CN113368220A - AHCO composition, and preparation and application thereof - Google Patents
AHCO composition, and preparation and application thereof Download PDFInfo
- Publication number
- CN113368220A CN113368220A CN202110754869.5A CN202110754869A CN113368220A CN 113368220 A CN113368220 A CN 113368220A CN 202110754869 A CN202110754869 A CN 202110754869A CN 113368220 A CN113368220 A CN 113368220A
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- China
- Prior art keywords
- ahco
- composition
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- astaxanthin
- hyaluronic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/39—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/125—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/17—Amino acids, peptides or proteins
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/12—Ketones
- A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
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- A—HUMAN NECESSITIES
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- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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- Proteomics, Peptides & Aminoacids (AREA)
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- Zoology (AREA)
- Dermatology (AREA)
- Botany (AREA)
- Pain & Pain Management (AREA)
- Gastroenterology & Hepatology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses an AHCO composition, and a preparation and application thereof. The AHCO composition consists of astaxanthin, type II collagen and hyaluronic acid. The preparation is the AHCO composition, and auxiliary materials are added into the AHCO composition to prepare tablets, oral liquid, capsules, granules, powder, pills, injection, film agents or patches. The application is the application in products for preventing/improving/treating diseases related to cartilage degradation. The AHCO composition can prevent cartilage degradation, increase the number of chondrocytes, relieve joint inflammation and oxidative stress, and has obvious improvement effects on symptoms of knee Osteoarthritis (OA) of middle-aged and old people, such as pain, knee swelling and joint movement freedom.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to an AHCO composition, and a preparation and application thereof.
Background
Osteoarthritis (OA) is a progressive disease characterized by cartilage degradation, affecting more than 2.4 million people, and is a major cause of disability. The disease is strongly age-dependent and is characterized by increased destructive changes in articular cartilage, synovial tissue and subchondral bone, and osteophyte formation. Osteoarthritis is mainly characterized by cartilage degradation due to imbalance of cartilage homeostasis, and various factors activate chondrocytes to promote extracellular matrix degradation. Once cartilage homeostasis is disrupted, the injury-associated signal will be transduced and amplified by a feed-forward loop, ultimately leading to degradation and loss of cartilage. Many OA factors can trigger low levels of chronic inflammation and an imbalance in oxidation-antioxidant levels, stimulating chondrocytes to produce Reactive Oxygen Species (ROS) and pro-inflammatory cytokines, including IL-1 β and TNF- α, which are also second messengers of intracellular signaling pathways that regulate the expression of target genes encoding matrix degrading enzymes.
Disclosure of Invention
A first object of the present invention is to provide an AHCO composition; a second object is to provide a formulation of said AHCO composition; the third purpose is to provide the application of the AHCO composition.
The first object of the present invention is achieved by the AHCO composition consisting of astaxanthin, type ii collagen and hyaluronic acid.
The second purpose of the invention is realized by adding auxiliary materials into the AHCO composition to prepare tablets, oral liquid, capsules, granules, powder, pills, injections, films or patches.
The third purpose of the invention is realized by the application of the AHCO composition in the preparation of products for preventing/improving/treating diseases related to cartilage degradation.
Astaxanthin (Ast), known as "marine carotenoids", is widely found in aquatic animals and has an antioxidant effect 100 times that of canthaxanthin and beta-carotene, and as a result of its strong biological activity and safety, Ast has been approved by the FDA as a food additive and is widely used by athletes as a nutritional product. Research shows that astaxanthin extracted from Haematococcus pluvialis has the effects of promoting cell proliferation, collagen production and antioxidant property, and can also regenerate damaged skin. Astaxanthin therefore plays an important role in aquaculture, food and cosmetics.
There is increasing scientific evidence to suggest the effectiveness of collagen peptides in supporting joint structure and function. In clinical studies, the biological activity of collagen peptides has been shown to soothe joint discomfort, improve joint function and joint mobility, and support the formation of cartilage matrix components. Clinical trials further demonstrated that subjects with joint degeneration benefited from the efficacy of the present formula.
Hyaluronic acid is a natural linear glycosaminoglycan with high hydrophilicity, non-toxicity, non-immunogenicity and good biocompatibility. Hyaluronic acid is one of the major components of the extracellular matrix (ECM) of mammalian connective tissue, and has dual physiological, chemical, and biological functions. Hyaluronic acid stimulates cell adhesion, proliferation and differentiation by interacting directly or indirectly with specific binding proteins such as CD44, transforming growth factor-beta (TGF- β) and the like. The new research finds that the hyaluronic acid has obvious potential in the aspects of enhancing the compressive strength of the bone cement and obviously improving the bone inductivity.
In summary, we carried out a new combination (AHCO) of astaxanthin hyaluronic acid and type II collagen, and the specific formula is as follows: astaxanthin (1-24 mg), hyaluronic acid (5-100 mg), type II collagen (50-800 mg).
The purpose of the present composition is to explore the impact of the oral dosage form of the formulation on the joint degenerative process and to focus on the mechanism of action. The results of the study are based on close observations of cartilage structure, chondrocyte number and synovial membrane changes, indicating that significant chondroprotective and anti-inflammatory effects are present in damaged joints.
The pharmaceutical composition is added with auxiliary materials required by preparation of different dosage forms, and prepared into any pharmaceutically acceptable dosage form according to a conventional preparation method. The dosage form can be tablets, oral liquid, capsules, granules, powder, pills, injection, films or patches and other reagents accepted by human bodies, is not limited to the listed reagents, and can be processed by slightly different processing methods according to different dosage forms, but the essential substances of the reagents are the same.
The AHCO composition can prevent cartilage degradation, increase the number of chondrocytes, relieve joint inflammation and oxidative stress, and has obvious improvement effects on symptoms of knee Osteoarthritis (OA) of middle-aged and old people, such as pain, knee swelling and joint movement freedom.
Drawings
FIG. 1 is a schematic representation of the effect of an AHCO composition of the present invention in preventing cartilage degradation;
FIG. 2 is a schematic representation of the AHCO compositions of the present invention increasing the number of proteoglycan-secreting chondrocytes administered;
FIG. 3 is a schematic diagram of the effect of the AHCO composition of the present invention in ameliorating joint inflammation.
Detailed Description
The present invention is further illustrated by the following examples and the accompanying drawings, but the present invention is not limited thereto in any way, and any modifications or alterations based on the teaching of the present invention are within the scope of the present invention.
The AHCO composition consists of astaxanthin, type II collagen and hyaluronic acid.
The AHCO composition comprises 1-50 parts by weight of astaxanthin, 50-1000 parts by weight of type II collagen and 5-150 parts by weight of hyaluronic acid.
The AHCO composition comprises 1-25 parts by weight of astaxanthin, 50-800 parts by weight of type II collagen and 5-100 parts by weight of hyaluronic acid.
The AHCO composition comprises, by weight, 20-25 parts of astaxanthin, 400-800 parts of type II collagen and 50-100 parts of hyaluronic acid.
The AHCO composition consists of 24 parts by weight of astaxanthin, 600 parts by weight of type II collagen and 80 parts by weight of hyaluronic acid.
The preparation of the AHCO composition is prepared by adding auxiliary materials into the AHCO composition to prepare tablets, oral liquid, capsules, granules, powder, pills, injections, films or patches.
The application of the AHCO composition is the application of the AHCO composition in preparing products for preventing/improving/treating diseases related to cartilage degradation.
The AHCO composition is used for preventing/improving/treating diseases related to cartilage degradation by promoting the synthesis of cartilage matrixes.
The disease associated with cartilage degradation is osteoarthritis.
The product is a medicine, a food or a health-care food.
The invention is further illustrated by the following specific examples:
example 1
1mg of astaxanthin, 50mg of type II collagen and 5mg of hyaluronic acid are weighed and mixed uniformly to obtain the target AHCO composition.
Example 2
20mg of astaxanthin, 400mg of type II collagen and 50mg of hyaluronic acid are weighed and mixed uniformly to obtain the target AHCO composition.
Example 3
24mg of astaxanthin, 600mg of type II collagen and 80mg of hyaluronic acid were weighed and mixed to obtain a target AHCO composition.
Example 4
25mg of astaxanthin, 800mg of type II collagen and 100mg of hyaluronic acid were weighed and mixed to obtain a target AHCO composition.
Example 5
50mg of astaxanthin, 1000mg of type II collagen and 150mg of hyaluronic acid were weighed and mixed to obtain a target AHCO composition.
Example 6
30mg of astaxanthin, 700mg of type II collagen and 90mg of hyaluronic acid are weighed and mixed uniformly to obtain the target AHCO composition.
Example 7
40mg of astaxanthin, 900mg of type II collagen and 120mg of hyaluronic acid were weighed and mixed to obtain a target AHCO composition.
Example 8
5mg of astaxanthin, 1000mg of type II collagen and 150mg of hyaluronic acid were weighed and mixed to obtain a target AHCO composition.
Example 9
50mg of astaxanthin, 300mg of type II collagen and 90mg of hyaluronic acid are weighed and mixed uniformly to obtain the target AHCO composition.
Example 10
The AHCO composition prepared in example 3 was added with pharmaceutically acceptable excipients to prepare tablets.
Example 11
The AHCO composition prepared in example 6 was added with pharmaceutically acceptable excipients to prepare an oral liquid.
Example 12
Capsules were prepared by adding pharmaceutically acceptable excipients to the AHCO composition prepared in example 5.
Example 13
The AHCO composition prepared in example 8 was added with pharmaceutically acceptable excipients to prepare granules.
Example 14
The AHCO composition prepared in example 9 was mixed with pharmaceutically acceptable excipients to prepare a powder.
Example 15
The AHCO composition prepared in example 2 is added with pharmaceutically acceptable auxiliary materials to prepare pills.
Example 16
An injection is prepared by adding pharmaceutically acceptable auxiliary materials into the AHCO composition prepared in the example 5.
Example 17
The AHCO composition prepared in example 1 is added with pharmaceutically acceptable auxiliary materials to prepare a film forming agent.
Example 18
A patch is prepared by adding pharmaceutically acceptable auxiliary materials into the AHCO composition prepared in example 3.
Example 19
The AHCO composition prepared in example 3 was tested as follows:
1. feeding the AHCO composition prepared in example 3 to animals stimulates chondrocytes, promotes the synthesis of new cartilage matrix, and reduces arthritis. The AHCO compositions prepared in example 3 were orally ingested daily at either a low dose of 100mg (LD) or a high dose of 200mg (HD), while the other group received controls. Four weeks after the start of supplementation, post-traumatic osteoarthritis (PTOA) was induced by applying meniscal damage and medial collateral ligament damage to the right hind limb knee joint (MLI). Twelve weeks after OA induction received controls. The knee joint was examined histologically, and the area of the (tibial) cartilage was quantified and compared to healthy animals (Health).
1) Example 3 prevention of cartilage degradation by AHCO compositions prepared
Referring to fig. 1, Osteoarthritis (OA) was induced by surgery in mice that received two different doses (LD and HD) of the AHCO composition prepared in example 3, examined histologically in the knee joint, quantified the area of the cartilage (shin), and compared to healthy animals, as can be seen from the figure, the normalized cartilage area was significantly increased in mice that received the AHCO composition prepared in example 3 (p < 0.001).
2) Example 3 the AHCO compositions prepared may increase the number of proteoglycan-secreting chondrocytes
Referring to fig. 2, twelve weeks after OA induction, cartilage structure was evaluated to determine the percentage of chondrocytes in the uncalcified cartilage of the tibia, and the results showed that the percentage of chondrocytes in the uncalcified cartilage of the tibia of mice administered the Low Dose (LD) and High Dose (HD) AHCO compositions prepared in example 3 was significantly increased (. p < 0.05).
3) Example 3 the AHCO composition prepared may ameliorate joint inflammation
The results showed that mice administered the Low Dose (LD) and High Dose (HD) AHCO compositions prepared in example 3 had significantly reduced gene expression of the inflammatory marker TNF- α (p < 0.05).
4) Example 3 the AHCO composition prepared may reduce oxidative stress
Table 1 Effect of AHCO compositions prepared in example 3 on Complete Freund's Adjuvant (CFA) -induced oxidative stress markers and antioxidant markers in rats
The data values are expressed as mean ± sem, 5 mice per group, # p <0.001 responses (control group), # p <0.05, # p < 0.01 responses OA (CFA) groups, and the results show that the oxidative stress indicators LPO, GSH, and SOD of mice administered the high and low dose AHCO composition groups prepared in example 3 were significantly changed and the oxidative stress was significantly improved relative to the OA (CFA) groups.
2. Examples of the applications
2.1 group design
A prospective, randomized, double-blind, placebo-controlled study evaluated the efficacy of oral administration of the AHCO composition prepared in example 3 for symptomatic relief of osteoarthritis of the elderly knee (OA). The study subjects were 60 patients with symptomatic knee osteoarthritis in men and women (40-75).
2.2 diagnostic criteria
The diagnosis refers to relevant standards in osteoarthritis diagnosis and treatment guidelines (2007 edition) < 2 >, the diagnosis is carried out, knee joint pain is repeated within 1 month, the X-ray sheet (standing or weight bearing position) shows that joint clearance becomes narrow, subchondral bone sclerosis and/or cystic degeneration and joint marginal osteophyte are formed, joint fluid is clear and sticky for at least 2 times, WBC is less than 2000/mL, the middle-aged and old patients (more than or equal to 55 years old) are diagnosed, morning stiffness is less than or equal to 3min, and bone rubbing sound is produced during movement. Through the comprehensive clinical, laboratory and X-ray examination, the knee Osteoarthritis (OA) is diagnosed according to the results of (i) strip(s), or (i), third (i), fifth (plus), sixth (plus), or (i), fourth (plus), fifth (plus) sixth (plus).
This experiment excluded patients with rheumatoid arthritis or any other inflammatory joint disease or secondary osteoarthritis. In addition, patients with any significant problems in the liver, kidney, motor or nervous system were not included in this study. Subjects were asked to discontinue use at least one month prior to use of the AHCO composition prepared in example 3 if they were to take any supplement at enrollment that might alleviate knee symptoms. Likewise, a subject who has received an intra-articular injection must wait at least 3 months before taking the medication.
2.3 design of the experiment
The study was a randomized, double-blind placebo-controlled trial. The AHCO compositions prepared in example 3 were divided into four groups, high dose (OA + HD) and low dose (OA + LD)) treatment group and healthy group (Health), OA Placebo group (Placebo), and the age, sex ratio grading between the two groups was balanced by a stratified randomization procedure. The subjects in the AHCO composition group prepared in example 3 were asked to take 4 hard capsules containing a total of 200mg or 100mg of the AHCO composition prepared in example 3 after breakfast every day for 12 months. In the placebo group, subjects were asked to take 4 hard capsules containing only corn starch. Questionnaires were performed before and after treatment using the national KOA knee joint WOMAC rating scale. The joint pain is judged by a VAS (visual analogue) scale method (0-10 min) according to the curative effect judgment standard and two groups of curative effects according to related standards in the traditional Chinese medicine disease diagnosis curative effect standard, wherein the curative effect judgment standard comprises the steps of completely eliminating the joint swelling and pain, treating the joint swelling and pain after the normal recovery of the activity, basically eliminating the joint swelling and pain, effectively converting the joint activity into obvious effect, basically eliminating the joint swelling and pain, effectively limiting the slight degree of the joint activity, and ineffectively improving the joint swelling and pain and the activity. Total effective rate = (cure + significant effect + effective) cases/total cases × 100%.
2.4 statistical methods
Analyzing by using SPSS 22.0 statistical software, expressing the measurement data by (x +/-s), and adopting t test;
the count data are expressed as a percentage (%) and the difference is statistically significant at p <0.05 using the x2 test.
3. Results
3.1 WOMAC comparison before and after treatment, statistical comparison of VAS, joint tenderness, joint swelling, joint mobility and the like of each group is shown in Table 1,
TABLE 1 WOMAC comparison before and after treatment (min, x + -s) for each group
The results show that the WOMAC score of the high dose (200 mg) and low dose (100 mg) treatment groups of the AHCO composition prepared in example 3 is significantly lower than that of the control group (OA), the joint function of the AHCO composition treated group prepared in example 3 is significantly improved, and the difference between the groups has statistical significance (p < 0.05).
3.2 comparing the clinical curative effect, satisfaction and compliance of each group, see table 2,
TABLE 2 comparison of clinical efficacy, satisfaction and compliance of each group
The evaluation results show that the total effective rate, satisfaction degree and compliance of the AHCO composition (LD) prepared in example 3 and the AHCO composition (HD) treated group prepared in example 3 are higher than those of the control group (OA) compared with each other in clinical curative effect, satisfaction degree and compliance, and the evaluation results have statistical significance (p is less than 0.05).
4. Conclusion
The AHCO composition prepared in example 3 can prevent cartilage degradation, increase the number of chondrocytes, relieve joint inflammation and oxidative stress, and have significant improving effects on the symptoms of Osteoarthritis (OA) of the knee joint of middle and old aged, such as pain, knee swelling, and freedom of joint movement.
Example 20
The results of the experiments carried out in example 1, example 2, example 4, example 5, example 6, example 7, example 8 and example 9, respectively, and the same method as example 19, all show that the AHCO composition of the present invention can prevent cartilage degradation, increase chondrocyte numbers, relieve joint inflammation and oxidative stress, and significantly improve the symptoms of Osteoarthritis (OA) of middle and old aged knee, such as pain, knee swelling and joint movement freedom.
Claims (10)
1. An AHCO composition, wherein said AHCO composition is comprised of astaxanthin, type II collagen, and hyaluronic acid.
2. The AHCO composition of claim 1, wherein said AHCO composition is comprised of, by weight, 1 to 50 parts astaxanthin, 50 to 1000 parts collagen type II, and 5 to 150 parts hyaluronic acid.
3. The AHCO composition of claim 1, wherein said AHCO composition is comprised of, by weight, 1 to 25 parts astaxanthin, 50 to 800 parts collagen type II, and 5 to 100 parts hyaluronic acid.
4. The AHCO composition of claim 1, wherein said AHCO composition is comprised of, by weight, 20 to 25 parts astaxanthin, 400 to 800 parts collagen type II, and 50 to 100 parts hyaluronic acid.
5. The AHCO composition of claim 1 wherein the AHCO composition is comprised of, by weight, 24 parts astaxanthin, 600 parts collagen type ii, and 80 parts hyaluronic acid.
6. The AHCO composition preparation as claimed in any one of claims 1 to 5, wherein said AHCO composition preparation is prepared by adding auxiliary materials into said AHCO composition to prepare tablets, oral liquids, capsules, granules, powders, pills, injections, films or patches.
7. The use of the AHCO composition of any one of claims 1 to 5, wherein said AHCO composition is used in the preparation of a product for preventing/ameliorating/treating a disease associated with cartilage degradation.
8. The use of the AHCO composition of claim 7, wherein said AHCO composition is for preventing/ameliorating/treating cartilage degradation related diseases by promoting the synthesis of cartilage matrix.
9. The use of an AHCO composition of claim 7 or 8 wherein said disease associated with cartilage degradation is osteoarthritis.
10. The use of the AHCO composition of claim 7, wherein said product is a pharmaceutical, food or nutraceutical product.
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