CN115025158A - Extract of Chinese medicinal herb powder and application thereof - Google Patents

Extract of Chinese medicinal herb powder and application thereof Download PDF

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CN115025158A
CN115025158A CN202210722755.7A CN202210722755A CN115025158A CN 115025158 A CN115025158 A CN 115025158A CN 202210722755 A CN202210722755 A CN 202210722755A CN 115025158 A CN115025158 A CN 115025158A
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preparation
compared
isodon
chinese medicinal
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杨晓阳
侯金才
李丹
马腾
郭勇
邹妍
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Jingjinji Lianchuang Drug Research Beijing Co ltd
Shenwei Pharmaceutical Group Co Ltd
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Shenwei Pharmaceutical Group Co Ltd
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Abstract

The invention provides a preparation method of an extract of kuaisan, which comprises the following steps: decocting each decoction piece in the prescription with 8-12 times of water for 2-3 times, 1-3 hours each time; filtering, mixing, and concentrating under reduced pressure. The inventive extract has the functions of increasing the number of red blood cells, increasing the concentration of hemoglobin, and reducing the liver index.

Description

Extract of Chinese medicinal herb powder and application thereof
Technical Field
The invention belongs to the field of traditional Chinese medicines, and particularly relates to a kuaisan water extract and application thereof.
Background
The different-effect powder is from infant medicine syndrome DC formula of Song Dynasty B, the original prescription is paediatric medicine, and the clinical practice shows that the different-effect powder has very obvious curative effect on treating anemia caused by chronic diseases. The prescription comprises five traditional Chinese medicines of ginseng, bran-fried bighead atractylodes rhizome, poria cocos, honey-fried licorice root and dried orange peel.
The safe pharmacological result of the mouse shows that all doses of the Chinese medicinal composition have no obvious influence on the coordination capability of the mouse body, and the Chinese medicinal composition is converted into the human clinical dose of 50.83-203.21g crude drugs/d and supports the clinical dose of 100 g/d.
The toxicological study results showed that the non-toxic response dose (NOAEL) for a single dose toxicity test was about 56.7 times the daily intended dose in humans. Multiple dose toxicity test the non-toxic response dose (NOAEL) was about 42.6 times the daily dose intended for human clinical use.
However, the powder for treating the abnormal menstruation is a traditional Chinese medicine, has complex chemical components, contains various effective components, ineffective components and toxic components. The effective components of the Chinese medicinal composition are extracted, and further separated and purified, so that the inherent quality and the clinical treatment effect of the Chinese medicinal composition are improved, and the effect of the Chinese medicinal composition on the abnormal menstruation is exerted to the maximum extent.
Chinese patent 201410359462.2 discloses: a method for preparing Chinese medicinal extract and the prepared Chinese medicinal extract are provided. The preparation method comprises the following steps: extracting volatile oil from cortex Cinnamomi, and clathrating the volatile oil with beta-cyclodextrin; extracting the cinnamon residues and other medicinal materials by using an ethanol solution with the volume percentage concentration of 30-80%; refining the extract with macroporous adsorbent resin, drying to obtain dry extract powder, adding the volatile oil clathrate, and mixing. The content of active substances and pharmacological action of the traditional Chinese medicine extract are obviously improved.
Chinese patent 201410772690.2 discloses: a method for preparing a Chinese medicinal extract comprises: extracting volatile oil from ramulus Cinnamomi and cortex moutan, and clathrating the volatile oil with beta-cyclodextrin; extracting ramulus Cinnamomi and cortex moutan residue with 70-90% ethanol solution; extracting the residues with water, adding ethanol extract, drying to obtain dry extract powder, adding the volatile oil clathrate, and mixing. The pharmacodynamic action of the cassia twig and the tuckahoe is obviously improved, and the prepared traditional Chinese medicine extract is obviously improved in treating gynecological diseases, especially gynecological chronic pelvic inflammation.
In the prior art, research on an extraction method of the isogonyao is less, and a preparation method of the isogonyao extract is urgently needed to be researched and developed, so that the isogonyao extract is better applied to clinic and the drug effect is improved.
Disclosure of Invention
In order to solve the problems, the invention provides an isogonellae water extract and application thereof.
In the invention, the decoction pieces refer to the traditional Chinese medicine for prescription prepared by processing the traditional Chinese medicine according to the requirement, or the traditional Chinese medicine which can be directly used in the clinical traditional Chinese medicine.
In the present invention, "concentration under reduced pressure" is to reduce the boiling temperature of water by vacuum pumping to evaporate and dry the water.
In the invention, the extract refers to a powdery or pasty preparation prepared by leaching (or decocting) effective components of medicinal materials by using a proper solvent, concentrating and adjusting the concentration to a specified standard.
In the present invention, "chronic anemia" is also referred to as anemia of chronic disease, and means hematopoietic disorders in a human body mainly caused by other diseases.
In one aspect, the invention provides a preparation method of an extract of Isogonella prokinensis.
The preparation method comprises the following steps: decocting each decoction piece in the prescription with 8-12 times of water for 2-3 times, 1-3 hours each time; filtering, mixing, and concentrating under reduced pressure.
The extract of the Chinese medicinal herbs of the rhubarb and the Indian skullcap roots is an extract with a relative density of 1.10-1.20.
The extract comprises the following components (mg/g):
Figure BDA0003702516260000021
the prescription is ginseng: stir-frying rhizoma atractylodis macrocephalae with bran: tuckahoe, poria cocos: dried orange peel: 1, honey-fried licorice root: 1: 1: 1: 1.
preferably, the preparation method comprises the following steps: decocting each decoction piece in the prescription with 10-12 times of water for 2 times, 1-3 hours each time; filtering, mixing, and concentrating under reduced pressure.
Preferably, the preparation method comprises the following steps: decocting each decoction piece in the prescription with 12 times of water for 2 times, each time for 2.5 hours; filtering, mixing, and concentrating under reduced pressure.
The reduced pressure concentration is carried out at 60-80 deg.C and-0.06-0.1 MPa.
Preferably, the extract comprises the following components (mg/g):
Figure BDA0003702516260000022
in another aspect, the present invention provides a kuaisan extract.
The extract of the Chinese medicinal herbs is prepared by the preparation method.
The extract of the Chinese medicinal herbs of the rhubarb and the Indian skullcap roots is an extract with a relative density of 1.10-1.20.
The medicine aims at the indication of the abnormal menstruation.
The indication of the dysfunctional uterine bleeding includes but is not limited to chronic anemia.
Preferably, the dosage form of the medicine is granules.
In yet another aspect, the present invention provides a medicament.
The medicine comprises the extract of the powder.
The medicine aims at the indication of the abnormal menstruation.
The indication of the dysfunctional uterine bleeding includes but is not limited to chronic anemia.
Preferably, the medicament is granules.
The medicine also comprises other pharmaceutically acceptable carriers or excipients.
In another aspect, the invention also provides a preparation method of the medicine.
The preparation method of the medicine comprises the preparation method of the extract of the Chinese medicinal herbs.
The preparation method of the medicine also comprises other possible medicine preparation steps, such as preparation of granules, preparation of dry paste and the like.
Preferably, the preparation method of the dry paste comprises the following steps: spray drying the extract with relative density of 1.10-1.20(60 deg.C) (air inlet temperature of 170-190 deg.C and air outlet temperature of 80-90 deg.C) to obtain dry extract powder.
The invention has the beneficial effects that:
the inventive extract has the functions of increasing the number of red blood cells, increasing the concentration of hemoglobin, and reducing the liver index. Compared with other extraction methods, the method for preparing the extract of the kusnezoff monkshood root has better effect.
Drawings
FIG. 1 shows the effect of 2 weeks of administration on red blood cells and hemoglobin in anemia model of chronic disease in mice, # P <0.05, # P <0.01, compared to normal control group.
FIG. 2 shows the effect of Isogonella extract on red blood cells and hemoglobin of anemia model of chronic disease in mice after 3 weeks of administration, wherein # P is less than 0.05 and # P is less than 0.01 compared with normal control group; p <0.05, P <0.01 compared to model group.
Figure 3 shows the effect of the extract on the liver and spleen indexes of anemia models of chronic diseases of mice, # # P <0.01 compared with normal control group, # # P <0.05 compared with model group.
FIG. 4 shows the effects of Isogonella extract on serum iron and tissue iron in anemia model of mouse chronic disease, # P <0.05, # P <0.01, compared with normal control group.
Detailed Description
The present invention will be further illustrated in detail with reference to the following specific examples, which are not intended to limit the present invention but are merely illustrative thereof. The experimental methods used in the following examples are not specifically described, and the materials, reagents and the like used in the following examples are generally commercially available under the usual conditions without specific descriptions.
In the following examples:
ginseng is planted artificially, and the supplier is the professional cooperative of organic plants of Baicaowang, Fusong county, the producing area is Jilin, and the batch number is 20062711. The execution standard and the processing method are according to the relevant regulations of the item of ginseng in the first part of the 2020 edition of Chinese pharmacopoeia, and the processing method comprises moistening thoroughly, slicing, drying, or crushing and pounding with time. The ginseng medicinal materials and the processed products thereof all conform to the relevant regulations of the first part of the ' Chinese pharmacopoeia ' 2015 edition and the ' 2020 edition.
The rhizoma Atractylodis Macrocephalae is planted artificially, and the supplier is Hebei Jincao pharmaceutical Co., Ltd, the production place is Anhui, and the batch number is 191101001. The execution standard and the processing method of the bran-fried largehead atractylodes rhizome are both according to the relevant regulations under the item of the largehead atractylodes rhizome in the first part of the 2020 edition of Chinese pharmacopoeia, and the processing method comprises the steps of removing impurities, cleaning, moistening, slicing into thick slices, and drying to obtain largehead atractylodes rhizome slices; spreading the bran processed with honey into a hot pot, adding Atractylodis rhizoma tablet when smoking, parching to brown, discharging burnt smell, taking out, and sieving to remove bran processed with honey. Every 100kg of the white atractylodes rhizome tablets are roasted by 10kg of bran with honey. The Largehead Atractylodes rhizome stir-baked with bran conforms to the relevant regulations in the section of Chinese pharmacopoeia 2015 edition and 2020 edition.
Poria is cultivated artificially, and the supplier is Yuexi county Baoya Chinese medicinal material professional cooperative, and the production place is Anhui. The execution standard and processing method are according to the relevant regulations of Poria under item 251 page of first part of the 2020 edition of Chinese pharmacopoeia, and the processing method comprises soaking Poria, cleaning, moistening, slightly steaming, timely peeling, cutting into blocks or thick slices, and sun drying. The tuckahoe medicinal material and the processed products thereof all conform to the relevant regulations of the first part of the ' Chinese pharmacopoeia ' 2015 edition and the ' 2020 edition.
The Glycyrrhrizae radix is dried root and rhizome of Glycyrrhiza uralensis Fisch of Leguminosae, and cultivated artificially, and has a supplier of Hebei gold grass pharmaceutical industry Co., Ltd and a production place of inner Mongolia. The execution standard and processing method are according to the relevant regulations of the item of 88 pages licorice in the first part of the 2020 edition of Chinese pharmacopoeia, and the processing method comprises removing impurities, cleaning, moistening thoroughly, slicing into thick pieces, and drying to obtain the licorice pieces. Parching Glycyrrhrizae radix tablet with honey (until 0213) to yellow to dark yellow, taking out when it is not sticky, and cooling. The prepared licorice root meets the relevant regulations of the first part of the ' Chinese pharmacopoeia ' 2015 edition and the ' 2020 edition.
The dried orange peel is planted artificially, the supplier is the professional cooperative of the Hongshenger Chinese medicinal plant farmer in the city of Yangzhou, the production area is the northwest of Hu, the dried orange peel medicinal material lot number 2006101, and the processed product lot number 20062811. The dried orange peel medicinal material and the processed product thereof all conform to the relevant regulations of the first part of Chinese pharmacopoeia 2015 edition and 2020 edition.
Example 1 an extract of Isogonella powder
Prescription: ginseng: stir-frying white atractylodes rhizome with bran: tuckahoe, poria cocos: dried orange peel: 1, honey-fried licorice root: 1: 1: 1: 1, 50g each in this example.
(1) Pretreatment
Referring to 'Chinese pharmacopoeia' 2020 edition, 15mm mesh of ginseng in the prescription is crushed, and the rest medicines have no pretreatment requirement.
(2) Extracting, and separating solid and liquid
Weighing decoction pieces (Ginseng radix, bran-parched Atractylodis rhizoma, Poria, pericarpium Citri Tangerinae, and radix Glycyrrhizae Preparata), decocting each decoction piece with 12 times of drinking water for 2 times (2.5 hr each time), and filtering the two decoctions with 200 mesh nylon filter cloth under normal pressure to obtain extractive solution. The first decoction is carried out to obtain 2779.6g of extract, and the second decoction is carried out to obtain 3605.3g of extract.
(3) Concentrating
Concentrating the extractive solution under reduced pressure (60 deg.C to 80 deg.C, 0.06MPa to-0.1 MPa) to obtain extract with relative density of 1.10-1.20(60 deg.C). 880.8g of extract (concentrated solution) is prepared.
The component determination method comprises the following steps:
ginsenoside Rb 1 Content determination method
Chromatographic conditions and system applicability test: octadecylsilane chemically bonded silica is used as a filling agent; acetonitrile is taken as a mobile phase A, 0.05 percent phosphoric acid is taken as a mobile phase B, and gradient elution is carried out according to the specification in the following table; the flow rate is 1 mL/min; the detection wavelength was 203 nm.
Figure BDA0003702516260000051
Preparation of control solutions: taking appropriate amount of ginsenoside Rb1 reference substance, precisely weighing, and adding methanol to obtain a solution containing ginsenoside Rb 1mL 1 160. mu.g of solution.
Preparing an extracting solution test solution: taking a proper amount of the extract (about 0.16g of ginseng medicinal material and 15mL of actual dosage), precisely weighing, extracting with water-saturated n-butanol for 3 times, 30mL each time, combining n-butanol solutions, evaporating to dryness in water bath, dissolving the residue with methanol, fixing the volume to a 10mL measuring flask, shaking up, and filtering to obtain the final product.
Preparing a concentrated solution test solution: taking a proper amount of concentrated solution (about equal to 0.16g of ginseng medicinal material, and the actual dosage is 1g), precisely weighing, adding water to supplement the volume before concentration, extracting with water saturated n-butanol for 3 times, 30mL each time, mixing n-butanol solutions, evaporating in water bath, dissolving the residue with methanol, metering to 10mL measuring flask, shaking up, and filtering to obtain the final product.
The determination method comprises the following steps: precisely sucking 10 μ L of reference solution and sample solution respectively, injecting into liquid chromatograph, and measuring.
Method for measuring content of glycyrrhiza glycoside, glycyrrhizic acid and hesperidin
Chromatographic conditions and system applicability test: octadecylsilane chemically bonded silica is used as a filling agent; acetonitrile is taken as a mobile phase A, 0.05 percent phosphoric acid is taken as a mobile phase B, and gradient elution is carried out according to the specification in the following table; the flow rate is 1 ml/min; the detection wavelength was 237 nm.
Figure BDA0003702516260000061
Preparation of control solutions: taking appropriate amount of liquiritin reference substance, ammonium glycyrrhizinate reference substance, and hesperidin reference substance, precisely weighing, and adding methanol to obtain mixed reference substance solution containing liquiritin 90 μ g, ammonium glycyrrhizinate 190 μ g, and hesperidin 120 μ g per 1 mL.
Preparing an extract test solution: taking a proper amount of the extracting solution (about equivalent to 0.1g of liquorice, 0.1g of dried orange peel and 8mL of actual dosage), precisely weighing, placing in a 10mL measuring flask, adding water to dissolve or dilute to a scale, shaking uniformly, and filtering to obtain the traditional Chinese medicine composition.
Preparing a concentrated solution test solution: taking a proper amount of concentrated solution (about equivalent to 0.1g of licorice medicinal material, 0.1g of dried orange peel medicinal material and 0.5g of actual dosage), precisely weighing, placing in a 10mL measuring flask, adding water to dissolve or dilute to a scale, shaking up, and filtering to obtain the final product.
The determination method comprises the following steps: precisely sucking 10 μ L of each of the reference solution and the sample solution, injecting into liquid chromatograph, and measuring.
Third determination of cream yield/solid content
The preparation method of the dry paste comprises the following steps: spray drying the extract with relative density of 1.10-1.20(60 deg.C) (air inlet temperature of 170-190 deg.C and air outlet temperature of 80-90 deg.C) to obtain dry extract powder. The total weight of the paste is 519.5 g.
The results of the extraction verification test are as follows:
Figure BDA0003702516260000062
Figure BDA0003702516260000071
example 2 efficacy of Isogonella extract
This experimental example was conducted on the extract obtained in example 1.
The effect of the abnormal power dissipation on the concentration of red blood cells and hemoglobin
A mouse chronic disease anemia model is established by a method of intraperitoneal injection of LPS and saccharose A solution, and different process extracts are administered by intragastric gavage for 2 consecutive weeks. The experimental result shows that compared with a normal control group, the number of red blood cells and the concentration of hemoglobin of the mouse in the model group are obviously reduced, and the statistical difference is obvious (P < 0.01).
The administration mode comprises the following steps: oral administration;
mouse equivalent dose estimation:
the daily dosage of the crude drug is about 1.43 g/kg/d, calculated according to 70kg of body weight. Approximate calculation formula lgS ═ 0.8762+0.698lgW [ S is body surface area (cm) 2 ) W is body weight (g)]. The human body weight is 70kg, and the body surface area is 1.8117m 2 The mouse takes 20g, the body surface area is 0.0061m 2 In terms of conversion, the mouse equivalent dose is about 100g crude drug/1.8117 m 2 ×0.0061m 2 0.02kg about 16.835g crude drug/kg.
Two weeks after the treatment with the Isogonella powder extract, the number of erythrocytes and the hemoglobin concentration of the administered group (YGS-1) were restored, but there was no statistical difference from the model group.
After three weeks of treatment with the Isodon powder extract, the administered group showed a significant recovery in both red blood cell count and hemoglobin concentration, and the group of example 1 was statistically different from the model group (P < 0.05).
The results are shown in FIGS. 1-2 and the following table:
effect of Isogonella extract on red blood cells and hemoglobin of anemia model of mouse chronic disease
Figure BDA0003702516260000072
Note: # P <0.01 compared to control and # P <0.05, 0.01 compared to model.
Effect of Isogongsan on liver index and spleen index
Mice were anesthetized and dissected at the end of the experiment, livers and spleens were removed, respectively, and after residual blood was blotted with filter paper, weighed (g), recorded and calculated according to the following formula:
spleen index ═ 10 [ spleen (g)/mouse body weight (g) ];
liver index ═ liver (g)/mouse body weight (g) x 10.
Compared with the control group, the liver index and the spleen index of the model group mice are obviously increased, and the difference has statistical significance (P < 0.01). After the prognosis of the abnormal functional stem, the administration group has the obvious effect of reducing the liver index, and compared with the model group, the difference has statistical significance. No significant effect on spleen index was observed. The results are shown in FIG. 3 and the following table:
Figure BDA0003702516260000081
note: # P <0.01 compared to control and # P <0.05 compared to model.
③ Effect of Isogongyan on serum iron and tissue iron
The method for measuring the serum iron content comprises the following steps: collecting about 200 μ L of whole blood via retroorbital venous plexus, separating serum at 3000r/min for 25min at 4 deg.C, about 40 μ L, and detecting Serum Iron (SI) by colorimetry.
The method for measuring the tissue iron content comprises the following steps: iron in liver and spleen tissues is observed by prussian blue staining, and the percentage of the positive area of prussian blue iron ions is analyzed by using image. Pro Plus 6.0 software.
Compared with the control group, the iron content in the serum and the iron content in the spleen tissue of the model group are both obviously reduced, and the difference is statistically different (P <0.05 or P < 0.01). Compared with the model group, the administration group has no significant influence on the serum iron content, the spleen tissue iron content and the liver tissue iron content (P is more than 0.05). The results are shown in FIG. 4 and the following table:
effect of Isogonella extract on serum iron and tissue iron of anemia model of mouse chronic disease
Figure BDA0003702516260000082
Note: # P <0.01 and # P <0.05 compared to control.
The effect of the Isodon japonicus extract on a mouse chronic anemia model is observed. The results suggest that the extract of this example has the effects of increasing the number of red blood cells, increasing the concentration of hemoglobin, and decreasing the liver index.
Comparative example 1
Reference is made to the procedure of example 1, except that the aqueous extraction is replaced by 70% alcoholic extraction.
Comparative example 1 is actually an experiment performed simultaneously with example 1, and thus the control group and the model group refer to example 1.
Comparative example 1 the results of the action of the test sample on red blood cells and hemoglobin of an anemia model of chronic diseases of mice are as follows:
Figure BDA0003702516260000083
Figure BDA0003702516260000091
note: # P <0.01 compared to control and # P <0.05, 0.01 compared to model.
Comparative example 1 effect on liver and spleen indices of anemia model of chronic disease in mice:
Figure BDA0003702516260000092
note: # P <0.01 compared to control and # P <0.05 compared to model.
Comparative example 1 effect on serum iron and tissue iron in anemia model of mouse chronic disease:
Figure BDA0003702516260000093
note: # P <0.01 compared to control and # P <0.05 compared to model.
Comparative example 2
Referring to the method of example 1, the drug was mixed with water and extracted.
Comparative example 2 is actually an experiment performed simultaneously with example 1, and thus the control group and the model group refer to example 1.
Comparative example 2 the results of the action of the red blood cells and hemoglobin on the anemia model of the mouse chronic disease are as follows:
Figure BDA0003702516260000094
note: # P <0.01 compared to control and # P <0.05, 0.01 compared to model.
Comparative example 2 effect on liver and spleen indices of anemia model of chronic disease in mice:
Figure BDA0003702516260000095
note: # P <0.01 compared to control group and # P <0.05 compared to model group.
Comparative example 2 effects on serum iron and tissue iron in anemia models of mouse Chronic disease:
Figure BDA0003702516260000096
note: # P <0.01 compared to control and # P <0.05 compared to model.

Claims (10)

1. A method for preparing a Chinese medicinal extract of Isodon japonicus, which is characterized by comprising the following steps: decocting each decoction piece in the prescription with 8-12 times of water for 2-3 times, 1-3 hours each time; filtering, mixing, and concentrating under reduced pressure.
2. The preparation method according to claim 1, wherein the extract of Isodon japonicus Houtt-S is an extract with a relative density of 1.10-1.20.
3. The method of claim 1, comprising: decocting each decoction piece in the prescription with 10-12 times of water for 2 times, 1-3 hours each time; filtering, mixing, and concentrating under reduced pressure.
4. The process according to claim 1, wherein the concentration under reduced pressure is carried out at a temperature of from 60 ℃ to 80 ℃ and from-0.06 MPa to-0.1 MPa.
5. A Isogonella abortus extract, which is prepared by the preparation method according to any one of claims 1 to 4.
6. The extract of Isodon japonicus according to claim 5, which is an extract having a relative density of 1.10-1.20.
7. Use of the extract of Isodon according to claims 5-6 for the preparation of a medicament for the indication of Isodon.
8. The use of claim 7, wherein the indication of heterodispersion is: chronic anemia.
9. A medicament, comprising the extract of Isodon according to any one of claims 5-6.
10. The medicament of claim 9, wherein the indications for the dysfunctional powders are: chronic anemia.
CN202210722755.7A 2022-06-20 2022-06-20 Extract of Chinese medicinal herb powder and application thereof Pending CN115025158A (en)

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108066458A (en) * 2017-12-29 2018-05-25 罗梅宏 Yigong San powder with marveous Effect is in splenomegaly caused by preparation treatment anemia of chronic disease, infection or diseases associated with inflammation and the application in injury of mitochondria drug

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108066458A (en) * 2017-12-29 2018-05-25 罗梅宏 Yigong San powder with marveous Effect is in splenomegaly caused by preparation treatment anemia of chronic disease, infection or diseases associated with inflammation and the application in injury of mitochondria drug

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