CN110664922A - Composition with chloasma removing function and preparation method and application thereof - Google Patents
Composition with chloasma removing function and preparation method and application thereof Download PDFInfo
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- CN110664922A CN110664922A CN201910906614.9A CN201910906614A CN110664922A CN 110664922 A CN110664922 A CN 110664922A CN 201910906614 A CN201910906614 A CN 201910906614A CN 110664922 A CN110664922 A CN 110664922A
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Abstract
The invention provides a composition with a chloasma removing function, which is characterized by comprising 1-12 parts by weight of Chinese angelica, 1-15 parts by weight of white paeony root, 1-10 parts by weight of rhizoma cyperi, 1-12 parts by weight of semen cuscutae and 2-10 parts by weight of liquorice. Functional experiments prove that after the composition and the preparation thereof are prepared by different processes, the average chloasma area of a subject is obviously reduced, the color integral is obviously reduced, new chloasma is not generated, and the composition and the preparation have obvious difference compared with a blank control group before and after test eating.
Description
Technical Field
The invention relates to the technical field of medicines, health-care products and foods, in particular to a composition with a chloasma-removing function and a preparation method and application thereof.
Background
Chloasma is commonly called butterfly spot, liver spot or pregnancy spot, mainly occurs on face, mainly cheeks, nose, forehead and chin, and is a brown or black spot with unclear boundary, which is mostly symmetrical. Chloasma is a pigmentary dermatosis, and the facial skin of a patient can generate light brown or brown pigment spots, sometimes in a butterfly wing shape. It usually occurs in the cheek and forehead, with different sizes and shapes, and some cheeks are distributed symmetrically. Chloasma is a color spot which most affects the appearance in pigments, brings much trouble to the life of people, and is particularly suitable for young ladies who love beauty.
The traditional Chinese medicine considers that the chloasma is caused by the condition that qi and blood cannot be presented on the face due to the external wind evil (wind heat and cold) and the disharmony of qi and blood; the method is also one of the important reasons for the persistence and disappearance of chloasma, which are caused by improper diet, partial taste, overstrain, kidney essence loss after middle-aged people, macula generation due to the lack of moistening of face, or qi disorder due to emotional distress, liver injury due to anger, spleen injury due to anxiety, kidney injury due to fright, etc., or adverse emotions such as long-term stress, depression, etc. The yellowish-brown spots appear outside but inside, which are the signals of the imbalance of qi, blood, yin and yang in the body and reflect the abundance or insufficiency of the zang-fu organs. Therefore, the search for a spot-removing preparation with reasonable composition, high efficiency and safety becomes a research hotspot in the fields of pharmacy, health care products and cosmetics at present.
Disclosure of Invention
The invention aims to provide a composition with a chloasma-removing function, which is characterized by comprising 1-12 parts by weight of angelica sinensis, 1-15 parts by weight of radix paeoniae alba, 1-10 parts by weight of rhizoma cyperi, 1-12 parts by weight of semen cuscutae and 2-10 parts by weight of liquorice. Wherein the composition and the raw materials can be directly ground into powder, or can be prepared into extract or other forms by conventional methods.
Further, the composition comprises 2-10 parts of angelica, 2-10 parts of white peony root, 2-5 parts of rhizoma cyperi, 2-10 parts of semen cuscutae and 2-5 parts of liquorice.
Preferably, the composition comprises 3.41 parts of angelica, 3.41 parts of white peony root, 3.41 parts of nutgrass galingale rhizome, 5.12 parts of south dodder seed and 2.05 parts of liquorice.
The application of any one of the compositions in preparing medicines, health-care products or foods with the function of removing chloasma.
The invention also provides a medicament, a health-care product or food containing the composition with the function of removing the chloasma.
Specifically, the medicine, the health product or the food is selected from oral, injection or external preparations.
The composition of the present invention can be prepared by the following method:
extracting the angelica, the white paeony root, the rhizoma cyperi, the semen cuscutae and the liquorice in parts by weight, concentrating, drying, crushing, sieving, adding a proper amount of filler, fully mixing, granulating, drying, sieving, mixing, adding no or a proper amount of auxiliary materials, and preparing a pharmaceutically acceptable preparation according to a conventional process.
For example, the composition can be prepared into oral health-care food in the form of solid preparations such as common tablets (buccal tablets, chewable tablets and effervescent tablets), capsules (hard capsules and soft capsules) and granules, and can also be prepared into oral health-care food in the form of liquid preparations such as syrup, wine and oral liquid.
The preparation process of the preparation of the tablet, the capsule, the granule and the like in the invention relates to a granulation process, and wet granulation or one-step granulation can be adopted.
The auxiliary materials in the invention can be different according to different preparations, such as common surface active agents, diluents, preservatives, stabilizers, flavoring agents, thickening agents, glidants and the like in liquid preparation forms such as oral liquid and the like; diluents, disintegrants, excipients, binders, lubricants, surfactants, fillers, and the like, which are commonly used in solid preparations such as tablets, capsules, granules, and the like.
Common adjuvants such as starch, lactose, sucrose, dextrin, maltodextrin, microcrystalline cellulose, mannitol, xylitol, polyethylene glycol, calcium carbonate, modified starch, sorbitol, sodium carboxymethylcellulose, hydroxypropylmethyl cellulose, methyl cellulose, ethyl cellulose, carboxymethyl starch sodium, hydroxypropyl cellulose, povidone K30, pregelatinized starch, magnesium stearate, talc, aerosil, stevioside, betaine, aspartame, citric acid, glycyrrhizin, saccharin sodium, crystal sugar, honey, citric acid, sodium bicarbonate, sodium carbonate, carrageenan, agar, gelatin, sodium alginate, xanthan gum, guar gum, tragacanth gum, acacia gum, locust bean gum, stearic acid, crosslinked sodium polyacrylate, polyvinyl alcohol, carbomer, sorbic acid, potassium sorbate, ethylparaben, benzyl alcohol, glycerol, propylene glycol, etc.
The invention also proposes a process for the preparation of a composition as defined in any one of the preceding claims, comprising the following steps:
extraction: extracting radix Angelicae sinensis, radix Paeoniae alba, rhizoma Cyperi, semen Cuscutae, and Glycyrrhrizae radix with water to obtain extractive solution;
concentration: concentrating the extracting solution to obtain a concentrated solution;
impurity removal: adding a chitosan solution into the concentrated solution, stirring, standing and centrifuging;
and (3) re-concentration: concentrating the supernatant to obtain extract.
Further, the preparation method of the composition comprises the following steps:
extraction: extracting radix Angelicae sinensis, radix Paeoniae alba, rhizoma Cyperi, semen Cuscutae, and Glycyrrhrizae radix with water for 1-3 times to obtain extractive solution;
concentration: vacuum concentrating the extractive solution to relative density of 1.10-1.20 at 65-75 deg.C, and filtering to obtain concentrated solution;
impurity removal: adding 0.5-1 wt% chitosan solution into the concentrated solution, stirring for 20 min, standing at low temperature for 24 hr, and centrifuging;
and (3) re-concentration: centrifuging the obtained supernatant, and concentrating under reduced pressure at 65-75 deg.C to obtain extract with relative density of 1.10-1.20;
and (3) drying: drying the extract to obtain a dry extract;
crushing: pulverizing, and sieving.
The preparation method of the composition tablet of the invention can be as follows: taking the dry paste powder of the angelica, the white paeony root, the rhizoma cyperi, the semen cuscutae and the liquorice in parts by weight, sieving, adding a proper amount of filler, fully mixing, granulating by purified water, drying, finishing granules, adding a proper amount of lubricant, uniformly mixing, tabletting, and coating or not coating to obtain the tablet. Wherein the filler is one or more of starch, pregelatinized starch, dextrin, and microcrystalline cellulose; the lubricant is one or more of magnesium stearate, silica gel micropowder and pulvis Talci.
The preparation method of the composition tablet can also comprise the following steps: taking the dry paste powder of the angelica, the white paeony root, the rhizoma cyperi, the semen cuscutae and the liquorice in parts by weight, sieving, adding a proper amount of filler, fully mixing, granulating by purified water, drying, finishing granules, adding a proper amount of lubricant, uniformly mixing, tabletting, and coating or not coating to obtain the tablet. Wherein, the film coating agent comprises the following components: hydroxypropyl methylcellulose, polyvinyl alcohol, glyceryl triacetate, titanium dioxide, aluminum green lake, aluminum brilliant blue lake and talcum powder.
The invention also provides a preparation method of the medicine with the chloasma-removing function, wherein the medicine is selected from tablets, and is characterized by comprising the following steps:
extraction: extracting 3.41 parts of angelica, 3.41 parts of white peony root, 3.41 parts of rhizoma cyperi, 5.12 parts of semen cuscutae and 2.05 parts of liquorice with water for 2 times, adding water with the weight 10 times of that of the medicinal materials for reflux extraction for 2 hours for the first time, adding water with the weight 10 times of that of the medicinal materials for reflux extraction for 2 hours for the second time, and combining the extracting solutions;
concentration: vacuum concentrating the extractive solution to relative density of 1.10-1.20 at 70 deg.C, and filtering to obtain concentrated solution;
impurity removal: preparing 1% chitosan solution with 1% glacial acetic acid solution, adding 0.7% chitosan solution into the concentrated solution, stirring for 20 min, standing at low temperature for 24 hr, and centrifuging;
and (3) re-concentration: centrifuging the obtained supernatant, and concentrating under reduced pressure at 70 deg.C to obtain extract with relative density of 1.25;
and (3) drying: spreading the extract in a tray, and drying at 70 deg.C under reduced pressure to obtain dry extract;
crushing: pulverizing with universal pulverizer, and sieving with 100 mesh sieve to obtain dry extract powder;
mixing: uniformly mixing the dry paste powder and microcrystalline cellulose to obtain uniformly mixed powder for later use;
and (3) granulating: adding water into the uniformly mixed powder to prepare a soft material, granulating by using a 20-mesh sieve, drying at 70 ℃, and grading by using the 20-mesh sieve to obtain granules;
tabletting: adding croscarmellose sodium and magnesium stearate, mixing, and tabletting to obtain tablet.
The components of the invention have the following characteristics:
angelica sinensis is the dried root of Angelica sinensis of Umbelliferae, and it is warm in nature, sweet and pungent in flavor, and enters heart and spleen channels. Has the effects of enriching and activating blood, regulating menstruation and relieving pain, and relaxing bowel, and is an essential blood-qi-tonifying medicine. Can be used for treating blood deficiency, sallow complexion, vertigo, palpitation, menoxenia, amenorrhea, and dysmenorrhea. The record of the Jingyue full book, Ben Cao Zheng: chinese angelica, which is sweet and heavy in flavor, is specially used for enriching blood; it is mild and pungent in qi and can promote blood circulation. Tonify the middle energizer and tonify the middle energizer, they are good at qi and blood and also good at the holy herbs. The angelica can improve the chloasma of the skin by the mode of promoting blood circulation and enriching the blood.
Bai Shao strengthens five zang organs, tonifies kidney qi, and treats sinking and swelling of heart and abdomen, removing blood stasis and removing pus. According to modern prescriptions, radix paeoniae alba has the effects of calming the liver, relieving pain, nourishing blood, regulating menstruation, astringing yin and arresting sweating, and is used for treating headache, dizziness, hypochondriac pain, abdominal pain, limb spasm and pain, blood deficiency, chlorosis, irregular menstruation, spontaneous perspiration, night sweat and the like. Radix Paeoniae alba can also improve human body pigmentation by suppressing hyperactive liver and softening liver, thereby reducing formation of chloasma.
The rhizoma Cyperi is dried rhizome of Cyerrus rotundus L. of Cyperaceae family, and has effects of dispersing stagnated liver qi, regulating menstruation and relieving pain. The rhizoma cyperi can regulate menstruation, relieve pain, enhance the effects of promoting blood circulation and removing blood stasis, and therefore, the rhizoma cyperi can play a certain role in treating chloasma
Dodder seed, pungent and sweet in flavor and slightly warm in nature, enters liver, kidney and spleen meridians, is listed as the superior in Shen nong Ben Cao Jing, and has the functions of tonifying kidney, replenishing vital essence, nourishing liver, improving eyesight, strengthening spleen and consolidating fetus. Modern medicine proves that the dodder can eliminate excessive oxygen free radicals, inhibit the activity of tyrosinase and further prevent the generation of melanin, so that the dodder can be used for removing chloasma.
The licorice root, being sweet and neutral in nature, can tonify spleen and qi, clear heat and remove toxicity, dispel phlegm and stop cough, relieve spasm and alleviate pain, and harmonize the effects of the other drugs, so it is said to be "ten drugs and nine herbs". From ancient times to date, research on licorice has never been interrupted. The main effects of liquorice are as follows: replenishing qi, strengthening the middle warmer, expelling phlegm, arresting cough, relieving spasm, alleviating pain, alleviating drug property, clearing away heat and toxic materials, etc. The liquorice can tonify spleen and qi, clear heat and remove free radicals, so the liquorice has certain effect on treating chloasma.
The invention provides a novel speckle-removing preparation with reasonable formula, high efficiency and safety, and functional experiments prove that after the composition and the preparation thereof are prepared by different processes, the average chloasma area of a subject is obviously reduced, the color integral is obviously reduced, no new chloasma is generated, and the composition and the preparation have obvious difference compared with a blank control group before and after trial eating. Moreover, the invention also searches various process parameters in the preparation production process to obtain a better preparation method. In addition, chitosan is skillfully applied to remove impurities in the preparation process of the composition, so that effective substances are effectively reserved and improved, the daily dose is greatly reduced, the health-care function of removing chloasma of the product is ensured, and functional tests show that the composition has good safety.
Detailed Description
The present invention will now be described in more detail with reference to specific embodiments thereof so that the aspects and advantages of the invention may be better understood. However, the contents of the specific embodiments described below are for illustrative purposes only and are not limiting of the present invention.
It should be noted that, if the specific conditions are not specified, the procedures are carried out according to the conventional conditions or the conditions recommended by the manufacturer, and the raw materials or auxiliary materials used, and the reagents or equipment used are not specified by the manufacturer, and are conventional products commercially available. All percentages, ratios, proportions, or parts are by weight unless otherwise specified.
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. In addition, any methods and materials similar or equivalent to those described herein can be used in the practice of the present invention.
Examination of extraction preparation Process
1 Single factor investigation of extraction Process conditions
1.1 Single factor study of decoction time
The raw medicinal materials with the formula proportion in example 1 are extracted for 2 times by 10 times of purified water, the extraction time is considered by taking the paeoniflorin extraction amount as an index and adopting a single-factor test scheme, the medicinal materials with the same formula amount are taken, the material-liquid ratio is kept consistent, the extraction time is respectively considered for 0.5 hour, 1 hour, 1.5 hours and 2 hours, and the experimental results are shown in table 1.
TABLE 1 extraction time Single factor test
And (4) conclusion: the extraction time is 0.5 hour, the extraction amount of paeoniflorin is the lowest, the results of 1.0 hour, 1.5 hours and 2.0 hours are similar, wherein the extraction amount of paeoniflorin is the highest when the extraction time is 1.5 hours, so the decoction time of 1.5 hours is the best.
1.2 solvent-fold amount investigation
Taking the medicinal materials with the formula proportion in example 1, setting the extraction time to be 1.5 hours, setting the solvent times to be 6 times, 8 times and 10 times, extracting for 2 times, adopting a single-factor test scheme to investigate, and taking the paeoniflorin extraction amount as an index. The results are shown in Table 2.
TABLE 2 solvent-fold amount investigation test
And (4) conclusion: as can be seen from the data in the table, paeoniflorin extraction was highest when 10 times of water addition was performed, and 551.85mg was used when 8 times of water addition was performed, which is close to 10 times of water addition, and from the viewpoint of actual production, 8 times of feed-to-liquid ratio was selected to meet the actual production, so 8 times of water addition was selected as a process parameter.
2 extraction Process orthogonal test investigation
According to the result of single-factor research of the extraction process and literature data, the paeoniflorin transfer rate is taken as a research index, and an L9(34) orthogonal test scheme is adopted to research the feed-liquid ratio, the extraction time and the extraction frequency. The factor levels are shown in Table 3.
TABLE 3 factor level table
Test methods and data: 290g of each 9 parts of the five-ingredient medicinal decoction pieces are taken according to the formula proportion in the example 1, the extraction is carried out according to the requirements of related parameters of an L9(34) orthogonal table, the transfer rate of paeoniflorin in the extracting solution is measured, and the experimental results are shown in Table 4.
TABLE 4 orthogonal test Table
And (4) conclusion: as can be seen from Table 4, the transfer rate of paeoniflorin in the extract is considered as an index, and the influence of each factor on the extraction process is extremely poor, namely the R value is; c > B > A, the range of the extraction times of medicinal materials (factor C) is the largest, among all factors, C3> C2> C1, B3> B2> B1 and A3> A2> A1, so the optimal extraction process of visual analysis is A3B3C3, and because the difference between one extraction and two extraction and three extraction is large, and the difference between 2 extraction and 3 extraction is not large, the factor A3B3C2 is selected from the consideration of saving cost and improving efficiency, the factor A3B3C2 is selected, and the requirements of industrial production are met, namely 10 times of water is added each time, and the reflux extraction is performed for 2 times and each time is 2 hours.
And (3) verification of an extraction process: performing three-batch verification experiment according to orthogonal optimization result, adding 10 times of water into the medicinal materials, reflux-extracting for 2 times, each time for 2h, filtering decoction, mixing, and measuring the transfer rate of paeoniflorin to verify the feasibility of the extraction process. The results are shown in Table 5.
TABLE 5 extraction Process verification test
The verification result shows that the optimized extraction process is adopted for verification, the paeoniflorin transfer rate in the extracting solution is consistent with the orthogonal test result, and the three verification tests are stable, so that the extraction process is stable and feasible.
3 determination of concentration process of decoction of medicinal materials
Under the above preferred extraction process conditions, the concentration temperature conditions of the composition were studied, using the transfer rate of paeoniflorin as an index, and the same amount of extract was taken and concentrated by a rotary evaporator, with the concentration temperature set at 60, 70, 80 ℃, and the final concentration density at 1.05, and the experimental results are shown in table 6.
TABLE 6 concentration temperature test investigation
And (4) conclusion: the concentration process condition of the extract of the product is selected for reduced pressure concentration, the water extract contains paeoniflorin active ingredients, and as can be seen from the table, the transfer rate of paeoniflorin is not greatly different at the temperature of 60 ℃ and 70 ℃, the transfer rate of paeoniflorin is reduced at the temperature of 80 ℃, and the concentration process condition of 70 ℃ is selected for consideration of improving the production efficiency and being beneficial to maximally retaining index ingredients.
4 determination of drying process of concentrated solution of medicinal materials
According to the literature report and the practical situation of production equipment, the reduced pressure drying at 70 ℃ is selected. Three batches of process verification are carried out according to the selected drying method, the content of the effective components before and after drying is calculated, three batches of process verification tests show that the drying process is stable and feasible, and the experimental results are shown in table 7.
TABLE 7 verification of the drying Process for three batches of samples
In summary, through the above tests: the preparation process of the composition of the invention is stable and feasible, and preferably comprises the following steps: extracting with 10 times of water for 2 times, and one time for 2 hours; the concentration temperature is 70 +/-5 ℃; the drying temperature was set at 70. + -. 5 ℃.
5 study of granulation Process
5.1 selection of adjuvants
Through experimental study, proper auxiliary materials are required to be added so as to solve the problems of sticking of fine powder, large difference of tablet weight, difficulty in tablet disintegration and the like in the preparation process. In the selection process of the diluent, the auxiliary materials such as starch, sucrose and microcrystalline cellulose which are commonly used in pharmacy are selected according to the properties of the intermediate, three auxiliary materials are tested, and the experimental results are shown in table 8.
TABLE 8 selection of diluents and test results
The test result shows that different auxiliary materials are selected to have certain influence on granulation, tabletting and disintegration of the preparation, and the microcrystalline cellulose has the best effect, so that 30 percent of microcrystalline cellulose in weight ratio is selected as the diluent of the product.
5.2 selection of wetting Agents
Taking a proper amount (3 parts) of medicinal powder, respectively adding purified water and ethanol with different concentrations as wetting agents, granulating by using a 20-mesh screen (observing the condition of preparing and sieving soft materials), drying at 65 +/-5 ℃, grading by using a 20-mesh screen, collecting and weighing granules, and calculating the qualified rate of the granules, wherein the experimental results are shown in table 9.
TABLE 9 wetting agent investigation
The results show that granulation with 90% and 50% ethanol is difficult, granulation with purified water is easy, and the wetting agent is the best for granulation.
5.3 selection of Lubricants
Experiments show that the flowability of the granules is poor in the process of granulation, so that lubricating agents such as magnesium stearate, silicon dioxide and the like need to be added, and 1% of magnesium stearate is selected as the lubricating agent according to the reference and the material properties of the granules.
5.4 selection of disintegrating Agents
The composition is a traditional Chinese medicine extract, the disintegration time of the tablet is 40-50 minutes, and the disintegration time is longer, so that a disintegrating agent is required to be added to improve the disintegration condition of the tablet. The disintegrant has dispersing and diluting effects on the traditional Chinese medicine extract powder by selecting dry starch, hydroxypropyl methylcellulose and croscarmellose sodium. The dry starch, hydroxypropyl methylcellulose and croscarmellose sodium were each added at 7% during granulation and added with mixing after granulation, and the effect of the disintegrant on the disintegration time of the tablets was examined, as shown in table 10.
TABLE 10 disintegrant observations
Test results show that under the condition of the same auxiliary material dosage, the effect of the croscarmellose sodium on the disintegration time limit of the tablet is better, and the disintegration time is within 30min, so the influence of the auxiliary material on tabletting and disintegration is integrated, and the croscarmellose sodium is preferably used as a disintegrating agent. From the influence result of the addition mode of the disintegrant on the disintegration time, the influence of the internal addition method and the external addition method selected by the croscarmellose sodium on the disintegration time of the preparation is small, so that the 7 percent of the croscarmellose sodium is preferably added in the external addition method for granulation and tabletting, and the disintegration time of the tablet can be ensured.
Through the above formulation process studies, the preferred process for determining the composition comprises: mixing the extracts of radix Angelicae sinensis, radix Paeoniae alba, rhizoma Cyperi, semen Cuscutae and Glycyrrhrizae radix at a certain proportion, adding microcrystalline cellulose, mixing, granulating with purified water, drying, adding croscarmellose sodium and magnesium stearate, granulating with 20 mesh sieve, tabletting, coating, and packaging to obtain the final product.
Example 1
Preparation of a composition tablet
Chinese angelica root 341g, root of herbaceous peony 341g, cyperus tuber 341g, dodder seed 512g, licorice root 205g
The preparation method of the composition tablet of the embodiment comprises the following steps:
extraction: extracting radix Angelicae sinensis, radix Paeoniae alba, rhizoma Cyperi, semen Cuscutae, and Glycyrrhrizae radix with drinking water for 2 times, reflux-extracting with 10 times of purified water for 2.0 hr for the first time, reflux-extracting with 10 times of drinking water for 2.0 hr for the second time, and mixing extractive solutions;
concentration: vacuum concentrating the extractive solution to relative density of 1.10-1.20 at 70 deg.C, and filtering to obtain concentrated solution;
impurity removal: adding chitosan solution (the chitosan is prepared into 1% solution with 1% glacial acetic acid solution, the dosage is 0.7% of the raw material dosage), stirring for 20 min, standing at low temperature for 24 hr, and centrifuging;
concentration: centrifuging the obtained supernatant, concentrating under reduced pressure at 70 deg.C to obtain extract with relative density of 1.25
And (3) drying: spreading the concentrated solution on a tray, and drying at 70 deg.C under reduced pressure to obtain dry extract;
crushing: crushing by a universal crusher, and sieving by a 100-mesh sieve for later use;
mixing: uniformly mixing the dry paste powder and microcrystalline cellulose to obtain uniformly mixed powder for later use;
and (3) granulating: adding purified water into the uniformly mixed powder to prepare a soft material, granulating by using a 20-mesh sieve, drying at 70 ℃, and grading by using the 20-mesh sieve to obtain granules;
tabletting: adding croscarmellose sodium and magnesium stearate, mixing, and tabletting to obtain tablet 0.89 g/tablet.
Two function test
1. Materials and methods
1.1 sample
Drug group (prepared according to example 1 of the present invention);
blank control group.
1.2 subject selection
1.2.1 inclusion criteria:
volunteers who met the following criteria by physical examination.
The face is light brown to dark brown, and the clear spot is generally distributed symmetrically and has no inflammatory expression and scales; no obvious subjective symptoms; it occurs mainly after puberty, and women frequently; the disease condition is seasonal, and the disease is severe in summer and mild in winter; has no obvious endocrine diseases, and discharges pigmentation caused by other diseases.
1.2.2 exclusion criteria: people under 18 years old or over 65 years old, pregnant or lactating women, people with allergic constitution and people allergic to the health food; patients with serious diseases of cardiovascular, cerebrovascular, liver, kidney and hemopoietic system, endocrine diseases, and psychosis; alcoholics or smokers; taking articles related to the tested function in a short time to influence the judgment of the result; if the subject is not taken as prescribed, the efficacy or the safety is judged to be affected by incomplete data.
1.3 Experimental design and grouping
Two control designs, self and group, were used. The test method comprises the steps of randomly dividing the test subjects into a medicine group and a blank control group according to the chloasma color and the area condition of the test subjects, considering main factors influencing results such as outdoor activity conditions, age and the like as much as possible, and carrying out balance test to ensure comparability among the groups. Not less than 50 subjects per group.
1.4 test methods
The test groups take the corresponding medicines according to the regulation, and the test period is 30 days, 2 times a day, 3 tablets each time (equivalent to 17.4g crude drugs/day). The subject stops using other oral and external skin care and freckle removing products during the food test period, and the original dietary habit and normal diet are not changed during the food test period.
1.5 instruments and reagents
A full-automatic biochemical analyzer, a biochemical kit, a full-automatic blood cell analyzer, a urine chemical analyzer, a B-ultrasonic machine, an X-ray fluoroscopy machine and an electrocardiograph.
1.6 Observation index
1.6.1 safety index
1.6.1.1 general conditions: including mental, sleep, diet, stool and urine, blood pressure, etc.
1.6.1.2 routine examination of blood, urine and feces: red blood cell count (RBC), Hemoglobin (HB), white blood cell count (WBC), urine, stool routine.
1.6.1.3 biochemical indexes of liver and kidney functions, and the like: serum albumin ALB, total protein TP, liver and kidney functions (alanine aminotransferase ALT, aspartate aminotransferase AST, urea nitrogen BUN, creatinine CRE), blood glucose GLU, blood lipids (total cholesterol TC, triglyceride TG, high density lipoprotein cholesterol HDL-C).
1.6.1.4 chest X-ray, electrocardiogram, abdomen B-ultrasonic examination (only one examination before test)
1.6.2 efficacy index
1.6.2.1 facial chloasma area size detection: measuring the area (mm) of chloasma on the whole face before and after the test with a ruler2)。
1.6.2.2 detection of chloasma on face: according to the research and development of the geographical research of Chinese academy of sciences, the brown (Y + M + Bk, namely the stack of yellow + magenta + black) color card in the practical standard color card (first edition) published by the mapping and publishing agency in 1992 is the judgment standard of the chloasma shade: i degrees (15, 20, 5), II degrees (30, 40, 10), III degrees (40, 60, 15).
1.7 data processing and result determination
1.7.1 data processing
Counting the chloasma color integral and the area change before and after the test eating, and simultaneously calculating the effective rate. The I degree, the II degree and the III degree of the color chart are respectively divided into 1 point, 2 points and 3 points. Results are expressed as mean ± standard deviation. The measured data is tested by t and the effective rate is tested by x 2.
1.7.2 efficacy determination criteria:
the method has the following advantages: the chloasma color is reduced by I degree, the area is reduced by more than 10 percent, and no new chloasma is generated.
And (4) invalidation: the chloasma has no obvious change or aggravation in color and area.
1.7.3 results determination:
the area of the chloasma in the medicine group is averagely reduced and is more than or equal to 10 percent, the color integral is obviously reduced, the difference is significant by comparing the medicine group with the front and back and comparing the medicine group with a blank control group, and new chloasma is not generated, so that the composition has the function of removing the chloasma;
2. results
2.1 analysis of balance between groups before group entry
2.1.1 general data comparison
The general data (sex, age, height, weight, respiration, heart rate, blood pressure, body temperature and course) of the patients in the two groups are compared, and the difference has no statistical significance (P is more than 0.05), which indicates that the general data of the two groups of cases before the patients are in the group have comparability.
2.1.2 comparison of chloasma area and chloasma color before administration
Compared with the prior art, the chloasma area and the chloasma color group have no significant difference (P is more than 0.05), which shows that the prior two groups of subjects have similar disease conditions and better comparability.
2.2 Observation of efficacy:
2.2.1 integral change of the shade of the chloasma color:
TABLE 11 integral change of the depth of chloasma before and after tasting
2.2.2 change of chloasma area size:
table 12 change of chloasma area before and after tasting
2.3 Security Observation
2.3.1 general case
The subjects in the drug and placebo groups had no significant changes in mental status, sleep, diet, stool and urine before and after the test. Adverse reactions and allergic reactions were not observed in all subjects during the test.
2.3.2 examination of safety-related indices before and after eating trial
Before and after the test eating, a plurality of safety indexes of the liver function, the kidney function, the blood biochemistry, the urine, the defecation convention and the like of the tested person have no obvious change.
2.3.3 No obvious abnormality is seen in the subjects before B-mode ultrasonography in abdomen, electrocardiogram and X-ray chest fluoroscopy.
3. Conclusion
The test results show that the average chloasma area of the drug group is obviously reduced, is more than 10 percent and is as high as 26.82 percent, the color integral is obviously reduced, new chloasma is not generated, and the significant difference exists before and after the trial eating and compared with a blank control group.
In conclusion, the composition has the function of removing chloasma.
Example 2
Preparation of a composition capsule
Chinese angelica root 341g, root of herbaceous peony 341g, cyperus tuber 341g, dodder seed 512g, licorice root 205g
The preparation method of the composition capsule comprises the following steps:
extraction: extracting radix Angelicae sinensis, radix Paeoniae alba, rhizoma Cyperi, semen Cuscutae, and Glycyrrhrizae radix with drinking water for 1 time, adding purified water with an amount of 8 times of the medicinal materials, and reflux-extracting for 3.0 hr;
concentration: vacuum concentrating the extractive solution to relative density of 1.10-1.20 at 65 deg.C, and filtering to obtain concentrated solution;
impurity removal: adding chitosan solution (the chitosan is prepared into 1% solution with 1% glacial acetic acid solution, the dosage is 0.5% of the raw material dosage), stirring for 20 min, standing at low temperature for 24 hr, and centrifuging;
concentration: centrifuging the obtained supernatant, and concentrating under reduced pressure at 65 deg.C to obtain extract with relative density of 1.20;
and (3) drying: spreading the concentrated solution on a tray, and drying in a reduced pressure drying mode to obtain a dry extract;
crushing: crushing by a universal crusher, and sieving by a 100-mesh sieve for later use;
mixing: uniformly mixing the dry paste powder and microcrystalline cellulose to obtain uniformly mixed powder for later use;
and (3) granulating: adding purified water into the uniformly mixed powder to prepare a soft material, granulating by using a 20-mesh sieve, drying at 65 ℃, and grading by using the 20-mesh sieve to obtain granules;
filling: adding croscarmellose sodium and magnesium stearate, mixing, and canning the obtained granule to obtain capsule.
Two function test
1. Materials and methods the same as example 1
2. Results
2.1 analysis of balance between groups before group entry
2.1.1 general data comparison
The general data (sex, age, height, weight, respiration, heart rate, blood pressure, body temperature and course) of the patients in the two groups are compared, and the difference has no statistical significance (P is more than 0.05), which indicates that the general data of the two groups of cases before the patients are in the group have comparability.
2.1.2 comparison of chloasma area and chloasma color before administration
Compared with the prior art, the chloasma area and the chloasma color group have no significant difference (P is more than 0.05), which shows that the prior two groups of subjects have similar disease conditions and better comparability.
2.2 Observation of efficacy:
2.2.1 integral change of the shade of the chloasma color:
TABLE 13 integral change of chloasma shade before and after tasting
2.2.2 change of chloasma area size:
TABLE 14 change of chloasma area before and after tasting
2.3 Security Observation
2.3.1 general case
The subjects in the drug and placebo groups had no significant changes in mental status, sleep, diet, stool and urine before and after the test. Adverse reactions and allergic reactions were not observed in all subjects during the test.
2.3.2 examination of safety-related indices before and after eating trial
Before and after the test eating, a plurality of safety indexes of the liver function, the kidney function, the blood biochemistry, the urine, the defecation convention and the like of the tested person have no obvious change.
2.3.3 No obvious abnormality is seen in the subjects before B-mode ultrasonography in abdomen, electrocardiogram and X-ray chest fluoroscopy.
3. Conclusion
The test results show that the chloasma area of the drug group is obviously reduced averagely and is more than 10%, the color integral is obviously reduced, no new chloasma is generated, and the significant difference exists before and after the test feeding and compared with a blank control group.
In conclusion, the composition has the function of removing chloasma.
Example 3
Chinese angelica root 341g, root of herbaceous peony 341g, cyperus tuber 341g, dodder seed 512g, licorice root 205g
The preparation method of the composition tablet of the embodiment comprises the following steps:
extraction: extracting radix Angelicae sinensis, radix Paeoniae alba, rhizoma Cyperi, semen Cuscutae, and Glycyrrhrizae radix with drinking water for 3 times, adding purified water 12 times the weight of the medicinal materials each time, reflux-extracting for 1.0 hr, and mixing extractive solutions;
concentration: vacuum concentrating the extractive solution to relative density of 1.10-1.20 at 75 deg.C, and filtering to obtain concentrated solution;
impurity removal: adding chitosan solution (the chitosan is prepared into 1% solution with 1% glacial acetic acid solution, the dosage is 1% of the raw material dosage), stirring for 20 min, standing at low temperature for 24 hr, and centrifuging;
concentration: centrifuging the obtained supernatant, and concentrating under reduced pressure at 75 deg.C to obtain extract with relative density of 1.20;
and (3) drying: spreading the concentrated solution on a tray, and drying in a reduced pressure drying mode to obtain a dry extract;
crushing: crushing by a universal crusher, and sieving by a 100-mesh sieve for later use;
mixing: uniformly mixing the dry paste powder and microcrystalline cellulose to obtain uniformly mixed powder for later use;
and (3) granulating: adding purified water into the uniformly mixed powder to prepare a soft material, granulating by using a 20-mesh sieve, drying at 70 ℃, and grading by using the 20-mesh sieve to obtain granules;
tabletting: adding croscarmellose sodium and magnesium stearate, mixing, and tabletting to obtain tablet.
Two function test
1. Materials and methods the same as example 1
2. Results
2.1 analysis of balance between groups before group entry
2.1.1 general data comparison
The general data (sex, age, height, weight, respiration, heart rate, blood pressure, body temperature and course) of the patients in the two groups are compared, and the difference has no statistical significance (P is more than 0.05), which indicates that the general data of the two groups of cases before the patients are in the group have comparability.
2.1.2 comparison of chloasma area and chloasma color before administration
Compared with the prior art, the chloasma area and the chloasma color group have no significant difference (P is more than 0.05), which shows that the prior two groups of subjects have similar disease conditions and better comparability.
2.2 Observation of efficacy:
2.2.1 integral change of the shade of the chloasma color:
TABLE 15 integral change of chloasma color shade before and after tasting
2.2.2 change of chloasma area size:
TABLE 16 change of chloasma area before and after tasting
2.3 Security Observation
2.3.1 general case
The subjects in the drug and placebo groups had no significant changes in mental status, sleep, diet, stool and urine before and after the test. Adverse reactions and allergic reactions were not observed in all subjects during the test.
2.3.2 examination of safety-related indices before and after eating trial
Before and after the test eating, a plurality of safety indexes of the liver function, the kidney function, the blood biochemistry, the urine, the defecation convention and the like of the tested person have no obvious change.
2.3.3 No obvious abnormality is seen in the subjects before B-mode ultrasonography in abdomen, electrocardiogram and X-ray chest fluoroscopy.
3. Conclusion
The test results show that the chloasma area of the drug group is obviously reduced averagely and is more than or equal to 10%, the color integral is obviously reduced, no new chloasma is generated, and the significant difference exists before and after the test feeding and compared with a blank control group.
In conclusion, the composition has the function of removing chloasma.
The above description of the embodiments is only intended to facilitate the understanding of the method of the invention and its core idea. It should be noted that, for those skilled in the art, it is possible to make various improvements and modifications to the present invention without departing from the principle of the present invention, and those improvements and modifications also fall within the scope of the claims of the present invention.
Claims (10)
1. A composition with a chloasma removing function is characterized by comprising, by weight, 1-12 parts of Chinese angelica, 1-15 parts of white paeony root, 1-10 parts of rhizoma cyperi, 1-12 parts of semen cuscutae and 2-10 parts of liquorice.
2. The composition of claim 1, wherein the composition comprises 2-10 parts of angelica sinensis, 2-10 parts of radix paeoniae alba, 2-5 parts of rhizoma cyperi, 2-10 parts of semen cuscutae and 2-5 parts of liquorice.
3. The composition of claim 1, wherein the composition comprises 3.41 parts of angelica sinensis, 3.41 parts of radix paeoniae alba, 3.41 parts of rhizoma cyperi, 5.12 parts of semen cuscutae and 2.05 parts of liquorice.
4. The use of the composition of any one of claims 1-3 in the preparation of a medicament, health product or food with chloasma-removing function.
5. A medicine, health product or food containing the composition with chloasma-removing function according to any one of claims 1 to 3.
6. The medicament, health product or food of claim 5, wherein the medicament, health product or food is selected from oral, injectable or topical dosage forms.
7. The drug, health product or food of claim 6, wherein the drug, health product or food is selected from the group consisting of a buccal tablet, a chewable tablet, an effervescent tablet, a hard capsule, a soft capsule, a granule, a syrup, a medicated wine, and an oral liquid.
8. A process for the preparation of a composition according to any one of claims 1 to 3, comprising the steps of:
extraction: extracting radix Angelicae sinensis, radix Paeoniae alba, rhizoma Cyperi, semen Cuscutae, and Glycyrrhrizae radix with water to obtain extractive solution;
concentration: concentrating the extracting solution to obtain a concentrated solution;
impurity removal: adding a chitosan solution into the concentrated solution, stirring, standing and centrifuging;
and (3) re-concentration: concentrating the supernatant to obtain extract.
9. The method of claim 8, comprising the steps of:
extraction: extracting radix Angelicae sinensis, radix Paeoniae alba, rhizoma Cyperi, semen Cuscutae, and Glycyrrhrizae radix with water for 1-3 times to obtain extractive solution;
concentration: vacuum concentrating the extractive solution to relative density of 1.10-1.20 at 65-75 deg.C, and filtering to obtain concentrated solution;
impurity removal: adding 0.5-1 wt% chitosan solution into the concentrated solution, stirring for 20 min, standing at low temperature for 24 hr, and centrifuging;
and (3) re-concentration: centrifuging the obtained supernatant, and concentrating under reduced pressure at 65-75 deg.C to obtain extract with relative density of 1.10-1.20;
and (3) drying: drying the extract to obtain a dry extract;
crushing: pulverizing, and sieving.
10. The preparation method of the medicine with the function of removing chloasma is characterized by comprising the following steps:
extraction: extracting 3.41 parts of angelica, 3.41 parts of white peony root, 3.41 parts of rhizoma cyperi, 5.12 parts of semen cuscutae and 2.05 parts of liquorice with water for 2 times, adding water with the weight 10 times of that of the medicinal materials for reflux extraction for 2 hours for the first time, adding water with the weight 10 times of that of the medicinal materials for reflux extraction for 2 hours for the second time, and combining the extracting solutions;
concentration: vacuum concentrating the extractive solution to relative density of 1.10-1.20 at 70 deg.C, and filtering to obtain concentrated solution;
impurity removal: preparing 1% chitosan solution with 1% glacial acetic acid solution, adding 0.7% chitosan solution into the concentrated solution, stirring for 20 min, standing at low temperature for 24 hr, and centrifuging;
and (3) re-concentration: centrifuging the obtained supernatant, and concentrating under reduced pressure at 70 deg.C to obtain extract with relative density of 1.25;
and (3) drying: spreading the extract in a tray, and drying at 70 deg.C under reduced pressure to obtain dry extract;
crushing: pulverizing with universal pulverizer, and sieving with 100 mesh sieve to obtain dry extract powder;
mixing: uniformly mixing the dry paste powder and microcrystalline cellulose to obtain uniformly mixed powder for later use;
and (3) granulating: adding water into the uniformly mixed powder to prepare a soft material, granulating by using a 20-mesh sieve, drying at 70 ℃, and grading by using the 20-mesh sieve to obtain granules;
tabletting: adding croscarmellose sodium and magnesium stearate, mixing, and tabletting to obtain tablet.
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| CN1736428A (en) * | 2004-08-17 | 2006-02-22 | 江苏中康药物科技有限公司 | Method for extracting herbal composite medicine for treating chloasma |
| CN104127800A (en) * | 2014-06-16 | 2014-11-05 | 习文忠 | Traditional Chinese medicine composition capable of benefiting qi, beautifying and removing spot |
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| CN105267657A (en) * | 2015-10-16 | 2016-01-27 | 施君平 | Traditional Chinese medicine preparation for treating female endocrine disorders |
| CN110664922A (en) * | 2019-09-24 | 2020-01-10 | 江苏康缘药业股份有限公司 | Composition with chloasma removing function and preparation method and application thereof |
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| CN1736428A (en) * | 2004-08-17 | 2006-02-22 | 江苏中康药物科技有限公司 | Method for extracting herbal composite medicine for treating chloasma |
| CN104127800A (en) * | 2014-06-16 | 2014-11-05 | 习文忠 | Traditional Chinese medicine composition capable of benefiting qi, beautifying and removing spot |
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