Traditional Chinese medicine preparation for treating dizziness, palpitation, insomnia and forgetfulness and preparation method of traditional Chinese medicine preparation

A technology for insomnia, forgetfulness, and traditional Chinese medicine preparations, which is applied in the direction of medical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc. It can solve problems such as unsatisfactory and incomplete extraction of active ingredients, and achieve low production costs. , Guarantee the content and curative effect of active ingredients, and improve the effect of curative effect

Inactive Publication Date: 2017-11-07

广西大海阳光药业有限公司

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AI-Extracted Technical Summary

Problems solved by technology

The extraction process of the patent "a traditional Chinese medicine preparation with nourishing blood and calming nerves and its preparation method" (application number 200510003181.4) is as follows: the medicinal materials are extracted with water, concentrated, and then subjected to alcohol precipitation twice to remove impurities. Alcohol removed impurities twice, but the Radix Polygoni Multiflori medicina...

Method used

[0063] Surfactant has the effect of wetting and solubilization in pharmaceutical preparations, adding surfactant in the prescription of dispersible tablets can greatly improve the dissolution rate of dispersible table...

Abstract

The invention discloses a traditional Chinese medicine preparation for treating dizziness, palpitation, insomnia and forgetfulness and a preparation method of the traditional Chinese medicine preparation. The preparation is prepared from the following components in parts by weight: 80-120 parts of hairyvein agrimony, 40-80 parts of eclipta, 40-80 parts of caulis spatholobi, 40-80 parts of radix rehmanniae praeparata, 40-80 parts of radix rehmanniae, 40-80 parts of cortex albiziae, 45-75 parts of vine multiflower knotweed, 30-50 parts of sodium alginate, 10-20 parts of hydroxypropyl methyl cellulose, 20-40 parts of calcium sulfate, 20-30 parts of crosslinking polyvingypyrrolidone, 20-40 parts of glucan, 5-15 parts of sodium dodecyl sulfate and 1-3 parts of aerosil. The preparation is a dispersed tablet, and the preparation method comprises the steps of preparing dry paste powder from medicinal materials through extraction; preparing a clathrate compound from the dry paste powder; and further preparing the dispersed table from the clathrate compound. The product is capable of obviously improving the solubleness of an indissolvable drug in the medicinal material extract dry paste powder, shortening the disintegration time limit and improving the bioavailability. The preparation method is simple in process, low in production cost and low in energy consumption, and industrial production is easy to implement.

Application Domain

Nervous disorderDigestive system +4

Technology Topic

Hydroxypropylmethyl celluloseGlucan +15

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Examples

Experimental program(3)

Example Embodiment

[0080] Example 1

[0081] A preparation method of dispersible tablets prepared from a traditional Chinese medicine preparation for treating dizziness, palpitations, insomnia and forgetfulness, includes the following steps:

[0082] T1. Take the following components: hydroxypropyl methyl cellulose, pregelatinized starch, crospovidone, sodium carboxymethyl starch, sodium lauryl sulfate, micronized silica gel, crushed through a 100 mesh sieve, and set aside ;

[0083] T2. Weigh the components according to the following parts by weight: Agrimony 800g, Eclipta prostrata 400g, Cortis spatholobi 400g, Rehmannia glutinosa 400g, Rehmannia glutinosa 400g, Albizia julibrissin 400g, Shouwu vine 450g, Sodium alginate 300g, Hypromellose Base cellulose 100g, calcium sulfate 200g, crospovidone 200g, dextran 200g, sodium lauryl sulfate 50g, micronized silica gel 10g;

[0084] T3. Preparation of medicinal material extract dry paste powder: take Shouwu vine, add 3 times the amount of 70% ethanol solution and reflux for 2 times, 2 hours each time, combine the extracts, filter with 200 mesh, and recover the ethanol from the filtrate and concentrate to relative density At 80℃, it is 1.25 clear ointment A; take agrimony, Eclipta prostrata, spatholobi, rehmannia glutinosa, rehmannia glutinosa, albizia bark, and ethanol-extracted Shouwu vine medicinal materials plus 6 times the amount of water to decoct 2 times , 2 hours each time, combine the decoction, filter, and concentrate the filtrate to a clear ointment with a relative density of 1.03 at 70°C, add 95% ethanol equal to the amount of the clear ointment, place it at 5°C for 12 hours, take it out, 200 Mesh filtration, take the filtrate to recover ethanol and concentrate it to clear ointment B with a relative density of 1.25 at 80°C; take clear ointment A and B, mix well, vacuum dry at 60°C for 8 hours, take out, crush, and pass through 80 mesh sieve to obtain medicinal materials The dry powder of the extract was determined to have a moisture content of 2.4%.

[0085] T4. Take the dry powder of medicinal material extract to prepare the main drug inclusion compound: take the dry powder of medicinal material extract, add 1000g of 65% ethanol solution to dissolve it to make a dilute ethanol solution of the dry powder of medicinal material extract; take sodium alginate Put it in a batching tank, add 3000g of water, heat at 45℃ to dissolve it to obtain sodium alginate solution; slowly add the dilute ethanol solution of the medicinal material extract dry paste powder to the sodium alginate solution, while adding at 40 rpm Stir at stirring speed, keep the temperature at 45℃, stir for 3 hours, put it at room temperature and place it at 4℃ for 8 hours, filter, discard the mother liquor, dry the filter residue at 60℃ for 8 hours, pass through an 80 mesh sieve, and make the main medicine package The measured moisture content is 2.1%.

[0086] T5. Dissolve hydroxypropyl methyl cellulose in 600 g 65% ethanol solution to make a dilute ethanol solution of hydroxypropyl methyl cellulose;

[0087] T6. Take calcium sulfate, crospovidone, dextran, sodium lauryl sulfate and the main drug inclusion compound prepared in step T4 and add them to the mixer, stir well and add the hydroxypropyl methylcellulose of step T5 Ethanol solution, stirred for 10 minutes to make soft material, wet granulation through a 20-mesh sieve, drying at 60°C for 10 hours, and sizing through a 50-mesh sieve to obtain dry granules. The moisture content was determined to be 2.6%;

[0088] T7. Take the dry granules under step T6, add micro-powdered silica gel and mix for 30 minutes to make a mixed powder, press the tablet, and get ready.

Example Embodiment

[0089] Example 2

[0090] A preparation method of dispersible tablets prepared from a traditional Chinese medicine preparation for treating dizziness, palpitations, insomnia and forgetfulness, includes the following steps:

[0091] T1. Take the following components: hydroxypropyl methyl cellulose, pregelatinized starch, crospovidone, sodium carboxymethyl starch, sodium lauryl sulfate, micronized silica gel, crushed through a 100 mesh sieve, and set aside ;

[0092] T2. Weigh the components according to the following parts by weight: Agrimonia 1200g, Eclipta prostrata 800g, Copris spatholobi 800g, Rehmannia glutinosa 800g, Rehmannia glutinosa 800g, Albizia julibrissin 800g, Shouwu vine 750g, Sodium alginate 500g, Hypromellose Base cellulose 200g, calcium sulfate 400g, crospovidone 300g, dextran 400g, sodium lauryl sulfate 15g, micronized silica gel 3g;

[0093] T3. Preparation of dry powder of medicinal material extract: Take Shouwu vine, add 5 times the amount of 70% ethanol solution and reflux for 2 times, 3 hours each time, combine the extracts, filter with 200 meshes, and recover the ethanol from the filtrate and concentrate to relative density At 80℃, it is 1.30 clear ointment A; take agrimony, Eclipta prostrata, spatholobi, rehmannia glutinosa, rehmannia glutinosa, albizia bark, and ethanol-extracted Shouwu vine medicinal materials and 8 times the amount of water to decoct 2 times , 4 hours each time, combine the decoction, filter, and concentrate the filtrate to a clear ointment with a relative density of 1.07 at 70°C, add 95% ethanol equal to the amount of the clear ointment, place it at 10°C for 24 hours, take it out, 200 Mesh filtration, take the filtrate to recover ethanol and concentrate to clear ointment B with a relative density of 1.30 at 80°C; take clear ointment A and B and mix well, vacuum dry at 80°C for 6 hours, take out, crush, pass through 80 mesh sieve to obtain medicinal materials The extract is dry paste powder, and the measured moisture content is 2.5%.

[0094] T4. Take the dry powder of medicinal material extract to prepare the main drug inclusion compound: take the dry powder of medicinal material extract, add 3000g 65% ethanol solution to dissolve, make the dry powder of medicinal material extract dilute ethanol solution; take sodium alginate Put it in a batching tank, add 5000g water, heat at 55℃ to dissolve it to obtain a sodium alginate solution; slowly add the dilute ethanol solution of the medicinal extract dry paste powder to the sodium alginate solution, while adding it at 60rpm Stir at stirring speed, keep the temperature at 55℃, stir for 5 hours, put it at room temperature and put it at 10℃ for 12 hours, filter, discard the mother liquor, dry the filter residue at 80℃ for 6 hours, pass through an 80 mesh sieve, and make the main medicine package The measured moisture content is 2.3%.

[0095] T5. Dissolve hydroxypropyl methyl cellulose in 1000 g 65% ethanol solution to make a dilute ethanol solution of hydroxypropyl methyl cellulose;

[0096] T6. Take calcium sulfate, crospovidone, dextran, sodium lauryl sulfate and the main drug inclusion compound prepared in step T4 and add them to the mixer, stir well and add the hydroxypropyl methylcellulose of step T5 Ethanol solution, stirred for 15 minutes to make soft material, wet granulation through a 20-mesh sieve, drying at 80°C for 8 hours, and sizing through a 50-mesh sieve to obtain dry particles. The moisture content was determined to be 2.8%;

[0097] T7. Take the dry granules under step T6, add micro-powdered silica gel and mix for 30 minutes to make a mixed powder, press the tablet, and get ready.

Example Embodiment

[0098] Example 3

[0099] A preparation method of dispersible tablets prepared from a traditional Chinese medicine preparation for treating dizziness, palpitations, insomnia and forgetfulness, includes the following steps:

[0100] T1. Take the following components: hydroxypropyl methyl cellulose, pregelatinized starch, crospovidone, sodium carboxymethyl starch, sodium lauryl sulfate, micronized silica gel, crushed through a 100 mesh sieve, and set aside ;

[0101] T2. Weigh the components according to the following parts by weight: Agrimonia vulgaris 1000g, Eclipta prostrata 600g, Caulis spatholobi 600g, Rehmannia glutinosa 600g, Rehmannia glutinosa 600g, Albizia julibrissin 600g, Shouwu vine 600g, sodium alginate 400g, hypromellose 150g base cellulose, 300g calcium sulfate, 250g crospovidone, 300g dextran, 10g sodium lauryl sulfate, 2g micronized silica gel;

[0102] T3. Preparation of dry powder of medicinal material extract: Take Shouwu vine, add 4 times the amount of 70% ethanol solution and reflux for 2 times, 2.5 hours each time, combine the extracts, filter with 200 mesh, and recover the ethanol from the filtrate and concentrate to relative density 1.27 Qing Gao A at 80℃; take agrimony, Eclipta prostrata, Coprinus spatholobi, Rehmannia glutinosa, Rehmannia glutinosa, Albizia julibrissin, and ethanol-extracted Shouwu vine medicinal materials plus 7 times the amount of water to decoct 2 times , Each time for 3 hours, combine the decoction, filter, and concentrate the filtrate to a clear ointment with a relative density of 1.05 at 70°C, add 95% ethanol equal to the amount of the clear ointment, place it at 8°C for 18 hours, take it out, 200 Mesh filtration, take the filtrate to recover ethanol and concentrate it to clear ointment B with a relative density of 1.28 at 80°C; take clear ointment A and B and mix well, vacuum dry at 70°C for 7 hours, take out, crush, and pass through 80 mesh sieve to obtain medicinal materials The dry powder of the extract was determined to have a moisture content of 2.4%.

[0103] T4. Take the dry powder of medicinal material extract to prepare the main drug inclusion compound: take the dry powder of medicinal material extract and add 2000g of 65% ethanol solution to dissolve it to make a dilute ethanol solution of dry powder of medicinal material extract; take sodium alginate Place it in a batching tank, add 4000g of water, and heat at 50℃ to dissolve it to obtain a sodium alginate solution; slowly add the dilute ethanol solution of the medicinal extract dry paste powder to the sodium alginate solution, while adding it at 50 rpm Stir at stirring speed, keep the temperature at 50℃ and stir for 4 hours, put it at room temperature and put it at 7℃ for 10 hours, filter, discard the mother liquor, dry the filter residue at 70℃ for 7 hours, pass through 80 mesh sieve, and make the main medicine package The moisture content is 2.5%.

[0104] T5. Dissolve hydroxypropyl methyl cellulose in 800 g 65% ethanol solution to make a dilute ethanol solution of hydroxypropyl methyl cellulose;

[0105] T6. Take calcium sulfate, crospovidone, dextran, sodium lauryl sulfate and the main drug inclusion compound prepared in step T4 and add them to the mixer, stir well and add the hydroxypropyl methylcellulose of step T5 Ethanol solution, stirred for 13 minutes to make soft material, wet granulation through a 20-mesh sieve, drying at 70°C for 9 hours, and sizing through a 50-mesh sieve to obtain dry granules. The moisture content was determined to be 2.7%;

[0106] T7. Take the dry granules under step T6, add micro-powdered silica gel and mix for 30 minutes to make a mixed powder, press the tablet, and get ready.

[0107] 4. Quality evaluation of traditional Chinese medicine preparations for treating dizziness, palpitations, insomnia and forgetfulness

[0108] 1. Determine the disintegration time limit

[0109] Using the Chinese Pharmacopoeia 2015 edition of the "Disintegration Time Limit Inspection Method" (General Principle 0921), the traditional Chinese medicine preparations for the treatment of dizziness, palpitations, insomnia and forgetfulness of Examples 1-3 and the commercially available Yangxue Anshen tablets (sugar-coated tablets) were tested and recorded respectively. The disintegration time limit, the results are shown in Table 9.

[0110] Table 9 Determination of disintegration time limit

[0111]

[0112] It can be seen from Table 9 that the disintegration time of the traditional Chinese medicine preparation for treating dizziness, palpitations, insomnia and forgetfulness of the present invention is much shorter than that of the commercially available Yangxue Anshen tablets (sugar-coated tablets), indicating that its absorption is faster and can take effect quickly, which is beneficial to Improve efficacy.

[0113] 2. Determination of dissolution

[0114] Using the first method (General Principles 0931) of the 2015 edition of the Chinese Pharmacopoeia "Dissolution and Release Determination Method", the traditional Chinese medicine preparations of Examples 1-3 for the treatment of dizziness, palpitations, insomnia and forgetfulness and the commercially available Yangxue Anshen tablets (sugar-coated tablets) For detection, the sample content was determined by high performance liquid chromatography, with emodin as the reference substance, and the dissolution rate was calculated. The results are shown in Table 10.

[0115] Table 10 Dissolution test situation

[0116]

[0117] It can be seen from Table 10 that the Chinese medicinal preparation for treating dizziness, palpitations, insomnia and forgetfulness of the present invention has a significantly higher dissolution rate than commercially available Yangxue Anshen tablets (sugar-coated tablets), indicating that its bioavailability is higher.

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