CN1814053A - Kanggongyan drop-pills for treating gynecopathy and preparing method - Google Patents
Kanggongyan drop-pills for treating gynecopathy and preparing method Download PDFInfo
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Abstract
The invention relates to a drug combination for curing gynaecological disease, providing an anti-cervicitis oral pill drop, having characters of high biologic utilization ratio, fast releasing, fast taking effect, high drug content, convenience to taking and low price and no pollution in production. And the pill drop is prepared of the raw materials: extractives from the three traditional Chinese medicines--dry extract of Guangdong beautyberry leaf, dry extract of motherwort, dry extract of combined Spicebush root, and a medicinal carrier as substrate.
Description
Technical field
The present invention relates to treat the pharmaceutical composition of gynaecological disease, is a kind of drug composition oral preparation that feedstock production forms with 3 kinds of Chinese medicine extract such as Callicarpa kwangtungensis Chun dry extract, Herba Leonuri dry extract, Radix Linderae dry extracts particularly.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The KANGGONGYAN PIAN that the preparation method that provides among-the B-2149-96 is prepared from, it is a kind of clearing away damp-heat that has, leukorrhagia stopping is effect down, be used for the damp invasion of lower energizer that causes because of chronic cervicitis, leucorrhea with red and white discharge, cervical erosion, the hemorrhage oral tablet that waits the disease treatment, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
According to another Zhang Guangxian, Hu Hanghui is published in the article " pharmacodynamic study of Yuqin's KANGGONGYAN PIAN " of the 6th the 12nd phase of volume of December in 2000 of Chinese medicine Leader, Hunan and introduces: by various contrast tests, KANGGONGYAN PIAN and gynecological's good medicine QIANJIN PIAN have roughly the same drug effect, and this has also illustrated KANGGONGYAN PIAN credibility clinically.
93103268.7 number Chinese invention patent also discloses " a kind of manufacture method of anti-inflammation tablet for metritis ", the drug standard that draw wherein disclosed technology contents and front slightly together.
01102354.6 number Chinese invention patent also discloses a kind of " nano medicine ' Kanggongyan ' and preparation method thereof ", wherein also mention the employing nanotechnology in 4 in the claims and made drop pill, but in description, there is not the introduction of any relevant method for preparing drop pills, only according to its disclosed description, the drop pill that at all just can't prepare anti-cervicitis comes.
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 drop pill that adopts solid dispersion technology to be prepared from has thoroughly changed the existing defective of conventional oral formulations from the frame mode of medicine.Owing to make the active component of medicine and substrate fusion be one and form liquid in advance, make active constituents of medicine fully dissolve and be dispersed in uniformly in the chemical lattice of substrate fused solution, thereby make the effective surface area of drug molecule (group) increase greatly, improved the contact area of active constituents of medicine dissolving back with gastrointestinal tract mucosa; Owing to the ease of solubility of substrate, make drop pill after taking, can dissolve rapidly, and absorbed simultaneously, played high speed, good effect efficiently by gastrointestinal tract mucosa.In addition because the medicament contg height of drop pill, volume is little, dissolution velocity is fast, dissolving back mouthfeel is good, also can adopt the mode of sublingual administration, can make effective ingredient directly absorb and enter blood circulation by the Sublingual mucosa, avoid the first pass effect of conventional oral formulations effectively, also avoid some drugs gastrointestinal tract to be produced the side effect that stimulates without gastrointestinal tract and liver.
Yet, because the preparation technology of drop pill is still not really ripe, its relevant device does not yet reach standardized degree, when utilizing the prior art for preparing drop pill, product quality is subjected to the physicochemical property of medicine, the kind of substrate and with the ratio of medicament mixed, factor affecting such as condensing agent and temperature thereof, the rounding rate, the quality index of the relevant dropping pill formulation of defined differs bigger in indexs such as the ball method of double differences is different and the national drug standards, such product is in use having a strong impact on the accuracy of dosage, also make the qualification rate of product reduce aborning, increased production cost, thereby also indirect increase patient's drug cost, thereby make its practicality also decrease.
Summary of the invention
Purpose of the present invention, be to replenish the existing deficiency that is used for the treatment of the gynaecological disease oral drug preparation, a kind of quality index that can satisfy the relevant dropping pill formulation of defined in the national drug standards fully is provided, also possesses simultaneously the bioavailability height, release fast, quick produce effects, taking convenience, cheap, and free of contamination aborning anti-cervicitis drop pill.Anti-cervicitis drop pill involved in the present invention is a raw material with 3 kinds of Chinese medicine extract such as Callicarpa kwangtungensis Chun dry extract, Herba Leonuri dry extract, Radix Linderae dry extracts, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain anti-cervicitis drop pill involved in the present invention:
[preparation method]
1. the preparation of medicinal mixture
The preparation of Callicarpa kwangtungensis Chun dry extract
Get Callicarpa kwangtungensis Chun, run through, be cut into segment or former, decoct with water secondary, 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, and filtrate is concentrated into the thick paste shape, drying under reduced pressure, promptly.Every 1g dry extract is equivalent to crude drug 33.0g;
The preparation of Herba Leonuri dry extract
Get Herba Leonuri, chopping decocts with water secondary, and each 2 hours, collecting decoction filtered, and filtrate is condensed into the thick paste shape, drying under reduced pressure, promptly; Every 1g dry extract is equivalent to crude drug 14.0g;
The preparation of Radix Linderae dry extract
Get the Radix Linderae, section decocts with water secondary, and each 2 hours, collecting decoction filtered, and filtrate is condensed into the thick paste shape, drying under reduced pressure, promptly; Every 1g dry extract is equivalent to crude drug 18g approximately;
The preparation of medicinal mixture
More than three the flavor, be ground into fine powder, mix homogeneously, standby;
2. substrate: the mixture of one or more in pharmaceutically suitable carrier such as 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;
3. proportioning: with g or kg is unit, medicinal mixture: substrate=1: 1～1: 9;
More preferred ratio range is medicinal mixture: substrate=1: 1～1: 5;
4. according to aforementioned proportion, accurately take by weighing medicinal mixture and substrate, be placed in the heating container heating while stirring, standby until the fused solution that obtains containing medicinal mixture and substrate and/or emulsion and/or suspension;
5. adopt homemade or general drop pill machine (as the product of Changzheng Tianmin High Science ﹠ Technology Co., Ltd., Beijing), and the temperature control system of adjustment drop pill machine, make the water dropper temperature heating of drop pill machine and remain on 50 ℃～90 ℃, the temperature cooling of condensing agent also remains on 40 ℃～-5 ℃;
6. when treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and reaching desired state of temperature, to contain the fused solution of medicinal mixture and substrate and/or emulsion and/or suspension places in the dropping-pill machine head jar, splash in the condensing agent, shrink shaping, promptly.
Annotate: condensing agent can be 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 KANGGONGYAN PIAN that the preparation method that provides among-the B-2149-96 is prepared from, it is a kind of clearing away damp-heat that has, leukorrhagia stopping is effect down, be used for the damp invasion of lower energizer that causes because of chronic cervicitis, leucorrhea with red and white discharge, cervical erosion, the hemorrhage oral tablet that waits the disease treatment, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.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 drop pill that adopts solid dispersion technology to be prepared from has thoroughly changed the existing defective of conventional oral formulations from the frame mode of medicine.Yet, because the preparation technology of drop pill is still not really ripe, its relevant device does not yet reach standardized degree, when utilizing the prior art for preparing drop pill, product quality is subjected to the physicochemical property of medicine, the kind of substrate and with the ratio of medicament mixed, factor affecting such as condensing agent and temperature thereof, the rounding rate, the quality index of the relevant dropping pill formulation of defined differs bigger in indexs such as the ball method of double differences is different and the national drug standards, such product is in use having a strong impact on the accuracy of dosage, also make the qualification rate of product reduce aborning, increased production cost, thereby also indirect increase patient's drug cost, thereby make its practicality also decrease.
Anti-cervicitis drop pill involved in the present invention has following beneficial effect:
1. anti-cervicitis drop pill involved in the present invention, scope, proportioning and the process conditions of used adjuvant have been determined by a large amount of tests, and select the equipment of function admirable for use, make technology of preparing disclosed in this invention more be useful for industrial production requirement, the yield rate height, accurate measurement, production cost is lower.
2. anti-cervicitis drop pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion with 3 kinds of Chinese medicine extract such as Callicarpa kwangtungensis Chun dry extract, Herba Leonuri dry extract, Radix Linderae dry extracts; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases; and substrate is hydrophilic; contact promptly with saliva and to dissolve rapidly; and absorb by oral mucosa; can make medicine molten microgranule or the solution of loosing into rapidly; thereby make the dissolving of medicine and absorb to accelerate, thereby improved bioavailability, bring into play efficient, quick-acting effects etc.
3. antiphlogistic bezoar dripping pill involved in the present invention mixes medicine material 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. the labor intensity of preparation drop pill is low, the production efficiency height, and simultaneously workshop does not have dust, helps labor protection and environmental protection yet, and its production cost is usually with kind tablet, capsular about 50%.
The specific embodiment
Now with several groups of specific embodiments, be described further with regard to the preparation method of anti-cervicitis drop pill of the present invention.
[selection of prescription]
1. raw material: make 3 kinds of Chinese medicine extract dry extracts such as Callicarpa kwangtungensis Chun, Herba Leonuri, the Radix Linderae in advance according to [preparation method 1], be ground into fine powder, mix homogeneously, standby;
2. single-matrix: be selected from Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, a kind of in the carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
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;
The combination of (1) two kind 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;
The combination of (2) 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;
The combination of (3) 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 medicine material and substrate (with g or kg is unit, by weight):
Medicine material: substrate=1: 1～1: 9;
5. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the anti-cervicitis drop pill of different size.
Test the test of a single-matrix
With g or kg is unit, according to 1: 1,1: 3,1: 9 ratio, with medicinal mixture 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, and make anti-cervicitis drop pill quality situation such as table 1～table 3.
Test the composite test of 2 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, make up with 1 part, 5 parts, 10 parts Polyethylene Glycol respectively, again medicinal mixture and composite substrate are matched the anti-cervicitis drop pill quality situation such as the table 4～table 6 that make with 1: 1,1: 3,1: 9 ratio respectively.
Test the composite test of three or 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 medicinal mixture and composite substrate are matched the anti-cervicitis drop pill quality situation such as the table 7～table 9 that make with 1: 1,1: 3,1: 9 ratio respectively.
Test the composite test of four or 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 medicinal mixture and composite substrate are matched the anti-cervicitis drop pill quality situation such as the table 10～table 12 that make with 1: 1,1: 3,1: 9 ratio respectively.
The group practices of table 1 medicinal mixture and single-matrix
(medicinal mixture: 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 | 78 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 6000 | 50.0 | 80 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 10000 | 50.0 | 80 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 79 | ＜30 | ＞10 | ++ |
| Span 40 | 50.0 | 62 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 78 | ＜30 | ＞10 | ++ |
| Poloxamer | 50.0 | 82 | ＜30 | ＞10 | ++ |
| Sodium lauryl sulphate | 50.0 | 61 | ＞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 medicinal mixture and single-matrix
(medicinal mixture: 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 | 79 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 25.0 | 88 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 25.0 | 88 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 87 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 86 | ＜30 | ＜10 | +++ |
| Span 40 | 25.0 | 65 | ＜30 | ＞10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 83 | ＜30 | ＞10 | ++ |
| Poloxamer | 25.0 | 86 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 25.0 | 73 | ＞30 | ＞10 | ++ |
| Stearic acid | 25.0 | 73 | ＞30 | ＞10 | +++ |
| Sodium stearate | 25.0 | 72 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 25.0 | 71 | ＞30 | ＞10 | ++ |
| Lac | 25.0 | 71 | ＞30 | ＞10 | ++ |
The group practices of table 3 medicinal mixture and single-matrix
(medicinal mixture: substrate=1: 10)
| 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 | 89 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 88 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 86 | ＜30 | ＜10 | +++ |
| Span 40 | 10.0 | 66 | ＜30 | ＞10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 84 | ＜30 | ＞10 | ++ |
| Poloxamer | 10.0 | 87 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 10.0 | 73 | ＞30 | ＞10 | +++ |
| Stearic acid | 10.0 | 74 | ＞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 medicinal mixture and two kinds of substrate
(medicinal mixture: 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 | 89 | ＜30 | ＜10 | +++ |
| S40 ester: Polyethylene Glycol=1: 10 | 50.0 | 89 | ＜30 | ＜10 | +++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 1 | 50.0 | 81 | ＜30 | ＞10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 5 | 50.0 | 82 | ＜30 | ＞10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 10 | 50.0 | 85 | ＜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 | 87 | ＜30 | ＜10 | +++ |
| Tween: Polyethylene Glycol=1: 1 | 50.0 | 79 | ＜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 medicinal mixture and two kinds of substrate
(medicinal mixture: 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 | 90 | ＜30 | ＜10 | +++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 1 | 25.0 | 84 | ＜30 | ＞10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 5 | 25.0 | 84 | ＜30 | ＞10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 10 | 25.0 | 85 | ＜30 | ＞10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25.0 | 85 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25.0 | 85 | ＜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 | 80 | ＜30 | ＞10 | ++ |
The group practices of table 6 medicinal mixture and two kinds of substrate
(medicinal mixture: 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 | 91 | ＜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 | 85 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 10.0 | 87 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10.0 | 88 | ＜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 medicinal mixture and three kinds of substrate
(medicinal mixture: 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 | 87 | ＜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 | 88 | ＞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 | 82 | ＜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 medicinal mixture and three kinds of substrate
(medicinal mixture: 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 | 86 | ＜30 | ＜10 | +++ |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 3: 5 | 25.0 | 89 | ＜30 | ＜10 | +++ |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 5: 10 | 25.0 | 90 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 0.5: 1 | 25.0 | 85 | ＜30 | ＞10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 3: 5 | 25.0 | 88 | ＞30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 5: 10 | 25.0 | 89 | ＞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 medicinal mixture and three kinds of substrate
(medicinal mixture: 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 | 90 | ＜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 | 88 | ＞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 | 86 | ＜30 | ＜10 | +++ |
| S40 ester: tween: Polyethylene Glycol=1: 5: 10 | 10.0 | 88 | ＜30 | ＜10 | +++ |
The group practices of table 10 medicinal mixture and four kinds of substrate
(medicinal mixture: 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: 05: 05: 1 | 50.0 | 82 | ＞30 | ＞10 | ++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 3: 3: 5 | 50.0 | 83 | ＞30 | ＞10 | ++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 5: 5: 10 | 50.0 | 83 | ＞30 | ＞10 | ++ |
The group practices of table 11 medicinal mixture and four kinds of substrate
(medicinal mixture: 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 | 84 | ＜30 | ＞10 | ++ |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 3: 3: 5 | 25.0 | 85 | ＜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 | 86 | ＞30 | ＜10 | ++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 3: 3: 5 | 25.0 | 86 | ＞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 medicinal mixture and four kinds of substrate
(medicinal mixture: 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 | 87 | ＜30 | ＜10 | ++ |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 3: 3: 5 | 10.0 | 88 | ＜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: 05: 05: 1 | 10.0 | 86 | ＞30 | ＜10 | ++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 3: 3: 5 | 10.0 | 87 | ＞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 medicinal mixture 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 medicinal mixture 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 medicinal mixture 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 (7)
1. anti-cervicitis drop pill that is used for the treatment of gynaecological disease, with 3 kinds of Chinese medicine extract such as Callicarpa kwangtungensis Chun dry extract, Herba Leonuri dry extract, Radix Linderae dry extracts is raw material, be prepared from pharmaceutically suitable carrier, it is characterized in that described preparation process is as follows as substrate:
(1) preparation of medicinal mixture
Get Callicarpa kwangtungensis Chun, run through, be cut into segment or former, decoct with water secondary, 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, and filtrate is concentrated into the thick paste shape, drying under reduced pressure, promptly;
Get Herba Leonuri, chopping decocts with water secondary, and each 2 hours, collecting decoction filtered, and filtrate is condensed into the thick paste shape, drying under reduced pressure, promptly;
Get the Radix Linderae, section decocts with water secondary, and each 2 hours, collecting decoction filtered, and filtrate is condensed into the thick paste shape, drying under reduced pressure, promptly;
More than three the flavor, be ground into fine powder, mix homogeneously, standby;
(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, the mixture of one or more in above-mentioned pharmaceutically suitable carrier;
(3) be unit with g or kg, medicinal mixture: substrate=1: 1～1: 9;
(4) according to aforementioned proportion, accurately take by weighing medicinal mixture and substrate, be placed in the heating container heating while stirring, standby until the fused solution that obtains containing medicinal mixture and substrate and/or emulsion and/or suspension;
(5) 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 40 ℃～-5 ℃;
When (6) treating in dropping-pill machine head and the condensation column that the temperature of condensing agent reaches desired state of temperature respectively, fused solution and/or the emulsion and/or the suspension that will contain medicinal mixture and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent and shrink molding promptly.
2. anti-cervicitis drop pill 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. anti-cervicitis drop pill 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. anti-cervicitis drop pill 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 2 or 3 or 4 described any anti-cervicitis drop pill, it is characterized in that: the mixed proportion of described medicament mixed liquid 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. anti-cervicitis drop pill as claimed in claim 1 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 200510127978 CN1814053A (en) | 2005-07-26 | 2005-12-09 | Kanggongyan drop-pills for treating gynecopathy and preparing method |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200510087058 | 2005-07-26 | ||
| CN200510087058.5 | 2005-07-26 | ||
| CN 200510127978 CN1814053A (en) | 2005-07-26 | 2005-12-09 | Kanggongyan drop-pills for treating gynecopathy and preparing method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1814053A true CN1814053A (en) | 2006-08-09 |
Family
ID=36906485
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510127978 Pending CN1814053A (en) | 2005-07-26 | 2005-12-09 | Kanggongyan drop-pills for treating gynecopathy and preparing method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1814053A (en) |
-
2005
- 2005-12-09 CN CN 200510127978 patent/CN1814053A/en active Pending
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