CN1679677A - Danqi drops for activating blood and eliminating blood stasis and preparation thereof - Google Patents
Danqi drops for activating blood and eliminating blood stasis and preparation thereof Download PDFInfo
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Abstract
A Danqi dripping pill based on Shuxiong tablet for treating blood and Qi stasis, cardialgia, thoracalgia, dizziness and menalgia is disclosed. Its advantages are high release speed and quickly taking its high curative effect.
Description
Technical field
The present invention relates to a kind of function of promoting blood circulation to disperse blood clots that has, be used for the treatment of stagnation of QI and blood, cardiodynia, dizziness and headache, the pharmaceutical composition of diseases such as abdominal pain in menstruation particularly based on the Chinese traditional patent formulation DANQI PIAN, is changed a social system a kind of drug composition oral dropping pill formulation that forms through dosage form.
Background technology---1-48 promulgated by the ministries or commissions of the Central Government
According to national drug standards WS
3The DANQI PIAN that prescription that provides among-the B-0047-89 and preparation technology are prepared from, it is a kind of function of promoting blood circulation to disperse blood clots that has, be used for the treatment of stagnation of QI and blood, cardiodynia, dizziness and headache, the oral Chinese medicine preparation of symptoms such as abdominal pain in menstruation, 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 drug standard WS
3Prescription that provides among-the B-0047-89 and preparation technology:
Prescription: Radix Salviae Miltiorrhizae 150g, Radix Notoginseng 150g;
Method for making: above two flavors, Radix Notoginseng powder is broken into fine powder; Radix Salviae Miltiorrhizae decocts with water three times, and collecting decoction filters, and filtrate decompression is concentrated into the clear paste that relative density is 1.35-1.4 (50 ℃).1 part of qinghuo reagent adds 1 part of Radix Notoginseng fine powder, mixing, and drying is pressed into 600, or sugar coating again, promptly.
In the appended DANQI PIAN description this kind is explained as follows:
Nomenclature of drug: DANQI PIAN;
Main component: Radix Salviae Miltiorrhizae, Radix Notoginseng;
Character: this product is a coated tablet, remove sugar-coat after, show brown; Feeble QI, bitter in the mouth;
Function cures mainly: invigorate blood circulation blood stasis dispelling, pain relieving.Be used for blood stasis type coronary heart disease, angina pectoris, arrhythmia, pain due to blood stasis, traumatic injury.；
Usage and dosage: oral, one time 5,3 times on the one;
Taboo; Blood stasis is avoided usefulness due to the careful usefulness of anemia of pregnant woman, heat symptom-complex;
Points for attention: sealing.
Writing out a prescription with this is that other oral formulations that make on the basis also has capsule etc., its characteristics, the effect identical.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.
In addition, conventional peroral dosage form 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 to have now and be used for the treatment of stagnation of QI and blood, cardiodynia, dizziness and headache, the deficiency of the oral drug preparation of symptoms such as abdominal pain in menstruation, provide a kind of bioavailability height, release fast, produce effects fast, toxic and side effects is little, the medicament contg height, cheap, and free of contamination aborning drug composition oral preparation DANQI DIWAN.
DANQI DIWAN involved in the present invention determines that through a large amount of experiment sievings based on the preparation technology of Chinese traditional patent formulation DANQI PIAN, process is adjusted part technology, and cooperates drop pill preparation technology to be prepared from.Be prepared by the following technical solutions, can obtain DANQI DIWAN involved in the present invention:
[preparation method]
1. be unit with g or kg, calculate, get each 1 part of Radix Salviae Miltiorrhizae, Radix Notoginseng according to weight, more than two flavors to make medicine dry powder through the preparation method of routine 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 medicine dry powder: substrate=1: 1～1: 9.
4. according to the given ratio of prescription, accurately take by weighing medicine dry powder and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing medicine dry powder 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 (50～100) ℃, 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, fused solution and/or the emulsion and/or the suspension that will contain medicine dry powder 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 dry powder]
With g or kg is unit, according to the weight portion meter, gets each 1 part of Radix Salviae Miltiorrhizae, Radix Notoginseng.More than two the flavor, Radix Notoginseng powder is broken into fine powder; Radix Salviae Miltiorrhizae decocts with water three times, and collecting decoction filters, and filtrate decompression is concentrated into the clear paste that relative density is 1.35-1.4 (50 ℃).1 part of qinghuo reagent adds 1 part of Radix Notoginseng fine powder, and mixing is dried and crushed into dry powder promptly through decompression (0.1Mpa) low temperature (60 ℃) again.
Given here is according to the preparation method of a kind of Chinese medicine dry powder 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
According to national drug standards WS
3The DANQI PIAN that prescription that provides among-the B-0047-89 and preparation technology are prepared from, it is a kind of function of promoting blood circulation to disperse blood clots that has, be used for the treatment of stagnation of QI and blood, cardiodynia, dizziness and headache, the oral Chinese medicine preparation of symptoms such as abdominal pain in menstruation, 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 the syrups 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.
DANQI DIWAN involved in the present invention is compared with DANQI PIAN, capsule containing red sage root and notoginseng has following beneficial effect:
1. DANQI DIWAN involved in the present invention; utilize surfactant to be substrate; make solid dispersion with the dry powder that contains two flavor active ingredient of Chinese herbs such as Radix Salviae Miltiorrhizae, Radix Notoginseng, make medicine be molecule, colloid or microcrystalline state and be scattered in the substrate, the total surface area of medicine increases; and substrate is hydrophilic; medicine is had wetting action, can make that medicine is rapidly molten to loose into microgranule or solution, thereby make the dissolving of medicine and absorb and accelerate; thereby improved bioavailability, brought into play efficient, quick-acting effects etc.
Compare with the administering mode of other red seven oral formulations, 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, avoided first pass effect effectively, also avoided gastrointestinal irritation, thereby thereby it is rapid to make that DANQI DIWAN involved in the present invention has an onset, the bioavailability height, characteristics such as side effect is little, and medication is convenient.
2. DANQI DIWAN 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. DANQI DIWAN involved in the present invention is mixed 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 DANQI DIWAN 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 DANQI DIWAN 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 medicine dry powder that contains Radix Salviae Miltiorrhizae, two kinds of active ingredient of Chinese herbs of Radix Notoginseng earlier according to [appendix: a kind of preparation method of Chinese medicine dry powder] 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 medicine dry powder: substrate=1: 1～1: 9;
4. be prepared according to the process of [preparation method] 4～7 again, promptly can make the DANQI DIWAN 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 DANQI DIWAN 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 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 DANQI DIWAN 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 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 DANQI DIWAN 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 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, again according to [appendix; A kind of preparation method of Chinese medicine dry powder] to make the medicine dry powder that contains Radix Salviae Miltiorrhizae, two kinds of active ingredient of Chinese herbs of Radix Notoginseng earlier standby for a joint;
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 dry powder: mixed-matrix weight and=1: 1～1: 9,
4. be prepared according to [preparation method] again, promptly can make the DANQI DIWAN 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 DANQI DIWAN 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 pharmaceutical compositions that dry powder and mixed-matrix constituted experiments that contain active constituents of medicine, 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 DANQI DIWAN 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 pharmaceutical compositions that dry powder and mixed-matrix constituted experiments that contain active constituents of medicine, 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 DANQI DIWAN 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 pharmaceutical compositions that dry powder and mixed-matrix constituted experiments that contain active constituents of medicine, 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 DANQI DIWAN 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 pharmaceutical compositions that dry powder and mixed-matrix constituted experiments that contain active constituents of medicine, 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 DANQI DIWAN 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 pharmaceutical compositions that dry powder and mixed-matrix constituted experiments that contain active constituents of medicine, 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 DANQI DIWAN 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 pharmaceutical compositions that dry powder and mixed-matrix constituted experiments that contain active constituents of medicine, 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 DANQI DIWAN 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 pharmaceutical compositions that dry powder and mixed-matrix constituted experiments that contain active constituents of medicine, 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 DANQI DIWAN 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 pharmaceutical compositions that dry powder and mixed-matrix constituted experiments that contain active constituents of medicine, 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 DANQI DIWAN 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 pharmaceutical compositions that dry powder and mixed-matrix constituted experiments that contain active constituents of medicine, and obtain 4 groups of different experimental results and see Table 12.
The group practices of table 1 medicine dry powder 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 | ????63 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 4000 | ????50.0 | ????75 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 6000 | ????50.0 | ????80 | ????＜30 | ????＞10 | +++ |
| Polyethylene Glycol 8000 | ????50.0 | ????82 | ????＜30 | ????＞10 | +++ |
| Polyethylene Glycol 10000 | ????50.0 | ????83 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????50.0 | ????84 | ????＜30 | ????＜10 | +++ |
| Polyoxyethylene stearate 40 esters | ????50.0 | ????75 | ????＜30 | ????＞10 | ++ |
| Betacyclodextrin | ????50.0 | ????70 | ????＜30 | ????＞10 | ++ |
| Poloxamer | ????50.0 | ????73 | ????＜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 | ????57 | ????＜30 | ????＞10 | +++ |
| Lac | ????50.0 | ????54 | ????＞30 | ????＞10 | +++ |
The group practices of table 2 medicine dry powder 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 | ????81 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 4000 | ????25.0 | ????86 | ????＜30 | ????＜10 | ++ |
| Polyethylene Glycol 6000 | ????25.0 | ????93 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????25.0 | ????91 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????25.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????25.0 | ????91 | ????＜30 | ????＜10 | ++ |
| Polyoxyethylene stearate 40 esters | ????25.0 | ????92 | ????＜30 | ????＜10 | ++ |
| Betacyclodextrin | ????25.0 | ????85 | ????＜30 | ????＞10 | ++ |
| Poloxamer | ????25.0 | ????89 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????25.0 | ????82 | ????＜30 | ????＞10 | ++ |
| Sodium lauryl sulphate | ????25.0 | ????77 | ????＜30 | ????＞10 | ++ |
| Stearic acid | ????25.0 | ????73 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????25.0 | ????72 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????25.0 | ????74 | ????＞30 | ????＞10 | +++ |
| Lac | ????25.0 | ????72 | ????＞30 | ????＞10 | +++ |
The group practices of table 3 medicine dry powder and single-matrix
(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 | ????84 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 4000 | ????10.0 | ????93 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 6000 | ????10.0 | ????91 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????10.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????10.0 | ????93 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????10.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyoxyethylene stearate 40 esters | ????10.0 | ????93 | ????＜30 | ????＜10 | ++ |
| Betacyclodextrin | ????10.0 | ????88 | ????＜30 | ????＜10 | ++ |
| Poloxamer | ????10.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????10.0 | ????86 | ????＜30 | ????＜10 | +++ |
| Sodium lauryl sulphate | ????10.0 | ????83 | ????＜30 | ????＞10 | +++ |
| Stearic acid | ????10.0 | ????79 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????10.0 | ????77 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????10.0 | ????74 | ????＞30 | ????＞10 | +++ |
| Lac | ????10.0 | ????75 | ????＞30 | ????＞10 | +++ |
The group practices of table 4 medicine dry powder 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 | ????86 | ????＜30 | ????＜10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????50 | ????85 | ????＜30 | ????＜10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????50 | ????81 | ????＜30 | ????＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????50 | ????78 | ????＜30 | ????＞10 | + |
The group practices of table 5 medicine dry powder 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 | ????92 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????25 | ????93 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????25 | ????89 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????25 | ????86 | ????＜30 | ????＞10 | ++ |
The group practices of table 6 medicine dry powder 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 | ????93 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????10 | ????92 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????10 | ????90 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????10 | ????87 | ????＜30 | ????＞10 | +++ |
The group practices of table 7 medicine dry powder 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 | ????93 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????50 | ????94 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????50 | ????89 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????50 | ????86 | ????＜30 | ????＞10 | ++ |
The group practices of table 8 medicine dry powder 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 | ????94 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????25 | ????92 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????25 | ????91 | ????＜30 | ????＜10 | ++ |
The group practices of table 9 medicine dry powder 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 | ????93 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????10 | ????94 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????10 | ????91 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????10 | ????89 | ????＜30 | ????＜10 | +++ |
The group practices of table 10 medicine dry powder 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 | ????92 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????50 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????50 | ????89 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????50 | ????84 | ????＜30 | ????＞10 | +++ |
The group practices of table 11 medicine dry powder 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 | ????93 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????25 | ????90 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????25 | ????88 | ????＜30 | ????＜10 | +++ |
The group practices of table 12 medicine dry powder 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 | ????93 | ????＜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 being 1: 1 when medicine dry powder with the ratio of substrate, its rounding rate, the ball method of double differences is different and index such as hardness is all undesirable, and dissolve scattered time limit institute is influenced not obvious.
2. when the ratio of medicine dry powder 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 medicine dry powder 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 (7)
1. one kind is used for the treatment of stagnation of QI and blood, cardiodynia, and dizziness and headache, the pharmaceutical composition DANQI DIWAN of symptoms such as abdominal pain in menstruation is a raw material with salviamiltiorrhizabung, Radix Notoginseng, is prepared from a certain proportion of pharmaceutically suitable carrier, wherein:
1.1. with g or kg is unit, calculates according to weight, gets each 1 part of Radix Salviae Miltiorrhizae, Radix Notoginseng, makes medicine dry powder;
1.2. 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;
1.3. proportioning---with g or kg is unit, by weight, and medicine dry powder: substrate=1: 1～1: 9.
2. DANQI DIWAN 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.
3. any DANQI DIWAN as claimed in claim 1 or 2 is characterized in that: the mixed proportion of described medicine dry powder and substrate is 1: 1～1: 5.
4. DANQI DIWAN as claimed in claim 1, it is characterized in that described medicine dry powder obtains by the following method: with g or kg is unit, according to the weight portion meter, gets each 1 part of Radix Salviae Miltiorrhizae, Radix Notoginseng.More than two the flavor, Radix Notoginseng powder is broken into fine powder; Radix Salviae Miltiorrhizae decocts with water three times, and collecting decoction filters, and filtrate decompression is concentrated into the clear paste that relative density is 1.35-1.4 (50 ℃).1 part of qinghuo reagent adds 1 part of Radix Notoginseng fine powder, and mixing is dried and crushed into dry powder promptly through decompression (0.1Mpa) low temperature (60 ℃) again.
5. the preparation method of a DANQI DIWAN is characterized in that being made of following process:
5.1. with g or kg is unit, calculates according to weight, gets each 1 part of Radix Salviae Miltiorrhizae, Radix Notoginseng, more than two flavors to make medicine dry powder through the preparation method of routine standby;
5.2. 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;
5.3. proportioning---with g or kg is unit, by weight, and medicine dry powder: substrate=1: 1～1: 9.
5.4., accurately take by weighing medicine dry powder 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 medicine dry powder and substrate and/or emulsion and/or suspension;
5.5. adopt homemade or general drop pill machine, and 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-5 ℃～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, to contain in the fused solution and/or emulsion and/or suspension of medicine dry powder 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.
6. as the preparation method of chest relaxing drop pills as described in the claim 5, it is characterized in that method 5.1 described medicine dry powder obtain by the following method: with g or kg is unit, according to the weight portion meter, gets each 1 part of Radix Salviae Miltiorrhizae, Radix Notoginseng.More than two the flavor, Radix Notoginseng powder is broken into fine powder; Radix Salviae Miltiorrhizae decocts with water three times, and collecting decoction filters, and filtrate decompression is concentrated into the clear paste that relative density is 1.35-1.4 (50 ℃).1 part of qinghuo reagent adds 1 part of Radix Notoginseng fine powder, and mixing is dried and crushed into dry powder promptly through decompression (0.1Mpa) low temperature (60 ℃) again.
7. as the preparation method of DANQI DIWAN as described in the claim 5, it is characterized in that: method 5.6 described condensing agents are methyl-silicone oils or/and liquid paraffin or/and vegetable oil.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510002887 CN1679677A (en) | 2005-01-28 | 2005-01-28 | Danqi drops for activating blood and eliminating blood stasis and preparation thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510002887 CN1679677A (en) | 2005-01-28 | 2005-01-28 | Danqi drops for activating blood and eliminating blood stasis and preparation thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1679677A true CN1679677A (en) | 2005-10-12 |
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ID=35066683
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510002887 Pending CN1679677A (en) | 2005-01-28 | 2005-01-28 | Danqi drops for activating blood and eliminating blood stasis and preparation thereof |
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| Country | Link |
|---|---|
| CN (1) | CN1679677A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100389789C (en) * | 2005-10-20 | 2008-05-28 | 北京汉典中西药研究开发中心 | Preparation method of capsule containing red sage root and notoginseng |
| CN112156129A (en) * | 2020-10-20 | 2021-01-01 | 云南楚雄天利药业有限公司 | Red lead blood-activating dropping pill and preparation method thereof |
-
2005
- 2005-01-28 CN CN 200510002887 patent/CN1679677A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100389789C (en) * | 2005-10-20 | 2008-05-28 | 北京汉典中西药研究开发中心 | Preparation method of capsule containing red sage root and notoginseng |
| CN112156129A (en) * | 2020-10-20 | 2021-01-01 | 云南楚雄天利药业有限公司 | Red lead blood-activating dropping pill and preparation method thereof |
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