CN112076250A - Prunella vulgaris extract and preparation method and application thereof - Google Patents
Prunella vulgaris extract and preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a selfheal extract and a preparation method and application thereof, wherein the content of rosmarinic acid in the extract is not lower than 5 mg/g. Obtained by the following preparation method: decocting Prunellae Spica in water for 1-3 times, each for 2-3 hr, filtering, concentrating the decoction, adding 70-90% ethanol to ethanol content of 55-60%, standing, collecting supernatant, and concentrating to obtain extract. Animal experiments show that the long-term administration of the Prunella vulgaris extract can effectively reduce the risk of the generation of the thyroid follicular paracellular tumorous hyperplasia (also called tumorous C cell hyperplasia) under the condition of not influencing survival rate and normal metabolism.
Description
Technical Field
The invention relates to the field of medicines, in particular to a selfheal extract, a preparation method and application thereof.
Background
Thyroid cancer is the most common malignancy of the endocrine system. 2019 national cancer reports issued by the national cancer center show that thyroid cancer is a 7 th high-grade malignant tumor of the general population in China and is a 4 th high-grade malignant tumor of women. Medullary Thyroid Carcinoma (MTC), a malignant tumor originating from the parafollicular cells of the thyroid gland (also called C cells), can be divided into hereditary and sporadic types, accounting for about 2-3% of total thyroid cancer, and although the incidence rate is much lower than that of highly differentiated thyroid cancer (WDTC, accounting for about 90% of total thyroid cancer), the prognosis of MTC, especially hereditary MTC, is usually poor because the malignancy degree is significantly higher than WDTC and the invasion and early metastasis are more likely to occur.
Because MTC is not sensitive to radiotherapy and chemotherapy, surgery becomes the main treatment for MTC. Currently, the clinical surgical treatment of MTC is divided into prophylactic and therapeutic. The preventive operation is usually applied to the offspring of the hereditary MTC patients, according to the RET gene mutation screening result, the children in the highest risk group of the hereditary MTC are recommended to carry out preventive thyroidectomy within 1 year, while the children in the high risk group are recommended to carry out thyroidectomy within 5 years, but the operation is probably to cause serious influence on the neural development of the children and possibly damage parathyroid gland, so that the preventive treatment is controversial. Therapeutic surgery is applicable to both hereditary and sporadic MTC patients, but its efficacy depends largely on the stage of disease diagnosis, and for advanced MTC patients (stage IV), the 10-year survival rate is only 21% even with surgical treatment. Therefore, reducing the risk of disease occurrence while delaying the disease progression is of great importance for the prevention and treatment of MTC, but no effective means is currently available.
Prunellae Spica (Prunella vulgaris L.) is a perennial herb of Labiatae, and has been used in traditional Chinese medicine for over a thousand years to treat thyroid insufficiency, goiter and neck mass. Modern medicine proves that selfheal has the effects of resisting tumor, inflammation, bacteria, oxidation and the like, recent research shows that selfheal has certain prevention and treatment capacity on WDTC, but the influence on MTC with low degree of differentiation and precancerous lesion of the MTC is yet to be clarified, and related research results provide a new idea for searching an MTC early prevention and control strategy.
Disclosure of Invention
In order to solve the technical problems, the invention provides a selfheal extract and a preparation method and application thereof.
The invention is realized by the following technical scheme:
a Prunellae Spica extract is characterized in that the content of rosmarinic acid in the extract is not less than 5 mg/g.
A selfheal extract is obtained by the following preparation method: decocting Prunellae Spica with water (pH of 5-7) for 1-3 times (each for 1.6-3.0 hr), filtering, concentrating decoction, adding 70-90% ethanol to ethanol content of 55-60%, standing, collecting supernatant, and concentrating to obtain extract.
Further preferably, the selfheal extract is prepared by the following preparation method: taking a selfheal medicinal material, adding 15-16 times of drinking water for the first time, decocting for 1.6-3.0 hours, filtering a liquid medicine with 100 meshes, and putting the liquid medicine into a storage tank; adding 13-15 times of drinking water for the second time, decocting for 1.6-3.0 hr, filtering with 100 mesh sieve, mixing with the first medicinal liquid, concentrating to relative density of 1.06-1.09 (55-60 deg.C), adding 70-90% ethanol to ethanol content of 55-60%, standing, collecting supernatant, and collecting residue; recovering ethanol, concentrating to relative density of 1.15-1.25 (55-60 deg.C), collecting paste, measuring total solid, and weighing.
Further preferably, the medicine residue in the above steps is centrifuged, the centrifugate and the supernatant are combined, then the ethanol is recovered, the supernatant is centrifuged for 1 to 3 times, the centrifugate is concentrated to the relative density of 1.15 to 1.25(55 ℃ to 60 ℃) to obtain paste, the total solid is measured and weighed.
The invention also discloses a preparation method of the selfheal, which comprises the following steps:
adding 15-16 times of drinking water into selfheal medicinal material for the first time, decocting for 1.6-3.0 hours, filtering the liquid medicine with 100 meshes, and putting the filtered liquid medicine into a storage tank; adding 13-15 times of drinking water for the second time, decocting for 1.6-3.0 hr, filtering with 100 mesh sieve, mixing with the first medicinal liquid, concentrating to relative density of 1.06-1.09 (55-60 deg.C), adding 70-90% ethanol to ethanol content of 55-60%, standing, collecting supernatant, and collecting residue; recovering ethanol, concentrating to relative density of 1.15-1.25 (55-60 deg.C), collecting paste, measuring total solid, and weighing.
Further preferably, the medicine residue in the above steps is centrifuged, the centrifugate and the supernatant are combined, then the ethanol is recovered, the supernatant is centrifuged for 1 to 3 times, the centrifugate is concentrated to the relative density of 1.15 to 1.25(55 ℃ to 60 ℃) to obtain paste, the total solid is measured and weighed.
The invention also provides application of the selfheal extract in preparing a drug for preventing and controlling medullary thyroid carcinoma. The medullary thyroid cancer is hereditary. The selfheal of the invention can prevent and treat hereditary thyroid medullary precancerous lesion parathyroid follicular cell tumorous hyperplasia (namely tumorous C cell hyperplasia CCH).
The invention also provides a medicinal composition containing the selfheal.
The pharmaceutical composition of the invention can be in any form of medicine which can be taken: such as tablets, sugar-coated tablets, film-coated tablets, enteric-coated tablets, capsules, hard capsules, soft capsules, oral liquids, buccal agents, granules, pills, powders, ointments, salves, suspensions, powders, solutions, injections, suppositories, ointments, plasters, creams, sprays, drops or patches.
The pharmaceutical compositions of the present invention are preferably in the form of a unit dose pharmaceutical formulation.
When the pharmaceutical composition is prepared into a medicament, the medicament with unit dose can contain 0.1-1000mg of the pharmaceutical active substance, and the balance is a pharmaceutically acceptable carrier. The pharmaceutically acceptable carrier may be 0.01-99.99% by weight of the total weight of the formulation.
The composition of the present invention is used in an amount determined according to the condition of the patient, for example, 1 to 3 times a day. 1-10 tablets at a time, etc.
Preferably, the composition of the present invention is an oral preparation or an injection.
Wherein the oral preparation is selected from one of capsules, tablets, dripping pills, granules, concentrated pills, oral liquid and mixture.
Wherein, the injection is selected from one of injection, freeze-dried powder injection and water injection.
The pharmaceutical composition of the present invention, the preparation for oral administration thereof, may contain conventional excipients such as binders, fillers, diluents, tabletting agents, lubricants, disintegrants, coloring agents, flavoring agents or wetting agents, and the tablet may be coated if necessary.
Suitable fillers include cellulose, mannitol, lactose or other similar fillers. Suitable disintegrants include starch, polyvinylpyrrolidone or starch derivatives, preferably sodium starch glycolate. A suitable lubricant is magnesium stearate. A suitable wetting agent is sodium lauryl sulphate.
The pharmaceutical composition of the present invention can be prepared into solid oral compositions by conventional methods such as mixing, filling, tabletting and the like. Repeated mixing can result in distribution of the active throughout the composition using a large amount of filler.
Oral liquid preparations may be in the form of aqueous or oily suspensions, solutions, emulsions, syrups or elixirs, or may be presented as a dry product for constitution with water or other suitable vehicle before use. Such liquid preparations may contain conventional additives such as suspending agents, for example sorbitol, syrup, methyl cellulose, gelatin, hydroxyethyl cellulose, carboxymethyl cellulose, aluminium stearate gel or hydrogenated edible fats, emulsifying agents, for example lecithin, sorbitan monooleate or acacia; non-aqueous carriers (which may include edible oils), for example almond oil, fractionated coconut oil, oily esters such as glycerides, propylene glycol or ethyl alcohol; preservatives, for example p-hydroxybenzoic acid methyl ester, propyl p-hydroxybenzoate or sorbic acid, and, if desired, conventional flavouring or colouring agents.
For injections, liquid unit dosage forms are prepared containing the active substances of the invention and a sterile carrier. Depending on the carrier and concentration, the compound may be suspended or dissolved. Solutions are generally prepared by dissolving the active substance in a carrier, filter sterilising before filling it into a suitable vial or ampoule and then sealing. Adjuvants such as a local anaesthetic, preservatives and buffering agents may also be dissolved in the vehicle. To improve its stability, the composition can be frozen after filling into vials and the water removed under vacuum.
The pharmaceutical composition of the invention can be optionally added with a suitable pharmaceutically acceptable carrier when being prepared into a medicament, and the pharmaceutically acceptable carrier is selected from one or more of the following: mannitol, sorbitol, sodium metabisulfite, sodium bisulfite, sodium thiosulfate, cysteine hydrochloride, thioglycolic acid, methionine, vitamin C, EDTA disodium, calcium sodium EDTA, monovalent alkali metal carbonates, acetates, phosphates or aqueous solutions thereof, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acids, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivatives, cellulose and derivatives thereof, alginates, gelatin, polyvinylpyrrolidone, glycerol, Tween 80, agar, calcium carbonate, calcium bicarbonate, surfactants, polyethylene glycol, cyclodextrin, beta-cyclodextrin, phospholipid-based materials, kaolin, talc, calcium stearate, magnesium stearate, and the like.
The dosage form of the invention is not limited to this, and it can be prepared into more dosage forms, such as dripping pills, sustained release preparations and any other administrable pharmaceutical forms.
The invention shows the beneficial effects through the following test examples
1 experimental drugs: EXAMPLE 1 Prunella vulgaris extract (PV)
2 method of experiment
2.1PV dose design
PV aqueous extract (example 1, batch 110301) was supplied by wanoge pharmaceutical limited (guangdong, china). Different doses of PV water extract powder were added to the basal feed to prepare a special PV feed. The final PV concentration in the feed is 2.5, 8.25 and 25g/kg bw respectively, which is equivalent to 10, 33 and 100 times of the maximum daily dose of adult PV recommended by Chinese pharmacopoeia. Both rat basal feed and special PV feed were produced and purchased from the medical laboratory animal center in guangdong province.
2.2 animal Experimental design
552 SPF-grade Wistar rats, each half female and half, were purchased from southern medical university laboratory animal centers and fed in standard environments (20-26 ℃, 40-70% humidity and 12 hour light/dark cycle) in SPF animal houses. After 1 week of acclimatization, the rats were randomly divided into 4 groups (69 female +69 male rats per group) according to body weight, and fed with the following feeds: basal feed (control), 2.5g/kg bw PV feed (low PV group), 8.25g/kg bw PV feed (medium PV group) and 25g/kg bw PV daily feed (high PV group). PV was administered orally in the manner described above for 24 months, and body weight and food intake were recorded periodically. At month 12, 24 rats (12 female and 12 male) per group were sacrificed according to the specifications, and the remainder were performed at month 24. Abdominal aortic blood and thyroid tissue from the fasting animals were collected. The experimental scheme is approved by the animal experiment ethics committee of the Guangdong disease prevention and control center (SYXK 2011-.
2.3 Metabolic index detection
The abdominal aorta blood sample was centrifuged at 200g for 20 minutes at room temperature to obtain a serum sample, which was stored at-80 ℃. The full-automatic biochemical instrument (Hitachi 7600-010) detects the contents of serum glutamic-pyruvic transaminase (ALT), aspartate Aminotransferase (AST), Total Protein (TP), Albumin (ALB), Blood Urea Nitrogen (BUN), Creatinine (CREA), glucose, Triglyceride (TG) and Total Cholesterol (TC), and the kit is purchased from Nanjing institute of bioengineering.
2.4 histological examination
Thyroid tissue was fixed with 10% neutral formalin overnight at 4 ℃ and then embedded in paraffin. Histological examination was performed after tissue sections (4-6 μm) were stained with hematoxylin and eosin (H & E). The histological type of the tumors and precancerous lesions was confirmed by two pathologists using light microscopy for diagnosis.
2.5 statistical analysis
Data are presented as mean ± standard deviation and statistical analysis was performed using SPSS 17.0 and SAS 9.1.3 software. Survival rates of rats in each group were compared using Kaplan-Meier survival analysis and log rank test. Repeated measures anova was used to analyze body weight and food intake. Differences between groups in metabolic indicators were tested using one-way ANOVA (one-way ANOVA), and minimal significant differences (LSD) between groups compared pairwise. By Fisher's exact probability test or chi2The test compares the incidence of thyroid cancer and precancerous neoplastic C-cell hyperplasia (CCH). The P < 0.05 prompt difference has statistical significance.
3 results
3.1 Long-term administration of PV does not affect the survival rate of rats
No mortality was observed at month 12. After 24 months of treatment, 66, 69, 71 and 71 rats survived in the control, low PV, medium PV and high PV groups, respectively. Although the difference in survival between groups was not statistically significant (fig. 1), the high PV group males showed an increased survival rate.
3.2 Effect of PV on food intake and body weight
During the feeding process of the feed containing PV, the food intake of four groups of rats fluctuates (fig. 2A-B), but the fluctuation of the food intake does not have obvious influence on the body weight, and the body weight of each group of rats, particularly male rats, changes basically uniformly (fig. 2C-D).
3.3 Effect of PV on Metabolic indices
At the end of feeding, there were no statistical differences in serum ALT, TP, ALB, BUN, CREA, glucose, TG and TC in each group (Table 1). The AST in the male group was significantly lower (P < 0.05) than in the control group in the high PV group, while similar results were not seen in female rats, suggesting that the potential protective effect of PV on liver function may depend on gender. The long-term administration of PV will not damage liver and kidney function and glycolipid metabolism.
TABLE 1 Effect of PV on metabolic indices (mean. + -. SD)
aP < 0.05, compared to control group. ALT, glutamic-pyruvic transaminase; AST, aspartate aminotransferase; TP, total protein; ALB, albumin; BUN, blood urea nitrogen; CREA, creatinine; TG, triglycerides; TC, total cholesterol.
3.4 Effect of PV on idiopathic thyroid carcinoma
At 12 months, no rats developed thyroid cancer. At 24 months, there were 14, 15 and 8 rats diagnosed with thyroid cancer in the control, low PV, medium PV and high PV groups, respectively. The histological types of thyroid cancer were follicular papillary thyroid carcinoma (fvptt, fig. 3A), medullary thyroid carcinoma (MTC, fig. 3B), and poorly differentiated thyroid carcinoma (PDTC, fig. 3C), with MTC being the most common, PDTC being found only in male rats (table 2). Secondary cancer was not found in all thyroid tissues. The total incidence rate of thyroid cancer or incidence rate of each histological type of rats in each group has no statistical difference. From Table 2, it is seen that the incidence of medullary thyroid carcinoma in the rats in the high PV group is decreased compared with that in the control group.
TABLE 2 Effect of PV on idiopathic thyroid carcinoma and precancerous lesions
Data are expressed in terms of counts (rates).aP < 0.05 vs control. Fvptt, follicular papillary thyroid carcinoma; PDTC, poorly differentiated thyroid carcinoma; MTC, medullary thyroid carcinoma; CCH, C cell proliferation.
3.5 Long-term administration of PV can reduce incidence of tumorous CCH
The tumorous CCH is a precancerous lesion of hereditary MTC, and the incidence of medullary thyroid cancer can be reduced by inhibiting the tumorous CCH.
This study showed that the incidence of tumorous CCH (fig. 3D) was significantly different between groups (P < 0.05, table 2). The incidence of tumorous CCH in rats in the low PV, medium PV and high PV groups was lower than that in the control group, with the lowest incidence in the high PV group.
It should be noted that the present invention, in the results "long-term PV consumption can reduce the incidence of tumorous CCH" mentioned that PV can reduce the risk of tumorous CCH of premalignant hereditary MTC, but in the results "influence of 3.4PV on spontaneous thyroid cancer" no significant influence of PV on MTC incidence was observed, because MTC can be generally classified into hereditary and sporadic types, and the spontaneous MTC observed in rats of the present invention is closer to sporadic rather than hereditary, so it is reasonable that the influence of PV on MTC incidence cannot be observed.
In summary, the present invention discusses the effect of aqueous extracts of Prunellae Spica (PV) on the survival rate, spontaneous thyroid cancer and its precancerous lesions in rats. The extract disclosed by the invention is found for the first time to reduce the occurrence risk of hereditary MTC precancerous lesion and tumorous CCH (continuous negative channel) on the premise of not influencing survival rate and normal metabolism after being taken for a long time.
Drawings
FIG. 1 is a graph showing the effect of PV on the survival of female (A) and male (B) rats in the experimental examples of the present invention.
FIG. 2 shows the food intake and body weight of the rats during the dry test period in the experimental example of the present invention. A food intake of female mice; b, food intake of male mice; c, the weight of the female mouse; and D, the body weight of the male mouse. Data are presented as mean ± SD.*P < 0.05 compared to the control group,**p < 0.01 compared to control group. PV, selfheal.
FIG. 3 is a section of thyroid tissue (H & E, 100X) in the test example of the present invention. Follicular papillary thyroid carcinoma; medullary thyroid carcinoma (medullary thyroid carcinoma); c poorly differentiated thyroid carcinoma; d neoplastic C cell proliferation.
Fig. 4 shows a fingerprint of prunella vulgaris according to an embodiment of the present invention.
Detailed Description
The following detailed description of the present invention is provided in conjunction with the accompanying drawings, but it should be understood that the scope of the present invention is not limited to the specific embodiments.
Throughout the specification and claims, unless explicitly stated otherwise, the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element or component but not the exclusion of any other element or component.
Example 1:
collecting Prunellae Spica about 1200kg (batch number: A1203001), adding 15 times (about 18 tons) of drinking water (pH 5-7) for the first time, decocting for 2 hr, filtering with 100 mesh sieve, and storing in a storage tank.
Adding 13 times (about 15 tons) of drinking water (pH 5-7) for the second time, decocting for 1 hr, filtering with 100 mesh sieve, mixing with the first medicinal liquid, concentrating to relative density of 1.06-1.09 (55-60 deg.C), adding 70% ethanol to reach ethanol content of 55%, standing for over 24 hr, standing, collecting supernatant (the residue is centrifuged, and the ethanol precipitation medicinal liquid is recovered), recovering ethanol (the medicinal liquid is centrifuged for 2 times), concentrating to relative density of 1.15-1.25 (55-60 deg.C), collecting paste, measuring total solid, and weighing. The rosmarinic acid content was determined to be 5.85 mg/g.
Example 2
Collecting Prunellae Spica 1200kg (batch number: A1203001), adding 16 times of drinking water (pH 5-7) for the first time, decocting for 3 hr, filtering to obtain medicinal liquid of 100 meshes, and storing in a storage tank; adding 15 times of drinking water (pH 5-7) for the second time, decocting for 3 hr, filtering the medicinal liquid with 100 mesh sieve, mixing with the first medicinal liquid, concentrating to relative density of 1.06-1.09 (55-60 deg.C), adding appropriate amount of 90% ethanol until ethanol content is 60%, standing, collecting supernatant, and collecting residue; recovering ethanol, concentrating to relative density of 1.15-1.25 (55-60 deg.C), collecting paste, measuring total solid, and weighing. The rosmarinic acid content was determined to be 5.32 mg/g.
Example 3
Collecting Prunellae Spica 1200kg (batch number: A1203001), adding 15 times of drinking water (pH 5-7) for the first time, decocting for 1.6 hr, filtering medicinal liquid with 100 mesh sieve, and storing in a storage tank; adding 14 times of drinking water (pH 5-7) for the second time, decocting for 1.6 hr, filtering with 100 mesh sieve, mixing with the first medicinal liquid, concentrating to relative density of 1.06-1.09 (55-60 deg.C), adding 80% ethanol to ethanol content of 55%, standing, collecting supernatant, and collecting residue; recovering ethanol, concentrating to relative density of 1.15-1.25 (55-60 deg.C), collecting paste, measuring total solid, and weighing. The rosmarinic acid content was determined to be 5.68 mg/g.
Example 4
Modifying the extract obtained in the example 1 with dextrin, spray-drying, pulverizing into fine powder, adding adjuvants such as sucrose, dextrin, mannitol, correctant, etc., spray-granulating, drying at 60 deg.C, adding appropriate amount of magnesium stearate, and making into 1000 tablets to obtain chewable tablet.
Example 5
The extract of example 1 is taken and added with a proper amount of ethanol and sucrose to prepare syrup.
Example 6
100g of the extract in the example 1, 16g of sodium hydroxide, 50g of citric acid, 29g of citric acid, 400ml of simple syrup and 10ml of 4% ethylparaben solution are taken, and distilled water is added to 100ml to obtain the suspension.
Example 7
Diluting the extract of example 1 with normal saline, filtering, sterilizing, adjusting pH to 6.5 with anhydrous sodium carbonate, fine filtering, packaging, and sterilizing at 105 deg.C under hot pressure for 45min to obtain injection.
Example 8
Taking 1000g of the extract of the embodiment 1, 21000g of calcium carbonate and 2100g of starch, mixing the calcium carbonate and the starch uniformly, sieving, mixing with an extract diluted by a proper amount of ethanol uniformly, sieving by a No. seven sieve, drying at 60-70 ℃, and encapsulating to prepare 10 ten thousand capsules.
Example 9
100g of gelatin, 30g of glycerol and 130g of water, and adding a proper amount of water into the gelatin to expand the gelatin into gelatin solution. Mixing 1000g of the extract of example 1 with 3000g of edible vegetable oil, and fully stirring to obtain oil liquid; placing the prepared gelatin solution in gelatin solution storage tank at 60 deg.C, placing the oil solution in medicinal liquid storage tank, and preferably making the liquid paraffin have a temperature of 10-17 deg.C. Dripping at room temperature of 10-20 deg.C and dripper temperature of 40-50 deg.C, drying, wiping, and packaging to obtain soft capsule.
Example 10
500g of the extract of example 1, 125g of microcrystalline cellulose, 30g of starch, 20g of aerosil, 15g of talcum powder and 10g of magnesium stearate are mixed uniformly and pressed into 1000 tablets.
Example 11
500g of the extract of example 1, sodium bicarbonate, citric acid, fumaric acid, sodium cyclamate, polyethylene glycol and lactose are prepared into effervescent tablets.
EXAMPLE 12 method for measuring the content of rosmarinic acid
1. Preparing a test sample:
1g of the extract in the embodiment 1-3 is precisely weighed, distilled water is added to a constant volume of 25ml, and 1ml of the extract is filtered through a 0.45 mu m microporous filter membrane to obtain the extract.
2. Preparing a standard substance:
precisely weighing rosmarinic acid, and adding methanol to obtain solution containing 0.18mg per 1 ml.
3. Chromatographic conditions are as follows: a chromatographic column: agilent ZORBAX SB-C18 (250X 4.6mm, 5 μm), detection wavelength (nm): 235, column temperature (° c): 30, flow rate (mL/min): 1, sample size (μ L): 10
Mobile phase table 3A 0.1% formic acid B acetonitrile
| Time (min) | B(％) |
| 0～7 | 5 |
| 7～20 | 5→10 |
| 20～30 | 10→11 |
| 30～35 | 11→19 |
| 35～40 | 19→20 |
| 40～55 | 20→30 |
| 55～65 | 30→46 |
| 65～70 | 46→52 |
The foregoing descriptions of specific exemplary embodiments of the present invention have been presented for purposes of illustration and description. It is not intended to limit the invention to the precise form disclosed, and obviously many modifications and variations are possible in light of the above teaching. The exemplary embodiments were chosen and described in order to explain certain principles of the invention and its practical application to enable one skilled in the art to make and use various exemplary embodiments of the invention and various alternatives and modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims and their equivalents.
Claims (10)
1. A Prunellae Spica extract is characterized in that the content of rosmarinic acid in the extract is not less than 5 mg/g.
2. The Prunella vulgaris extract of claim 1, which is obtained by the following preparation method: decocting Prunellae Spica with water at pH of 5-7 for 1-3 times (each for 1.6-3.0 hr), filtering, concentrating decoction, adding 70-90% ethanol to ethanol content of 55-60%, standing, collecting supernatant, and concentrating to obtain extract.
3. The Prunella vulgaris extract of claim 2, which is obtained by the following preparation method: taking a selfheal medicinal material, adding 15-16 times of drinking water for the first time, decocting for 1.6-3.0 hours, filtering a liquid medicine with 100 meshes, and putting the liquid medicine into a storage tank; adding 13-15 times of drinking water for the second time, decocting for 1.6-3.0 hr, filtering with 100 mesh sieve, mixing with the first medicinal liquid, concentrating to relative density of 1.06-1.09 at 55-60 deg.C, adding 70-90% ethanol to ethanol content of 55-60%, standing, collecting supernatant, and collecting residue; recovering ethanol, concentrating to relative density of 1.15-1.25 at 55-60 deg.C, determining total solid, and weighing.
4. A prunella vulgaris extract according to claim 2 or 3 obtained by the following preparation method: centrifuging the residues in the above steps, mixing the centrifugate and the supernatant, recovering ethanol, centrifuging the supernatant for 1-3 times, concentrating the centrifugate to obtain extract with relative density of 1.15-1.25 at 55-60 deg.C, measuring total solids, and weighing.
5. The process for producing Prunella vulgaris according to any of claims 1-4, comprising the steps of: taking a selfheal medicinal material, adding 15-16 times of drinking water for the first time, decocting for 1.6-3.0 hours, filtering a liquid medicine with 100 meshes, and putting the liquid medicine into a storage tank; adding 13-15 times of drinking water for the second time, decocting for 1.6-3.0 hr, filtering with 100 mesh sieve, mixing with the first medicinal liquid, concentrating to relative density of 1.06-1.09 at 55-60 deg.C, adding 70-90% ethanol to ethanol content of 55-60%, standing, collecting supernatant, and collecting residue; recovering ethanol, concentrating to relative density of 1.15-1.25 at 55-60 deg.C, determining total solid, and weighing.
6. The method for preparing selfheal of claim 5, which comprises the following steps: centrifuging the residues in the above steps, mixing the centrifugate and the supernatant, recovering ethanol, centrifuging the supernatant for 1-3 times, concentrating the centrifugate to obtain extract with relative density of 1.15-1.25 at 55-60 deg.C, measuring total solids, and weighing.
7. A pharmaceutical composition characterized in that it comprises the prunella vulgaris extract according to any one of claims 1-4 and a pharmaceutically acceptable carrier.
8. The use of an extract of Prunella vulgaris as claimed in any one of claims 1-4 in the preparation of a medicament for the prevention and treatment of medullary thyroid carcinoma.
9. The use of claim 8, wherein: the medullary thyroid cancer is hereditary.
10. Use according to claim 7 or 8, characterized in that: can prevent and control the precancerous lesion of hereditary medullary thyroid carcinoma, namely the neoplastic hyperplasia of cells beside the thyroid follicle, which is also called as the neoplastic C cell hyperplasia.
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| CN105816643A (en) * | 2015-01-04 | 2016-08-03 | 扬子江药业集团上海海尼药业有限公司 | Application of traditional Chinese medicine composition for preventing and treating thyroid nodules |
| CN105106303A (en) * | 2015-09-21 | 2015-12-02 | 上海中医药大学 | Medical application of selfheal aqueous extract |
| CN107812038A (en) * | 2017-11-21 | 2018-03-20 | 广州王老吉药业股份有限公司 | A kind of selfheal treats and prevents the new application of thyroid cancer |
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Application publication date: 20201215 |