CN105362393A - Fengtongning tablet and preparation method thereof - Google Patents

Abstract

The invention discloses a Fengtongning tablet and a preparation method thereof. The preparation method is characterized by comprising the following steps: taking 78 g of dichroae radix, 36 g of cortex ailanthic, 42 g of prepared kusnezoff monkshood root, 32 g of notopterygium root, 52 g of radix angelicae pubescentis, 6 g of radix aconiti carmichaeli, 15 g of frankincense, 15 g of myrrh, 45 g of Angelica sinensis, 32 g of medicinal cyathula root, 25 g of pawpaw, 20 g of ephedra and 15 g of cassia twig; extracting by using a carbon dioxide supercritical extraction method; drying under reduced pressure; pulverizing into nano dried cream by using a high-energy nano impact mill; and adding functional auxiliary materials and preparing into the Fengtongning tablet. The disintegration time is shortened remarkably, and the curative effect is remarkably higher than that of Fengtongning tablets in markets, and the positive effect is achieved.

Description

A kind of FENGTONGNING PIAN and preparation method thereof

Technical field

The present invention relates to the field of Chinese medicines, be specifically related to a kind of FENGTONGNING PIAN and preparation method thereof.

Background technology

FENGTONGNING PIAN dispeiling pathogenic wind and removing dampness, cold expelling is invigorated blood circulation, muscles and tendons relaxing to alleviate pain.For rheumatic arthritis and rheumatoid arthritis.Commercially available FENGTONGNING PIAN is due to prescription and technological reason, and curative effect is not satisfactory, and preparation adopts traditional handicraft preparation, there is the deficiencies such as prolonged disintegration, curative effect are low.

Summary of the invention

The present invention, for overcoming above-mentioned deficiency, provides FENGTONGNING PIAN that a kind of disintegration rate is fast, curative effect is high and preparation method thereof.

Invention embodiment is as follows:

Get Radix Dichroae 78g, Herba Eupatorii 23.4g, Cortex Ailanthi 36g, Radix Aconiti Kusnezoffii Preparata 42g, Rhizoma Et Radix Notopterygii 32g, Radix Angelicae Pubescentis 52g, Radix Aconiti Lateralis Preparata 6g, Olibanum 15g, Myrrha 15g, Radix Angelicae Sinensis 45g, Radix Cyathulae 32g, Fructus Chaenomelis 25g, Herba Ephedrae 20g, Ramulus Cinnamomi 15g, be ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 21 ~ 44Mpa, extraction temperature 17 ~ 41 DEG C, separator pressure 10 ~ 19Mpa, separator temperature 43 ~ 58 DEG C, disengaging time 2.1 ~ 3.6 hours, carbon dioxide flow 24 ~ 37L per hour, obtains extracting solution; Get extracting solution 63 ~ 77 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add citric acid 80 ~ 120g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 35 ~ 45g, hyprolose 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, aluminium-magnesium silicate 15 ~ 25g, sodium chloride 5 ~ 15g, mannitol 4 ~ 6g, maltodextrin 4 ~ 6g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional sodium alginate 7 ~ 9g, boric acid 1 ~ 3g, granulate, tabletting, obtained FENGTONGNING PIAN 650.

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

Radix Dichroae: China's coastal port one ministerial standard.This product is the dry root of saxifragaceae plant Radix Dichroae DichroaferifugaLour..Autumn excavates, and removing fibrous root, cleans, dry.

Herba Eupatorii: China's coastal port one ministerial standard.This product is the dry aerial parts of feverfew Herba Eupatorii EupatoriumfortuneiTurcz..Summer, Qiu Erji tap at twice, and removing impurity, dries.

Cortex Ailanthi: China's coastal port one ministerial standard.This product is quassia ailanthus altissima (mill.) swingle Ailanthusaltissima(Mill.) the dry root bark of Swingle or dried bark.The whole year all can strip, and dries, or scrapes off rough bark and dry.

Radix Aconiti Kusnezoffii Preparata: China's coastal port one ministerial standard.This product is the Preparation process product of Radix Aconiti Kusnezoffii.

Rhizoma Et Radix Notopterygii: China's coastal port one ministerial standard.This product is dry rhizome and the root of samphire Rhizoma Et Radix Notopterygii NotopterygiumTingexH.T.Chang or Radix et Rhizoma Notopterygii NotopterygiumforbesiiBoiss..Spring, Qiu Erji dig, and removing fibrous root and silt, dry.

Radix Angelicae Pubescentis: China's coastal port one ministerial standard.This product is the dry root of samphire Angelica pubescens AngelicapubescensMaxim.f.biserrataShanetYuan.Excavate when Seedling at the beginning of spring has just germinateed or autumn Mo, stem and leaf was withered, removing fibrous root and silt, be dried to half-dried, bank up 2-3 days, is dried to absolutely dry after feeling like jelly again.Radix Aconiti Lateralis Preparata

Olibanum: China's coastal port one ministerial standard.Real name smokes land, and the smoked Lu Xiang of another name, horse hair is fragrant, nipple is fragrant, the perfume (or spice) that collapses, sky pool is fragrant, Moller is fragrant, many gals Luo Xiang etc., and Latin literary fame Boswelliacarteri. is the cured resin of Burseraceae aiphyllium.Because it drips into mamillary, thus fragrant also known as nipple.

Myrrha: Chinese Pharmacopoeia version one ministerial standard in 2015.This product is olive subject plant Herba Violae tree CommiphoramyrrhaEngl.

Or breathe out the dry resin of Herba Violae tree CommiphoramolmolEngl..Be divided into natural Myrrha and gum opoponax.

Radix Angelicae Sinensis: China's coastal port one ministerial standard.This product is umbelliferae angelica Angelicasinensis(Oliv.) dry root of Diels.Autumn end excavates, and removing fibrous root and silt, after moisture slightly evaporates, be bundled into wisp, upper canopy, with pyrotechnics slowly smoke-dried beancurd.

Radix Cyathulae: China's coastal port one ministerial standard.This product is the dry root of amaranthaceous plant Radix Cyathulae CyathulaoficinalisKuan.Autumn, season in winter two excavate, and except removing LU, fibrous root and silt, dry or shine to half-dried, heap puts back to profit, then dries or dry.

Fructus Chaenomelis: China's coastal port one ministerial standard.This product is rosaceous plant chaenomeles lagenaria Chaenomelesspeciosa(Sweet) the dry almost ripe fruit of Nakai.Summer, autumn two gather when season, fruit was greenish-yellow, and put in boiling water and scald to crust canescence, double vertical profile, dries.

Herba Ephedrae: China's coastal port one ministerial standard.This product is the dry herb stem of Ephedraceae plant plait Herba Ephedrae EphedrasinicaStapf, epheday intermedia EphedraintermediaSchrenketC.A.Mey. or ephedra equisetina EphedraequisetinaBge..Tap green herb stem autumn, dry.

Ramulus Cinnamomi: China's coastal port one ministerial standard.This product is the dry twig of canella Cortex Cinnamomi CinnamomumcassiaPresl.Spring, Xia Erji gather, and except defoliation, dry, or section is dried.

Citric acid: Chinese Pharmacopoeia version two ministerial standard in 2010.

Microcrystalline Cellulose: Chinese Pharmacopoeia version two ministerial standard in 2010.

Hyprolose: Chinese Pharmacopoeia version two ministerial standard in 2010.

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

Aluminium-magnesium silicate: Chinese Pharmacopoeia version two ministerial standard in 2010.

Sodium chloride: Chinese Pharmacopoeia version two ministerial standard in 2010.

Mannitol: Chinese Pharmacopoeia version two ministerial standard in 2010.

Maltodextrin: Chinese Pharmacopoeia version two ministerial standard in 2010.

Sodium alginate: Chinese Pharmacopoeia version two ministerial standard in 2010.

Boric acid: Chinese Pharmacopoeia version two ministerial standard in 2010.

Raw material used by above FENGTONGNING PIAN all can be bought from pharmaceuticals and obtain, and all can be used to implement the present invention program as long as meet national standard.

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

Unit g in the present invention also can 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, 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

Get Radix Dichroae 78g, Herba Eupatorii 23.4g, Cortex Ailanthi 36g, Radix Aconiti Kusnezoffii Preparata 42g, Rhizoma Et Radix Notopterygii 32g, Radix Angelicae Pubescentis 52g, Radix Aconiti Lateralis Preparata 6g, Olibanum 15g, Myrrha 15g, Radix Angelicae Sinensis 45g, Radix Cyathulae 32g, Fructus Chaenomelis 25g, Herba Ephedrae 20g, Ramulus Cinnamomi 15g, be ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 21Mpa, extraction temperature 17 DEG C, separator pressure 10Mpa, separator temperature 43 DEG C, disengaging time 2.1 hours, carbon dioxide flow 24L per hour, obtains extracting solution; Get extracting solution 63 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add citric acid 80g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 35g, hyprolose 35g, cross-linking sodium carboxymethyl cellulose 35g, aluminium-magnesium silicate 15g, sodium chloride 5g, mannitol 4g, maltodextrin 4g, mix homogeneously, with 50% ethanol wet granulation, 60 DEG C of dryings, additional sodium alginate 7g, boric acid 1g, granulate, tabletting, obtained FENGTONGNING PIAN 650.

Specific embodiments of the invention 2

Get Radix Dichroae 78g, Herba Eupatorii 23.4g, Cortex Ailanthi 36g, Radix Aconiti Kusnezoffii Preparata 42g, Rhizoma Et Radix Notopterygii 32g, Radix Angelicae Pubescentis 52g, Radix Aconiti Lateralis Preparata 6g, Olibanum 15g, Myrrha 15g, Radix Angelicae Sinensis 45g, Radix Cyathulae 32g, Fructus Chaenomelis 25g, Herba Ephedrae 20g, Ramulus Cinnamomi 15g, be ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 44Mpa, extraction temperature 41 DEG C, separator pressure 19Mpa, separator temperature 58 DEG C, disengaging time 3.6 hours, carbon dioxide flow 37L per hour, obtains extracting solution; Get extracting solution 77 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add citric acid 120g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 45g, hyprolose 45g, cross-linking sodium carboxymethyl cellulose 45g, aluminium-magnesium silicate 25g, sodium chloride 15g, mannitol 6g, maltodextrin 6g, mix homogeneously, with 70% ethanol wet granulation, 80 DEG C of dryings, additional sodium alginate 9g, boric acid 3g, granulate, tabletting, obtained FENGTONGNING PIAN 650.

Specific embodiments of the invention 3

Get Radix Dichroae 78g, Herba Eupatorii 23.4g, Cortex Ailanthi 36g, Radix Aconiti Kusnezoffii Preparata 42g, Rhizoma Et Radix Notopterygii 32g, Radix Angelicae Pubescentis 52g, Radix Aconiti Lateralis Preparata 6g, Olibanum 15g, Myrrha 15g, Radix Angelicae Sinensis 45g, Radix Cyathulae 32g, Fructus Chaenomelis 25g, Herba Ephedrae 20g, Ramulus Cinnamomi 15g, be ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 33Mpa, extraction temperature 29 DEG C, separator pressure 15Mpa, separator temperature 51 DEG C, disengaging time 3 hours, carbon dioxide flow 31L per hour, obtains extracting solution; Get extracting solution 70 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add citric acid 100g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 40g, hyprolose 40g, cross-linking sodium carboxymethyl cellulose 40g, aluminium-magnesium silicate 20g, sodium chloride 10g, mannitol 5g, maltodextrin 5g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C of dryings, additional sodium alginate 8g, boric acid 2g, granulate, tabletting, obtained FENGTONGNING PIAN 650.

Above embodiment illustrates, adopts the extreme condition of embodiment of the present invention and optimal conditions all can make FENGTONGNING PIAN.

Actual effect of the present invention is investigated below with the FENGTONGNING PIAN that embodiment 3 is obtained:

(1) embodiment 3 FENGTONGNING PIAN and contrast disintegration of commercially available FENGTONGNING PIAN

1 disintegration time mensuration method

Measure by Chinese Pharmacopoeia version annex Ⅻ A in 2010.

Contrast 2 disintegrations

Table 1 embodiment 3 FENGTONGNING PIAN and commercially available FENGTONGNING PIAN contrast table disintegration

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

(2) embodiment 3 FENGTONGNING PIAN and commercially available FENGTONGNING PIAN treat rheumatic arthritis and rheumatoid arthritis disease clinical observation on the therapeutic effect

1 case scenario

Statistics outpatient service and inpatient, observe rheumatic arthritis and rheumatoid arthritis disease case 142 example, 55 years old mean age altogether.Patient is divided into two groups, test group takes embodiment 3 FENGTONGNING PIAN, and matched group takes commercially available FENGTONGNING PIAN.

2 efficacy assessment standards

According to new Chinese medicine treatment 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 the rear integration of integration-treatment) ÷ treatment integration] × 100%.

3 clinical observation result

Table 2 embodiment 3 FENGTONGNING PIAN and commercially available FENGTONGNING PIAN clinical efficacy contrast table

Above-mentioned clinical observation on the therapeutic effect result shows, FENGTONGNING PIAN prepared by the present invention is when treating rheumatic arthritis and rheumatoid arthritis disease, evident in efficacy higher than commercially available FENGTONGNING PIAN, p < 0.05.

Claims (3)

1. treat the Chinese medicine of rheumatic arthritis and rheumatoid arthritis for one kind, it is characterized in that getting Radix Dichroae 78g, Herba Eupatorii 23.4g, Cortex Ailanthi 36g, Radix Aconiti Kusnezoffii Preparata 42g, Rhizoma Et Radix Notopterygii 32g, Radix Angelicae Pubescentis 52g, Radix Aconiti Lateralis Preparata 6g, Olibanum 15g, Myrrha 15g, Radix Angelicae Sinensis 45g, Radix Cyathulae 32g, Fructus Chaenomelis 25g, Herba Ephedrae 20g, Ramulus Cinnamomi 15g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 21 ~ 44Mpa, extraction temperature 17 ~ 41 DEG C, separator pressure 10 ~ 19Mpa, separator temperature 43 ~ 58 DEG C, disengaging time 2.1 ~ 3.6 hours, carbon dioxide flow 24 ~ 37L per hour, obtain extracting solution, get extracting solution 63 ~ 77 DEG C of drying under reduced pressure, get dry extract, get dry cream and add citric acid 80 ~ 120g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm, get mixing dried cream powder, microcrystalline Cellulose 35 ~ 45g, hyprolose 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, aluminium-magnesium silicate 15 ~ 25g, sodium chloride 5 ~ 15g, mannitol 4 ~ 6g, maltodextrin 4 ~ 6g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional sodium alginate 7 ~ 9g, boric acid 1 ~ 3g, granulate, tabletting, obtained FENGTONGNING PIAN.

2. the preparation method of Chinese medicine according to claim 1, is characterized in that getting Radix Dichroae 78g, Herba Eupatorii 23.4g, Cortex Ailanthi 36g, Radix Aconiti Kusnezoffii Preparata 42g, Rhizoma Et Radix Notopterygii 32g, Radix Angelicae Pubescentis 52g, Radix Aconiti Lateralis Preparata 6g, Olibanum 15g, Myrrha 15g, Radix Angelicae Sinensis 45g, Radix Cyathulae 32g, Fructus Chaenomelis 25g, Herba Ephedrae 20g, Ramulus Cinnamomi 15g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 21 ~ 44Mpa, extraction temperature 17 ~ 41 DEG C, separator pressure 10 ~ 19Mpa, separator temperature 43 ~ 58 DEG C, disengaging time 2.1 ~ 3.6 hours, carbon dioxide flow 24 ~ 37L per hour, obtains extracting solution; Get extracting solution 63 ~ 77 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add citric acid 80 ~ 120g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 35 ~ 45g, hyprolose 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, aluminium-magnesium silicate 15 ~ 25g, sodium chloride 5 ~ 15g, mannitol 4 ~ 6g, maltodextrin 4 ~ 6g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional sodium alginate 7 ~ 9g, boric acid 1 ~ 3g, granulate, tabletting, obtained FENGTONGNING PIAN.

3. the preparation method of Chinese medicine according to claim 1, gets Radix Dichroae 78g, Herba Eupatorii 23.4g, Cortex Ailanthi 36g, Radix Aconiti Kusnezoffii Preparata 42g, Rhizoma Et Radix Notopterygii 32g, Radix Angelicae Pubescentis 52g, Radix Aconiti Lateralis Preparata 6g, Olibanum 15g, Myrrha 15g, Radix Angelicae Sinensis 45g, Radix Cyathulae 32g, Fructus Chaenomelis 25g, Herba Ephedrae 20g, Ramulus Cinnamomi 15g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 33Mpa, extraction temperature 29 DEG C, separator pressure 15Mpa, separator temperature 51 DEG C, disengaging time 3 hours, carbon dioxide flow 31L per hour, obtains extracting solution; Get extracting solution 70 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add citric acid 100g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 40g, hyprolose 40g, cross-linking sodium carboxymethyl cellulose 40g, aluminium-magnesium silicate 20g, sodium chloride 10g, mannitol 5g, maltodextrin 5g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C of dryings, additional sodium alginate 8g, boric acid 2g, granulate, tabletting, obtained FENGTONGNING PIAN.