CN101024060B - Jinsangsanjie preparation preparing method - Google Patents
Jinsangsanjie preparation preparing method Download PDFInfo
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Abstract
The present invention relates to a Jinsang Sanjie Chinese medicine preparation for effectively curing sore-throat and laryngopharyngitis with obvious therapeutic effect. Said Chinese medicine is made up by using 16 Chinese medicinal materials of zedoary, peach kernel, sparganium root, salvia root, lonicera flower, carthamus flower and others through a certain preparation process.
Description
Affiliated technical field: the invention belongs to Chinese medicine novel form and preparation method thereof, specifically is a kind of Jinsangsanjie preparation and preparation method thereof.Described preparation is meant Jinsangsanjie concentrated pill, granule, tablet, dispersible tablet, buccal tablet, soft capsule.
Background technology:
Existing Jinsangsanjie prescription has heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, dampness removing clears phlegm.Be used for the hoarseness that pyretic toxicity holds knot, caused by energy stagnation and blood stasis, vocal congestion, swelling; Chronic laryngitis, vocal nodule, polyp of vocal cord are seen above-mentioned disease person.The existing dosage form of this product is the Jinsangsanjie ball, comprises two kinds of water-honeyed pill, big honeyed pills.Because of this side's determined curative effect, list " one one of Chinese pharmacopoeia version in 2005 in.The water-honeyed pill of existing dosage form is that all pulverizing medicinal materials are become fine powder with the big honeyed pills its preparation method, sieves, and mixing is made water-honeyed pill or big honeyed pills.
Existing dosage form and preparation method thereof is traditional dosage form and a method for making for many years, has following shortcoming:
1, dose is bigger, the difficulty of swallowing: as the heavy 1g of per 10 balls of the water-honeyed pill of making, oral one time 60～120 ball; The heavy 9g of the every ball of big honeyed pills, oral one time 1～2 ball is unfavorable for that especially child, old people and dysphagia person take;
2, medicine disintegrate, absorb slowlyer, bioavailability is low: because of water-honeyed pill, big honeyed pills entirely for the vegetalitas powder is used as medicine, in the powder effective ingredient major part be wrapped in do not broken up as yet in the cell, slower through disintegrate, stripping, absorption, onset after oral;
3, be easy to damage by worms and go mouldy: water-honeyed pill, big honeyed pills all easily mildew and are unfavorable for preserving, and honeyed pill particularly is because of containing a large amount of refined honeys, easily by germ contamination etc.;
4, packing is difficult for mechanization: honeyed pill paraffin paper packing commonly used, though but machinery production wax shell, mechanization degree is not high during packing;
5, in sum, existing dosage form and method for making bring great inconvenience for clinical practice and industrialized mass.
The objective of the invention is in order to overcome the above-mentioned defective of prior art, for people provide a kind of have the drug utilization degree better, rapid-action, help Jinsangsanjie preparation of characteristics such as clinical practice and industrialized mass and preparation method thereof, described preparation comprises Jinsangsanjie concentrated pill, granule, tablet, dispersible tablet, buccal tablet, soft capsule.
The objective of the invention is to realize by following technical proposals.
Summary of the invention: Jinsangsanjie preparation of the present invention, form by following raw materials by weight percent: Lasiosphaera Seu Calvatia 1～3%, Rhizoma Curcumae (vinegar stir-fry), Semen Persicae (
), rhizoma sparganic (vinegar stir-fry), Flos Carthami, Endothelium Corneum Gigeriae Galli (stir-fry) each 2～6%, Flos Lonicerae, Radix Scrophulariae, Radix Isatidis, Herba Taraxaci each 5～15%, Radix Salviae Miltiorrhizae, Bulbus Fritillariae Thunbergii, Rhizoma Alismatis, Periostracum Cicadae, Semen Oroxyli each 3～9%, Radix Ophiopogonis 4～12%, technology addition concentrated pill, granule, tablet, dispersible tablet, buccal tablet, soft capsule routinely.
In the such scheme, the preferable percentage by weight of described raw material be Lasiosphaera Seu Calvatia 2%, Rhizoma Curcumae (vinegar stir-fry) 4%, Flos Lonicerae 10%, Semen Persicae (
) 4%, Radix Scrophulariae 10%, rhizoma sparganic (vinegar stir-fry) 4%, Flos Carthami 4%, Radix Salviae Miltiorrhizae 6%, Radix Isatidis 10%, Radix Ophiopogonis 8%, Bulbus Fritillariae Thunbergii 6%, Rhizoma Alismatis 6%, Endothelium Corneum Gigeriae Galli (stir-fry) 4%, Periostracum Cicadae 6%, Semen Oroxyli 6%, Herba Taraxaci 10%.
The preparation method of Jinsangsanjie preparation of the present invention be according to above-mentioned raw materials medical material character characteristics separately will be wherein the extract of part material medical material with wherein the protogenic medicinal powder and the additive of part material medical material are mixed and made into above-mentioned required dosage form, the extract of described medical material is meant the effective ingredient that adopts one or more extracting method to extract with a kind of raw material, and described additive is adjuvant, excipient, additives.Extracting method comprises that water is carried or other solvent extraction.
In the such scheme, what described extract accounted for said medicine constituent gross weight is 75～100%.The granular size of described protogenic medicinal powder is 80～160 purpose fine powders or 200～300 purpose superfine powder.
In the such scheme, described extracting method adopts following principle to carry out according to raw medicinal material character characteristics separately:
Few valuable medicine, the malicious drastic of 1 starch-containing more medical material, consumption, some contains a small amount of fragrant volatile ingredient medical material and some mineral drug directly is ground into fine powder, i.e. protogenic medicinal powder.
But 2, contain also extracting section volatile ingredient of the more medical material of volatile ingredient, as volatile oil.
3, fibre-bearing is more, viscosity is bigger or scleroid medical material, adopts the decocting effective component extracting.
44, contain pure soluble components, available different concentration ethanol effective component extracting.
5, effective ingredient had both contained water soluble ingredient in the medicine, contained liposoluble constituent again, then according to the not same-action that its effective ingredient rose, can adopt the extraction of part decocting, part ethanol extraction.
6, the clear and definite person of effective ingredient can adopt the specific method effective component extracting according to the effective ingredient characteristic.
In the such scheme, the extracting solution that described decocting extracts or ethanol extraction obtained be condensed into relative density be 1.03～1.05 clear paste or be condensed into relative density be 1.05～1.40 soak (thick) cream, gained soak (thick) cream, get fine powder or superfine powder by drying, and then adopt routine techniques and the molding of additive hybrid process.
In the such scheme, described medicinal liquid concentrates and is preferably concentrating under reduced pressure; Soak the dry best vacuum drying/spray drying that is of (thick) cream, the vacuum drying temperature is controlled at 50～80 ℃, and the best is 60 ℃; The spray drying inlet temperature is 100～200 ℃, and leaving air temp is 50～150 ℃, and best inlet temperature is 150～180 ℃, and leaving air temp is 80～100 ℃, all can significantly reduce loss of active ingredients.
In the such scheme, the 30-70% that gets Bulbus Fritillariae Thunbergii, Endothelium Corneum Gigeriae Galli amount is ground into fine powder, standby; Rhizoma Curcumae (vinegar stir-fry), Semen Persicae (
), each 30-70% of Flos Carthami amount extracts volatile oil, collects volatile oil, standby; Herba Taraxaci, Flos Lonicerae 35-70% amount add hydro-thermal with the residue Flos Carthami and soak secondary, each 1～3 hour, filter merging filtrate, standby; Radix Salviae Miltiorrhizae, each 35-70% amount of Lasiosphaera Seu Calvatia decoct with water 1～3 time with the surplus of all the other raw medicinal materials and above-mentioned raw materials medical material, and each 1～3 hour, merge medicinal liquid, standby, filter; Radix Salviae Miltiorrhizae, Lasiosphaera Seu Calvatia surplus add 70% alcohol heating reflux secondary, each 1～3 hour, filter, merging filtrate, reclaim ethanol, with above-mentioned medicinal liquid merge total medicinal liquid, standby, then fine powder, volatile oil, total medicinal liquid on one are processed into Jinsangsanjie concentrated pill, granule, tablet, dispersible tablet, buccal tablet, soft capsule.
Jinsangsanjie novel formulation (Jinsangsanjie concentrated pill, granule, tablet, dispersible tablet, buccal tablet, soft capsule) used excipient in the preparation method, adjuvant, additives can be: Mel (refined honey), water, wine, vinegar, sucrose, gelatin, river wax, the Cinnabaris powder, Pulvis Talci, Realgar powder, the Indigo Naturalis powder, BAICAO powder, Lapis Micae Aureus powder or other coating materials, aluminium hydroxide, the gel powder, calcium carbonate, calcium hydrogen phosphate, calcium glycerophosphate, magnesium oxide, magnesium carbonate, beta-schardinger dextrin-, the hydroxyl beta-schardinger dextrin-, starch, dextrin, ethanol, polyvidone k30, micropowder silica gel, steviosin (sugar), Aspartane, magnesium stearate, microcrystalline Cellulose, carboxymethyl starch sodium, sodium carboxymethyl cellulose, pregelatinized Starch, soluble starch, hyprolose, lactose, protein sugar, calcium sulfate, silicon dioxide, carboxymethyl starch sodium, essence, glycerol, sorbitol, PGE400, oil with hydrogenated soybean, Cera Flava, any/multiple mixing in each vegetable oil is used.
The present invention is the technical scheme that the inventor passes through the science practicality that years of researches obtain, it has broken the constraint of traditional view, make novel formulation and preparation method thereof not only overcome the deficiency of present existing water-honeyed pill, big honeyed pills and preparation method thereof, and have following advantage:
1, dose is little and taking dose is accurate, the convenient use: because of the adjuvant that adds is few, the novel formulation dosage after making is controlled easily, and difference is little, and the novel formulation dose is few and easy to carry, and granule especially is beneficial to child, old people and dysphagia person and takes;
2, absorption, rapid-action, the bioavailability height, steady quality, ensure clinical efficacy: according to different medical material character in the prescription take respectively to pulverize, extract, concentrate, method such as drying, reduce loss of active ingredients to greatest extent, make more science, reasonable of preparation method, medical material has improved the effective ingredient intake after extracting:
For example the main effective ingredient of Flos Carthami is a safflower oil, only depend on the method for pulverizing to extract, thereby adopt special-purpose extractive technique can obtain pure safflower oil, drug effect is better, consumption reduces, and a part of Flos Carthami can be obtained other aqueous soluble active constituents of Flos Carthami with water logging, is to avoid effective ingredient to be subjected to vaporization at high temperature without decocting in water.The processing of other medicines composition can be by that analogy.
In addition, extracting solution adopts concentrating under reduced pressure to become extractum, to concentrate back extractum employing and be spray dried to the cream powder, drying time is short, effective ingredient is not easy to be damaged in dry run, and because of using the adjuvant amount few, has reduced the pollution of antibacterial, and the novel formulation of making is easy to sterilization, and shortened disintegrate, dissolution time; It is directly molten diffusing that the granule of making is taken the no disintegrating procedue in back, absorb fast, pill, tablet, soft capsule disintegration time pharmacopeia regulation are no more than 1 hour, the concentrated pill that new method makes, tablet, soft capsule then can be controlled in 0.5 hour, the dispersible tablet disintegration time then can be controlled in 3 minutes, can be with the detection index of dissolution as quality standard;
3, novel formulation all can adopt modern advanced production, packaging facilities and technology, and immediate packaging materials all can adopt the packaging material that meet national medicinal standard, and the mechanization degree height is beneficial to the mechanization mass industrialized production.
4, the present invention has also enriched kind dosage form and clinical application selection, has used, made things convenient for extensive patients, can satisfy and ensure people's medication demand better, and the control criterion that when making novel formulation, improves the quality, can better control product quality, guarantee drug safety, effective, hold the hoarseness of knot, caused by energy stagnation and blood stasis for vast pyretic toxicity, vocal congestion, swelling; Chronic laryngitis, the patient of diseases such as vocal nodule, polyp of vocal cord benefits.
The invention is further illustrated by the following examples.The present invention is not limited only to described embodiment.
The specific embodiment:
Embodiment one
Prepare the Jinsangsanjie novel formulation by following processing step, comprise concentrated pill, granule, tablet, dispersible tablet, buccal tablet, soft capsule:
Get Lasiosphaera Seu Calvatia 30g, Rhizoma Curcumae (vinegar stir-fry) 120g, Semen Persicae (
) 65g, rhizoma sparganic (vinegar stir-fry) 130g, Flos Carthami 80g, Endothelium Corneum Gigeriae Galli (stir-fry) 125g, Flos Lonicerae 150g, Radix Scrophulariae 300g, Radix Isatidis 320g, Herba Taraxaci 200g Radix Salviae Miltiorrhizae 200g, Bulbus Fritillariae Thunbergii 200g, Rhizoma Alismatis 100g, Periostracum Cicadae 100g, Semen Oroxyli 200g, Radix Ophiopogonis 250g;
In A, the above medicine, extracting honeysuckle 60g, Bulbus Fritillariae Thunbergii 65g, each 30g of Flos Carthami are ground into fine powder, sieve, and mixing, the Lasiosphaera Seu Calvatia sieve is got the 12g fine powder, and is standby; The fine particle size is 80～160 purpose fine powders or 200～300 purpose superfine powder;
The surplus of B, all the other flavour of a drug and above-mentioned four Chinese medicine decocts with water secondary, and each 1～3 hour, collecting decoction filters, and gets filtrate, and was standby;
C, filtrate is concentrated into relative density is 1.03～1.05 clear paste; Or medicinal liquid is concentrated into the thick paste that relative density is 1.28～1.32 (85 ℃); Or filtrate is concentrated into the extractum that relative density is 1.03～1.20 (85 ℃), be dried to powder;
D, with above-mentioned cream or cream powder and fine powder mixing, add suitable excipient, make the spheric pill of sphere or class, coating or polishing, drying, concentrated pill.
Or with above-mentioned cream or cream powder and fine powder mixing; Add appropriate amount of auxiliary materials, mixing is made granule.
Or with above-mentioned cream or cream powder and fine powder mixing; Add appropriate amount of auxiliary materials, mixing, the system granule, tabletting, (coating, drying) in case of necessity makes tablet, dispersible tablet, buccal tablet.
Or, be sealed in the soft capsule material and make soft capsule above-mentioned ointment and fine powder and an amount of plant wet goods additives mixing.
The Jinsangsanjie novel formulation that this preparation method is made (Jinsangsanjie concentrated pill, granule, tablet, dispersible tablet, buccal tablet, soft capsule) secundum legem detects, with control of quality, mainly comprise: the detection that quality inspection standard is checked by the rules of preparations requirement, the result is up to specification; The chromatograph of baicalin, chlorogenic acid, Radix Salviae Miltiorrhizae, Bulbus Fritillariae Thunbergii, Radix Ophiopogonis, Flos Carthami differentiates and detects that the result is up to specification; Heavy metal must not cross 10/1000000ths, arsenic salt must not be crossed 2/1000000ths limit detection, and the result is up to specification; Assay: contain Flos Lonicerae with chlorogenic acid (C
16H
18O
9) meter, each intake is answered 〉=6.0mg, and the result is up to specification.
Embodiment two
Prepare the Jinsangsanjie novel formulation by following processing step, comprise concentrated pill, granule, tablet, dispersible tablet, buccal tablet, soft capsule:
Get Lasiosphaera Seu Calvatia 60g Rhizoma Curcumae (vinegar stir-fry) 60g, Semen Persicae (
) 130g, rhizoma sparganic (vinegar stir-fry) 70g, Flos Carthami 120g, Endothelium Corneum Gigeriae Galli (stir-fry) 75g, Flos Lonicerae 300g, Radix Scrophulariae 150g, Radix Isatidis 150g, Herba Taraxaci 320g Radix Salviae Miltiorrhizae 100g, Bulbus Fritillariae Thunbergii 100g, Rhizoma Alismatis 190g, Periostracum Cicadae 185g, Semen Oroxyli 100g, Radix Ophiopogonis 100g, above flavour of a drug decoct with water secondary, each 1～3 hour, collecting decoction, filter, get filtrate, standby; Except that not adding the fine powder, surplus processes by embodiment one becomes concentrated pill, granule, tablet, dispersible tablet, buccal tablet, soft capsule.
Embodiment three
Prepare the Jinsangsanjie novel formulation by following processing step, comprise concentrated pill, granule, tablet, dispersible tablet, buccal tablet, soft capsule:
Get Lasiosphaera Seu Calvatia 50g, Rhizoma Curcumae (vinegar stir-fry) 100g, Flos Lonicerae 250g, Semen Persicae (
) 100g, Radix Scrophulariae 250g, rhizoma sparganic (vinegar stir-fry) 100g, Flos Carthami 100g, Radix Salviae Miltiorrhizae 150g, Radix Isatidis 250g, Radix Ophiopogonis 200g, Bulbus Fritillariae Thunbergii 150g, Rhizoma Alismatis 150g, Endothelium Corneum Gigeriae Galli (stir-fry) 100g, Periostracum Cicadae 150g, Semen Oroxyli 150g, Herba Taraxaci 250g, standby;
In A, the above medicine, get Bulbus Fritillariae Thunbergii 50g, Endothelium Corneum Gigeriae Galli 33g, be ground into fine powder, sieve, mixing, standby; The fine particle size is 80～160 purpose fine powders or 200～300 purpose superfine powder;
B, Rhizoma Curcumae (vinegar stir-fry) 50g, Semen Persicae (
) 50g, Flos Carthami 50g extract volatile oil, collects volatile oil, and be standby;
C, Herba Taraxaci 125g, Flos Lonicerae 125g add hydro-thermal with the residue Flos Carthami and soak secondary, each 1～3 hour, filter merging filtrate;
The surplus of D, Radix Salviae Miltiorrhizae 75g, Lasiosphaera Seu Calvatia 25g and all the other flavour of a drug and above-mentioned flavour of a drug decocts with water 1～3 time, and each 1～3 hour, merge medicinal liquid, filter;
E, Radix Salviae Miltiorrhizae, Lasiosphaera Seu Calvatia surplus add 70% alcohol heating reflux secondary, and each 1～3 hour, filter, merging filtrate reclaims ethanol, merges with above-mentioned medicinal liquid;
Then, the processes by embodiment one becomes concentrated pill, granule, tablet, dispersible tablet, buccal tablet, soft capsule.
Embodiment four
Prepare the Jinsangsanjie novel formulation by following processing step, comprise concentrated pill, granule, tablet, dispersible tablet, buccal tablet, soft capsule:
Get Lasiosphaera Seu Calvatia 50g, Rhizoma Curcumae (vinegar stir-fry) 100g, Flos Lonicerae 250g, Semen Persicae (
) 100g, Radix Scrophulariae 250g, rhizoma sparganic (vinegar stir-fry) 100g, Flos Carthami 100g, Radix Salviae Miltiorrhizae 150g, Radix Isatidis 250g, Radix Ophiopogonis 200g, Bulbus Fritillariae Thunbergii 150g, Rhizoma Alismatis 150g, Endothelium Corneum Gigeriae Galli (stir-fry) 100g, Periostracum Cicadae 150g, Semen Oroxyli 150g, Herba Taraxaci 250g, standby;
In A, the above medicine, get Bulbus Fritillariae Thunbergii, each 1/3 amount of Endothelium Corneum Gigeriae Galli, be ground into fine powder, sieve, mixing, standby; Granular size is 80～160 purpose fine powders or 200～300 purpose superfine powder;
B, Rhizoma Curcumae (vinegar stir-fry) 60g, Semen Persicae (
) 55g, Flos Carthami 58g extract volatile oil, collects volatile oil, and be standby;
C, Herba Taraxaci 150g, Flos Lonicerae 145g add hydro-thermal with the residue Flos Carthami and soak secondary, each 1～3 hour, filter merging filtrate;
The surplus of D, Radix Salviae Miltiorrhizae 110g, Lasiosphaera Seu Calvatia 35g and all the other flavour of a drug and above-mentioned flavour of a drug decocts with water 1～3 time, and each 1～3 hour, merge medicinal liquid, filter;
E, Radix Salviae Miltiorrhizae, Lasiosphaera Seu Calvatia surplus add 70% alcohol heating reflux secondary, and each 1～3 hour, filter, merging filtrate reclaims ethanol, merges with above-mentioned medicinal liquid;
Processes by embodiment one becomes concentrated pill, granule, tablet, dispersible tablet, buccal tablet, soft capsule.
Embodiment five
Prepare the Jinsangsanjie novel formulation by following processing step, comprise concentrated pill, granule, tablet, dispersible tablet, buccal tablet, soft capsule:
Get Lasiosphaera Seu Calvatia 60g, Rhizoma Curcumae (vinegar stir-fry) 110g, Flos Lonicerae 220g, Semen Persicae (
) 120g, Radix Scrophulariae 200g, rhizoma sparganic (vinegar stir-fry) 130g, Flos Carthami 120g, Radix Salviae Miltiorrhizae 160g, Radix Isatidis 200g, Radix Ophiopogonis 180g, Bulbus Fritillariae Thunbergii 160g, Rhizoma Alismatis 165g, Endothelium Corneum Gigeriae Galli (stir-fry) 130g, Periostracum Cicadae 170g, Semen Oroxyli 180g, Herba Taraxaci 200g, standby;
In A, the above medicine, get Bulbus Fritillariae Thunbergii 128g, Endothelium Corneum Gigeriae Galli 85g, be ground into fine powder, sieve, mixing, standby; The fine particle size is 80～160 purpose fine powders or 200～300 purpose superfine powder;
B, Rhizoma Curcumae (vinegar stir-fry) 72g, Semen Persicae (
) 80g, Flos Carthami 75g extract volatile oil, collects volatile oil, and be standby;
C, Herba Taraxaci 136g, Flos Lonicerae 150g add hydro-thermal with the residue Flos Carthami and soak secondary, each 1～3 hour, filter merging filtrate;
The surplus of D, Radix Salviae Miltiorrhizae 95g, Lasiosphaera Seu Calvatia 40g and all the other flavour of a drug and above-mentioned flavour of a drug decocts with water 1～3 time, and each 1～3 hour, merge medicinal liquid, filter;
E, Radix Salviae Miltiorrhizae, Lasiosphaera Seu Calvatia surplus add 70% alcohol heating reflux secondary, and each 1～3 hour, filter, merging filtrate reclaims ethanol, merges with above-mentioned medicinal liquid;
Processes by embodiment one becomes concentrated pill, granule, tablet, dispersible tablet, buccal tablet, soft capsule.
Embodiment six
Prepare the Jinsangsanjie novel formulation by following processing step, comprise concentrated pill, granule, tablet, dispersible tablet, buccal tablet, soft capsule:
Get Lasiosphaera Seu Calvatia 45g, Rhizoma Curcumae (vinegar stir-fry) 85g, Flos Lonicerae 270g, Semen Persicae (
) 90g, Radix Scrophulariae 280g, rhizoma sparganic (vinegar stir-fry) 95g, Flos Carthami 85g, Radix Salviae Miltiorrhizae 140g, Radix Isatidis 200g, Radix Ophiopogonis 210g, Bulbus Fritillariae Thunbergii 140g, Rhizoma Alismatis 145g, Endothelium Corneum Gigeriae Galli (stir-fry) 90g, Periostracum Cicadae 145g, Semen Oroxyli 190g, Herba Taraxaci 210g, standby;
In A, the above medicine, get Bulbus Fritillariae Thunbergii 45g, Endothelium Corneum Gigeriae Galli 35g, be ground into fine powder, sieve, mixing, standby; The fine particle size is 80～160 purpose fine powders or 200～300 purpose superfine powder;
B, Rhizoma Curcumae (vinegar stir-fry) 28g, Semen Persicae (
) 32g, Flos Carthami 28g extract volatile oil, collects volatile oil, and be standby;
C, Herba Taraxaci 65g, Flos Lonicerae 85g add hydro-thermal with the residue Flos Carthami and soak secondary, each 1～3 hour, filter merging filtrate;
The surplus of D, Radix Salviae Miltiorrhizae 45g, Lasiosphaera Seu Calvatia 15g and all the other flavour of a drug and above-mentioned flavour of a drug decocts with water 1～3 time, and each 1～3 hour, merge medicinal liquid, filter;
E, Radix Salviae Miltiorrhizae, Lasiosphaera Seu Calvatia surplus add 70% alcohol heating reflux secondary, and each 1～3 hour, filter, merging filtrate reclaims ethanol, merges with above-mentioned medicinal liquid;
Processes by embodiment one becomes concentrated pill, granule, tablet, dispersible tablet, buccal tablet, soft capsule.
The foregoing description prepares concentrated pill, granule, tablet, dispersible tablet, buccal tablet, soft capsule, the ball of making/grain baking temperature: less than 80 ℃.The optimum drying temperature is 50～70 ℃.Described medicinal liquid concentrates preferable employing concentrating under reduced pressure; Soak the dry best vacuum drying/spray drying that is of (thick) cream, the vacuum drying temperature is controlled at 50～80 ℃, and the best is 60 ℃; The spray drying inlet temperature is 100～200 ℃, and leaving air temp is 50～150 ℃, and best inlet temperature is 150～180 ℃, and leaving air temp is 80～100 ℃, all can significantly reduce loss of active ingredients.
The foregoing description such as extraction have volatile ingredient (as volatile oil), and its interpolation requirement is:
The preparation concentrated pill is as adding volatile oil, its adding method:
A, volatile oil add in the just dry unpolished hair ball, polishing, drying.
B, volatile oil add in the polishing fluid, with this polishing fluid first exsiccant hair ball are polished drying.
C, volatile oil is added among the ball mother drying after with cyclodextrin inclusion compound.
After d, the pill polishing, add volatile oil, mixing, airtight 24 hours.
Concentrated pill volatile oil adding method the best is: after pill, the polishing, add volatile oil, be heated to 30～40 ℃, in hermetic container airtight vexed 24 hours.
Preparation granule, tablet, dispersible tablet, buccal tablet then after making granule, add volatile oil as adding volatile oil, in hermetic container airtight vexed 24 hours.
The preparation soft capsule then adopts the method with volatile oil and ointment and an amount of plant wet goods additives mixing to add as adding volatile oil.
In the foregoing description, except that embodiment two, other embodiment has adopted several different methods to extract, and its better effects if is as shown in table 1.
Subordinate list 1,2 is that the preparation method of product of the present invention and existing dosage form and the performance of products obtained therefrom compare, and therefrom the performance of visible preparation method products obtained therefrom of the present invention is better than prior art greatly.
Subordinate list 1 is existing dosage form (water-honeyed pill, big honeyed pills) and preparation method thereof, method of quality control, properties of product etc.
Subordinate list 2 is product novel formulation of the present invention (Jinsangsanjie concentrated pill, granule, tablet, dispersible tablet, buccal tablet, soft capsule) and preparation method thereof, method of quality control, properties of product etc.
Subordinate list 1
Claims (1)
1. the preparation method of a Jinsangsanjie preparation, described preparation is made by following raw materials by weight percent: Lasiosphaera Seu Calvatia 1～3%, Rhizoma Curcumae Phaeocaulis (parched with vineger), fiery single Semen Persicae, vinegar fry rhizoma sparganic, Flos Carthami, Endothelium Corneum Gigeriae Galli (parched) each 2～6%, Flos Lonicerae, Radix Scrophulariae, Radix Isatidis, Herba Taraxaci each 5～15%, Radix Salviae Miltiorrhizae, Bulbus Fritillariae Thunbergii, Rhizoma Alismatis, Periostracum Cicadae, Semen Oroxyli each 3～9%, Radix Ophiopogonis 4～12%, it is characterized in that preparation method is that the 30-70% that gets Bulbus Fritillariae Thunbergii, Endothelium Corneum Gigeriae Galli amount is ground into fine powder, standby; Rhizoma Curcumae Phaeocaulis (parched with vineger), fiery single Semen Persicae, each 30-70% amount of Flos Carthami are extracted volatile oil, collect volatile oil, standby; Herba Taraxaci, Flos Lonicerae 35-70% amount add hydro-thermal with the residue Flos Carthami and soak secondary, each 1～3 hour, filter merging filtrate, standby; Radix Salviae Miltiorrhizae, each 35-70% amount of Lasiosphaera Seu Calvatia decoct with water 1～3 time with the surplus of all the other raw medicinal materials and above-mentioned raw materials medical material, and each 1～3 hour, merge medicinal liquid, standby, filter; Radix Salviae Miltiorrhizae, Lasiosphaera Seu Calvatia surplus add 70% alcohol heating reflux secondary, each 1～3 hour, filter, merging filtrate, reclaim ethanol, with above-mentioned medicinal liquid merge total medicinal liquid, standby, then above fine powder, volatile oil, total medicinal liquid are processed into Jinsangsanjie concentrated pill, granule, tablet or soft capsule.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2006100091699A CN101024060B (en) | 2006-02-19 | 2006-02-19 | Jinsangsanjie preparation preparing method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2006100091699A CN101024060B (en) | 2006-02-19 | 2006-02-19 | Jinsangsanjie preparation preparing method |
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| Publication Number | Publication Date |
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| CN101024060A CN101024060A (en) | 2007-08-29 |
| CN101024060B true CN101024060B (en) | 2010-07-07 |
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| CN102363017B (en) * | 2011-10-26 | 2013-04-03 | 西安碑林药业股份有限公司 | Chinese medicinal composition having effects of clearing away heat and toxic materials, promoting blood circulation by removing blood stasis, removing dampness through diuresis and reducing phlegm and preparation method thereof |
| CN102363018B (en) * | 2011-10-26 | 2013-04-03 | 西安碑林药业股份有限公司 | Throat stagnation eliminating Chinese medicinal composition and preparation method thereof |
| CN110361496A (en) * | 2019-08-01 | 2019-10-22 | 西安碑林药业股份有限公司 | The detection method of scutelloside in a kind of Chinese materia medica preparation Jinsangsanjie ball |
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| 中华人民共和国卫生部药品标准中药成方制剂第12册.药典委员会,96. * |
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