CN1730041A - Dripping pills of polygonum capitatum and its preparation process - Google Patents
Dripping pills of polygonum capitatum and its preparation process Download PDFInfo
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- CN1730041A CN1730041A CN 200510090142 CN200510090142A CN1730041A CN 1730041 A CN1730041 A CN 1730041A CN 200510090142 CN200510090142 CN 200510090142 CN 200510090142 A CN200510090142 A CN 200510090142A CN 1730041 A CN1730041 A CN 1730041A
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Abstract
The invention discloses a medicinal composition for heat clearing and detoxicating, especially a dripping pill of polygonum capitatum and its preparation process, wherein the dripping pill is prepared from polygonum capitatum, and medicinal carrying agent as the base material. The dripping pill has the advantages of high biological availability, quick-speed medicine release, quick-speed effect, higher medicinal content, easy administering, and low price.
Description
Technical field
The present invention relates to a kind of heat-clearing and toxic substances removing that has, diuresis inducing function is used for damp-heat accumulation; yellowish or reddish urine, odynuria; urinary tract infection, pyelitis are seen the pharmaceutical composition of above-mentioned card marquis person treatment, are a kind of drug composition oral preparation that feedstock production forms with the Chinese medicine Herba Polygoni Capitati particularly.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The clear granule of the pyretic stranguria that the preparation method that provides among-the B-3303-98 is prepared from, it is a kind of heat-clearing and toxic substances removing that has, diuresis inducing function, be used for damp-heat accumulation, yellowish or reddish urine, odynuria, urinary tract infection, pyelitis is seen the oral granular formulation of above-mentioned card marquis person treatment, through clinical verification for many years, 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-3303-98 and technology and brief description:
Prescription: headdress flower is few
Method for making: get Herba Polygoni Capitati 1000g and decoct with water secondary, each 1.5 hours, collecting decoction, filter, filtrate is concentrated into the thick paste that relative density is 1.38 (80 ℃), drying, pulverize, make granule, drying, make 400g, or add suitable amount of sucrose powder, mixing, make granule, drying is made 800g, promptly.
Function cures mainly: heat-clearing and toxic substances removing, inducing diuresis for treating stranguria syndrome.Be used for damp-heat accumulation, the disease of yellowish or reddish urine, odynuria, urinary tract infection, pyelitis is seen above-mentioned card marquis person.
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 is as tablet, capsule, granule (electuary) etc., in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.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 existing be used for the treatment of damp-heat accumulation, yellowish or reddish urine, odynuria, urinary tract infection, pyelitis is seen the deficiency of above-mentioned card marquis person's oral drug preparation, a kind of bioavailability height is provided, and has quick release, fast produce effects, the medicament contg height, taking convenience, cheap, and the few drop pill of free of contamination aborning headdress flower.The few drop pill of headdress flower involved in the present invention, few with the Chinese medicine headdress flower is raw material, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain the few drop pill of headdress flower involved in the present invention:
[preparation method]
1. the preparation of drug extract: with g or kg is unit, and it is an amount of to get Herba Polygoni Capitati, decocts with water secondary, and each 1.5 hours, collecting decoction filtered, and it is 1.3～1.4 thick paste that filtrate is concentrated into relative density, promptly gets the drug extract thick paste; Or continue to make drying, and be ground into dry powder, promptly get drug extract dry powder;
2. substrate: substrate is selected from polyethylene glycols, sorbitol anhydride class, polyoxyethylene sorbitol acid anhydride class, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac, the mixture of one or more in above-mentioned pharmaceutically suitable carrier;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
More practical ratio: drug extract: substrate=1: 1～1: 5;
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, TZDW-1 type drop pill machine as Changzheng Tianmin High Science ﹠ Technology Co., Ltd., Beijing's production, and the temperature control system of adjustment drop pill machine, make the water dropper temperature heating of drop pill machine and remain on 50 ℃～90 ℃, the temperature cooling of condensing agent also remains on 40 ℃～-5 ℃;
6. when treating in dropping-pill machine head and the condensation column that the temperature of condensing agent reaches desired state of temperature respectively, to contain fused solution and/or the emulsion and/or the suspension of drug extract and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent, cooling is shunk and is shaped, promptly.
Annotate 1: described condensing agent is any one or the two or more mixture in liquid paraffin, methyl-silicone oil, the vegetable oil.
[beneficial effect]
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The clear granule of the pyretic stranguria that the preparation method that provides among-the B-3303-98 is prepared from, it is a kind of heat-clearing and toxic substances removing that has, diuresis inducing function, be used for damp-heat accumulation, yellowish or reddish urine, odynuria, urinary tract infection, pyelitis is seen the oral granular formulation of above-mentioned card marquis person treatment, through clinical verification for many years, 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.In addition, conventional peroral dosage form is as tablet, capsule, granule (electuary) etc., in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.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.
The few drop pill of headdress flower involved in the present invention is compared with the clear granule of pyretic stranguria has following beneficial effect:
1. the few drop pill of headdress flower involved in the present invention; utilize surfactant to be substrate; make solid dispersion with the extract that contains the few effective ingredient of Chinese medicine headdress flower, 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.
2. the few drop pill of headdress flower 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. the few drop pill of headdress flower involved in the present invention mixes the extract that contains active constituents of medicine mutually with molten matrix, splashes in the not miscible condensed fluid and makes.Therefore, the stability of drug height, not facile hydrolysis, oxidation, and the operation be under liquid state, to carry out, no dust pollution is not subject to the influence of crystal formation, thereby has guaranteed the quality of medicine, has increased stability.
4. production technology, the equipment of preparation drop pill are simple, easy to operate, the automaticity height, and labor intensity is low, the production efficiency height.Workshop does not have dust simultaneously, helps labor protection and environmental protection yet.
5. the production cost of preparation drop pill is usually with about 50% of other oral formulations of kind, and compares with oral liquid, and the dosage of drop pill is accurate, thereby makes the patient take metering control easily.
The specific embodiment
Now with several groups of specific embodiments, be described further with regard to the preparation method of the few drop pill of headdress flower of the present invention.
[selection of prescription]
1. raw material: according to the method that [preparation method 1] provided, it is standby to make the drug extract dry powder that contains the few effective ingredient of Chinese medicine headdress flower in advance;
2. single-matrix: Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac etc.;
3. composite substrate: with g or kg is unit, by weight, selects carriers such as Polyethylene Glycol, polyoxyethylene stearate 40 esters, carboxymethyl starch sodium, betacyclodextrin, tween to carry out composite test;
3.1 the combination of two kinds of different substrates: with g or kg is unit, by weight, gets 1 part polyoxyethylene stearate 40 esters or betacyclodextrin or carboxymethyl starch sodium or tween, makes up with 1～10 part Polyethylene Glycol, and Polyethylene Glycol wherein is meant Polyethylene Glycol
1000～Polyethylene Glycol
20000In any one or two or more mixture;
3.2 the combination of three kinds of different substrates: with g or kg is unit, by weight, get 1 part polyoxyethylene stearate 40 esters and 0.5～5 part carboxymethyl starch sodium (or betacyclodextrin or tween) and 1～10 part Polyethylene Glycol and make up, Polyethylene Glycol wherein is meant Polyethylene Glycol
1000～Polyethylene Glycol
20000In any one or two or more mixture;
3.3 the combination of four kinds of different substrates: with g or kg is unit, by weight, get 1 part polyoxyethylene stearate 40 esters and 0.5～5 part carboxymethyl starch sodium (or betacyclodextrin) and make up with 0.5～5 part tween and 1～10 part Polyethylene Glycol, Polyethylene Glycol wherein is a Polyethylene Glycol
1000～Polyethylene Glycol
20000In one or more mixture;
The proportioning of drug extract and substrate (with g or kg is unit, by weight):
Drug extract: substrate=1: 1～1: 9;
5. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the few drop pill of headdress flower of different size.
Test the test of a single-matrix
Cooperating the few drop pill of prepared headdress flower in qualitative difference with different substrates in order to observe drug extract, is unit with g or kg, according to 1: 1,1: 3,1: 9 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, matrix phases such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac cooperate, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 3 groups of drug extracts and different substrates, and obtain 3 groups of different experimental results and see Table 1～table 3.
Test the composite test of 2 two kinds of different substrates
Cooperate the few drop pill of prepared headdress flower in qualitative difference in order to observe drug extract with two kinds of different substrates, with g or kg is unit, get 1 part polyoxyethylene stearate 40 esters (S40 ester) or betacyclodextrin (beta cyclodextrin) or carboxymethyl starch sodium or tween, respectively with 1 part, 5 parts, 10 parts Polyethylene Glycol makes up, again with drug extract and composite substrate respectively with 1: 1,1: 3,1: 9 ratio matches, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 3 groups of drug extracts and various combination substrate, and obtain 3 groups of different experimental results and see Table 4～table 6.
Test the composite test of three or three kinds of different substrates
Cooperate the few drop pill of prepared headdress flower in qualitative difference in order to observe drug extract with three kinds of different substrates, with g or kg is unit, get 1 part polyoxyethylene stearate 40 esters (S40 ester) respectively with 0.5 part, 3 parts, 5 parts beta cyclodextrin (or carboxymethyl starch sodium or tween), and 1 part, 5 parts, 10 parts Polyethylene Glycol makes up, again with drug extract and composite substrate respectively with 1: 1,1: 3,1: 9 ratio matches, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 3 groups of drug extracts and various combination substrate, and obtain 3 groups of different experimental results and see Table 7～table 9.
Test the composite test of four or four kinds of different substrates
Cooperate the few drop pill of prepared headdress flower in qualitative difference in order to observe drug extract with four kinds of different substrates, with g or kg is unit, get 1 part polyoxyethylene stearate 40 esters (S40 ester) respectively with 0.5 part, 3 parts, 5 parts beta cyclodextrin (or carboxymethyl starch sodium), and 0.5 part, 3 parts, 5 parts tween, and 1 part, 5 parts, 10 parts Polyethylene Glycol makes up, again with drug extract and composite substrate respectively with 1: 1,1: 3,1: 9 ratio matches, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 3 groups of drug extracts and various combination substrate, and obtain 3 groups of different experimental results and see Table 10～table 12.
The group practices of table 1 drug extract and single-matrix
(drug extract: substrate=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 50.0 | 66 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 50.0 | 81 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 6000 | 50.0 | 81 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 10000 | 50.0 | 81 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 81 | ＜30 | ＞10 | ++ |
| Span 40 | 50.0 | 60 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 80 | ＜30 | ＞10 | ++ |
| Poloxamer | 50.0 | 82 | ＜30 | ＞10 | ++ |
| Sodium lauryl sulphate | 50.0 | 60 | ＞30 | ＞10 | ++ |
| Stearic acid | 50.0 | 61 | ＞30 | ＞10 | +++ |
| Sodium stearate | 50.0 | 61 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 50.0 | 60 | ＞30 | ＞10 | ++ |
| Lac | 50.0 | 59 | ＞30 | ＞10 | + |
The group practices of table 2 drug extract and single-matrix
(drug extract: substrate=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 25.0 | 80 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 25.0 | 88 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 25.0 | 88 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 88 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 89 | ＜30 | ＜10 | +++ |
| Span 40 | 25.0 | 65 | ＜30 | ＞10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 84 | ＜30 | ＞10 | ++ |
| Poloxamer | 25.0 | 86 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 25.0 | 74 | ＞30 | ＞10 | ++ |
| Stearic acid | 25.0 | 74 | ＞30 | ＞10 | +++ |
| Sodium stearate | 25.0 | 72 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 25.0 | 72 | ＞30 | ＞10 | ++ |
| Lac | 25.0 | 71 | ＞30 | ＞10 | ++ |
The group practices of table 3 drug extract and single-matrix
(drug extract: substrate=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 10.0 | 85 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 10.0 | 88 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 88 | ＜30 | ＜10 | +++ |
| Span 40 | 10.0 | 66 | ＜30 | ＞10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 85 | ＜30 | ＞10 | ++ |
| Poloxamer | 10.0 | 87 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 10.0 | 76 | ＞30 | ＞10 | +++ |
| Stearic acid | 10.0 | 76 | ＞30 | ＞10 | +++ |
| Sodium stearate | 10.0 | 73 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 10.0 | 73 | ＞30 | ＞10 | +++ |
| Lac | 10.0 | 72 | ＞30 | ＞10 | ++ |
The group practices of table 4 drug extract and two kinds of substrate
(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 |
| S40 ester: Polyethylene Glycol=1: 1 | 50.0 | 87 | ＜30 | ＜10 | +++ |
| S40 ester: Polyethylene Glycol=1: 5 | 50.0 | 87 | ＜30 | ＜10 | +++ |
| S40 ester: Polyethylene Glycol=1: 10 | 50.0 | 87 | ＜30 | ＜10 | +++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 1 | 50.0 | 83 | ＜30 | ＞10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 5 | 50.0 | 84 | ＜30 | ＞10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 10 | 50.0 | 84 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50.0 | 85 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50.0 | 86 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50.0 | 86 | ＜30 | ＜10 | +++ |
| Tween: Polyethylene Glycol=1: 1 | 50.0 | 80 | ＜30 | ＞10 | ++ |
| Tween: Polyethylene Glycol=1: 5 | 50.0 | 82 | ＜30 | ＞10 | ++ |
| Tween: Polyethylene Glycol=1: 10 | 50.0 | 84 | ＜30 | ＞10 | ++ |
The group practices of table 5 drug extract and two kinds of substrate
(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 |
| S40 ester: Polyethylene Glycol=1: 1 | 25.0 | 88 | ＜30 | ＞10 | +++ |
| S40 ester: Polyethylene Glycol=1: 5 | 25.0 | 89 | ＜30 | ＜10 | +++ |
| S40 ester: Polyethylene Glycol=1: 10 | 25.0 | 89 | ＜30 | ＜10 | +++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 1 | 25.0 | 84 | ＜30 | ＞10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 5 | 25.0 | 85 | ＜30 | ＞10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 10 | 25.0 | 85 | ＜30 | ＞10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25.0 | 83 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25.0 | 86 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25.0 | 86 | ＞30 | ＞10 | +++ |
| Tween: Polyethylene Glycol=1: 1 | 25.0 | 77 | ＞30 | ＞10 | ++ |
| Tween: Polyethylene Glycol=1: 5 | 25.0 | 80 | ＞30 | ＞10 | ++ |
| Tween: Polyethylene Glycol=1: 10 | 25.0 | 81 | ＞30 | ＞10 | ++ |
The group practices of table 6 drug extract and two kinds of substrate
(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 |
| S40 ester: Polyethylene Glycol=1: 1 | 10.0 | 89 | ＜30 | ＞10 | +++ |
| S40 ester: Polyethylene Glycol=1: 5 | 10.0 | 91 | ＜30 | ＜10 | +++ |
| S40 ester: Polyethylene Glycol=1: 10 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 1 | 10.0 | 87 | ＜30 | ＜10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 5 | 10.0 | 89 | ＜30 | ＜10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 10 | 10.0 | 89 | ＜30 | ＜10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10.0 | 83 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 10.0 | 86 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10.0 | 87 | ＞30 | ＜10 | +++ |
| Tween: Polyethylene Glycol=1: 1 | 10.0 | 79 | ＞30 | ＞10 | ++ |
| Tween: Polyethylene Glycol=1: 5 | 10.0 | 82 | ＞30 | ＞10 | ++ |
| Tween: Polyethylene Glycol=1: 10 | 10.0 | 82 | ＞30 | ＞10 | ++ |
The group practices of table 7 drug extract and three kinds of substrate
(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 |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 0.5: 1 | 50.0 | 85 | ＜30 | ＞10 | +++ |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 3: 5 | 50.0 | 88 | ＜30 | ＜10 | +++ |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 5: 10 | 50.0 | 88 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 0.5: 1 | 50.0 | 89 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 3: 5 | 50.0 | 90 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 5: 10 | 50.0 | 90 | ＜30 | ＜10 | +++ |
| S40 ester: tween: Polyethylene Glycol=1: 0.5: 1 | 50.0 | 83 | ＜30 | ＞10 | ++ |
| S40 ester: tween: Polyethylene Glycol=1: 3: 5 | 50.0 | 84 | ＜30 | ＞10 | ++ |
| S40 ester: tween: Polyethylene Glycol=1: 5: 10 | 50.0 | 85 | ＜30 | ＞10 | ++ |
The group practices of table 8 drug extract and three kinds of substrate
(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 |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 0.5: 1 | 25.0 | 89 | ＜30 | ＜10 | +++ |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 3: 5 | 25.0 | 91 | ＜30 | ＜10 | +++ |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 5: 10 | 25.0 | 91 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 0.5: 1 | 25.0 | 89 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 3: 5 | 25.0 | 89 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 5: 10 | 25.0 | 90 | ＜30 | ＜10 | +++ |
| S40 ester: tween: Polyethylene Glycol=1: 0.5: 1 | 25.0 | 85 | ＜30 | ＞10 | +++ |
| S40 ester: tween: Polyethylene Glycol=1: 3: 5 | 25.0 | 87 | ＜30 | ＜10 | +++ |
| S40 ester: tween: Polyethylene Glycol=1: 5: 10 | 25.0 | 88 | ＜30 | ＜10 | +++ |
The group practices of table 9 drug extract and three kinds of substrate
(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 |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 0.5: 1 | 10.0 | 89 | ＜30 | ＜10 | ++ |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 3: 5 | 10.0 | 91 | ＜30 | ＜10 | +++ |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 5: 10 | 10.0 | 91 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 0.5: 1 | 10.0 | 87 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 3: 5 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 5: 10 | 10.0 | 90 | ＜30 | ＜10 | +++ |
| S40 ester: tween: Polyethylene Glycol=1: 0.5: 1 | 10.0 | 86 | ＜30 | ＜10 | +++ |
| S40 ester: tween: Polyethylene Glycol=1: 3: 5 | 10.0 | 87 | ＜30 | ＜10 | +++ |
| S40 ester: tween: Polyethylene Glycol=1: 5: 10 | 10.0 | 88 | ＜30 | ＜10 | +++ |
The group practices of table 10 drug extract and four kinds of substrate
(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 |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 0.5: 0.5: 1 | 50.0 | 83 | ＜30 | ＞10 | ++ |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 3: 3: 5 | 50.0 | 84 | ＜30 | ＞10 | ++ |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 5: 5: 10 | 50.0 | 85 | ＜30 | ＞10 | +++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 0.5: 0.5: 1 | 50.0 | 84 | ＜30 | ＞10 | ++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 3: 3: 5 | 50.0 | 85 | ＜30 | ＞10 | ++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 5: 5: 10 | 50.0 | 85 | ＜30 | ＞10 | ++ |
The group practices of table 11 drug extract and four kinds of substrate
(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 |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 0.5: 0.5: 1 | 25.0 | 85 | ＜30 | ＞10 | ++ |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 3: 3: 5 | 25.0 | 86 | ＜30 | ＜10 | +++ |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 5: 5: 10 | 25.0 | 87 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 0.5: 0.5: 1 | 25.0 | 87 | ＜30 | ＜10 | ++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 3: 3: 5 | 25.0 | 88 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 5: 5: 10 | 25.0 | 88 | ＜30 | ＜10 | +++ |
The group practices of table 12 drug extract and four kinds of substrate
(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 |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 0.5: 0.5: 1 | 10.0 | 89 | ＜30 | ＜10 | ++ |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 3: 3: 5 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 5: 5: 10 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 0.5: 0.5: 1 | 10.0 | 86 | ＜30 | ＜10 | ++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 3: 3: 5 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 5: 5: 10 | 10.0 | 88 | ＜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 hardness etc. 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 (8)
1. one kind is used for heat-clearing and toxic substances removing, and the few drop pill of pharmaceutical composition headdress flower of inducing diuresis for treating stranguria syndrome is a raw material with the extract that contains the few effective ingredient of Chinese medicine headdress flower, be prepared from pharmaceutically suitable carrier as substrate, wherein:
1.1 described drug extract is made by following method: with g or kg is unit, and it is an amount of to get Herba Polygoni Capitati, decocts with water secondary, and each 1.5 hours, collecting decoction filtered, and it is 1.3～1.4 thick paste that filtrate is concentrated into relative density, promptly gets the drug extract thick paste; Or continue to make drying, and be ground into dry powder, promptly get drug extract dry powder;
1.2 described substrate is selected from polyethylene glycols, sorbitol anhydride class, polyoxyethylene sorbitol acid anhydride class, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac, above-mentioned carrier one or more mixture wherein;
1.3 with g or kg is unit, drug extract: substrate=1: 1～1: 9.
2. the few drop pill of headdress flower as claimed in claim 1 is characterized in that: described substrate is the mixture of S40 ester or carboxymethyl starch sodium or beta cyclodextrin or tween and Polyethylene Glycol, and its mixed proportion is 1: 1～1: 10.
3. the few drop pill of headdress flower as claimed in claim 1 is characterized in that: described substrate is the mixture of S40 ester, beta cyclodextrin or carboxymethyl starch sodium or tween and Polyethylene Glycol, and its mixed proportion is 1: 0.5: 1～1: 5: 10.
4. the few drop pill of headdress flower as claimed in claim 1 is characterized in that: described substrate is the mixture of S40 ester, beta cyclodextrin or carboxymethyl starch sodium, tween and Polyethylene Glycol, and its mixed proportion is 1: 0.5: 0.5: 1～1: 5: 5: 10.
5. as claim 1 or the few drop pill of 2 or 3 or 4 described any headdress flowers, it is characterized in that: the mixed proportion of described drug extract and substrate is 1: 1～1: 5.
6. as claim 2 or 3 or 4 described composite substrates, it is characterized in that: described Polyethylene Glycol is selected from Polyethylene Glycol
1000～Polyethylene Glycol
20000In any one or two or more mixture.
7. preparation method that is used for the few drop pill of the described headdress flower of claim 1 is characterized in that being made of following process:
7.1 the preparation of drug extract: with g or kg is unit, and it is an amount of to get Herba Polygoni Capitati, decocts with water secondary, and each 1.5 hours, collecting decoction filtered, and it is 1.3～1.4 thick paste that filtrate is concentrated into relative density, promptly gets the drug extract thick paste; Or continue to make drying, and be ground into dry powder, promptly get drug extract dry powder;
7.2 substrate: substrate is selected from polyethylene glycols, sorbitol anhydride class, polyoxyethylene sorbitol acid anhydride class, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac, above-mentioned carrier one or more mixture wherein;
7.3 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
7.4, 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;
7.5 adjust the temperature control system of drop pill machine, make the water dropper temperature heating of drop pill machine and remain on 50 ℃～90 ℃, the temperature cooling of condensing agent also remains on 40 ℃～-5 ℃;
7.6 when treating in dropping-pill machine head and the condensation column that the temperature of condensing agent reaches desired state of temperature respectively, to contain fused solution and/or the emulsion and/or the suspension of drug extract and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent, cooling is shunk and is shaped, promptly.
8. preparation method as claimed in claim 7 is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510090142 CN1730041A (en) | 2005-08-11 | 2005-08-11 | Dripping pills of polygonum capitatum and its preparation process |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510090142 CN1730041A (en) | 2005-08-11 | 2005-08-11 | Dripping pills of polygonum capitatum and its preparation process |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102441041A (en) * | 2010-10-09 | 2012-05-09 | 安徽科创中药天然药物研究所有限责任公司 | Polygonun capitatum oral preparation, its formula, preparation method and quality control technique |
| CN102716194A (en) * | 2012-02-13 | 2012-10-10 | 李兴惠 | Polygonum capitatum composition for preventing or treating whelk |
| TWI832471B (en) * | 2022-10-04 | 2024-02-11 | 嘉藥學校財團法人嘉南藥理大學 | Free radical scavenging and pro-whitening polygonum capitatum microcapsule carrier and preparation method and use thereof |
-
2005
- 2005-08-11 CN CN 200510090142 patent/CN1730041A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102441041A (en) * | 2010-10-09 | 2012-05-09 | 安徽科创中药天然药物研究所有限责任公司 | Polygonun capitatum oral preparation, its formula, preparation method and quality control technique |
| CN102716194A (en) * | 2012-02-13 | 2012-10-10 | 李兴惠 | Polygonum capitatum composition for preventing or treating whelk |
| CN102716194B (en) * | 2012-02-13 | 2014-08-06 | 谢雁鸣 | Polygonum capitatum composition for preventing or treating whelk |
| TWI832471B (en) * | 2022-10-04 | 2024-02-11 | 嘉藥學校財團法人嘉南藥理大學 | Free radical scavenging and pro-whitening polygonum capitatum microcapsule carrier and preparation method and use thereof |
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