CN1297255C - Dripping pills for treating high blood fat and its preparing method - Google Patents
Dripping pills for treating high blood fat and its preparing method Download PDFInfo
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Abstract
The present invention relates to a medicine composite with the functions of promoting blood flow, dissolving turgidity and reducing blood fat, which is used for treating hyperlipoidemia caused by the stagnation of damp turgidity. The present invention has the purposes of overcoming the defects of the existing oral medicine preparations for the hyperlipoidemia caused by the stagnation of damp turgidity, and providing yellow and fragrant oral medicine composite preparation dripping pills with high biologic utilization, fast medicine releasing, rapid effect taking, little toxic side effect, high medicine content, small administration dose, accurate administration dose, convenient administration and convenient carrying for outgoing. The medicine composite is prepared by the dripping pill preparation technology on the basis of the extraction process of yellow and fragrant granules of a Chinese traditional patent formulation.
Description
Technical field
The present invention relates to a kind of activating blood circulation to eliminate turbid effect for reducing fat that has, be used for the treatment of the pharmaceutical composition of hyperlipemia due to the turbid wet resistance of the stasis of blood, particularly become the Colophonium granule, a kind of drug composition oral dropping pill formulation that forms through the dosage form transformation of the way based on Chinese medicine.
Background technology
The Colophonium granule that is prepared from according to the prescription that provides among the national drug standards WS-10902 (ZD-0902)-2002 and extraction process, it is a kind of activating blood circulation to eliminate turbid effect for reducing fat that has, the oral pure Chinese medicinal preparation that is used for the treatment of hyperlipemia due to the turbid wet resistance of the stasis of blood, through clinical verification, steady quality, determined curative effect is the common drug preparation that clinical and family is used for the treatment of above disease.
Below be the part particular content of this standard:
Prescription: Radix Et Rhizoma Rhei 200g, Herba Pogostemonis 200g, sucrose 800g;
Method for making: above two flavor medical materials, Radix Et Rhizoma Rhei powder is broken into coarse powder, adds the alcohol reflux secondary, each 1.5 hours, filters; Herba Pogostemonis extracts volatile oil with steam distillation, and aqueous solution filters, and filtrate merges with Radix Et Rhizoma Rhei extract, and being concentrated into relative density is the clear paste of 1.30～1.35 (50 ℃), adds cane sugar powder, makes 1000g, and drying is put coldly, and spray and add above-mentioned volatile oil, mixing, promptly.
Be explained as follows for this granule in the appended Colophonium granule description:
Nomenclature of drug: Colophonium granule;
Main component: Radix Et Rhizoma Rhei, Herba Pogostemonis;
Character: this product is a brown granular; Gas perfume (or spice), it is sweet to distinguish the flavor of;
Function cures mainly: activating blood circulation to eliminate turbid, blood fat reducing.Be used for the hyperlipemia due to the turbid wet resistance of the stasis of blood;
Usage and dosage: boiled water is taken after mixing it with water, a 5g, 2～3 times on the one;
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 that granular preparation also exists medicament contg is low, and taking dose is big, and taking dose is inaccurate, takes inconvenient characteristics, also is not easy to go out to carry wait deficiency.
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 deficiency that is used for the treatment of the oral drug preparation of hyperlipemia due to the turbid wet resistance of the stasis of blood, provide a kind of bioavailability height, release fast, quick produce effects, toxic and side effects is littler, and the medicament contg height, and taking dose is little, taking dose is accurate, taking convenience, cheap, and be convenient to the drug composition oral preparation dripping pills for treating high blood fat of going out to carry.
Dripping pills for treating high blood fat involved in the present invention is determined through a large amount of experiment sievings, based on the particulate extraction process of Chinese traditional patent formulation Colophonium, cooperates drop pill preparation technology to be prepared from.
Be prepared by the following technical solutions, can obtain dripping pills for treating high blood fat involved in the present invention:
[preparation method]
1. be unit with g or kg, calculate according to weight, 1 part of Radix Et Rhizoma Rhei, 1 part of Herba Pogostemonis, more than two flavors through the extracting method of routine make the drug extract thick paste or dry powder standby;
2. substrate---Polyethylene Glycol
(2000,4000,6000,8000,10000,20000), 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. treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively is in above the 2nd step during desired state of temperature, the volatile oil adding of extracting in the Herba Pogostemonis is contained in the fused solution and/or emulsion and/or suspension of drug extract and substrate, under the temperature conditions close, make evenly through fully stirring with the water dropper temperature, insulation, place in the water dropper jar of drop pill machine, splash in the condensing agent by water dropper; 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 Chinese medicine extract]
Get Radix Et Rhizoma Rhei and be ground into coarse powder for 1 part, add the alcohol reflux secondary, each 1.5 hours, filter; Herba Pogostemonis extracts volatile oil with steam distillation for 1 part, and aqueous solution filters, and filtrate and Radix Et Rhizoma Rhei extract merge, and 70 ℃ of cryoconcentration of 0.1Mpa decompression are to the thick paste of relative density 1.30-1.35 (50 ℃); Or with thick paste through the low-temperature reduced-pressure drying, pulverize, promptly get dry powder.
Given here is according to a kind of preparation method of extract comparatively commonly used, its processing step adjustment is formed again.Similarly method is a lot, is not limited to this a kind of method during actual enforcement.
Beneficial effect
The Colophonium granule that is prepared from according to the prescription that provides among the national drug standards WS-10902 (ZD-0902)-2002 and extraction process, it is a kind of activating blood circulation to eliminate turbid effect for reducing fat that has, the oral pure Chinese medicinal preparation that is used for the treatment of hyperlipemia due to the turbid wet resistance of the stasis of blood, through clinical verification, steady quality, determined curative effect is the common drug preparation that clinical and family is used for the treatment of above 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 that granular preparation also exists medicament contg is low, and taking dose is big, and clothes first dosage is inaccurate, takes inconvenient characteristics, also is not easy to go out to carry wait deficiency.
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.
Dripping pills for treating high blood fat involved in the present invention is compared with the Colophonium granule has following beneficial effect:
1. dripping pills for treating high blood fat involved in the present invention utilizes surfactant to be substrate, makes solid dispersion with the extractum or the dry powder that contain Radix Et Rhizoma Rhei, Herba Pogostemonis two flavor active ingredient of Chinese herbs, makes medicine be molecule, colloid or microcrystalline state and is scattered in the substrate.The total surface area of medicine increases, and substrate is hydrophilic, and medicine is had wetting action, can make that medicine is molten rapidly to loose into microgranule or solution, thereby makes the dissolving of medicine and absorb and accelerate, thereby has improved bioavailability, brings into play efficient, quick-acting effects etc.
Compare with the administering mode of Colophonium granule, exist essential distinction.Utilize the drop pill of solid dispersion technology preparation, can adopt oral and sublingual administration, effective ingredient is fully contacted with mucomembranous surface, absorb, directly enter blood circulation by mucomembranous epithelial cell.Because active constituents of medicine directly enters blood circulation without gastrointestinal tract and liver, has avoided first pass effect effectively, has also avoided gastrointestinal irritation, thereby it is rapid to make dripping pills for treating high blood fat involved in the present invention have an onset, the bioavailability height, side effect is little, characteristics such as medication convenience.
2. dripping pills for treating high blood fat 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.
3. dripping pills for treating high blood fat 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.
In sum, make dripping pills for treating high blood fat involved in the present invention have the advantage of triple effect (quick-acting, efficient, long-acting), three little (taking dose is little, toxicity is little, side effect little), five convenience (convenient for production, store convenience, convenient transportation, easy to carry, easy to use).
The specific embodiment
Now with several groups of specific embodiments, be described further with regard to the preparation method of dripping pills for treating high blood fat of the present invention.
First group: the test of single-matrix
1. the ratio that provides according to [preparation method] 1 takes by weighing the raw material of Chinese medicine of some, and it is standby to make the extract dry powder and the volatile oil that contain Radix Et Rhizoma Rhei, two kinds of pure active ingredient of Chinese herbs of Herba Pogostemonis earlier according to [appendix: a kind of preparation method of Chinese medicine extract] joint again;
2. substrate: Polyethylene Glycol
(2000,4000,6000,8000,10000,20000), 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 dripping pills for treating high blood fat of various different sizes.
[result of the test]
Test 1: for observe the dry powder that contains active constituents of medicine and different substrates when 1: 1 the proportioning prepared dripping pills for treating high blood fat in qualitative difference, according to 1: 1 ratio, the dry powder that will contain active constituents of medicine 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 that dry powder, volatile oil and different substrates constituted experiments that contain active constituents of medicine, and obtain 15 groups of different experimental results and see Table 1.
Test 2: for observe the dry powder that contains active constituents of medicine and different substrates when 1: 3 the proportioning prepared dripping pills for treating high blood fat in qualitative difference, according to 1: 3 ratio, the dry powder that will contain active constituents of medicine 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 that dry powder, volatile oil and different substrates constituted experiments that contain active constituents of medicine, and obtain 15 groups of different experimental results and see Table 2.
Test 3: for observe the dry powder that contains active constituents of medicine and different substrates when 1: 9 the proportioning prepared dripping pills for treating high blood fat in qualitative difference, according to 1: 9 ratio, the dry powder that will contain active constituents of medicine 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 that dry powder, volatile oil and different substrates constituted experiments that contain active constituents of medicine, and obtain 15 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. the ratio that provides according to [preparation method] 1 takes by weighing the raw material of Chinese medicine of some, and it is standby to make the extract dry powder and the volatile oil that contain Radix Et Rhizoma Rhei, two kinds of pure active ingredient of Chinese herbs of Herba Pogostemonis earlier according to [appendix: a kind of preparation method of Chinese medicine extract] joint again;
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. (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,
4. be prepared according to [preparation method] again, promptly can make the dripping pills for treating high blood fat of various different sizes.
[result of the test]
Test 4: for observe the dry powder that contains active constituents of medicine and mixed-matrix when 1: 1 the proportioning prepared dripping pills for treating high blood fat 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, the dry powder that will contain active constituents of medicine according to 1: 1 ratio mixes mutually with 4 kinds of different mixed-matrixes and makes evenly again, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 4 dry powder that contain active constituents of medicine, the experiment of pharmaceutical composition that volatile oil and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 4.
Test 5: for observe the dry powder that contains active constituents of medicine and mixed-matrix when 1: 3 the proportioning prepared dripping pills for treating high blood fat 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, the dry powder that will contain active constituents of medicine according to 1: 3 ratio mixes mutually with 4 kinds of different mixed-matrixes and makes evenly again, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 4 dry powder that contain active constituents of medicine, the experiment of pharmaceutical composition that volatile oil and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 5.
Test 6: for observe the dry powder that contains active constituents of medicine and mixed-matrix when 1: 9 the proportioning prepared dripping pills for treating high blood fat 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, the dry powder that will contain active constituents of medicine according to 1: 9 ratio mixes mutually with 4 kinds of different mixed-matrixes and makes evenly again, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 4 dry powder that contain active constituents of medicine, the experiment of pharmaceutical composition that volatile oil and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 6.
Test 7: for observe the dry powder that contains active constituents of medicine and mixed-matrix when 1: 1 the proportioning prepared dripping pills for treating high blood fat 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, the dry powder that will contain active constituents of medicine according to 1: 1 ratio mixes mutually with 4 kinds of different mixed-matrixes and makes evenly again, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 4 dry powder that contain active constituents of medicine, the experiment of pharmaceutical composition that volatile oil and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 7.
Test 8: for observe the dry powder that contains active constituents of medicine and mixed-matrix when 1: 3 the proportioning prepared dripping pills for treating high blood fat 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, the dry powder that will contain active constituents of medicine according to 1: 3 ratio mixes mutually with 4 kinds of different mixed-matrixes and makes evenly again, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 4 dry powder that contain active constituents of medicine, the experiment of pharmaceutical composition that volatile oil and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 8.
Test 9: for observe the dry powder that contains active constituents of medicine and mixed-matrix when 1: 9 the proportioning prepared dripping pills for treating high blood fat 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, the dry powder that will contain active constituents of medicine according to 1: 9 ratio mixes mutually with 4 kinds of different mixed-matrixes and makes evenly again, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 4 dry powder that contain active constituents of medicine, the experiment of pharmaceutical composition that volatile oil and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 9.
Test 10: for observe the dry powder that contains active constituents of medicine and mixed-matrix when 1: 1 the proportioning prepared dripping pills for treating high blood fat 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, the dry powder that will contain active constituents of medicine according to 1: 1 ratio mixes mutually with 4 kinds of different mixed-matrixes and makes evenly again, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 4 dry powder that contain active constituents of medicine, the experiment of pharmaceutical composition that volatile oil and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 10.
Test 11: for observe the dry powder that contains active constituents of medicine and mixed-matrix when 1: 3 the proportioning prepared dripping pills for treating high blood fat 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, the dry powder that will contain active constituents of medicine according to 1: 3 ratio mixes mutually with 4 kinds of different mixed-matrixes and makes evenly again, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 4 dry powder that contain active constituents of medicine, the experiment of pharmaceutical composition that volatile oil and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 11.
Test 12: for observe the dry powder that contains active constituents of medicine and mixed-matrix when 1: 9 the proportioning prepared dripping pills for treating high blood fat 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, the dry powder that will contain active constituents of medicine according to 1: 9 ratio mixes mutually with 4 kinds of different mixed-matrixes and makes evenly again, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 4 dry powder that contain active constituents of medicine, the experiment of pharmaceutical composition that volatile oil and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 12.
The group practices of table 1 medicine dry powder, volatile oil and single-matrix
(medicine dry powder: 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 | 82 | ＜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 | 75 | ＜30 | ＞10 | ++ |
| Betacyclodextrin | 50.0 | 72 | ＜30 | ＞10 | ++ |
| Poloxamer | 50.0 | 71 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium | 50.0 | 71 | ＜30 | ＞10 | ++ |
| Sodium lauryl sulphate | 50.0 | 70 | ＜30 | ＞10 | ++ |
| Stearic acid | 50.0 | 54 | ＜30 | ＞10 | ++ |
| Sodium stearate | 50.0 | 56 | ＜30 | ＞10 | +++ |
| Glycerin gelatine | 50.0 | 55 | ＜30 | ＞10 | +++ |
| Lac | 50.0 | 52 | ＞30 | ＞10 | +++ |
The group practices of table 2 medicine dry powder, volatile oil and single-matrix
(medicine dry powder: 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 | 80 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 25.0 | 84 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 25.0 | 90 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 25.0 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 92 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 85 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 25.0 | 82 | ＜30 | ＜10 | ++ |
| Poloxamer | 25.0 | 85 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 25.0 | 81 | ＜30 | ＞10 | ++ |
| Sodium lauryl sulphate | 25.0 | 74 | ＜30 | ＞10 | ++ |
| Stearic acid | 25.0 | 72 | ＞30 | ＞10 | ++ |
| Sodium stearate | 25.0 | 72 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 25.0 | 67 | ＞30 | ＞10 | +++ |
| Lac | 25.0 | 70 | ＞30 | ＞10 | +++ |
The group practices of table 3 medicine dry powder, volatile oil and different substrates
(medicine dry powder: 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 | 85 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 10.0 | 87 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 10.0 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 10.0 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 94 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 90 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 10.0 | 87 | ＜30 | ＜10 | ++ |
| Poloxamer | 10.0 | 91 | ＜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 | 83 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 10.0 | 75 | ＞30 | ＞10 | +++ |
| Lac | 10.0 | 76 | ＞30 | ＞10 | +++ |
The group practices of table 4 medicine dry powder, volatile oil and mixed-matrix
(medicine dry powder: 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 | 80 | ＜30 | ＞10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 50 | 81 | ＜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 medicine dry powder, volatile oil and mixed-matrix
(medicine dry powder: 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 | 87 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25 | 86 | ＜30 | ＜10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 25 | 87 | ＜30 | ＞10 | ++ |
The group practices of table 6 medicine dry powder, volatile oil and mixed-matrix
(medicine dry powder: 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 | 90 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 10 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10 | 93 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 10 | 90 | ＜30 | ＜10 | +++ |
The group practices of table 7 medicine dry powder, volatile oil and mixed-matrix
(medicine dry powder: 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 | 85 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 50 | 84 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50 | 86 | ＜30 | ＜10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 50 | 84 | ＜30 | ＞10 | ++ |
The group practices of table 8 medicine dry powder, volatile oil and mixed-matrix
(medicine dry powder: 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 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 25 | 89 | ＜30 | ＜10 | ++ |
The group practices of table 9 medicine dry powder, volatile oil and mixed-matrix
(medicine dry powder: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 10 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 10 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 10 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 10 | 91 | ＜30 | ＜10 | +++ |
The group practices of table 10 medicine dry powder, volatile oil and mixed-matrix
(medicine dry powder: 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 | 89 | ＜30 | ＜10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50 | 89 | ＜30 | ＜10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 50 | 87 | ＜30 | ＞10 | ++ |
The group practices of table 11 medicine dry powder, volatile oil and mixed-matrix
(medicine dry powder: 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 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 25 | 91 | ＜30 | ＜10 | +++ |
The group practices of table 12 medicine dry powder, volatile oil and mixed-matrix
(medicine dry powder: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 10 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 10 | 90 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10 | 92 | ＜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 the dry powder that contains active constituents of medicine 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 dry powder that contains active constituents of medicine 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 dry powder that contains active constituents of medicine 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 dripping pills for treating high blood fat that is used for the treatment of hyperlipemia due to the turbid wet resistance of the stasis of blood is a raw material with Chinese herb rhubarb, Herba Pogostemonis, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that preparation process is as follows:
(1) gets Radix Et Rhizoma Rhei and be ground into coarse powder for 1 part, add the alcohol reflux secondary, each 1.5 hours, filter; Herba Pogostemonis extracts volatile oil with steam distillation for 1 part, and aqueous solution filters, and filtrate and Radix Et Rhizoma Rhei extract merging are decompressed to 0.1Mpa, and 70 ℃ of low temperature are concentrated into relative density and are 1.30～1.40 thick paste; Or with thick paste through cold drying, pulverize, promptly get dry powder.
(2) described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or poloxamer, and by weight, polyoxyethylene stearate 40 esters or poloxamer are 1: 1～1: 10 with the ratio of Polyethylene Glycol, and described extract is 1: 1～1: 9 with the ratio of substrate;
(3) according to the given ratio of above-mentioned prescription, accurately take by weighing drug extract and substrate, be placed in the heating container heating while stirring, standby until the fused solution that obtains containing drug extract and substrate and/or emulsion and/or suspension;
(4) temperature control system of adjustment drop pill machine makes the water dropper temperature heating of drop pill machine and remains on 50 ℃～90 ℃, and the temperature cooling of condensing agent also remains on-5 ℃～40 ℃;
When (5) temperature for the treatment of dropping-pill machine head and condensing agent reaches described state respectively, the volatile oil adding is contained in the fused solution and/or emulsion and/or suspension of drug extract and substrate, under the temperature conditions close, make evenly through fully stirring with the water dropper temperature, insulation, place in the water dropper jar of drop pill machine, splash in the condensing agent by water dropper and shrink shaping promptly.
2. dripping pills for treating high blood fat as claimed in claim 1 is characterized in that: described condensing agent is methyl-silicone oil or liquid paraffin or vegetable oil.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2004100963316A CN1297255C (en) | 2004-11-30 | 2004-11-30 | Dripping pills for treating high blood fat and its preparing method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100963316A CN1297255C (en) | 2004-11-30 | 2004-11-30 | Dripping pills for treating high blood fat and its preparing method |
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| CN1297255C true CN1297255C (en) | 2007-01-31 |
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| CN104013683B (en) * | 2014-06-27 | 2016-03-02 | 山东金诃药物研究开发有限公司 | A kind of pharmaceutical composition for the treatment of hyperlipemia and preparation method thereof |
| CN104173470B (en) * | 2014-09-03 | 2016-04-27 | 山东金诃药物研究开发有限公司 | A kind of preparation method of Colophonium pharmaceutical composition |
| CN105232652A (en) * | 2015-11-19 | 2016-01-13 | 哈尔滨圣吉药业股份有限公司 | Huangxiang dispersible tablet and preparation method thereof |
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| CN1436549A (en) * | 2002-02-07 | 2003-08-20 | 黄海波 | Compound Chinese medicine notoginseng dripping pills and its prepn process |
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