CN107823152A - A kind of preparation method of lotus sesame sulfathiazole - Google Patents
A kind of preparation method of lotus sesame sulfathiazole Download PDFInfo
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- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/55—Liquid-liquid separation; Phase separation
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Abstract
A kind of preparation method of lotus sesame sulfathiazole, belong to technical field of traditional Chinese medicine preparation, it is by the Herba Andrographis dry extractum containing total andrographolide, Radix Helicteris dry extractum powder composition, its advantage is that auxiliary material mainly uses pueraria starch, can play a part of bonding and improve the drug effect of lotus sesame medicine;Lotus sesame powder mixture is added to after in the starch mud prepared in advance, the dissolution rate after tablet is taken can be accelerated;Cornstarch is finally added in lotus sesame starch mud, it is possible to reduce the gelatinization degree of cornstarch, improve the disintegration rate after tablet is taken;Assimilation effect of the medicine in patient's body can be effectively improved on the whole;Wherein used Herba Andrographis dry extractum is that the ethanol of proper proportion and concentration ultrasonic extraction at a proper temperature is used after appropriate temperature baking, clean concentration again, the paste-forming rate of creat lactone can not only be effectively improved, purity can also be improved, greatly improves the quality and production efficiency of product.
Description
Technical field
The present invention relates to a kind of preparation method of Chinese medicine preparation, and in particular to a kind of preparation method of lotus sesame sulfathiazole.
Background technology
Lotus sesame sulfathiazole is recorded in hygienic ministerial standard WS3- B-3977-98-8, by Herba Andrographis dry extractum(With andrographolide
Meter)15g, Radix Helicteris dry extractum 43g are made as bulk drug, clearing heat and detoxicating, the cool blood detumescence of energy, have for lung stomach in hot, fiery poison
Sheng causes the diseases such as cough and asthma, mumps, acute tonsillitis, larynx numbness pharyngalgia.
In the prior art, lotus sesame sulfathiazole is prepared in the preparation using cornstarch as auxiliary material, and technique is coarse
Using effect of the lotus sesame sulfathiazole in actual clinical it is unsatisfactory, its disintegration rate of clinical discovery is slower, and dissolution rate is slow,
So that the action time of medicine is delayed.
In addition, existing lotus sesame sulfathiazole directly uses Herba Andrographis dry extractum, rather than it is former using Herba Andrographitis Chinese herbal medicine
Medicine, the purity of the quality particularly total andrographolide of this dry extract can not ensure, also have impact on medicine to a certain extent
The effect of thing.
The content of the invention
The purpose of the present invention provides a kind of use for above-mentioned technical problem and special procures the preparation of auxiliary material combination specific process
Lotus sesame sulfathiazole, to improve disintegration rate and dissolution rate and improve assimilation effect of the medicine in patient's body, while provide one
Kind bulk drug extracting method simple to operate, to improve the effective component recovery rate of Herba Andrographitis, the treatment of medicine is improved on the whole
Effect.
In order to solve the above technical problems, the technical solution adopted in the present invention is a kind of preparation method of lotus sesame sulfathiazole,
It is characterized in that it is prepared by the raw material and auxiliary material of following parts by weight.
(1) the Herba Andrographis dry extractum containing 15 parts of total andrographolide is taken, 43 parts of Radix Helicteris dry extractum is taken, is ground into dry powder, mistake
100 mesh sieves, it is well mixed, obtains lotus sesame powder mixture.
(2) auxiliary material is taken, and the parts by weight of auxiliary material subtract Herba Andrographis dry extractum parts by weight and Radix Helicteris dry extractum weight for 280 parts
Part, auxiliary material is made up of pueraria starch, dextrin, sucrose, cornstarch, and its proportion of composing is:109 parts of pueraria starch:Dextrin 23.5
Part:33.3 parts of sucrose:20 parts of cornstarch.
(3) sucrose is added to the syrup for being configured to that concentration is 30% in purified water.
(4) pueraria starch, dextrin are added in syrup and are sufficiently mixed stirring and obtain starch mud, stand 5-10 minutes.
(5) lotus sesame powder mixture is added in starch mud, stirred, then stood 10-15 minutes, obtain Lian Zhi
Starch mud.
(6) cornstarch is added in lotus sesame starch mud, stirred, obtained lotus sesame mixture softwood, then made
Grain, drying, whole grain, tabletting, obtain lotus sesame sulfathiazole.
The Herba Andrographis dry extractum comprises the following steps.
1. Folium Andrographis are crushed, 4 mesh sieves are crossed, obtain Herba Andrographitis coarse powder.
2. Herba Andrographitis coarse powder is put into curing environment and is warmed to 67-77 DEG C.
3. the Herba Andrographitis coarse powder after heating is passed through with 90% ethanol solution at a temperature of 65-67 DEG C according to 4ml/g solid-liquid ratios
35-40kHz ultrasonic extractions 60 minutes, then filter to take liquid;According still further to 8ml/g solid-liquid ratios by filter residue with 90% ethanol solution in 65-
By 35-40kHz ultrasonic extractions 90 minutes at a temperature of 67 DEG C, liquid is then filtered to take, merges extract solution.
4. adding 0.15 part of activated carbon according to every part of Herba Andrographitis coarse powder of parts by weight, flow back 30min in 72 DEG C of temperature environments
Decolourize, filter while hot, filtrate add 0.1 part of activated carbon flow back in 72 DEG C of temperature environments 30min decolourize, filter while hot.
5. ethanol is recovered under reduced pressure and concentrates, the volume of concentrate is concentrated into:Medicinal material gross weight ratio is 1mL:1g, then add etc.
The purified water of volume is measured, is boiled 23-27 minutes, stands two days, filtering.
6. concentrating filtrate to density is 1.30-1.35g/mL thick paste, then is dried under reduced pressure, crushes, produce punching
Lotus dry extract.
The beneficial effects of the invention are as follows auxiliary material mainly to use pueraria starch, and pueraria starch is used in lotus sesame sulfathiazole not only
The due effect of starch can be played, additionally it is possible to improve the drug effect of lotus sesame medicine, promote the absorption of active ingredient;Lotus sesame dry powder mixes
Compound is added to after in the starch mud prepared in advance, can accelerate the dissolution rate after tablet is taken;Cornstarch is last
It is added in lotus sesame starch mud, it is possible to reduce the gelatinization degree of cornstarch, improve the disintegration rate after tablet is taken;In entirety
On can effectively improve assimilation effect of the medicine in patient's body;Wherein used Herba Andrographis dry extractum is in appropriate temperature
, not only can be effective using proper proportion and the ethanol ultrasonic extraction, then the concentration that cleans at a proper temperature of concentration after baking
The paste-forming rate of creat lactone is improved, purity can also be improved, greatly improve the quality and production efficiency of lotus sesame sulfathiazole.
Embodiment
With reference to embodiment, the invention will be further described, and following examples are intended to illustrate invention rather than to this
The further restriction of invention, should not be limited the scope of the invention with this.
Embodiment 1:Prepare Herba Andrographis dry extractum.
1. Folium Andrographis are crushed, 4 mesh sieves are crossed, Herba Andrographitis coarse powder is obtained, takes Herba Andrographitis coarse powder 5kg standby.
2. Herba Andrographitis coarse powder is put into baking box and is warmed to 67 DEG C.
3. the Herba Andrographitis coarse powder after heating is carried with 20 liter of 90% ethanol solution at a temperature of 65 DEG C with 35kHz ultrasounds first
Take 60 minutes, then filter to take liquid;Filter residue is used into 35kHz ultrasonic extractions 90 with 40 liter of 90% ethanol solution at a temperature of 65 DEG C again
Minute, liquid is then filtered to take, merges extract solution.
4. adding 0.75kg activated carbons into filtrate, the 30min that flowed back in 72 DEG C of temperature environments decolourizes, and filters while hot, so
0.5kg activated carbons are added in filtrate afterwards, the 30min that flowed back in 72 DEG C of temperature environments decolourizes, and filters take liquid while hot.
5. by decompression filtrate recycling ethanol and concentrating, 5 liters are concentrated into, 5 liters of purified waters is then added, boils 23 minutes, it is quiet
Put two days, filter to take liquid.
6. concentrating filtrate to density is 1.30-1.35g/mL thick paste, then is dried under reduced pressure, crushes, obtain punching
Lotus dry extract 115g.
Embodiment 2.Prepare Herba Andrographis dry extractum.
1. Folium Andrographis are crushed, 4 mesh sieves are crossed, Herba Andrographitis coarse powder is obtained, takes Herba Andrographitis coarse powder 10kg standby.
2. Herba Andrographitis coarse powder is put into baking box and is warmed to 72 DEG C.
3. the Herba Andrographitis coarse powder after heating is carried with 40 liter of 90% ethanol solution at a temperature of 66 DEG C with 37kHz ultrasounds first
Take 60 minutes, then filter to take liquid;Filter residue is used into 37kHz ultrasonic extractions 90 with 80 liter of 90% ethanol solution at a temperature of 66 DEG C again
Minute, liquid is then filtered to take, merges extract solution.
4. adding 1.5kg activated carbons into filtrate, the 30min that flowed back in 72 DEG C of temperature environments decolourizes, and filters while hot, then
1.0kg activated carbons are added in filtrate, the 30min that flowed back in 72 DEG C of temperature environments decolourizes, and filters take liquid while hot.
5. by decompression filtrate recycling ethanol and concentrating, 10 liters are concentrated into, 10 liters of purified waters is then added, boils 25 minutes,
Two days are stood, filters to take liquid.
6. concentrating filtrate to density is 1.30-1.35g/mL thick paste, then is dried under reduced pressure, crushes, obtain punching
Lotus dry extract 236g.
Embodiment 3.Prepare Herba Andrographis dry extractum.
1. Folium Andrographis are crushed, 4 mesh sieves are crossed, Herba Andrographitis coarse powder is obtained, takes Herba Andrographitis coarse powder 20kg standby.
2. Herba Andrographitis coarse powder is put into baking box and is warmed to 77 DEG C.
3. the Herba Andrographitis coarse powder after heating is carried with 80 liter of 90% ethanol solution at a temperature of 67 DEG C with 40kHz ultrasounds first
Take 60 minutes, then filter to take liquid;Filter residue is used into 40kHz ultrasonic extractions 90 with 160 liter of 90% ethanol solution at a temperature of 67 DEG C again
Minute, liquid is then filtered to take, merges extract solution.
4. adding 3.0kg activated carbons into filtrate, the 30min that flowed back in 72 DEG C of temperature environments decolourizes, and filters while hot, then
2.0kg activated carbons are added in filtrate, the 30min that flowed back in 72 DEG C of temperature environments decolourizes, and filters take liquid while hot.
5. by decompression filtrate recycling ethanol and concentrating, 20 liters are concentrated into, 20 liters of purified waters is then added, boils 27 minutes,
Two days are stood, filters to take liquid.
6. concentrating filtrate to density is 1.30-1.35g/mL thick paste, then is dried under reduced pressure, crushes, obtain punching
Lotus dry extract 466g.
Embodiment 4:Prepare lotus sesame sulfathiazole.
(1) Herba Andrographis dry extractum 52g is taken, measures and includes total andrographolide 15g, Radix Helicteris dry extractum 43g is taken, is ground into
Dry powder, 100 mesh sieves are crossed, be well mixed, obtain lotus sesame powder mixture.
(2) pueraria starch 109g, dextrin 23.5g, sucrose 33.3g, cornstarch 20g are taken.
(3) sucrose is added to the syrup for being configured to that concentration is 30% in purified water, obtains 111g syrup.
(4) pueraria starch, dextrin are added in syrup to be sufficiently mixed and are uniformly mixing to obtain starch mud, stand 5-10 minutes.
(5) and then lotus sesame powder mixture is added in starch mud, stirred, then stood 5-10 minutes, obtain lotus
Sesame starch mud.
(6) and then cornstarch is added in lotus sesame starch mud, stirs, obtain lotus sesame mixture softwood, Ran Houjin
Row granulation, drying, whole grain, tabletting, coating, obtain lotus sesame sulfathiazole 1000, every 0.28g.
Embodiment 5:Prepare lotus sesame sulfathiazole.
(1) Herba Andrographis dry extractum 51.5kg is taken, measures and includes total andrographolide 1.5kg, takes Radix Helicteris dry extractum 4.3kg,
Dry powder is ground into, crosses 100 mesh sieves, is well mixed, obtains lotus sesame powder mixture.
(2) pueraria starch 10.9kg, dextrin 2.35kg, sucrose 3.33kg, cornstarch 2.0kg are taken.
(3) sucrose is added to the syrup for being configured to that concentration is 30% in purified water, obtains 11.1kg syrup.
(4) pueraria starch, dextrin are added in syrup to be sufficiently mixed and are uniformly mixing to obtain starch mud, stand 5-10 minutes.
(5) and then lotus sesame powder mixture is added in starch mud, stirred, then stood 5-10 minutes, obtain lotus
Sesame starch mud.
(6) and then cornstarch is added in lotus sesame starch mud, stirs, obtain lotus sesame mixture softwood, Ran Houjin
Row granulation, drying, whole grain, tabletting, coating, obtain lotus sesame sulfathiazole 100000, every 0.28g.
Comparative example 6:Lotus sesame sulfathiazole is prepared with conventional method.
(1) Herba Andrographis dry extractum 51.8g is taken, measures and includes total andrographolide 15g, takes Radix Helicteris dry extractum 43g, is crushed
Into dry powder, then extracting corn starch 130g, dextrin 18.6g, sucrose 37.2g.
(2) sucrose is added to the syrup for being configured to that concentration is 30% in purified water, obtains 124g syrup.
(3) Herba Andrographis dry extractum powder, Radix Helicteris dry extractum powder, cornstarch, dextrin are mixed, suspension is agitated by air-flow
Into fluidisation state, dry 20-30 minutes obtain powder mixture below 50-80 DEG C, and then syrup is sprayed and done through spray gun spray nozzle
Powder mixture is mixed, and is bonded to particle, and dry particl is obtained after heated-air drying, drying, whole grain, tabletting, coating is then proceeded to, obtains
To lotus sesame sulfathiazole 1000, every 0.28g.
Contrast test 1:Lotus sesame sulfathiazole of the present invention is with conventional lotus sesame sulfathiazole in terms of disintegration rate and dissolution rate
Contrast test.
Dispersing uniformity, disintegration time limited and the Their Dissolution Test in vitro of lotus sesame sulfathiazole.
The detection method of dispersing uniformity:The tablet that embodiment 4,5 and comparative example 6 produce respectively is taken 2, is placed in 20
In DEG C ± 1 DEG C of 100mL water, 3min is shaken, crosses No. 2 medicines sieves(National standard R40/3 series).
Disintegration time limited detection method:According to 2010 editions Chinese Pharmacopoeias, two defined methods, Example 4,5 and contrast are real
Each 6 of the tablet of the production of example 6 is applied, in the water that temperature is 37 DEG C ± 1 DEG C, is detected using lift disintegration of tablet instrument.
Table 1:Scattered and disintegration time limited table.
As shown in table 1, the disintegration time limited of product of the present invention only needs 5-6 minutes, and according to the production of existing preparation method production
The disintegration time limited of product wants 12 minutes or so.
Dissolution detection method:According to 2010 editions Chinese Pharmacopoeias, two defined dissolution methods, operate in accordance with the law, according to
UV-VIS spectrophotometry determines every stripping quantity.
Table 2:Dissolution rate detects table.
As shown in table 2, embodiment 4, the dissolution percentage of 5 tablets are 87% or so in 4 minutes, in 6 minutes all
Dissolution.The dissolution percentage just whole dissolutions at 45% or so, 8 minute in 4 minutes of the tablet of comparative example 6.
It can be seen that the lotus sesame anti-inflammatory flake products produced according to the inventive method can greatly improve disintegration rate and dissolution rate.
Claims (2)
1. a kind of preparation method of lotus sesame sulfathiazole, it is characterised in that be prepared by the raw material and auxiliary material of following parts by weight:
(1) the Herba Andrographis dry extractum containing 15 parts of total andrographolide is taken, takes 43 parts of Radix Helicteris dry extractum, is ground into dry powder, crosses 100
Mesh sieve, it is well mixed, obtains lotus sesame powder mixture;
(2) auxiliary material is taken, and the parts by weight of auxiliary material subtract Herba Andrographis dry extractum parts by weight and Radix Helicteris dry extractum parts by weight for 280 parts, auxiliary
Material is made up of pueraria starch, dextrin, sucrose, cornstarch, and its proportion of composing is:109 parts of pueraria starch:23.5 parts of dextrin:Sugarcane
33.3 parts of sugar:20 parts of cornstarch;
(3) sucrose is added to the syrup for being configured to that concentration is 30% in purified water;
(4) pueraria starch, dextrin are added in syrup and are sufficiently mixed stirring and obtain starch mud, stand 5-15 minutes;
(5) lotus sesame powder mixture is added in starch mud, stirred, then stood 10-25 minutes, obtain lotus sesame starch
Mud;
(6) cornstarch is added in lotus sesame starch mud, stirred, obtain lotus sesame mixture softwood, then pelletized,
Drying, whole grain, tabletting, obtain lotus sesame sulfathiazole.
2. the preparation method of lotus sesame sulfathiazole according to claim 1, it is characterised in that the Herba Andrographis dry extractum is by such as
Lower section method is made:
1. Folium Andrographis are crushed, 4 mesh sieves are crossed, obtain Herba Andrographitis coarse powder;
2. Herba Andrographitis coarse powder is put into curing environment and is warmed to 65-80 DEG C;
3. the Herba Andrographitis coarse powder after heating is passed through into 35- with 90% ethanol solution at a temperature of 65-67 DEG C according to 4ml/g solid-liquid ratios
40kHz ultrasonic extractions 60 minutes, then filter to take liquid;According still further to 8ml/g solid-liquid ratios by filter residue with 90% ethanol solution in 60-70
By 35-40kHz ultrasonic extractions 90 minutes at a temperature of DEG C, liquid is then filtered to take, merges extract solution;
4. adding 0.15 part of activated carbon according to every part of Herba Andrographitis coarse powder of parts by weight, the 30min that flowed back in 72 DEG C of temperature environments decolourizes,
Filter while hot, filtrate add 0.1 part of activated carbon flowed back in 72 DEG C of temperature environments 30min decolouring, filter while hot;
5. ethanol is recovered under reduced pressure and concentrates, the volume of concentrate is concentrated into:Medicinal material gross weight ratio is 1mL:1g, then add equivalent body
Long-pending purified water, boil 20-30 minutes, stand two days, filtering;
6. concentrating filtrate to density is 1.30-1.35g/mL thick paste, then is dried under reduced pressure, crushes, produce Herba Andrographitis and do
Medicinal extract.
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Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1660364A (en) * | 2005-01-31 | 2005-08-31 | 北京正大绿洲医药科技有限公司 | 'Lianzhi' anti inflammation drop pill in use for clearing away heat and toxic material and preparation method |
CN102327313A (en) * | 2011-09-23 | 2012-01-25 | 江西普正制药有限公司 | Preparation method of Lianzhi anti-inflammation soft capsule |
-
2017
- 2017-11-09 CN CN201711095256.5A patent/CN107823152B/en active Active
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1660364A (en) * | 2005-01-31 | 2005-08-31 | 北京正大绿洲医药科技有限公司 | 'Lianzhi' anti inflammation drop pill in use for clearing away heat and toxic material and preparation method |
CN102327313A (en) * | 2011-09-23 | 2012-01-25 | 江西普正制药有限公司 | Preparation method of Lianzhi anti-inflammation soft capsule |
Non-Patent Citations (3)
Title |
---|
XU-BIN SUO等: "HPLC determination of andrographolide in rat whole blood: study on the pharmacokinetics of andrographolide incorporated in liposomes and tablets", 《BIOMEDICAL CHROMATOGRAPHY》 * |
郑如文等: "莲芝消炎胶囊一步制粒工艺研究", 《中国药业》 * |
韦宾等: "莲芝消炎片(薄膜包衣片)生产中的质量控制", 《科技创新导报》 * |
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Denomination of invention: A preparation method of Lianzhi Xiaoyan tablet Effective date of registration: 20220124 Granted publication date: 20200211 Pledgee: Chongqing Rural Commercial Bank Co.,Ltd. Qianjiang sub branch Pledgor: CHONGQING KERUI NANHAI PHARMACEUTICAL Co.,Ltd. Registration number: Y2022500000003 |