CN102772444A - Method for processing traditional Chinese medicinal ultramicro wall-broken oral tablet slices - Google Patents
Method for processing traditional Chinese medicinal ultramicro wall-broken oral tablet slices Download PDFInfo
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- CN102772444A CN102772444A CN2012102390949A CN201210239094A CN102772444A CN 102772444 A CN102772444 A CN 102772444A CN 2012102390949 A CN2012102390949 A CN 2012102390949A CN 201210239094 A CN201210239094 A CN 201210239094A CN 102772444 A CN102772444 A CN 102772444A
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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Abstract
The invention discloses a method for processing traditional Chinese medicinal ultramicro wall-broken oral tablet slices. The method mainly comprises the steps of standardizing, processing and cutting single traditional Chinese medicinal material, then removing pesticide residues through high-pressure cleaning, drying, processing the cut traditional Chinese medicinal materials into coarse powder, dipping to remove heavy metals, processing the coarse powder into ultramicro wall-broken powder through ultramicro grinding, mixing the ultramicro wall-broken powder with pharmaceutical adjuvant powder according to a certain ratio and sterilizing after reaching the standard of quality control to finally obtain the tablet slices. The new tablet slices are prepared from single traditional Chinese medicinal slice, can be directly swallowed without brewing, have various flavors and integrate the advantages of ultramicro power and oral tablets, so that the effective time can be controlled, the usage amount of the pharmaceutical adjuvants is less, the drug-loading rate is high, and a new method is innovated for the modernization of traditional Chinese medicines.
Description
Technical field
The invention belongs to field of traditional Chinese, particularly a kind of processing method of Chinese medicine ultra micro breaking cellular wall oral tablet decoction pieces.
Background technology
Chinese medicine is the conventional medicament of China, and the greatest feature of Chinese medicine just is to use the medical material of single, varies with each individual, and faces the disease prescription, only through 600 kinds of medical materials commonly used, and thousands upon thousands prescriptions of just filling a prescription out, treatment various diseases.For thousands of years, generally be all medical materials to be closed fry in shallow oil, abandon medicinal residues, drink medicinal liquid.So even to this day, Chinese medicine is still continued to use above-mentioned decoction, exposes inconvenience, and is not only thick but also big like low, the traditional decoction pieces of processing criterion, carry inconvenience, decoct trouble, the medical material waste, take mouthfeel difference etc.
The Chinese patent medicine of current popular is made up of fixing several kinds of medical materials; Process Chinese patent medicine through decocting, refine, concentrating,, can only treat specific, fixed disease though a lot of development of dosage form are very fast; Do not reach and face the flexible and convenient of disease compatibility, the process of refining does not simultaneously meet the original intention of Chinese medicine yet.
Recently, there is report that the single medicinal material material is condensed into granule through refinement, processes Chinese medicinal granule (be the Chinese prescription granule again or exempt to fry in shallow oil Chinese medicine),, refine spissated process and still departed from the genuine origin of Chinese crude drug though improved deficiency.
Chinese patent ZL01114467.X discloses a kind of Chinese medicine preparing superfine particles, is characterized in processing granule again with adopting superfine communication technique to make it become micropowders after the prepared slices of Chinese crude drugs drying.When taking, need to use boiled water to brew, this Chinese medicine ultramicro powder has only been avoided the trouble that decocts, and does not improve for aspects such as drug effect absorption and mouthfeels.
How promptly keeping the Chinese medicine tradition to overcome the shortcoming of existence again, promote prepared slices of Chinese crude drugs quality simultaneously comprehensively, is puzzling and being entangled with of current prepared slices of Chinese crude drugs development.Obviously Chinese medicine also should grow with each passing hour, and could adapt to the development of times demand.
Summary of the invention
In view of the above-mentioned defective that exists in the prior art, the invention provides a kind of processing method of Chinese medicine ultra micro breaking cellular wall oral tablet decoction pieces, the single medicinal material decoction pieces is processed directly to swallow need not to brew and have the oral tablet decoction pieces novel form of various tastes; This dosage form has merged the advantage of ultra-micro powder and oral tablet type; And may command onset time, supplementary product consumption is few, and drug loading is high; Disintegrate is rapid, has started a kind of new method of the modernization of Chinese medicine.
The processing method of Chinese medicine ultra micro breaking cellular wall oral tablet decoction pieces is characterized in that may further comprise the steps:
1) standardization of single medicinal material material is concocted; Wherein plant class and animal medicinal material are cleaned, after the cutting operation, are soaked in water half an hour through routine, and the mobile drinking water high pressure of reuse washes more than three times range hydraulic pressure 1～10MPa repeatedly;
2) adopt far-infrared ray drying, microwave drying or hot air drying, the plant medicine material is dried to moisture less than 15%, animal medicinal material is dried to moisture less than 18%, and the mineral substance medical material is dried to moisture less than 10%;
3) dried pulverizing medicinal materials is become 30～50 purpose coarse powder, soaked into, run through, stir 2 hours with clean water or ethanol; Filter is dried, dry then, makes moisture less than 10%;
4) micronizing: adopt the method for comminution by gas stream or mechanical activation comminution, dried Chinese crude drug coarse powder and pharmaceutic adjuvant are processed into ultra-micro powder; Wherein mineral substance medical material particle diameter is 0.01～250 micron, and plant class and animal medicinal material particle diameter are 0.1～300 micron, and the pharmaceutic adjuvant particle diameter is 0.01～500 micron;
Said pharmaceutic adjuvant is the mixture of disintegrating agent and flavoring agent, and wherein the Weight control of disintegrating agent is 30～50% of a Chinese crude drug weight; Said disintegrating agent is a kind of in microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, carboxymethyl starch sodium, tween 80, sodium lauryl sulphate, polyvinylpolypyrrolidone, the 30 POVIDONE K 30 BP/USP 30 or several mixture;
5) Chinese crude drug ultra-micro powder and pharmaceutic adjuvant ultra-micro powder is even with the mixed between the mass ratio 1: 1 to 1: 2;
6) sterilization: use ozone sterilization method or high temperature sterilize method, above-mentioned ultra-micro powder is sterilized, the total number of bacteria that makes the every gram powder in sterilization back is less than 900, and wherein mycete and yeast sum are less than 90, and coliform is less than 90, and the escherichia coli number is zero;
7) adopt pressing that ultra-micro powder is pressed into oral tablet, the tablet total weight amount is 0.1g～2.5g; Be added into pharmaceutical adjunct in the film-making process, the pharmaceutical adjunct addition is that said pharmaceutical adjunct is that weight ratio is binding agent and the lubricant between 1: 1 to 1: 1.5 in 1～2 times of medical material ultra-micro powder weight.
Further, the described flavoring agent of step 4 is a kind of in aspartame, sucrose, aspartame, acesulfame-K, the sweet peptide factor, milk flavour, fruity flavor, cyclamate, steviol glycosides, protein sugar, Mel, the fruity flavor or several mixture.
The described binding agent of step 7 is a kind of in water, ethanol, hydroxypropyl emthylcellulose, polyvinylpyrrolidone, methylcellulose, 30 POVIDONE K 30 BP/USP 30 or the cyclodextrin or several mixture; Described lubricant is a kind of in stearic acid magnesium sulfate, Pulvis Talci, Stepanol MG, micropowder silica gel, magnesium stearate, water, ethanol, Polyethylene Glycol, fumaric acid, ethanedioic acid, PEG400 or the Polyethylene Glycol 6600 or several mixture.
Pharmaceutical adjunct in the step 7 also comprises coating materials, filler, effervescent, masking agent, defoamer or stabilizing agent; Said coating materials is a kind of in ethyl cellulose, cellulose acetate, cellulose propionate, cellulose triacetate, polyacrylic acid resin, polypropylene, polyvinyl alcohol, polyvidone, methylcellulose, hydroxypropyl cellulose, the hypromellose or several mixture; Said filler is a kind of in cellulose, hydroxypropyl cellulose, lactose, mannitol, pregelatinized Starch, the hypromellose or several mixture.Said effervescent also comprises a kind of of sodium bicarbonate, citric acid, Tartaric acid or citric acid or several mixture.
Single medicinal material among the present invention is selected to go through and records in the medical material any one in edition pharmacopeia and each province's Chinese crude drug standard and concocted specification and " the Chinese medicine voluminous dictionary ".Standardization concoct be meant the concocting method recorded in the Chinese crude drug concocted specification that national standard and each province Bureau of Drugs Supervision announce as: methods such as washing, cut, simmer, fry, stew is carried out early stage to medical material and is processed.Plant class and animal medicinal material soak more than half an hour after the segment operation is cleaned, cut to routine again, wash repeatedly more than three times with mobile drinking water high pressure; Pressure limit 1～10MPa, purpose is to remove the pesticide residues of Chinese crude drug, makes content of sulfur dioxide be lower than per kilogram 150ppm; The dichlorvos per kilogram is lower than 0.2mg, and the clofenotane per kilogram is lower than 0.2mg, and the Rogor per kilogram is lower than 1.0mg; The Gamma Hexaochlorocyclohexane per kilogram is lower than 0.3mg, and the chlopyrifos per kilogram is lower than 1.0mg etc. and meets the persticide residue standard.
In the drying steps, can adopt far-infrared ray drying, microwave drying or hot air drying.Chinese crude drug through concocting processing adopts different suitable drying meanss (like room temperature, low temperature, vacuum, decompression, infrared ray etc.) to carry out drying respectively according to different classes, attribute, quality (like mineral, plant roots, leaves of plants, animal bone, pluck), (viscosity, oiliness class fruit and seed, the animal class is referring to flow chart Fig. 1 or adopt other suitable general drying means).The plant medicine material is dried to moisture less than 15%; Animal medicinal material is dried to moisture less than 18%, and the mineral substance medical material is dried to moisture less than 10%, helps the effect of follow-up micronizing; The too high pulverized particles particle diameter of water content is big, and plant cell wall breaking is incomplete.
Dried pulverizing medicinal materials is become 30～50 purpose coarse powder, soaked into, run through, stir 2 hours with clean water or ethanol; Temperature is controlled at 0 ℃～70 ℃, and pressure is in 5 atmospheric pressure.The effect of this procedure is the heavy metal of removing in the Chinese crude drug, makes that the lead content in the medical material is lower than 100/1000000ths, and cadmium content is lower than 80/10000000ths, and arsenic content is lower than 50/1000000ths, and copper content is lower than 200/1000000ths, makes it meet the content of beary metal standard.
Adopt super micron mill or air-flow super micron mill that the first powder of medical material is carried out micronizing, plant class, animal medicinal material are machined to 0.1～300 micron, form the breaking cellular wall powder.Mineral substance is processed into 0.01～250 micron superfine powder.The full composition of ultra micro breaking cellular wall powder after the direct pulverizing of single decoction pieces is used as medicine; Granularity is controlled at 0.01～300 micron; The powder of this diameter can make plant cell wall broken just, makes the quick and whole strippings of medicine active ingredient, but does not change molecular structure and arrangement.Therefore, the medical substance basis of ultra micro breaking cellular wall powder is constant, and meridian distribution of property and flavor, function cure mainly with traditional decoction pieces consistent, has kept the tcm characteristic that varies with each individual, faces the disease plus-minus simultaneously.
Adopt mechanical crushing method, pharmaceutic adjuvant (comprising disintegrating agent and flavoring agent) is ground into 0.01～500 micron superfine powder.Pharmaceutic adjuvant is processed micropowder, help with the Chinese crude drug superfine powder mix with the film-making process in, with Chinese crude drug superfine powder parcel evenly, disintegrating agent wherein can better play a role, and medicine is decomposed rapidly in human body.
Chinese crude drug ultra-micro powder and pharmaceutic adjuvant ultra-micro powder is even with the mixed between the mass ratio 1: 1 to 1: 2, and wherein the Weight control of disintegrating agent is 30～50% of a Chinese crude drug weight.Use this ratio to process oral; Disintegrating agent in the pharmaceutic adjuvant can make to be taken the back Chinese medicine ultra-fine powder and decomposes at the appointed time that (the molten diffusing time of no coated tablet was controlled in 15 minutes; What coated tablet was arranged dissolved the time of loosing in 35 minutes), medicine is absorbed by the body fast.After adding the flavoring agent micropowder, can change bitterness, the astringent taste of Chinese medicine, make medicine have sweet taste or fruity, help taking of child.
Adopt microwave, ozone and pyritous method, Chinese medicine ultra micro breaking cellular wall powder and pharmaceutic adjuvant micropowder are sterilized, sterilization time was controlled at 1～4 hour; Make total number of bacteria in 900; Wherein mycete and yeast count are in 90, and coliform is in 90, and the escherichia coli number is zero.
Adopt pressing that ultra-micro powder is pressed into oral tablet, the oral tablet gross weight is at 0.1g～2.5g; Being added into weight ratio in the film-making process is binding agent and the lubricant between 1: 1 to 1: 1.5, and the pharmaceutical adjunct addition is in 1～2 times of medical material ultra-micro powder weight.
At oral preparing technical field, adopt traditional handicraft to prepare oral and need add a large amount of adjuvants often and help molding, therefore extract oral sheet carrying drug ratio is on the low side usually.The present invention is processed into ultra-micro powder in the micronizing step with Chinese crude drug and pharmaceutic adjuvant, and adopts mass ratio 1: 1 to 1: 2 even with interior mixed; In the film-making process, be added into the pharmaceutical adjunct of rational proportion, make supplementary product consumption few; Oral drug loading is high, and release is uniform and stable, and made oral all has the uniformity preferably; Narrow diameter distribution also has higher intensity and hardness, pine can not occur and collapse phenomenon.
Characteristic elements such as the present invention holds on to the prepared slices of Chinese crude drugs, single, does not decoct, do not refine, genuineness, novel form, high standard; Adopt the single medicinal material decoction pieces after the modern pharmaceutical technology will be concocted directly to be processed into micron-sized ultra micro breaking cellular wall powder; Add an amount of pharmaceutic adjuvant superfine powder again; Oral tablet type, the single medicinal material ultra micro breaking cellular wall oral tablet decoction pieces novel form that formation can directly be swallowed are processed in combination first.This prepared slices of Chinese crude drugs novel form has the following advantages:
1) concocts in the operation of cleaning in routine; Increased the step that high pressure rinse and powder embathe after the cutting; Significantly reduce the sulfur dioxide in the Chinese crude drug, persticide residue and content of beary metal, improved the quality of the prepared slices of Chinese crude drugs, be direct oral the laying a good foundation of the prepared slices of Chinese crude drugs.
2) the full composition of ultra micro breaking cellular wall powder after the direct pulverizing of single decoction pieces is used as medicine; Granularity is controlled at 0.01～300 micron; The powder of this diameter can make plant cell wall broken just, makes the quick and whole strippings of medicine active ingredient, but does not change molecular structure and arrangement.Therefore, the medical substance basis of ultra micro breaking cellular wall powder is constant, and meridian distribution of property and flavor, function cure mainly with traditional decoction pieces consistent, has kept the tcm characteristic that varies with each individual, faces the disease plus-minus simultaneously.
3) the oral tablet type that can directly swallow has been forgone fully and has been carried that inconvenience, all medicines are closed and fried in shallow oil, boiled water brews, the shortcoming of mouthfeel difference; Can collapse diffusing onset rapidly after taking; Expanded the scope of application of the prepared slices of Chinese crude drugs in emergency treatment, rescue, field, the oral tablet type comprises common plain sheet, buccal tablet, chewable tablet, dispersible tablet, effervescent tablet because of production technology is similar.
4) in prepared slices of Chinese crude drugs processing, introduce to the invention property the superfine powder of special-purpose pharmaceutic adjuvant, add the disintegrating agent micropowder, can make and take the decomposition rapidly at the appointed time of back Chinese medicine ultra-fine powder, medicine is absorbed by the body fast; After adding the flavoring agent micropowder, can change bitterness, the astringent taste of Chinese medicine, make medicine have sweet taste or fruity, help taking of child.Thoroughly changed outward appearance, the taste of Chinese medicine decoction pieces and taken mode, realized artificial control onset time (dissolving the time of loosing) first, thereby enlarged the scope of application of the prepared slices of Chinese crude drugs and different crowds.
The characteristics that the present invention has promptly kept the full composition of Chinese medicine single decoction pieces to be used as medicine; Merged the dosage form advantage that Western medicine is directly swallowed again; More introduced medicinal auxiliary material and special quality control index, improved prepared slices of Chinese crude drugs quality, make Chinese crude drug production, process, take and reach new high; The advantage of ultra-micro powder and oral tablet type has not only been merged in the present invention, has also solved the shortcoming of granule, has more thoroughly changed the tradition of a large amount of medical herbs decoction in several thousand.
Description of drawings
Fig. 1 is a flow process chart of the present invention.
The specific embodiment
As shown in Figure 1; The processing method of Chinese medicine ultra micro breaking cellular wall oral tablet decoction pieces of the present invention mainly comprises after the single medicinal material material standardization process of preparing Chinese medicine drying; Be processed into the powder of ultra micro and breaking cellular wall through micronizing; After quality control reaches standard,, process the step of oral tablet decoction pieces at last with warp sterilization again after a certain proportion of pharmaceutic adjuvant micropowder combination.Concrete processing method is:
1) with the process of preparing Chinese medicine that standardizes of single medicinal material material.Wherein plant class and animal medicinal material are cleaned, after the cutting operation, are soaked in water half an hour through routine, and the mobile drinking water high pressure of reuse washes more than three times range hydraulic pressure 1～10Mpa repeatedly.Remove the pesticide residues of Chinese crude drug; Make content of sulfur dioxide be lower than per kilogram 150ppm; The dichlorvos per kilogram is lower than 0.2mg, and the clofenotane per kilogram is lower than 0.2mg, and the Rogor per kilogram is lower than 1.0mg; The Gamma Hexaochlorocyclohexane per kilogram is lower than 0.3mg, and the chlopyrifos per kilogram is lower than 1.0mg etc. and meets the persticide residue standard.
The single medicinal material material is selected to go through and records in the medical material any one in edition pharmacopeia and each province's Chinese crude drug standard and concocted specification and " the Chinese medicine voluminous dictionary ".Standardization concoct be meant the concocting method recorded in the Chinese crude drug concocted specification that national standard and each province Bureau of Drugs Supervision announce as: methods such as washing, cut, simmer, fry, stew is carried out early stage to medical material and is processed.
2) drying: the Chinese crude drug through concocting processing adopts different suitable drying meanss (like room temperature, low temperature, vacuum, decompression, infrared ray etc.) to carry out drying respectively according to different classes, attribute, quality (like mineral, plant roots, leaves of plants, animal bone, pluck), (viscosity, oiliness class fruit and seed, the animal class is referring to flow chart Fig. 1 or adopt other suitable general drying means).The plant medicine material is dried to moisture less than 15%, and animal medicinal material is dried to moisture less than 18%, and the mineral substance medical material is dried to moisture less than 10%.
3) dried pulverizing medicinal materials is become 30～50 purpose coarse powder, soaked into, run through, stir 2 hours with clean water or ethanol; Temperature is controlled at 0 ℃～70 ℃, and pressure is in 5 atmospheric pressure.To remove the heavy metal in the Chinese crude drug, make that the lead content in the medical material is lower than 100/1000000ths, cadmium content is lower than 80/10000000ths, and arsenic content is lower than 50/1000000ths, and copper content is lower than 200/1000000ths, makes it meet the content of beary metal standard.Filter is dried, dry then, makes moisture less than 10%.
4) micronizing: adopt the method for comminution by gas stream or mechanical activation comminution, dried Chinese crude drug coarse powder and pharmaceutic adjuvant are processed into ultra-micro powder; Wherein mineral substance medical material particle diameter is 0.01～250 micron, and plant class and animal medicinal material particle diameter are 0.1～300 micron, and the pharmaceutic adjuvant particle diameter is 0.01～500 micron;
Pharmaceutic adjuvant is the mixture of disintegrating agent and flavoring agent, and wherein the Weight control of disintegrating agent is 30～50% of a Chinese crude drug weight.Disintegrating agent is a kind of in microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, carboxymethyl starch sodium, tween 80, sodium lauryl sulphate, polyvinylpolypyrrolidone, the 30 POVIDONE K 30 BP/USP 30 or several mixture.Flavoring agent is a kind of in aspartame, sucrose, aspartame, acesulfame-K, the sweet peptide factor, milk flavour, fruity flavor, cyclamate, steviol glycosides, protein sugar, Mel or the fruity flavor or several mixture.
5) Chinese crude drug ultra-micro powder and pharmaceutic adjuvant ultra-micro powder is even with the mixed between the mass ratio 1: 1 to 1: 2.
6) sterilization: use microwave, ozone sterilization method or high temperature sterilize method; Above-mentioned ultra-micro powder is sterilized, and the total number of bacteria that makes the every gram powder in sterilization back is less than 900, and wherein mycete and yeast sum are less than 90; Coliform is less than 90, and the escherichia coli number is zero;
7) adopt pressing that ultra-micro powder is pressed into oral tablet, the oral tablet gross weight is 0.1g～2.5g; Be added into pharmaceutical adjunct in the film-making process, the pharmaceutical adjunct addition is that pharmaceutical adjunct is that weight ratio is binding agent and the lubricant between 1: 1 to 1: 1.5 in 1～2 times of medical material ultra-micro powder weight.
Binding agent is a kind of in water, ethanol, hydroxypropyl emthylcellulose, polyvinylpyrrolidone, methylcellulose, 30 POVIDONE K 30 BP/USP 30 or the cyclodextrin or several mixture.Lubricant is a kind of in stearic acid magnesium sulfate, Pulvis Talci, Stepanol MG, micropowder silica gel, magnesium stearate, water, ethanol, Polyethylene Glycol, fumaric acid, ethanedioic acid, PEG400 or the Macrogol 600 or several mixture.
Pharmaceutical adjunct wherein can also comprise coating materials, filler, masking agent, effervescent, defoamer or stabilizing agent.Coating materials is a kind of in ethyl cellulose, cellulose acetate, cellulose propionate, cellulose triacetate, polyacrylic acid resin, polypropylene, polyvinyl alcohol, polyvidone, methylcellulose, hydroxypropyl cellulose, the hypromellose or several mixture.Filler is a kind of in cellulose, hydroxypropyl cellulose, lactose, mannitol, pregelatinized Starch, the hypromellose or several mixture.Effervescent comprises a kind of of sodium bicarbonate, citric acid, citric acid, Tartaric acid or several mixture.
Claims (4)
1. the processing method of Chinese medicine ultra micro breaking cellular wall oral tablet decoction pieces is characterized in that may further comprise the steps:
1) standardization of single medicinal material material is concocted; Wherein plant class and animal medicinal material are cleaned, after the cutting operation, are soaked in water half an hour through routine, and the mobile drinking water high pressure of reuse washes more than three times range hydraulic pressure 1～10MPa repeatedly;
2) adopt far-infrared ray drying, microwave drying or hot air drying, the plant medicine material is dried to moisture less than 15%, animal medicinal material is dried to moisture less than 18%, and the mineral substance medical material is dried to moisture less than 10%;
3) dried pulverizing medicinal materials is become 30～50 purpose coarse powder, soaked into, run through, stir 2 hours with clean water or ethanol; Filter is dried, dry then, makes moisture less than 10%;
4) micronizing: adopt the method for comminution by gas stream or mechanical activation comminution, dried Chinese crude drug coarse powder and pharmaceutic adjuvant are processed into ultra-micro powder; Wherein mineral substance medical material particle diameter is 0.01～250 micron, and plant class and animal medicinal material particle diameter are 0.1～300 micron, and the pharmaceutic adjuvant particle diameter is 0.01～500 micron;
Said pharmaceutic adjuvant is the mixture of disintegrating agent and flavoring agent, and wherein the Weight control of disintegrating agent is 30～50% of a Chinese crude drug weight; Said disintegrating agent is a kind of in microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, carboxymethyl starch sodium, tween 80, sodium lauryl sulphate, polyvinylpolypyrrolidone, the 30 POVIDONE K 30 BP/USP 30 or several mixture;
5) with Chinese crude drug ultra-micro powder and pharmaceutic adjuvant ultra-micro powder with mass ratio 1: 1 to 1: 2 between mixed even;
6) sterilization: use ozone sterilization method or high temperature sterilize method, above-mentioned ultra-micro powder is sterilized, the total number of bacteria that makes the every gram powder in sterilization back is less than 900, and wherein mycete and yeast sum are less than 90, and coliform is less than 90, and the escherichia coli number is zero;
7) adopt pressing that ultra-micro powder is pressed into oral tablet, the oral tablet gross weight is at 0.1g～2.5g; Be added into pharmaceutical adjunct in the film-making process, the pharmaceutical adjunct addition is that said pharmaceutical adjunct is that weight ratio is binding agent and the lubricant between 1: 1 to 1: 1.5 in 1～2 times of medical material ultra-micro powder weight.
2. processing method as claimed in claim 1; It is characterized in that the described flavoring agent of step 4 is a kind of in aspartame, sucrose, aspartame, acesulfame-K, the sweet peptide factor, milk flavour, fruity flavor, cyclamate, steviol glycosides, protein sugar, Mel, the fruity flavor or several mixture.
3. processing method as claimed in claim 1 is characterized in that, the described binding agent of step 7 is a kind of in water, ethanol, hydroxypropyl emthylcellulose, polyvinylpyrrolidone, methylcellulose, 30 POVIDONE K 30 BP/USP 30 or the cyclodextrin or several mixture; Described lubricant is a kind of in stearic acid magnesium sulfate, Pulvis Talci, Stepanol MG, micropowder silica gel, magnesium stearate, water, ethanol, Polyethylene Glycol, fumaric acid, ethanedioic acid, PEG400 or the Macrogol 600 or several mixture.
4. processing method as claimed in claim 1 is characterized in that the pharmaceutical adjunct in the step 7 also comprises coating materials, filler, masking agent, defoamer, effervescent or stabilizing agent; Said coating materials is a kind of in ethyl cellulose, cellulose acetate, cellulose propionate, cellulose triacetate, polyacrylic acid resin, polypropylene, polyvinyl alcohol, polyvidone, methylcellulose, hydroxypropyl cellulose, the hypromellose or several mixture; Said filler is a kind of in cellulose, hydroxypropyl cellulose, lactose, mannitol, pregelatinized Starch, the hypromellose or several mixture; Said effervescent is a kind of of sodium bicarbonate, citric acid, citric acid, Tartaric acid or several mixture.
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| CN109394807A (en) * | 2018-11-26 | 2019-03-01 | 苏州九珍堂健康药业有限公司 | A kind of prepared slices of Chinese crude drugs processing technology |
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| US10800779B2 (en) | 2015-04-03 | 2020-10-13 | Incyte Corporation | Heterocyclic compounds as LSD1 inhibitors |
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| CN108185438A (en) * | 2017-12-22 | 2018-06-22 | 中国科学院西北高原生物研究所 | The tabletting of black fruit fructus lycii powder and its preparation process |
| US10968200B2 (en) | 2018-08-31 | 2021-04-06 | Incyte Corporation | Salts of an LSD1 inhibitor and processes for preparing the same |
| US11512064B2 (en) | 2018-08-31 | 2022-11-29 | Incyte Corporation | Salts of an LSD1 inhibitor and processes for preparing the same |
| CN109394807A (en) * | 2018-11-26 | 2019-03-01 | 苏州九珍堂健康药业有限公司 | A kind of prepared slices of Chinese crude drugs processing technology |
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