CN117338869A - A Chinese medicinal capsule and its preparation method - Google Patents

A Chinese medicinal capsule and its preparation method Download PDF

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Publication number
CN117338869A
CN117338869A CN202311562921.2A CN202311562921A CN117338869A CN 117338869 A CN117338869 A CN 117338869A CN 202311562921 A CN202311562921 A CN 202311562921A CN 117338869 A CN117338869 A CN 117338869A
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parts
extract
aloe
traditional chinese
chinese medicine
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郭炜
陈玉娟
潘小萌
王环
郭宇松
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Hebei Medical University
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Hebei Medical University
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/35Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
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    • A61K31/3533,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A61K31/355Tocopherols, e.g. vitamin E
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/58Meliaceae (Chinaberry or Mahogany family), e.g. Azadirachta (neem)
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    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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Abstract

The invention provides a traditional Chinese medicine capsule and a preparation method thereof, wherein the traditional Chinese medicine capsule comprises the following components: 100 parts of aloe extract, 450-550 parts of costustoot extract, 80-100 parts of Chinese toon extract, 45-55 parts of pearl and 2-3 parts of vitamin E; the traditional Chinese medicine capsule provided by the invention has the advantages that the components are combined in a reasonable relationship and have a specific proportion, the effects of clearing the intestines and defecating, improving the intestines and promoting the peristalsis of the intestines and the stomach are facilitated, and the constipation is treated and the darkness of the skin caused by the constipation can be obviously improved.

Description

A Chinese medicinal capsule and its preparation method
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine capsule and a preparation method thereof
Background
Constipation refers to the reduction of defecation times, difficulty in defecation and dry feces; the defecation times per week are less than 3 times, and the disease course is more than 6 months. The prevalence rate of chronic constipation for adults in China is 4-6%, and the prevalence rate of chronic constipation for people over 60 years old is 22%. The causes of chronic constipation are numerous, including: reduced daily activity, increased mental stress, insufficient fiber or fluid intake due to unbalanced diet, reduced intestinal peristalsis due to reduced body function, atrophy of intestinal mucosa and intestinal wall fibers, etc. Constipation affects toxin excretion in the body, further leading to dark skin tone, color spots, etc.
In terms of treatment, at present, most Western medicine adopts permeability, irritation and lubricating laxatives (such as lactulose, enema, polyethylene glycol and the like) and secretagogues and prokinetic medicines, but the adverse effects of medicine treatment are more, and long-term administration is easy to generate dependence and influence the absorption of calcium, phosphorus and fat-soluble vitamins, and long-term administration of the irritation laxatives can cause irreversible enteric nerve damage and can not improve the darkness of skin.
Disclosure of Invention
The invention aims to overcome the defects and provide a traditional Chinese medicine capsule which consists of traditional Chinese medicines and traditional Chinese medicine active extracts and a preparation method thereof, and has the characteristics of long-term use safety and ideal effect.
In a first aspect of the invention, a traditional Chinese medicine capsule for treating constipation and improving skin color is provided, wherein the capsule content comprises the following components in parts by weight:
preferably, the composition comprises the following components in weight:
more preferably, the composition comprises the following components in weight:
the preparation method of the aloe extract comprises the following steps:
(1) Dissolving sulfobutyl-beta-cyclodextrin in 35% -40% ethanol to obtain 40-50mg/mL solution as extraction solvent;
(2) Pulverizing Aloe, reflux extracting with 4-5 times of extraction solvent for 2-3 hr, filtering the extractive solution, removing ethanol under reduced pressure, and lyophilizing the filtrate to obtain Aloe extract.
The preparation method of the costustoot extract comprises the following steps:
(1) Pulverizing radix aucklandiae, soaking in 7-10 times of water for 3-5 hr, adding lecithin, and extracting volatile oil by steam distillation for 1-2 hr;
(2) Adding sodium bicarbonate to adjust pH to 8.0-8.5, adding alkaline protease, and continuing steam distillation for 1-2h, and then adding flavourzyme, and continuing steam distillation for 1-2h;
(3) Collecting volatile oil, dissolving the volatile oil in 40-50mg/mL sulfobutyl-beta-cyclodextrin solution, clathrating, and freeze drying to obtain radix aucklandiae extract 1;
(4) Filtering the extractive solution, and lyophilizing to obtain radix aucklandiae extract 2;
(5) Mixing the radix aucklandiae extract 1 and the radix aucklandiae extract 2 to obtain radix aucklandiae extract.
The preparation method of the toona sinensis extract comprises the following steps:
(1) Dissolving sulfobutyl-beta-cyclodextrin in 15% -25% ethanol to obtain 40-50mg/mL solution as extraction solvent;
(2) Pulverizing Toona sinensis, reflux extracting with 5-6 times of extraction solvent for 2-3 hr, filtering the extractive solution, removing ethanol under reduced pressure, and lyophilizing the filtrate to obtain Toona sinensis extract.
Further, in the aloe extract, the weight of the lecithin is 0.01-0.1 times, preferably 0.06 times of the weight of the costustoot; the weight of the alkaline protease is 0.02-0.06 times of the weight of the costustoot, preferably 0.04 times; the weight of the flavourzyme is 0.08-0.15 times of the weight of the costustoot, preferably 0.12 times; the weight of the sulfobutyl-beta-cyclodextrin solution is 1-1.5 times, preferably 1.2 times of the weight of the costustoot.
Furthermore, the traditional Chinese medicine capsule for treating constipation and improving skin color also comprises pharmaceutically acceptable auxiliary materials, wherein the auxiliary materials are preferably corn starch, magnesium stearate, polyvinylpyrrolidone K30 and the like.
Further, a traditional Chinese medicine capsule for treating constipation and improving skin color comprises the following components in parts by weight:
in some embodiments of the present invention, a traditional Chinese medicine capsule for treating constipation and improving skin color, the capsule content is composed of the following components by weight:
in other embodiments of the present invention, a traditional Chinese medicine capsule for treating constipation and improving skin color, the capsule content is composed of the following components by weight:
the second aspect of the invention provides a preparation method of the traditional Chinese medicine capsule for treating constipation and improving skin color.
A preparation method of a traditional Chinese medicine capsule for treating constipation and improving skin color comprises the following steps:
(1) Preparation of the adhesive:
dissolving polyvinylpyrrolidone K30 in water to obtain solution with adhesive concentration of 12-14%, heating to 40deg.C, and keeping;
(2) Premixing and wet granulating:
mixing aloe extract, radix aucklandiae extract, toonae sinensis extract, margarita, vitamin E, and corn starch in wet mixing granulator, stirring, pre-mixing, spraying binder solution under stirring, and wet granulating.
(3) Drying and granulating:
drying at 40-45deg.C, adding the dried granule into a granulator, and sieving with sieve with aperture of 2.0mm;
(4) Total mixing:
adding magnesium stearate into the granules after finishing, and uniformly mixing;
(5) And (3) filling: the granules are filled into capsules.
Compared with the prior art, the invention has the following beneficial effects:
(1) The raw materials are safer; the aloe, the costustoot, the pearl, the toona sinensis, the vitamin E and the like are used as components for treating constipation, so that the raw materials are safe to use; animal tests and crowd tests prove that the capsule can treat constipation, promote defecation of patients, has no toxic or side effect, and improve skin darkness.
(2) The aloe extract, the costustoot extract and the Chinese toon extract are obtained by adopting a specific extraction process, so that effective substances in the aloe extract, the costustoot extract and the Chinese toon extract can be extracted to the greatest extent, constipation can be treated, and meanwhile, skin darkness caused by the constipation can be remarkably improved.
(3) The components in the traditional Chinese medicine capsule for treating constipation and improving skin color are combined in a reasonable relationship and have a specific proportion, so that the traditional Chinese medicine capsule is beneficial to the effects of clearing the bowels, improving the intestinal tracts and promoting the peristalsis of the intestines and the stomach. Aloe, costustoot, pearl, chinese toon and vitamin E are mixed according to the ratio of 2:10:1.8:1:0.05, so that the patient can remove food retention, resolve phlegm heat, clear heat and detoxify while promoting the circulation of intestines and stomach, and can obviously improve the skin darkness caused by constipation while treating constipation.
Detailed Description
The invention discloses a traditional Chinese medicine capsule for treating constipation and improving skin color and a preparation method thereof, and a person skilled in the art can refer to the content of the traditional Chinese medicine capsule and combine related principles of medicine extraction and medicine preparation to properly improve technological parameters. It is expressly noted that all such similar substitutions and modifications will be apparent to those skilled in the art, and are deemed to be included within the scope of the present invention. While the invention has been described with reference to preferred embodiments, it will be apparent to those skilled in the relevant art that variations and modifications can be made in the methods and applications described herein, or in appropriate changes and combinations, without departing from the spirit and scope of the invention.
For a better understanding of the present invention, and not to limit its scope, all numbers expressing quantities, percentages, and other values used in the present application are to be understood as being modified in all instances by the term "about". Each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.
The invention is further illustrated by the following examples, which are not intended to limit the invention in any way.
Preparation example 1: radix aucklandiae extract
(1) 500g of costustoot is crushed, 9 times of water is added for soaking for 4 hours, 30g of lecithin is added, and the volatile oil is extracted by a steam distillation method for 1.5 hours.
(2) Sodium bicarbonate was added to adjust the pH to 8.4, alkaline protease was added in an amount of 20g, and after further steam distillation was continued for 1.5 hours, flavourzyme was added in an amount of 60g, and steam distillation was continued for 1.5 hours.
(3) Collecting volatile oil, dissolving the volatile oil in 600g of 45mg/mL sulfobutyl-beta-cyclodextrin solution, clarifying the solution, and freeze-drying to obtain radix aucklandiae extract 1.
(4) Filtering the extractive solution, and lyophilizing to obtain radix aucklandiae extract 2;
(5) Mixing the radix aucklandiae extract 1 and the radix aucklandiae extract 2 to obtain radix aucklandiae extract.
Preparation example 2: radix aucklandiae extract
(1) 500g of costustoot is crushed, 8 times of water is added for soaking for 4 hours, 30g of lecithin is added, and the volatile oil is extracted by a steam distillation method for 1.5 hours.
(2) Sodium bicarbonate was added to adjust the pH to 8.2, alkaline protease was added in an amount of 20g, and after further steam distillation was continued for 1.5 hours, flavourzyme was added in an amount of 60g, and steam distillation was continued for 1.5 hours.
(3) Collecting volatile oil, dissolving the volatile oil in 600g of 50mg/mL sulfobutyl-beta-cyclodextrin solution, clarifying the solution, and freeze-drying to obtain radix aucklandiae extract 1.
(4) Filtering the extractive solution, and lyophilizing to obtain radix aucklandiae extract 2;
(5) Mixing the radix aucklandiae extract 1 and the radix aucklandiae extract 2 to obtain radix aucklandiae extract.
Preparation example 3: radix aucklandiae extract
(1) 500g of costustoot is crushed, 9 times of water is added for soaking for 4 hours, 30g of lecithin is added, and the volatile oil is extracted by a steam distillation method for 1.5 hours.
(2) Sodium bicarbonate was added to adjust the pH to 8.4, alkaline protease was added in an amount of 20g, and after further steam distillation was continued for 1.5 hours, flavourzyme was added in an amount of 60g, and steam distillation was continued for 1.5 hours.
(3) Collecting volatile oil, dissolving the volatile oil in 600g of 30mg/mL sulfobutyl-beta-cyclodextrin solution, clarifying the solution, and freeze-drying to obtain radix aucklandiae extract 1.
(4) Filtering the extractive solution, and lyophilizing to obtain radix aucklandiae extract 2;
(5) Mixing the radix aucklandiae extract 1 and the radix aucklandiae extract 2 to obtain radix aucklandiae extract.
Preparation example 4: radix aucklandiae extract
(1) 500g of costustoot is crushed, 9 times of water is added for soaking for 4 hours, 30g of lecithin is added, and the volatile oil is extracted by a steam distillation method for 1.5 hours.
(2) Sodium bicarbonate was added to adjust the pH to 8.4, alkaline protease was added in an amount of 20g, and after further steam distillation was continued for 1.5 hours, flavourzyme was added in an amount of 60g, and steam distillation was continued for 1.5 hours.
(3) Collecting volatile oil, dissolving the volatile oil in 400g of 45mg/mL sulfobutyl-beta-cyclodextrin solution, and freeze drying to obtain radix aucklandiae extract 1.
(4) Filtering the extractive solution, and lyophilizing to obtain radix aucklandiae extract 2;
(5) Mixing the radix aucklandiae extract 1 and the radix aucklandiae extract 2 to obtain radix aucklandiae extract.
Preparation example 5: aloe extract
(1) Dissolving sulfobutyl-beta-cyclodextrin in 35% ethanol to obtain a solution with the concentration of 45mg/mL as an extraction solvent;
(2) Pulverizing aloe 100g, reflux extracting with 4.5 times of extraction solvent for 2.5 hr, filtering the extractive solution, removing ethanol under reduced pressure, and lyophilizing the filtrate to obtain aloe extract.
Preparation example 6: aloe extract
(1) Dissolving sulfobutyl-beta-cyclodextrin in 30% ethanol to obtain a solution with the concentration of 45mg/mL as an extraction solvent;
(2) Pulverizing aloe 100g, reflux extracting with 4.5 times of extraction solvent for 2.5 hr, filtering the extractive solution, removing ethanol under reduced pressure, and lyophilizing the filtrate to obtain aloe extract.
Preparation example 7: aloe extract
(1) Dissolving sulfobutyl-beta-cyclodextrin in 35% ethanol to obtain a solution with the concentration of 30mg/mL as an extraction solvent;
(2) Pulverizing aloe 100g, reflux extracting with 4.5 times of extraction solvent for 2.5 hr, filtering the extractive solution, removing ethanol under reduced pressure, and lyophilizing the filtrate to obtain aloe extract.
Preparation example 8: cedrela sinensis extract
(1) Dissolving sulfobutyl-beta-cyclodextrin in 20% ethanol to obtain a solution with the concentration of 45mg/mL as an extraction solvent;
(2) Pulverizing Toona sinensis 90g, reflux extracting with 6 times of extraction solvent for 2.5 hr, filtering, removing ethanol under reduced pressure, and lyophilizing the filtrate to obtain Toona sinensis extract.
Preparation example 9: cedrela sinensis extract
(1) Dissolving sulfobutyl-beta-cyclodextrin in 10% ethanol to obtain a solution with the concentration of 45mg/mL as an extraction solvent;
(2) Pulverizing Toona sinensis 90g, reflux extracting with 6 times of extraction solvent for 2.5 hr, filtering, removing ethanol under reduced pressure, and lyophilizing the filtrate to obtain Toona sinensis extract.
Preparation example 10: cedrela sinensis extract
(1) Dissolving sulfobutyl-beta-cyclodextrin in 20% ethanol to obtain 35mg/mL solution as extraction solvent;
(2) Pulverizing Toona sinensis 90g, reflux extracting with 6 times of extraction solvent for 2.5 hr, filtering, removing ethanol under reduced pressure, and lyophilizing the filtrate to obtain Toona sinensis extract.
Examples 1 to 10: traditional Chinese medicine capsule for treating constipation and improving skin color
Composition of the capsule contents
Examples 1-10 the composition of the capsule contents is shown in table 1 below, wherein aloe extract, costustoot extract, cedrela sinensis extract were prepared by different methods, and are specifically shown in table 2.
TABLE 1
TABLE 2
Examples Aloe extract Radix aucklandiae extract Cedrela sinensis extract
Example 1 Preparation example 1 Preparation example 5 Preparation example 8
Example 2 Preparation example 2 Preparation example 5 Preparation example 8
Example 3 Preparation example 3 Preparation example 5 Preparation example 8
Example 4 Preparation example 4 Preparation example 5 Preparation example 8
Example 5 Preparation example 1 Preparation example 6 Preparation example 8
Example 6 Preparation example 1 Preparation example 7 Preparation example 8
Example 7 Preparation example 1 Preparation example 5 Preparation example 9
Example 8 Preparation example 1 Preparation example 5 Preparation example 10
Preparation example 9 Preparation example 3 Preparation example 7 Preparation example 9
Preparation example 10 Preparation example 4 Preparation example 6 Preparation example 10
(II) preparation method:
(1) Preparation of the adhesive:
dissolving polyvinylpyrrolidone K30 in water to obtain solution with adhesive concentration of 13%, heating to 40deg.C, and maintaining;
(2) Premixing and wet granulating:
mixing aloe extract, radix aucklandiae extract, toonae sinensis extract, margarita, vitamin E, and corn starch in wet mixing granulator, stirring, pre-mixing, spraying binder solution under stirring, and wet granulating.
(3) Drying and granulating:
drying at 40-45deg.C, adding the dried granule into a granulator, and sieving with sieve with aperture of 2.0mm;
(4) Total mixing:
adding magnesium stearate into the granules after finishing, and uniformly mixing;
(5) And (3) filling: the granules are filled into capsules.
Examples 11-12 Chinese medicinal capsules for treating constipation and improving skin tone
Composition of the capsule contents
The composition of the contents of the capsules of examples 11-12 is shown in Table 3 below, wherein aloe extract was prepared by the method of preparation example 1, costustoot extract was prepared by the method of preparation example 5, and Cedrela sinensis extract was prepared by the method of preparation example 8.
TABLE 3 Table 3
(II) preparation method
As in example 1.
Examples 13 to 16: traditional Chinese medicine capsule for treating constipation and improving skin color
Composition of the capsule contents: as in example 1.
(II) preparation method: step (1) the adhesive was prepared as shown in Table 4, and steps (2) to (5) were the same as in example 1.
TABLE 4 Table 4
Example 17: detecting the difference of the loading quantity:
according to the method for detecting the loading difference of the four general rules '0103 capsules' of the edition 2020 of Chinese pharmacopoeia, the loading difference of the traditional Chinese medicine capsules for treating constipation and improving skin color prepared in example 1-example 15 is shown in Table 5.
TABLE 5
From comparison of the results of example 1 and example 13-example 16, it is clear that the concentration of the adhesive polyvinylpyrrolidone K30 and the temperature of the adhesive during granulation affect the capsule loading difference, and only the traditional Chinese medicine capsule loading difference for treating constipation and improving skin color, which is prepared by the polyvinylpyrrolidone K30 in a specific concentration range (12% -14%) and a specific temperature (40 ℃), can meet the rules of pharmacopoeia.
Example 18: evaluation of constipation effect:
1. test design
Male C57BL/6 mice, weighing 20-30g, 10 in each group, 150 in total. Divided into 14 groups
Wherein 130 mice are filled with the stomach molding drug loperamide hydrochloride with the dosage of 50mg/Kg, and the continuous stomach filling is carried out for 7 days, thus establishing a mouse intestinal constipation model. Another 10 blank groups;
test article: the traditional Chinese medicine capsules for treating constipation and improving skin color prepared in the embodiments 1-12 are 12 groups, and the model control group does not take any medicine; the doses were 2.5g (Chinese medicinal capsule content for treating constipation and improving skin color)/kg (mice), respectively, and the administration was performed once a day for 5 days.
Observing the first defecation time (min) and the weight (g) of the excrement
2. Test results
The test results are shown in Table 6.
TABLE 6
Note that: # P<0.05; ## P<0.01; compared with the model group
* P<0.05; ** P<0.01; compared with the blank control group
P<0.05; ★★ P<0.01; compared with the group of the embodiment 1
(1) Compared with the blank control group, the first defecation time of the model group is obviously increased, the weight of excrement is obviously reduced, and the two have very obvious difference (P is less than 0.01), which indicates that the model is successful.
(2) Compared with a model control group, the traditional Chinese medicine capsules for treating constipation and improving skin color prepared in the embodiment 1-2 can obviously reduce the first defecation time and improve the weight of excrement, and have obvious differences (P is less than 0.01); compared with a blank control group, the traditional Chinese medicine capsules for treating constipation and improving skin color prepared in the examples 1-2 are equivalent in the aspects of first defecation time, fecal weight and the like, and have no obvious difference (P is more than 0.05). The traditional Chinese medicine capsules for treating constipation and improving skin color prepared in the embodiment 1-2 are obvious in treatment effect, and after 5 days of treatment, the treatment effect is equivalent to that of a blank control group.
(3) Compared with a model control group, the traditional Chinese medicine capsules for treating constipation and improving skin color prepared in examples 3-8 and examples 11-12 can remarkably reduce the first defecation time and improve the weight of excrement, and have remarkable differences (P is less than 0.01); compared with the blank control group, the traditional Chinese medicine capsules for treating constipation and improving skin color prepared in examples 3-8 and examples 11-12 have obvious differences (P is less than 0.05) in the aspects of first defecation time, fecal weight and the like. The traditional Chinese medicine capsules for treating constipation and improving skin color prepared in examples 3-8 are obvious in treatment effect, but after 5 days of treatment, the treatment effect is obviously different from that of a blank control group (P is less than 0.05).
(4) Compared with a model control group, the traditional Chinese medicine capsules for treating constipation and improving skin color prepared in the examples 9-10 can obviously reduce the first defecation time and improve the fecal weight, and all have obvious differences (P is less than 0.05); compared with a blank control group, the traditional Chinese medicine capsules for treating constipation and improving skin color prepared in examples 9-10 have obvious differences (P is less than 0.01) in the aspects of first defecation time, fecal weight and the like. The traditional Chinese medicine capsules for treating constipation and improving skin color prepared in examples 3-8 have a certain effect, but after 5 days of treatment, the treatment effect is significantly different from that of a blank control group (P is less than 0.01).
(5) Compared with the group of the example 1, the traditional Chinese medicine capsules for treating constipation and improving skin color prepared in the examples 9-10 can reduce the first defecation time and improve the weight of excrement, but all have very obvious differences (P < 0.01), which shows that the traditional Chinese medicine capsules for treating constipation and improving skin color prepared in the examples 9-10 have obviously worse constipation treating effect than the group of the example 1 and very obvious differences (P < 0.01)
Therefore, only the specific proportion of aloe, costustoot, pearl, chinese toon and vitamin E is in a proportion mode of 2:10:1.8:1:0.05, and the aloe, costustoot and Chinese toon are extracted by a specific method, so that the prepared traditional Chinese medicine capsule for treating constipation and improving skin color has the synergistic effect of all the components, the effect of treating constipation is optimal, and the treatment is close to healing (equivalent to that of a blank control group) after 5 days of treatment.
Example 19: evaluation of skin dullness improving Effect
(1) Tyrosinase activity inhibition assay
Taking mouse melanoma B16 cells in logarithmic growth phase at 5×10 4 Each/mL was inoculated into 6-well cell culture plates, 2mL per well, and cultured overnight. The contents of the capsules of examples 1-15 were added to a final volume fraction of 2% respectively, with the untreated group as the cell control group and 2 duplicate wells per group. After 48h incubation, washing 1 with PBS, adding 100. Mu.L of lysate to each well, scraping the collected cells, and centrifuging to collect the supernatant. mu.L of the cell supernatant was taken into a 96-well plate, and 50. Mu.L of a solution of L-dopa was added thereto, and incubated at 37℃for 1 hour, and absorbance was measured at 475nm by a spectrophotometer.
Relative tyrosinase activity (%) = (assay well absorbance value-blank absorbance value)/(cell control absorbance value-blank absorbance value) ×100%.
(2) Melanin synthesis inhibition assay
Taking mouse melanoma B16 cells in logarithmic growth phase, inoculating the cells into a T25 cell culture flask, and culturing overnight. The contents of the capsules of examples 1-15 were added to a final volume fraction of 2% respectively, with the untreated group as the cell control group. After 48h incubation, washing 1 time with PBS, adding 1mL of 1mol/L NaOH solution, scraping the collected cells, placing in a 80℃water bath for 30min, taking the supernatant, adding into a 96-well plate, and measuring the absorbance at 475nm wavelength with a spectrophotometer. .
Relative melanin content (%) = (measured well absorbance value-blank absorbance value)/(cell control absorbance value-blank absorbance value) ×100%.
The tyrosinase activity and melanin synthesis inhibition test results are shown in Table 3, wherein the tyrosinase activity of the control group is 100%, and the melanin content of the control group is 100%.
(3) Test results
The test results are shown in Table 7.
TABLE 7
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As can be seen from table 7: the traditional Chinese medicine capsule for treating constipation and improving skin color provided by the embodiments 1-2 can obviously inhibit the activity of relative tyrosinase, reduce the generation of melanin, obviously improve skin darkness, and have synergistic interaction between the components, and if one component or a preparation method of a certain component is absent, the effect is obviously reduced.

Claims (8)

1. A traditional Chinese medicine capsule, which is characterized in that the capsule content comprises the following components in parts by weight:
100 parts of aloe extract, 450-550 parts of costustoot extract, 80-100 parts of Chinese toon extract, 45-55 parts of pearl and 2-3 parts of vitamin E;
the preparation method of the aloe extract comprises the following steps:
(1) Dissolving sulfobutyl-beta-cyclodextrin in 35% -40% ethanol to obtain 40-50mg/mL solution as extraction solvent;
(2) Pulverizing Aloe, reflux-extracting with 4-5 times of extraction solvent for 2-3 hr, filtering the extractive solution, removing ethanol under reduced pressure, and lyophilizing the filtrate to obtain Aloe extract;
the preparation method of the costustoot extract comprises the following steps:
(1) Pulverizing radix aucklandiae, soaking in 7-10 times of water for 3-5 hr, adding lecithin, and extracting volatile oil by steam distillation for 1-2 hr;
(2) Adding sodium bicarbonate to adjust pH to 8.0-8.5, adding alkaline protease, and steam distilling for 1 hr, and adding flavourzyme, and steam distilling for 1 hr;
(3) Collecting volatile oil, dissolving the volatile oil in 40-50mg/mL sulfobutyl-beta-cyclodextrin solution, clathrating, and freeze drying to obtain radix aucklandiae extract 1;
(4) Filtering the extractive solution, and lyophilizing to obtain radix aucklandiae extract 2;
(5) Mixing the radix aucklandiae extract 1 and the radix aucklandiae extract 2 to obtain radix aucklandiae extract;
the preparation method of the toona sinensis extract comprises the following steps:
(1) Dissolving sulfobutyl-beta-cyclodextrin in 15% -25% ethanol to obtain 40-50mg/mL solution as extraction solvent;
(2) Pulverizing Toona sinensis, reflux extracting with 5-6 times of extraction solvent for 2-3 hr, filtering the extractive solution, removing ethanol under reduced pressure, and lyophilizing the filtrate to obtain Toona sinensis extract.
2. The traditional Chinese medicine capsule according to claim 1, wherein the capsule content comprises the following components:
100 parts of aloe extract, 490-505 parts of costustoot extract, 85-95 parts of Chinese toon extract, 49-51 parts of pearl and 2-3 parts of vitamin E.
3. The traditional Chinese medicine capsule according to claim 2, wherein the capsule content comprises the following components:
the aloe extract weight is 100 parts of aloe, the costustoot extract weight is 500 parts of costustoot, the Chinese toon extract weight is 90 parts of Chinese toon, 50 parts of pearl and 2.5 parts of vitamin E.
4. The traditional Chinese medicine capsule according to claim 3, further comprising pharmaceutically acceptable auxiliary materials, wherein the auxiliary materials are preferably corn starch, magnesium stearate and polyvinylpyrrolidone K30.
5. The traditional Chinese medicine capsule according to claim 4, wherein the capsule content consists of the following components:
the aloe extract comprises, by weight, 100 parts of aloe, 450-550 parts of costustoot, 80-100 parts of Chinese toon extract, 45-55 parts of pearl, 2-3 parts of vitamin E, 30-30 parts of polyvinylpyrrolidone K, 180-220 parts of corn starch and 10-20 parts of magnesium stearate.
6. The traditional Chinese medicine capsule according to claim 5, wherein the capsule content consists of the following components:
100 parts of aloe extract, 500 parts of costustoot extract, 90 parts of Chinese toon extract, 50 parts of pearl, 2.5 parts of vitamin E, 30 parts of polyvinylpyrrolidone K24 parts, 200 parts of corn starch and 16 parts of magnesium stearate.
7. A method for preparing a traditional Chinese medicine capsule according to any one of claims 1-5, comprising the steps of:
(1) Preparation of the adhesive:
dissolving polyvinylpyrrolidone K30 in water to obtain solution with adhesive concentration of 12-14%, heating to 40deg.C, and keeping;
(2) Premixing and wet granulating:
mixing aloe extract, radix aucklandiae extract, toonae sinensis extract, margarita, vitamin E and corn starch in a wet mixing granulator, stirring, pre-mixing, spraying binder solution under stirring, and wet granulating;
(3) Drying and granulating: drying at 40-45deg.C, adding the dried granule into a granulator, and sieving with sieve with aperture of 2.0mm;
(4) Total mixing: adding magnesium stearate into the granules after finishing, and uniformly mixing;
(5) And (3) filling: the granules are filled into capsules.
8. The method for preparing a Chinese medicinal capsule according to claim 7, wherein the concentration of the binder in the step (1) is preferably 13%.
CN202311562921.2A 2023-11-22 2023-11-22 A Chinese medicinal capsule and its preparation method Pending CN117338869A (en)

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