CN105770021A - Pearl and chrysanthemum antihypertension tablet and preparation method thereof - Google Patents

Abstract

The invention discloses a pearl and chrysanthemum antihypertension tablet and a preparation method thereof. The preparation method is characterized by comprising the following steps of taking 80 to 120g of roots of common peony, 180 to 220g of wild chrysanthemum flowers and 80 to 120g of pearl layer powder; performing extraction by a carbon dioxide supercritical extraction method; performing drying under reduced pressure; crushing the ingredients into nanometer dry paste by a high-energy nanometer impact mill; adding functional auxiliary materials; and making the ingredients into the pearl and chrysanthemum antihypertension tablet. The pearl and chrysanthemum antihypertension tablet has the advantages that the disintegration time is obviously shortened; the curative effect is obviously superior to that of a commercially available pearl and chrysanthemum antihypertension tablet; and a positive effect is achieved.

Description

Zhenju Jiangya Tablet and preparation method thereof

Technical field

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

Background technology

Zhenju Jiangya Tablet has antihypertensive effect, for vascular hypertension.Existing Zhenju Jiangya 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 Zhenju Jiangya Tablet that a kind of disintegration rate is fast, curative effect is high and preparation method thereof.

Invention embodiment is as follows:

Take Radix Paeoniae Rubra 80～120g, Flos Chrysanthemi Indici 180～220g, Margarita layer powder 80～120g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 20～40Mpa, extraction temperature 20～40 DEG C, separator pressure 10～20Mpa, separator temperature 40～60 DEG C, disengaging time 2～4 hours, carbon dioxide flow is 20～40L 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 80～120g, 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, microcrystalline Cellulose 35～45g, crospolyvinylpyrrolidone 35～45g, cross-linking sodium carboxymethyl cellulose 35～45g, hypromellose 25～35g, lactose 4～6g, 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 1000, prepares Zhenju Jiangya Tablet.

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

Radix Paeoniae Rubra: China's coastal port one ministerial standard.This product is ranunculaceae plant Radix Paeoniae PaeonialactifloraPall. or the dry root of river Radix Paeoniae Rubra PaeoniaveitchiiLynch.Spring, season in autumn two excavate, and remove rhizome, fibrous root and silt, dry.

Flos Chrysanthemi Indici: China's coastal port one ministerial standard.This product is the dry capitulum of feverfew Herba Dendranthematis indici ChrysanthemumindicumL..Autumn, pluck when spending in season in winter two just open, dry, or dry after steaming.

Margarita layer powder: the 6th standard of Traditional Chinese medicine historical preparation.

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

Microcrystalline Cellulose: 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.

Hypromellose: Chinese Pharmacopoeia version two ministerial standard in 2010.

Lactose: Chinese Pharmacopoeia version two ministerial standard in 2010.

Carboxymethylstach sodium: Chinese Pharmacopoeia version two ministerial standard in 2010.

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

Raw material used in above Zhenju Jiangya 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 Radix Paeoniae Rubra 80g, Flos Chrysanthemi Indici 180g, Margarita layer powder 80g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 20Mpa, extraction temperature 20 DEG C, separator pressure 10Mpa, separator temperature 40 DEG C, disengaging time 2 hours, carbon dioxide flow is 20L 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 80g, 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, microcrystalline Cellulose 35g, crospolyvinylpyrrolidone 35g, cross-linking sodium carboxymethyl cellulose 35g, hypromellose 25g, lactose 4g, mix homogeneously, with 50% ethanol wet granulation, 60 DEG C dry, additional carboxymethyl starch sodium 7g, magnesium stearate 1g, granulate, is pressed into 1000, prepares Zhenju Jiangya Tablet.

Specific embodiments of the invention 2

Take Radix Paeoniae Rubra 120g, Flos Chrysanthemi Indici 220g, Margarita layer powder 120g, 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 40L 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 120g, 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, microcrystalline Cellulose 45g, crospolyvinylpyrrolidone 45g, cross-linking sodium carboxymethyl cellulose 45g, hypromellose 35g, lactose 6g, mix homogeneously, with 70% ethanol wet granulation, 80 DEG C dry, additional carboxymethyl starch sodium 9g, magnesium stearate 3g, granulate, is pressed into 1000, prepares Zhenju Jiangya Tablet.

Specific embodiments of the invention 3

Take Radix Paeoniae Rubra 100g, Flos Chrysanthemi Indici 200g, Margarita layer powder 100g, 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 15Mpa, separator temperature 50 DEG C, disengaging time 3 hours, carbon dioxide flow is 30L 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 100g, 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, microcrystalline Cellulose 40g, crospolyvinylpyrrolidone 40g, cross-linking sodium carboxymethyl cellulose 40g, hypromellose 30g, lactose 5g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C dry, additional carboxymethyl starch sodium 8g, magnesium stearate 2g, granulate, is pressed into 1000, prepares Zhenju Jiangya Tablet.

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

(1) embodiment 3 Zhenju Jiangya Tablet and contrast disintegration of commercially available Zhenju Jiangya Tablet

1 disintegration time mensuration method

Measure by Chinese Pharmacopoeia version annex Ⅻ A in 2010.

Contrast 2 disintegrations

Table 1 embodiment 3 Zhenju Jiangya Tablet and commercially available Zhenju Jiangya Tablet contrast table disintegration

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

(2) embodiment 3 Zhenju Jiangya Tablet and commercially available Zhenju Jiangya Tablet treatment vascular hypertension clinical observation on the therapeutic effect

1 case scenario

Statistics outpatient service and inpatient, observe vascular hypertension case 116 example, 53 years old mean age altogether.Patient is divided into two groups, and test group takes embodiment 3 Zhenju Jiangya Tablet, and matched group takes commercially available Zhenju Jiangya Tablet.

2 efficacy assessment standards

Guideline of clinical investigations tcm syndrome curative effect determinate standard according to new Chinese medicine Hypertension:

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 Zhenju Jiangya Tablet and commercially available Zhenju Jiangya Tablet clinical efficacy contrast table

Above-mentioned clinical observation on the therapeutic effect is it is shown that the Zhenju Jiangya Tablet prepared of the present invention is when Hypertension, evident in efficacy higher than commercially available Zhenju Jiangya Tablet, p < 0.05.

Claims (3)

1. treat a Chinese medicine for high blood pressure disease, it is characterized in that taking Radix Paeoniae Rubra 80～120g, Flos Chrysanthemi Indici 180～220g, Margarita layer powder 80～120g, it is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 20～40Mpa, extraction temperature 20～40 DEG C, separator pressure 10～20Mpa, separator temperature 40～60 DEG C, disengaging time 2～4 hours, carbon dioxide flow is 20～40L 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 80～120g, 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, microcrystalline Cellulose 35～45g, crospolyvinylpyrrolidone 35～45g, cross-linking sodium carboxymethyl cellulose 35～45g, hypromellose 25～35g, lactose 4～6g, 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 prepared Zhenju Jiangya Tablet.

2. the preparation method of Chinese medicine according to claim 1, is characterized in that taking Radix Paeoniae Rubra 80～120g, Flos Chrysanthemi Indici 180～220g, Margarita layer powder 80～120g, it is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 20～40Mpa, extraction temperature 20～40 DEG C, separator pressure 10～20Mpa, separator temperature 40～60 DEG C, disengaging time 2～4 hours, carbon dioxide flow is 20～40L 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 80～120g, 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, microcrystalline Cellulose 35～45g, crospolyvinylpyrrolidone 35～45g, cross-linking sodium carboxymethyl cellulose 35～45g, hypromellose 25～35g, lactose 4～6g, 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, prepares Zhenju Jiangya Tablet.

3. the preparation method of Chinese medicine according to claim 1, takes Radix Paeoniae Rubra 100g, Flos Chrysanthemi Indici 200g, Margarita layer powder 100g, it is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 30Mpa, extraction temperature 30 DEG C, separator pressure 15Mpa, separator temperature 50 DEG C, disengaging time 3 hours, carbon dioxide flow is 30L 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 100g, 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, microcrystalline Cellulose 40g, crospolyvinylpyrrolidone 40g, cross-linking sodium carboxymethyl cellulose 40g, hypromellose 30g, lactose 5g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C dry, additional carboxymethyl starch sodium 8g, magnesium stearate 2g, granulate, prepare Zhenju Jiangya Tablet.