CN102772437A - Processing method of ultra-micro wall-breaking oral liquid-preparation decoction pieces by traditional Chinese medicines - Google Patents
Processing method of ultra-micro wall-breaking oral liquid-preparation decoction pieces by traditional Chinese medicines Download PDFInfo
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Abstract
The invention discloses a processing method of ultra-micro wall-breaking oral liquid-preparation decoction pieces by traditional Chinese medicines, which mainly comprises the following steps that: pesticide residues are washed by using high pressure after single traditional Chinese medicinal materials are processed and cut in a standardization way, the traditional Chinese medicinal materials are processed into coarse powder after being dried, heavy metal is removed by dipping, then the coarse powder is processed into ultra-micro wall-breaking powder by ultra-micro pulverization, afterwards the powder is sterilized after being combined with the micro-powder of medicinal auxiliary materials with a certain proportion after quality control reaches a standard, and finally, the step of preparing the oral liquid-preparation decoction pieces is finished. According to the processing method of the ultra-micro wall-breaking oral liquid-preparation decoction pieces by the traditional Chinese medicines, the decoction pieces of single traditional Chinese medicines are prepared into a novel preparation of the oral liquid-preparation decoction pieces, which can be directly taken orally without infusion and also has various tastes. According to the preparation, the advantages of ultra-micro powder and an oral liquid preparation are fused, the aim of direct acting can also be realized, the use quantity of the auxiliary materials is little, the medicine loading quantity is high, and a novel method for modernizing traditional Chinese medicines is initiated.
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 fluid agent 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 fluid agent decoction pieces, the single medicinal material decoction pieces is processed the oral fluid agent decoction pieces novel form that can directly orally need not to brew and have various tastes; This dosage form has merged the advantage of ultra-micro powder and liquid oral dosage form; And may command onset time, supplementary product consumption is few, and drug loading is high; Need not to brew, directly onset, started a kind of new method of the modernization of Chinese medicine.
The processing method of Chinese medicine ultra micro breaking cellular wall oral fluid agent 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 a flavoring agent, and wherein the Weight control of flavoring agent is 10～30% of a Chinese crude drug weight; Described 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, fruity flavor, 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: 0.1 to 1: 0.3;
6) add distilled water and add the liquid agent that the pharmaceutical adjunct fill becomes all size; Be added into pharmaceutical adjunct in the preparation process, the pharmaceutical adjunct addition is that said pharmaceutical adjunct is that weight ratio is antiseptic and the stabilizing agent between 1: 0.5 to 1: 1 in 0.1～0.8 times of medical material ultra-micro powder weight.
7) sterilization: use ozone sterilization method or high temperature sterilize method, above-mentioned liquid oral is sterilized sterilization time 1～4 hour; The total number of bacteria that makes every milliliter of sterilization back is less than 900; Wherein mycete and yeast sum are less than 90, and coliform is less than 90, and the escherichia coli number is zero;
The described antiseptic of step 6 is: sorbic acid, sodium benzoate, sodium lactate, calcium propionate, sodium diacetate, polylysine sodium a kind of or several mixture.Described stabilizing agent is: Polysorbate, phospholipid, methylcellulose, polyvidone, glucosan, sodium sulfite and calcium disodium edetate a kind of or several mixture.
Pharmaceutical adjunct in the step 6 also comprises masking agent, defoamer or regulator: said regulator is a kind of of sodium hydroxide, 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 system 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 (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 preparation process in, with Chinese crude drug superfine powder parcel evenly, flavoring agent wherein can better play a role.
With Chinese crude drug ultra-micro powder and pharmaceutic adjuvant ultra-micro powder mix homogeneously, wherein the Weight control of flavoring agent is 10～30% of a Chinese crude drug weight.The liquid oral that uses this ratio to process can change bitterness, the astringent taste of Chinese medicine, makes the sweet taste of medicine or fruity moderate, helps taking of child.
With distilled water oral fluid agent is processed in the ultra-micro powder fill; Liquid agent can be made into all size; Container adopts suitable bottle, bag etc.; Being added into weight ratio in the preparation process is antiseptic and the stabilizing agent between 1: 0.5 to 1: 1, and the pharmaceutical adjunct addition is in 0.1～0.8 times of medical material ultra-micro powder weight.
Adopt microwave, ozone and pyritous method, oral fluid agent is sterilized, sterilization time was controlled at 1～4 hour, made total number of bacteria in 900, and wherein mycete and yeast count are in 90, and coliform is in 90, and the escherichia coli number is zero.
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; Liquid oral dosage form, the single medicinal material ultra micro breaking cellular wall oral fluid agent decoction pieces novel form that formation can be directly oral 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) can directly oral liquid oral dosage form have forgone fully and carried that inconvenience, all medicines are closed and fried in shallow oil, boiled water brews, the shortcoming of mouthfeel difference; Onset rapidly after taking; Expanded the scope of application of the prepared slices of Chinese crude drugs in emergency treatment, rescue, field, the liquid oral dosage form comprises common oral liquid, mixture, emulsion, syrup, suspension because of production technology is similar.
4) superfine powder of special-purpose pharmaceutic adjuvant is introduced on the invention property ground in prepared slices of Chinese crude drugs processing, behind the adding flavoring agent micropowder, can change bitterness, the astringent taste of Chinese medicine, makes medicine have sweet taste or fruity, helps taking of child.Thoroughly change outward appearance, the taste of Chinese medicine decoction pieces and taken mode, 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 directly oral dosage form advantage of Western medicine 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 liquid oral dosage form 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 fluid agent 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, with after the combination of a certain proportion of pharmaceutic adjuvant micropowder again through fill, seal, sterilize, process the step of oral fluid agent decoction pieces at last.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 a flavoring agent, and wherein the Weight control of flavoring agent is 10～30% of a Chinese crude drug weight.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: 0.1 to 1: 0.3.
6) with distilled water ultra-micro powder is processed oral fluid agent, liquid agent can be made into all size and adopts different packing containers; Be added into pharmaceutical adjunct in the preparation process, the pharmaceutical adjunct addition is that pharmaceutical adjunct is that weight ratio is antiseptic and the stabilizing agent between 1: 0.5 to 1: 1 in 0.5～1.0 times of medical material ultra-micro powder weight.
7) sterilization: use microwave, ozone sterilization method or high temperature sterilize method, agent is sterilized to aforesaid liquid, and the time was at 1～4 hour; The total number of bacteria that makes every milliliter of end, sterilization back is less than 900; Wherein mycete and yeast sum are less than 90, and coliform is less than 90, and the escherichia coli number is zero;
Antiseptic in the above-mentioned steps 6 is: sorbic acid, sodium benzoate, sodium lactate, calcium propionate, sodium diacetate, polylysine sodium a kind of or several mixture.Stabilizing agent is: Polysorbate, phospholipid, methylcellulose, polyvidone, glucosan, sodium sulfite and calcium disodium edetate a kind of or several mixture.
Pharmaceutical adjunct wherein can also comprise masking agent, defoamer or regulator.Regulator comprises a kind of of sodium hydroxide and sodium citrate or several mixture.
Claims (3)
1. the processing method of Chinese medicine ultra micro breaking cellular wall oral fluid agent 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 a flavoring agent, and wherein the Weight control of flavoring agent is 10～30% of a Chinese crude drug weight; Described 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, the fruity flavor or several mixture.
5) with Chinese crude drug ultra-micro powder and pharmaceutic adjuvant ultra-micro powder with mass ratio 1: 0.1 to 1: 0.3 between mixed even;
6) become oral liquid with the distilled water fill, liquid agent can be made into all size and adopts various packings; Be added into pharmaceutical adjunct in the preparation process, the pharmaceutical adjunct addition is that said pharmaceutical adjunct is that weight ratio is antiseptic and the stabilizing agent between 1: 0.5 to 1: 1 in 0.1～0.8 times of medical material ultra-micro powder weight.
7) sterilization: use ozone sterilization method or high temperature sterilize method, agent is sterilized to aforesaid liquid, and sterilization time was at 1～4 hour; The total number of bacteria that makes every milliliter of sterilization back is less than 900; Wherein mycete and yeast sum are less than 90, and coliform is less than 90, and the escherichia coli number is zero.
2. processing method as claimed in claim 1 is characterized in that, the described antiseptic of step 6 is: sorbic acid, sodium benzoate, sodium lactate, calcium propionate, sodium diacetate, gather a kind of of propylhomoserin sodium or several mixture.Described stabilizing agent is: Polysorbate, phospholipid, methylcellulose, polyvidone, glucosan, sodium sulfite and calcium disodium edetate a kind of or several mixture.
3. processing method as claimed in claim 1 is characterized in that the pharmaceutical adjunct in the step 6 also comprises masking agent, defoamer, regulator; Said regulator is a kind of of sodium hydroxide, citric acid or several mixture.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107260900A (en) * | 2017-05-24 | 2017-10-20 | 浙江大学 | A kind of safflower ultramicro decoction piece preparation method |
| CN107488559A (en) * | 2016-06-13 | 2017-12-19 | 毛嘉明 | A kind of preparation method of wall breaking health care wine |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1386495A (en) * | 2001-05-17 | 2002-12-25 | 湖南省中医药研究院 | Process for preparing superfine particles of Chinese medicine |
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2012
- 2012-07-07 CN CN2012102381776A patent/CN102772437A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1386495A (en) * | 2001-05-17 | 2002-12-25 | 湖南省中医药研究院 | Process for preparing superfine particles of Chinese medicine |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107488559A (en) * | 2016-06-13 | 2017-12-19 | 毛嘉明 | A kind of preparation method of wall breaking health care wine |
| CN107260900A (en) * | 2017-05-24 | 2017-10-20 | 浙江大学 | A kind of safflower ultramicro decoction piece preparation method |
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Application publication date: 20121114 |