 3 ratio, with drug extract respectively with 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, adopt homemade drop pill machine, 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 15 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared rehabilitation spring drop pill in qualitative difference, according to 1: 9 ratio, with drug extract respectively with 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, adopt homemade drop pill machine, 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 15 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. the preparation of drug extract: be prepared according to [appendix: a kind of preparation method of drug extract], the extract dry powder that obtains containing pharmaceutically active ingredient in 4 flavors such as the Radix Astragali, Radix Ginseng, Rhizoma Polygonati Odorati, Lac regis apis is standby;
2. substrate:
2.1 Polyethylene Glycol---English name Macrogol,
2.2 polyoxyethylene stearate 40 esters---English name Polyoxyl (40) Stearate, molecular formula is with C
17H
35COO (CH
2CH
2O)
nH represents that n is about 40,
2.3 poloxamer---English name Poloxamer, polyoxyethylene poly-oxygen propylene aether, molecular formula HO (C
2H
4O)
a(C
3H
6O)
b(C
2H
4O)
cH,
The sodium salt of the starch carboxymethyl ester that 2.4 carboxymethyl starch sodium---English name Carboxymethylstach Sodium, starch generates with the monoxone effect under alkali condition,
2.5 betacyclodextrin---English name Betacyclodextrin, molecular formula C
6H
10O
5, this product is that ring dextrin glucosyl transferase acts on 7 glucoses that starch generates with α-1, the bonded cyclic oligosaccharide of 4-glycosidic bond;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the rehabilitation spring drop pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared rehabilitation spring drop 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, adopt homemade drop pill machine, 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: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared rehabilitation spring drop 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, adopt homemade drop pill machine, 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: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared rehabilitation spring drop 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, adopt homemade drop pill machine, 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: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared rehabilitation spring drop 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, adopt homemade drop pill machine, 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: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared rehabilitation spring drop 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, adopt homemade drop pill machine, 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: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared rehabilitation spring drop 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, adopt homemade drop pill machine, 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 the mass discrepancy of drug extract and mixed-matrix obtained rehabilitation spring drop pill when 1: 1 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, adopt homemade drop pill machine, 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 the mass discrepancy of drug extract and mixed-matrix obtained rehabilitation spring drop pill when 1: 3 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, adopt homemade drop pill machine, 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 the mass discrepancy of drug extract and mixed-matrix obtained rehabilitation spring drop pill when 1: 9 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, adopt homemade drop pill machine, 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 2000 | ????50.0 | ????64 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 4000 | ????50.0 | ????76 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 6000 | ????50.0 | ????80 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 8000 | ????50.0 | ????83 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 10000 | ????50.0 | ????85 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 20000 | ????50.0 | ????86 | ????＜30 | ????＞10 | ++ |
| Polyoxyethylene stearate 40 esters | ????50.0 | ????74 | ????＜30 | ????＞10 | ++ |
| Betacyclodextrin | ????50.0 | ????72 | ????＜30 | ????＞10 | + |
| Poloxamer | ????50.0 | ????73 | ????＜30 | ????＞10 | ++ |
| Carboxymethyl starch sodium | ????50.0 | ????71 | ????＜30 | ????＞10 | + |
| Sodium lauryl sulphate | ????50.0 | ????69 | ????＞30 | ????＞10 | ++ |
| Stearic acid | ????50.0 | ????58 | ????＞30 | ????＞10 | ++ |
| Sodium stearate | ????50.0 | ????54 | ????＞30 | ????＞10 | ++ |
| Glycerin gelatine | ????50.0 | ????56 | ????＞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 2000 | ????25.0 | ????79 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 4000 | ????25.0 | ????86 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 6000 | ????25.0 | ????91 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????25.0 | ????91 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????25.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????25.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyoxyethylene stearate 40 esters | ????25.0 | ????93 | ????＜30 | ????＜10 | ++ |
| Betacyclodextrin | ????25.0 | ????83 | ????＜30 | ????＞10 | ++ |
| Poloxamer | ????25.0 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????25.0 | ????86 | ????＜30 | ????＜10 | +++ |
| Sodium lauryl sulphate | ????25.0 | ????77 | ????＜30 | ????＞10 | ++ |
| Stearic acid | ????25.0 | ????73 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????25.0 | ????71 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????25.0 | ????70 | ????＞30 | ????＞10 | +++ |
| Lac | ????25.0 | ????70 | ????＞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 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 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????10.0 | ????94 | ????＜30 | ????＜10 | +++ |
| Polyoxyethylene stearate 40 esters | ????10.0 | ????89 | ????＜30 | ????＜10 | ++ |
| Betacyclodextrin | ????10.0 | ????87 | ????＜30 | ????＜10 | ++ |
| Poloxamer | ????10.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????10.0 | ????82 | ????＜30 | ????＞10 | +++ |
| Sodium lauryl sulphate | ????10.0 | ????81 | ????＜30 | ????＞10 | +++ |
| Stearic acid | ????10.0 | ????79 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????10.0 | ????80 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????10.0 | ????76 | ????＞30 | ????＞10 | +++ |
| Lac | ????10.0 | ????78 | ????＞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 | ????72 | ????＜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 | ????88 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????25 | ????89 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????25 | ????86 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????25 | ????82 | ????＜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 | ????88 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????10 | ????86 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????10 | ????83 | ????＜30 | ????＞10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????10 | ????80 | ????＜30 | ????＞10 | +++ |
The group practices of table 7 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | ????50 | ????91 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????50 | ????90 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????50 | ????90 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????50 | ????86 | ????＜30 | ????＜10 | ++ |
The group practices of table 8 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 | ????93 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????25 | ????93 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????25 | ????91 | ????＜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 | ????92 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????10 | ????92 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????10 | ????89 | ????＜30 | ????＜10 | +++ |
The group practices of table 10 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | ????50 | ????92 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????50 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????50 | ????87 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????50 | ????84 | ????＜30 | ????＞10 | +++ |
The group practices of table 11 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | ????25 | ????92 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????25 | ????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 | ????91 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????10 | ????91 | ????＜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 (7)
1. one kind is used for the treatment of all void of heart spleen, diet is thought less, the abdominal distention abdominal distention, weak breath is weak, nervous cardiopalmus, tired mind, the pharmaceutical composition rehabilitation spring drop pill of diseases such as insomnia is a raw material with 4 flavor Chinese medicines such as the Radix Astragali, Radix Ginseng, Rhizoma Polygonati Odorati, Lac regis apis, after extraction obtains containing the extract of pharmaceutically active ingredient in above 4 flavors, be prepared from pharmaceutically suitable carrier again as substrate, wherein:
1.1 active pharmaceutical ingredient: the extract that contains pharmaceutically active ingredient in 4 flavors such as the Radix Astragali, Radix Ginseng, Rhizoma Polygonati Odorati, Lac regis apis;
1.2 substrate---Polyethylene Glycol
(2000～20000), polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac, the mixture of wherein one or more;
1.3 proportioning---with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9.
2. rehabilitation spring drop pill as claimed in claim 1, it is characterized in that the described Radix Astragali that contains, Radix Ginseng, Rhizoma Polygonati Odorati, the extract of pharmaceutically active ingredient is made by following method in 4 flavors such as Lac regis apis: be unit with g, get Radix Astragali 200g, Radix Ginseng 7.5g, Rhizoma Polygonati Odorati 10g, Lac regis apis 25g, more than four the flavor, with the Radix Astragali, Radix Ginseng, Rhizoma Polygonati Odorati is given as one thinks fit cataclasm, add water logging after 2 hours, decoct each 1～1.5 hour three times, collecting decoction, filter, filtrate decompression is concentrated into 2 times of amounts of medical material, adds ethanol and makes and contain the alcohol amount and reach 70%, fully stir, cold preservation 24 hours filters, and filtrate recycling ethanol is to there not being the alcohol flavor, add Lac regis apis, decompression (0.1MPa), be condensed into relative density under low temperature (60 ℃) condition and be 1.3～1.35 thick paste, perhaps continue to make drying, be ground into dry powder, promptly.
3. rehabilitation spring drop 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 rehabilitation spring drop pill, 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 rehabilitation spring drop pill is characterized in that being made of following process:
5.1 active pharmaceutical ingredient: the extract that contains pharmaceutically active ingredient in 4 flavors such as the Radix Astragali, Radix Ginseng, Rhizoma Polygonati Odorati, Lac regis apis;
5.2 substrate: Polyethylene Glycol
(2000～20000), polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac, the mixture of wherein one or more;
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 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) ℃;
5.6 when treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and being in the desired state of temperature of previous step, fused solution and/or the emulsion and/or the suspension that will contain drug extract and substrate, under the temperature conditions close, make evenly through fully stirring with the water dropper temperature, place in the water dropper jar of drop pill machine, splash in the condensing agent by water dropper, shrink molding promptly.
6. the preparation method of rehabilitation spring drop pill as claimed in claim 5, it is characterized in that the described Radix Astragali that contains, Radix Ginseng, Rhizoma Polygonati Odorati, the extract of pharmaceutically active ingredient is made by following method in 4 flavors such as Lac regis apis: be unit with g, get Radix Astragali 200g, Radix Ginseng 7.5g, Rhizoma Polygonati Odorati 10g, Lac regis apis 25g, more than four the flavor, with the Radix Astragali, Radix Ginseng, Rhizoma Polygonati Odorati is given as one thinks fit cataclasm, add water logging after 2 hours, decoct each 1～1.5 hour three times, collecting decoction, filter, filtrate decompression is concentrated into 2 times of amounts of medical material, adds ethanol and makes and contain the alcohol amount and reach 70%, fully stir, cold preservation 24 hours filters, and filtrate recycling ethanol is to there not being the alcohol flavor, add Lac regis apis, decompression (0.1MPa), be condensed into relative density under low temperature (60 ℃) condition and be 1.3～1.35 thick paste, perhaps continue to make drying, be ground into dry powder, promptly.
7. as the preparation method of rehabilitation spring drop pill as described in the claim 4, it is characterized in that: method 4.6 described condensing agents are methyl-silicone oils or/and liquid paraffin or/and vegetable oil.
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| CNB2005100074203A CN1292737C (en) | 2005-02-18 | 2005-02-18 | Oral administration dripping pill for nourishing heart to calm mind and its preparing method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100074203A CN1292737C (en) | 2005-02-18 | 2005-02-18 | Oral administration dripping pill for nourishing heart to calm mind and its preparing method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1682804A true CN1682804A (en) | 2005-10-19 |
| CN1292737C CN1292737C (en) | 2007-01-03 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103181562A (en) * | 2011-12-31 | 2013-07-03 | 谢鸣 | Health food having effects of life cultivation and health preservation in summer and preparation method thereof |
| CN103396920A (en) * | 2013-07-30 | 2013-11-20 | 孟宗科 | Preparation method of ginseng healthcare wine |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1202816C (en) * | 2002-02-07 | 2005-05-25 | 王志刚 | Glimepiride dripping pills |
| CN1546027A (en) * | 2003-12-02 | 2004-11-17 | 北京正大绿洲医药科技有限公司 | Dripping pills for treating allergic disease and its preparation process |
| CN1256954C (en) * | 2003-12-12 | 2006-05-24 | 北京科信必成医药科技发展有限公司 | Blumea oil dripping pills and its preparation process |
-
2005
- 2005-02-18 CN CNB2005100074203A patent/CN1292737C/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103181562A (en) * | 2011-12-31 | 2013-07-03 | 谢鸣 | Health food having effects of life cultivation and health preservation in summer and preparation method thereof |
| CN103181562B (en) * | 2011-12-31 | 2015-08-12 | 谢鸣 | A kind of have health food of Summertime health-care effect and preparation method thereof |
| CN103396920A (en) * | 2013-07-30 | 2013-11-20 | 孟宗科 | Preparation method of ginseng healthcare wine |
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