CN106938012B - Medicine for treating alopecia and preparation method thereof - Google Patents
Medicine for treating alopecia and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a medicine for treating alopecia, which comprises the following preparation raw materials in parts by weight: 1050-3150 parts of Chinese angelica, 410-1230 parts of notopterygium root, 410-1230 parts of ligusticum wallichii, 2050-6135 parts of prepared rehmannia root, 1050-3150 parts of semen cuscutae, 615-1845 parts of pawpaw, 2045-6135 parts of prepared polygonum multiflorum, 205-615 parts of rhizoma gastrodiae and 1050-3150 parts of white paeony root; meanwhile, the invention also discloses a preparation method of the medicine for treating alopecia, and the medicine for treating alopecia prepared by the method has the advantages of high extraction efficiency of effective components, small dosage and more stable quality, and is not easy to damage.
Description
Technical Field
The invention relates to the technical field of medicine preparation processes, in particular to a medicine for treating alopecia and a preparation method thereof.
Background
Alopecia is a common skin disease, and western medicine considers that the alopecia is mainly caused by excessive secretion of male hormone and grease and the like. The traditional medicine considers that the kidney stores essence, the essence is bloomed in the hair, the kidney qi is weakened, the hair falls off, the hair is early white, and the hair is the rest of blood. Liver stores blood, and essence and blood are mutually transformed, so the quality of hair growth is directly related to liver, kidney and qi and blood, and alopecia patients are mostly deficient in both liver and kidney and deficiency of both qi and blood. The capsule for nourishing blood and growing hair is a pure Chinese medicinal preparation for treating alopecia, selects high-quality pure Chinese medicinal herbs according to the principle of 'treatment of principal and secondary aspect of disease' in the traditional Chinese medicine, has a scientific formula, and is refined by adopting the modern pharmaceutical technology.
The blood-nourishing hair-growing capsule is collected in the first part of the Chinese pharmacopoeia (2015 edition), the prescription of the capsule is prepared from nine medicinal materials of prepared rehmannia root, Chinese angelica, notopterygium root, pawpaw, szechuan lovage rhizome, white paeony root, south dodder seed, tall gastrodia tuber and prepared tuber fleeceflower root, and the preparation method comprises the following steps: pulverizing radix Angelicae sinensis, Notopterygii rhizoma, rhizoma Ligustici Chuanxiong, radix Polygoni Multiflori Preparata, and rhizoma Gastrodiae into fine powder; decocting the rest four materials with water for three times, 2 hr for the first time and the second time and 1 hr for the third time, mixing decoctions, filtering, concentrating the filtrate to appropriate amount, mixing with the above fine powder, granulating, drying, sieving, and making into capsule. It has the actions of nourishing blood, dispelling wind, tonifying kidney and replenishing essence. Can be used for treating alopecia caused by blood deficiency, wind excess, and kidney essence deficiency, with symptoms of loose or sparse hair, dry or greasy hair, and scalp pruritus; alopecia areata, alopecia totalis, seborrheic alopecia, alopecia after illness and parturition, and the above symptoms; in the preparation process, part of the medicinal materials are directly used as powder without being extracted, which is not beneficial to absorption and utilization of the medicine and has large administration dosage. The preparation process adopts the traditional wet granulation and steam box type drying method, the prepared granules are easy to be bonded in the drying process, the drying efficiency is low, the working hours are consumed, and the active ingredients are easy to be damaged in the drying process.
And in another research literature: the preparation method comprises the steps of Chua giri, experimental study on improvement of a blood-nourishing hair-growing capsule process, 2014, 24(3):178-181, wherein only a granulation method is improved, a medicinal material extraction method is not improved, and a fluidization one-step granulation method is adopted to damage some volatile components in a prescription.
The purpose of traditional Chinese medicine extraction is to extract effective components (or index components) in medicinal materials to the maximum extent and leach ineffective or even harmful components such as impurities, heavy metals and the like to the minimum extent. At present, the preparation process of the product recorded in Chinese pharmacopoeia is more traditional and simple, partial medicinal materials are directly used as powder without extraction, for example, partial medicinal materials are directly used as powder without extraction in the preparation process of the blood-nourishing and hair-growing capsule in the prior art, so that the preparation process has the defects of more ineffective or harmful components such as impurities, heavy metals and the like, low extraction efficiency of effective components, large dosage and inconvenience for taking by many patients because 4 capsules 0 (0.5 g in each capsule) are required to be taken every time. In addition, the traditional wet granulation and steam box type drying method are adopted in the preparation process, the prepared particles are easy to be adhered to connected blocks in the drying process, the continuous size stabilization is needed, the labor intensity is high, the heat conduction speed of the steam drying method is very slow, the drying efficiency is low, the material is heated unevenly, the internal and external temperature difference is generated on the heated material, the quality stability of the product is influenced, and for example, the main effective component stilbene glucoside in the prepared polygonum multiflorum can be damaged due to high-temperature heating.
Disclosure of Invention
Based on the above, the invention aims to overcome the defects of the prior art and provide the medicine for treating alopecia, which has the advantages of high extraction efficiency of effective components, difficult damage, small dosage and more stable quality.
In order to achieve the purpose, the invention adopts the technical scheme that: a medicine for treating alopecia comprises the following preparation raw materials in parts by weight: 1050-3150 parts of angelica sinensis, 410-1230 parts of notopterygium root, 410-1230 parts of ligusticum wallichii, 2050-6135 parts of prepared rehmannia root, 1050-3150 parts of semen cuscutae, 615-1845 parts of pawpaw, 2045-6135 parts of prepared polygonum multiflorum, 205-615 parts of gastrodia elata and 1050-3150 parts of radix paeoniae alba.
The angelica sinensis is sweet and heavy in taste, can specially enrich the blood, is the first medicine for enriching the blood, and is suitable for symptoms such as pale or sallow complexion, fatigue and hypodynamia, pale and lusterless lips and nails, light headedness, palpitation and insomnia and the like caused by heart-liver blood deficiency; radix Angelicae sinensis is combined with radix rehmanniae Preparata, radix Paeoniae alba, and rhizoma Ligustici Chuanxiong to make up a representative blood-tonifying prescription, named as SIWU decoction, with effects of regulating menstruation and tonifying blood; notopterygii rhizoma can be used for treating sexual impotence, spermatorrhea, enuresis, frequent micturition, lumbago, knee pain, and asthma due to kidney deficiency; the rhizoma ligustici wallichii can activate blood and relieve pain, search liver qi, supplement liver blood, moisten liver dryness and supplement wind deficiency; the prepared rehmannia root has the effects of nourishing yin and supplementing blood, replenishing vital essence and replenishing marrow and the like; can be used for treating deficiency of liver-yin and kidney-yin, soreness of waist and knees, hectic fever, night sweat, nocturnal emission, internal heat, diabetes, blood deficiency, sallow complexion, cardiopalmus, menoxenia, giddiness, tinnitus, and premature gray hair; the dodder has the efficacies of nourishing liver and kidney, securing essence and reducing urination, preventing miscarriage, improving eyesight and stopping diarrhea, and is listed as the superior product from Shen nong Ben Cao Jing; has effects in invigorating yang and nourishing yin, and has the advantages of warm but not dry, and tonifying without stagnation; the enzymes contained in the pawpaw are similar to the growth hormone of the human body, and people can keep youth after eating more enzymes; the contained abundant vitamin C, iron, potassium, calcium, carotene, lutein, etc. can provide multiple nutrients for hair, remove old waste protein accumulation, provide deep cleaning and nourishing for hair, and improve alopecia; the processed product of the prepared fleece-flower root is irregular shrivelled block pieces with the thickness of about 1 cm; the functions of the Chinese medicinal preparation mainly comprise tonifying liver and kidney, benefiting essence and blood, blackening beard and hair and strengthening bones and muscles; the rhizoma Gastrodiae has certain effects in treating hereditary poliosis, nervous poliosis, young and middle-aged poliosis, seborrheic alopecia, nervous alopecia, alopecia areata, and alopecia totalis; radix Paeoniae alba, the root of radix Paeoniae alba is radix Cynanchi auriculati in Yunnan Lijiang province, and has effects of suppressing hyperactive liver, relieving pain, nourishing blood and regulating menstruation.
The formula is refined by selecting high-quality pure Chinese herbal medicines according to the principle of 'treating the root causes and seeking the symptoms' of the traditional Chinese medicine, scientifically preparing the formula, and integrating the traditional Chinese medicine and modern technology into a whole, the formula integrates the advantages of various methods for treating alopecia, takes the principles of nourishing liver and kidney, consolidating the constitution, tonifying qi, nourishing blood and growing hair as the rules, and can fundamentally achieve the purposes of preventing and treating alopecia, nourishing beard and hair and promoting new hair growth; in the prescription, prepared fleece flower root and dodder seed are used for tonifying liver and kidney; radix rehmanniae Preparata, radix Angelicae sinensis, and radix Paeoniae alba can nourish yin and blood; rhizoma Ligustici Chuanxiong has effects in promoting blood circulation and activating qi-flowing; the gastrodia elata, the pawpaw and the notopterygium root have the effects of dispelling wind and eliminating dampness, and the medicines are used together to play the roles of tonifying liver and kidney, nourishing yin and blood, dispelling wind and eliminating dampness and promoting hair growth, so that the traditional Chinese medicine is suitable for treating various alopecia.
In another aspect, the present invention also provides a method for preparing the above-mentioned medicament for treating alopecia, comprising the steps of:
(1) weighing angelica, notopterygium root and ligusticum wallichii according to the weight parts, and then carrying out supercritical CO
2Extracting to obtain a fat-soluble extract A and medicine residue B, and clathrating the obtained fat-soluble extract A with β -cyclodextrin to obtain a clathrate F;
(2) weighing prepared polygonum multiflorum, white paeony root and gastrodia elata according to parts by weight, mixing the prepared polygonum multiflorum, white paeony root and gastrodia elata with the medicine residue B obtained in the step (1), performing ultrasonic extraction, and concentrating the obtained extracting solution in vacuum to obtain thick paste C;
(3) weighing prepared rehmannia root, pawpaw and dodder in parts by weight, decocting with water, filtering, and concentrating the obtained decoction into thick paste D;
(4) uniformly mixing the thick paste C and the thick paste D according to the mass ratio of 1.1-1.3: 1, performing microwave vacuum drying to obtain dry paste, crushing to obtain dry paste powder E, uniformly mixing with the inclusion compound F, adding auxiliary materials, performing dry granulation, and filling into capsules to obtain the medicine for treating alopecia.
The "dry granulation" is a method in which the drug is uniformly mixed with an auxiliary material such as a diluent, a disintegrant, a lubricant, etc., and the mixture is processed by a rolling method or a tabletting method l to 3 times, pressed into a sheet or a strip of a desired hardness, and then pulverized into particles of a desired size.
Preferably, the extraction conditions in step (1) are: the extraction pressure is 20-30 MPa, the extraction temperature is 35-60 ℃, the desorption pressure is 5-8 MPa, the desorption temperature is 30-50 ℃, and the extraction time is 1-3 hours; more preferably, the extraction conditions in step (1) are: the extraction pressure is 25Mpa, the extraction temperature is 50 ℃, the resolution pressure is 7Mpa, the resolution temperature is 40 ℃, and the extraction time is 2 hours, so that the yield of the volatile oil in the medicine is high, and volatile components in the medicine can be extracted to the maximum extent.
Preferably, the conditions of the inclusion in the step (1) are that the mass ratio of the fat-soluble extract A to the β -cyclodextrin is 1: 4-6, the inclusion temperature is 40-60 ℃, and the inclusion time is 1-2 hours, and more preferably, the inclusion ratio of the fat-soluble extract A to the β -cyclodextrin in the step (1) is 1:5, the inclusion temperature is 50 ℃, and the inclusion time is 1.5 hours.
Preferably, an alcoholic solution is adopted for ultrasonic extraction in the step (2), and the alcoholic solution is an ethanol solution with the volume fraction of 50-80%; more preferably, the ethanol solution is added with the mass 7-10 times of the total mass of the prepared fleece-flower root, the white paeony root and the tall gastrodia tuber, the ultrasonic extraction frequency is 1-3 times, each time lasts for 1-3 hours, the extract is filtered, the temperature of vacuum concentration is 50-60 ℃, and the density of the thick paste C relative to water at 50 ℃ is 1.28-1.30; more preferably, the alcohol solution in the step (2) is an alcohol solution with a volume fraction of 65%, the alcohol solution is added with 8 times of the total weight of the prepared fleece-flower root, the white paeony root and the tall gastrodia tuber, the ultrasonic extraction is carried out for 2 times, the first time lasts for 2 hours, the second time lasts for 1.5 hours, and the alcohol extracts obtained by the two ultrasonic extractions are combined and filtered, and the vacuum concentration temperature is 55 ℃.
Preferably, the water added in the step (3) is 8-12 times of the total weight of the prepared rehmannia root, the pawpaw and the dodder, the decoction is carried out for 1-3 times and 1-3 hours each time, the decoction is filtered, and the filtrate is decompressed and concentrated until the density of the thick paste D relative to water at 50 ℃ is 1.28-1.30; more preferably, in the step (3), the water is added in an amount which is 10 times of the total amount of the prepared rehmannia root, the pawpaw and the dodder, and the decoction is carried out for 2 times, 2 hours each time.
Preferably, the temperature of the vacuum microwave drying in the step (4) is 50-60 ℃; more preferably, the vacuum microwave drying temperature in the step (4) is 55 ℃.
Preferably, the auxiliary material in the step (4) is magnesium stearate, the adding mass of the magnesium stearate is 0.1-0.5% of the mass of the mixture of the clathrate compound F and the dry extract powder E, and the granulating method is dry granulating; more preferably, the magnesium stearate added in the step (4) accounts for 0.3% of the mass of the mixture of the clathrate compound F and the dry extract powder E.
Compared with the prior art, the invention has the beneficial effects that:
1. the invention provides an effective and reliable medicine preparation method by combining the characteristics of the effective ingredients of the traditional Chinese medicinal materials in the prescription of the blood-nourishing and hair-growing capsule, namely, the supercritical CO is adopted
2The extraction method, the ultrasonic extraction method and other modern technical means are used for carrying out targeted extraction on the medicinal materials, extracting effective components in the medicinal materials to the maximum extent, and leaching ineffective or even harmful components such as impurities, heavy metals and the like to the minimum extent;
2. the β -cyclodextrin inclusion technology is used for including the volatile components, and the microwave vacuum low-temperature drying technology and the dry granulation technology are used for drying and granulating, so that the damage to the volatile components and the heat-sensitive components in the preparation process of the product can be effectively reduced, the dosage is reduced, and the curative effect of the product is ensured;
3. the invention reduces the daily dose on the premise of ensuring the curative effect of the product, the original process is to take 4 capsules each time for 2 times per day, the process sample of the invention is to take 2 capsules each time for 2 times per day, the daily dose is reduced to half of the original process preparation, and the compliance of clinical medication of patients is greatly improved;
4. in the invention, the content of active ingredients such as gastrodin, paeoniflorin, ferulic acid, stilbene glucoside, notopterygium alcohol, isoimperatorin and the like in the product prepared by the novel preparation method is monitored by adopting a high performance liquid chromatography technology, and the scientific rationality of the preparation process is verified.
Drawings
Fig. 1 is a process flow chart of the preparation process of the blood nourishing and hair growing capsule of the invention.
Detailed Description
The invention aims to provide a preparation method of a medicament for treating alopecia, which has a better process, improves and optimizes the existing preparation process of the blood-nourishing and hair-growing capsule, and aims to provide a preparation process or a method with high extraction efficiency of effective components (or index components), small administration dosage and stable product quality; the invention mainly aims at the medicinal materials directly taking powder as medicine and the medicinal materials partially containing heat-unstable effective components in the prior preparation process and adopts supercritical CO
2The preparation method is scientific and reasonable in preparation process, high in effective component extraction efficiency, not easy to damage, small in taking dosage, greatly improves the compliance of clinical medication of patients, and is more stable in product quality.
The invention provides an effective and reliable medicine preparation method by combining the characteristics of the effective ingredients of the traditional Chinese medicinal materials in the prescription of the blood-nourishing and hair-growing capsule, namely, the supercritical CO is adopted
2The method comprises the following steps of performing targeted extraction on medicinal materials, extracting effective components in the medicinal materials to the maximum extent, leaching ineffective or even harmful components such as impurities, heavy metals and the like to the minimum extent, performing inclusion on easily volatile components by using an β -cyclodextrin inclusion technology, drying and granulating by using a microwave vacuum low-temperature drying technology and a dry granulation technology, effectively reducing damage of the easily volatile components and heat sensitive components in the preparation process of the product, and ensuring the curative effect of the product while reducing the administration dosageThe contents of active ingredients such as ferulic acid, stilbene glucoside, notopterygium alcohol, isoimperatorin and the like are monitored to verify the scientific reasonability of the preparation process.
The above object of the present invention is achieved by the following technical solutions:
a preparation method of a medicine for treating alopecia is disclosed, wherein the medicine is a blood-nourishing and hair-growing capsule, and the preparation method mainly comprises the following steps: radix Angelicae sinensis, Notopterygii rhizoma, and rhizoma Ligustici Chuanxiong by supercritical CO
2Extracting by clathrating the supercritical extract with β -cyclodextrin, and mixing radix Polygoni Multiflori Preparata, radix Paeoniae alba, rhizoma Gastrodiae and supercritical CO
2Mixing the extracted residues, performing ultrasonic extraction, and concentrating the extract at low temperature under vacuum to obtain a first thick paste; decocting radix rehmanniae Preparata, fructus Chaenomelis, and semen Cuscutae in water, filtering the decoction, and concentrating to obtain second soft extract; mixing the above two soft extracts, drying at low temperature under microwave vacuum, pulverizing the obtained dry extract, mixing the obtained dry extract powder with clathrate, adding appropriate amount of adjuvant, granulating by dry method, and making into capsule to obtain the medicine for treating alopecia.
The beneficial effects of the present invention over the prior art will be verified by the following methods: the content of the effective components in samples of different processes is detected by adopting a high performance liquid chromatography so as to show the difference between the preparation method of the invention and the prior art. The high performance liquid chromatography method of the present invention will be described in detail below.
1. High performance liquid chromatography: the contents of paeoniflorin in the white paeony root and gastrodin in the gastrodia elata are simultaneously measured by adopting a gradient elution method.
Wherein, the chromatographic conditions are as follows: octadecylsilane chemically bonded silica is used as a filling agent; gradient elution is adopted, acetonitrile is taken as a mobile phase A, and 0.1% acetic acid solution is taken as a mobile phase B; the detection wavelength is 225 nm; column temperature: 30 ℃; flow rate: 1 ml/min; the gradient elution procedure is shown in table 1.
Table 1 mobile phase gradient elution procedure
| Time (min) | Mobile phase A (%) | Mobile phase B (%) |
| 0～15 | 15 | 85 |
| 15～25 | 25 | 75 |
Preparation of control solutions: accurately weighing appropriate amount of gastrodine reference substance and penoniflorin reference substance, and adding methanol to obtain mixed solution with gastrodine concentration of 10 μ g/ml and penoniflorin concentration of 50 μ g/ml.
Preparation of a test solution: taking the content of the product, grinding, taking about 0.5g, precisely weighing, placing in a conical flask with a plug, precisely adding 50ml of ethanol with the volume fraction of 70%, sealing, weighing, ultrasonically treating (power 360W, frequency 40kHz) for 30 minutes, cooling, weighing again, complementing the lost mass with 70% ethanol, shaking up, filtering, and taking the subsequent filtrate to obtain the product.
The determination method comprises the following steps: precisely sucking 10 μ l of each of the reference solution and the sample solution, injecting into high performance liquid chromatograph, and measuring.
2. And (2) high performance liquid chromatography II: the contents of ferulic acid in radix Angelicae sinensis and rhizoma Ligustici Chuanxiong, stilbene glucoside in radix Polygoni Multiflori Preparata, Notopterygii rhizoma alcohol and isoimperatorin in Notopterygii rhizoma are determined simultaneously by gradient elution method.
Wherein, the chromatographic conditions are as follows: octadecylsilane chemically bonded silica is used as a filling agent; the gradient elution is adopted, and the gradient elution is adopted,
acetonitrile is taken as a mobile phase A, and a 0.1% glacial acetic acid solution is taken as a mobile phase B; the detection wavelength is 310 nm; column temperature: 30 ℃; flow rate: 1 ml/min. The gradient elution procedure is shown in table 2.
Table 2 mobile phase gradient elution procedure
| Time (min) | Mobile phase A (%) | Mobile phase B (%) |
| 0～10 | 5 | 95 |
| 10～40 | 15 | 85 |
| 40～60 | 50 | 50 |
| 60～80 | 90 | 10 |
Preparation of a reference solution: taking appropriate amount of ferulic acid reference substance, stilbene glucoside reference substance, Notopterygii rhizoma alcohol reference substance, and isoimperatorin reference substance, precisely weighing, and adding methanol to obtain mixed solution containing each component with concentration of 10 μ g/ml, 50 μ g/ml, 10 μ g/ml, and 10 μ g/ml respectively.
Preparing a test solution: taking the content of the product, grinding, taking about 0.5g, precisely weighing, placing in a conical flask with a plug, precisely adding 50ml of methanol with the volume fraction of 70%, sealing, weighing, ultrasonically treating (power 360W, frequency 40kHz) for 30 minutes, cooling, weighing again, supplementing the lost mass with 70% of methanol, shaking up, filtering, and taking the subsequent filtrate to obtain the product.
The determination method comprises the following steps: precisely sucking 20 μ l of each of the reference solution and the sample solution, injecting into high performance liquid chromatograph, and measuring.
In order to make the technical solutions of the present invention better understood, the present invention is further described in detail by the following specific examples, which are only used for illustrating the present invention and are not meant to limit the scope of the present invention.
The medicinal materials and the reagents used in the invention are commercially available, and the reference substances are purchased from China food and drug testing research institute. Supercritical CO used in the present invention
2The extraction method, the ultrasonic extraction method, the β -cyclodextrin inclusion technology, the microwave vacuum low-temperature drying technology, the dry granulation technology and other technologies all adopt the procedures or steps known in the art.
Example 1
A medicine for treating alopecia is prepared by the following steps: weighing 1050g of angelica, 410g of notopterygium root and 410g of ligusticum wallichii, and adopting supercritical CO
2Extracting under 25MPa, 50 deg.C, 7MPa, 40 deg.C and 2 hr to obtain 65g of liposoluble extract A and 1737g of medicinal residue B, mixing 2045g of radix Polygoni Multiflori Preparata, 205g of rhizoma Gastrodiae and 1050g of radix Paeoniae alba with the medicinal residue B obtained by supercritical extraction, adding 8 times of 65% ethanol solution, ultrasonic extracting for 2 times, 2 hr for the first time and 1.5 hr for the second time, mixing the ethanol extractive solutions, filtering, concentrating the filtrate under reduced pressure (55 deg.C) to obtain 2455g of soft extract C with relative water density of 1.28(50 deg.C), mixing 2050g of radix rehmanniae Preparata, 615g of fructus Chaenomelis and 1050g of semen Cuscutae, decocting with 10 times of water for 2 hr each time, mixing the decoctions, filtering, concentrating the filtrate under reduced pressure to obtain 1974g of soft extract D with relative water density of 1.28(50 deg.C), vacuum drying (55 g and 2120) to obtain dry extract E, clathrating the soft extract with β -3578 deg.C and β deg.C to obtain clathrate, and clathrating the extract with the liposoluble cyclodextrin under 1.C and 1.C to obtain clathrate of cyclodextrin clathrate, and clathrating the extract C, and the extract A under microwave cyclodextrin clathrate of 1.5 hr to obtain the extract C, and the clathrate ofMixing the dry extract powder E and the clathrate F uniformly, adding 0.3% of magnesium stearate, mixing uniformly, granulating by a dry method, and encapsulating to obtain the medicine for treating alopecia. The contents of gastrodin, paeoniflorin, ferulic acid, stilbene glucoside, notopterygium alcohol and isoimperatorin in the blood-nourishing and hair-growing capsule prepared under the process conditions are measured according to the high performance liquid chromatography I and the high performance liquid chromatography II, and are compared with the original process.
Example 2
A medicine for treating alopecia is prepared by the following steps: weighing 2100g of Chinese angelica, 820g of notopterygium root and 820g of ligusticum wallichii by adopting supercritical CO
2Extracting under 20Mpa at 60 deg.C under 8Mpa at 50 deg.C for 3 hr to obtain 125g of liposoluble extract A and 3503g of residue B, mixing 4090g of radix Polygoni Multiflori Preparata, 410g of rhizoma Gastrodiae, 2100g of radix Paeoniae alba with the residue B after supercritical extraction, adding 7 times of 50% ethanol solution, ultrasonic extracting for 3 times, 1.5 hr for the first time, 1.5 hr for the second time, and 1 hr for the third time, mixing the ethanol extractive solutions, filtering, concentrating the filtrate under reduced pressure (50 deg.C) to obtain 4822g of soft extract C with relative density of 1.29(50 deg.C), mixing radix rehmanniae Preparata, 4090g of fructus Chaenomelis, 1230g of semen Cuscutae, decocting with 12 times of water for 1 time, decocting for 3 hr, filtering, concentrating the filtrate under reduced pressure to obtain 3905g of soft extract D with relative density of 1.29(50 deg.C), vacuum drying (50 deg.C), pulverizing to obtain 4136g of clathrate, adding 3583-83% of cyclodextrin, mixing the soft extract with the extract of notopterygium root extract, and cyclodextrin, and granulating the mixture by microwave-assisted extraction process to obtain a dry extract, wherein the first-second-4% cyclodextrin clathrate of notopterygium root clathrate of cyclodextrin clathrate of notopterygium root.
Example 3
A Chinese medicinal composition for treating alopecia, and its preparation method,the preparation method comprises the following steps: weighing 3150g of angelica, 1230g of notopterygium root and 1230g of ligusticum wallichii, and adopting supercritical CO
2The preparation method comprises the steps of extracting under the conditions of an extraction pressure of 30Mpa, an extraction temperature of 35 ℃, an analytic pressure of 5Mpa, an analytic temperature of 30 ℃ and an extraction time of 1 hour to obtain 198g of fat-soluble extract A and 5287g of medicine residue B, weighing 6135g of prepared fleece-flower root, 615g of rhizoma gastrodiae and 3150g of white paeony root, mixing with the medicine residue B obtained by supercritical extraction, adding 10 times of ethanol solution with the volume fraction of 80% for ultrasonic extraction for 1 time and 3 hours, filtering the extract, concentrating the filtrate under reduced pressure (at 60 ℃) to obtain 6953g of thick paste C with the relative density of 1.30 (at 50 ℃), weighing 6135g of prepared rehmannia root, 1845g of pawpaw and 3150g of semen cuscutae, adding 8 times of water for decocting for 3 times and 1 hour each time, combining decoction, filtering, concentrating the filtrate under reduced pressure to obtain 5640g of thick paste D with the relative density of 1.30 (at 50 ℃), mixing the thick paste C with the thick paste C, drying under vacuum (60) to obtain 6108g of dry extract E, clathrating the extract A with β -cyclodextrin, preparing 356% of the extract of the notopterygium root, and mixing with the notopterygium root extract, and preparing the capsule, and carrying out the high-6% of the high-lipid-soluble extract by the high-cyclodextrin clathrate compound of the high-enriched capsule, and the high-enriched capsule for the high-performance liquid chromatography to obtain the capsule for the high.
Example 4
The blood nourishing and hair growth promoting capsules prepared in the above examples and the original process samples are subjected to content measurement (according to the detection of the first high performance liquid chromatography and the second high performance liquid chromatography), and the measurement results are shown in the following table 3.
TABLE 3 content of specific ingredients in the blood nourishing and hair growth promoting capsule prepared by the preparation method of the present invention
Therefore, the content of each effective component (or index component) in the sample prepared by the method is obviously higher than that of the original process sample, and the preparation method disclosed by the invention has the advantages that compared with the prior art, the extraction efficiency of each effective component (or index component) is higher while the dosage of the product is reduced, so that the curative effect of the medicine for treating alopecia is ensured.
Example 5
In addition, according to the method for measuring the volatile oil 2204 in the four ministry of China pharmacopoeia 2015, the content of the volatile oil in the samples obtained by the prior process (namely the original process) and the preparation method of the invention is measured, and the results are shown in the following table 4.
TABLE 4 content of volatile oil in sample obtained by the preparation method of the present invention
The results show that in the preparation process of the sample in the prior art, due to high temperature and more loss of volatile components during drying and wet granulation, the volatile components play important roles in nourishing blood and enriching blood and can play a curative effect on alopecia caused by deficiency of both qi and blood, for example, angelica volatile oil contains multiple chemical components such as ligustilide, butenyl phthalide, palmitic acid, phthalic acid and the like, has the effects of enriching and activating blood, promoting hair growth, improving ischemia and the like, ligusticum volatile oil contains α -pinene, carotenol, ligusticum lactone, ligustilide, palmitic acid and other chemical components, has the effects of activating blood and activating qi, improving blood flow and the like, notopterygium volatile oil contains α -pinene, β -pinene and other chemical components, and has corresponding roles in dispelling wind and eliminating dampness and increasing nutritional blood flow, and the preparation method of the invention adopts supercritical CO
2Extraction, β -cyclodextrin inclusion, microwave vacuum low-temperature drying and dry granulation technology, so that volatile components in the sample are well retained.
Finally, it should be noted that the above embodiments are only used for illustrating the technical solutions of the present invention and not for limiting the protection scope of the present invention, and although the present invention is described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that modifications or equivalent substitutions can be made on the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention.
Claims (7)
1. A preparation method of a medicine for treating alopecia comprises the following raw materials: 1050-3150 parts of Chinese angelica, 410-1230 parts of notopterygium root, 410-1230 parts of ligusticum wallichii, 2050-6135 parts of prepared rehmannia root, 1050-3150 parts of semen cuscutae, 615-1845 parts of pawpaw, 2045-6135 parts of prepared polygonum multiflorum, 205-615 parts of rhizoma gastrodiae and 1050-3150 parts of white paeony root; the method is characterized by comprising the following steps:
(1) weighing angelica, notopterygium root and ligusticum wallichii according to the weight parts, and then carrying out supercritical CO
2Extracting to obtain a fat-soluble extract A and medicine residue B, and clathrating the obtained fat-soluble extract A with β -cyclodextrin to obtain a clathrate F;
(2) weighing prepared polygonum multiflorum, white paeony root and gastrodia elata according to parts by weight, mixing the prepared polygonum multiflorum, white paeony root and gastrodia elata with the medicine residue B obtained in the step (1), performing ultrasonic extraction, and concentrating the obtained extracting solution in vacuum to obtain thick paste C;
(3) weighing prepared rehmannia root, pawpaw and dodder in parts by weight, decocting with water, filtering, and concentrating the obtained decoction into thick paste D;
(4) uniformly mixing the thick paste C and the thick paste D according to the mass ratio of 1.1-1.3: 1, performing microwave vacuum drying to obtain dry paste, crushing to obtain dry paste powder E, uniformly mixing with the inclusion compound F, adding auxiliary materials, performing dry granulation, and filling into capsules to obtain the medicine for treating alopecia; the temperature of the vacuum microwave drying in the step (4) is 50-60 ℃.
2. The method according to claim 1, wherein the extraction conditions in the step (1) are: the extraction pressure is 20-30 MPa, the extraction temperature is 35-60 ℃, the desorption pressure is 5-8 MPa, the desorption temperature is 30-50 ℃, and the extraction time is 1-3 hours.
3. The preparation method according to claim 1, wherein the inclusion in step (1) is carried out under conditions that the mass ratio of the fat-soluble extract A to β -cyclodextrin is 1: 4-6, the inclusion temperature is 40-60 ℃, and the inclusion time is 1-2 hours.
4. The preparation method according to claim 1, wherein the step (2) is carried out by ultrasonic extraction with an alcohol solution, wherein the alcohol solution is an ethanol solution with a volume fraction of 50-80%.
5. The preparation method according to claim 4, wherein in the step (2), the ethanol solution is added by 7-10 times of the total weight of the prepared fleece-flower root, the white paeony root and the tall gastrodia tuber, the ultrasonic extraction is performed for 1-3 times, each time lasts for 1-3 hours, the extract is filtered, the temperature of vacuum concentration is 50-60 ℃, and the density of the thick paste C relative to water at 50 ℃ is 1.28-1.30.
6. The preparation method according to claim 1, wherein the water added in the step (3) is 8-12 times of the total amount of the prepared rehmannia root, the pawpaw and the dodder, the decoction is carried out for 1-3 times and 1-3 hours each time, the decoction is filtered, and the filtrate is subjected to reduced pressure concentration until the density of the thick paste D at 50 ℃ relative to water is 1.28-1.30.
7. The preparation method according to claim 1, wherein the auxiliary material in the step (4) is magnesium stearate, the added mass of the magnesium stearate is 0.1-0.5% of the total mass of the mixture of the clathrate compound F and the dry extract powder E, and the granulation method is dry granulation.
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| CN101062157A (en) * | 2007-05-29 | 2007-10-31 | 南京中山制药有限公司 | Process for preparing particles for Zhizhu |
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