CN114848600A - Fresh motherwort traditional Chinese medicine formula particle and preparation method thereof - Google Patents
Fresh motherwort traditional Chinese medicine formula particle and preparation method thereof Download PDFInfo
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- CN114848600A CN114848600A CN202210668884.2A CN202210668884A CN114848600A CN 114848600 A CN114848600 A CN 114848600A CN 202210668884 A CN202210668884 A CN 202210668884A CN 114848600 A CN114848600 A CN 114848600A
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- motherwort
- fresh motherwort
- preparation
- decoction
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- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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Abstract
The invention provides a preparation method of fresh motherwort formula granules, which comprises the following steps: obtaining fresh motherwort herb decoction pieces; mixing the fresh motherwort decoction pieces with boiling water, and decocting to prepare a fresh motherwort extracting solution; filtering the fresh motherwort extract, concentrating the filtrate, and preparing fresh motherwort clear paste; mixing the fresh herba Leonuri fluid extract with adjuvants, drying, and granulating. The preparation method has high yield and low cost, and the prepared fresh herba Leonuri granule has high content of effective components and high safety.
Description
Technical Field
The invention relates to the field of traditional Chinese medicine preparations, in particular to a fresh motherwort traditional Chinese medicine formula particle and a preparation method thereof.
Background
Fresh motherwort is a fresh overground part of Leonurus japonicus Houtt. of the family labiatae, is collected from the young seedling stage to the early summer flower stage in spring, is slightly cold in nature, bitter and pungent in taste, has the effects of promoting blood circulation to regulate menstruation, inducing diuresis to reduce edema and clearing heat and toxic materials, is commonly used for treating irregular menstruation, dysmenorrheal amenorrhea, incomplete lochiorrhea, edema and oliguria, sore and ulcer and sore pyogenic infections and the like in clinic, is known as a gynecological essential drug, and is a fresh medicine commonly used in traditional Chinese medicine.
The main chemical components of fresh motherwort include alkaloids, flavonoids, terpenes, phenylethanoid glycosides, volatile oils and the like, wherein the alkaloids and the flavonoids are substances which mainly exert the drug effect. The research shows that the stachydrine and the leonurine have obvious pharmacological activity on the uterus and the heart, the motherwort water-soluble alkaloid and the total flavone have an exciting effect on the isolated uterus of mice, and the fat-soluble alkaloid has an inhibiting effect on the isolated uterus. In addition, the alkaloid and flavone components in herba Leonuri can also effectively inhibit ischemia injury of myocardial tissue caused by Isoproterenol (ISO).
Currently, common motherwort preparations such as motherwort capsules, motherwort fluid extracts, motherwort tablets and the like are clinically used, the used medicinal materials are dry motherwort, but the dry motherwort products and the fresh motherwort products have the advantages ofThe two cannot be mixed in a large difference. The content of motherwort in the edition of new and revised contents compilation of the year 2000 (part one) of the Chinese pharmacopoeia is determined as follows: the product contains alkaloid (stachydrine hydrochloride C) calculated on dry product 7 H 13 NO 2 HCl), the dry product should not be less than 0.40%, the fresh product should not be less than 1.0%. Therefore, the content of the stachydrine hydrochloride in the fresh motherwort is 2 times of that of the dry product. Meanwhile, researches show that after fresh motherwort is dried, various components such as alkaloids (stachydrine and leonurine) and flavones (rutin, quercetin, apigenin and genkwanin) are changed in different degrees, wherein the content of the stachydrine hydrochloride and the leonurine hydrochloride is reduced by about one time, the content of the rutin, the quercetin and the genkwanin is also reduced, and the content of the apigenin is increased after the fresh motherwort is dried. In addition, the fresh motherwort and the dry motherwort are different in harvesting period, and the fresh motherwort is harvested from the seedling stage in spring to the early stage of early summer flower; the dried product is harvested in summer when stem and leaf flourish, flower do not bloom or are primarily bloomed, and the total alkaloid content of the herba Leonuri gradually decreases from seedling stage to flowering to mature fruiting in the whole growth process of herba Leonuri. Meanwhile, under the same dosage, the pharmacodynamic effects of the motherwort in different growth periods are different, and the contractile effects of the motherwort in different growth periods on isolated uterus of rats are in the early stage of fresh flowers from strong to weak>Bud phase>In the full-bloom stage. Therefore, the fresh motherwort is greatly different from the dry motherwort.
The traditional method prepares the fresh motherwort powder by the steps of cleaning, chopping, juicing, concentrating under reduced pressure and freeze drying, but the obtained juice is less, the yield is low after squeezing, the product cost is increased, and the unqualified microorganism indexes are easily caused, so that the safety of medication is difficult to ensure.
The other traditional method is to crush fresh motherwort, pulp, squeeze juice, take juice, add proper amount of water into residue, mix well, squeeze juice, repeat 2-3 times, combine juice, filter, concentrate, spray dry. Although the preparation method can cause the components to flow out by breaking cell walls and solves the problem of administration of fresh motherwort to a certain extent, the finally prepared fresh motherwort particles still have the problems of low content of various effective components and low transfer rate.
Disclosure of Invention
Therefore, there is a need for a method for preparing fresh motherwort herb formula particles, which has high yield, low cost, high content of active ingredients of the prepared fresh motherwort herb formula particles and high safety.
The invention is realized by the following technical scheme.
A method for preparing fresh herba Leonuri granule comprises the following steps:
obtaining fresh motherwort herb decoction pieces;
mixing the fresh motherwort decoction pieces with boiling water, and decocting to prepare a fresh motherwort extracting solution;
filtering the fresh motherwort extract, concentrating the filtrate, and preparing fresh motherwort clear paste;
mixing the fresh herba Leonuri fluid extract with adjuvants, drying, and granulating.
In one embodiment, the number of times of decoction is 1 to 3.
In one embodiment, the mass ratio of the fresh motherwort decoction pieces to the boiling water in each decoction is independently selected from 1 (5-18).
In one embodiment, the time for each decoction is independently selected from 0.5h to 2 h.
In one embodiment, the preparation of the fresh motherwort decoction pieces comprises the following steps:
removing impurities from fresh herba Leonuri plant, cleaning, removing surface water, cutting into segments, and waiting for material preparation;
wherein the specification of the cutting segment is 0.5 cm-2 cm.
In one embodiment, the time for loading is within 4 hours.
In one embodiment, the conditions of concentration include: concentrating under reduced pressure at 40-80 ℃ to obtain clear paste with the relative density of 1.02-1.20.
In one embodiment, the method of drying is selected from one or both of freeze drying and spray drying.
In one embodiment, the adjuvant is selected from one or more of maltodextrin, dextrin, starch, lactose, silicon dioxide and magnesium stearate.
The invention also provides the fresh motherwort formula particle prepared by the preparation method of the fresh motherwort formula particle.
Compared with the prior art, the preparation method of the fresh motherwort formula particle has the following beneficial effects:
the preparation method of the fresh motherwort prescription granule adopts a decoction extraction process and combines a concentration process, so that the content of active ingredients of the fresh motherwort is obviously improved, the active ingredients comprise leonurine hydrochloride, stachydrine hydrochloride and the like, the yield can be effectively improved, and the cost is reduced. Meanwhile, the invention takes water as solvent for extraction in the decocting process, the usage is safer, the traditional Chinese medicine theory is met, and the content and the yield of the effective components can be further improved by the boiling water feeding process. In addition, the step of water decoction also greatly improves the microorganism qualification probability of the obtained fresh motherwort extract and ensures the safety of the clinical medication of the fresh medicine.
Furthermore, the fresh motherwort Chinese medicine formula particle prepared by the preparation method of the fresh motherwort formula particle can not only keep the original curative effect and characteristics of decoction, but also be convenient to carry, take, store and dose a little.
Drawings
Fig. 1 is a schematic view of a preparation process of a fresh motherwort formula granule provided by the present invention;
FIG. 2 is a control profile provided by the present invention; wherein, peak 1 represents neochlorogenic acid, peak 3 represents chlorogenic acid, peak 6 represents leonurine hydrochloride, and peak 8 represents rutin.
Detailed Description
To facilitate an understanding of the invention, the invention will now be described more fully with reference to the accompanying drawings. Preferred embodiments of the present invention are shown in the drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.
Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or to implicitly indicate the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of the invention, "a plurality" means at least two, e.g., two, three, etc., unless explicitly specified otherwise. In the description of the present invention, "a plurality" means at least one, e.g., one, two, etc., unless specifically limited otherwise.
The words "preferably," "more preferably," and the like, in the present disclosure mean embodiments of the disclosure that may, in some instances, provide certain benefits. However, other embodiments may be preferred, under the same or other circumstances. Furthermore, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful, nor is it intended to exclude other embodiments from the scope of the invention.
When a range of values is disclosed herein, the range is considered to be continuous and includes both the minimum and maximum values of the range, as well as each value between such minimum and maximum values. Further, when a range refers to an integer, each integer between the minimum and maximum values of the range is included. Further, when multiple range-describing features or characteristics are provided, the ranges may be combined. In other words, unless otherwise indicated, all ranges disclosed herein are to be understood to encompass any and all subranges subsumed therein.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
Referring to fig. 1, the present invention provides a method for preparing fresh motherwort formula granules, comprising the following steps:
obtaining fresh motherwort herb decoction pieces;
mixing the fresh motherwort decoction pieces with boiling water, and decocting to obtain fresh motherwort extract;
filtering the fresh herba Leonuri extractive solution, concentrating the filtrate, and preparing fresh herba Leonuri fluid extract;
mixing the fresh herba Leonuri fluid extract with adjuvants, drying, and granulating.
The Chinese medicinal formula particle is a particle prepared by carrying out water extraction, concentration, drying and granulation on single Chinese medicinal decoction pieces, is taken by patients after being prepared according to a Chinese medicinal clinical prescription under the guidance of the theory of traditional Chinese medicine, has the advantages of consistent clinical curative effect with the preservation of the corresponding decoction pieces, no need of decoction, small dosage, convenient carrying and the like, and the fresh motherwort is prepared into the fresh motherwort formula particle, so that the characteristics of fresh medicaments are kept, the effective components can be extracted more fully, the loss can be reduced, and the production cost is reduced.
The boiling water feeding process can obviously improve the content of effective components, and simultaneously can effectively improve the yield and reduce the cost.
In a specific example, the number of times of decoction is 1 to 3 times.
In a specific example, the mass ratio of the fresh motherwort decoction pieces to the boiling water in each decoction is respectively and independently selected from 1 (5-18).
It is understood that, in the present invention, the mass ratio of the fresh motherwort decoction pieces to the boiling water in each decoction includes, but is not limited to, 1:5, 1:6, 1:7, 1:8, 1:9, 1:10, 1:11, 1:12, 1:14, 1:16, and 1: 18.
In a specific example, the time for each decoction is independently selected from 0.5h to 2 h.
It is understood that in the present invention, the time of each decoction includes, but is not limited to, 0.5h, 0.6h, 0.7h, 0.8h, 0.9h, 1.0h, 1.1h, 1.2h, 1.5h, 2 h.
In a specific example, the preparation of the fresh motherwort decoction pieces comprises the following steps:
removing impurities from fresh herba Leonuri plant, cleaning, removing surface water, cutting into segments, and waiting for material preparation;
wherein the specification of the cutting segment is 0.5 cm-2 cm.
It is understood that the size of the cut segment includes, but is not limited to, 0.5cm, 0.6cm, 0.7cm, 0.8cm, 0.9cm, 1cm, 1.2cm, 1.4cm, 1.6cm, 1.8cm, 2 cm.
It is understood that in the present invention, waiting refers to waiting for the next processing.
In one specific example, the material is prepared by placing the cut material in air at room temperature.
In one particular example, the time to feed is within 4 hours. It is understood that the time to feed includes, but is not limited to, 0h, 1h, 2h, 3h, 4 h.
The fresh motherwort decoction pieces have obvious variation trend in the material preparation process, and the material preparation time is controlled within 4 hours in order to control the preservation of the full components in the fresh motherwort formula particles as far as possible.
In one specific example, the conditions of concentration include: concentrating under reduced pressure at 40-80 ℃ to obtain clear paste with the relative density of 1.02-1.20.
The invention adopts vacuum low-temperature concentration in the concentration process, reduces the heating time of the heat-sensitive components, further effectively avoids the inactivation of the components and improves the medicinal value of the product.
In a specific example, the method of drying is selected from one or both of freeze drying and spray drying.
In a particular example, the adjunct is selected from maltodextrins.
In one particular example, the granulation is dry granulation.
Preferably, the preparation method of the fresh motherwort formula particle comprises the following steps:
obtaining fresh motherwort herb decoction pieces;
mixing fresh motherwort decoction pieces with boiling water, and decocting for 1-3 times to prepare a fresh motherwort extracting solution; wherein, in each decoction, the mass ratio of the fresh motherwort decoction pieces to the boiling water is respectively and independently selected from 1 (5-18); and/or the time for each decoction is independently selected from 0.5h to 2 h;
filtering the fresh motherwort extract, and concentrating the filtrate at 40-80 ℃ under reduced pressure to obtain clear paste with the relative density of 1.02-1.20 to prepare the fresh motherwort clear paste;
mixing the fresh herba Leonuri fluid extract with adjuvants, drying, and granulating.
In a more specific example, the method for preparing the fresh motherwort formula comprises the following steps:
pretreatment: removing impurities from fresh herba Leonuri plant, cleaning, and cutting to obtain fresh herba Leonuri decoction pieces; wherein the specification of the cutting section is 0.5 cm-2 cm;
extraction: taking fresh motherwort decoction pieces, adding boiling water, decocting for 1-3 times, adding 5-18 times of water each time, decocting for 0.5-2 hours, and mixing to obtain a fresh motherwort extracting solution;
concentration: filtering the extracting solution, and concentrating the filtrate at 40-80 ℃ under reduced pressure to obtain clear paste with the relative density of 1.02-1.20 to obtain fresh motherwort clear paste;
and (3) drying: dissolving the fresh herba Leonuri fluid extract with adjuvant, and drying to obtain fresh herba Leonuri dry extract powder;
and (3) granulating: taking the fresh motherwort dry paste powder, adding a proper amount of auxiliary materials, and performing dry granulation to obtain the fresh motherwort formula granules.
The invention also provides the fresh motherwort formula particle prepared by the preparation method of the fresh motherwort formula particle.
The following are specific examples, and the raw materials used in the examples are all commercially available products unless otherwise specified.
Example 1
The embodiment provides a preparation method of fresh motherwort particles, which comprises the following steps:
a. removing impurities from fresh herba Leonuri, cleaning, draining surface water, and cutting into 1cm segments;
b. decocting fresh herba Leonuri with water twice, adding 10 times of water, heating to boil, adding decoction pieces, and decocting for 1.0 hr; adding water with the amount of 8 times of the batch size for the second time, heating to boil, decocting for 0.5h, mixing decoctions, and filtering (sieving with a 120-400-mesh sieve) to obtain fresh herba Leonuri extractive solution;
c. taking fresh motherwort extract, and concentrating the fresh motherwort extract at 40-80 ℃ under reduced pressure to obtain clear paste with the relative density of 1.02-1.20 to obtain 'fresh motherwort clear paste';
d. taking the fresh motherwort clear paste, filtering (sieving by a 120-250 mesh sieve), adding a proper amount of auxiliary materials, dissolving, and performing spray drying to obtain fresh motherwort dry paste powder;
e. taking the fresh motherwort dry extract powder, adding a proper amount of auxiliary materials, granulating by a dry method, and packaging to obtain the fresh motherwort particles.
Example 2
The embodiment provides a preparation method of fresh motherwort particles, which comprises the following steps:
a. removing impurities from fresh herba Leonuri, cleaning, draining surface water, and cutting into 1cm segments;
b. decocting fresh herba Leonuri with water twice, adding 10 times of water, heating to boil, adding decoction pieces, and decocting for 1.0 hr; adding water with the amount of 8 times of the batch size for the second time, heating to boil, decocting for 0.5h, mixing decoctions, and filtering (sieving with a 120-400-mesh sieve) to obtain fresh herba Leonuri extractive solution;
c. taking fresh motherwort extract, and concentrating the fresh motherwort extract at 40-80 ℃ under reduced pressure to obtain clear paste with the relative density of 1.02-1.20 to obtain 'fresh motherwort clear paste';
d. taking the fresh motherwort herb clear paste, filtering (sieving by a 120-250 mesh sieve), adding a proper amount of auxiliary materials, dissolving, and freeze-drying to obtain fresh motherwort herb dry paste powder;
e. taking fresh motherwort dry paste powder, adding a proper amount of auxiliary materials, performing dry granulation, and packaging to obtain fresh motherwort granules.
Example 3
The embodiment provides a preparation method of fresh motherwort particles, which comprises the following steps:
a. removing impurities from fresh herba Leonuri, cleaning, draining surface water, and cutting into 1cm segments;
b. adding 18 times of water into cut fresh motherwort, heating to boil, adding decoction pieces, decocting for 1.0h, and filtering (with 120-400 mesh sieve) to obtain fresh motherwort extract;
c. taking fresh motherwort extract, and concentrating the fresh motherwort extract at 40-80 ℃ under reduced pressure to obtain clear paste with the relative density of 1.02-1.20 to obtain 'fresh motherwort clear paste';
d. taking the fresh motherwort herb clear paste, filtering (sieving by a 120-250 mesh sieve), adding a proper amount of maltodextrin, dissolving, and performing spray drying to obtain fresh motherwort herb dry paste powder;
e. taking fresh motherwort dry paste powder, adding a proper amount of maltodextrin, performing dry granulation, and packaging to obtain fresh motherwort granules.
Example 4
The embodiment provides a preparation method of fresh motherwort particles, which comprises the following steps:
a. removing impurities from fresh herba Leonuri, cleaning, draining surface water, and cutting into 2cm segments;
b. decocting fresh herba Leonuri with water twice, adding 9 times of water, heating to boil, adding decoction pieces, and decocting for 1.0 hr; adding water with the amount 7 times of the batch size for the second time, heating to boil, decocting for 0.5h, mixing decoctions, and filtering (sieving with 120-400 mesh sieve) to obtain fresh herba Leonuri extractive solution;
c. taking fresh motherwort extract, and concentrating the fresh motherwort extract at 40-80 ℃ under reduced pressure to obtain clear paste with the relative density of 1.02-1.20 to obtain 'fresh motherwort clear paste';
d. taking the fresh motherwort herb clear paste, filtering (sieving by a 120-250 mesh sieve), adding a proper amount of maltodextrin, dissolving, and performing spray drying to obtain fresh motherwort herb dry paste powder;
e. taking fresh motherwort dry paste powder, adding a proper amount of maltodextrin, performing dry granulation, and packaging to obtain fresh motherwort granules.
Example 5
The embodiment provides a preparation method of fresh motherwort particles, which comprises the following steps:
a. removing impurities from fresh herba Leonuri, cleaning, draining surface water, and cutting into 1cm segments;
b. decocting fresh herba Leonuri with water twice, adding 12 times of water, heating to boil, adding decoction pieces, and decocting for 1.0 hr; adding 10 times of water for the second time, heating to boil, decocting for 1.0h, mixing decoctions, and filtering (with 120-400 mesh sieve) to obtain fresh herba Leonuri extractive solution;
c. taking fresh motherwort extract, and concentrating the fresh motherwort extract at 40-80 ℃ under reduced pressure to obtain clear paste with the relative density of 1.02-1.20 to obtain 'fresh motherwort clear paste';
d. taking the fresh motherwort herb clear paste, filtering (sieving by a 120-250 mesh sieve), adding a proper amount of maltodextrin, dissolving, and performing spray drying to obtain fresh motherwort herb dry paste powder;
e. taking fresh motherwort dry paste powder, adding a proper amount of maltodextrin, performing dry granulation, and packaging to obtain fresh motherwort granules.
Comparative example 1
The comparative example provides a preparation method of dry motherwort particles, which comprises the following specific steps:
a. taking dry motherwort decoction pieces, removing impurities, and cutting into sections of 1 cm;
b. decocting segmented herba Leonuri with water twice, adding decoction pieces, adding 9 times of water, heating to boil, and decocting for 1.0 hr; adding water with the amount 7 times of the batch size for the second time, heating to boil, decocting for 0.5h, mixing decoctions, and filtering (sieving with a 120-400 mesh sieve) to obtain herba Leonuri extractive solution;
c. taking motherwort herb extract, and concentrating the motherwort herb extract under reduced pressure at 40-80 ℃ to obtain a clear paste with the relative density of 1.02-1.20 to obtain a motherwort herb clear paste;
d. taking the motherwort herb clear paste, filtering (sieving by a 120-250 mesh sieve), adding a proper amount of maltodextrin, dissolving, and performing spray drying to obtain motherwort herb dry paste powder;
e. taking the motherwort dry paste powder, adding a proper amount of maltodextrin, granulating by a dry method, and packaging to obtain the motherwort particles.
Comparative example 2
The comparative example provides a preparation method of fresh motherwort (juice) formula particles, which comprises the following steps:
a. removing impurities from fresh herba Leonuri, cleaning, draining surface water, and cutting into 1cm segments;
b. crushing the cut fresh motherwort by a coarse crusher, pulping, juicing, adding a proper amount of water into residues, uniformly mixing, juicing, repeating for 2-3 times, combining the juices, and filtering to obtain fresh motherwort juice;
c. taking fresh motherwort juice, and concentrating under reduced pressure at 55-65 ℃ until the relative density is 1.02 to obtain fresh motherwort concentrated juice;
d. taking concentrated fresh motherwort juice, filtering (sieving by a 120-250 mesh sieve), adding a proper amount of maltodextrin, dissolving, and performing spray drying to obtain motherwort dry paste powder;
e. taking the motherwort dry paste powder, adding a proper amount of maltodextrin, performing dry granulation, and packaging to obtain the fresh motherwort (juice) formula granules.
Comparative example 3
The comparative example provides a preparation method of fresh motherwort formula granules, which comprises the following steps:
a. removing impurities from fresh herba Leonuri, cleaning, draining surface water, and cutting into 1cm segments;
b. decocting fresh herba Leonuri with water at normal temperature twice, adding water 10 times of the decoction pieces, heating to boil, and decocting for 1.0 hr; adding water (normal temperature) with the amount of 8 times of the batch size for the second time, heating to boil, decocting for 0.5h, mixing decoctions, and filtering (sieving with 120-400 mesh sieve) to obtain fresh herba Leonuri extractive solution;
c. taking fresh motherwort extract, and concentrating the fresh motherwort extract at 40-80 ℃ under reduced pressure to obtain clear paste with the relative density of 1.02-1.20 to obtain 'fresh motherwort clear paste';
d. taking the fresh motherwort herb clear paste, filtering (sieving by a 120-250 mesh sieve), adding a proper amount of maltodextrin, dissolving, and performing spray drying to obtain fresh motherwort herb dry paste powder;
e. taking fresh motherwort dry paste powder, adding a proper amount of maltodextrin, performing dry granulation, and packaging to obtain fresh motherwort granules.
Comparative example 4
The comparative example provides a method for investigating the material waiting time of fresh motherwort decoction pieces, which comprises the following steps:
a. removing impurities from fresh herba Leonuri, cleaning, draining surface water, and cutting into 1cm segments;
b. taking the cut pieces, and respectively placing for 0, 2, 4 and 6 hours at normal temperature to obtain the fresh motherwort herb pieces.
Effect testing experiment
The extraction rate, the index component content, the characteristic spectrum and the microorganism condition of the motherwort herb granules in the examples 1 to 5 and the comparative examples 1 to 3, and the index component content and the characteristic spectrum of the fresh motherwort herb decoction pieces in the comparative example 4 are measured.
The method for measuring the cream yield comprises the following steps:
the method is determined according to the method under the item of the determination method of water-soluble extracts (China pharmacopoeia 2020 edition general rule 2201). The specific method comprises precisely measuring 25mL of filtrate, placing in an evaporating dish M1 dried to constant weight, drying in water bath, drying at 105 deg.C for 3 hr, cooling in a desiccator for 30min, and rapidly and precisely weighing M2. The feeding amount of the decoction pieces is M, the volume of the extracting solution is V, and the paste yield calculation formula is as follows:
the measuring method of the content of the index components comprises the following steps:
leonurine hydrochloride: the determination is carried out by high performance liquid chromatography (China pharmacopoeia 2020 edition general rule 0512).
Octadecylsilane chemically bonded silica is used as a filler in chromatographic conditions and system applicability tests; taking acetonitrile-0.4% sodium octane sulfonate 0.1% phosphoric acid solution (24:76) as a mobile phase; the detection wavelength was 277 nm. The number of theoretical plates is not less than 6000 calculated according to leonurine hydrochloride peak.
Stachydrine hydrochloride: the determination is carried out by high performance liquid chromatography (China pharmacopoeia 2020 edition general rule 0512).
Chromatographic conditions and system applicability tests adopt propyl amide bonded silica gel as a filler; acetonitrile-0.2% glacial acetic acid solution (80: 20) is used as a mobile phase; detection was by evaporative light scattering detector. The number of theoretical plates is not less than 6000 calculated according to the stachydrine hydrochloride peak.
The measurement method of the characteristic spectrum comprises the following steps:
the determination is carried out by high performance liquid chromatography (China pharmacopoeia 2020 edition general rule 0512).
Octadecylsilane chemically bonded silica is used as a filler (the column length is 100mm, the inner diameter is 2.1mm, and the particle size is 1.8 mu m); acetonitrile is used as a mobile phase A, 0.1% phosphoric acid aqueous solution is used as a mobile phase B, and the gradient elution procedure is as follows: 0-11 min, 3% → 10% (A), 97% → 90% (B); 11-15 min, 10% → 11% (A), 90% → 89% (B); 15-22 min, 11% → 12% (A), 89% → 88% (B); 22-28 min, 12% → 16% (A), 88% → 84% (B); 28-30 min, 16% → 20% (A), 84% → 80% (B); 30-34 min, 20% → 22% (A), 80% → 78% (B); 34-40 min, 22% → 60% (A), 78% → 40% (B); 40-41 min, 60% → 3% (A), 40% → 97% (B); 41-50 min, 3% → 97% (A), 97% → 3% (B); the flow rate was 0.25mL per minute; the column temperature is 30 ℃; the detection wavelength was 277 nm.
8 characteristic peaks are presented in the chromatogram of the test sample, wherein 4 peaks respectively correspond to the retention time of the reference substance peak of the corresponding reference substance; the peak corresponding to the chlorogenic acid reference peak is the S1 peak, and the relative retention time of the characteristic peak 2 and the S1 peak is calculated to be within ± 10% of the specified value: 0.90 (peak 2); the peak corresponding to the leonurine hydrochloride reference peak is the S2 peak, the relative retention times of the characteristic peaks 4, 5, 7 and S2 peak are calculated, and should be within ± 10% of the specified values: 0.94 (peak 4), 0.97 (peak 5), 1.19 (peak 7). The reference characteristic spectrum of fresh herba Leonuri is shown in FIG. 2.
Method for measuring microbiological conditions: reference to non-sterile product microbial limit check: the method measurement under the item of the microorganism counting method and the control bacteria inspection method (1105-1106 is the Chinese pharmacopoeia 2020 published by the Specification).
The preparation methods and parameters, the cream yield, the content of the index components, the peak areas of the characteristic patterns and the results of the microbial condition examination of examples 1 to 5 and comparative examples 1 to 3 are shown in table 1, wherein the ratio of the sampling amount of the characteristic patterns of example 1 to comparative example 1 is 1: 2.
TABLE 1
From examples 1 to 5, it can be seen that the effective components (leonurine hydrochloride and stachydrine hydrochloride) of the fresh motherwort herb granules prepared by the method have high content, and the microbial detection is qualified.
Compared with the examples 2-5, the difference of the example 1 is the difference of parameters such as the specification of decoction pieces, the decoction times, the time, the amount of water added and the like, and the parameters have certain influence on the content of the effective components.
Comparative example 1 is directly prepared by using dried motherwort decoction pieces, and it can be seen from comparative example 1 that the fresh motherwort particles in example 1 have larger differences from motherwort formula particles in cream yield, index component content and characteristic spectrum, the cream yield differs by about 1.5 times, the leonurine hydrochloride and stachydrine hydrochloride differ by about 2-3 times, the characteristic spectrum also shows obvious differences, when the sampling amount of the dried motherwort particles is doubled, the peak areas of neochlorogenic acid, peak 2, chlorogenic acid, peak 5, peak 7 and rutin in the characteristic spectrum are still obviously lower than those of the fresh motherwort particles except for peak 4 and leonurine hydrochloride, and the difference of the maximum rutin peak area is 3.5 times, which indicates that the fresh motherwort particles prepared by the method are obviously different from the motherwort formula particles in the current market.
Compared with the embodiment 1, the comparative example 2 adopts the processes of adding cold water for juicing and concentrating at 55-65 ℃. As can be seen from Table 1, the fresh motherwort herb granules prepared by the water extraction process in example 1 have significantly higher contents of leonurine hydrochloride and stachydrine hydrochloride than those of the granules prepared by juicing, the peak areas of the characteristic patterns of the water extraction process are larger than those of the juicing, and in addition, the total number of aerobic bacterial colonies and the microbial indexes of mold and yeast are beyond the specified limits due to the low temperature of the whole preparation process and the lack of an effective sterilization technology in comparative example 3. The invention can extract the effective components of fresh motherwort to the maximum extent, thereby ensuring the clinical efficacy of the fresh motherwort, and simultaneously, the invention can strictly control the microorganism of the product, solve the problem of unqualified microorganism of the fresh medicine preparation and ensure the safety of the clinical medication of the fresh medicine.
In contrast to example 1, comparative example 3 was cold water extracted in a conventional manner. As can be seen from table 1, the extraction rate and the index component content of the fresh motherwort particles prepared by the boiling water extraction process in example 1 are obviously higher than those of cold water extraction, the peak areas of the characteristic spectrum extracted by the boiling water are also improved to different degrees compared with those of the cold water extraction, and the total peak area is improved by more than 15%, which indicates that the content of each component in the fresh motherwort particles can be obviously improved by adopting the boiling water extraction method.
The measurement results of the index component contents and the peak areas of the characteristic maps of the fresh motherwort herb decoction pieces in the comparative example 4 are shown in table 2.
TABLE 2
As can be seen from Table 2, the fresh motherwort herb decoction pieces have obvious trend of change in the material preparation process, the components of leonurine hydrochloride and stachydrine hydrochloride are increased, and the peak areas of peak 7 and rutin are obviously reduced. In order to control the preservation of the full components in the fresh motherwort formula particles as much as possible, the waiting time should be controlled within 4 h.
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.
Claims (10)
1. A preparation method of fresh motherwort formula granules is characterized by comprising the following steps:
obtaining fresh motherwort herb decoction pieces;
mixing the fresh motherwort decoction pieces with boiling water, and decocting to prepare a fresh motherwort extracting solution;
filtering the fresh motherwort extract, concentrating the filtrate, and preparing fresh motherwort clear paste;
mixing the fresh herba Leonuri fluid extract with adjuvants, drying, and granulating.
2. The method for preparing fresh motherwort formulation granule as claimed in claim 1, wherein the number of times of decoction is 1 to 3.
3. The method for preparing fresh motherwort prescription granule as claimed in claim 2, wherein the mass ratio of fresh motherwort decoction pieces to boiling water in each decoction is selected from 1 (5-18) respectively.
4. The method for preparing fresh motherwort formulation granule as claimed in claim 2, wherein the time for each decoction is independently selected from 0.5h to 2 h.
5. The method for preparing fresh motherwort prescription granule as claimed in claim 1, wherein the preparation of fresh motherwort decoction pieces includes the following steps:
removing impurities from fresh herba Leonuri plant, cleaning, removing surface water, cutting into segments, and waiting for material preparation;
wherein the specification of the cutting segment is 0.5 cm-2 cm.
6. The method for preparing fresh motherwort formulation granule as claimed in claim 5, wherein the time for filling is within 4 hours.
7. The method of claim 1, wherein the concentrating conditions comprise: concentrating under reduced pressure at 40-80 ℃ to obtain clear paste with the relative density of 1.02-1.20.
8. The method of claim 1, wherein the fresh motherwort formulation is dried by one or two of freeze drying and spray drying.
9. The method for preparing fresh motherwort formulation granule according to claim 1, wherein the auxiliary material is selected from one or more of maltodextrin, dextrin, starch, lactose, silicon dioxide and magnesium stearate.
10. Fresh motherwort prescription granule prepared by the method for preparing fresh motherwort prescription granule as claimed in any one of claims 1 to 9.
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| CN1456257A (en) * | 2003-02-20 | 2003-11-19 | 毛友昌 | Fresh motherwort particle preparing method |
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| CN103933115A (en) * | 2014-04-01 | 2014-07-23 | 回音必集团安徽制药有限公司 | Motherwort granule preparation technology |
| RU2589507C1 (en) * | 2015-03-20 | 2016-07-10 | Открытое Акционерное Общество "Татхимфармпрепараты" | Agent based on dry motherwort extract and method for production thereof |
| CN110123907A (en) * | 2019-06-21 | 2019-08-16 | 广东一方制药有限公司 | A kind of flavour amino acid granule and preparation method thereof |
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| CN1456257A (en) * | 2003-02-20 | 2003-11-19 | 毛友昌 | Fresh motherwort particle preparing method |
| CN102058661A (en) * | 2010-01-20 | 2011-05-18 | 浙江大德药业集团有限公司 | Method for preparing fresh motherwort preparation |
| CN103933115A (en) * | 2014-04-01 | 2014-07-23 | 回音必集团安徽制药有限公司 | Motherwort granule preparation technology |
| RU2589507C1 (en) * | 2015-03-20 | 2016-07-10 | Открытое Акционерное Общество "Татхимфармпрепараты" | Agent based on dry motherwort extract and method for production thereof |
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