CN104224956A - Mind-calming tablet and preparation method thereof - Google Patents

Mind-calming tablet and preparation method thereof Download PDF

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Publication number
CN104224956A
CN104224956A CN201410402604.9A CN201410402604A CN104224956A CN 104224956 A CN104224956 A CN 104224956A CN 201410402604 A CN201410402604 A CN 201410402604A CN 104224956 A CN104224956 A CN 104224956A
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China
Prior art keywords
carbon dioxide
ground
mind
xinning
tablets
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CN201410402604.9A
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Chinese (zh)
Inventor
朱文军
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Heilongjiang Jiangheng Pharmaceutical Co Ltd
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Heilongjiang Jiangheng Pharmaceutical Co Ltd
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Priority to CN201410402604.9A priority Critical patent/CN104224956A/en
Publication of CN104224956A publication Critical patent/CN104224956A/en
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Abstract

The invention discloses a mind-calming tablet and a preparation method thereof. The mind-calming tablet disclosed by the invention is characterized by being prepared from the following components: 300g of the root of red-rooted salvia, 150g of piper cubeba, 150g of sophora flower, 150g of ligusticum wallichii, 54g of pseudo-ginseng and 150g of root of common peony. The preparation method comprises the following steps of: extracting by using a supercritical carbon dioxide extraction method, drying under reduced pressure, crushing into nano dry paste by using a high-energy nano impact mill, and adding functional auxiliaries, thus obtaining the mind-calming tablet. The mind-calming tablet provided by the invention, the disintegration time is obviously shortened; the curative effect is obviously prior to that of the commercial mind-calming tablet; and active effects are obtained.

Description

A kind of Xinning tablets and preparation method thereof
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of Xinning tablets and preparation method thereof.
Background technology
Xinning tablets is used for the caused by energy stagnation and blood stasis thoracic obstruction, and disease is seen uncomfortable in chest, chest pain, cardiopalmus, breathed hard; Angina pectoris is shown in above-mentioned patient.Existing Xinning tablets 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 Xinning tablets that a kind of disintegration rate is fast, curative effect is high and preparation method thereof.
Invention embodiment is as follows:
Get Radix Salviae Miltiorrhizae 300g, Fructus Litseae 150g, Flos Sophorae 150g, Rhizoma Chuanxiong 150g, Radix Notoginseng 54g, Radix Paeoniae Rubra 150g, be ground into 60 order coarse powder, adopt 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 20 ~ 40L per hour, obtains extracting solution; Get extracting solution 60 DEG C ~ 80 DEG C drying under reduced pressure, get dry extract; Get dry cream and add calcium sulfate 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, crospolyvinylpyrrolidone 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, hypromellose 25 ~ 35g, micropowder silica gel 15 ~ 25g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional carboxymethyl starch sodium 7 ~ 9g, magnesium stearate 1 ~ 3g, granulate, is pressed into 3000, obtained Xinning tablets.
The raw material standards that above-mentioned embodiment is mentioned is as follows:
Radix Salviae Miltiorrhizae: China's coastal port one ministerial standard.This product is the dry root and rhizome of labiate Radix Salviae Miltiorrhizae Salvia miltiorrhiza Bge..Spring, Qiu Erji excavate, removing silt, dry.
Fructus Litseae: China's coastal port one ministerial standard.This product is canella cubeb litsen tree Litsea cubeba(Lour.) dry mature fruit of Pers..Gather during fruit maturation in autumn, removing impurity dries.
Flos Sophorae: China's coastal port one ministerial standard.This product is the dry flower and alabastrum of leguminous plant Chinese scholartree Sophora japonica L..Summer, the flowers are in blossom put or alabastrum is formed time gather, dry in time, except debranching, stalk and impurity.The former practises title " Flos Sophorae ", and the latter practises title " Flos Sophorae Immaturus ".
Rhizoma Chuanxiong: China's coastal port one ministerial standard.This product is the dry rhizome of samphire Rhizoma Chuanxiong Ligusticum chuanriong Hort..The joint dish that summer works as on stem is significantly outstanding, and excavates during purplish, and removing silt, shines post-drying, then remove fibrous root.
Radix Notoginseng: China's coastal port one ministerial standard.This product is the dry root and rhizome of panax araliaceae plant Punax notoginseng (Burk.) F.H.Chen.Autumn excavates before the flowers are in blossom, cleans, and separately main root, a root and rhizome, dry.Supporting root is practised and is claimed " rib ", and rhizome is practised and claimed " clip ".
Radix Paeoniae Rubra: China's coastal port one ministerial standard.This product is the dry root of ranunculaceae plant Radix Paeoniae Paeonia lactiflora Pall. or river Radix Paeoniae Rubra Paeonia veitchii Lynch.Spring, Qiu Erji excavate, and removing rhizome, fibrous root and silt, dry.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.
Micropowder silica gel: 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 by above Xinning tablets 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 Salviae Miltiorrhizae 300g, Fructus Litseae 150g, Flos Sophorae 150g, Rhizoma Chuanxiong 150g, Radix Notoginseng 54g, Radix Paeoniae Rubra 150g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 20Mpa, extraction temperature 20 DEG C, separator pressure 10Mpa, separator temperature 40 DEG C, disengaging time 2 hours, carbon dioxide flow 20L per hour, obtains extracting solution; Get extracting solution 60 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add calcium sulfate 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, crospolyvinylpyrrolidone 35g, cross-linking sodium carboxymethyl cellulose 35g, hypromellose 25g, micropowder silica gel 15g, mix homogeneously, with 50% ethanol wet granulation, 60 DEG C of dryings, additional carboxymethyl starch sodium 7g, magnesium stearate 1g, granulate, is pressed into 3000, obtained Xinning tablets.
Specific embodiments of the invention 2
Get Radix Salviae Miltiorrhizae 300g, Fructus Litseae 150g, Flos Sophorae 150g, Rhizoma Chuanxiong 150g, Radix Notoginseng 54g, Radix Paeoniae Rubra 150g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 40Mpa, extraction temperature 40 DEG C, separator pressure 20Mpa, separator temperature 60 DEG C, disengaging time 4 hours, carbon dioxide flow 40L per hour, obtains extracting solution; Get extracting solution 80 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add calcium sulfate 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, crospolyvinylpyrrolidone 45g, cross-linking sodium carboxymethyl cellulose 45g, hypromellose 35g, micropowder silica gel 25g, mix homogeneously, with 70% ethanol wet granulation, 80 DEG C of dryings, additional carboxymethyl starch sodium 9g, magnesium stearate 3g, granulate, is pressed into 3000, obtained Xinning tablets.
Specific embodiments of the invention 3
Get Radix Salviae Miltiorrhizae 300g, Fructus Litseae 150g, Flos Sophorae 150g, Rhizoma Chuanxiong 150g, Radix Notoginseng 54g, Radix Paeoniae Rubra 150g, be ground into 60 order coarse powder, adopt 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 30L per hour, obtains extracting solution; Get extracting solution 70 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add calcium sulfate 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, crospolyvinylpyrrolidone 40g, cross-linking sodium carboxymethyl cellulose 40g, hypromellose 30g, micropowder silica gel 20g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C of dryings, additional carboxymethyl starch sodium 8g, magnesium stearate 2g, granulate, is pressed into 3000, obtained Xinning tablets.
Above embodiment illustrates, adopts the extreme condition of embodiment of the present invention and optimal conditions all can make Xinning tablets.Actual effect of the present invention is investigated below with the Xinning tablets that embodiment 3 is obtained:
(1) embodiment 3 Xinning tablets and commercially available Xinning tablets contrast disintegration
1 disintegration time mensuration method
Measure by Chinese Pharmacopoeia version annex Ⅻ A in 2010.
Contrast 2 disintegrations
Table 1 embodiment 3 Xinning tablets and commercially available Xinning tablets contrast table disintegration
The above results shows, Xinning tablets prepared by the present invention has the remarkable advantages such as disintegration rate is fast, bioavailability is high relative to commercially available Xinning tablets.
(2) embodiment 3 Xinning tablets and commercially available Xinning tablets treat angina pectoris Disease Clinical observation of curative effect
1 case scenario
Statistics outpatient service and inpatient, observe angina pectoris disease case 110 example, 55 years old mean age altogether.Patient is divided into two groups, test group takes embodiment 3 Xinning tablets, and matched group takes commercially available Xinning tablets.
2 efficacy assessment standards
According to new Chinese medicine treatment angina pectoris guideline of clinical investigations tcm syndrome curative effect determinate standard:
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%.
Increase the weight of: tcm clinical practice symptom, sign all have and increase the weight of, syndrome integral reduces < 0.
Computing formula: [before (before treatment the rear integration of integration-treatment) ÷ treatment integration] × 100%.
3 clinical observation result
Table 2 embodiment 3 Xinning tablets and commercially available Xinning tablets clinical efficacy contrast table
Above-mentioned clinical observation on the therapeutic effect result shows, Xinning tablets prepared by the present invention is when treating angina pectoris disease, evident in efficacy higher than commercially available Xinning tablets, p < 0.05.
  

Claims (3)

1. treat a Chinese medicine for angina pectoris disease, it is characterized in that getting Radix Salviae Miltiorrhizae 300g, Fructus Litseae 150g, Flos Sophorae 150g, Rhizoma Chuanxiong 150g, Radix Notoginseng 54g, Radix Paeoniae Rubra 150g, 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 20 ~ 40L per hour, obtains extracting solution; Get extracting solution 60 DEG C ~ 80 DEG C drying under reduced pressure, get dry extract; Get dry cream and add calcium sulfate 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, crospolyvinylpyrrolidone 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, hypromellose 25 ~ 35g, micropowder silica gel 15 ~ 25g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional carboxymethyl starch sodium 7 ~ 9g, magnesium stearate 1 ~ 3g, ascorbic acid 80 ~ 120g, granulate, obtained Xinning tablets.
2. the preparation method of Chinese medicine according to claim 1, is characterized in that getting Radix Salviae Miltiorrhizae 300g, Fructus Litseae 150g, Flos Sophorae 150g, Rhizoma Chuanxiong 150g, Radix Notoginseng 54g, Radix Paeoniae Rubra 150g, 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 20 ~ 40L per hour, obtains extracting solution; Get extracting solution 60 DEG C ~ 80 DEG C drying under reduced pressure, get dry extract; Get dry cream and add calcium sulfate 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, crospolyvinylpyrrolidone 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, hypromellose 25 ~ 35g, micropowder silica gel 15 ~ 25g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional carboxymethyl starch sodium 7 ~ 9g, magnesium stearate 1 ~ 3g, ascorbic acid 80 ~ 120g, granulate, obtained Xinning tablets.
3. the preparation method of Chinese medicine according to claim 1, gets Radix Salviae Miltiorrhizae 300g, Fructus Litseae 150g, Flos Sophorae 150g, Rhizoma Chuanxiong 150g, Radix Notoginseng 54g, Radix Paeoniae Rubra 150g, 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 30L per hour, obtains extracting solution; Get extracting solution 70 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add calcium sulfate 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, crospolyvinylpyrrolidone 40g, cross-linking sodium carboxymethyl cellulose 40g, hypromellose 30g, micropowder silica gel 20g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C of dryings, additional carboxymethyl starch sodium 8g, magnesium stearate 2g, ascorbic acid 100g, granulate, obtained Xinning tablets.
CN201410402604.9A 2014-08-16 2014-08-16 Mind-calming tablet and preparation method thereof Pending CN104224956A (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102600234A (en) * 2012-04-13 2012-07-25 孙长海 Swertia mileensis dispersible tablet and preparation method thereof
CN102824425A (en) * 2012-09-24 2012-12-19 南京正亮医药科技有限公司 Method for preparing mental stress relieving tablets

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102600234A (en) * 2012-04-13 2012-07-25 孙长海 Swertia mileensis dispersible tablet and preparation method thereof
CN102824425A (en) * 2012-09-24 2012-12-19 南京正亮医药科技有限公司 Method for preparing mental stress relieving tablets

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