CN100376287C - Preparation of pinellia decoction for purging stomach fire, its preparing method and application - Google Patents
Preparation of pinellia decoction for purging stomach fire, its preparing method and application Download PDFInfo
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- CN100376287C CN100376287C CNB2004100184321A CN200410018432A CN100376287C CN 100376287 C CN100376287 C CN 100376287C CN B2004100184321 A CNB2004100184321 A CN B2004100184321A CN 200410018432 A CN200410018432 A CN 200410018432A CN 100376287 C CN100376287 C CN 100376287C
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Abstract
The present invention discloses a troche and a capsule of pinellisa decoction for purging stomach-fire, a preparing method thereof and an application thereof. The traditional Chinese medicine compound, namely pinelliae decoction for purging stomach-fire, is used as raw materials for medicinal materials, effective substances are extracted by water or ethanol solution, and extractive powders are made through spray drying or drying under reduced pressure; granules are made by a dry granulation method or a wet granulation method through adding medicinal auxiliary materials; a capsule is filled, or tabletting operation is carried out to make the tablet. In the present invention, a traditional preparation is replaced by a modern preparation which can be conveniently taken. The present invention has the characteristics that the dosage is decreased because the raw materials have a reasonable proportion, and the effective constituents are extracted in the fine manner, the capsule and the tablet which are prepared can quickly realize disintegration so that the medicine is influenced by gastric emptying at a small degree, and the therapeutic action is thoroughly performed on treating sites. The present invention has favorable curative effects on superficial gastritis, particularly gastritis and gastric ulcers, which are caused by helicobacter pylori. The present invention can be conveniently taken at a small dosage.
Description
Technical field
The present invention relates to Chinese medicine compound banxia xiexin decoction preparation and preparation method thereof, relating in particular to the Chinese medicine compound banxia xiexin decoction is the capsule and the tablet of active component.
Background technology
Superficial gastritis is a kind of commonly encountered diseases, frequently-occurring disease, and the course of disease is long, easily recurrence, and western medicine generally adopts three or quadruple chemotherapy, and medical expense height, side effect are big.Banxia xiexin decoction is that Zhang Zhongjing is shown the classics recipe in the treatise on Febrile Diseases, side commonly used for modern Chinese medicine clinical treatment chronic gastritis, gastric ulcer, therapeutic effect is good, relapse rate is low and side effect is little, but still there is not this square preparation listing at present, clinical practice is taken with decoction, dose is big, and it is also bigger that medicine is influenced by gastric emptying, has brought inconvenience for patient's treatment use.
Summary of the invention
The technical issues that need to address of the present invention are to disclose a kind of banxia xiexin decoction preparation and its production and application, and big to overcome the dose that prior art exists, it is also bigger that medicine is influenced by gastric emptying, use the defective of making troubles for patient's treatment.
Banxia xiexin decoction preparation of the present invention comprises the banxia xiexin decoction extract for the treatment of effective dose and pharmaceutically acceptable carrier;
Said banxia xiexin decoction extract is to adopt following parts by weight proportion raw material medicine to extract:
Medical material Rhizoma Pinelliae 18-24, Radix Scutellariae 13-19, Radix Codonopsis or Radix Ginseng 13-19, Rhizoma Zingiberis 13-19,
Fructus Jujubae 13-19, Radix Glycyrrhizae Preparata 7-13, Rhizoma Coptidis 2-8.
The addition of said carrier is 30%～80% of a banxia xiexin decoction extract formulation weight;
Said carrier comprises one or more in filler, disintegrating agent, lubricant or the wetting agent;
Filler is selected from a kind of in starch, pregelatinized Starch, microcrystalline Cellulose, sodium carboxymethyl cellulose or the polyvinylpyrrolidone;
Disintegrating agent is selected from carboxymethyl starch sodium, sodium carboxymethyl cellulose or its mixture, and lubricant is selected from magnesium stearate or Pulvis Talci, and wetting agent is selected from a kind of in the alcoholic solution of water, alcoholic solution or polyvinylpyrrolidone.
Above-mentioned banxia xiexin decoction preparation comprises tablet and capsule.
The preparation method of above-mentioned banxia xiexin decoction preparation comprises the steps:
Above raw material is with 50%～80% alcoholic solution reflux, extract, of the water of 15～25 times of amounts or 15～22 times of amounts, extraction time is 1～2 hour, preferably divide reflux, extract, 2～3 times, each 1～2 hour, merge extractive liquid,, filter, the relative density when filtrate is concentrated into 60 ℃ is 1.05～1.15, and spray drying or drying under reduced pressure obtain extract powder.
Intake air temperature is 120～160 ℃ during spray drying; The vacuum of drying under reduced pressure is-0.06～-0.1MPa.
Extract powder sieves, and adds filler, disintegrating agent and wetting agent with method wet method system granule well known in the art, or adding filler, disintegrating agent granulate with method dry pressing well known in the art, promptly obtains banxia xiexin decoction preparation of the present invention;
The preparation that is obtained is filled in the capsule, promptly obtain the banxia xiexin decoction capsule;
Or further in the banxia xiexin decoction preparation, add lubricant with method tabletting well known in the art, and use film coating, promptly obtain the banxia xiexin decoction tablet.
Banxia xiexin decoction preparation of the present invention comprises capsule and tablet, can be used for treating diseases such as chronic gastritis, gastric ulcer, and dosage commonly used is 1.0～2.0 grams/50 kg body weight, specifically can be according to patient's age, sex and state of an illness decision.
The present invention is the modern formulation replacement conventional dosage forms with taking convenience, and characteristics of the present invention are reasonable raw material proportioning, essence is carried effective ingredient, reduces dose, and the disintegrate of made capsule and tablet is rapid, it is less to make medicine influenced by gastric emptying, treats at therapentic part and gives full play to therapeutical effect.
Rhizoma Pinelliae removing pathogen in the heart sheet or capsule active constituent content height with this method preparation have good curative effect to the microbial gastritis of superficial gastritis especially helicobacter pylorus, gastric ulcer, taking convenience, and dose is few.
The specific embodiment
Embodiment 1
Take by weighing the 2kg medical material by the banxia xiexin decoction prescription, wherein:
Medical material Rhizoma Pinelliae 0.46kg, Radix Scutellariae 0.33kg, Radix Ginseng 0.33kg, Rhizoma Zingiberis 0.32,
Fructus Jujubae 0.32kg, Radix Glycyrrhizae Preparata 0.19kg, Rhizoma Coptidis 0.05kg
With 70% alcoholic solution of 36kg, heating in water bath reflux, extract, twice, add 20kg for the first time, extract 2h, add 16kg for the second time, extract 1h; Filter, the relative density when filtrate is concentrated into 25 ℃ is 1.1, and spray drying obtains extract powder.Extract powder sieves, and adds microcrystalline Cellulose 148g, and polyvinylpyrrolidone 26g and sodium carboxymethyl cellulose 26g granulate with dry pressing, and filled capsules is made Rhizoma Pinelliae removing pathogen in the heart capsule behind the granulate.
Embodiment 2
Take by weighing the 2kg medical material by the banxia xiexin decoction prescription, wherein:
The medical material Rhizoma Pinelliae 0.40, Radix Scutellariae 0.31, Radix Codonopsis 0.32, Rhizoma Zingiberis 0.32,
Fructus Jujubae 0.31, Radix Glycyrrhizae Preparata 0.21, Rhizoma Coptidis 0.13.
With 60% alcoholic solution of 44kg, heating in water bath reflux, extract, twice, add 24kg for the first time, extract 2h, add 20kg for the second time, extract 1h; Filter, the relative density when filtrate is concentrated into 25 ℃ is 1.1, and spray drying obtains extract powder.Extract powder sieves, and adds microcrystalline Cellulose 148g, and polyvinylpyrrolidone 26g and sodium carboxymethyl cellulose 26g granulate with dry pressing, and filled capsules is made Rhizoma Pinelliae removing pathogen in the heart capsule behind the granulate.
Embodiment 3
Adopt the method for embodiment 2, and granulate with method dry pressing well known in the art, add magnesium stearate 4g tabletting behind the granulate, make Rhizoma Pinelliae removing pathogen in the heart sheet, tablet adopts known method bag film-coat with acrylic resin.
Embodiment 4
Method according to identical with embodiment 1 changes drying means into drying under reduced pressure, dry thing after crushed extract powder.
Embodiment 4
Method according to identical with embodiment 2 changes " decocting boils 2 times " into " 70% alcoholic solution, twice of heating in water bath reflux, extract, ".
Embodiment 5
Banxia xiexin decoction tablet and capsule are to the pharmacodynamic study of helicobacter pylori infections gastritis model
1, experiment material
Medicine and reagent banxia xiexin decoction tablet and capsule (self-control), bismuth potassium citrate (production of the beautiful pearl in Zhuhai pharmaceutical factory), urokinase, oxidase, catalase (available from Sigerma company), 0.9% sodium chloride injection, 5%Na
2HCO
3Solution, PBS solution (autogamy).
Animal Wister rat, at 4 monthly ages, body weight 112～158g is provided by the court's animal center.
2, method
The preparation of drug sample is mixed with suitable concentration with 0.9% sodium chloride injection and is for experiment by dosage in the table 1 2.1 be for experiment.
2.2 the preparation of helicobacter pylori (HP) infection model
2.2.1HP strain culturing is got the chronic active gastritis patient mucosa tissue pincers of Dndoscope Laboratory inspection and is got thing, be inoculated on the campylobacter jejuni selective medium, put little oxygen environment, cultivated 72 hours for 37 ℃, check bacterium colony, the negative bacillus of Gram, urokinase, oxidase, the catalase test positive, after being defined as the HP bacterium, going down to posterity and cultivate as test strain.
2.2.2 the infection method is got 176 of Wister rats, male and female half and half are divided into 12 groups (wherein 2 groups is 8, and 1 group is blank group, does not carry out HP and infects) at random, 16 every group, and sub-cage rearing.Fasting was used 5%Na after 12 hours
2HCO
3A solution 2ml/ ig gives behind the 15min and mixes Hp bacterial strain (10
12Cfu/L bacterium liquid) a 2ml/ ig takes food behind the 30min.Infect totally 4 times weekly 1 time.
2.3 anti-Hp infects the gastritis test
After 2.3.1 the experiment grouping is infected a week with medication Hp last, press the column split administration respectively: sample low dose group (No. 1, No. 2, No. 3, No. 4 each group), sample high dose group (No. 1, No. 2, No. 3, No. 4 each one group), NS matched group, positive drug (bismuth potassium citrate) matched group, every day, the ig administration was 1 time, 10 days courses of treatment.Dosage sees Table 1.Administration is divided into 2 groups at random with above-mentioned 10 groups every group after finishing, each 8, finish back next day and finish back 1 month acute execution animal respectively at treatment, stomach is got by the sterile working, cuts off PBS liquid flush away gastric content along greater gastric curvature, get 5 block organizations at pylorus end relative fixed position, cultivate for direct smear, urease test, Hp, all the other put into by 10% formalin of PBS liquid preparation fixing, for pathological examination.Pathological examination method: the gastric tissue section is dyeed with HE, with the pathological changes situation of each animal subject gastric mucosa of microscopic examination.
2.3.2 the result judges three inspections of Hp: smear for microscopic examination is not checked through Hp, urease test reaction negative, Hp and cultivates and do not see that HP person is for turning out cloudy, calculate every group of negative conversion rate with the number of animals of turning out cloudy, negative conversion rate after the treatment is the HP clearance rate, and the HP negative conversion rate that treatment finished after month is an eradication rate.
3, result
Prepare one group of HP infected group of arbitrary extracting 3.1HP infect the gastritis model, get mucosa tissue and carry out smear for microscopic examination, urokinase test, 8 Mus all can detect HP in the infected group, and 8 gastric mucosa of rat of blank group are organized and all do not detected HP.
3.2 the anti-HP effect of given the test agent
3.2.1 the clearance rate of HP and each reagent group of eradication rate and positive control drug group are all had certain clearance rate and eradication rate to HP, banxia xiexin decoction tablet and capsule high dose group and positive control drug group effect are better, with matched group comparing difference highly significant (P＜0.01), other each group also has certain anti-HP effect, all has significance (P＜0.05) with the matched group comparing difference.Wherein, banxia xiexin decoction tablet and capsule high dose group are suitable with positive control drug group effect, and difference does not have significance (P＞0.05) each other.The results are shown in Table 1.
Each group of table 1 is to clearance rate and the eradication rate of HP
| Group | Dosage (mg/kg) | N | To the HP clearance rate | To the HP eradication rate | ||
| The P number of turning out cloudy | Clearance rate (%) | The HP number of turning out cloudy | Eradication rate (%) | |||
| Normal saline matched group banxia xiexin decoction tablet low dose group banxia xiexin decoction tablet high dose group banxia xiexin decoction capsule low dose group banxia xiexin decoction capsule high dose group bismuth potassium citrate group | 20ml/kg 150 200 100 200 40 | 8 8 8 8 8 8 | 1 3 6 5 7 7 | 12.5 37.5 75.0 62.5 87.5 87.5 | 0 1 5 4 6 6 | 0 12.5 62.5 50.0 75.0 75.0 |
3.2.2 pathological change normal saline matched group: the gastric mucosa body of gland destroys, interstitial edema companion inflammatory cell infiltration.Banxia xiexin decoction tablet low dose group: gastric mucosa focal inflammation cell effect.Banxia xiexin decoction tablet high dose group, banxia xiexin decoction capsule low dose group: the gastric mucosa body of gland is normal, and shallow-layer has a small amount of inflammatory cell.High dose banxia xiexin decoction capsule high dose group and bismuth potassium citrate group: gastric gland is normal, does not see inflammatory cell.
4, brief summary
Result of study shows that banxia xiexin decoction tablet and capsule all have anti-preferably HP effect, and wherein banxia xiexin decoction capsule high dose group best results is suitable with the anti-HP effect of positive control drug.
Claims (3)
1. the preparation method of banxia xiexin decoction preparation is characterized in that, comprises the steps:
With crude drug water or alcoholic solution reflux, extract,, extraction time is 1～2 hour, filters, and the relative density when filtrate is concentrated into 60 ℃ is 1.05～1.15, and spray drying or drying under reduced pressure obtain extract powder, and it is as follows that said raw material medicines in portions by weight is counted proportioning:
Medical material Rhizoma Pinelliae 18-24, Radix Scutellariae 13-19, Radix Codonopsis or Radix Ginseng 13-19, Rhizoma Zingiberis 13-19,
Fructus Jujubae 13-19, Radix Glycyrrhizae Preparata 7-13, Rhizoma Coptidis 2-8.
2. the preparation method of banxia xiexin decoction preparation according to claim 1 is characterized in that, with 50%～80% the alcoholic solution reflux, extract, of said crude drug with the water of 15～25 times of amounts or 15～22 times of amounts.
3. the preparation method of banxia xiexin decoction preparation according to claim 2 is characterized in that, divides 2～3 times reflux, extract,, each 1～2 hour.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101780263A (en) * | 2010-03-25 | 2010-07-21 | 江苏济川制药有限公司 | Traditional Chinese medicine composition for treating chronic gastritis and preparation method thereof |
| CN101797370B (en) * | 2010-04-02 | 2011-10-26 | 吕红权 | Traditional Chinese medicinal composition for treating gastroptosis |
| CN102614481A (en) * | 2011-10-18 | 2012-08-01 | 宋协勘 | Chinese medicine for treating chronic gastritis |
| CN102772759A (en) * | 2012-07-05 | 2012-11-14 | 李承平 | Group of tablets for clearing heat, eliminating mass and removing stasis |
| CN102743735B (en) * | 2012-07-25 | 2014-07-23 | 黑龙江中医药大学 | Preparation method of pinellia tuber heart-fire purging decoction gastric stagnation tablet |
| CN102764422B (en) * | 2012-08-17 | 2014-01-29 | 河南中医学院 | Xialian Yiyou capsule for curing chronic gastritis |
| CN103479992A (en) * | 2013-10-14 | 2014-01-01 | 张桂赫 | Traditional Chinese medicine pill for treating anxiety neurosis accompanied with digestive tract symptom and preparation method thereof |
| CN106421684A (en) * | 2016-08-26 | 2017-02-22 | 广西慧投互联网金融服务有限公司 | Composition capable of diminishing inflammation and strengthening stomach |
| CN110269925A (en) * | 2018-09-25 | 2019-09-24 | 李世昌 | A kind of stomach medicine and preparation method for treating atrophic gastritis |
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Non-Patent Citations (1)
| Title |
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| 方剂学. 段富津，62，63，上海科学技术出版社. 1995 * |
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