CN112716931B - External pharmaceutical composition for improving thyroid nodule - Google Patents
External pharmaceutical composition for improving thyroid nodule Download PDFInfo
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- CN112716931B CN112716931B CN202011613872.7A CN202011613872A CN112716931B CN 112716931 B CN112716931 B CN 112716931B CN 202011613872 A CN202011613872 A CN 202011613872A CN 112716931 B CN112716931 B CN 112716931B
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
- A61K31/201—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having one or two double bonds, e.g. oleic, linoleic acids
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Abstract
The invention provides an external pharmaceutical composition for improving thyroid nodules, and particularly provides a pharmaceutical composition, which comprises the following components in part by weight: 20-32 parts of caprylic acid, 15-30 parts of oleic acid, 15-30 parts of capric acid, 5-10 parts of limonene, 5-10 parts of linoleic acid, 2-6 parts of trans-caryophyllene, 2-6 parts of 3-thujone, 1-4 parts of alpha-pinene and 1-4 parts of palmitic acid. The pharmaceutical composition may be administered transdermally to a thyroid nodule patient to ameliorate or control the symptoms of the patient.
Description
Technical Field
The invention relates to the field of medicines, and particularly provides an external medicine composition for improving thyroid nodules.
Background
Thyroid nodule is a lump in the thyroid gland, can move up and down along with the thyroid gland along with swallowing action, is a common clinical disease and can be caused by various causes; various thyroid diseases are clinically manifested, such as thyroid degeneration, inflammation, autoimmunity, neoplasms and the like as nodules; thyroid nodules can be single-shot or multiple-shot, and multiple nodules have higher morbidity than single nodules, but the incidence rate of thyroid cancer of single nodules is higher.
The etiology of thyroid nodules is unclear and is generally related to age, environment, iodine deficiency, and family genetic history. Most thyroid glands are benign and require periodic review of the size of the nodule, and if the nodule becomes large, examination or surgery is required.
There is no effective means to alleviate and alleviate thyroid nodules other than surgical incisions, and therefore there is a great need in the art to provide pharmaceutical compositions that can be used to improve thyroid nodules.
Disclosure of Invention
The invention aims to provide a pharmaceutical composition capable of being used for improving thyroid nodules.
In a first aspect of the present invention, there is provided a pharmaceutical composition comprising:
20-32 parts of caprylic acid, 15-30 parts of oleic acid, 15-30 parts of capric acid, 5-10 parts of limonene, 5-10 parts of linoleic acid, 2-6 parts of trans-caryophyllene, 2-6 parts of 3-thujone, 1-4 parts of alpha-pinene and 1-4 parts of palmitic acid.
In another preferred embodiment, the pharmaceutical composition comprises:
22-30 parts of caprylic acid, 18-25 parts of oleic acid, 20-25 parts of capric acid, 6-9 parts of limonene, 6-9 parts of linoleic acid, 3-5 parts of trans-caryophyllene, 2-4 parts of 3-thujone, 2-3 parts of alpha-pinene and 2-3 parts of palmitic acid.
In another preferred embodiment, the pharmaceutical composition comprises:
24-28 parts of caprylic acid, 20-24 parts of oleic acid, 21-24 parts of capric acid, 6-9 parts of limonene, 6-9 parts of linoleic acid, 3-5 parts of trans-caryophyllene, 2-4 parts of 3-thujone, 2-3 parts of alpha-pinene and 2-3 parts of palmitic acid.
In another preferred embodiment, the pharmaceutical composition comprises:
24-28 parts of caprylic acid, 21-23 parts of oleic acid, 21-24 parts of capric acid, 6-9 parts of limonene, 6-8 parts of linoleic acid, 3-5 parts of trans-caryophyllene, 2-4 parts of 3-thujone, 2-3 parts of alpha-pinene and 2-3 parts of palmitic acid.
In a second aspect of the present invention, there is provided a process for the preparation of a pharmaceutical composition according to the first aspect of the present invention, said process comprising the steps of: providing 20-32 parts by weight of caprylic acid, 15-30 parts by weight of oleic acid, 15-30 parts by weight of capric acid, 5-10 parts by weight of limonene, 5-10 parts by weight of linoleic acid, 2-6 parts by weight of trans-caryophyllene, 2-6 parts by weight of 3-thujone, 1-4 parts by weight of alpha-pinene and 1-4 parts by weight of palmitic acid, and uniformly mixing to obtain the required pharmaceutical composition.
In a third aspect of the present invention, there is provided a process for the preparation of a pharmaceutical composition according to the first aspect of the present invention, said process comprising the steps of:
s101: cleaning and crushing the roots and stems of angelica sinensis and jasmine petals, and performing first extraction by using supercritical carbon dioxide;
s102: pulverizing Olibanum, helichrysum arenarium, copaiba balsam, rhizoma Zingiberis recens, flos Caryophylli, herba Rosae Rugosae and Lavender, mixing, performing second extraction by steam distillation, filtering the product after the second extraction, and collecting the second filtrate;
s103: cleaning green pericarpium Citri Tangerinae, semen Sesami and sweet pericarpium Citri Junoris, and extracting by cold pressing;
s104: the products from S101, S102 and S103 are mixed homogeneously to obtain the pharmaceutical composition according to the first aspect of the invention.
In another preferred example, in step S101, the temperature of the supercritical carbon dioxide for the first extraction is 45-50 ℃, and the pressure of the gas flow is 12-18MPa.
In another preferred example, the first extraction time is 70-90min.
In another preferred embodiment, the flow rate of the supercritical carbon dioxide in the first extraction process is 28-32kg/h.
In another preferred example, in step S102, the mass ratio of the added water to the crushed solid product is 4-6.
In another preferred example, the time for steam distillation extraction is 250-350min.
In another preferred example, in the step S103, the cold pressing is performed at pH =7 to 8; preferably, the cold pressing is carried out at a temperature of 5 to 10 ℃.
In a fourth aspect of the invention, there is provided the use of a pharmaceutical composition according to the first aspect of the invention for the manufacture of a medicament for the treatment of thyroid nodules.
In another preferred embodiment, the medicament is a transdermal administration preparation.
It is to be understood that within the scope of the present invention, the above-described features of the present invention and those specifically described below (e.g., in the examples) may be combined with each other to form new or preferred embodiments. Not to be repeated herein, depending on the space.
Detailed Description
The present inventors have conducted extensive and intensive studies for a long time to obtain a pharmaceutical composition for external use which can be used for improving thyroid nodules. The composition adopts
External pharmaceutical composition
The invention provides an external pharmaceutical composition, which comprises the following raw material components in parts by weight: 20-30 parts of caprylic acid, 15-25 parts of oleic acid, 15-25 parts of capric acid, 5-10 parts of limonene, 5-10 parts of linoleic acid, 2-5 parts of trans-caryophyllene, 2-5 parts of 3-thujone, 1-3 parts of alpha-pinene and 1-3 parts of palmitic acid.
In a further embodiment of the invention, comprises: 26 parts of caprylic acid, 21 parts of oleic acid, 21 parts of capric acid, 8 parts of limonene, 8 parts of linoleic acid, 3 parts of trans-caryophyllene, 3 parts of 3-thujone, 2 parts of alpha-pinene and 2 parts of palmitic acid.
The pharmaceutical composition can be obtained by directly purchasing the raw material components in the pharmaceutical composition and then uniformly mixing the raw material components, or can be prepared by adopting the following method provided by the invention:
(1) Cleaning and crushing the roots and stems of angelica sinensis and jasmine petals, and performing first extraction by using supercritical carbon dioxide, wherein the temperature of the first extraction is 48 ℃, the pressure is 15.80MPa, the time is 80min, and the flow rate of the supercritical carbon dioxide is 30kg/h.
(2) Pulverizing Olibanum, helichrysum arenarium, copaiba balsam, rhizoma Zingiberis recens, flos Caryophylli, herba Rosae Rugosae and Lavender, mixing, performing second extraction by steam distillation, filtering the product after second extraction, and collecting the second filtrate; wherein, the time of steam distillation is 300min, and the mass ratio of the added water to the crushed product is 5.
(3) Cleaning green pericarpium Citri Tangerinae, sweet pericarpium Citri Junoris and semen Sesami, and extracting by cold pressing; wherein, in the preferred extraction mode, the pH value of the cold pressing method is 7 to 8, and the temperature is 5 to 10 ℃.
And (3) uniformly mixing the products obtained in the steps (1), (2) and (3) to obtain the pharmaceutical composition.
The pharmaceutical composition of the present invention may be administered in the form of a topical formulation, for example, by transdermal administration to the affected area. In the using process, the medicine can directly penetrate into the subcutaneous blood capillary from the corneal layer of the skin and the accessory structure of the skin, is convenient and simple to use and has good safety. In a preferred embodiment, when using the pharmaceutical composition of the present invention, the pharmaceutical composition is applied directly to the thyroid gland area and massaged until absorption.
Compared with the prior art, the invention has the main advantages that:
(1) The pharmaceutical composition disclosed by the invention is safe and free from toxic and side effects, and has excellent effects of resisting inflammation, sterilizing and enhancing human immunity. The composition prepared by the method provided by the invention has the advantages of remarkable curative effect, quick response, good stability, convenience in use and wide application value.
(2) By adopting the preparation method of the pharmaceutical composition provided by the invention, active ingredients of the raw material medicines can be retained to the maximum extent, and meanwhile, the active ingredients in the raw material medicines can be fully released, so that the finally prepared pharmaceutical composition has excellent effects.
(3) The preparation method of the pharmaceutical composition provided by the invention has the advantages of stable process, high yield, good quality, low energy consumption, wide raw materials and simple and economical process; the production can be finished by adopting the existing equipment, the equipment requirement is reduced, and the environmental pollution is zero.
(4) The pharmaceutical composition provided by the invention is convenient to use, can be directly smeared on the thyroid gland part, and can achieve excellent curative effect after being absorbed by massage.
The invention will be further illustrated with reference to the following specific examples. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. The experimental procedures, in which specific conditions are not noted in the following examples, are generally carried out under conventional conditions or conditions recommended by the manufacturers. Unless otherwise indicated, percentages and parts are by weight.
In each of the following examples, octanoic acid, oleic acid, decanoic acid, limonene, linoleic acid, trans-caryophyllene, 3-thujone, alpha-pinene, and palmitic acid were chemically pure commercially available products.
The angelica, jasmine, frankincense, helichrysum, copaiba balsam, ginger, clove, rose, lavender, green orange, sesame and sweet orange used in the following examples all meet the relevant regulations under each medicinal material item in the text of the chinese pharmacopoeia (2015 edition). Before feeding, the material objects are identified to be consistent with the names of the medicinal materials, and the quality is in accordance with the standard. Wherein, extracting essential oil from jasmine, helichrysum, clove and lavender petal, peels of sweet orange and green orange, stems and leaves of roselle, seeds of sesame, twigs of copaiba balsam tree and boswellia serrata, and rhizome parts of angelica and ginger.
Example 1
The pharmaceutical composition of this embodiment comprises: 26 parts of caprylic acid, 21 parts of oleic acid, 21 parts of capric acid, 8 parts of limonene, 8 parts of linoleic acid, 3 parts of trans-caryophyllene, 3 parts of 3-thujone, 2 parts of alpha-pinene and 2 parts of palmitic acid: the raw material components are uniformly mixed to obtain the medicinal composition, and the medicinal composition is placed in a brown bottle for later use.
Example 2
The pharmaceutical composition of this embodiment comprises: 25 parts of caprylic acid, 20 parts of oleic acid, 20 parts of capric acid, 9 parts of limonene, 9 parts of linoleic acid, 4 parts of trans-caryophyllene, 4 parts of 3-thujone, 3 parts of alpha-pinene and 3 parts of palmitic acid: the raw material components are uniformly mixed to obtain the medicinal composition, and the medicinal composition is placed in a brown bottle for later use.
Example 3
The pharmaceutical composition of this embodiment comprises: 25 parts of caprylic acid, 21 parts of oleic acid, 22 parts of capric acid, 8 parts of limonene, 8 parts of linoleic acid, 4 parts of trans-caryophyllene, 2 parts of 3-thujone, 2 parts of alpha-pinene and 3 parts of palmitic acid: the raw material components are uniformly mixed to obtain the medicinal composition, and the medicinal composition is placed in a brown bottle for later use.
Example 4
The pharmaceutical composition of this embodiment comprises: 24 parts of caprylic acid, 21 parts of oleic acid, 21 parts of capric acid, 7 parts of limonene, 7 parts of linoleic acid, 4 parts of trans-caryophyllene, 2 parts of 3-thujone, 3 parts of alpha-pinene and 2 parts of palmitic acid: the raw material components are uniformly mixed to obtain the medicinal composition, and the medicinal composition is placed in a brown bottle for later use.
Example 5
The pharmaceutical composition of this embodiment comprises: 26 parts of caprylic acid, 23 parts of oleic acid, 22 parts of capric acid, 6 parts of limonene, 8 parts of linoleic acid, 3 parts of trans-caryophyllene, 3 parts of 3-thujone, 2 parts of alpha-pinene and 2 parts of palmitic acid: the raw material components are uniformly mixed to obtain the medicinal composition, and the medicinal composition is placed in a brown bottle for later use.
Example 6
The pharmaceutical composition of this embodiment comprises: 28 parts of caprylic acid, 24 parts of oleic acid, 22 parts of capric acid, 7 parts of limonene, 6 parts of linoleic acid, 5 parts of trans-caryophyllene, 4 parts of 3-thujone, 2 parts of alpha-pinene and 2 parts of palmitic acid: the raw material components are uniformly mixed to obtain the medicinal composition, and the medicinal composition is placed in a brown bottle for later use.
Example 7
(1) Cleaning and pulverizing radix Angelicae sinensis rhizome and flos Jasmini sambac petal, collecting 1000g, and extracting with supercritical carbon dioxide under 15.80 MPa. During the extraction process, the temperature in the holding system is 48 ℃, and the flow rate of the supercritical carbon dioxide is 30kg/h. After 80min of extraction, the introduction of supercritical carbon dioxide was stopped and the product was collected.
(2) Pulverizing Olibanum, helichrysum Chinense, copaiba balsam, rhizoma Zingiberis recens, flos Caryophylli, herba Rosae Rugosae and Lavender, mixing, adding 100g into a distillation device, adding 500ml water, and performing steam distillation at 30 deg.C for extraction. After 300min, the heating was removed and the distillate was collected.
(3) Cleaning green pericarpium Citri Tangerinae, semen Sesami and sweet pericarpium Citri Junoris, squeezing to allow oil to flow out, standing the obtained liquid for 48 hr, collecting upper oil, and maintaining at 6 deg.C during squeezing.
And (4) uniformly mixing the products obtained in the steps (1), (2) and (3) to obtain a pharmaceutical composition, and placing the pharmaceutical composition in a brown bottle for later use.
Example 8
(1) Cleaning and pulverizing radix Angelicae sinensis rhizome and flos Jasmini sambac petal, collecting 1000g, and extracting with supercritical carbon dioxide under 17.80 MPa. During the extraction process, the temperature in the maintaining system is 45 ℃, and the flow rate of the supercritical carbon dioxide is 30kg/h. After 60min of extraction, the introduction of supercritical carbon dioxide was stopped and the product was collected.
(2) Pulverizing Olibanum, helichrysum Chinense, copaiba balsam, rhizoma Zingiberis recens, flos Caryophylli, herba Rosae Rugosae and Lavender, mixing, adding 100g into a distillation device, adding 500ml water, and performing steam distillation at 33 deg.C for extraction. After 300min, the heating was removed and the distillate was collected.
(3) Cleaning green pericarpium Citri Tangerinae, semen Sesami and sweet pericarpium Citri Junoris, squeezing to allow oil to flow out, standing the obtained liquid for 48 hr, collecting upper oil, and maintaining the temperature at 7.5 deg.C during squeezing.
And (4) uniformly mixing the products obtained in the steps (1), (2) and (3) to obtain a pharmaceutical composition, and placing the pharmaceutical composition in a brown bottle for later use.
Example 9
(1) Cleaning and pulverizing radix Angelicae sinensis rhizome and flos Jasmini sambac petal, collecting 1000g, and extracting with supercritical carbon dioxide under 17.00 MPa. During the extraction process, the temperature in the holding system was 45 deg.C, and the flow rate of supercritical carbon dioxide was 28kg/h. After 80min of extraction, the introduction of supercritical carbon dioxide was stopped and the product was collected.
(2) Pulverizing Olibanum, helichrysum Chinense, copaiba balsam, rhizoma Zingiberis recens, flos Caryophylli, herba Rosae Rugosae and Lavender, mixing, adding 100g into a distillation device, adding 300ml water, and performing steam distillation at 32 deg.C for extraction. After 200min, the heating was removed and the distillate was collected.
(3) Cleaning green pericarpium Citri Tangerinae, semen Sesami and sweet pericarpium Citri Junoris, squeezing to allow oil to flow out, standing the obtained liquid for 48 hr, collecting upper oil, and maintaining the temperature at 7.0 deg.C during squeezing.
And (3) uniformly mixing the products obtained in the steps (1), (2) and (3) to obtain the pharmaceutical composition, and placing the pharmaceutical composition in a brown bottle for later use.
Example 10
(1) Cleaning and pulverizing radix Angelicae sinensis rhizome and flos Jasmini sambac petal, collecting 1000g, and extracting with supercritical carbon dioxide under 17.00 MPa. During the extraction process, the temperature in the holding system is 45 deg.C, and the flow rate of supercritical carbon dioxide is 30kg/h. After 70min of extraction, the introduction of supercritical carbon dioxide was stopped and the product was collected.
(2) Pulverizing Olibanum, helichrysum Chinense, copaiba balsam, rhizoma Zingiberis recens, flos Caryophylli, herba Rosae Rugosae and Lavender, mixing, adding 100g into a distillation device, adding 400ml water, and performing steam distillation extraction at 31 deg.C. After 250min, the heating was removed and the distillate was collected.
(3) Cleaning green pericarpium Citri Tangerinae, semen Sesami and sweet pericarpium Citri Junoris, squeezing to allow oil to flow out, standing the obtained liquid for 48 hr, collecting upper layer oil, and maintaining at 7.0 deg.C during squeezing.
And (3) uniformly mixing the products obtained in the steps (1), (2) and (3) to obtain the pharmaceutical composition, and placing the pharmaceutical composition in a brown bottle for later use.
Test example
1. Component determination
The ingredients of the pharmaceutical compositions of examples 1 to 10 were examined by GC-MS and the main ingredients in the examples are listed in the following table:
TABLE 1
2. Toxicity test
80 Swiss mice (40 males and females) weighing 18-22g were selected and divided into 10 groups of 4 males and females, and the mice were subjected to back unhairing to expose the outer skin, with the unhairing range of 2 cm. Times.2 cm, and the 1 st-10 th groups were each coated with the pharmaceutical composition prepared in examples 1-10 of the present invention at an administration dose of 5g for 30 days continuously. During the administration period and 1 week after the withdrawal, the mice were observed for growth state and active diet, and the hematology, blood biochemistry, organ organization and urinary index were identified. The results show that all mice survive healthily during and after the administration process, which suggests that the pharmaceutical composition of the invention has no obvious toxic and side effects.
The mice were sacrificed and dissected, and the hemogram, liver function and organ tissue status were observed, which were not different from the normal index of Swiss mice. Experiments prove that the external medicine composition provided by the invention is non-toxic and safe and reliable in medication.
3. Effect testing
100 volunteers with thyroid nodules were enrolled, and each patient had thyroid ultrasonography B showing various degrees of thyroid benign nodules. Or blood test reports of patients show different degrees of abnormality in the indexes of thyroid stimulating hormone, FT3 and FT 4.
Each patient was divided into 10 groups of 10 patients each. The pharmaceutical compositions of the examples 1-10 of the present invention were applied to the skin on the thyroid gland surface and massaged until absorption in groups 1-10. The application is continued for 3 months, 2 times daily (once in the morning and evening), and the dosage is 3g each time.
The curative effect is observed respectively at 1 month, 2 months and 3 months of trial. The curative effect is judged as follows:
and (4) observing the size of thyroid nodules through thyroid B ultrasonic examination, and judging that the thyroid nodules are effective if the thyroid nodules are reduced or disappear and the blood examination reports that the levels of all hormones tend to normal values. And if the thyroid nodule is not aggravated and the blood test reports that the levels of the hormones are not changed, judging the thyroid nodule to be controllable. If the thyroid nodule is aggravated and the blood test reports that the levels of each hormone are far from normal, the thyroid nodule is judged to be invalid.
The results of the use are shown in table 2 below. The results show that the pharmaceutical compositions of examples 1-10 improved the thyroid nodule problem in patients after use, and that after 3 months of use, most patients had reduced or eliminated thyroid nodules, and blood tests reported that the levels of each hormone tended to normal or returned to normal levels.
TABLE 2 Change in thyroid nodule status in a patient following administration of a pharmaceutical composition of the invention
All documents mentioned in this application are incorporated by reference in this application as if each were individually incorporated by reference. Furthermore, it should be understood that various changes and modifications of the present invention can be made by those skilled in the art after reading the above teachings of the present invention, and these equivalents also fall within the scope of the present invention as defined by the appended claims.
Claims (7)
1. A method of preparing a pharmaceutical composition comprising:
20-32 parts of caprylic acid, 15-30 parts of oleic acid, 15-30 parts of capric acid, 5-10 parts of limonene, 5-10 parts of linoleic acid, 2-6 parts of trans-caryophyllene, 2-6 parts of 3-thujone, 1-4 parts of alpha-pinene and 1-4 parts of palmitic acid;
the method is characterized by comprising the following steps:
s101: cleaning and crushing the roots and stems of angelica sinensis and jasmine petals, and performing first extraction by using supercritical carbon dioxide; in the step S101, the temperature of the supercritical carbon dioxide for the first extraction is 45-50 ℃, and the airflow pressure is 12-18Mpa;
s102: pulverizing Olibanum, helichrysum arenarium, copaiba balsam, rhizoma Zingiberis recens, flos Caryophylli, herba Rosae Rugosae and Lavender, mixing, performing second extraction by steam distillation, filtering the product after the second extraction, and collecting the second filtrate;
s103: cleaning green pericarpium Citri Tangerinae, semen Sesami and sweet pericarpium Citri Junoris, and extracting by cold pressing;
s104: and (3) uniformly mixing products obtained in the steps S101, S102 and S103 to obtain the pharmaceutical composition.
2. The method according to claim 1, wherein in step S102, the ratio of the mass of water added to the mass of the solid product after pulverization is 4-6.
3. The method of claim 1, wherein the cold pressing in step S103 is performed at pH =7 to 8.
4. The method of claim 1, wherein in step S103, the cold pressing is performed at a temperature of 5 to 10 ℃.
5. The method of claim 1, wherein the pharmaceutical composition comprises:
22-30 parts of caprylic acid, 18-25 parts of oleic acid, 20-25 parts of capric acid, 6-9 parts of limonene, 6-9 parts of linoleic acid, 3-5 parts of trans-caryophyllene, 2-4 parts of 3-thujone, 2-3 parts of alpha-pinene and 2-3 parts of palmitic acid.
6. The method of claim 1, wherein the pharmaceutical composition comprises:
24-28 parts of caprylic acid, 20-24 parts of oleic acid, 21-24 parts of capric acid, 6-9 parts of limonene, 6-9 parts of linoleic acid, 3-5 parts of trans-caryophyllene, 2-4 parts of 3-thujone, 2-3 parts of alpha-pinene and 2-3 parts of palmitic acid.
7. The method of claim 1, wherein the pharmaceutical composition comprises:
24-28 parts of caprylic acid, 21-23 parts of oleic acid, 21-24 parts of capric acid, 6-9 parts of limonene, 6-8 parts of linoleic acid, 3-5 parts of trans-caryophyllene, 2-4 parts of 3-thujone, 2-3 parts of alpha-pinene and 2-3 parts of palmitic acid.
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