CN105641142A - A liver-protecting tablet and a preparing method thereof - Google Patents

Abstract

A liver-protecting tablet and a preparing method thereof are disclosed. The tablet and the method are characterized in that 180 g of cortex cinnamomi, 180 g of immature orange fruit, 313 g of radix bupleuri, 313 g of virgate wormwood herb and 313 g of isatis root are extracted by adopting a carbon dioxide supercritical extraction process, dried under vacuum, and smashed into nanometer dry paste through a high-energy nanometer impact grinder, functional auxiliary materials are added to prepare the tablet, disintegration time of the tablet is significantly shortened, curative effects of the tablet are significantly superior to those of commercially available liver-protecting tablets, and positive effects are achieved.

Description

A kind of liver-protecting tablet and preparation method thereof

Technical field

The present invention relates to the field of Chinese medicines, be specifically related to a kind of liver-protecting tablet and preparation method thereof.

Background technology

Liver-protecting tablet energy depressed liver-energy dispersing and QI regulating, strengthening the spleen to promote digestion, there is the effect reducing transaminase, it is widely used in the preventing and treating of fatty liver, alcoholic liver, drug induced hepatic injury, chronic hepatitis and early stage liver cirrhosis clinically, can also be used for schistosomicide hepatopathy and hyperthyroid hepatic injury, be one of the most frequently used at present hepatosis treating medicine. Commercially available liver-protecting tablet is due to prescription and technological reason, and curative effect is not satisfactory, and preparation adopts traditional handicraft to prepare, and there is the deficiencies such as prolonged disintegration, curative effect are low.

Summary of the invention

The present invention is for overcoming above-mentioned deficiency, it is provided that liver-protecting tablet that a kind of disintegration rate is fast, curative effect is high and preparation method thereof.

Invention embodiment is as follows:

Take Cortex Cinnamomi 180g, Fructus Aurantii Immaturus 180g, Radix Bupleuri 313g, Herba Artemisiae Scopariae 313g, Radix Isatidis 313g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 30��40Mpa, extraction temperature 30��40 DEG C, separator pressure 10��20Mpa, separator temperature 50��60 DEG C, disengaging time 2��4 hours, carbon dioxide flow is 40��50L per hour, obtains extracting solution; Take 60 DEG C��80 DEG C drying under reduced pressure of extracting solution, get dry extract; Take dry cream and add calcium sulfate 150��200g, adopt high energy nanometer impact grinding to be ground into the mixing dried cream powder of particle diameter 200��300nm; Take mixing dried cream powder, dextrin 45��55g, crospolyvinylpyrrolidone 45��55g, cross-linking sodium carboxymethyl cellulose 35��45g, mix homogeneously, with 50��70% ethanol wet granulations, 60 DEG C��80 DEG C dry, additional carboxymethyl starch sodium 7��9g, magnesium stearate 1��3g, granulate, is pressed into 3000, prepares liver-protecting tablet.

The raw material standards that the embodiment above is previously mentioned is as follows:

Cortex Cinnamomi: China's coastal port one ministerial standard, this product is the dry bark of canella Cortex Cinnamomi CiNNamomumcassiaPresl. Strip more than autumn, dry in the shade.

Fructus Aurantii Immaturus: China's coastal port one ministerial standard. This product is rutaceae Citrus aurantium Linn. CitrusaurantiumL. and the dry young fruit of variety or Fructus Citri sinensis CitrussinensisOsbeck thereof. Being collected from the fruit fallen the 5-6 month, remove impurity, be two halves from middle part crosscut, dry or cold drying, smaller directly dries or cold drying.

Radix Bupleuri: China's coastal port one ministerial standard, this product is umbelliferae bupleurum BupleurumchinenseDC. or the dry root of Radix Bupeuri Scorzonerfolii. BupleurumscocrzonerifoliumWilld.. Different by character, practise title " Radix Bupleuri " and " Radix Bupleuri Scorzonerifolii " respectively. Spring, season in autumn two excavate, and remove stem and leaf and silt, dry.

Herba Artemisiae Scopariae: China's coastal port one ministerial standard, this product is feverfew Artemisia scoparia Waldst. et Kit. ArtemisiascopariaWaldst.etKit. or the dry aerial parts of Herba Artemisiae Scopariae ArtemisiacapillarisThunb..Gather during seedling height 6-10cm in spring or autumn alabastrum tap when growing up to, remove impurity and old stem, dry. The habit gathered spring claims " capillary wormwood ", and the title tapped autumn " Herba Artemisiae Scopariae: this product is On Polyporaceae Poria Poriacocos(Schw.) dry sclerotia of Wolf. Excavate more than the 7-9 month, remove silt after digging out, bank up after " diaphoresis ", spread out and dry in the air to dry tack free, then " diaphoresis ", after repeatedly scattering and disappearing to now wrinkle, the big portion of internal moisture for several times, dry in the shade, be called " Poria "; Or fresh Poria is pressed different parts cutting, cloudy in, be called " Cortex Sclerotii Poriae " and " Poria block ".

Radix Isatidis: China's coastal port one ministerial standard, this product is the dry root of cruciferae isatis IsatisindigoticaFort.. Autumn digs, and removes silt, dries.

Calcium sulfate: Chinese Pharmacopoeia version two ministerial standard in 2010.

Dextrin: Chinese Pharmacopoeia version two ministerial standard in 2010.

Crospolyvinylpyrrolidone: Chinese Pharmacopoeia version two ministerial standard in 2010.

Cross-linking sodium carboxymethyl cellulose: Chinese Pharmacopoeia version two ministerial standard in 2010.

Carboxymethyl starch sodium: Chinese Pharmacopoeia version two ministerial standard in 2010.

Magnesium stearate: Chinese Pharmacopoeia version two ministerial standard in 2010.

Raw material used in above liver-protecting tablet all can be commercially available from pharmaceuticals, all can be used to implement the present invention program as long as meeting national standard.

In foregoing invention scheme, term used is pharmacy proprietary term, all defers to Chinese Pharmacopoeia regulation and pharmaceutical practice of being correlated with such as " decompression " etc.

Unit g in the present invention can also be other weight portion, does not affect the enforcement of the present invention program.

Equipment Market described in the present invention program all has sale, however it is not limited to typical production producer, as long as technical specification can reach requirement, all can be used to realize the present invention.

Four detailed description of the invention

Specific embodiments of the invention 1

Take Cortex Cinnamomi 180g, Fructus Aurantii Immaturus 180g, Radix Bupleuri 313g, Herba Artemisiae Scopariae 313g, Radix Isatidis 313g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 30Mpa, extraction temperature 30 DEG C, separator pressure 10Mpa, separator temperature 50 DEG C, disengaging time 2 hours, carbon dioxide flow is 40L per hour, obtains extracting solution; Take 60 DEG C of drying under reduced pressure of extracting solution, get dry extract; Take dry cream and add calcium sulfate 150g, adopt high energy nanometer impact grinding to be ground into the mixing dried cream powder of particle diameter 200��300nm; Taking mixing dried cream powder, dextrin 45g, crospolyvinylpyrrolidone 45g, cross-linking sodium carboxymethyl cellulose 35g, mix homogeneously, with 50% ethanol wet granulation, 60 DEG C dry, additional carboxymethyl starch sodium 7g, magnesium stearate 1g, and granulate is pressed into 3000, prepares liver-protecting tablet.

Specific embodiments of the invention 2

Take Cortex Cinnamomi 180g, Fructus Aurantii Immaturus 180g, Radix Bupleuri 313g, Herba Artemisiae Scopariae 313g, Radix Isatidis 313g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 40Mpa, extraction temperature 40 DEG C, separator pressure 20Mpa, separator temperature 60 DEG C, disengaging time 4 hours, carbon dioxide flow is 50L per hour, obtains extracting solution; Take 80 DEG C of drying under reduced pressure of extracting solution, get dry extract; Take dry cream and add calcium sulfate 200g, adopt high energy nanometer impact grinding to be ground into the mixing dried cream powder of particle diameter 200��300nm; Taking mixing dried cream powder, dextrin 55g, crospolyvinylpyrrolidone 55g, cross-linking sodium carboxymethyl cellulose 45g, mix homogeneously, with 70% ethanol wet granulation, 80 DEG C dry, additional carboxymethyl starch sodium 9g, magnesium stearate 3g, and granulate is pressed into 3000, prepares liver-protecting tablet.

Specific embodiments of the invention 3

Take Cortex Cinnamomi 180g, Fructus Aurantii Immaturus 180g, Radix Bupleuri 313g, Herba Artemisiae Scopariae 313g, Radix Isatidis 313g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 35Mpa, extraction temperature 35 DEG C, separator pressure 15Mpa, separator temperature 55 DEG C, disengaging time 3 hours, carbon dioxide flow is 45L per hour, obtains extracting solution; Take 70 DEG C of drying under reduced pressure of extracting solution, get dry extract; Take dry cream and add calcium sulfate 175g, adopt high energy nanometer impact grinding to be ground into the mixing dried cream powder of particle diameter 200��300nm; Taking mixing dried cream powder, dextrin 50g, crospolyvinylpyrrolidone 50g, cross-linking sodium carboxymethyl cellulose 40g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C dry, additional carboxymethyl starch sodium 8g, magnesium stearate 2g, and granulate is pressed into 3000, prepares liver-protecting tablet.

Above example illustrates, adopts the extreme condition of embodiment of the present invention and optimal conditions all can make liver-protecting tablet. The liver-protecting tablet prepared with embodiment 3 below investigates the actual effect of the present invention:

(1) embodiment 3 liver-protecting tablet and contrast disintegration of commercially available liver-protecting tablet

1 disintegration time mensuration method

Measure by Chinese Pharmacopoeia version annex �� A in 2010.

Contrast 2 disintegrations

Table 1 embodiment 3 liver-protecting tablet and commercially available liver-protecting tablet contrast table disintegration

The above results shows, liver-protecting tablet prepared by the present invention has the remarkable advantages such as disintegration rate is fast, bioavailability is high relative to commercially available liver-protecting tablet.

(2) embodiment 3 liver-protecting tablet and commercially available Hugan Pills in Treating fatty liver, alcoholic liver, drug induced hepatic injury, chronic hepatitis and early stage liver cirrhosis clinical observation on the therapeutic effect

1 case scenario

Statistics outpatient service and inpatient, observe fatty liver, alcoholic liver, drug induced hepatic injury, chronic hepatitis and early stage liver cirrhosis case 150 example, 43 years old mean age altogether. Patient is divided into two groups, and test group takes embodiment 3 liver-protecting tablet, and matched group takes commercially available liver-protecting tablet.

2 efficacy assessment standards

According to new Chinese medicine treatment viral hepatitis guideline of clinical investigations tcm syndrome curative effect determinate standard:

Clinical recovery: tcm clinical practice symptom, sign disappear or substantially disappear, syndrome integral reduces >=95%.

Effective: tcm clinical practice symptom, sign are obviously improved, syndrome integral reduces >=70%.

Effective: tcm clinical practice symptom, sign all take a favorable turn, syndrome integral reduces >=30%.

Invalid: tcm clinical practice symptom, sign are all not improved or increase the weight of, syndrome integral reduces < 30%.

Computing formula: [before (before treatment integration after integration-treatment) �� treatment integration] �� 100%.

3 clinical observation result

Table 2 embodiment 3 liver-protecting tablet and commercially available liver-protecting tablet clinical efficacy contrast table

Above-mentioned clinical observation on the therapeutic effect is it is shown that the liver-protecting tablet prepared of the present invention is when treating fatty liver, alcoholic liver, drug induced hepatic injury, chronic hepatitis and early stage liver cirrhosis, evident in efficacy higher than commercially available liver-protecting tablet, p < 0.05.

Claims (3)

1. treat a Chinese medicine for fatty liver, alcoholic liver, drug induced hepatic injury, chronic hepatitis and early stage liver cirrhosis, it is characterized in that taking Cortex Cinnamomi 180g, Fructus Aurantii Immaturus 180g, Radix Bupleuri 313g, Herba Artemisiae Scopariae 313g, Radix Isatidis 313g, it is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 30��40Mpa, extraction temperature 30��40 DEG C, separator pressure 10��20Mpa, separator temperature 50��60 DEG C, disengaging time 2��4 hours, carbon dioxide flow is 40��50L per hour, obtains extracting solution;Take 60 DEG C��80 DEG C drying under reduced pressure of extracting solution, get dry extract; Take dry cream and add calcium sulfate 150��200g, adopt high energy nanometer impact grinding to be ground into the mixing dried cream powder of particle diameter 200��300nm; Take mixing dried cream powder, dextrin 45��55g, crospolyvinylpyrrolidone 45��55g, cross-linking sodium carboxymethyl cellulose 35��45g, mix homogeneously, with 50��70% ethanol wet granulations, 60 DEG C��80 DEG C dry, additional carboxymethyl starch sodium 7��9g, magnesium stearate 1��3g, granulate, suppress to obtain liver-protecting tablet.

2. the preparation method of Chinese medicine according to claim 1, is characterized in that taking Cortex Cinnamomi 180g, Fructus Aurantii Immaturus 180g, Radix Bupleuri 313g, Herba Artemisiae Scopariae 313g, Radix Isatidis 313g, it is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 30��40Mpa, extraction temperature 30��40 DEG C, separator pressure 10��20Mpa, separator temperature 50��60 DEG C, disengaging time 2��4 hours, carbon dioxide flow is 40��50L per hour, obtains extracting solution; Take 60 DEG C��80 DEG C drying under reduced pressure of extracting solution, get dry extract; Take dry cream and add calcium sulfate 150��200g, adopt high energy nanometer impact grinding to be ground into the mixing dried cream powder of particle diameter 200��300nm; Take mixing dried cream powder, dextrin 45��55g, crospolyvinylpyrrolidone 45��55g, cross-linking sodium carboxymethyl cellulose 35��45g, mix homogeneously, with 50��70% ethanol wet granulations, 60 DEG C��80 DEG C dry, additional carboxymethyl starch sodium 7��9g, magnesium stearate 1��3g, granulate, suppress to obtain liver-protecting tablet.

3. the preparation method of Chinese medicine according to claim 1, takes Cortex Cinnamomi 180g, Fructus Aurantii Immaturus 180g, Radix Bupleuri 313g, Herba Artemisiae Scopariae 313g, Radix Isatidis 313g, it is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 35Mpa, extraction temperature 35 DEG C, separator pressure 15Mpa, separator temperature 55 DEG C, disengaging time 3 hours, carbon dioxide flow is 45L per hour, obtains extracting solution; Take 70 DEG C of drying under reduced pressure of extracting solution, get dry extract; Take dry cream and add calcium sulfate 175g, adopt high energy nanometer impact grinding to be ground into the mixing dried cream powder of particle diameter 200��300nm; Taking mixing dried cream powder, dextrin 50g, crospolyvinylpyrrolidone 50g, cross-linking sodium carboxymethyl cellulose 40g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C dry, additional carboxymethyl starch sodium 8g, magnesium stearate 2g, and granulate suppresses to obtain liver-protecting tablet.