CN113679782A - Traditional Chinese medicine composition, traditional Chinese medicine preparation and application thereof, and preparation method of oral liquid - Google Patents
Traditional Chinese medicine composition, traditional Chinese medicine preparation and application thereof, and preparation method of oral liquid Download PDFInfo
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- CN113679782A CN113679782A CN202011028201.4A CN202011028201A CN113679782A CN 113679782 A CN113679782 A CN 113679782A CN 202011028201 A CN202011028201 A CN 202011028201A CN 113679782 A CN113679782 A CN 113679782A
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Abstract
The application relates to the field of traditional Chinese medicine preparations, and particularly discloses a traditional Chinese medicine composition, a traditional Chinese medicine preparation and application thereof, and a preparation method of an oral liquid. The composition comprises: 10-20 parts of calcined nacre, 10-20 parts of salvia miltiorrhiza, 8-15 parts of Chinese waxgourd peel, 6-12 parts of persimmon leaf, 6-10 parts of herba lycopi, 4-10 parts of prepared rhizoma polygonati, 2-5 parts of radix bupleuri and 4-8 parts of radix angelicae; the composition preparation comprises granules, tablets or oral liquid and the like; use of the composition: the application in preparing the medicine for treating chloasma; the preparation method of the oral liquid comprises the following steps: distilling radix Angelicae Dahuricae and bupleuri radix, fractionating to obtain volatile oil, mixing the other materials with the residue of radix Angelicae Dahuricae and bupleuri radix, decocting, sieving, concentrating under reduced pressure to obtain extract a, mixing extract a with water, adding volatile oil, stirring, and making into oral liquid. Therefore, the application has the advantages of conditioning the endocrine system of the human body from the inside, adjusting the function of the human body and effectively treating chloasma.
Description
Technical Field
The application relates to the field of traditional Chinese medicine preparations, in particular to a traditional Chinese medicine composition, a traditional Chinese medicine preparation, application and a preparation method of oral liquid.
Background
Chloasma is a yellowish-brown pigmentation of the face, mostly distributed on the cheeks, and commonly seen in women. The formation of the chloasma on the face is mainly caused by endocrine dyscrasia, high mental stress, various diseases (liver and kidney insufficiency, gynecopathy and diabetes), lack of vitamins in a body, external chemical medicine stimulation and the like of women. The chloasma is related to pregnancy and menstrual disorder, and is caused by the disharmony of qi and blood of the face due to liver qi stagnation, heat generated after long-term stasis and the disharmony of qi and blood of the face, and is relatively close to the liver, spleen and kidney, so the chloasma is also called as liver spots and blackish spots in the traditional Chinese medicine.
At present, cosmetics containing various chemical additives are frequently used in the market, the use of the cosmetics has certain dangerousness and toxic and side effects, the recurrence rate is high, chloasma is quickly eliminated and relieved or eliminated, good living dietary habits are developed, the metabolism and endocrine system of a human body also need to be regulated in a natural and harmless mode, the function of the human body is regulated, and the chloasma is thoroughly treated by a treatment means from inside to outside.
The traditional Chinese medicine mainly comprises plant medicines, animal medicines and mineral medicines, the plant medicines account for most of the traditional Chinese medicines, so the traditional Chinese medicines are also called as Chinese herbal medicines, the curative effect of the Chinese herbal medicines is more and more emphasized in the world at present, and like Chinese acupuncture and moxibustion and decoction of the Chinese herbal medicines are all deep into all parts of the world. According to the research, the Chinese herbal medicines can dredge the path and regulate the blood vessels, and can treat the symptoms of chloasma caused by spleen and kidney deficiency, disharmony of blood and qi, qi stagnation and blood stasis and qi and blood deficiency; also has effects in regulating internal organs, harmonizing color, and moistening skin.
Therefore, the application develops a traditional Chinese medicine composition, a traditional Chinese medicine preparation, application and a preparation method of oral liquid, regulates the metabolism and endocrine system of a human body from inside, adjusts the function of the human body, and effectively treats chloasma through a treatment means from inside to outside.
Disclosure of Invention
Aiming at the defects in the prior art, the application provides a traditional Chinese medicine composition, a traditional Chinese medicine preparation, an application and a preparation method of an oral liquid, and the traditional Chinese medicine composition can regulate the endocrine system of a human body from inside and adjust the function of the human body by a treatment means from inside to outside, so that chloasma can be effectively treated.
In a first aspect, the present application provides a Chinese medicinal composition, which adopts the following technical scheme:
a traditional Chinese medicine composition, comprising (by weight parts):
10-20 parts of calcined nacre, 10-20 parts of salvia miltiorrhiza, 8-15 parts of Chinese waxgourd peel, 6-12 parts of persimmon leaf, 6-10 parts of herba lycopi, 4-10 parts of prepared rhizoma polygonati, 2-5 parts of radix bupleuri and 4-8 parts of radix angelicae.
The mother-of-pearl mainly contains more than 92 percent of calcium carbonate and more than 5 percent of organic matters, wherein the mother-of-pearl mainly contains keratin and contains various amino acids and various inorganic elements such as aluminum, copper, iron, magnesium, sodium, zinc, phosphorus, barium, sulfur, chlorine, potassium, silicon and the like. According to the records of Chinese medical dictionary, Concha Margaritifera has the effects of nourishing liver yin, clearing liver fire, and treating female blood heat, palpitation and insomnia. Heating Concha Margaritifera with fire, and calcining to crisp to obtain calcined Concha Margaritifera. The mother-of-pearl is cool but astringent after being calcined, and has better effect.
Salvia miltiorrhiza, being bitter in taste and slightly cold in nature, can activate blood and regulate menstruation, remove blood stasis and relieve pain, cool blood and cure carbuncle, relieve restlessness and calm nerves. According to the records of the compendium of materia medica, the root of red-rooted salvia can break old blood and supplement new blood; it is also commonly used for irregular menstruation, amenorrhea, dysmenorrhea and postpartum abdominal pain due to blood stasis.
The exocarpium Benincase is the dry outer pericarp of fructus Benincasae of Cucurbitaceae, and has sweet taste and cool nature. According to records in Ben Cao gang mu, the Chinese waxgourd peel is used for treating blood stagnation and waist soreness; according to the record of 'Renxin herbal medicine', the Chinese waxgourd peel goes through the skin, removes dampness and dispels wind, tonifies spleen and purges fire.
Folium kaki is bitter and cold in nature, and contains flavonoid glycoside, tannin, phenols, resin, coumarins compounds, reducing sugar, polysaccharide, volatile oil, and organic acid (betulinic acid, oleanolic acid, and ursolic acid). According to the record of Yunnan materia Medica, ecthyma is applied by frost leaves; and the persimmon leaves can soothe the nerves, beautify the face and eliminate the senile plaques, and the flavonoid glycoside in the persimmon leaves can clear heat and cool.
Herba Lycopi is bitter and pungent in taste, mild in nature, and contains volatile oil, glucoside, tannin, tree substance, flavonoid glycoside, phenols, amino acids, organic acids, saponin, herba Lycopi sugar, stachyose, galactose, fructose, etc. According to the record of the compendium of materia medica, herba lycopi can nourish nutrient qi, break persistent blood, treat emaciation of women and key herbs of the female department, and is mainly used for treating irregular menstruation, amenorrhea, dysmenorrhea, postpartum abdominal pain due to blood stasis, sores and carbuncles and pyogenic infections.
Rhizoma Polygonati is sweet and neutral, and contains nicotinic acid, quinones, starch, and sugar. Rhizoma Polygonati contains 17 kinds of amino acids, human restrictive amino acids such as lysine and threonine, and inorganic elements such as ferrum, zinc, copper and manganese, and vitamins such as vitamin C and vitamin B. According to records in He Ji Ju Fang, Huang Jing can tonify spleen and kidney, and nourish essence and blood, and is used for treating deficiency of both qi and yin.
Bupleurum root, radix bupleuri is bitter and pungent in flavor and slightly cold in nature. According to the records of Ben Cao gang mu, it is indicated for sinking of yang-qi, calming liver, gallbladder, triple energizer, enveloping fire, heat entering blood chamber and irregular menstruation of women, and has the actions of harmonizing exterior and interior, soothing liver and raising yang.
The angelica dahurica is pungent in taste and warm in nature, mainly contains volatile oil, various coumarin compounds such as imperatorin and byak-angelicin, angelica dahurica toxin, zanthoxylum toxin, sterol, stearic acid and the like. According to records in Shen nong Ben Cao Jing, Bai Zhi is effective in treating red and white discharge, swelling and blood retention in the yin, chills and fever, wind head invading the eyes and tear, skin growth and moistening.
In the technical scheme of the application, calcined nacre and salvia miltiorrhiza are used as main medicines, enter heart and liver channels, and have the effects of nourishing liver yin, clearing liver fire, promoting blood circulation and regulating menstruation; herba lycopi, rhizoma polygonati preparata and radix bupleuri are added as auxiliary materials, the effects of soothing the liver, regulating menstruation and regulating qi are achieved, the wax gourd peel, the persimmon leaf and the radix angelicae are used for promoting blood circulation and beautifying, the effects of soothing the liver, regulating qi, promoting blood circulation and removing blood stasis can be achieved through the synergistic effect of the traditional Chinese medicines, the liver and kidney can be nourished, and the heat and dampness can be removed, so that the effects of regulating menstruation and beautifying are achieved, and the traditional Chinese medicine is suitable for women with chloasma. Therefore, the composition has the effect of treating chloasma.
Preferably, the composition consists of (in parts by weight):
14-16 parts of calcined nacre, 13-16 parts of salvia miltiorrhiza, 8-10 parts of Chinese waxgourd peel, 8-10 parts of persimmon leaf, 6-8 parts of herba lycopi, 5-8 parts of prepared rhizoma polygonati, 3-5 parts of radix bupleuri and 4-6 parts of radix angelicae.
By adopting the technical scheme, the proportion of the traditional Chinese medicine composition is optimized, the conditioning of the traditional Chinese medicine composition on the secretion system in the human body can be enhanced, and the treatment effect on chloasma is improved.
Preferably, the composition further comprises (in parts by weight):
8-16 parts of refined honey and 0.05-0.2 part of preservative.
By adopting the technical scheme, the honey is fragrant and slightly sweet, has the effects of tonifying middle-jiao and Qi, moistening dryness and detoxifying, and has the function of correcting taste; the refined honey is prepared by processing and decocting honey to prepare a honey product, the processed refined honey has milder drug property and more excellent medicinal effect, on one hand, enzyme for decomposing glycosides can be damaged, stability of the glycosides is enhanced, drug effect preservation is facilitated, on the other hand, solubility of aglycone can be increased, and absorption is promoted. The antiseptic can improve antibacterial property of the Chinese medicinal composition, and prolong storage time.
In a second aspect, the present application provides a Chinese medicinal preparation, which can be a liquid preparation prepared from the above Chinese medicinal composition and a liquid medium (e.g. water), such as syrup and oral liquid; or solid preparation prepared from the above Chinese medicinal composition, such as granule, tablet, capsule, pill, etc.
In a third aspect, the application provides an application of any one of the traditional Chinese medicine compositions, and the application of the traditional Chinese medicine composition in preparing a medicine for treating chloasma.
In a fourth aspect, the application provides a preparation method of a traditional Chinese medicine oral liquid, which adopts the following technical scheme:
a preparation method of an oral liquid comprises the following steps:
A. distilling radix Angelicae Dahuricae and bupleuri radix to obtain volatile oil, and collecting residue;
B. mixing Saviae Miltiorrhizae radix, exocarpium Benincase, folium kaki, herba Lycopi, rhizoma Polygonati preparata, and Concha Margaritifera preparata with the residue, decocting in sequence, and sieving to obtain extractive solution a; or
Mixing Saviae Miltiorrhizae radix, exocarpium Benincase, folium kaki, herba Lycopi, and rhizoma Polygonati preparata with the residue, decocting in sequence, and sieving to obtain filtrate a 1; sequentially grinding calcined nacre, sieving, decocting, filtering, collecting filtrate a2, and mixing filtrate a1 and filtrate a2 to obtain extractive solution a;
C. concentrating the extracting solution a under reduced pressure to obtain an extract a,the extract has a relative density of 1.18-1.22kg/m at 50 deg.C3；
D. Mixing the volatile oil, extract a and water, heating to 70-90 deg.C, and stirring to obtain oral liquid;
wherein, the calcined nacre is 10-20 parts, the red sage root is 10-20 parts, the Chinese waxgourd peel is 8-15 parts, the persimmon leaf is 6-12 parts, the herba lycopi is 6-10 parts, the prepared rhizoma polygonati is 4-10 parts, the bupleurum root is 2-5 parts, and the angelica dahurica is 4-8 parts.
By adopting the technical scheme, the effective components in the traditional Chinese medicine can be extracted by decocting the traditional Chinese medicine, and the extract a is obtained by decompression and concentration, and can be used as an intermediate for preparing oral liquid, so that the storage is convenient, and the practicability of the traditional Chinese medicine composition is improved; because calcined nacre is hard, the calcined nacre needs to be ground firstly and decocted for a plurality of times, so that the effective ingredients in the calcined nacre can be better extracted. The volatile oil mainly comprises monoterpene, sesquiterpene compound, small molecule aromatic compound, small molecule aldehyde and ester compound, has strong lipid solubility, active physicochemical property, high bioavailability and rapid absorption, and can easily penetrate in vivo biological membrane; the volatile oil and the extract a are mixed to prepare the oral liquid, so that the drug effect of the traditional Chinese medicine composition can be quickly exerted.
Preferably, 14-16 parts of calcined nacre, 13-16 parts of salvia miltiorrhiza, 8-10 parts of exocarpium benincasae, 8-10 parts of persimmon leaves, 6-8 parts of herba lycopi, 5-8 parts of rhizoma polygonati preparata, 3-5 parts of radix bupleuri and 4-6 parts of radix angelicae.
By adopting the technical scheme, the proportion of the traditional Chinese medicine composition is optimized, the conditioning of the traditional Chinese medicine composition on the secretion system in the human body can be enhanced, and the treatment effect of the oral liquid on chloasma is improved.
Preferably, in the step C, the extract a is subjected to two times of vacuum concentration to obtain an extract a, and alcohol precipitation is performed between the two times of vacuum concentration, wherein the alcohol precipitation comprises:
adding 70-95% ethanol into the extract a1 subjected to primary vacuum concentration, wherein the amount of the ethanol is 2-3 times of the volume of the extract a1, standing for 24-48 h, filtering, collecting supernatant, and performing secondary vacuum concentration.
By adopting the technical scheme, the effective components in the traditional Chinese medicine can be dissolved in ethanol, and impurities are not dissolved in the ethanol, so that the effective components in the extracting solution can be dissolved in the ethanol by adding the ethanol in the process of pressure concentration, and water-soluble impurities such as protein, polysaccharide, pigment, inorganic salt and the like in the traditional Chinese medicine are removed; and the ethanol has the sterilization function and can play a role in corrosion prevention, so that the traditional Chinese medicine components in the extracting solution can be extracted and directly absorbed.
Preferably, in the step D, before the volatile oil is added, polysorbate 80 and the volatile oil are mixed and stirred uniformly; the volume ratio of the polysorbate 80 to the volatile oil is (0.5-1) to 1.
By adopting the technical scheme, the polysorbate 80 is used as the surfactant, the volatile oil and the solution can be compatible, and the polysorbate 80 can wrap the volatile oil by mixing the polysorbate 80 and the volatile oil, so that the stability of the volatile oil is maintained.
Preferably, in the step D, the extract a, the refined honey, the preservative and the water are mixed, heated to 70-90 ℃, stirred to be dissolved, then the volatile oil is added, and stirred uniformly;
wherein, the refined honey is 8 to 16 parts, and the preservative is 0.05 to 0.2 part.
By adopting the technical scheme, the refined honey, the preservative and the extract a are mixed, so that the sweetness of the traditional Chinese medicine composition is increased, the palatability of the traditional Chinese medicine composition is improved, meanwhile, the antibacterial performance of the traditional Chinese medicine composition is improved, and the storage time is prolonged.
In summary, the present application has the following beneficial effects:
1. because the calcined nacre and the salvia miltiorrhiza are used as main medicines, the eupatorium japonicum, the rhizoma polygonati preparata and the radix bupleuri are used as auxiliary medicines, and the Chinese waxgourd peel, the persimmon leaf and the radix angelicae are used for activating blood and beautifying, the traditional Chinese medicine composition has the effects of soothing liver and regulating qi, activating blood and dissolving stasis, nourishing liver and kidney, clearing heat and eliminating dampness, and regulating menstruation and beautifying, and can achieve the effect of effectively treating chloasma;
2. according to the method, the Chinese medicinal composition is decocted and pressurized for concentration, the effective Chinese medicinal components of the Chinese medicinal composition are completely extracted, and finally the extract is prepared, so that the practicability of the Chinese medicinal composition is improved.
Detailed Description
The present application is further illustrated by examples. It should be understood that the composition and method described in the examples are only for illustrating the present invention and not for limiting the present invention, and that simple modifications of the preparation method of the present invention based on the concept of the present invention are within the scope of the claimed invention.
Examples
Examples of the preparation method of oral liquid, the amounts of the Chinese medicinal materials of the following examples 1 to 3 are shown in table 1. In the embodiment, the preservative is sorbic acid, and the calcined nacre, the red sage root, the herba lycopi, the prepared rhizoma polygonati, the radix bupleuri, the exocarpium benincasae, the persimmon leaf, the radix angelicae, the refined honey, the sorbic acid and the polysorbate 80 are all sold in the market, wherein the relative density of the refined honey is 1.36-1.38.
Examples 1 to 5:
mixing radix Angelicae Dahuricae and bupleuri radix, adding water 10 times of the total weight of radix Angelicae Dahuricae and bupleuri radix, heating to 95-105 deg.C, boiling and distilling for 3 hr, fractionating to obtain volatile oil, and collecting residue.
Mixing Saviae Miltiorrhizae radix, exocarpium Benincase, folium kaki, herba Lycopi, rhizoma Polygonati preparata and the residue, adding water 8-10 times of the total weight of the Chinese medicinal materials, decocting for 2 times, heating to 95-105 deg.C, decocting for 3 hr, mixing decoctions, and filtering with 100 mesh to obtain filtrate a 1.
Grinding calcined Concha Margarit, sieving with 80 mesh sieve, adding water 4-8 times of calcined Concha Margarit, decocting for 3 times, heating to 95-105 deg.C, decocting for 3 hr, mixing decoctions, and filtering with 100 mesh sieve to obtain filtrate a 2.
Mixing the filtrate a1 and the filtrate a2 to obtain an extracting solution a, and carrying out primary reduced pressure concentration on the extracting solution a under the environment of vacuum degree of-0.04 to-0.08 MPa and temperature of 50-80 ℃ until an extract a1 with the relative density of 1.14-1.18 (measured at 50 ℃) is obtained; and then cooling to 30 ℃, adding 95% ethanol, uniformly mixing, standing for 48h, taking supernatant, and concentrating under reduced pressure again in an environment with the vacuum degree of-0.06-0.08 Mpa and the temperature of 60-70 ℃ until the extract a with the relative density of 1.18-1.22 (measured at 50 ℃) is obtained.
Dissolving the volatile oil with polysorbate-80, mixing the extract a and the volatile oil, stirring, blending with pure water to 40L, stirring to mix well, and subpackaging in 5mL filling bottles to obtain the oral liquid.
Examples 6 to 11: the difference from the embodiment 1 is that the volatile oil is dissolved by polysorbate-80, the extract a, the refined honey and sorbic acid are mixed, the mixture is heated to 70-90 ℃, stirred evenly, the volatile oil is added, stirred evenly, prepared to 40L by pure water and stirred evenly, and subpackaged in 5mL filling bottles for filling to obtain the oral liquid.
Example 12: the difference from the embodiment 7 is that the salvia miltiorrhiza, the Chinese waxgourd peel, the persimmon leaf, the eupatorium japonicum, the prepared rhizoma polygonati and the calcined nacre are mixed with the residue, water with the weight 6-10 times of the total weight of the traditional Chinese medicines is respectively added for 3 times of decoction, the decoction is heated to 95-105 ℃, the decoction is boiled for 3 hours each time, the liquid medicine is combined, and the liquid medicine is filtered by a 100-mesh sieve to obtain the extracting solution a for standby.
Example 13: the difference from the embodiment 7 is that the angelica dahurica, the radix bupleuri, the salvia miltiorrhiza, the Chinese waxgourd peel, the persimmon leaf, the herba lycopi and the prepared rhizoma polygonati are directly mixed, water with the weight 8-10 times of the total weight of the traditional Chinese medicines is respectively added for 2 times of decoction, the decoction is heated to 95-105 ℃, the decoction is boiled for 3 hours each time, the liquid medicines are combined, and the filtrate a1 is obtained for standby after 100-mesh filtration.
The oral liquids prepared in examples 1-13 were all tan liquids.
TABLE 1 dosage (kg) of the Chinese medicinal composition of examples 1-13
Performance test
Detection example 1: the oral liquid samples prepared in examples 1 to 11 and comparative example 1 were examined for aerobic bacteria count, mold count, yeast count, staphylococcus count, and pseudomonas aeruginosa count.
The detection method comprises the following steps:
taking 10mL of oral liquid, diluting to 100mL with sterile sodium chloride-peptone buffer solution with pH of 7.0, and shaking uniformly at 45 deg.C to obtain a 1:10 test solution. Taking 10mL of test solution, diluting to 20mL with sterile sodium chloride-peptone buffer solution with pH of 7.0, and shaking uniformly at 45 deg.C to obtain 1:20 solution to be tested.
Aerobic bacteria count: and (3) taking 1mL of the solution to be detected, injecting the solution into a culture dish, uniformly shaking, pouring 15-20 mL of trypticase soy peptone agar culture medium with the temperature not more than 45 ℃, and culturing for 5 days at the temperature of 30-35 ℃. Three replicate samples were prepared.
Mold and yeast counts: and (3) taking 1mL of the solution to be detected, injecting into a culture dish, uniformly shaking, pouring 15-20 mL of a Sabouraud's dextrose agar culture medium with the temperature not more than 45 ℃, and culturing for 7 days at 20-25 ℃. Three replicate samples were prepared.
And (3) adding 10mL of the solution to be detected into 100mL of trypticase soytone liquid medium, culturing at 30-35 ℃ for 18-24 hours, taking 1mL of the culture, inoculating into 100mL of Mackanka liquid medium, and culturing at 42-44 ℃ for 24-48 hours. Taking the Mackanka liquid culture, streaking and inoculating the Mackanka liquid culture on a Mackanka agar culture medium plate, and culturing for 18-72 hours at the temperature of 30-35 ℃. The results are shown in Table 2.
TABLE 2 measurement results of aerobic bacteria count, mold count, yeast count and Escherichia coli count in the oral liquids of examples 1 to 13
| Sample (I) | Aerobic count (cfu/mL) | Number of moulds (cfu/mL) | Yeast count (cfu/mL) | Escherichia coli |
| Example 1 | <100 | <10 | <10 | Has not detected |
| Example 2 | <100 | <10 | <10 | Has not detected |
| Example 3 | <100 | <10 | <10 | Has not detected |
| Example 4 | <100 | <10 | <10 | Has not detected |
| Example 5 | <100 | <10 | <10 | Has not detected |
| Example 6 | <100 | <10 | <10 | Has not detected |
| Example 7 | <100 | <10 | <10 | Has not detected |
| Example 8 | <100 | <10 | <10 | Has not detected |
| Example 9 | <100 | <10 | <10 | Has not detected |
| Example 10 | <100 | <10 | <10 | Has not detected |
| Example 11 | <100 | <10 | <10 | Has not detected |
| Example 12 | <100 | <10 | <10 | Has not detected |
| Example 13 | <100 | <10 | <10 | Has not detected |
As shown in Table 3, in examples 1 to 13, the number of aerobic bacteria did not exceed 102The cfu/ML, the number of the mold and the number of the microzyme do not exceed 10cfu/mL, and no Escherichia coli is detected in each milliliter of oral liquid, so that the number of aerobic bacteria, the number of mold, the number of yeast and the Escherichia coli all meet the standard.
Detection example 2: the properties, taste, protocatechualdehyde, protocatechuic acid and polygonatum contents of the oral liquid samples prepared in examples 1 to 13 were examined.
The detection method comprises the following steps:
1. reagent and test solution: methanol, cyclohexane, ethyl acetate, formic acid, a 1% ethanol solution of ferric trichloride, chloroform, a 10% ethanol solution of phosphomolybdic acid, and acetone are all commercially available.
2. The operation method comprises the following steps: 2-1, rhizoma polygonati: extracting 40mL of the oral liquid with chloroform under shaking for 2 times (40 mL each time), mixing chloroform solutions, evaporating to dryness, and dissolving the residue with chloroform 1mL to obtain sample solution. Decocting rhizoma Polygonati 1g with water for 30 min, filtering, adding chloroform 40mL into the filtrate, and making into control medicinal solution. According to a thin layer chromatography standard operating procedure test, 5 mu L of each solution is sucked, the two solutions are respectively spotted on the same silica gel G thin layer plate, chloroform-acetone (4:1) is used as a developing agent, the two solutions are sequentially developed, taken out and dried, 10% phosphomolybdic acid ethanol solution is sprayed, and the solution is heated at 105 ℃ until spots are clearly developed. Spots of the same color appear on the chromatogram of the test solution at the positions corresponding to those on the chromatogram of the control solution.
2-2, protocatechuic acid: mixing oral liquid 30mL with water 10mL, extracting with ethyl acetate for 2 times (30 mL each time), mixing ethyl acetate solutions, evaporating to dryness, and dissolving the residue with methanol 1mL to obtain sample solution. Adding methanol into protocatechuic acid control to obtain 1mg solution per 1mL as control solution. According to the thin layer chromatography operating procedure test, 5 μ L of each of the two solutions is absorbed, respectively spotted on the same silica gel GF254 thin layer plate, and developed by taking cyclohexane-ethyl acetate-formic acid (20:10:1) as a developing agent, taken out, dried and inspected under an ultraviolet lamp (254 nm). Spots of the same color appear in the chromatogram of the test solution at positions corresponding to those in the chromatogram of the control solution.
2-3, protocatechualdehyde:
preparation of control solutions: accurately weighing 10mg protocatechualdehyde reference substance, placing in a 50mL measuring flask, adding methanol for dissolving and diluting to scale, shaking up, accurately weighing 1mL protocatechualdehyde reference substance, placing in a 10mL measuring flask, adding methanol to scale, and shaking up to obtain the final product.
Preparation of a test solution: precisely measuring 5mL of oral liquid, adding 20mL of water and 1mL of hydrochloric acid, mixing, transferring into a separating funnel, extracting with diethyl ether under shaking for 5 times (25mL, 15mL), mixing the ethyl ether solutions, volatilizing, dissolving the residue with appropriate amount of methanol, quantitatively transferring to a 25mL measuring flask, adding methanol to scale, shaking, filtering with microporous membrane (0.45 μm), and collecting the filtrate.
Precisely sucking 10 μ L of each of the reference solution and the sample solution, injecting into HPLC for detection, wherein the filler is octadecylsilane chemically bonded silica, the mobile phase is methanol-0.05% phosphoric acid solution (5:95), and the detection wavelength is 280 nm. The results are shown in Table 3.
TABLE 3 examination results of properties, taste, protocatechualdehyde content, protocatechuic acid and Polygonatum sibiricum in the oral liquids of examples 1 to 13
| Sample (I) | Taste of the product | Protocatechualdehyde (mg/mL) | Protocatechuic acid | Polygonatum sibiricum |
| Example 1 | Fragrant and slightly bitter | 0.03 | Detect out | Detect out |
| Example 2 | Fragrant and slightly bitter | 0.04 | Detect out | Detect out |
| Example 3 | Fragrant and slightly bitter | 0.05 | Detect out | Detect out |
| Example 4 | Fragrant and slightly bitter | 0.051 | Detect out | Detect out |
| Example 5 | Fragrant and slightly bitter | 0.054 | Detect out | Detect out |
| Example 6 | Fragrant, sweet and slightly bitter | 0.04 | Detect out | Detect out |
| Example 7 | Fragrant, sweet and slightly bitter | 0.05 | Detect out | Detect out |
| Example 8 | Fragrant, sweet and slightly bitter | 0.051 | Detect out | Detect out |
| Example 9 | Fragrant, sweet and slightly bitter | 0.04 | Detect out | Detect out |
| Example 10 | Fragrant, sweet and slightly bitter | 0.053 | Detect out | Detect out |
| Example 11 | Fragrant, sweet and slightly bitter | 0.05 | Detect out | Detect out |
| Example 12 | Fragrant, sweet and slightly bitter | 0.05 | Detect out | Detect out |
| Example 13 | Fragrant, sweet and slightly bitter | 0.05 | Detect out | Detect out |
As shown in table 3, in examples 1 to 8, the content of protocatechualdehyde increased, wherein protocatechualdehyde mainly originated from salvia miltiorrhiza, and therefore, when the addition amount of salvia miltiorrhiza increased, the protocatechualdehyde content also increased, but in 40L of the oral liquid, when the addition amount of salvia miltiorrhiza exceeded 15kg, the increase in protocatechualdehyde in the oral liquid decreased with the increase in the addition amount of salvia miltiorrhiza. And by comparing examples 7 and 9-10, 13kg, 15kg and 18kg of salvia miltiorrhiza are respectively added into 40L of oral liquid, and the content of protocatechuic aldehyde is respectively 0.04mg/mL, 0.05mg/mL and 0.053mg/mL, so that after the addition amount of the salvia miltiorrhiza exceeds 15kg, the increase of protocatechuic aldehyde in the oral liquid is reduced along with the increase of the addition amount of the salvia miltiorrhiza in the 40L of oral liquid.
Detection example 3: the therapeutic effect of the oral liquid prepared in examples 1 to 13 on chloasma model mice was examined.
Experimental animals: 120 female Kunming mice were selected, weighing 20-25g, and randomly divided into 15 groups of 8 mice each, examples 1-13, model and blank.
The experimental method comprises the following steps:
model mice: the mice were depilated on their backs and the skin on their backs was exposed sufficiently, and the exposure of the exposed skin of the mice to ultraviolet light was set at 12uw/cm2Irradiating for 20min/d for 8 weeks to establish chloasma model mouse.
Blank mice: the back of the mice was dehaired and the skin of the back of the mice was fully exposed.
Among them, the mice in examples 1 to 3 and the model group were model mice, and the mice in the blank group were normal mice.
Examples 1-13 mice were enema-treated with oral liquid, model groups and blank groups were enema-treated with 0.9% sterile physiological saline, and after 2 months of enema feeding, the mice were immediately sacrificed, and then the back of the mice was dehaired, and the skin of the back and the liver of the mice were taken.
Judging the index: the superoxide dismutase activity and the malondialdehyde content in the liver and the skin of each group of mice are measured.
The detection method comprises the following steps: selecting a Malondialdehyde (MDA) kit and a superoxide dismutase (SOD) determination kit. The test results are shown in Table 3.
TABLE 3 results of measuring superoxide dismutase Activity and malondialdehyde content in liver and skin of mice of examples 1-13, blank group and model group
As shown in table 3, after irradiation with ultraviolet rays, the malondialdehyde content in the skin and liver of the model group mice was increased, and the superoxide dismutase activity in the skin and liver of the model group mice was decreased, as compared to the blank group.
Superoxide dismutase activity in the skin and liver of the mice in examples 1-13 was increased, and malondialdehyde content in the skin and liver of the mice in examples 1-13 was increased, as compared to the model group; among them, the mouse in example 7 had the highest superoxide dismutase activity and malondialdehyde content in the skin and liver. Therefore, the oral liquid administered in example 7 is the most effective in the present application.
Of examples 1-5, mice in example 3 had the highest superoxide dismutase activity and the lowest malondialdehyde in the skin and liver, followed by examples 2 and 4, and finally examples 1 and 5.
Compared with example 2, the effect of the oral liquid of example 6 is slightly higher than that of the oral liquid of example 2; compared with example 3, the effect of the oral liquid of example 7 is slightly higher than that of the oral liquid of example 2; compared with example 4, the effect of the oral liquid of example 8 is slightly higher than that of the oral liquid of example 2.
Compared with example 7, the content of malondialdehyde in the skin of the mice in examples 9-11 is higher than that of malondialdehyde in the skin of the mice in example 7, and the activity of superoxide dismutase in the skin and liver of the mice in examples 9-11 is higher than that of superoxide dismutase in the skin and liver of the mice in example 7, wherein the effect of the oral liquid in example 7 is better than that of the oral liquid in examples 9-11, when the addition amount of salvia miltiorrhiza is 15kg and the addition amount of polygonatum sibiricum is 7kg in 40L of the oral liquid, the drug effect of the oral liquid is best, and when the addition amount of salvia miltiorrhiza and polygonatum sibiricum is too high or too low, the effect of the oral liquid for treating chloasma is influenced. Therefore, the effect of the oral liquid for treating chloasma can be improved through the synergistic effect between the salvia miltiorrhiza and the rhizoma polygonati preparata.
Example 7 compared to example 12, the superoxide dismutase activity in the skin and liver of the mouse of example 7 was very significantly lower than that of the mouse of example 12, and the malondialdehyde content in the skin and liver of the mouse of example 7 was very significantly lower than that of the mouse of example 12. Therefore, in the preparation process of the oral liquid, the efficacy of separately decocting the calcined nacre and other medicinal materials is better, because the calcined nacre is harder, the effective components in the calcined nacre cannot be completely extracted by direct decoction, thereby influencing the efficacy of the calcined nacre.
Example 7 compared to example 13, the superoxide dismutase activity in the skin and liver of the mouse of example 7 was very significantly lower than that of the mouse of example 13, and the malondialdehyde content in the skin and liver of the mouse of example 7 was very significantly lower than that of the mouse of example 13. Therefore, in the preparation process of the oral liquid, the angelica dahurica and the radix bupleuri are added into the extract a after the volatile oil is extracted, so that the effect of the oral liquid can be improved.
The present embodiment is only for explaining the present application, and it is not limited to the present application, and those skilled in the art can make modifications of the present embodiment without inventive contribution as needed after reading the present specification, but all of them are protected by patent law within the scope of the claims of the present application.
Claims (10)
1. A traditional Chinese medicine composition is characterized by comprising the following components in parts by weight:
10-20 parts of calcined nacre, 10-20 parts of salvia miltiorrhiza, 8-15 parts of Chinese waxgourd peel, 6-12 parts of persimmon leaf, 6-10 parts of herba lycopi, 4-10 parts of prepared rhizoma polygonati, 2-5 parts of radix bupleuri and 4-8 parts of radix angelicae.
2. The traditional Chinese medicine composition according to claim 1, wherein the composition comprises (in parts by weight):
14-16 parts of calcined nacre, 13-16 parts of salvia miltiorrhiza, 8-10 parts of Chinese waxgourd peel, 8-10 parts of persimmon leaf, 6-8 parts of herba lycopi, 5-8 parts of prepared rhizoma polygonati, 3-5 parts of radix bupleuri and 4-6 parts of radix angelicae.
3. The traditional Chinese medicine composition according to claim 1, wherein the composition further comprises (in parts by weight):
8-16 parts of refined honey and 0.05-0.2 part of preservative.
4. A Chinese medicinal preparation comprising the composition of any one of claims 1 to 3, wherein the preparation is in the form of granules, tablets, capsules, pills, tinctures, mixtures, syrups or oral liquids.
5. The use of the traditional Chinese medicine composition as claimed in any one of claims 1 to 3, characterized by being used for preparing a medicament for treating chloasma.
6. The preparation method of the oral liquid is characterized by comprising the following steps:
A. distilling radix Angelicae Dahuricae and bupleuri radix to obtain volatile oil, and collecting residue;
B. mixing Saviae Miltiorrhizae radix, exocarpium Benincase, folium kaki, herba Lycopi, rhizoma Polygonati preparata, and Concha Margaritifera preparata with the residue, decocting in sequence, and sieving to obtain extractive solution a; or
Mixing Saviae Miltiorrhizae radix, exocarpium Benincase, folium kaki, herba Lycopi, and rhizoma Polygonati preparata with the residue, decocting in sequence, and sieving to obtain filtrate a 1; sequentially grinding calcined nacre, sieving, decocting, filtering, collecting filtrate a2, and mixing filtrate a1 and filtrate a2 to obtain extractive solution a;
C. concentrating the extracting solution a under reduced pressure to obtain an extract a, wherein the relative density of the extract a at 50 ℃ is 1.18-1.22kg/m for carrying out thin film planting;
D. mixing the extract a with water, heating and stirring uniformly, adding the volatile oil, and stirring uniformly to obtain an oral liquid;
wherein (by weight parts) the calcined nacre 10-20 parts, the red sage root 10-20 parts, the Chinese waxgourd peel 8-15 parts, the persimmon leaf 6-12 parts, the herba lycopi 6-10 parts, the rhizoma polygonati preparata 4-10 parts, the bupleurum root 2-5 parts, and the angelica dahurica 4-8 parts.
7. The preparation method of claim 6, wherein the calcined nacre is 14-16 parts, the red sage root is 13-16 parts, the exocarpium benincasae is 8-10 parts, the persimmon leaf is 8-10 parts, the herba lycopi is 6-8 parts, the rhizoma polygonati preparata is 5-8 parts, the radix bupleuri is 3-5 parts, and the radix angelicae is 4-6 parts.
8. The preparation method according to claim 6 or 7, wherein in the step C, the extract a is subjected to two times of reduced pressure concentration to obtain an extract a, and alcohol precipitation is performed between the two times of reduced pressure concentration, wherein the alcohol precipitation comprises the following steps:
adding 70-95% ethanol into the extract a1 subjected to primary vacuum concentration, wherein the amount of the ethanol is 2-3 times of the volume of the extract a1, standing for 24-48 h, filtering, collecting supernatant, and performing secondary vacuum concentration.
9. The preparation method according to claim 6 or 7, wherein in the step D, polysorbate 80 and the volatile oil are mixed and stirred uniformly before the volatile oil is added;
the volume ratio of the polysorbate 80 to the volatile oil is (0.5-1) to 1.
10. The preparation method according to claim 9, wherein in the step D, the extract a, the refined honey, the preservative and the water are mixed, heated to 70-90 ℃, stirred to be dissolved, then the volatile oil is added, and stirred uniformly;
wherein, the refined honey is 8 to 16 parts, and the preservative is 0.05 to 0.2 part.
Priority Applications (1)
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN116440243A (en) * | 2023-05-05 | 2023-07-18 | 御本堂控股集团有限公司 | Preparation method of qi-regulating and stasis-removing oral liquid |
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| CN105362807A (en) * | 2015-11-28 | 2016-03-02 | 苏赵珍 | Traditional Chinese medicine mask having efficacy of activating skin, dispersing stasis and removing yellow spots |
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| CN105362807A (en) * | 2015-11-28 | 2016-03-02 | 苏赵珍 | Traditional Chinese medicine mask having efficacy of activating skin, dispersing stasis and removing yellow spots |
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| CN116440243A (en) * | 2023-05-05 | 2023-07-18 | 御本堂控股集团有限公司 | Preparation method of qi-regulating and stasis-removing oral liquid |
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Application publication date: 20211123 |