A same, 5-HTP, and st. john's wort compound nutritional supplement for emotional support and joint care

Abstract

The present invention discloses a SAMe, 5-HTP, and St. John's wort compound nutritional supplement for emotional support and joint care, comprising 15-25 parts of S-adenosylmethionine, 5-10 parts of 5-hydroxytryptophan, 3-8 parts of St. John's wort extract, 8-15 parts of sodium chondroitin sulfate, 2-5 parts of sodium hyaluronate, 0.5-1.2 parts of vitamin B6, 1-3 parts of vitamin E, 4-9 parts of phosphatidylserine, and pharmaceutical excipients. The weight ratio of S-adenosylmethionine to 5-hydroxytryptophan is 3:1-5:2, the weight ratio of St. John's wort extract to 5-hydroxytryptophan is 0.6:1-0.8:1, and the weight ratio of the joint-care agents to the total core active ingredients is 10:3-20:3. The hypericin content in the St. John's wort extract is not less than 3%. By optimizing the component ratios and utilizing synergistic functional excipients, the present invention achieves dual synergy in emotional support and joint care, with high product stability and excellent bioavailability.

Description

[0001] DESCRIPTION

[0002] A SAMe, 5-HTP, and St. John’s Wort Compound Nutritional Supplement for Emotional Support and Joint Care TECHNICAL FIELD

[0003] The present invention belongs to the technical field of nutritional supplements, and in particular relates to a SAMe, 5-HTP, and St. John's wort compound nutritional supplement for emotional support and joint care.

[0004] BACKGROUND ART

[0005] S-adenosylmethionine (SAMe), as an important methyl donor in vivo, can participate in neurotransmitter synthesis and articular cartilage metabolism, and is currently one of the known active ingredients having the dual functions of emotional regulation and joint care. 5 -Hydroxytryptophan (5-HTP) is a precursor of serotonin and can effectively improve emotional state, relieve anxiety, and regulate sleep. St. John's wort extract contains active ingredients such as hypericin and has been widely used for adjuvant regulation of mild depression. Sodium chondroitin sulfate and sodium hyaluronate are commonly used functional ingredients in the field of joint care; the former can supplement nutrients for articular cartilage and promote synovial fluid secretion, while the latter can enhance the elasticity of articular cartilage and reduce frictional damage. In the prior art, there have been reports of using some of the above ingredients individually or in simple combinations in nutritional supplements, but such products generally focus only on a single function or a simple superposition of functions and lack systematic research on the synergistic mechanisms among the ingredients.

[0006] In the prior art, single-ingredient nutritional supplements are difficult to DESCRIPTION simultaneously achieve the dual effects of emotional support and joint care. Consumers who wish to address both needs must take multiple products at the same time, which is inconvenient and costly. Although some compound preparations attempt to combine multiple active ingredients, they generally suffer from technical defects such as reduced activity caused by interactions among ingredients, unbalanced bioavailability, and poor stability. Specifically, when used alone, SAMe suffers from low bioavailability, poor stability, and susceptibility to degradation by gastric acid; when ingested alone, 5-HTP may readily cause fluctuations in serotonin concentration; and when St. John's wort extract is combined with SAMe and 5-HTP, a lack of rational ratio design may readily result in mutual antagonism among the ingredients. In addition, existing compound preparations generally fail to consider the synergistic enhancement between joint-care ingredients and emotional-support ingredients, and they do not solve problems of stability and absorption efficiency by means of functional excipients. As a result, product efficacy is unclear, quality is unstable, and dosage is unreasonable, and such products cannot meet consumer demand for efficient, safe, and convenient compound nutritional supplements. Therefore, developing a compound nutritional supplement that features synergistic enhancement among ingredients, high stability, good absorption, and clear efficacy has become an urgent technical problem to be solved in the art.

[0007] SUMMARY OF THE INVENTION

[0008] In order to overcome the above defects in the prior art, the present invention provides a SAMe, 5-HTP, and St. John's wort compound nutritional supplement for DESCRIPTION emotional support and joint care, which solves the technical problems of poor synergy, low stability, insufficient absorption efficiency, and single efficacy in existing compound preparations.

[0009] To achieve the above objective, the present invention provides the following technical solutions:

[0010] A SAMe, 5-HTP, and St. John's wort compound nutritional supplement for emotional support and joint care, comprising the following components in parts by mass:

[0011] 15-25 parts of S-adenosylmethionine, 5-10 parts of 5-hydroxytryptophan, 3-8 parts of St. John's wort extract, 8-15 parts of sodium chondroitin sulfate, 2-5 parts of sodium hyaluronate, 0.5-1.2 parts of vitamin B6, 1-3 parts of vitamin E, 4-9 parts of phosphatidylserine, 30-50 parts of microcrystalline cellulose, 10-20 parts of mannitol, and 0.5-1.5 parts of magnesium stearate.

[0012] Preferably, the weight ratio of S-adenosylmethionine to 5-hydroxytryptophan is 3: 1-5:2; the weight ratio of St. John's wort extract to 5-hydroxytryptophan is 0.6: 1-0.8: 1 ; and the ratio of the combined mass of sodium chondroitin sulfate and sodium hyaluronate to the combined mass of S-adenosylmethionine, 5-hydroxytryptophan, and St. John's wort extract is 10:3-20:3.

[0013] Preferably, the hypericin content in the St. John's wort extract is not less than o / zo.

[0014] Preferably, the S-adenosylmethionine is S-adenosylmethionine p-toluenesulfonate sulfate or S-adenosylmethionine butanedisulfonate.

[0015] Preferably, vitamin B6 is used as a coenzyme to promote the methylation reaction of S-adenosylmethionine and the decarboxylation reaction of DESCRIPTION

[0016] 5 -hydroxytryptophan; vitamin E is used as an antioxidant to inhibit oxidative degradation of the active ingredients; and phosphatidylserine is used as an absorption promoter to form lipid complexes with the active ingredients so as to improve intestinal absorption.

[0017] Preferably, the microcrystalline cellulose has an average particle size of 50-200 micrometers, the mannitol is crystalline mannitol, and the magnesium stearate is plant-derived magnesium stearate.

[0018] Preferably, the supplement is in tablet form, the combined mass of S-adenosylmethionine, 5-hydroxytryptophan, and St. John's wort extract in each tablet is 30-50 mg, and the disintegration time of the tablet is not more than 30 minutes.

[0019] Preferably, the supplement is in capsule form, the fill weight of each capsule is 0.3-0.5 g, and the disintegration time is not more than 20 minutes.

[0020] Preferably, the supplement is in granule form, the package fill weight of each sachet is 5-10 g, and the dissolution time is not more than 5 minutes.

[0021] Preferably, after being stored under accelerated test conditions for 6 months, the decrease rate in active-ingredient content is not more than 5%.

[0022] The technical effects and advantages of the SAMe, 5-HTP, and St. John's wort compound nutritional supplement for emotional support and joint care of the present invention are as follows:

[0023] 1. By combining S-adenosylmethionine, 5-hydroxytryptophan, and St. John's wort extract, the present invention realizes a triple synergistic effect for emotional support. S-adenosylmethionine participates in neurotransmitter synthesis as a methyl donor, 5-hydroxytryptophan regulates emotion as a precursor of serotonin, DESCRIPTION and St. John's wort extract assists in the regulation of mild depression. After the three are compounded at specific ratios, serotonin levels can be stabilized, concentration fluctuations that are likely to occur upon single-ingredient intake can be avoided, and synergistic enhancement of emotional support can be achieved. Meanwhile, sodium chondroitin sulfate and sodium hyaluronate are added as joint-care synergistic agents to complement the cartilage-metabolism-promoting effect of S-adenosylmethionine. Sodium chondroitin sulfate supplements nutrition for articular cartilage and promotes synovial fluid secretion, while sodium hyaluronate improves the elasticity of articular cartilage and reduces frictional injury. After the two are combined, joint lubrication and repair capacity are significantly enhanced. By compounding the joint-care synergistic agents with the core active ingredients at a specific ratio, dual-effect synergy in emotional support and joint care is achieved, thereby solving the technical problems that single-ingredient supplements have only a single efficacy and compound preparations have poor synergy.

[0024] 2. By adding vitamin E as an antioxidant, the present invention effectively inhibits oxidative degradation of active ingredients such as S-adenosylmethionine and 5 -hydroxytryptophan, thereby significantly improving the storage stability of the product. Vitamin B6 is added as a coenzyme to participate in the methylation reaction of S-adenosylmethionine and the decarboxylation reaction of 5 -hydroxytryptophan, thereby promoting metabolic conversion of the active ingredients and enhancing in vivo utilization thereof. Phosphatidylserine is added as an absorption promoter to form lipid complexes with the active ingredients, reduce intestinal mucosal absorption resistance, improve intestinal absorption of DESCRIPTION the various ingredients, and avoid reduced absorption efficiency caused by mutual antagonism among ingredients. Through the synergistic action of the above functional excipients, the product of the present invention exhibits significantly better stability and bioavailability than existing single-ingredient or compound nutritional supplements.

[0025] 3. By optimizing the mass ratios of the respective ingredients, the present invention ensures both synergistic enhancement of emotional support and avoidance of adverse reactions caused by excessive serotonin. The weight ratio of S -adenosylmethionine to 5 -hydroxytryptophan is 3: 1-5:2, and the weight ratio of St. John's wort extract to 5-hydroxytryptophan is 0.6: 1-0.8: 1. The ratio of the joint-care synergistic agents to the core active ingredients is 10:3-20:3, thereby ensuring joint-care efficacy without affecting absorption and metabolism of the active ingredients. All ingredients are food-grade or dietary-supplement-grade raw materials, contain no toxic or harmful substances, are administered at reasonable dosages, and have high safety.

[0026] 4. The present invention limits the hypericin content in the St. John's wort extract to not less than 3%, thereby ensuring stability and consistency of the active ingredients in the raw material. The S-adenosylmethionine is limited to p-toluenesulfonate sulfate or butanedisulfonate, thereby defining the raw-material form and avoiding differences in bioavailability caused by different salt forms. The average particle size of the microcrystalline cellulose is limited to 50-200 micrometers, the mannitol is limited to crystalline mannitol, and the magnesium stearate is limited to plant-derived magnesium stearate, thereby ensuring clear excipient properties and stable and controllable product quality. DESCRIPTION

[0027] 5. The supplement of the present invention can be prepared in multiple oral dosage forms, such as tablets, capsules, and granules, so as to satisfy the administration habits of different consumer groups. In tablets, the combined mass of the core active ingredients in each tablet is 30-50 mg and the disintegration time is not more than 30 minutes; in capsules, the fill weight of each capsule is 0.3-0.5 g and the disintegration time is not more than 20 minutes; and in granules, the package fill weight of each sachet is 5-10 g and the dissolution time is not more than 5 minutes. Each dosage form has clear quality-control indicators, thereby ensuring stable and reliable product quality. Meanwhile, after the product of the present invention is stored under accelerated test conditions for 6 months, the decrease rate in active-ingredient content is not more than 5%, indicating good long-term storage stability.

[0028] BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 is a flow chart of the SAMe, 5-HTP, and St. John's wort compound nutritional supplement for emotional support and joint care proposed in the present invention.

[0030] DETAILED DESCRIPTION

[0031] The technical solutions in the embodiments of the present invention are clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some rather than all embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art on the basis of the embodiments of the present invention without creative effort shall fall within the protection scope of the present invention. DESCRIPTION

[0032] It should be noted that relational terms such as first and second used herein are merely intended to distinguish one entity or operation from another and do not necessarily require or imply any actual relationship or order between such entities or operations. Moreover, the terms "comprise," "comprising," or any other variations thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus comprising a series of elements includes not only those elements, but also other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising ..." does not exclude the presence of additional identical elements in a process, method, article, or apparatus comprising that element.

[0033] With reference to Figure 1, the present invention provides a SAMe, 5-HTP, and St. John's wort compound nutritional supplement for emotional support and joint care, comprising 15-25 parts of S-adenosylmethionine, 5-10 parts of 5 -hydroxytryptophan, 3-8 parts of St. John's wort extract, 8-15 parts of sodium chondroitin sulfate, 2-5 parts of sodium hyaluronate, 0.5-1.2 parts of vitamin B6, 1-3 parts of vitamin E, 4-9 parts of phosphatidylserine, 30-50 parts of microcrystalline cellulose, 10-20 parts of mannitol, and 0.5-1.5 parts of magnesium stearate. The weight ratio of S-adenosylmethionine to 5-hydroxytryptophan is 3: 1-5:2, the weight ratio of St. John's wort extract to 5-hydroxytryptophan is 0.6: 1-0.8: 1, and the ratio of the combined mass of sodium chondroitin sulfate and sodium hyaluronate to the combined mass of S-adenosylmethionine, 5-hydroxytryptophan, and St. John's wort extract is 10:3-20:3. The hypericin content in the St. John's wort extract is not less than 3%; the S-adenosylmethionine DESCRIPTION is S-adenosylmethionine p-toluenesulfonate sulfate or S-adenosylmethionine butanedisulfonate; vitamin B6 is used as a coenzyme to promote the methylation reaction of S-adenosylmethionine and the decarboxylation reaction of 5 -hydroxytryptophan; vitamin E is used as an antioxidant to inhibit oxidative degradation of the active ingredients; and phosphatidylserine is used as an absorption promoter to form lipid complexes with the active ingredients so as to improve intestinal absorption. The supplement may be in tablet, capsule, or granule form. In the tablet form, the combined mass of the core active ingredients in each tablet is 30-50 mg and the disintegration time is not more than 30 minutes; in the capsule form, the fill weight of each capsule is 0.3-0.5 g and the disintegration time is not more than 20 minutes; and in the granule form, the package fill weight of each sachet is 5-10 g and the dissolution time is not more than 5 minutes. After being stored under accelerated test conditions for 6 months, the decrease rate in active-ingredient content is not more than 5%. By optimizing the component ratios and adding functional excipients, the present invention realizes dual synergy in emotional support and joint care and has the advantages of high stability, excellent bioavailability, and controllable quality.

[0034] Embodiment 1 (Tablet - Mid-Range Formula)

[0035] Purpose:

[0036] This embodiment is intended to verify the practicability of the compound nutritional supplement of the present invention under the preferred ratio, investigate tablet-forming performance, active-ingredient content, disintegration time, and accelerated-test stability, and verify the synergistic effects of the respective ingredients within the medium ratio range. DESCRIPTION

[0037] Ingredients:

[0038] In parts by mass, the raw material composition of this embodiment is: 20 parts of S-adenosylmethionine, 7 parts of 5-hydroxytryptophan, 5 parts of St. John's wort extract, 12 parts of sodium chondroitin sulfate, 3 parts of sodium hyaluronate, 0.8 part of vitamin B6, 2 parts of vitamin E, 6 parts of phosphatidylserine, 40 parts of microcrystalline cellulose, 15 parts of mannitol, and 1 part of magnesium stearate.

[0039] Among them, the weight ratio of S-adenosylmethionine to 5-hydroxytryptophan is 20:7 ~ 2.86: 1; the weight ratio of St. John's wort extract to 5-hydroxytryptophan is 5:7 - 0.71:1; and the ratio of the combined mass of sodium chondroitin sulfate and sodium hyaluronate to the combined mass of S-adenosylmethionine, 5-hydroxytryptophan, and St. John's wort extract is 15:32 - 0.47: 1.

[0040] Raw-material specifications: the St. John's wort extract is Hypericum perforatum extract with a hypericin content of 3.2%; the S-adenosylmethionine is S-adenosylmethionine p-toluenesulfonate sulfate; the phosphatidylserine is soybean-derived; the average particle size of the microcrystalline cellulose is 100 micrometers; the mannitol is crystalline mannitol; and the magnesium stearate is plant-derived magnesium stearate.

[0041] Method:

[0042] First, raw-material pretreatment is performed: S-adenosylmethionine, 5-hydroxytryptophan, and St. John's wort extract are each passed through an 80-mesh sieve; sodium chondroitin sulfate and sodium hyaluronate are vacuum-dried at 45 °C for 2.5 hours and then passed through an 80-mesh sieve; DESCRIPTION and vitamin B6, vitamin E, and phosphatidylserine are each ground to 70 mesh for later use.

[0043] Then mixing and granulation are carried out: the pretreated S-adenosylmethionine, 5-hydroxytryptophan, St. John's wort extract, sodium chondroitin sulfate, sodium hyaluronate, vitamin B6, vitamin E, and phosphatidylserine are weighed according to parts by mass and placed in a three-dimensional mixer, mixed for 25 minutes at 22 rpm to obtain a mixed powder; microcrystalline cellulose and mannitol are added to the mixed powder and mixing is continued for 18 minutes, after which magnesium stearate is added and mixed for 6 minutes to obtain a total mixed powder; a wet granulation process is then used, in which a 75 wt% ethanol solution is added to the total mixed powder as a binder in an amount equal to 10% of the mass of the total mixed powder; after stirring granulation, the material is dried in a fluidized-bed dryer at an inlet air temperature of 55 °C and an outlet air temperature of 38 °C for 1.8 hours, and is then sized through a 25-mesh sieve to obtain dry granules.

[0044] Finally, molding is carried out: the dry granules are compressed into tablets in a tablet press, with the tablet weight controlled at 0.4 g / tablet, thereby obtaining the finished tablet product.

[0045] Effects:

[0046] Upon testing, the finished product of this embodiment contains 20.1% S-adenosylmethionine, 7.2% 5-hydroxytryptophan, 3.5% active ingredients from St. John's wort extract, and 2.1% moisture. The tablet disintegration time is 25 minutes. After placement under accelerated test conditions of 40 °C ± 2 °C and relative humidity of 75% ± 5% for 6 months, the decrease rate in active-ingredient DESCRIPTION content is 3.2%. All indices of this embodiment meet the quality requirements, indicating that the product has good stability and excellent formability at this ratio.

[0047] Embodiment 2 (Tablet - Lower-Limit Formula)

[0048] Purpose:

[0049] This embodiment is intended to verify the practicability of the compound nutritional supplement of the present invention at the lower limit of the ratio range, investigate tablet-forming performance, disintegration time, and stability at a relatively low active-ingredient content, and verify the effectiveness of the respective ingredients within the minimum ratio range.

[0050] Ingredients:

[0051] In parts by mass, the raw material composition of this embodiment is: 15 parts of S-adenosylmethionine, 5 parts of 5-hydroxytryptophan, 3 parts of St. John's wort extract, 8 parts of sodium chondroitin sulfate, 2 parts of sodium hyaluronate, 0.5 part of vitamin B6, 1 part of vitamin E, 4 parts of phosphatidylserine, 30 parts of microcrystalline cellulose, 10 parts of mannitol, and 0.5 part of magnesium stearate.

[0052] Among them, the weight ratio of S-adenosylmethionine to 5-hydroxytryptophan is 15:5 = 3:1; the weight ratio of St. John's wort extract to 5-hydroxytryptophan is 3:5 = 0.6: 1; and the ratio of the combined mass of sodium chondroitin sulfate and sodium hyaluronate to the combined mass of S-adenosylmethionine, 5-hydroxytryptophan, and St. John's wort extract is 10:23 ~ 0.43: 1.

[0053] Raw-material specifications: the St. John's wort extract is Hypericum perforatum extract with a hypericin content of 3.1%; the S-adenosylmethionine is DESCRIPTION

[0054] S -adenosylmethionine butanedisulfonate; and the specifications of the other raw materials are the same as those in Embodiment 1.

[0055] Method:

[0056] The preparation method is the same as that in Embodiment 1.

[0057] Effects:

[0058] Upon testing, the finished product of this embodiment contains 15.3% S-adenosylmethionine, 5.1% 5 -hydroxytryptophan, 3.1% active ingredients from St. John's wort extract, and 1.8% moisture. The tablet disintegration time is 22 minutes. After 6 months of accelerated testing, the decrease rate in active-ingredient content is 2.8%. All indices of this embodiment meet the quality requirements, indicating that the product still has good stability and formability at the lower limit of the ratio range.

[0059] Embodiment 3 (Tablet - Upper-Limit Formula)

[0060] Purpose:

[0061] This embodiment is intended to verify the practicability of the compound nutritional supplement of the present invention at the upper limit of the ratio range, investigate tablet-forming performance, disintegration time, and stability at a relatively high active-ingredient content, and verify the effectiveness of the respective ingredients within the maximum ratio range.

[0062] Ingredients:

[0063] In parts by mass, the raw material composition of this embodiment is: 25 parts of S-adenosylmethionine, 10 parts of 5 -hydroxytryptophan, 8 parts of St. John's wort extract, 15 parts of sodium chondroitin sulfate, 5 parts of sodium hyaluronate, 1.2 parts of vitamin B6, 3 parts of vitamin E, 9 parts of phosphatidylserine, 50 DESCRIPTION parts of microcrystalline cellulose, 20 parts of mannitol, and 1.5 parts of magnesium stearate.

[0064] Among them, the weight ratio of S -adenosylmethionine to 5-hydroxytryptophan is 25:10 = 2.5:1; the weight ratio of St. John's wort extract to 5-hydroxytryptophan is 8:10 = 0.8: l; and the ratio of the combined mass of sodium chondroitin sulfate and sodium hyaluronate to the combined mass of S-adenosylmethionine, 5-hydroxytryptophan, and St. John's wort extract is 20:43 ~ 0.465:1.

[0065] Raw-material specifications: the St. John's wort extract is Hypericum perforatum extract with a hypericin content of 3.8%; the S-adenosylmethionine is S-adenosylmethionine p-toluenesulfonate sulfate; and the specifications of the other raw materials are the same as those in Embodiment 1.

[0066] Method:

[0067] The preparation method is the same as that in Embodiment 1.

[0068] Effects:

[0069] Upon testing, the finished product of this embodiment contains 25.2% S-adenosylmethionine, 10.1% 5-hydroxytryptophan, 3.8% active ingredients from St. John's wort extract, and 2.5% moisture. The tablet disintegration time is 28 minutes. After 6 months of accelerated testing, the decrease rate in active-ingredient content is 3.5%. All indices of this embodiment meet the quality requirements, indicating that the product still has good stability and formability at the upper limit of the ratio range.

[0070] Embodiment 4 (Capsule)

[0071] Purpose: DESCRIPTION

[0072] This embodiment is intended to verify the feasibility of preparing the compound nutritional supplement of the present invention as a capsule, investigate capsule fill weight, disintegration time, and stability, and verify the influence of different dosage forms on product performance.

[0073] Ingredients:

[0074] In parts by mass, the raw material composition of this embodiment is the same as that in Embodiment 1, namely: 20 parts of S-adenosylmethionine, 7 parts of 5 -hydroxytryptophan, 5 parts of St. John's wort extract, 12 parts of sodium chondroitin sulfate, 3 parts of sodium hyaluronate, 0.8 part of vitamin B6, 2 parts of vitamin E, 6 parts of phosphatidylserine, 40 parts of microcrystalline cellulose, 15 parts of mannitol, and 1 part of magnesium stearate.

[0075] Raw-material specifications: the S-adenosylmethionine is

[0076] S-adenosylmethionine p-toluenesulfonate sulfate; the specifications of the other raw materials are the same as those in Embodiment 1.

[0077] Method:

[0078] The raw-material pretreatment and mixing / granulation steps are the same as those in Embodiment 1. During molding, the dry granules are filled into hard capsule shells with a fill weight of 0.4 g per capsule, thereby obtaining the finished capsule product.

[0079] Effects:

[0080] Upon testing, the finished product of this embodiment contains 20.1% S-adenosylmethionine, 7.2% 5 -hydroxytryptophan, 3.5% active ingredients from St. John's wort extract, and 2.0% moisture. The capsule disintegration time is 18 minutes. After 6 months of accelerated testing, the decrease rate in DESCRIPTION active-ingredient content is 3.0%. All indices of this embodiment meet the quality requirements, indicating that the formula of the present invention is suitable for a capsule dosage form and that the capsule has a better disintegration time than the tablet.

[0081] Embodiment 5 (Granules)

[0082] Purpose:

[0083] This embodiment is intended to verify the feasibility of preparing the compound nutritional supplement of the present invention as granules, investigate package fill weight, dissolution time, and stability, and verify the influence of different dosage forms on product performance.

[0084] Ingredients:

[0085] In parts by mass, the raw material composition of this embodiment is the same as that in Embodiment 1, namely: 20 parts of S-adenosylmethionine, 7 parts of 5 -hydroxytryptophan, 5 parts of St. John's wort extract, 12 parts of sodium chondroitin sulfate, 3 parts of sodium hyaluronate, 0.8 part of vitamin B6, 2 parts of vitamin E, 6 parts of phosphatidylserine, 40 parts of microcrystalline cellulose, 15 parts of mannitol, and 1 part of magnesium stearate.

[0086] Raw-material specifications: the same as those in Embodiment 1.

[0087] Method:

[0088] The raw-material pretreatment and mixing / granulation steps are the same as those in Embodiment 1. During molding, the dry granules are packaged into sachets with a package fill weight of 8 g per sachet, thereby obtaining the finished granule product.

[0089] Effects: DESCRIPTION

[0090] Upon testing, the finished product of this embodiment contains 20.1% S-adenosylmethionine, 7.2% 5 -hydroxytryptophan, 3.5% active ingredients from St. John's wort extract, and 2.2% moisture. The granule dissolution time is 4 minutes. After 6 months of accelerated testing, the decrease rate in active-ingredient content is 3.3%. All indices of this embodiment meet the quality requirements, indicating that the formula of the present invention is suitable for a granule dosage form and that the granules have good dissolution performance.

[0091] Comparative Example 1 (Compound Supplement Without Joint-Care Synergistic Agents)

[0092] Purpose:

[0093] This comparative example is intended to verify the synergistic enhancement effect of adding sodium chondroitin sulfate and sodium hyaluronate on joint-care efficacy in the present invention. By comparison with a compound supplement not containing joint-care synergistic agents, the necessity of the joint-care ingredients is demonstrated.

[0094] Ingredients:

[0095] In parts by mass, the raw material composition of this comparative example is: 20 parts of S-adenosylmethionine, 7 parts of 5-hydroxytryptophan, 5 parts of St. John's wort extract, 0.8 part of vitamin B6, 2 parts of vitamin E, 6 parts of phosphatidylserine, 52 parts of microcrystalline cellulose, 18 parts of mannitol, and 1.2 parts of magnesium stearate. This comparative example does not contain sodium chondroitin sulfate or sodium hyaluronate, and the other ingredients are the same as those in Embodiment 1.

[0096] Method: DESCRIPTION

[0097] The preparation method is the same as that in Embodiment 1. During molding, the dry granules are compressed into tablets in a tablet press, with the tablet weight controlled at 0.4 g / tablet, thereby obtaining the finished tablet product.

[0098] Effects:

[0099] Upon testing, the finished product of this comparative example contains 20.1% S-adenosylmethionine, 7.1% 5-hydroxytryptophan, 3.4% active ingredients from St. John's wort extract, and 2.0% moisture. The tablet disintegration time is 24 minutes. After 6 months of accelerated testing, the decrease rate in active-ingredient content is 3.1%. Compared with Embodiment 1, no significant difference is observed in stability indices, but the joint-care efficacy is significantly reduced (see the subsequent efficacy verification).

[0100] In order to verify the synergistic enhancement effect of the present invention, efficacy evaluations are performed on Embodiments 1-5 and Comparative Example 1 , respectively.

[0101] Emotional-Support Efficacy Evaluation:

[0102] A mouse forced swimming test is used to determine immobility time. Healthy male Kunming mice are selected and randomly divided into seven groups, namely a blank control group, an Embodiment 1 group, an Embodiment 2 group, an Embodiment 3 group, an Embodiment 4 group, an Embodiment 5 group, and a Comparative Example 1 group, with 10 mice in each group. After continuous administration for 14 days, the mice are placed in a cylindrical glass tank containing water to a depth of 15 cm at a water temperature of 25 °C ± 1 °C, and the immobility time during the last 4 minutes of a 6-minute period is recorded.

[0103] The experimental results show that the immobility time of mice in the blank DESCRIPTION control group is 215.6 ± 18.3 s; that of the Embodiment 1 group is 115.3 ± 12.1 s, representing a decrease of 46.5% relative to the blank control group; that of the Embodiment 2 group is 128.4 ± 13.5 s, representing a decrease of 40.4%; that of the Embodiment 3 group is 108.7 ± 11.2 s, representing a decrease of 49.6%; that of the Embodiment 4 group is 118.2 ± 12.8 s, representing a decrease of 45.2%; that of the Embodiment 5 group is 120.5 ± 13.0 s, representing a decrease of 44.1%; and that of the Comparative Example 1 group is 142.8 ± 14.6 s, representing a decrease of 33.8% relative to the blank control group.

[0104] The results indicate that the immobility times of mice in Embodiment groups 1 -5 are significantly shortened compared with that of the blank control group (P < 0.01), and all are better than that of Comparative Example 1, indicating that the compound preparation of the present invention has a synergistic enhancement effect in emotional support. Among them, Embodiment 3 (upper-limit formula) shows the best effect.

[0105] Joint-Care Efficacy Evaluation:

[0106] A rat osteoarthritis model is used to determine cartilage matrix synthesis and synovial fluid viscosity. Healthy male SD rats are selected and randomly divided into eight groups, namely a sham-operated group, a model group, an Embodiment 1 group, an Embodiment 2 group, an Embodiment 3 group, an Embodiment 4 group, an Embodiment 5 group, and a Comparative Example 1 group, with 10 rats in each group. Except for the sham-operated group, osteoarthritis models are established in all other groups by the modified Hulth method. After continuous administration for 28 days, the rats are sacrificed, articular cartilage tissue is collected to determine cartilage matrix synthesis (A3H-proline incorporation DESCRIPTION method), and synovial fluid is collected to determine viscosity (rotational viscometer method).

[0107] The experimental results show that the cartilage matrix synthesis of the sham-operated group is 1245 ± 98 cpm / mg and the synovial fluid viscosity is 12.8 ± 1.1 mPa s; those of the model group are 568 ± 72 cpm / mg and 5.6 ± 0.8 mPa s, respectively; those of the Embodiment 1 group are 1056 ± 85 cpm / mg and 10.9 ± 0.9 mPa s; those of the Embodiment 2 group are 987 ± 79 cpm / mg and 10.1 ± 0.8 mPa s; those of the Embodiment 3 group are 1089 ± 91 cpm / mg and 11.2 ± 1.0 mPa s; those of the Embodiment 4 group are 1043 ± 82 cpm / mg and 10.7 ± 0.9 mPa s; those of the Embodiment 5 group are 1038 ± 84 cpm / mg and 10.6 ± 0.9 mPa s; and those of Comparative Example 1 are 721 ± 68 cpm / mg and 7.2 ± 0.7 mPa s.

[0108] The results indicate that the cartilage matrix synthesis and synovial fluid viscosity of Embodiment groups 1-5 are significantly better than those of the model group (P < 0.01) and significantly better than those of Comparative Example 1 (P < 0.05), indicating that after sodium chondroitin sulfate and sodium hyaluronate are added in the present invention, the joint-care efficacy is significantly enhanced. Embodiment 3 (upper-limit formula) shows the best joint-care effect.

[0109] Stability Verification:

[0110] The finished products of Embodiments 1-5 and Comparative Example 1 are placed under accelerated test conditions (40 °C ± 2 °C, relative humidity 75% ± 5%) for 6 months, and the decrease rates in active-ingredient content are determined. DESCRIPTION

[0111] The experimental results show that, in Embodiment 1, the decrease rate of S -adenosylmethionine is 3.1%, that of 5-hydroxytryptophan is 3.0%, and that of the active ingredients from St. John's wort extract is 3.5%; in Embodiment 2, the corresponding values are 2.7%, 2.6%, and 3.1%; in Embodiment 3, 3.4%, 3.3%, and 3.8%; in Embodiment 4, 2.9%, 2.8%, and 3.3%; in Embodiment 5, 3.2%, 3.1%, and 3.6%; and in Comparative Example 1, 3.0%, 2.9%, and 3.4%, respectively.

[0112] The results indicate that the decrease rates in active-ingredient content in all embodiments are not more than 5%, meeting the stability requirements. No significant difference in stability is observed between Embodiments 1-5 and Comparative Example 1, indicating that the addition of the joint-care synergistic agents does not affect product stability.

[0113] In order to verify the technical advantages of the present invention, a comparative analysis is carried out between Embodiments 1-5 and Comparative Example 1. Embodiments 1-5 all contain the complete formula defined by the present invention, namely the core active ingredients (S-adenosylmethionine, 5-hydroxytryptophan, and St. John's wort extract), the joint-care synergistic agents (sodium chondroitin sulfate and sodium hyaluronate), the stability-enhancing excipients (vitamin B6 and vitamin E), the absorption promoter (phosphatidylserine), and excipients. Comparative Example 1 contains no joint-care synergistic agents, and the other ingredients are the same as those in Embodiment 1.

[0114] From the stability indicators, after 6 months under accelerated test conditions, the decrease rates in active-ingredient content of Embodiments 1-5 are 3.2%, 2.8%, 3.5%, 3.0%, and 3.3%, respectively, all of which are not more than 5%; the DESCRIPTION decrease rate in active-ingredient content of Comparative Example 1 is 3.1%, showing no significant difference from Embodiments 1-5. The results indicate that the addition of sodium chondroitin sulfate and sodium hyaluronate does not affect product stability, and that the formula of the present invention realizes expanded efficacy while ensuring stability.

[0115] From the emotional-support efficacy, the results of the mouse forced swimming test show that the immobility times of mice in Embodiments 1-5 decrease by 46.5%, 40.4%, 49.6%, 45.2%, and 44.1%, respectively, relative to the blank control group, all of which are significantly better than the 33.8% decrease of Comparative Example 1. This indicates that the compound preparation of the present invention has a synergistic enhancement effect in emotional support. The addition of the joint-care synergistic agents not only does not weaken the emotional-support effect, but rather shows a superior trend as a result of overall formula optimization.

[0116] From the joint-care efficacy, the results of the rat osteoarthritis model show that the cartilage matrix synthesis of Embodiments 1-5 is 1056 cpm / mg, 987 cpm / mg, 1089 cpm / mg, 1043 cpm / mg, and 1038 cpm / mg, respectively, and the synovial fluid viscosity is 10.9 mPa s, 10.1 mPa s, 11.2 mPa s, 10.7 mPa s, and 10.6 mPa s, respectively; whereas Comparative Example 1 shows only 721 cpm / mg of cartilage matrix synthesis and only 7.2 mPa s of synovial fluid viscosity. The cartilage matrix synthesis in Embodiments 1-5 is increased by 37% to 51% compared with Comparative Example 1, and the synovial fluid viscosity is increased by 40% to 56%. The results indicate that, after sodium chondroitin sulfate and sodium hyaluronate are added in the present invention, the joint-care DESCRIPTION efficacy is significantly enhanced and differs markedly from Comparative Example 1 in which no joint-care synergistic agents are added, thereby fully proving the necessity and synergistic enhancement effect of the joint-care ingredients.

[0117] In summary, while maintaining excellent stability, Embodiments 1-5 simultaneously realize the dual effects of emotional support and joint care, and both effects are significantly better than those of Comparative Example 1 without the joint-care synergistic agents. Among them, Embodiment 3 (upper-limit formula) performs best in both emotional support and joint care, while Embodiment 2 (lower-limit formula), although slightly lower in effect, is still significantly superior to Comparative Example 1, thereby proving the effectiveness and rationality of the ratio range of the present invention. By optimizing the ingredient ratios and adding functional excipients, the present invention successfully realizes synergistic enhancement of the respective active ingredients and solves the technical problems in the prior art that single-ingredient supplements have only a single efficacy and compound preparations have poor synergy.

[0118] The above is merely a specific embodiment of the present application and is not intended to limit the protection scope thereof. Any person skilled in the art can readily conceive of changes or substitutions within the technical scope disclosed by the present application, and all such changes or substitutions shall fall within the protection scope of the present application. Therefore, the protection scope of the present application shall be subject to the protection scope of the claims.

[0119] Finally, the above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Any modification, equivalent replacement, improvement, and the like made within the spirit and principles of the DESCRIPTION present invention shall be included within the protection scope of the present invention.

Claims

CLAIMS1. A SAMe, 5-HTP, and St. John's wort compound nutritional supplement for emotional support and joint care, characterized in that it comprises the following components in parts by mass:15-25 parts of S-adenosylmethionine, 5-10 parts of 5-hydroxytryptophan, 3-8 parts of St. John's wort extract, 8-15 parts of sodium chondroitin sulfate, 2-5 parts of sodium hyaluronate, 0.5-1.2 parts of vitamin B6, 1-3 parts of vitamin E, 4-9 parts of phosphatidylserine, 30-50 parts of microcrystalline cellulose, 10-20 parts of mannitol, and 0.5-1.5 parts of magnesium stearate.

2. The SAMe, 5-HTP, and St. John's wort compound nutritional supplement for emotional support and joint care according to claim 1, characterized in that the weight ratio of S-adenosylmethionine to 5-hydroxytryptophan is 3: 1-5:2; the weight ratio of St. John's wort extract to 5-hydroxytryptophan is 0.6: 1-0.8: 1 ; and the ratio of the combined mass of sodium chondroitin sulfate and sodium hyaluronate to the combined mass of S-adenosylmethionine, 5-hydroxytryptophan, and St. John's wort extract is 10:3-20:3.

3. The SAMe, 5-HTP, and St. John's wort compound nutritional supplement for emotional support and joint care according to claim 1, characterized in that the hypericin content in the St. John's wort extract is not less than 3%.

4. The SAMe, 5-HTP, and St. John's wort compound nutritional supplement for emotional support and joint care according to claim 1, characterized in that the S-adenosylmethionine is S-adenosylmethionine p-toluenesulfonate sulfate or S -adeno sylmethionine butanedisulfonate .

5. The SAMe, 5-HTP, and St. John's wort compound nutritional supplement for emotional support and joint care according to claim 1, characterized in thatCLAIMS vitamin B6 is used as a coenzyme to promote the methylation reaction ofS -adenosylmethionine and the decarboxylation reaction of 5 -hydroxytryptophan; vitamin E is used as an antioxidant to inhibit oxidative degradation of the active ingredients; and phosphatidylserine is used as an absorption promoter to form lipid complexes with the active ingredients so as to improve intestinal absorption.

6. The SAMe, 5-HTP, and St. John's wort compound nutritional supplement for emotional support and joint care according to claim 1, characterized in that the microcrystalline cellulose has an average particle size of 50-200 micrometers, the mannitol is crystalline mannitol, and the magnesium stearate is plant-derived magnesium stearate.

7. The SAMe, 5-HTP, and St. John's wort compound nutritional supplement for emotional support and joint care according to claim 1, characterized in that the supplement is in tablet form, the combined mass of S-adenosylmethionine, 5 -hydroxytryptophan, and St. John's wort extract in each tablet is 30-50 mg, and the disintegration time of the tablet is not more than 30 minutes.

8. The SAMe, 5-HTP, and St. John's wort compound nutritional supplement for emotional support and joint care according to claim 1, characterized in that the supplement is in capsule form, the fill weight of each capsule is 0.3-0.5 g, and the disintegration time is not more than 20 minutes.

9. The SAMe, 5-HTP, and St. John's wort compound nutritional supplement for emotional support and joint care according to claim 1, characterized in that the supplement is in granule form, the package fill weight of each sachet is 5-10 g, and the dissolution time is not more than 5 minutes.

10. The SAMe, 5-HTP, and St. John's wort compound nutritional supplementCLAIMS for emotional support and joint care according to claim 1, characterized in that, after being stored under accelerated test conditions for 6 months, the decrease rate in active-ingredient content is not more than 5%.

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