CN114594222B - Decoction piece detection method based on traditional Chinese medicine formula particles - Google Patents
Decoction piece detection method based on traditional Chinese medicine formula particles Download PDFInfo
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- CN114594222B CN114594222B CN202210318482.XA CN202210318482A CN114594222B CN 114594222 B CN114594222 B CN 114594222B CN 202210318482 A CN202210318482 A CN 202210318482A CN 114594222 B CN114594222 B CN 114594222B
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N5/00—Analysing materials by weighing, e.g. weighing small particles separated from a gas or liquid
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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
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Abstract
The invention relates to a decoction piece detection method based on traditional Chinese medicine formula particles, which comprises the following steps: s1: obtaining preparation parameters of traditional Chinese medicine formula particles; s2: calculating to obtain the lower limit of the water-alcohol soluble extract of the decoction pieces according to the preparation parameters; s3: measuring the actual decoction piece water-alcohol soluble extract of the decoction piece; s4: judging whether the decoction pieces can be prepared into qualified traditional Chinese medicine formula particles according to whether the actual decoction piece water-alcohol soluble extract is not lower than the lower limit of the decoction piece water-alcohol soluble extract. The invention can effectively avoid the production of unqualified decoction pieces in advance, and can save a large amount of resources.
Description
Technical Field
The invention relates to the field of preparation of traditional Chinese medicine formula particles, in particular to a decoction piece detection method based on traditional Chinese medicine formula particles.
Background
In terms of concept, the single Chinese medicine granule is a pure Chinese medicine product series prepared by taking traditional Chinese medicine decoction pieces meeting processing standards as raw materials, extracting with water, concentrating, separating, drying, granulating, packaging and refining by modern pharmaceutical technology. The effective components, the taste, the meridian tropism, the main treatment and the efficacy of the traditional Chinese medicine formula granule are completely consistent with those of the traditional Chinese medicine decoction pieces, so that all the characteristics of the traditional Chinese medicine decoction pieces are maintained, the characteristics of the traditional monarch, minister, assistant, guide and dialectical treatment and flexible addition and subtraction of the traditional Chinese medicine can be ensured, the traditional Chinese medicine formula granule is superior to the Chinese patent medicine, the trouble of traditional decoction of patients is avoided, and meanwhile, the single granule can be flexibly taken after being taken, and the traditional Chinese medicine formula granule is sanitary and effective.
In the national standard of traditional Chinese medicine formula particles, the key detection indexes comprise 4 items such as paste yield, alcohol soluble extract, main component content, characteristic spectrum and the like.
In the quality control of the traditional Chinese medicine formula particles, the finished product is mainly detected, but if decoction pieces adopted in the preparation of the traditional Chinese medicine formula particles are unqualified, the qualified traditional Chinese medicine formula particles cannot be obtained, so that the waste of decoction pieces is caused, and no method or product is used for detecting the decoction pieces adopted in the preparation of the traditional Chinese medicine formula particles at present to finish the quality control of the traditional Chinese medicine formula particles.
Disclosure of Invention
The invention aims to overcome the defects of the prior art, and provides a decoction piece detection method based on traditional Chinese medicine formula particles, which can effectively avoid the use of unqualified decoction pieces for production in advance and can save a large amount of resources.
The aim of the invention is realized by the following technical scheme:
a decoction piece detection method based on traditional Chinese medicine formula particles comprises the following steps:
s1: obtaining preparation parameters of traditional Chinese medicine formula particles;
s2: calculating to obtain the lower limit of the water-alcohol soluble extract of the decoction pieces according to the preparation parameters;
s3: measuring the actual decoction piece water-alcohol soluble extract of the decoction piece;
s4: judging whether the decoction pieces can be prepared into qualified traditional Chinese medicine formula particles according to whether the actual decoction piece water-alcohol soluble extract is not lower than the lower limit of the decoction piece water-alcohol soluble extract.
Further, the preparation parameters comprise granule preparation amount, granule water upper limit, granule alcohol soluble extract lower limit, maximum auxiliary material addition amount, auxiliary material alcohol soluble extract, decoction piece feeding amount, decoction piece water and transfer rate.
Further, the preparation parameters are determined according to the detection result of the qualified particles and the determined preparation standard; the lower limit of the alcohol-soluble extract of the particles is determined according to the detection result of the alcohol-soluble extract of the qualified particles.
Further, the method for determining the alcohol-soluble extract of the qualified particles comprises the following steps: taking a proper amount of qualified particles, grinding the qualified particles, precisely weighing, precisely adding ethanol into the qualified particles, and measuring according to a hot dipping method under the condition of alcohol-soluble extract measurement method (general rule 2201 of four parts of Chinese pharmacopoeia 2020).
As another design, the preparation parameters are determined according to the detection result of the qualified particles and the determined preparation standard; the lower limit of the alcohol-soluble extract of the granule is determined according to the national standard of the traditional Chinese medicine formula granule.
Further, the lower limit of the water-alcohol soluble extract of the decoction piece is calculated as follows:
lower limit of decoction piece water-alcohol soluble extract = (granule production amount× (1-granule moisture upper limit) ×granule alcohol soluble extract lower limit-maximum adjuvant addition amount×adjuvant alcohol soluble extract)/(decoction piece addition amount× (1-decoction piece moisture))/(transfer rate×100%
Further, the step S3 includes the following substeps:
s301: preparing the decoction pieces into dry paste powder;
s302: alcohol-soluble extract of the dry paste powder is obtained by measuring the alcohol-soluble extract of the dry paste powder;
s303: and calculating according to the dry paste powder alcohol-soluble extract to obtain the water-alcohol-soluble extract of the actual decoction pieces.
Further, the calculation formula of the water-alcohol soluble extract of the actual decoction pieces is as follows:
actual decoction piece water-alcohol soluble extract = dry extract powder alcohol soluble extract x dry extract powder weight ≡ (decoction piece input amount when making dry extract powder x (1-decoction piece moisture))
The beneficial effects of the invention are as follows:
can effectively avoid the use of unqualified decoction pieces for production in advance, and can save a large amount of resources.
Detailed Description
Other advantages and effects of the present invention will become apparent to those skilled in the art from the following disclosure, which describes the embodiments of the present invention with reference to specific examples. The invention may be practiced or carried out in other embodiments that depart from the specific details, and the details of the present description may be modified or varied from the spirit and scope of the present invention. It should be noted that the following embodiments and features in the embodiments may be combined with each other without conflict.
Embodiment one:
a decoction piece detection method based on traditional Chinese medicine formula particles comprises the following steps:
s1: obtaining preparation parameters of traditional Chinese medicine formula particles;
the preparation parameters comprise granule preparation amount, granule water upper limit, granule alcohol soluble extract lower limit, maximum auxiliary material addition amount, auxiliary material alcohol soluble extract, decoction piece addition amount, decoction piece water content and transfer rate;
the preparation parameters are determined according to the detection result of the qualified particles and the determined preparation standard (such as particle extract standard).
The lower limit of the alcohol-soluble extract of the particles is determined according to the detection result of the alcohol-soluble extract of the qualified particles.
The method for determining the alcohol-soluble extract of the qualified particles comprises the following steps: taking a proper amount of qualified particles, grinding the qualified particles, precisely weighing about 2g, precisely adding 50-100 ml of ethanol into the qualified particles, and measuring according to a hot dipping method under the condition of alcohol-soluble extract measurement method (general rule 2201 of four parts of Chinese pharmacopoeia 2020).
The lower limit of the alcohol-soluble extract of the granule can also be determined according to the national standard of the traditional Chinese medicine formula granule.
S2: calculating to obtain the lower limit of the water-alcohol soluble extract of the decoction pieces according to the preparation parameters;
the lower limit of the water-alcohol soluble extract of the decoction piece is calculated by the following formula:
lower limit of decoction piece water-alcohol soluble extract = (granule production amount× (1-granule moisture upper limit) ×granule alcohol soluble extract lower limit-maximum adjuvant addition amount×adjuvant alcohol soluble extract)/(decoction piece addition amount× (1-decoction piece moisture))/(transfer rate×100%
This is due to
Transfer ratio = particulate alcohol-soluble extract x theoretical particle amount x (1-particulate moisture)/(decoction piece amount x (1-decoction piece moisture) ×decoction piece water-alcohol-soluble extract)
S3: measuring the actual decoction piece water-alcohol soluble extract of the decoction piece;
s301: preparing the decoction pieces into dry paste powder;
taking a proper amount of decoction pieces, preparing the decoction pieces into powder (sieving with a second sieve), adding 25 times of water, soaking for 1 hour, heating and refluxing for 1 hour, filtering the extracting solution, concentrating under reduced pressure to be thick, and drying to obtain dry paste powder.
S302: alcohol-soluble extract of the dry paste powder is obtained by measuring the alcohol-soluble extract of the dry paste powder;
taking about 2g of the dry paste powder prepared in the step S301, precisely weighing, precisely adding 100ml of ethanol, and measuring according to a hot dipping method under the condition of alcohol-soluble extract measuring method (general rule 2201 of four parts of Chinese pharmacopoeia 2020);
s303: calculating according to the dry paste powder alcohol-soluble extract to obtain an actual decoction piece water-alcohol-soluble extract;
the calculation formula of the water-alcohol soluble extract of the actual decoction pieces is as follows:
actual decoction piece water-alcohol soluble extract = dry extract powder alcohol soluble extract x dry extract powder weight ≡ (decoction piece input amount when making dry extract powder x (1-decoction piece moisture))
S4: judging whether the decoction pieces can be prepared into qualified traditional Chinese medicine formula particles according to whether the actual decoction piece water-alcohol soluble extract is not lower than the lower limit of the decoction piece water-alcohol soluble extract.
If the practical water-alcohol soluble extract of the decoction pieces is not lower than the lower limit of the water-alcohol soluble extract of the decoction pieces, the decoction pieces can be prepared into qualified traditional Chinese medicine formula particles; if the practical water-alcohol soluble extract of the decoction pieces is lower than the lower limit of the water-alcohol soluble extract of the decoction pieces, the decoction pieces cannot be prepared into qualified traditional Chinese medicine formula particles.
Therefore, unqualified decoction pieces can be effectively avoided from being used for production in advance, and a large amount of resources can be saved.
The concept of water-alcohol soluble extract of decoction pieces is proposed by referring to key indexes of traditional Chinese medicine formula particles, and the basis is as follows: the formula particle is prepared by extracting, concentrating and drying the preparation by water. Therefore, the water-soluble extract of the decoction pieces is measured to obtain dry paste powder, and then the alcohol-soluble extract of the dry paste powder is measured to calculate the water-alcohol-soluble extract result of the decoction pieces. The corresponding relation between the particles and the key indexes of the decoction pieces is shown in the following table:
thus, by controlling the quality of decoction pieces, qualified granules are easier to prepare.
Embodiment two:
the decoction pieces of the scorched hawthorn fruit (the Chinese hawthorn fruit) are detected by adopting the decoction piece detection method based on the Chinese medicinal formula particles in the first embodiment aiming at the preparation of the scorched hawthorn fruit (the Chinese hawthorn fruit) Chinese medicinal formula particles.
The relevant detection data of the decoction pieces of the scorched hawthorn fruit (the hawthorn fruit) and the traditional Chinese medicine formula granules of the scorched hawthorn fruit (the hawthorn fruit) are shown in the table 1 and the table 2.
TABLE 1 detection data for decoction pieces of Crataegus pinnatifida (Crataegus pinnatifida)
Table 2 detection data of finished product of Chinese medicinal granule containing fructus crataegi (fructus crataegi)
The national standard of the Chinese medicinal granule of the formulation of the charred fructus crataegi (fructus crataegi) prescribes that: 1. the preparation method comprises the following steps: decocting the decoction pieces of the charred hawthorn in water 2000g, filtering, concentrating the filtrate into clear paste (the paste yield of the dry extract is 25% -40%), adding a proper amount of auxiliary materials, drying (or drying and crushing), adding a proper amount of auxiliary materials, uniformly mixing, granulating and preparing 1000 g. 2. The content of ethanol is not less than 26.0% as measured by hot dip method under alcohol soluble extract measurement (general rule 2201 of Chinese pharmacopoeia 2020 edition).
The water content of the lower-burnt hawthorn in the section of the 2020 edition of Chinese pharmacopoeia is specified as follows: less than 12.0% (general rule 0832 second method).
The upper limit of the water content of the granule is 8.0%, and the alcohol-soluble extract of the auxiliary material is 2%.
The following preparation parameters were obtained:
1000g of granule, 8.0% of granule water content, 26.0% of granule alcohol-soluble extract, 1000-2000×25% of maximum adjuvant addition (granule preparation-minimum clear paste obtained by concentrating decoction pieces of charred fructus crataegi), 2% of adjuvant alcohol-soluble extract, 2000g of decoction piece addition, 12.0% of decoction piece water content and 95.81% of transfer rate (average value of extract transfer rate in table 2)
Measuring actual decoction piece water-alcohol soluble extract of decoction pieces = (granule preparation amount× (1-granule moisture upper limit) ×granule alcohol soluble extract lower limit-maximum adjuvant addition amount×adjuvant alcohol soluble extract)/(decoction piece addition amount× (1-decoction piece moisture))/transfer rate×100% = (1000× (1-8.0%) ×26.0% - (1000-2000×25%) ×2%))/2000× (1× (1-12.0%)))/95.81% ×100% = 13.59%; judging whether the scorched hawthorn fruit (fructus crataegi) decoction pieces can be prepared into qualified traditional Chinese medicine formula granules according to whether the actual decoction piece water-alcohol soluble extract is not lower than the lower limit of the decoction piece water-alcohol soluble extract.
The internal control standard of the actual water-alcohol soluble extract of the scorched hawthorn fruit (fructus crataegi) decoction pieces is formulated as follows: taking a proper amount of the product (sieving with a second sieve), adding 25 times of water, soaking for 1 hour, heating and reflux-extracting for 1 hour, filtering the extracting solution, concentrating under reduced pressure to be thick, drying, taking about 2g of dry paste powder, precisely weighing, precisely adding 100ml of ethanol, and measuring according to a hot dipping method under the item of alcohol-soluble extract measuring method (general rule 2201 of four parts of Chinese pharmacopoeia 2020 edition), wherein the content of the ethanol is not less than 14.0 percent calculated by dry product.
Namely, decoction pieces with the water-alcohol soluble extract of the actual decoction pieces more than 14.0% are selected to prepare the traditional Chinese medicine formula particles, so that the alcohol soluble extract of the traditional Chinese medicine formula particles accords with the national standard.
Embodiment III:
aiming at the preparation of the bighead atractylodes rhizome traditional Chinese medicine formula granule, the bighead atractylodes rhizome decoction pieces are detected by adopting the decoction piece detection method based on the traditional Chinese medicine formula granule in the first embodiment.
The relevant detection data of the decoction pieces of bighead atractylodes rhizome and the traditional Chinese medicine formula particles of bighead atractylodes rhizome are shown in tables 3 and 4.
TABLE 3 detection data for Atractylodis rhizoma decoction pieces
TABLE 4 finished product detection data of Atractylodis rhizoma traditional Chinese medicine formula granule
The national standard of the largehead atractylodes rhizome formula particle prescribes that: 1. the preparation method comprises the following steps: decocting 1300g of rhizoma atractylodis macrocephalae decoction pieces in water, filtering, concentrating the filtrate into clear paste (the paste yield of the dry extract is 40% -74%), adding a proper amount of auxiliary materials, drying (or drying and crushing), adding a proper amount of auxiliary materials, uniformly mixing, granulating and preparing 1000 g. 2. The content of ethanol in the extract is not less than 5.0% as measured by hot dip method under alcohol soluble extract measurement (general rule 2201 of Chinese pharmacopoeia 2020 edition). The water content of bighead atractylodes rhizome under the item "bighead atractylodes rhizome" in the section of the 2020 edition of Chinese pharmacopoeia is specified as follows: less than 15.0% (general rule 0832, fourth method).
The upper limit of the water content of the granule is 8.0%, and the alcohol-soluble extract of the auxiliary material is 2%.
The following preparation parameters were obtained:
1000g of granule, 8.0% of granule water content, 5.0% of granule alcohol-soluble extract, 1000-1300×40% of maximum adjuvant addition (granule preparation-minimum clear paste obtained by concentrating decoction pieces of Atractylodis rhizoma), 2% of adjuvant alcohol-soluble extract, 1300g of decoction piece addition, 15.0% of decoction piece water content and 76.94% of transfer rate (average value of extract transfer rate in Table 4)
Lower limit of decoction piece water-alcohol soluble extract= (granule production amount× (1-granule moisture upper limit) ×lower limit of granule alcohol soluble extract-maximum adjuvant addition amount×adjuvant alcohol soluble extract)/(decoction piece addition amount× (1-decoction piece moisture)) ++transfer rate ++100% = (1000× (1-8.0%) ×5.0% - (1000-1300×40%) ×2%) ++1300× (1-15.0%)) ++ 76.94% ++100% = 4.28%) ++
Measuring the actual decoction piece water-alcohol soluble extract of the rhizoma atractylodis macrocephalae decoction pieces; judging whether the bighead atractylodes rhizome decoction pieces can be prepared into qualified traditional Chinese medicine formula particles according to whether the actual decoction piece water-alcohol soluble extract is not lower than the lower limit of the decoction piece water-alcohol soluble extract.
The internal control standard of the decoction piece water-alcohol soluble extract of the rhizoma atractylodis macrocephalae decoction piece is formulated as follows: taking a proper amount of the product (sieving with a second sieve), adding 25 times of water, soaking for 1 hour, heating and reflux-extracting for 1 hour, filtering the extracting solution, concentrating under reduced pressure to be thick, drying, taking about 2g of dry paste powder, precisely weighing, precisely adding 100ml of ethanol, and measuring according to a hot dipping method under the item of alcohol-soluble extract measuring method (general rule 2201 of four parts of Chinese pharmacopoeia 2020 edition), wherein the content of the extract is not less than 4.5 percent calculated by dry product.
Namely, decoction pieces with water-alcohol soluble extract of more than 4.5% are selected to prepare the traditional Chinese medicine formula granule, so that the alcohol soluble extract of the traditional Chinese medicine formula granule meets the national standard.
The foregoing examples merely illustrate specific embodiments of the invention, which are described in greater detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention.
Claims (4)
1. A decoction piece detection method based on traditional Chinese medicine formula particles is characterized by comprising the following steps: the method comprises the following steps:
s1: obtaining preparation parameters of traditional Chinese medicine formula particles;
s2: calculating to obtain the lower limit of the water-alcohol soluble extract of the decoction pieces according to the preparation parameters;
s3: measuring the actual decoction piece water-alcohol soluble extract of the decoction piece;
s4: judging whether the decoction pieces can be prepared into qualified traditional Chinese medicine formula particles according to whether the actual decoction piece water-alcohol soluble extract is not lower than the lower limit of the decoction piece water-alcohol soluble extract;
the preparation parameters comprise granule preparation amount, granule water upper limit, granule alcohol soluble extract lower limit, maximum auxiliary material addition amount, auxiliary material alcohol soluble extract, decoction piece addition amount, decoction piece water content and transfer rate;
the lower limit of the water-alcohol soluble extract of the decoction piece is calculated by the following formula:
lower limit of decoction piece water-alcohol soluble extract = (granule production amount× (1-granule moisture upper limit) ×granule alcohol soluble extract lower limit-maximum adjuvant addition amount×adjuvant alcohol soluble extract)/(decoction piece addition amount× (1-decoction piece moisture))/(transfer rate×100%
Said step S3 comprises the sub-steps of:
s301: preparing the decoction pieces into dry paste powder;
s302: alcohol-soluble extract of the dry paste powder is obtained by measuring the alcohol-soluble extract of the dry paste powder;
s303: calculating according to the dry paste powder alcohol-soluble extract to obtain an actual decoction piece water-alcohol-soluble extract;
the calculation formula of the water-alcohol soluble extract of the actual decoction pieces is as follows:
actual decoction piece water-alcohol soluble extract = dry extract powder alcohol soluble extract x dry extract powder weight ≡ (decoction piece input amount when dry extract powder is made x (1-decoction piece moisture)).
2. The decoction piece detection method based on traditional Chinese medicine formula particles according to claim 1, wherein the detection method is characterized in that: the preparation parameters are determined according to the detection result of the qualified particles and the determined preparation standard; the lower limit of the alcohol-soluble extract of the particles is determined according to the detection result of the alcohol-soluble extract of the qualified particles.
3. The decoction piece detection method based on traditional Chinese medicine formula particles according to claim 2, which is characterized in that: the method for determining the alcohol-soluble extract of the qualified particles comprises the following steps: taking a proper amount of qualified particles, grinding the qualified particles, precisely weighing, precisely adding ethanol into the qualified particles, and measuring according to a hot dipping method under the rule 2201 alcohol-soluble extract measuring method of four general rules of the year 2020 edition of Chinese pharmacopoeia.
4. The decoction piece detection method based on traditional Chinese medicine formula particles according to claim 1, wherein the detection method is characterized in that: the preparation parameters are determined according to the detection result of the qualified particles and the determined preparation standard; the lower limit of the alcohol-soluble extract of the granule is determined according to the national standard of the traditional Chinese medicine formula granule.
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