WO2021057089A1 - 一种具有祛黄褐斑功能的组合物及其制备方法和应用 - Google Patents
一种具有祛黄褐斑功能的组合物及其制备方法和应用 Download PDFInfo
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/232—Angelica
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/39—Convolvulaceae (Morning-glory family), e.g. bindweed
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/43—Cuscutaceae (Dodder family), e.g. Cuscuta epithymum or greater dodder
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/89—Cyperaceae (Sedge family)
- A61K36/8905—Cyperus (flatsedge)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
Definitions
- the invention relates to the technical fields of medicines, health products and foods, and in particular to a composition with the function of removing chloasma, and a preparation method and application thereof.
- Melasma commonly known as “butterfly spot”, “liver spot” or “pregnancy spot”, mainly occurs on the face, mainly on the cheeks, cheeks, nose, forehead, and chin. It is a brown or black spot with unclear borders. Films are mostly symmetrical. Melasma is a pigmented skin disease. The patient's facial skin will have light brown or brown pigmented spots, sometimes in the shape of butterfly wings. It mostly occurs on the cheeks and forehead, with different sizes and shapes, and some cheeks are symmetrically distributed. Melasma is the most influential color spot among the pigments, which brings a lot of troubles to people's lives, especially young ladies who love beauty.
- the chloasma shape appears on the outside, but its cause is inside. It is a signal of the imbalance of yin and yang in the body's qi and blood, and can reflect the ups and downs of the internal organs. Therefore, finding a reasonable, efficient and safe anti-freckle preparation has become a research hotspot in the fields of pharmacy, health care products and cosmetics.
- One of the objectives of the present invention is to provide a composition with the function of removing chloasma, which is characterized in that, by weight, the composition comprises 1-12 parts of Angelica sinensis, 1-15 parts of Radix Paeoniae Alba, and 1-10 parts of Cyperus rotundus Servings, 1-12 servings of dodder seeds, 2-10 servings of licorice.
- the composition and the raw materials used can be directly ground into powder, or it can be an extract prepared by conventional means or other forms.
- composition comprises 2-10 parts of Angelica sinensis, 2-10 parts of Radix Paeoniae Alba, 2-5 parts of Cyperus rotundus, 2-10 parts of Cuscuta Seed, and 2-5 parts of Licorice.
- the composition comprises 3.41 parts of Angelica sinensis, 3.41 parts of Radix Paeoniae Alba, 3.41 parts of Cyperus rotundus, 5.12 parts of Cuscuta Seed, and 2.05 parts of Licorice.
- the present invention also proposes a medicine, health care product or food containing any one of the aforementioned compositions with the function of removing chloasma.
- the medicine, health care product or food is selected from oral, injection or topical dosage forms.
- composition of the present invention can be prepared by the following method:
- oral health food in the form of commonly used tablets (lozenge, chewable tablet, effervescent tablet), capsule (hard capsule, soft capsule), granule, etc., or it can be made into syrup and alcohol.
- Oral liquid and other oral health foods in the form of liquid preparations can be made into oral health food in the form of commonly used tablets (lozenge, chewable tablet, effervescent tablet), capsule (hard capsule, soft capsule), granule, etc., or it can be made into syrup and alcohol.
- Oral liquid and other oral health foods in the form of liquid preparations in the form of liquid preparations.
- the preparation process of the tablets, capsules, granules and other preparations described in the present invention involving the granulation process can adopt wet granulation or one-step granulation.
- auxiliary materials described in the present invention can be different according to different formulations, such as surfactants, diluents, preservatives, stabilizers, flavoring agents, thickeners, glidants commonly used in liquid formulations such as oral liquids. Agents, etc.; diluents, disintegrants, excipients, binders, lubricants, surfactants, fillers, etc. commonly used in solid preparations such as tablets, capsules, and granules.
- formulations such as surfactants, diluents, preservatives, stabilizers, flavoring agents, thickeners, glidants commonly used in liquid formulations such as oral liquids. Agents, etc.; diluents, disintegrants, excipients, binders, lubricants, surfactants, fillers, etc. commonly used in solid preparations such as tablets, capsules, and granules.
- excipients such as starch, lactose, sucrose, dextrin, maltodextrin, microcrystalline cellulose, mannitol, xylitol, polyethylene glycol, calcium carbonate, modified starch, sorbitol, sodium carboxymethyl cellulose , Hydroxypropyl methyl cellulose, methyl cellulose, ethyl cellulose, sodium starch glycolate, hydroxypropyl cellulose, povidone K30, pregelatinized starch, magnesium stearate, talc, micronized silica gel, Steviol glycosides, betaine, aspartame, citric acid, glycyrrhizin, sodium saccharin, rock sugar, honey, citric acid, sodium bicarbonate, sodium carbonate, carrageenan, agar, gelatin, sodium alginate, xanthan Gum, guar gum, tragacanth, gum arabic, locust bean gum, stearic acid, cross-linked sodium polyacrylate
- the present invention also provides a preparation method of the composition as described in any one of the preceding items, which comprises the following steps:
- Impurity removal the concentrated liquid is added with the chitosan solution and stirred, left to stand, and centrifuged;
- Reconcentration the obtained supernatant is concentrated to obtain an extract.
- preparation method of the composition includes the following steps:
- the extract is concentrated in a vacuum to a relative density of 1.10-1.20 at 65-75°C and filtered to obtain a concentrated solution;
- Impurity removal the concentrated solution is added with 0.5-1% by weight of the original medicinal material chitosan solution, stirring continuously for 20 minutes, standing at low temperature for 24 hours, and centrifuging;
- Reconcentration the obtained supernatant is centrifuged, and again concentrated under reduced pressure at 65-75°C to an extract with a relative density of 1.10-1.20;
- Drying drying the extract to obtain a dry extract
- the preparation method of the composition tablet of the present invention can be: taking the dry powder of Angelica sinensis, Radix Paeoniae Rubra, Cyperus rotundus, Cuscuta Seed and Licorice in parts by weight, sieving, adding appropriate amount of filler, fully mixing, and granulating with purified water, After drying, granulating, adding appropriate amount of lubricant, mixing, tableting, with or without coating, tablets are obtained.
- filler refers to one or more of starch, pregelatinized starch, dextrin, and microcrystalline cellulose
- lubricant refers to one or more of magnesium stearate, micronized silica gel, and talc the above.
- the preparation method of the composition tablet of the present invention can also be: taking the weight parts of Angelica sinensis, Radix Paeoniae Rubra, Cyperus rotundus, Cuscuta Seed, and Licorice dry paste powder, sieving, adding appropriate amount of filler, fully mixing, and granulating with purified water, After drying, granulating, adding appropriate amount of lubricant, mixing, tableting, with or without coating, tablets are obtained.
- the film coating agent is composed of: hydroxypropyl methylcellulose, polyvinyl alcohol, glycerol triacetate, titanium dioxide, fruit green aluminum lake, bright blue aluminum lake, and talc.
- the present invention also provides a method for preparing a medicine with the function of removing chloasma.
- the medicine is selected from tablets and is characterized in that it comprises the following steps:
- the extract is concentrated in a vacuum to a relative density of 1.10-1.20 at 70°C, filtered to obtain a concentrated solution for later use;
- Impurity removal 1% glacial acetic acid solution is used to make a 1% chitosan solution, and 0.7% by weight of the original medicinal material of the chitosan solution is added to the concentrated solution, stirring is continued for 20 minutes, and left standing at low temperature 24 Hours, centrifugation;
- Reconcentration the obtained supernatant is centrifuged, and then concentrated under reduced pressure at 70°C to an extract with a relative density of 1.25;
- Drying spread the extract flatly on a tray, and dry it under reduced pressure at 70°C to obtain a dry extract
- Crushing Use a universal crusher to crush, and get dry paste powder for use after 100 meshes are passed;
- Mixing Mix the dry paste powder and microcrystalline cellulose evenly to obtain a mixed powder for later use;
- Granulation adding water to the mixed powder to prepare soft material, granulating with a 20-mesh sieve, drying at 70°C, and sizing with a 20-mesh sieve to obtain granules;
- Tableting adding croscarmellose sodium and magnesium stearate and mixing them, and then compressing the obtained granules to obtain tablets.
- Angelica sinensis is the dried root of Umbelliferae Angelica sinensis. It is warm in nature, sweet in taste, pungent, Guixin and Spleen Meridian. It has the effects of tonifying blood and promoting blood circulation, regulating menstruation and relieving pain, moistening the intestines and laxative. Used for blood deficiency, chlorosis, dizziness, palpitations, irregular menstruation, amenorrhea and dysmenorrhea. "Jingyue Quanshu ⁇ Materia Medica” records: Angelica sinensis, its taste is sweet and heavy, so it can nourish blood; its qi is light and pungent, so it can move blood. There is movement in nourishment, and nourishment in action. The medicine of Qi in sincerity and blood is also the holy medicine in blood. Angelica may improve skin chloasma by "activating blood and replenishing blood”.
- White peony strengthens the five internal organs, nourishes kidney qi, treats distended heart and belly, eliminates blood congestion, and can eat up pus.
- Modern prescriptions mostly record that white peony has the effects of calming liver and pain, nourishing blood and regulating menstruation, restraining yin and antiperspiration, and is used for headache, dizziness, hypochondriac pain, abdominal pain, limb contraction, blood deficiency and chlorosis, irregular menstruation, spontaneous sweating, night sweats, etc. .
- Paeonia lactiflora may improve the pigmentation of the human body by calming the liver and softening the liver, thereby reducing the formation of chloasma.
- Cyperus rotundus L. is a dry rhizome of Cyperus rotundus L., a perennial herb in the Cyperaceae family. It is pungent, slightly bitter, slightly sweet, and smooth, and has the functions of soothing the liver, regulating qi, regulating menstruation and relieving pain. Xiangfu can regulate menstruation and relieve pain, enhance blood circulation and remove blood stasis. Therefore, it may have a certain effect on the treatment of chloasma
- Cuscuta seeds are pungent and sweet in taste, warm in nature, and belong to the liver, kidney, and spleen meridians. They are listed as top-grade in "Shen Nong's Materia Medica", which has the functions of nourishing the kidney and essence, nourishing the liver and eyesight, strengthening the spleen and consolidating the fetus. Modern medicine proves that Cuscuta can scavenge excessive oxygen free radicals, inhibit the activity of tyrosinase, and then prevent the production of melanin, so it may be used to remove chloasma.
- Licorice is sweet and calming, can nourish the spleen and nourish qi, clear away heat and detoxify, eliminate phlegm and relieve cough, relieve emergency and relieve pain, and reconcile various medicines, so there is also the saying of "ten herbs and nine herbs". Since ancient times, people's research on licorice has never stopped. The main effects of licorice are: replenishing qi and nourishing the middle, expectorating and relieving cough, relieving emergency and relieving pain, relieving medicinal properties, and clearing away heat and detoxification. Licorice can nourish the spleen and qi, clear away heat, and scavenge free radicals, so it may have a certain effect on the treatment of chloasma.
- the present invention proposes a new anti-freckle preparation with reasonable formula, high efficiency and safety, and functional experiments have proved that after using the composition and preparation of the present invention prepared by different processes, the average chloasma area of subjects is obvious Decrease, the color score is significantly decreased, and no new chloasma is produced. There are significant differences before and after the test and compared with the blank control group. Not only that, the present invention also explored various process parameters in the preparation production process, and obtained a better preparation method.
- the present invention also cleverly uses chitosan to remove impurities during the preparation of the composition, thereby effectively retaining and improving the effective substances, which also greatly reduces the daily dosage and ensures the product's health care function of removing chloasma , And the functional test also shows that it has good safety.
- the extraction amount of paeoniflorin is the lowest when the extraction time is 0.5 hours, and the results of 1.0 hour, 1.5 hours, and 2.0 hours are similar. Among them, 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.
- Test method and data According to the prescription ratio of the five-flavored medicinal pieces in Example 1, take 9 copies of 290g each, extract according to the relevant parameters of the L9(34) orthogonal table, and determine the transfer rate of paeoniflorin in the extract. The experimental results are shown in the table 4.
- the factor A3B3C2 is selected, so the factor A3B3C2 is selected, which meets the requirements of industrial production, that is, add 10 times the amount of water each time, and extract 2 times by reflux , 2 hours each time.
- Extraction process verification According to the orthogonal optimization results, three batches of verification experiments were carried out. The medicinal materials were added with 10 times the amount of water, and the medicinal materials were extracted twice, 2h each time. The decoction was filtered and combined, and the transfer of paeoniflorin was determined. Rate to verify the feasibility of the extraction process. The experimental results are shown in Table 5.
- the verification results show that the optimized extraction process is used for verification, the transfer rate of paeoniflorin in the extract is consistent with the results of the orthogonal test and the three verification tests are relatively stable, indicating that the extraction process is stable and feasible.
- the concentration temperature conditions of the composition were studied, taking the transfer rate of paeoniflorin as an indicator, taking the same amount of extract and using a rotary evaporator to concentrate, and the concentration temperature was set to 60, 70 , 80°C, and the final concentration density is 1.05.
- the experimental results are shown in Table 6.
- the concentration of the extract of this product is concentrated under reduced pressure.
- the water extract contains the active ingredient of paeoniflorin. From the table, it can be seen that the transfer rate of paeoniflorin is not much different when the temperature is 60 and 70°C, and the temperature is 80. At °C, the transfer rate of paeoniflorin will decrease. Considering the improvement of production efficiency and the maximum retention of index components, we choose to concentrate at 70°C.
- the preparation process of the composition of the present invention is stable and feasible, preferably: 10 times the amount of water, extracted twice, once for 2 hours; the concentration temperature is 70 ⁇ 5°C; the drying temperature is set to 70 ⁇ 5 °C.
- microcrystalline cellulose has the best effect, so 30% by weight of microcrystalline cellulose is selected as the product. Thinner.
- lubricants such as magnesium stearate, silicon dioxide, etc. need to be added.
- 1% stearin is selected for this product Magnesium acid acts as a lubricant.
- the composition is an extract of Chinese medicinal materials.
- the disintegration time of the plain tablet is 40-50 minutes, and the disintegration time is longer. Therefore, it is necessary to increase the disintegrant to improve the disintegration of the tablet.
- Dry starch, hydroxypropyl methylcellulose and croscarmellose sodium are selected, and the disintegrant has the effect of dispersing and diluting the powder of the Chinese medicine extract.
- Dry starch, hydroxypropyl methyl cellulose and croscarmellose sodium are respectively added at 7% during granulation using the internal addition method added during granulation and the external addition method after granulation mixing, and the disintegration of the tablet is detected by the disintegrant
- Table 10 The influence of time is shown in Table 10.
- croscarmellose sodium has a better effect on the disintegration time of tablets, and the disintegration time is within 30 minutes. Therefore, the influence of comprehensive excipients on tablet compression and disintegration
- croscarmellose sodium is used as a disintegrant. Judging from the effect of the way of disintegrant addition on the disintegration time, the internal addition and external addition of croscarmellose sodium have little effect on the disintegration time of the preparation, so it is preferable to add 7% croscarmellose externally.
- the sodium methylcellulose is granulated and compressed to ensure the disintegration time of the tablet.
- the preferred process of the composition includes: Angelica sinensis, Radix Paeoniae Alba, Cyperus rotundus, Cuscuta Seed and Licorice extracts are mixed in proportions and mixed with microcrystalline cellulose uniformly, granulated with purified water, and dried and then added The sodium carboxymethyl cellulose and magnesium stearate are granulated with a 20-mesh sieve, tableted, coated, and packaged to obtain the finished product.
- Angelica 341g White Peony 341g, Cyperus rotundus 341g, Cuscuta 512g, Licorice 205g
- the extract is concentrated in a vacuum to a relative density of 1.10-1.20 at 70°C, filtered to obtain a concentrated solution for later use;
- Impurity removal Concentrate and chitosan solution (1% glacial acetic acid solution is used for chitosan to make a 1% solution, the dosage is 0.7% of the original medicinal material dosage), keep stirring for 20 minutes, and let stand at low temperature for 24 hours , Centrifugal;
- Drying spread the concentrated solution flat on a tray, and dry it under reduced pressure at 70°C to obtain a dry extract
- Crushing use a universal crusher to crush, pass 100 meshes, and spare;
- Mixing Mix the dry paste powder and microcrystalline cellulose uniformly to obtain a mixed powder for later use;
- Granulation adding purified water to the mixed powder to prepare soft material, granulating with a 20-mesh sieve, drying at 70°C, and sizing with a 20-mesh sieve to obtain granules;
- Tableting adding croscarmellose sodium and magnesium stearate, mixing, and compressing the obtained granules to obtain tablets, 0.89g/tablet.
- test group took the corresponding drugs according to regulations, and the test period was 30 days, 2 times a day, 3 tablets each time (equivalent to 17.4g crude drug/day).
- the subjects stopped using other oral and topical cosmetics and freckle removal products during the trial period. During the trial period, they did not change their original eating habits and ate normal.
- red blood cell count (RBC), hemoglobin (HB), white blood cell count (WBC), urine and stool routine.
- HB red blood cell count
- WBC white blood cell count
- liver and kidney function serum albumin ALB, total protein TP, liver and kidney function (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).
- Detection of the size of the chloasma area on the face use a ruler to measure the area of the chloasma on the face before and after the test (mm 2 ).
- the area of chloasma in the drug group was reduced on average, and was greater than or equal to 10%, and the color score was significantly reduced.
- the difference between itself before and after and compared with the blank control group was significant, and no new chloasma was produced, it was determined that the composition of the present invention Has the function of removing chloasma;
- the test results showed that the average chloasma area of the drug group was significantly reduced, and it was greater than 10%, as high as 26.82%, the color score was significantly reduced, and no new chloasma was produced.
- the comparison before and after the test and the comparison with the blank control group were both Significant difference.
- composition of the present invention has the function of removing chloasma.
- Angelica 341g White Peony 341g, Cyperus rotundus 341g, Cuscuta 512g, Licorice 205g
- the extract is concentrated in a vacuum to a relative density of 1.10-1.20 at 65°C, filtered to obtain a concentrated solution for later use;
- Decontamination Add chitosan solution to the concentrated solution (1% glacial acetic acid solution is used to make chitosan a 1% solution, and the amount is 0.5% of the original medicinal material dosage), keep stirring for 20 minutes, and let stand at low temperature for 24 hours , Centrifugal;
- Drying spread the concentrated solution flat in a tray, and dry it under reduced pressure to obtain a dry extract
- Crushing use a universal crusher to crush, pass 100 meshes, and spare;
- Mixing Mix the dry paste powder and microcrystalline cellulose uniformly to obtain a mixed powder for later use;
- Granulation adding purified water to the mixed powder to prepare soft material, granulating with a 20-mesh sieve, drying at 65°C, and sizing with a 20-mesh sieve to obtain granules;
- Filling add croscarmellose sodium and magnesium stearate, mix well, and can fill the obtained granules to obtain capsules.
- test results showed that the area of chloasma in the drug group was significantly reduced on average, and was greater than 10%, the color score was significantly decreased, and no new chloasma was produced. There were significant differences before and after the test and compared with the blank control group.
- composition of the present invention has the function of removing chloasma.
- Angelica 341g White Peony 341g, Cyperus rotundus 341g, Cuscuta 512g, Licorice 205g
- the extract is concentrated in a vacuum to a relative density of 1.10-1.20 at 75°C, filtered to obtain a concentrated solution for later use;
- Decontamination Add chitosan solution to the concentrated solution (1% glacial acetic acid solution is used to make chitosan into a 1% solution, and the amount is 1% of the original medicinal material dosage), keep stirring for 20 minutes, and let stand at low temperature for 24 hours , Centrifugal;
- Drying spread the concentrated solution flat in a tray, and dry it under reduced pressure to obtain a dry extract
- Crushing use a universal crusher to crush, pass 100 meshes, and spare;
- Mixing Mix the dry paste powder and microcrystalline cellulose uniformly to obtain a mixed powder for later use;
- Granulation adding purified water to the mixed powder to prepare soft material, granulating with a 20-mesh sieve, drying at 70°C, and sizing with a 20-mesh sieve to obtain granules;
- Tableting adding croscarmellose sodium and magnesium stearate, mixing them, and compressing the obtained granules to obtain tablets.
- test results showed that the area of melasma in the drug group was significantly reduced on average, and was greater than or equal to 10%, the color score was significantly reduced, and no new melasma was produced. There were significant differences before and after the test and compared with the blank control group. .
- composition of the present invention has the function of removing chloasma.
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Abstract
一种具有祛黄褐斑功能的组合物，包括当归1-12份、白芍1-15份、香附1-10份、菟丝子1-12份、甘草2-10份。含有该组合物的药物、保健品和食品选自含片、咀嚼片、泡腾片、硬胶囊、软胶囊剂、颗粒剂、糖浆、酒剂、口服液。实验证明，该组合物及其制剂能够使受试者平均黄褐斑面积明显减少，颜色积分明显下降，且不产生新的黄褐斑，与空白对照组比较有显著性差异。
Description
本发明涉及药品、保健品和食品技术领域，具体而言，涉及一种具有祛黄褐斑功能的组合物及其制备方法和应用。
黄褐斑俗称“蝴蝶斑”、“肝斑”或者“妊娠斑”，主要发生在面部，以颧部、颊部、鼻、前额、颏部为主，为边界不清楚的褐色或黑色的斑片，多为对称性。黄褐斑是一种色素性皮肤病，患者面部皮肤会出现淡褐色或褐色的色素斑，有时呈蝶翼状。多发生在脸颊与额头，大小形状不一，有的面颊部呈对称分布。黄褐斑是色素中最影响容貌的色斑，给人们生活带来不少烦恼，尤其是年轻的爱美女士。
中医认为，黄褐斑的发生原因，有因外受风邪(风热、风寒)，气血不和而使气血不能上呈于脸部者；有因饮食不节、偏嗜五味、劳倦过度或人到中年以后肾精亏损者，颜面不得滋润而生斑者，或因情志不遂、郁怒伤肝，忧思伤脾，惊恐伤肾等都可气机逆乱，或长期紧张、压抑等不良情绪，也可严重扰乱正常的内分泌，也是黄褐斑持续不消的重要原因之一。黄褐斑形现于外，而其因却在内，它是体内气血阴阳失调的信号，并可以反映脏腑功能的盛衰。因此，寻找组方合理、高效安全的祛斑制剂，已成为目前药学、保健品、化妆品领域的一个研究热点。
发明内容
本发明目的之一在于提供一种具有祛黄褐斑功能的组合物，其特征在于，以重量计，所述组合物包括当归1-12份、白芍1-15份、香附1-10份、菟丝子1-12份、甘草2-10份。其中，该组合物以及所用的原料可以直接研磨成粉，也可以是经过常规手段制得的提取物或其它形态等。
进一步地，所述组合物包括当归2-10份、白芍2-10份、香附2-5份、菟丝子2-10份、甘草2-5份。
优选地，所述组合物包括当归3.41份、白芍3.41份、香附3.41份、菟丝子5.12份、甘草2.05份。
如前任意一项组合物在制备具有祛黄褐斑功能的药物、保健品或食品中的应用。
本发明还提出了一种含有如前任意一项具有祛黄褐斑功能的组合物的药物、保健品或食品。
具体地，所述述药物、保健品或食品选自口服、注射或外用剂型。
本发明的组合物可以采用如下方法制备：
取所述重量份的当归、白芍、香附、菟丝子、甘草，经提取，浓缩，干燥，粉碎，过筛，加入适量填充剂，充分混合，制粒，干燥过筛，混合，不加或者加入适量辅料，按常规工艺制成药剂学上可接受的制剂。
如可以制成常用的片剂(含片、咀嚼片、泡腾片)、胶囊剂(硬胶囊、软胶囊剂)、颗粒剂等固体制剂形式的口服保健食品，也可以制成糖浆、酒剂、口服液等液体制剂形式的口服保健食品。
本发明中所述的片剂、胶囊剂、颗粒剂等制剂的制备工艺中涉及制粒工艺的可采用湿法制粒或者一步制粒。
本发明中所述的辅料，可以根据不同的制剂有所不同，如口服液等液体 制剂形式中常用的表面活性剂、稀释剂、防腐剂、稳定剂、矫味剂、增稠剂、助流剂等；在片剂、胶囊剂、颗粒剂等固体制剂中常用的稀释剂、崩解剂、赋形剂、粘合剂、润滑剂、表面活性剂、填充剂等。
常用的辅料如淀粉、乳糖、蔗糖、糊精、麦芽糊精、微晶纤维素、甘露醇、木糖醇、聚乙二醇、碳酸钙、改良淀粉、山梨醇、、羧甲基纤维素钠、羟丙甲基纤维素、甲基纤维素、乙基纤维素、羧甲淀粉钠、羟丙基纤维素、聚维酮K30、预胶化淀粉、硬脂酸镁、滑石粉、微粉硅胶、甜叶菊苷、甜菜碱、阿斯巴甜、柠檬酸、甘草甜素、糖精钠、冰糖、蜂蜜、枸橼酸、碳酸氢钠、碳酸钠、卡拉胶、琼脂、明胶、海藻酸钠、黄原胶、瓜耳豆胶、西黄耆胶、阿拉伯胶、槐豆胶、硬脂酸、交联型聚丙烯酸钠、聚乙烯醇、卡波姆、山梨酸、山梨酸钾、羟苯乙酯、苯甲醇、甘油、丙二醇等。
本发明还提出了如前任意一项所述的组合物的制备方法，其包括以下步骤：
提取：当归、白芍、香附、菟丝子、甘草用水提取，得提取液；
浓缩：所述提取液浓缩后，得浓缩液；
去杂：所述浓缩液加壳聚糖溶液搅拌、静置、离心；
再浓缩：所得上清液浓缩，得浸膏。
进一步地，所述的组合物的制备方法包括以下步骤：
提取：当归、白芍、香附、菟丝子、甘草用水提取1-3次，得提取液；
浓缩：所述提取液采用真空浓缩至65-75℃下相对密度为1.10-1.20，过滤，得浓缩液；
去杂：浓缩液加原药材0.5-1％重量比的壳聚糖溶液，持续搅拌20分钟，低温静置24小时，离心；
再浓缩：所得上清液离心，再次65-75℃减压浓缩至相对密度为1.10-1.20 的浸膏；
干燥：将所述浸膏干燥，得到干浸膏；
粉碎：粉碎，过筛。
本发明组合物片剂的制备方法可以为：取所述重量份的当归、白芍、香附、菟丝子、甘草的干膏粉，过筛，加入适量填充剂，充分混合，纯化水制粒，干燥，整粒，加入适量润滑剂，混匀，压片，包衣或不包衣，即得片剂。其中，填充剂是指淀粉、预胶化淀粉、糊精、微晶纤维素中的一种或一种以上；润滑剂是指硬脂酸镁、微粉硅胶、滑石粉中的一种或一种以上。
本发明组合物片剂的制备方法还可以为：取所述重量份的当归、白芍、香附、菟丝子、甘草干膏粉，过筛，加入适量填充剂，充分混合，纯化水制粒，干燥，整粒，加入适量润滑剂，混匀，压片，包衣或不包衣，即得片剂。其中，薄膜包衣剂的组成为：羟丙基甲基纤维素，聚乙烯醇，三乙酸甘油酯，二氧化钛，果绿铝色淀，亮蓝铝色淀，滑石粉。
本发明还提出了一种具有祛黄褐斑功能的药物的制备方法，所述药物选自片剂，其特征在于，包括以下步骤：
提取：当归3.41份、白芍3.41份、香附3.41份、菟丝子5.12份、甘草2.05份用水提取2次，第一次加药材重量10倍量水回流提取2小时，第二次加药材重量10倍水回流提取2小时，合并提取液；
浓缩：所述提取液采用真空浓缩至70℃下相对密度为1.10-1.20，过滤，得浓缩液备用；
去杂：用1％冰醋酸溶液制成浓度为1％的壳聚糖溶液，将原药材0.7％重量比的所述壳聚糖溶液加入所述浓缩液，持续搅拌20分钟，低温静置24小时，离心；
再浓缩：所得上清液离心，再次70℃下减压浓缩至相对密度为1.25的 浸膏；
干燥：将所述浸膏平铺于托盘中，70℃下采用减压干燥的方式干燥，得到干浸膏；
粉碎：采用万能粉碎机粉碎，过100目，得干膏粉备用；
混合：将所述干膏粉、微晶纤维素混合均匀，得混匀粉末备用；
制粒：所述混匀粉末中加入水制备软材，用20目筛进行制粒，70℃烘干，用20目筛进行整粒，得颗粒；
压片：加入交联羧甲基纤维素钠、硬脂酸镁混匀，将所得颗粒进行压片，得片剂。
本发明中各组分有如下特点：
当归为伞形科植物当归的干燥根，其性温，味甘，辛，归心、脾经。具有补血活血，调经止痛，润肠通便的功效，为血中气药、补血要药。用于血虚萎黄，眩晕心悸，月经不调，经闭痛经。《景岳全书·本草正》记载：当归，其味甘而重，故专能补血；其气轻而辛，故又能行血。补中有动，行中有补，诚血中之气药，亦血中之圣药也。当归或可通过“活血补血”的方式改善皮肤黄褐斑。
白芍强五脏，补肾气，治心腹坠胀，消淤血，能蚀脓。现代方书多记载白芍具有平肝止痛、养血调经、敛阴止汗之功效，用于头痛眩晕，胁痛，腹痛，四肢挛痛，血虚萎黄，月经不调，自汗，盗汗等。白芍或可通过平肝柔肝来改善人体色素沉着，进而减少黄褐斑的形成。
香附为莎草科多年生草本莎草Cyerus rotundus L.的干燥根茎，性辛、微苦、微甘、平，归肝、三焦经，具有疏肝理气，调经止痛的作用。香附能够调经止痛，增强活血化瘀作用，因此，可能对治疗黄褐斑有一定的作用
菟丝子，味辛、甘，性微温，归肝、肾、脾经，在《神农本草经》中被 列为上品，具有补肾益精，养肝明目，健脾固胎的作用。现代医学证明菟丝子能清除过多的氧自由基，抑制酪氨酸酶的活性，进而阻止黑色素的生成，因而可能被用于祛除黄褐斑。
甘草性甘，平，可补脾益气，清热解毒，祛痰止咳，缓急止痛，调和诸药，故又有“十药九草”之说法。从古至今，人们对甘草的研究从未间断过。甘草的主要功效有：益气补中、祛痰止咳、缓急止痛、缓和药性和清热解毒等。甘草能补脾益气，清热，清除自由基，因而对治疗黄褐斑可能有一定的作用。
本发明提出了一种新的组方合理、高效安全的祛斑制剂，并通过功能实验证明，在使用不同工艺制得的本发明的组合物及其制剂后，受试者平均黄褐斑面积明显减少，颜色积分明显下降，且不产生新的黄褐斑，试食前后比较及与空白对照组比较，均有显著性差异。不仅如此，本发明还对制剂生产过程中的各项工艺参数进行了摸索，得到了较优的制备方法。而且，本发明还在组合物制备过程巧妙地应用壳聚糖进行除杂，从而有效地保留并提高的有效物质，这也使得日服用剂量大大减少，并保证产品的祛黄褐斑的保健功能，且功能试验也表明其具有良好的安全性。
以下通过具体实施方式对本发明进行更加详细的说明，以便能够更好地理解本发明的方案及其各个方面的优点。然而，以下描述的具体实施方式的内容仅是说明的目的，而不是对本发明的限制。
需要注意的是，如未注明具体条件者，均按照常规条件或制造商建议的条件进行，所用原料或辅料，以及所用试剂或仪器未注明生产厂商者，均为可以通过市购获得的常规产品。除非另外说明，否则所有的百分数、比率、 比例或份数按重量计。
除非另行定义，文中所使用的所有专业与科学用语与本领域熟练人员所熟悉的意义相同。此外，任何与所记载内容相似或均等的方法及材料皆可应用与本发明。
提取制备工艺的考察
1提取工艺条件单因素考察
1.1煎煮时间单因素考察
采用实施例1所述处方比例的原药材，用10倍量纯化水提取2次，以芍药苷提取量为指标，采用单因素试验方案，对提取时间进行考察，取相同处方量的药材，保持料液比一致，提取时间分别考察0.5小时、1小时、1.5小时、2小时，实验结果见表1。
表1提取时间单因素试验
结论：提取时间为0.5小时时芍药苷提取量最低，1.0小时、1.5小时、2.0小时的结果相近，其中提取1.5小时时，芍药苷的提取量最高，因此1.5h的煎煮时间最佳。
1.2溶剂倍量考察
取实施例1所述处方比例的药材，提取时间设置为1.5小时，溶剂倍量设置为6倍、8倍、10倍，提取2次，采用单因素试验的方案进行考察，以芍药苷提取量为指标。实验结果见表2。
表2溶剂倍量考察试验
结论：通过表中数据可知，10倍加水量时芍药苷提取最高，而8倍量加水量时为551.85mg，与10倍量相近，从实际生产考虑，选择料液比为8倍量时符合实际生产，因此选择8倍量作为工艺参数。
2提取工艺正交试验考察
根据提取工艺单因素研究的结果及文献资料，以芍药苷转移率为考察指标，采用L9(34)正交试验方案，对料液比、提取时间、提取次数进行考察。因素水平见表3。
表3因素水平表
试验方法及数据：按实施例1五味药材饮片所述处方比例取9份各290g，按L9(34)正交表相关参数要求进行提取，测定提取液中芍药苷的转移率，实验结果见表4。
表4正交试验表
结论：以从表4可以看出，提取液中芍药苷的转移率为指标进行考察，各因素对提取工艺的影响极差R值为；C>B>A，药材提取次数(因素C)的极差最大，各因素中C3>C2>C1、B3>B2>B1、A3>A2>A1，故直观分析最佳提取工艺为A3B3C3，由于提取一次与提取两次、提取三次之间的相差较大，而提取2次与提取3次相差不大，从节约成本和提高效率考虑，选择因素A3B3C2，所以选择因素A3B3C2，符合工业化生产的要求，即每次加10倍量水，回流提取2次，每次2小时。
提取工艺验证：按正交优选的结果，进行三个批次的验证实验，药材加10倍量水，回流提取2次，每次2h，煎煮液滤过，合并，测定其中芍药苷的转移率，以验证提取工艺的可行性。实验结果见表5。
表5提取工艺验证试验
验证结果表明，采用优选后的提取工艺进行验证，提取液中芍药苷转移率与正交试验结果一致且三次验证试验比较稳定，说明了该提取工艺稳定可行。
3药材煎煮液浓缩工艺确定
在上述优选的提取工艺条件下，对该组合物的浓缩温度条件进行研究，以芍药苷的转移率为指标，取相同量的提取液，采用旋转蒸发仪进行浓缩，浓缩温度设置为60、70、80℃，最终浓缩密度为1.05，实验结果见表6。
表6浓缩温度试验考察
结论：本品提取液的浓缩工艺条件选择减压浓缩，水提取液中含有芍药苷活性成分，从表中可知，温度在60和70℃时，芍药苷的转移率相差不大，温度为80℃时，芍药苷的转移率减少，从提高生产效率及有利于最大程度保留指标性成分考虑，我们选择在70℃条件浓缩。
4药材浓缩液干燥工艺确定
根据文献报道并结合生产设备实际情况，选择在70℃条件减压干燥。按照选定的干燥方法进行三批工艺验证，并计算干燥前后有效成分的含量，经过三批工艺验证试验，表明干燥工艺稳定可行，实验结果见表7。
表7三批样品干燥工艺验证结果
综上所述，经过前述试验：本发明组合物的制备工艺稳定可行，优选为：10倍量水，提取2次，一次2小时；浓缩温度为70±5℃；干燥温度设为70±5℃。
5制粒工艺研究
5.1辅料的选择
经过试验研究，需加入适当的辅料，以克服在制剂过程中细粉粘冲、片重差异大、片剂崩解困难等问题。在稀释剂的选择过程中，我们根据中间体的性质，选择淀粉、蔗糖、微晶纤维素等制药常用辅料，对三种辅料进行试 验，实验结果见表8。
表8稀释剂的选择及试验结果
试验结果可知，选用不同的辅料，对制剂的制粒、压片、崩解均产生一定的影响，采用微晶纤维素的效果最好，因此选择30％重量比的微晶纤维素作为本产品稀释剂。
5.2润湿剂的选择
取药材粉适量(3份)分别加入纯化水及不同浓度乙醇为润湿剂，用20目筛网制粒(并观察制软材情况及软材过筛情况)，于65±5℃干燥，再通过20目筛整粒，收集颗粒称重，计算颗粒合格率，实验结果见表9。
表9润湿剂考察情况
结果表明，用90％、50％的乙醇制粒困难，纯化水制粒容易，为制颗粒的最佳湿润剂。
5.3润滑剂的选择
经过小试实验发现，在制粒过程中颗粒的流动性差，因此需要添加润滑剂，如硬脂酸镁、二氧化硅等，根据参考文献及颗粒的物料性质，本产品选择1％的硬脂酸镁作为润滑剂。
5.4崩解剂的选择
该组合物为中药材提取物，素片崩解时间在40-50分钟，崩解时间较长，因此需要增加崩解剂以改善片剂崩解情况。选用干淀粉、羟丙基甲基纤维素和交联羧甲基纤维素钠，崩解剂对中药提取物粉末有分散稀释的作用。干淀粉、羟丙基甲基纤维素和交联羧甲基纤维素钠分别按7％采用制粒时加入的内加法和制粒后混合的外加法，并检测崩解剂对片剂崩解时间的影响，见表10。
表10崩解剂考察情况
试验结果表明，在相同辅料用量情况下，交联羧甲基纤维素钠对片剂的崩解时限的影响效果较好，崩解时间在30min内，因此综合辅料对压片及崩解的影响，优选交联羧甲基纤维素钠作为崩解剂。从崩解剂加入方式对崩解时间的影响结果看，交联羧甲基纤维素钠选用内加法和外加法对本制剂的崩解时间的影响较小，因此优选外加法加入7％交联羧甲基纤维素钠进行制粒、压片，能够保证片剂的崩解时间。
通过以上的制剂工艺研究，确定该组合物的优选工艺包括：当归、白芍、香附、菟丝子和甘草提取物按比例混合加入微晶纤维素混合均匀，以纯化水制粒，干燥后加入交联羧甲基纤维素钠和硬脂酸镁，以20目筛整粒，压片、包衣、包装既得成品。
实施例1
一组合物片剂的制备
当归341g、白芍341g、香附341g、菟丝子512g、甘草205g
本实施例组合物片剂的制备方法包括：
提取：当归、白芍、香附、菟丝子、甘草用饮用水提取2次，第一次加药材重量10倍量纯化水回流提取2.0小时，第二次加药材重量10倍饮用水回流提取2.0小时，合并提取液；
浓缩：所述提取液采用真空浓缩至70℃下相对密度为1.10-1.20，过滤，得浓缩液备用；
去杂：浓缩液加壳聚糖溶液(壳聚糖用1％冰醋酸溶液制成浓度为1％的溶液，用量为原药材投料量的0.7％)，持续搅拌20分钟，低温静置24小时，离心；
浓缩：所得上清液离心再次70℃减压浓缩至相对密度为1.25的浸膏
干燥：将所述浓缩液平铺与托盘中，70℃下采用减压干燥的方式干燥，得到干浸膏；
粉碎：采用万能粉碎机粉碎，过100目，备用；
混合：将所述干膏粉、微晶纤维素混合均匀，得混匀粉末备用；
制粒：所述混匀粉末中加入纯化水制备软材，用20目筛进行制粒，70℃烘干，用20目筛进行整粒，得颗粒；
压片：加入交联羧甲基纤维素钠、硬脂酸镁，混匀，将所得颗粒进行压片，得片剂，0.89g/片。
二功能试验
1、材料与方法
1.1样品
药物组(按照本发明实施例1制备得到)；
空白对照组。
1.2受试者选择
1.2.1纳入标准：
经体检符合下列条件的自愿受试者。
面部淡褐色至深褐色，界限清楚的斑片，通常对称性分布，无炎性表现及鳞屑；无明显自觉症状；主要发生在青春期后，女性多发；病情有一定的季节性，夏重冬轻；无明显内分泌疾病，并排出其它疾病引起的色素沉着。
1.2.2排除标准：年龄在18岁以下或65岁以上者，妊娠或哺乳期妇女，过敏体质及对本保健食品过敏者；合并有心血管、脑血管、肝、肾和造血系统等严重疾病及内分泌疾病，精神病患者；嗜酒者或吸烟者；短期内服用与受试功能有关的物品，影响到对结果的判断者；未按规定服用受试物，无法判定功效或资料不全影响功效或安全性判断者。
1.3试验设计及分组
采用自身和组间两种对照设计。按受试者的黄褐斑颜色、面积情况随机分为药物组、和空白对照组，尽可能考虑影响结果的主要因素如户外活动情况、年龄等，进行均衡性检验，以保证组间的可比性。每组受试者不少于50例。
1.4试验方法
各试食组按照规定服用相对应的药物，试食周期均为30天，每日2次，每次3片(相当于17.4g生药/日)。受试者在试食期间停止使用其它口服及外用有关养颜祛斑的用品，试食期间不改变原来的饮食习惯，正常饮食。
1.5仪器与试剂
全自动生化分析仪，生化试剂盒，全自动血球分析仪，尿液化学分析仪，B超机，X线透视机，心电图机。
1.6观察指标
1.6.1安全性指标
1.6.1.1一般状况：包括精神、睡眠、饮食、大小便、血压等。
1.6.1.2血、尿、便常规检查：红细胞计数(RBC)、血红蛋白(HB)、白细胞计数(WBC)，尿、大便常规。
1.6.1.3肝、肾功能等生化指标检查：血清白蛋白ALB，总蛋白TP，肝肾功能(谷丙转氨酶ALT，谷草转氨酶AST，尿素氮BUN，肌酐CRE)，血糖GLU、血脂(总胆固醇TC、甘油三酯TG、高密度脂蛋白胆固醇HDL-C)。
1.6.1.4胸透、心电图、腹部B超检查(仅试验前检查一次)
1.6.2功效性指标
1.6.2.1颜面部黄褐斑面积大小检测：用标尺测量受试前后整个颜面部黄褐斑的面积(mm
2)。
1.6.2.2颜面部黄褐斑颜色深浅检测：按照中国科学院地理研究所设计研制，测绘出版社1992年出版的《实用标准色卡》(第一版)中的棕色(Y+M+Bk即黄+品红+黑的叠色)色卡为黄褐斑深浅的判断标准：I度(15、20、5)，II度(30、40、10)，III度(40、60、15)。
1.7数据处理和结果判定
1.7.1数据处理
对试食前后黄褐斑颜色积分和面积变化进行统计，同时计算有效率。色卡I度、II度和III度分别计分为1分、2分和3分。结果用均值±标准差表示。计量资料用t检验，有效率用χ2检验。
1.7.2功效判定标准：
有效：黄褐斑颜色下降I度，面积减少大于10％，且不产生新的黄褐斑。
无效：黄褐斑颜色及面积无明显变化或加重。
1.7.3结果判定：
药物组黄褐斑面积平均减少，且大于等于10％，颜色积分明显下降，自身前后比较及与空白对照组比较，差别均有显著性，且不产生新的黄褐斑，判定本发明组合物具有祛黄褐斑功能；
2、结果
2.1入组前组间均衡性分析
2.1.1一般资料比较
两组入组患者的一般资料(性别、年龄、身高、体重、呼吸、心率、血压、体温、病程)比较，差异均无统计学意义(P＞0.05)，说明入组前两组病例一般资料具有可比性。
2.1.2入组前黄褐斑面积及黄褐斑颜色比较
入组前黄褐斑面积及黄褐斑颜色组间比较均无显著性差异(P＞0.05)，说明入组前两组受试者的病情相近，具有较好可比性。
2.2功效观察：
2.2.1黄褐斑颜色深浅度积分变化：
表11试食前后黄褐斑颜色深浅度积分变化
2.2.2黄褐斑面积大小变化：
表12试食前后黄褐斑面积大小变化
2.3安全性观察
2.3.1一般情况
药物组和空白对照组受试对象在试验前、后的精神状况、睡眠、饮食、大小便等情况无明显改变。试验过程中所有受试对象均未见不良反应及过敏反应。
2.3.2试食前后安全性相关指标检查
试食前后，受试者肝功能、肾功能、血液生化、尿、便常规等多项安全性指标均未见明显变化。
2.3.3腹部B超、心电图、X线胸部透视试食前受试者均未见明显异常。
3、结论
试验结果显示，药物组平均黄褐斑面积明显减少，且大于10％，高达26.82％，颜色积分明显下降，且不产生新的黄褐斑，试食前后比较及与空白对照组比较，均有显著性差异。
综上，本发明组合物具有祛黄褐斑的功能。
实施例2
一组合物胶囊剂的制备
当归341g、白芍341g、香附341g、菟丝子512g、甘草205g
本实施例组合物胶囊剂的制备方法包括：
提取：当归、白芍、香附、菟丝子、甘草用饮用水提取1次，加药材重量8倍量纯化水回流提取3.0小时；
浓缩：所述提取液采用真空浓缩至65℃下相对密度为1.10-1.20，过滤，得浓缩液备用；
去杂：浓缩液加壳聚糖溶液(壳聚糖用1％冰醋酸溶液制成浓度为1％的 溶液，用量为原药材投料量的0.5％)，持续搅拌20分钟，低温静置24小时，离心；
浓缩：所得上清液离心再次65℃减压浓缩至相对密度为1.20的浸膏；
干燥：将所述浓缩液平铺与托盘中，采用减压干燥的方式干燥，得到干浸膏；
粉碎：采用万能粉碎机粉碎，过100目，备用；
混合：将所述干膏粉、微晶纤维素混合均匀，得混匀粉末备用；
制粒：所述混匀粉末中加入纯化水制备软材，用20目筛进行制粒，65℃烘干，用20目筛进行整粒，得颗粒；
灌装：加入交联羧甲基纤维素钠、硬脂酸镁，混匀，将所得颗粒进行罐装，得胶囊剂。
二功能试验
1、材料与方法同实施例1
2、结果
2.1入组前组间均衡性分析
2.1.1一般资料比较
两组入组患者的一般资料(性别、年龄、身高、体重、呼吸、心率、血压、体温、病程)比较，差异均无统计学意义(P＞0.05)，说明入组前两组病例一般资料具有可比性。
2.1.2入组前黄褐斑面积及黄褐斑颜色比较
入组前黄褐斑面积及黄褐斑颜色组间比较均无显著性差异(P＞0.05)，说明入组前两组受试者的病情相近，具有较好可比性。
2.2功效观察：
2.2.1黄褐斑颜色深浅度积分变化：
表13试食前后黄褐斑颜色深浅度积分变化
2.2.2黄褐斑面积大小变化：
表14试食前后黄褐斑面积大小变化
2.3安全性观察
2.3.1一般情况
药物组和空白对照组受试对象在试验前、后的精神状况、睡眠、饮食、大小便等情况无明显改变。试验过程中所有受试对象均未见不良反应及过敏反应。
2.3.2试食前后安全性相关指标检查
试食前后，受试者肝功能、肾功能、血液生化、尿、便常规等多项安全性指标均未见明显变化。
2.3.3腹部B超、心电图、X线胸部透视试食前受试者均未见明显异常。
3、结论
试验结果显示，药物组黄褐斑面积平均明显减少，且大于10％，颜色积 分明显下降，且不产生新的黄褐斑，试食前后比较及与空白对照组比较，均有显著性差异。
综上，本发明组合物具有祛黄褐斑的功能。
实施例3
当归341g、白芍341g、香附341g、菟丝子512g、甘草205g
本实施例组合物片剂的制备方法包括：
提取：当归、白芍、香附、菟丝子、甘草用饮用水提取3次，每次加药材重量12倍量纯化水回流提取1.0小时，合并提取液；
浓缩：所述提取液采用真空浓缩至75℃下相对密度为1.10-1.20，过滤，得浓缩液备用；
去杂：浓缩液加壳聚糖溶液(壳聚糖用1％冰醋酸溶液制成浓度为1％的溶液，用量为原药材投料量的1％)，持续搅拌20分钟，低温静置24小时，离心；
浓缩：所得上清液离心再次75℃减压浓缩至相对密度为1.20的浸膏；
干燥：将所述浓缩液平铺与托盘中，采用减压干燥的方式干燥，得到干浸膏；
粉碎：采用万能粉碎机粉碎，过100目，备用；
混合：将所述干膏粉、微晶纤维素混合均匀，得混匀粉末备用；
制粒：所述混匀粉末中加入纯化水制备软材，用20目筛进行制粒，70℃烘干，用20目筛进行整粒，得颗粒；
压片：加入交联羧甲基纤维素钠、硬脂酸镁，混匀，将所得颗粒进行压片，得片剂。
二功能试验
1、材料与方法同实施例1
2、结果
2.1入组前组间均衡性分析
2.1.1一般资料比较
两组入组患者的一般资料(性别、年龄、身高、体重、呼吸、心率、血压、体温、病程)比较，差异均无统计学意义(P＞0.05)，说明入组前两组病例一般资料具有可比性。
2.1.2入组前黄褐斑面积及黄褐斑颜色比较
入组前黄褐斑面积及黄褐斑颜色组间比较均无显著性差异(P＞0.05)，说明入组前两组受试者的病情相近，具有较好可比性。
2.2功效观察：
2.2.1黄褐斑颜色深浅度积分变化：
表15试食前后黄褐斑颜色深浅度积分变化
2.2.2黄褐斑面积大小变化：
表16试食前后黄褐斑面积大小变化
2.3安全性观察
2.3.1一般情况
药物组和空白对照组受试对象在试验前、后的精神状况、睡眠、饮食、大小便等情况无明显改变。试验过程中所有受试对象均未见不良反应及过敏反应。
2.3.2试食前后安全性相关指标检查
试食前后，受试者肝功能、肾功能、血液生化、尿、便常规等多项安全性指标均未见明显变化。
2.3.3腹部B超、心电图、X线胸部透视试食前受试者均未见明显异常。
3、结论
试验结果显示，药物组黄褐斑面积平均明显减少，且大于等于10％，颜色积分明显下降，且不产生新的黄褐斑，试食前后比较及与空白对照组比较，均有显著性差异。
综上，本发明组合物具有祛黄褐斑的功能。
以上实施例的说明只是用于帮助理解本发明的方法及其核心思想。应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以对本发明进行若干改进和修饰，这些改进和修饰也落入本发明权利要求的保护范围内。
Claims (10)
- 一种具有祛黄褐斑功能的组合物，其特征在于，以重量计，所述组合物包括当归1-12份、白芍1-15份、香附1-10份、菟丝子1-12份、甘草2-10份。
- 根据权利要求1所述的组合物，其特征在于，所述组合物包括当归2-10份、白芍2-10份、香附2-5份、菟丝子2-10份、甘草2-5份。
- 根据权利要求1所述的组合物，其特征在于，所述组合物包括当归3.41份、白芍3.41份、香附3.41份、菟丝子5.12份、甘草2.05份。
- 权利要求1-3任一项组合物在制备具有祛黄褐斑功能的药物、保健品或食品中的应用。
- 一种含有权利要求1-3任一项具有祛黄褐斑功能的组合物的药物、保健品或食品。
- 根据权利要求5所述的药物、保健品或食品，其特征在于，该药物、保健品或食品选自口服、注射或外用剂型。
- 根据权利要求6所述的药物、保健品或食品，其特征在于，该药物、保健品或食品选自含片、咀嚼片、泡腾片、硬胶囊、软胶囊剂、颗粒剂、糖浆、酒剂、口服液。
- 一种如权利要求1-3任一项所述的组合物的制备方法，其特征在于，包括以下步骤：提取：当归、白芍、香附、菟丝子、甘草用水提取，得提取液；浓缩：所述提取液浓缩后，得浓缩液；去杂：所述浓缩液加壳聚糖溶液搅拌、静置、离心；再浓缩：所得上清液浓缩，得浸膏。
- 如权利要求8所述的制备方法，其特征在于，包括以下步骤：提取：当归、白芍、香附、菟丝子、甘草用水提取1-3次，得提取液；浓缩：所述提取液采用真空浓缩至65-75℃下相对密度为1.10-1.20，过滤，得浓缩液；去杂：浓缩液加原药材0.5-1％重量比的壳聚糖溶液，持续搅拌20分钟，低温静置24小时，离心；再浓缩：所得上清液离心，再次65-75℃减压浓缩至相对密度为1.10-1.20的浸膏；干燥：将所述浸膏干燥，得到干浸膏；粉碎：粉碎，过筛。
- 一种具有祛黄褐斑功能的药物的制备方法，其特征在于，包括以下步骤：提取：当归3.41份、白芍3.41份、香附3.41份、菟丝子5.12份、甘草2.05份用水提取2次，第一次加药材重量10倍量水回流提取2小时，第二次加药材重量10倍水回流提取2小时，合并提取液；浓缩：所述提取液采用真空浓缩至70℃下相对密度为1.10-1.20，过滤，得浓缩液备用；去杂：用1％冰醋酸溶液制成浓度为1％的壳聚糖溶液，将原药材0.7％ 重量比的所述壳聚糖溶液加入所述浓缩液，持续搅拌20分钟，低温静置24小时，离心；再浓缩：所得上清液离心，再次70℃下减压浓缩至相对密度为1.25的浸膏；干燥：将所述浸膏平铺于托盘中，70℃下采用减压干燥的方式干燥，得到干浸膏；粉碎：采用万能粉碎机粉碎，过100目，得干膏粉备用；混合：将所述干膏粉、微晶纤维素混合均匀，得混匀粉末备用；制粒：所述混匀粉末中加入水制备软材，用20目筛进行制粒，70℃烘干，用20目筛进行整粒，得颗粒；压片：加入交联羧甲基纤维素钠、硬脂酸镁混匀，将所得颗粒进行压片，得片剂。
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