CN110292604A - Gynaecology's antipruritic sheet and preparation method thereof - Google Patents

Gynaecology's antipruritic sheet and preparation method thereof Download PDF

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Publication number
CN110292604A
CN110292604A CN201910581002.7A CN201910581002A CN110292604A CN 110292604 A CN110292604 A CN 110292604A CN 201910581002 A CN201910581002 A CN 201910581002A CN 110292604 A CN110292604 A CN 110292604A
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parts
gynaecology
preparation
ethanol solution
ethyl alcohol
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农常东
黄艳妮
毛金玲
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GUANGXI MEDICTOP PHARMACEUTICAL CO Ltd
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GUANGXI MEDICTOP PHARMACEUTICAL CO Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232—Angelica
    • A—HUMAN NECESSITIES
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/288—Taraxacum (dandelion)
    • A—HUMAN NECESSITIES
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
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    • A61K36/185—Magnoliopsida (dicotyledons)
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    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
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    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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Abstract

The invention discloses a kind of gynaecology's antipruritic sheets and preparation method thereof, and raw material is mainly grouped as by the group of following parts by weight: 435 parts of field pennycress, 435 parts of oldenlandia diffusa, 435 parts of dandelion, horizontal through 150 parts of seat, 435 parts of madder, 435 parts of Caulis Spatholobi, 290 parts of Radix Angelicae Sinensis, 100 parts of rhizoma corydalis (vinegar toast).Gynaecology's antipruritic sheet of preparation method production has disintegration rate fast, dissolution preferably, absorbs comparatively fast, onset of action is fast, bioavilability is high, the advantages that adverse reaction is few, convenient to take, through the Pharmacological experiment result shows that its it is anti-inflammatory and in terms of be superior to conventional method preparation gynaecology's antipruritic sheet, show through clinical test results, it belongs to damp-heat type in treatment vaginitis card and has a better effect, and takes securely and reliably, and have no adverse reaction side effect.

Description

Gynaecology's antipruritic sheet and preparation method thereof
Technical field
The present invention relates to medicine fields, and in particular to a kind of gynaecology's antipruritic sheet and preparation method thereof.
Background technique
Dispersible tablet (Dispersible tablets) is also known as water dispersion tablet (Water dispersible tablets), is Refer to that the tablet to form homogeneous viscous suspension can be disintegrated rapidly by meeting water.For conventional tablet, dispersible tablet can increase indissoluble Property drug dissolution, absorb fast, bioavilability is high, and adverse reaction is small, can reduce drug to the irritation of gastrointestinal tract.Dispersion Piece is convenient to take, can swallow, chew, containing sucking, and can also set and individually take after dispersing in water or with fruit juice, milk with taking, especially fit Close old, children and the patient for swallowing solid difficulty.
The antipruritic tablet recipe of gynaecology is recorded in national drug standards WS-5806 (B-0806) -2002, and the party mainly includes Patrinia scaniosaefolia It is grass, oldenlandia diffusa, dandelion, horizontal through seat, madder, Caulis Spatholobi, Radix Angelicae Sinensis, rhizoma corydalis (vinegar toast) 8 taste medicinal materials, have heat-clearing and damp-drying drug, The effect of desinsection is antipruritic, wherein the effect of each medicinal material are as follows: field pennycress, oldenlandia diffusa, dandelion are clearing heat and detoxicating；It is horizontal to invigorate blood circulation through seat Analgesic, madder cool blood, dissolving stasis, hemostasis, promoting menstruation；Caulis Spatholobi, Chinese angelica blood supplementing promoting blood circulation, menstruction regulating and pain relieving；Rhizoma corydalis promoting blood circulation, promoting the circulation of qi, only Bitterly.The original preparation process of gynaecology's antipruritic sheet is square taste of traditional Chinese medicine in addition to rhizoma corydalis (vinegar toast), and 8 taste such as remaining field pennycress adds water to cook two Secondary, 2 hours every time, collecting decoction, filtration was made fine powder after filtrate concentration, rhizoma corydalis fine powder is added, mixes, dry, pulverize, Be added appropriate amount of auxiliary materials, mix, tabletting, film coating to get.Gynaecology's antipruritic sheet has vaginitis card category damp-heat type patient certain Effect.Since original preparation process Chinese medicine is other than rhizoma corydalis (vinegar toast) raw medicine powder is used as medicine, remaining 7 taste medicine is that water mentions, and is had Effect constituents extraction is incomplete, and drug effect is difficult to ensure, and it is few as far as possible to be unable to satisfy Chinese medical extract impurity when prepared by dispersible tablet Requirement.
Summary of the invention
It is an object of the invention to the deficiencies for former gynaecology antipruritic sheet preparation process, are reasonably reformed, provide one Gynaecology's antipruritic sheet and preparation method thereof of kind good drug efficacy.
The technical solution adopted in the present invention is as follows:
A kind of gynaecology's antipruritic sheet, raw material are mainly grouped as by the group of following parts by weight: 435 parts of field pennycress, oldenlandia It is 435 parts of grass, 435 parts of dandelion, horizontal through 150 parts of seat, 435 parts of madder, 435 parts of Caulis Spatholobi, 290 parts of Radix Angelicae Sinensis, rhizoma corydalis (vinegar toast) 100 parts, preparation method includes the following steps:
R1. field pennycress, oldenlandia diffusa, dandelion, horizontal through seat, madder, Caulis Spatholobi, Radix Angelicae Sinensis, rhizoma corydalis (vinegar is taken respectively Toast), it cleans, it is dry；
R2. component is weighed by following parts by weight: 435 parts of field pennycress, 435 parts of oldenlandia diffusa, 435 parts of dandelion, horizontal warp 150 parts of seat, 435 parts of madder, 435 parts of Caulis Spatholobi, 290 parts of Radix Angelicae Sinensis, 100 parts of rhizoma corydalis (vinegar toast)；
R3. medicinal substances extract dried cream powder is prepared；
R4. take respectively the medicinal substances extract dried cream powder of step R3, crosslinked polyvinylpyrrolidone, hypromellose, Sodium alginate, calcium sulfate, magnesium stearate crushed 120 meshes, spare；
R5. weigh component by following parts by weight: 65 parts of medicinal material extract paste powder takes 10 parts of crosslinked polyvinylpyrrolidone, hydroxyl Third 5 parts of methylcellulose, 8 parts of sodium alginate, 1 part of magnesium stearate, 11 parts of calcium sulfate；
R6. it takes hypromellose to be dissolved in 70% ethanol solution and hypromellose ethanol solution is made；
R7. medicinal substances extract dried cream powder, crosslinked polyvinylpyrrolidone, sodium alginate, calcium sulfate is taken to be added in blender, It is stirring evenly and then adding into the hypromellose ethanol solution of step R6, softwood is made after mixing evenly, the granulation of 20 mesh is crossed, does It is dry, it takes out, 50 mesh sieves obtain dry particl；
R8. take the dry particl of step R7, stiffened fatty acid magnesium is uniformly mixed, tabletting to get.
Above-described gynaecology's antipruritic sheet, the method that preparation methods steps R3 prepares medicinal substances extract dried cream powder are as follows:
S1. take field pennycress, oldenlandia diffusa, dandelion, it is horizontal through seat, madder, Caulis Spatholobi, Radix Angelicae Sinensis, rhizoma corydalis (vinegar toast) plus Ethanol solution refluxing extraction, filtration, the dregs of a decoction are spare, and filtrate recycling ethanol obtains extract to no alcohol taste；
S2. the dregs of a decoction for taking step S1, add water to cook, and filtration, filtrate merges with the extract of step S1, is concentrated at 80 DEG C When relative density be 1.30~1.35 thick paste.
S3. the thick paste for taking step S2, add ethyl alcohol temperature soak, stir evenly, stand, take supernatant recycle ethyl alcohol, be concentrated into The thick paste that relative density is 1.25~1.30 at 80 DEG C, is dried under reduced pressure, get dry extract powder；
Above-described gynaecology's antipruritic sheet, described in step S1 plus ethanol solution refluxing extraction is plus 5-8 times is measured 70% ethyl alcohol Solution, which adds, holds reflux 2h.
Above-described gynaecology's antipruritic sheet, step S2 adds water to cook to add 6-10 times to measure water and decocting 2 times, 1-2 hours each.
Above-described gynaecology's antipruritic sheet, described in step S3 plus the leaching of ethyl alcohol temperature refers to plus 3 times of 95% ethyl alcohol 40~60 of amount DEG C temperature leaching.
The preparation method of gynaecology's antipruritic sheet described in more than one, comprising the following steps:
R1. field pennycress, oldenlandia diffusa, dandelion, horizontal through seat, madder, Caulis Spatholobi, Radix Angelicae Sinensis, rhizoma corydalis (vinegar is taken respectively Toast), it cleans, it is dry；
R2. component is weighed by following parts by weight: field pennycress 435g, oldenlandia diffusa 435g, dandelion 435g, horizontal through seat 150g, madder 435g, Caulis Spatholobi 435g, Radix Angelicae Sinensis 290g, rhizoma corydalis (vinegar toast) 100g；
R3. medicinal substances extract dried cream powder is prepared；
R4. take respectively the medicinal substances extract dried cream powder of step R3, crosslinked polyvinylpyrrolidone, hypromellose, Sodium alginate, calcium sulfate, magnesium stearate crushed 120 meshes, spare；
R5. weigh component by following parts by weight: 65 parts of medicinal material extract paste powder takes 10 parts of crosslinked polyvinylpyrrolidone, hydroxyl Third 5 parts of methylcellulose, 8 parts of sodium alginate, 1 part of magnesium stearate, 11 parts of calcium sulfate；
R6. it takes hypromellose to be dissolved in 70% ethanol solution and hypromellose ethanol solution is made；
R7. medicinal substances extract dried cream powder, crosslinked polyvinylpyrrolidone, sodium alginate, calcium sulfate is taken to be added in blender, It is stirring evenly and then adding into the hypromellose ethanol solution of step R6, softwood is made after mixing evenly, the granulation of 20 mesh is crossed, does It is dry, it takes out, 50 mesh sieves obtain dry particl；
R8. take the dry particl of step R7, stiffened fatty acid magnesium is uniformly mixed, tabletting to get.
7. the preparation method of gynaecology's antipruritic sheet according to claim 6, which is characterized in that step R3 prepares medicinal material and mentions The method for taking object dried cream powder are as follows:
S1. take field pennycress, oldenlandia diffusa, dandelion, it is horizontal through seat, madder, Caulis Spatholobi, Radix Angelicae Sinensis, rhizoma corydalis (vinegar toast) plus Ethanol solution refluxing extraction, filtration, the dregs of a decoction are spare, and filtrate recycling ethanol obtains extract to no alcohol taste；
S2. the dregs of a decoction for taking step S1, add water to cook, and filtration, filtrate merges with the extract of step S1, is concentrated at 80 DEG C When relative density be 1.30~1.35 thick paste.
S3. the thick paste for taking step S2, add ethyl alcohol temperature soak, stir evenly, stand, take supernatant recycle ethyl alcohol, be concentrated into The thick paste that relative density is 1.25~1.30 at 80 DEG C, is dried under reduced pressure, get dry extract powder；
8. the preparation method of gynaecology's antipruritic sheet according to claim 7, which is characterized in that add ethyl alcohol described in step S1 Solution refluxing extraction be plus 5-8 times measure 70% ethanol solution add hold reflux 2h.
9. the preparation method of gynaecology's antipruritic sheet according to claim 7, which is characterized in that step S2 add water to cook for Add 6-10 times to measure water to decoct 2 times, it is 1-2 hours each.
10. the preparation method of gynaecology's antipruritic sheet according to claim 7, which is characterized in that add second described in step S3 The leaching of alcohol temperature refers to plus 3 times of 95% ethyl alcohol of amount, 40~60 DEG C of temperature leachings.
The beneficial effects of the present invention are:
1. the present invention mentions water after the alcohol extracting of flavour of a drug each in prescription elder generation, then cleans through ethyl alcohol system, mentioning for effective component ensure that It takes entirely, while impurity can be effectively removed, improve the content of effective component in extract, ensure that the curative effect of product, through facing Bed test result shows that product of the present invention belongs to the total effective rate of damp-heat type up to 100% in treatment vaginitis card.
2. invention formulation overcomes, disintegration and action existing for conventional tablet, capsule are slower, and dissolution rate is low, biology benefit The problems such as expenditure is lower has disintegration rate fast, and dissolution preferably, absorbs comparatively fast, and onset of action is fast, and bioavilability is high, bad The advantages that reaction is few, convenient to take.
3. the simple process of the method for the present invention, to production equipment without particular/special requirement, it is easy to operate, energy consumption it is low, time saving, production It is at low cost, industrialized production easy to accomplish.
Specific embodiment
The invention will be further described combined with specific embodiments below, but does not limit the scope of the invention and apply Range:
One, the research of extraction process
In view of rhizoma corydalis is that full medicinal powder is used as medicine in former preparation, impurity is more, and purifying need to be extracted to it.In addition, side Taste of traditional Chinese medicine contains flavones ingredient antibacterial, that anti-inflammatory effect is stronger mostly, therefore has attempted other side's taste of traditional Chinese medicine elder generation alcohol extracting water again It mentions, then refining and edulcoration is carried out to extract.
1. the selection of alcohol extraction process concentration of alcohol
Tetrahydropalmatine, flavonoids have preferable solubility in ethanol, therefore the present invention selects ethanol solution to extract Solvent compared following extracting method:
(1) take field pennycress 50g, oldenlandia diffusa 50g, dandelion 50g, it is horizontal through seat 20g, madder 50g, Caulis Spatholobi 50g, when Return 30g, rhizoma corydalis (vinegar toast) 10g, 70% ethanol solution that 5 times of amounts are added carries out refluxing extraction 1 hour, filtration, filtrate concentration To thick paste.
(2) take field pennycress 50g, oldenlandia diffusa 50g, dandelion 50g, it is horizontal through seat 20g, madder 50g, Caulis Spatholobi 50g, when Return 30g, rhizoma corydalis (vinegar toast) 10g, 70% alcohol solution dipping of 5 times of amounts is added ultrasonic extraction 1 hour after 1 hour, filters, filter Liquid is concentrated into thick paste.
General flavone, the Content determination of dl-tetrahydropalmatine in above-mentioned thick paste are measured, the results are shown in Table 1.
The extraction result of 1 Different Extraction Method of table
As shown in Table 1, the general flavone and Content determination of dl-tetrahydropalmatine that method (1) is extracted are above method (2), therefore select ethyl alcohol Solution refluxing extraction.
On the basis of the above comparative experiments, screening test also has been carried out to the concentration of ethanol solution, using method (1), Compared 60%, 70%, the ethanol solution refluxing extraction of 80% 3 kind of various concentration as a result, being shown in Table 2.
The extraction result of 2 different concentration ethanol solution of table
As shown in Table 2,70% ethyl alcohol and 80% alcohol reflux extract general flavone and the content of tetrahydropalmatine is suitable, for The considerations of cost, selects 70% alcohol reflux to extract.
The time also extracted to 70% alcohol reflux is investigated, and compared 1h, 2h, 3h, as a result, be shown in Table 3.
The investigation result of the different extraction times of table 3
As shown in Table 3, the result of refluxing extraction 2h and 3h is not much different, due to cost considerations, selection reflux 2h.
2. the selection of thick paste process for refining condition
Since dispersible tablet needs to be added more auxiliary material, it is desirable that the impurity of drug ingedient lacking as far as possible, therefore, to be mentioned to medicinal material The thick paste taken is further refined.Since the extracted most of effective component of square taste of traditional Chinese medicine is dissolved in ethyl alcohol, therefore quasi- second Alcohol is refined, and has been investigated influence of the different ethanol concentration to refining effect respectively, has been carried out following comparative experiments:
Gained thick paste 100g is taken, is divided into three parts, respectively plus 3 times of 75%, 85%, 95% ethanol solutions of amount, 40 DEG C are stirred It mixes uniformly, stands 30 minutes, take supernatant, recycle ethyl alcohol and be concentrated into thick paste, be dried under reduced pressure, get dry extract powder, and weighing measures it In tetrahydropalmatine, general flavone content.It the results are shown in Table 4.
The upgrading result of 4 different concentration ethanol solution of table
As shown in Table 4, concentration of alcohol be 95% when, paste-forming rate is reduced by up to, general flavone, tetrahydropalmatine loss compared with It is small, therefore selective finishing concentration of alcohol is 95%.
Two, formulation conditions screen
1. the selection of disintegrating agent
The type and dosage of disintegrating agent are most important to the disintegration of dispersible tablet, result of extraction.It is commonly disintegrated in dispersible tablet Agent have sodium carboxymethyl starch (CMS-Na), low-substituted hydroxypropyl cellulose (L-HPC), cross-linked carboxymethyl cellulose sodium (cCMC-Na), Crosslinked polyvinylpyrrolidone (PVPP) etc..Using hydroxypropyl methyl cellulose as adhesive, superfine silica gel powder is glidant, right respectively 4 kinds of disintegrating agents of 10%CMS-Na, 10%L-HPC, 10%cCMC-Na, 10%PVPP carry out Selection experiment using interior addition, Overall merit is carried out by evaluation index of appearance, disintegration time limited and dispersing uniformity, to determine optimal disintegrating agent in dispersible tablet Type.It the results are shown in Table 5.
The Selection experiment result table of 5 disintegrating agent of table
It was found from the test result in table 5: it is smooth as tablet surface made from disintegrating agent using PVPP, and disintegration time limited and point Scattered uniformity is preferable, therefore the present invention selects 10%PVPP for disintegrating agent, is added using interior addition.
2. the selection of adhesive
Dispersible tablet has hydrophily using particle made of hydrophilic adhesive, surface, and moisture is easily wet after tabletting, penetrates into, Conducive to disintegration of tablet.Investigated in test hypromellose (HPMC), polyethylene pyrrole alkanone K30 (PVPK30), poly- second 70% ethanol solution of alkene pyrrolidone (PVP) makees adhesive, with situation of pelletizing, tablet appearance, disintegration time limited and is uniformly dispersed Property for evaluation index carry out overall merit, the results are shown in Table 6.
6 adhesive of table investigates result table
From in table 6: the present invention is imitated using 5%HPMC ethanol solution granulation situation, tablet forming and dispersing uniformity Fruit is best, therefore 70% ethanol solution of invention adhesives selection 5%HPMC.
3. being swollen the selection of auxiliary material
Dispersible tablet is mainly that drug is formed at least one disintegrating agent and swelling supplementary product compatibility.Once XANTHAN GUM, melon be compared Ear glue, sodium alginate, glucan do swelling auxiliary material, using disintegration time as inspection target, the results are shown in Table 7.
Table 7 is swollen auxiliary material and investigates result table
As shown in Table 7: being when being swollen auxiliary material with sodium alginate, the disintegration effect of dispersible tablet is best, therefore the present invention selects sea Mosanom is swelling auxiliary material.Compare through experiment investigation, it is to account for recipe quantity that sodium alginate, which is most suitable for dosage as swelling auxiliary material, 8%.
4. the selection of glidant
Compared in test 1% superfine silica gel powder, 1% magnesium stearate, 1% magnesium stearate-superfine silica gel powder (1: 1) as help stream Agent carries out overall merit using disintegration time and hardness as inspection target.It the results are shown in Table 8.
8 glidant of table investigates result table
As shown in Table 8: 1% superfine silica gel powder, 1% magnesium stearate and 1% magnesium stearate-superfine silica gel powder (1: 1) as help stream When agent, effect is fairly good, and due to cost considerations, therefore the present invention selects 1% magnesium stearate as glidant.
5. the selection of filler
Since invention formulation main ingredient dosage is smaller, tabletting is relatively difficult, attempts that mannitol, crystallite fibre is added in test Dimension element, calcium sulfate, calcium monohydrogen phosphate improve tabletting situation as filler, as a result, it has been found that tabletting when 11% calcium sulfate is added Effect is preferable, therefore the present invention selects 11% calcium sulfate as filler.
Three, the preparation method of gynaecology's antipruritic sheet
Embodiment 1
R1. field pennycress, oldenlandia diffusa, dandelion, horizontal through seat, madder, Caulis Spatholobi, Radix Angelicae Sinensis, rhizoma corydalis (vinegar is taken respectively Toast), it cleans, it is dry；
R2. component is weighed by following parts by weight: field pennycress 435g, oldenlandia diffusa 435g, dandelion 435g, horizontal through seat 150g, madder 435g, Caulis Spatholobi 435g, Radix Angelicae Sinensis 290g, rhizoma corydalis (vinegar toast) 100g；
R3. it prepares medicinal substances extract dried cream powder: taking field pennycress, oldenlandia diffusa, dandelion, horizontal through seat, madder, chicken blood Rattan, Radix Angelicae Sinensis, rhizoma corydalis (vinegar toast) plus 5 times of 70% ethanol solutions of amount are heated to reflux 2h, filter, the dregs of a decoction are spare, filtrate recycling ethanol To no alcohol taste, alcohol extracting thing is obtained；The dregs of a decoction are taken, are added water to cook 2 times, for the first time plus 8 times of amount water decoct 2h, the 2nd time plus 6 times of amount decoctings It boils 1 hour, merging filtrate, filters, filtrate alcohol extracting thing merges, and is concentrated into the thick paste that relative density is 1.30 at 80 DEG C；It takes Thick paste adds the temperature leaching of 40 DEG C of 3 times of 95% ethyl alcohol of amount, stirs evenly, stand, supernatant is taken to recycle ethyl alcohol, is concentrated at 80 DEG C The thick paste that relative density is 1.25, is dried under reduced pressure, get dry extract powder；
R4. take respectively the medicinal substances extract dried cream powder of step R3, crosslinked polyvinylpyrrolidone, hypromellose, Sodium alginate, calcium sulfate, magnesium stearate crushed 120 meshes, spare；
R5. component is weighed by following parts by weight: medicinal material extract paste powder 130g, taking crosslinked polyvinylpyrrolidone 20g, hydroxypropyl Methylcellulose 10g, sodium alginate 16g, magnesium stearate 2g, calcium sulfate 22g；
R6. it takes hypromellose to be dissolved in 70% ethanol solution and hypromellose ethanol solution is made；
R7. medicinal substances extract dried cream powder, crosslinked polyvinylpyrrolidone, sodium alginate, calcium sulfate is taken to be added in blender, It is stirring evenly and then adding into the hypromellose ethanol solution of step R6, softwood is made after mixing evenly, the granulation of 20 mesh is crossed, does It is dry, it takes out, 50 mesh sieves obtain dry particl
R8. take the dry particl of step R7, stiffened fatty acid magnesium is uniformly mixed, tabletting to get.
Embodiment 2
R1. field pennycress, oldenlandia diffusa, dandelion, horizontal through seat, madder, Caulis Spatholobi, Radix Angelicae Sinensis, rhizoma corydalis (vinegar is taken respectively Toast), it cleans, it is dry；
R2. component is weighed by following parts by weight: field pennycress 435g, oldenlandia diffusa 435g, dandelion 435g, horizontal through seat 150g, madder 435g, Caulis Spatholobi 435g, Radix Angelicae Sinensis 290g, rhizoma corydalis (vinegar toast) 100g；
R3. it prepares medicinal substances extract dried cream powder: taking field pennycress, oldenlandia diffusa, dandelion, horizontal through seat, madder, chicken blood Rattan, Radix Angelicae Sinensis, rhizoma corydalis (vinegar toast) plus 8 times of 70% ethanol solutions of amount are heated to reflux 2h, filter, the dregs of a decoction are spare, filtrate recycling ethanol To no alcohol taste, alcohol extracting thing is obtained；The dregs of a decoction are taken, are added water to cook 2 times, for the first time plus 10 times of amount water decoct 2h, the 2nd time plus 7 times of amount water It decocts 1 hour, merging filtrate, filtration, filtrate alcohol extracting thing merges, and is concentrated into the thick paste that relative density is 1.35 at 80 DEG C； Thick paste is taken, adds 3 times of 95% ethyl alcohol of amount, 60 DEG C of temperature leachings, stirs evenly, stand, take supernatant to recycle ethyl alcohol, be concentrated at 80 DEG C When relative density be 1.30 thick paste, be dried under reduced pressure, get dry extract powder；
R4. take respectively the medicinal substances extract dried cream powder of step R3, crosslinked polyvinylpyrrolidone, hypromellose, Sodium alginate, calcium sulfate, magnesium stearate crushed 120 meshes, spare；
R5. component is weighed by following parts by weight: medicinal material extract paste powder 195g, taking crosslinked polyvinylpyrrolidone 30g, hydroxypropyl Methylcellulose 15g, sodium alginate 24g, magnesium stearate 3g, calcium sulfate 33g；
R6. it takes hypromellose to be dissolved in 70% ethanol solution and hypromellose ethanol solution is made；
R7. medicinal substances extract dried cream powder, crosslinked polyvinylpyrrolidone, sodium alginate, calcium sulfate is taken to be added in blender, It is stirring evenly and then adding into the hypromellose ethanol solution of step R6, softwood is made after mixing evenly, the granulation of 20 mesh is crossed, does It is dry, it takes out, 50 mesh sieves obtain dry particl
R8. take the dry particl of step R7, stiffened fatty acid magnesium is uniformly mixed, tabletting to get.
Embodiment 3
R1. field pennycress, oldenlandia diffusa, dandelion, horizontal through seat, madder, Caulis Spatholobi, Radix Angelicae Sinensis, rhizoma corydalis (vinegar is taken respectively Toast), it cleans, it is dry；
R2. component is weighed by following parts by weight: field pennycress 435g, oldenlandia diffusa 435g, dandelion 435g, horizontal through seat 150g, madder 435g, Caulis Spatholobi 435g, Radix Angelicae Sinensis 290g, rhizoma corydalis (vinegar toast) 100g；
R3. it prepares medicinal substances extract dried cream powder: taking field pennycress, oldenlandia diffusa, dandelion, horizontal through seat, madder, chicken blood Rattan, Radix Angelicae Sinensis, rhizoma corydalis (vinegar toast) plus 6 times of 70% ethanol solutions of amount are heated to reflux 2h, filter, the dregs of a decoction are spare, filtrate recycling ethanol To no alcohol taste, alcohol extracting thing is obtained；The dregs of a decoction are taken, add 8 times of amount water to decoct 2 times, 2 hours every time, merging filtrate filtered, filtrate alcohol extracting It takes object to merge, is concentrated into the thick paste that relative density is 1.33 at 80 DEG C；Thick paste is taken, adds 3 times of 95% ethyl alcohol of amount, 50 DEG C of temperature leachings, stirs It mixes uniformly, stands, supernatant is taken to recycle ethyl alcohol, be concentrated into the thick paste that relative density is 1.28 at 80 DEG C, be dried under reduced pressure, obtain Dried cream powder；
R4. take respectively the medicinal substances extract dried cream powder of step R3, crosslinked polyvinylpyrrolidone, hypromellose, Sodium alginate, calcium sulfate, magnesium stearate crushed 120 meshes, spare；
R5. component is weighed by following parts by weight: medicinal material extract paste powder 260g, taking crosslinked polyvinylpyrrolidone 40g, hydroxypropyl Methylcellulose 20g, sodium alginate 32g, magnesium stearate 4g, calcium sulfate 44g；
R6. it takes hypromellose to be dissolved in 70% ethanol solution and hypromellose ethanol solution is made；
R7. medicinal substances extract dried cream powder, crosslinked polyvinylpyrrolidone, sodium alginate, calcium sulfate is taken to be added in blender, It is stirring evenly and then adding into the hypromellose ethanol solution of step R6, softwood is made after mixing evenly, the granulation of 20 mesh is crossed, does It is dry, it takes out, 50 mesh sieves obtain dry particl
R8. take the dry particl of step R7, stiffened fatty acid magnesium is uniformly mixed, tabletting to get.
Four, the quality evaluation of gynaecology's antipruritic sheet
1. measuring disintegration time limited
Using Chinese Pharmacopoeia version " disintegration time limit test " (general rule 0921) in 2015, Example 1-3 sample and city It sells gynaecology's antipruritic sheet (Film coated tablets) to be detected, records disintegration time limited respectively, the results are shown in Table 9.
9 disintegration time mensuration situation of table
By in table 9 it is found that gynaecology's antipruritic sheet of the present invention when gynaecology, city antipruritic sheet piece (Film coated tablets) time disintegration time limited Shorten, it is very fast to show that it is absorbed, energy quick acting is conducive to improve curative effect.
2. measuring dissolution rate
Using Chinese Pharmacopoeia 2015 version " dissolution rate and drug release determination method " first methods (general rule 0931), Example 1- 3 sample and commercially available gynaecology's antipruritic sheet (Film coated tablets) are detected, and sample size measurement is prolonged using high performance liquid chromatography The content of Hu Suo Yisu, then calculates dissolution rate, the results are shown in Table 10.
10 dissolution determination situation of table
As can be seen from Table 10, when commercially available gynaecology's antipruritic sheet (Film coated tablets) dissolution rate is bright for gynaecology's antipruritic sheet of the present invention It is aobvious to improve, show that its bioavilability is higher.
Five, pharmacological testing
(1) animal acute toxicity test
Give the mouse gavaging embodiment of the present invention 3 sample, administration 3 times in 12h, (adult (presses by accumulated dose 15g/kg, BW 60kg meter) taking dose is 30mg/kg.d), be administered that animal in 7d is strong to deposit, appetite, excrement are normal, weight without significant change, It is limited to drug concentration and volume, fails not go out LD50, therefore its LD50 must be greater than 15g/kg, BW (500 times of adult taking dose). Show that the oral safety of 3 sample of the embodiment of the present invention is very big.
(2) long-term toxicity test for animals
To rat by 60mg/kg, 1500mg/kg and 3000mg/kg (2 times, 50 times of respectively clinical quasi- daily dose and 100 times) continuously gavage 3 sample of the embodiment of the present invention 28 days, as a result animal appearance, behavior, body weight increase are normal, blood routine, blood The histological examinations no abnormality seens such as liquid is biochemical, hepatic and renal function and the heart, lung, liver,spleen,kidney, adrenal gland, testis, ovary.Show by It drafts dosage, approach and the course for the treatment of and takes 3 secure sample of the embodiment of the present invention and have no toxic side effect.
(3) Pharmacodynamic test of active extract
Purpose: the anti-inflammatory and bacteriostasis by investigating product of the present invention provides experimental basis for clinical application.
1 test material
Sample: 3 sample of the embodiment of the present invention, while positive control is done with commercially available gynaecology's antipruritic sheet (conventional method preparation).
Experimental animal: Kunming mouse, cleaning grade, male and female dual-purpose, 20 ± 2g of weight, by animal housing, Guangxi Medical University It provides.
2 methods and result
The experiment of 2.1 xylene-induced ear swelling in mice
Take Kunming mouse 50, be randomly divided into 5 groups: 3 sample of embodiment high (480mg/kg), in (240mg/kg), low (120mg/kg) three dosage groups, blank control group (give 0.9% physiological saline of same volume), positive controls (120mg/kg). Gastric infusion, 1 time/d, continuous 7d.30min after the last administration, each group mouse uniformly apply dimethylbenzene in the forward and backward face of mouse right ear 50 μ l cause inflammation, and cervical dislocation puts to death mouse after 1h, two ears of left and right are cut along auricle base line, with diameter 9mm punch respectively two Round auricle is laid at the same position of ear, weighs in time and ear swelling and swelling inhibiting rate is calculated as follows:
Ear swelling (mg)=auris dextra slice weight-left auricle weight；
Each group mouse right ear after inflammation is caused to occur the red and swollen phenomenon of height, compared with blank control group, the embodiment of the present invention 3 at once The ear swelling difference of the high, medium and low dosage group of sample and positive controls is statistically significant (P < 0.01 or P < 0.05)；3 The 3 sample administration group swelling of the embodiment of the present invention and swelling inhibiting rate of a various dose are in apparent dose-dependence.Knot Fruit shows that 3 sample of inventive embodiments can obviously reduce the auricle edema of mice caused by dimethylbenzene xylene within the scope of 120~480mg/kg, With anti-inflammatory effect, and acts on and be better than positive controls (conventional method preparation) sample.Specifically it is shown in Table 11.
The influence (x ± s) of 11 paraxylene of table cause mouse ear swelling
Note: with blank control group ratio:**P < 0.01
2.2 bacteriostasis
A certain number of small test tubes are taken, is divided into 10 groups, every group 10, is separately added into nutrient broth training respectively at each pipe of each group Support base 1ml.3 sample solution of the embodiment of the present invention (0.2g/ml) 1mL, 6-10 group first examination is added in first small test tube of 1-5 group Control sample (0.2g/ml) 1mL is added in pipe, and each group is respectively sucked out 1mL and is added in respective second small test tube, is repeated in after mixing Successively decrease and be diluted to the 9th pipe, after the 9th pipe mixes, 1mL mixed liquor is sucked out and discards, medical fluid is not added in the tenth pipe, then draws training It supports 24 hours and is diluted to 10-4~10-6Bacteria suspension (every 1mL containing bacterium number be about 100,000,000 cfu), each group is from the first pipe to the 8th pipe point Step up that 0.1mL is added, bacterium solution 0.1mL is also added in the tenth pipe, and bacterium is not added as negative control, the tenth pipe plus bacterium solution in the 9th pipe dosing Not dosing is used as positive control.The above-mentioned small test tube prepared is set into 36 DEG C culture 24-48 hours in incubator, is detected by an unaided eye Whether there is or not bacterial growths for each pipe, and as a result see Table 1 for details 2.
Inhibitory potency of the table 12 to experimental strain
Table 12 the result shows that, 3 sample of the embodiment of the present invention is in vitro to Candida albicans, escherichia coli, bacillus subtilis Bacterium and proteus have inhibiting effect, and antibacterial result is better than control sample.It is stronger to show that 3 sample of the embodiment of the present invention has Bacteriostasis.
The above results of pharmacodynamic test shows 3 sample oral administration of the embodiment of the present invention, mouse caused by paraxylene Ear swelling has certain inhibiting effect, shows the anti-inflammatory effect for having certain；Antibacterial experiment in vitro proves, the embodiment of the present invention 3 samples all have a strong inhibitory effect Candida albicans, escherichia coli, bacillus subtilis and proteus.In synthesis It states result to think, 3 sample of the embodiment of the present invention has anti-inflammatory and bacteriostasis, and function and effect are better than the woman of produced in conventional processes Section's antipruritic sheet illustrates that product of the present invention preparation method effectively increases validity.
Six, clinical test
1. data and method
1.1 general information
60 damp-heat type vaginitis patients are chosen, are randomly divided into 2 groups, i.e. test group and control group, every group 30.Its pilot scale Test 21~68 years old group age, average (44.58 ± 8.20) year, course of disease 7d~7 month, average (4.60 ± 2.85) moon；Control group Age 20~69 years old, average (44.95 ± 9.13) year, course of disease 10d~8 month, average (4.86 ± 2.70) moon.Two groups of patients one As data compare, no significant difference (P > 0.5) is comparable.
1.2 case selection
Above-mentioned case meets damp-heat type leukorrhagia diagnostic criteria vagina inflammation diagnostic criteria.Exclude gestation, nursing period and not Wed patient；It is associated with other genital system diseases patients such as cervicitis, pelvic inflammatory disease；Hepatic and kidney function obstacle patient；Spirit and consciousness barrier Hinder patient etc..
1.3. treatment method
Test group use 3 sample treatment of the embodiment of the present invention, take orally, one time 2,3 times a day, continuously take 30.It is right Commercially available Metronidazole Tablet is used according to group, is taken orally, a 0.2g 4 times a day continuously takes 30.
1.4 therapeutic evaluation
Observe two groups of therapeutic effects and adverse reaction situation.The standard of curative effect evaluation are as follows:
(1) fully recover: the clinical symptoms such as itch completely disappear, and leukorrhea restores normal；
(2) effective: the clinical symptoms such as itch disappear substantially, and leukorrhea returns to normal；
(4) effectively: the clinical symptoms such as itch make moderate progress, and leukorrhea returns to normal；
(3) invalid: the clinical symptoms such as itch are not eased, and leukorrhea is still abnormal.
1.5 statistical procedures
Data processing and analysis are carried out using 22.0 statistical software of SPSS, while being examined using t, as P < 0.05, table Bright difference is statistically significant.
2. result
2.1 adverse reactions and safety evaluatio
In therapeutic process, test group patient does not occur adverse reaction；Control group has 5 patients nausea, appetite occur not There are the adverse reactions such as headache, dizziness in the adverse reactions such as vibration, 1 patient, and it is bad anti-that flush, sufferings etc. occurs in 1 patient It answers.
2.2 Clinical efficacy comparison
It the results are shown in Table 13.
13 two groups of Clinical efficacy comparisons (example) of table
3. conclusion
The above clinical test results show 3 sample of embodiment produced through preparation method of the present invention in treatment vaginitis card Belong to and be better than control group in damp-heat type effect, the treatment for illustrating that it demonstrate,proves category damp-heat type to vaginitis has a better effect, and takes peace Complete reliable, have no adverse reaction side effect.

Claims (10)

1. a kind of gynaecology's antipruritic sheet, raw material are mainly grouped as by the group of following parts by weight: 435 parts of field pennycress, oldenlandia diffusa 435 parts, it is 435 parts of dandelion, horizontal through 150 parts of seat, 435 parts of madder, 435 parts of Caulis Spatholobi, 290 parts of Radix Angelicae Sinensis, rhizoma corydalis (vinegar toast) 100 Part, which is characterized in that preparation method includes the following steps:
R1. field pennycress, oldenlandia diffusa, dandelion, horizontal through seat, madder, Caulis Spatholobi, Radix Angelicae Sinensis, rhizoma corydalis (vinegar toast) is taken respectively, only Choosing, it is dry；
R2. component is weighed by following parts by weight: 435 parts of field pennycress, 435 parts of oldenlandia diffusa, 435 parts of dandelion, horizontal through seat 150 Part, 435 parts of madder, 435 parts of Caulis Spatholobi, 290 parts of Radix Angelicae Sinensis, 100 parts of rhizoma corydalis (vinegar toast)；
R3. medicinal substances extract dried cream powder is prepared；
R4. medicinal substances extract dried cream powder, the crosslinked polyvinylpyrrolidone, hypromellose, seaweed of step R3 are taken respectively Sour sodium, calcium sulfate, magnesium stearate crushed 120 meshes, spare；
R5. weigh component by following parts by weight: 65 parts of medicinal material extract paste powder takes 10 parts of crosslinked polyvinylpyrrolidone, hydroxypropyl first 5 parts of base cellulose, 8 parts of sodium alginate, 1 part of magnesium stearate, 11 parts of calcium sulfate；
R6. it takes hypromellose to be dissolved in 70% ethanol solution and hypromellose ethanol solution is made；
R7. medicinal substances extract dried cream powder, crosslinked polyvinylpyrrolidone, sodium alginate, calcium sulfate is taken to be added in blender, stirring The hypromellose ethanol solution of step R6 is added after uniformly, softwood is made after mixing evenly, crosses the granulation of 20 mesh, it is dry, It takes out, 50 mesh sieves obtain dry particl；
R8. take the dry particl of step R7, stiffened fatty acid magnesium is uniformly mixed, tabletting to get.
2. gynaecology's antipruritic sheet according to claim 1, which is characterized in that preparation methods steps R3 prepares medicinal substances extract The method of dried cream powder are as follows:
S1. field pennycress, oldenlandia diffusa, dandelion, horizontal through seat, madder, Caulis Spatholobi, Radix Angelicae Sinensis, rhizoma corydalis (vinegar toast) plus ethyl alcohol is taken Solution refluxing extraction, filtration, the dregs of a decoction are spare, and filtrate recycling ethanol obtains extract to no alcohol taste；
S2. the dregs of a decoction for taking step S1, add water to cook, and filtration, filtrate merges with the extract of step S1, is concentrated into 80 DEG C of phases The thick paste for being 1.30~1.35 to density.
S3. the thick paste for taking step S2 adds ethyl alcohol temperature to soak, stirs evenly, and stands, and takes supernatant to recycle ethyl alcohol, is concentrated into 80 DEG C when relative density be 1.25~1.30 thick paste, be dried under reduced pressure, get dry extract powder.
3. gynaecology's antipruritic sheet according to claim 2, which is characterized in that described in step S1 plus ethanol solution refluxing extraction is Add 5-8 times measure 70% ethanol solution add hold reflux 2h.
4. gynaecology's antipruritic sheet according to claim 2, which is characterized in that step S2 adds water to cook to add 6-10 times to measure decocting It boils 2 times, it is 1-2 hours each.
5. gynaecology's antipruritic sheet according to claim 2, which is characterized in that described in step S3 plus the leaching of ethyl alcohol temperature refers to adding 3 95% ethyl alcohol of amount, 40~60 DEG C of temperature leachings again.
6. a kind of preparation method of gynaecology's antipruritic sheet as described in claim 1, which comprises the following steps:
R1. field pennycress, oldenlandia diffusa, dandelion, horizontal through seat, madder, Caulis Spatholobi, Radix Angelicae Sinensis, rhizoma corydalis (vinegar toast) is taken respectively, only Choosing, it is dry；
R2. weigh component by following parts by weight: field pennycress 435g, oldenlandia diffusa 435g, dandelion 435g, it is horizontal through seat 150g, Madder 435g, Caulis Spatholobi 435g, Radix Angelicae Sinensis 290g, rhizoma corydalis (vinegar toast) 100g；
R3. medicinal substances extract dried cream powder is prepared；
R4. medicinal substances extract dried cream powder, the crosslinked polyvinylpyrrolidone, hypromellose, seaweed of step R3 are taken respectively Sour sodium, calcium sulfate, magnesium stearate crushed 120 meshes, spare；
R5. weigh component by following parts by weight: 65 parts of medicinal material extract paste powder takes 10 parts of crosslinked polyvinylpyrrolidone, hydroxypropyl first 5 parts of base cellulose, 8 parts of sodium alginate, 1 part of magnesium stearate, 11 parts of calcium sulfate；
R6. it takes hypromellose to be dissolved in 70% ethanol solution and hypromellose ethanol solution is made；
R7. medicinal substances extract dried cream powder, crosslinked polyvinylpyrrolidone, sodium alginate, calcium sulfate is taken to be added in blender, stirring The hypromellose ethanol solution of step R6 is added after uniformly, softwood is made after mixing evenly, crosses the granulation of 20 mesh, it is dry, It takes out, 50 mesh sieves obtain dry particl；
R8. take the dry particl of step R7, stiffened fatty acid magnesium is uniformly mixed, tabletting to get.
7. the preparation method of gynaecology's antipruritic sheet according to claim 6, which is characterized in that step R3 prepares medicinal substances extract The method of dried cream powder are as follows:
S1. field pennycress, oldenlandia diffusa, dandelion, horizontal through seat, madder, Caulis Spatholobi, Radix Angelicae Sinensis, rhizoma corydalis (vinegar toast) plus ethyl alcohol is taken Solution refluxing extraction, filtration, the dregs of a decoction are spare, and filtrate recycling ethanol obtains alcohol extracting thing to no alcohol taste；
S2. the dregs of a decoction for taking step S1, add water to cook, and filtration, filtrate merges with the alcohol extracting thing of step S1, is concentrated at 80 DEG C The thick paste that relative density is 1.30~1.35.
S3. the thick paste for taking step S2 adds ethyl alcohol temperature to soak, stirs evenly, and stands, and takes supernatant to recycle ethyl alcohol, is concentrated into 80 DEG C when relative density be 1.25~1.30 thick paste, be dried under reduced pressure, get dry extract powder.
8. the preparation method of gynaecology's antipruritic sheet according to claim 7, which is characterized in that add ethanol solution described in step S1 Refluxing extraction be plus 5-8 times measure 70% ethanol solution add hold reflux 2h.
9. the preparation method of gynaecology's antipruritic sheet according to claim 7, which is characterized in that step S2 adds water to cook to add 6- 10 times of amount water decoct 2 times, 1-2 hours each.
10. the preparation method of gynaecology's antipruritic sheet according to claim 7, which is characterized in that add ethyl alcohol temperature described in step S3 Leaching refers to plus 3 times of 95% ethyl alcohol of amount, 40~60 DEG C of temperature leachings.
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Publication number Priority date Publication date Assignee Title
CN1857482A (en) * 2006-03-21 2006-11-08 北京阜康仁生物制药科技有限公司 Compound Chinese medicine preparation for clearing away heat, drying damp, disinsecting and stopping itch and its preparing process
CN102000179A (en) * 2010-11-09 2011-04-06 承德颈复康药业集团有限公司 New stomachic core coated tablet and preparation method thereof

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