WO2020024247A1 - 一种颈肩腰腿痛用并具强筋健络功能的生物制剂 - Google Patents

一种颈肩腰腿痛用并具强筋健络功能的生物制剂 Download PDF

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WO2020024247A1
WO2020024247A1 PCT/CN2018/098467 CN2018098467W WO2020024247A1 WO 2020024247 A1 WO2020024247 A1 WO 2020024247A1 CN 2018098467 W CN2018098467 W CN 2018098467W WO 2020024247 A1 WO2020024247 A1 WO 2020024247A1
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molecular weight
acid
hyaluronic acid
agent
specifically
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PCT/CN2018/098467
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French (fr)
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王卫国
赵永亮
王冠轶
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郑州兰茜生物工程有限公司
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    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
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    • A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7076—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines containing purines, e.g. adenosine, adenylic acid
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    • 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
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Definitions

  • the invention belongs to the technical field of pain science and biomedicine and health products, and particularly relates to a patent application for a biological preparation product for neck, shoulder, waist, and leg pain, and having a strong tendon and strengthening function.
  • neck, shoulder, waist and leg pain has become a common and frequently-occurring disease.
  • the physical and neuromuscular functions and metabolic capacity of the body are reduced, neck, shoulder, waist, and leg pain or inexplicable muscles or joints are unknown chronic pain or soreness or stiffness or cramps Such discomfort has spread to almost all elderly people.
  • Neck, shoulder, waist and leg pain are mostly caused by chronic strain or improper exercise, or caused by cold, cold, dampness, and aseptic inflammation. They are a large group of common diseases and frequently occurring diseases, including pain, swelling and even limited function, including: Cervical spondylosis, periarthritis, tenosynovitis, lumbar disc herniation, lumbar muscle strain, bone hyperplasia and other unknown or unknown causes, commonly manifested as acute and chronic neck pain without epidermal damage, shoulder pain, arm pain, wrist pain, Back pain, leg pain, joint pain, muscle pain, neuralgia, or soreness or stiffness in the muscles of the body.
  • neck, shoulder, waist and leg pain are mainly divided into the following three categories: (a) acute damage to soft tissues: soft tissues are suddenly damaged by external forces, pressured by gravity, and pulled and twisted beyond the physiological range of soft tissues. (2) Chronic soft tissue damage: caused by lifestyle habits or occupational postures, such as: long-term bowing, sitting, prolonged bending and improper sleeping posture, or using high pillows, etc., leaving some soft tissues in a stretched state for a long time and being The blood vessels in the stretched tissue are in a semi-open state for a long time, which causes hypoxia of the tissue cells, which changes the permeability of blood vessels, blood cell exudation, tissue degeneration, and increased fibrous interstitial tissue. Soft tissue lesions cause neck, shoulder, waist, and leg pain.
  • Wind-cold-wetness and pain can reduce the body's tolerance to pain, make muscle spasm, contraction of small blood vessels, slow down lymphatic return, impair soft blood circulation, and produce aseptic inflammation, which can cause neck, shoulder, and waist Leg pain. Pain, swelling, numbness, rigidity, etc. will appear in the bones, joints, muscles and other parts when the disease occurs. In severe cases, it can cause paralysis, life can not take care of themselves, and even threaten life.
  • Commonly used western medicine analgesics are mainly non-steroidal anti-inflammatory drugs and central painkillers.
  • Common non-steroidal analgesics include aspirin, ibuprofen, indomethacin, paracetamol, etc .
  • central analgesics include pethidine, narcotic morphine, dulidine, and anxiolytic analgesics such as diazepam.
  • antispasmodic and analgesic drugs such as atropine, probencin, belladonna tablets, and anisodamine.
  • Commonly used Chinese medicines include pills, medicinal liquors, etc., which are made from Chinese herbal medicines that have the properties of relieving muscles and promoting blood circulation, and clearing collaterals and dissolving blood stasis.
  • external preparations such as plasters and sprays containing Chinese or / and western medicine ingredients.
  • surgical treatment is very harmful, physical therapy has limited effects.
  • western medicine has good effects, it has large toxic and side effects. If it is addictive, it can cause chronic interstitial nephritis, renal papillary necrosis, and renal insufficiency. It can stimulate gastric mucosa.
  • the purpose of this application is to provide a biological preparation product for neck, shoulder, waist, and leg pain, which has a strong tendon and strengthening network function.
  • the product is aimed at lower back, shoulders, neck, limbs, joints, and general muscle pain caused by a variety of reasons or unknown causes.
  • Anonymous pain has a significant effect. It also has a significant repair or rehabilitation effect on the neck, shoulder, waist, leg muscles, soreness, stiffness, or pain caused by cold, dampness, or muscle or bone strain or overwork. It is sprayed on the neck, shoulder, and waist of normal healthy people. Leg joints also have certain health effects.
  • a biological preparation with strong tendon and collateral function for neck, shoulder, waist and leg pain includes Huoxuetongluo agent, joint bio-lubricant, tendon muscle strengthening agent, cell physiological function conditioner and essential for normal cell growth and metabolism Agent, preferably, the biological agent further comprises a preservative; further preferably, the biological agent further comprises a safe carrier and / or auxiliary material acceptable to the agent;
  • the Huoxuetongluo agent includes, but is not limited to, Panax notoginseng extract, panax notoginseng saponin / glycoside, and VB12, and one or more mixtures of any ratio may be selected;
  • the joint bio-lubricant includes, but is not limited to, hyaluronic acid or / and hyaluronic acid salt, polyglutamic acid or / and polyglutamic acid salt, and one or more mixtures in any ratio may be selected;
  • the tendon muscle strengthening agent includes, but is not limited to, collagen, collagen peptides, glutamine, inositol, calcium phosphate, and calcium gluconate.
  • One or more mixtures can be selected in any ratio;
  • the cell physiological function conditioning agent includes, but is not limited to, ATP disodium, cytochrome C, trehalose, allantoin, taurine, vitamins, and coenzymes, and one or several mixtures in any ratio can be selected;
  • the necessary agents for normal growth and metabolism of the cells include, but are not limited to, amino acids, sugars, and organic acids, and one or more mixtures in any ratio may be selected;
  • the preservative should be a food-grade preservative, including, but not limited to, potassium sorbate, sodium dehydroacetate, potassium cinnamate, glycyrrhizic acid, glycyrrhizinate, and propionate, one or more of which can be selected in any ratio mixture;
  • the safe carrier or auxiliary material acceptable for the preparation includes, but is not limited to, polyethylene glycol (PEG) with different molecular weights and polyvinylpyrrolidone (PVP) with different molecular weights. One or several mixtures in any ratio can be selected. ;
  • the polyethylene glycols with different molecular weights refer to polyethylene glycols with a molecular weight of 400-20000 Daltons above food grade; the PVPs with different molecular weights include but are not limited to PVP K15 and PVP above pharmaceutical grade , PVP K60 and PVP K90, you can choose one or several mixtures in any ratio.
  • the total mass concentration of the active ingredients in the biological preparation for neck, shoulder, waist, and leg pain and the function of strengthening the gluten and strengthening the network is 0.5-38.0%; each component in the active ingredient is based on mass parts, specifically:
  • the Huoxuetongluo agent is composed of notoginseng extract, notoginseng saponin / glycoside and VB12, specifically: notoginseng extract 0.001-10.0, notoginseng total saponin / glycoside 0.001-2.0, VB12 0.001-10.0;
  • the joint bio-lubricant is composed of high, middle and low 3 different molecular weights of hyaluronic acid or hyaluronic acid salt and high, middle and low 3 different molecular weights of polyglutamic acid or polyglutamate, specifically In terms of: high molecular weight hyaluronic acid or / and hyaluronic acid salt 0.001-5.0, medium molecular weight hyaluronic acid or / and hyaluronic acid salt 0.001-8.0, low molecular weight hyaluronic acid or / and hyaluronic acid salt 0.001-10.0; high molecular weight polyglutamic acid or polyglutamate 0.001-4.0, medium molecular weight polyglutamic acid or polyglutamate 0.001-6.0, low molecular weight polyglutamic acid or / And polyglutamate 0.001-12.0;
  • the high molecular weight hyaluronic acid and the high molecular weight hyaluronic acid salt mean a molecular weight greater than 2.4 million (2.4 million) Daltons;
  • the medium molecular weight hyaluronic acid and the medium molecular weight hyaluronic acid salt refer to a molecular weight greater than 1 million (1000000), but not more than 1.8 million (1.8 million) Daltons;
  • the low molecular weight hyaluronic acid and the low molecular weight hyaluronic acid salt refer to a molecular weight of not more than 400,000 (400000) Daltons;
  • the high molecular weight polyglutamic acid and high molecular weight polyglutamic acid salt refer to a molecular weight greater than 1.4 million (1.4 million) Daltons;
  • the medium molecular weight polyglutamic acid and the medium molecular weight polyglutamic acid salt mean a molecular weight greater than 600,000 (600,000), but not more than 1.2 million (1.2 million) Daltons;
  • the low molecular weight polyglutamic acid and the low molecular weight polyglutamic acid salt refer to a molecular weight of not more than 300,000 (300,000) Daltons;
  • the tendon muscle strengthening agent is composed of collagen, collagen peptide, glutamine, inositol, calcium phosphate and calcium gluconate, specifically: collagen 0.001-10.0, collagen peptide 0.001-12.0, glutamine Amide 0.01-8.0, inositol 0.01-6.0, calcium phosphate 0.01-5.0, calcium gluconate 0.01-4.0;
  • the cell physiological function conditioning agent is composed of ATP disodium, cytochrome C, trehalose, allantoin, taurine, vitamins and coenzymes, specifically: ATP disodium 0.01-5.0, cytochrome C 0.001-5.0, trehalose 0.01-9.0, allantoin 0.001-2.0, taurine 0.01-5.0;
  • the essential agent for normal cell growth and metabolism is composed of amino acids, sugars, and organic acids, specifically: arginine 0.001-5.0, serine 0.001-5.0, glycine 0.001-9.0, glutamic acid 0.001-1.0, Alanine 0.001-6.0, proline 0.001-12.0, hydroxyproline 0.001-4.0, lysine 0.001-12.0, sodium glutamate 0.01-3.0; glucose 0.001-6.0, sucrose 0.001-6.0; tartaric acid 0.01- 5.0, malic acid 0.01-5.0, citric acid 0.01-5.0, lactic acid 0.01-5.0, and lactate 0.01-5.0;
  • the preservative is composed of potassium sorbate, sodium dehydroacetate, potassium cinnamate, glycyrrhizic acid, glycyrrhizinate and propionate, specifically: potassium sorbate 0.01-2.0, sodium dehydroacetate 0.01-2.0, Potassium cinnamate 0.01-2.0, glycyrrhizin 0.01-1.0, glycyrrhizin 0.01-3.0, propionate 0.01-2.0;
  • the glycyrrhizinate is a mixture of any one or two of potassium glycyrrhizinate and sodium glycyrrhizinate in any ratio;
  • the propionate is one or two mixtures of any ratio of sodium propionate and calcium propionate;
  • the acceptable safe carrier of the preparation may be composed of polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP), specifically: polyethylene glycol 0.001-12.0, PVP 0.001-10.0.
  • PEG polyethylene glycol
  • PVP polyvinylpyrrolidone
  • the total mass concentration of the active ingredients in the preferred formula is 1.0-36.0%; each component of the active ingredients is calculated in terms of mass parts, specifically:
  • the Huoxuetongluo agent consists of Panax notoginseng extract, panax notoginseng saponin / glycoside and VB12, specifically: panax notoginseng extract 0.01-10.0 panax notoginsenoside / glycoside 0.01-2.0, VB12 0.01-10.0;
  • the joint bio-lubricant is composed of three different molecular weights of hyaluronic acid or / and hyaluronic acid, and three different molecular weights of polyglutamic acid or / and polyglutamate, specifically, : High molecular weight hyaluronic acid or / and hyaluronic acid salt 0.01-4.0, medium molecular weight hyaluronic acid or / and hyaluronic acid salt 0.01-6.0, low molecular weight hyaluronic acid or / and hyaluronic acid salt 0.01- 8.0;
  • the tendon muscle strengthening agent is composed of collagen, collagen peptide, glutamine, inositol, calcium phosphate and calcium gluconate, specifically: collagen 0.01-8.0, collagen peptide 0.01-10.0, glutamine Amide 0.01-7.0, inositol 0.01-5.0, calcium phosphate 0.01-4.0, calcium gluconate 0.01-3.0;
  • the cell physiological function conditioner has an important regulating effect on the physiological functions of the body muscle cells, and is composed of ATP disodium, cytochrome C, trehalose, allantoin, taurine, vitamins and coenzymes. Words: ATP disodium 0.01-4.0, cytochrome C 0.001-4.0, trehalose 0.01-8.0, allantoin 0.01-2.0, taurine 0.01-4.0;
  • Vitamin VB1 0.01-5.0, vitamin VB2 0.01-1.0, nicotinamide 0.01-9.0, VB5 0.01-5.0, VB6 0.01-5.0, nicotinic acid 0.01-4.0, Vc 0.01-4.0, vitamin D 0.01-1.0, Ve 0.01-1.0;
  • the essential agent for normal cell growth and metabolism is composed of amino acids, sugars, and organic acids, specifically: arginine 0.001-4.0, serine 0.001-4.0, glycine 0.001-8.0, glutamic acid 0.002-1.0, Alanine 0.01-6.0, proline 0.001-10.0, hydroxyproline 0.01-4.0, lysine 0.001-10.0, sodium glutamate 0.01-2.0; glucose 0.001-5.0, sucrose 0.001-5.0; tartaric acid 0.01- 4.0, malic acid 0.01-4.0, citric acid 0.01-4.0, lactic acid 0.01-4.0, lactate 0.01-4.0;
  • the preservative is composed of potassium sorbate, sodium dehydroacetate, potassium cinnamate, glycyrrhizic acid, glycyrrhizinate and propionate, specifically: potassium sorbate 0.02-2.0, sodium dehydroacetate 0.02-2.0, Potassium cinnamate 0.02-2.0, glycyrrhizin 0.02-1.0, glycyrrhizin 0.01-2.0, propionate 0.02-2.0;
  • the safe carrier acceptable for the preparation is composed of polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP), specifically: polyethylene glycol 0.001-10.0, PVP 0.001-18.0.
  • PEG polyethylene glycol
  • PVP polyvinylpyrrolidone
  • the biological preparation for neck, shoulder, waist, and leg pain and having a strong tendon and strengthening function can be a liquid preparation or a solid preparation, preferably an aqueous gel, more preferably a spray or an elixir, so as to facilitate use. .
  • the preparation method of the biological preparation for neck, shoulder, waist, and leg pain which has the function of strengthening muscles and strengthening the network, specifically includes the following steps:
  • the active ingredients in biological preparations are divided into 4 groups according to the nature of the materials and the convenience and manufacturability of preparation.
  • the first group macromolecular saccharide compounds, protein peptide compounds, specifically: collagen, collagen peptides, high, medium and low 3 different molecular weight hyaluronic acid or / and hyaluronic acid salt and high, medium and low 3 different molecular weights Polyglutamate or polyglutamate;
  • the second group amino acids, small molecule sugars, organic acids, specifically: arginine, serine, glycine, glutamic acid, glutamine, alanine, proline, hydroxyproline, lysine Acid; glucose, trehalose, sucrose; tartaric acid, malic acid, citric acid, lactic acid, lactate, calcium gluconate;
  • vitamin coenzyme compounds specifically: vitamin VB1, vitamin VB2, nicotinamide, VB5, VB6, nicotinic acid, Vc, vitamin D, Ve; biotin, coenzyme Q10, coenzyme I, coenzyme II, VB12;
  • the fourth group other materials, specifically: ATP disodium, cytochrome C, allantoin, taurine, inositol, panax notoginseng extract, panax notoginseng saponin / glycoside, potassium sorbate, sodium dehydroacetate, Potassium cinnamate, glycyrrhizic acid, glycyrrhizinate, propionate; polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP);
  • step (1) The second group of materials weighed in step (1) is placed in a reaction kettle, and then a part of the formula (e.g. water) is added, stirred, dissolved, mixed, and left to obtain mixture A after removing impurities;
  • a part of the formula e.g. water
  • step (1) Put the third group and the fourth group of materials weighed in step (1) into a reaction kettle, and then add a part of the formula amount of the solvent, stir to dissolve and mix well, and leave to obtain mixture B after removing impurities;
  • the operating temperature should not be higher than 45 ° C, so as not to affect the stability of the efficacy and the quality of the final product, but it should not be lower than 15 °C, so as not to affect the effect of dissolution and mixing, it is preferred to perform the dissolution and mixing operation at about 25 ° C.
  • the main design theories of the function of the biological agents provided in this application are: the advantages and disadvantages of the existing analgesic theory-"pain gate control theory of western medicine-pain neural control theory” and “pain pain theory” of traditional Chinese medicine
  • the theory of "transdermal absorption, external use and internal effects” is based on the theory of homology of dystrophy and medicinal foods in life sciences and food nutrition and the medicine of the motherland.
  • a multi-component targeted preparation that is detoxifying, rejuvenating and strengthening the network, strengthening the muscles and strengthening the bones, removing saprophytic muscles, anti-inflammatory and anti-aging, nourishing nerves and muscles, and is safe, efficient, and free of toxic and side effects.
  • Preliminary application verification shows that this application provides Biologics not only have the effect of treating pain in the lower back, shoulders, neck, limbs, joints and whole body, or inexplicable pain caused by multiple reasons or unknown reasons, but also reduce and relieve colds Neck, shoulder, waist, and leg muscles caused by cold, dampness, or strained or overworked muscles can cause discomfort such as acid stiffness, stiffness, or pain.
  • it also has the effects of conditioning, healing, and activating the whole body's neuromuscular cell function and micro blood circulation system. Years of old pain.
  • the present invention has the following outstanding features:
  • the preparation does not contain any toxic or harmful components to the human body, and it is a targeted preparation that can provide the body with a variety of nutrition, health, conditioning or rehabilitation and therapeutic effects ;
  • the product of the present invention is different from the traditional western medicine or traditional Chinese medicine in the form and method of administration. Most of the traditional western medicine or traditional medicine in the form of pain are oral and injection. The amount of medicine reaching the lesion is significantly reduced, and it is difficult to avoid the liver. "First pass effect” and many side effects.
  • the product of the present invention is a topical preparation, not only does not have the "first pass effect”, but also has the characteristics of "missile drugs”. It belongs to targeted administration. Not only the dosage is greatly reduced, the effect is significant. It is direct and fast-acting; in addition, its medication is simple and convenient, and can be used anytime and anywhere, and the patient has good compliance;
  • the preparation method of the preparation of the invention has mild conditions, simple process, no environmental pollution, and can be prepared at normal or low temperature;
  • the product of the present invention not only has the efficacy of medicine, but also the safety of health food and cosmetics that can be repeatedly used for a long time.
  • the product of the present invention is an external product, its safety can meet the standards for internal use (oral) health food (it can regulate the function of the body and will not cause any acute, subacute or chronic harm to the human body).
  • oral health food it can regulate the function of the body and will not cause any acute, subacute or chronic harm to the human body.
  • It also conforms to national or international standards such as "Cosmetic Safety Technical Specifications" that can be used for long-term external use; therefore, it has high safety.
  • This embodiment provides a biological preparation for neck, shoulder, waist, and leg pain, which has a strong tendon and strengthening function.
  • the biological preparation is a liquid preparation, and the total mass concentration of the active ingredients is 8.0%, and the balance is water. Ingredients are measured in parts by mass, specifically:
  • the Huoxuetongluo agent is composed of notoginseng extract, notoginsenoside / glycoside and VB12, specifically: notoginseng extract 5.0, notoginsenoside / glycoside 0.5, VB12 5.0;
  • the joint bio-lubricant is composed of three kinds of high molecular weight hyaluronic acid or / and hyaluronic acid salt and three kinds of high molecular weight polyglutamic acid or polyglutamic acid salt.
  • high molecular weight hyaluronic acid 2.0, medium molecular weight sodium hyaluronate 4.0, low molecular weight sodium hyaluronate 5.0 high molecular weight sodium polyglutamate 2.0, medium molecular weight polyglutamic acid 3.0, low molecular weight Sodium polyglutamate 6.0;
  • the high molecular weight hyaluronic acid and the high molecular weight hyaluronic acid salt mean a molecular weight greater than 2.4 million (2.4 million) Daltons;
  • the medium molecular weight hyaluronic acid and the medium molecular weight hyaluronic acid salt mean a molecular weight of 1.2 million (1.2 million) Daltons;
  • the low molecular weight hyaluronic acid and the low molecular weight hyaluronic acid salt refer to a molecular weight of not more than 400,000 (400000) Daltons;
  • the high molecular weight polyglutamic acid and high molecular weight polyglutamic acid salt refer to a molecular weight greater than 1.4 million (1.4 million) Daltons;
  • the medium molecular weight polyglutamic acid and the medium molecular weight polyglutamic acid salt mean a molecular weight of 800,000 (800,000) Daltons;
  • the low molecular weight polyglutamic acid and the low molecular weight polyglutamic acid salt refer to a molecular weight of not more than 300,000 (300,000) Daltons;
  • the tendon muscle strengthening agent is composed of collagen, collagen peptide, glutamine, inositol, calcium phosphate and calcium gluconate, specifically: collagen 5.0, collagen peptide 6.0, glutamine 4.0, muscle Alcohol 3.0, calcium phosphate 3.0, calcium gluconate 2.0;
  • the cell physiological function conditioning agent is composed of ATP disodium, cytochrome C, trehalose, allantoin, taurine, vitamins and coenzymes, specifically: ATP disodium 2.5, cytochrome C 2.5, Trehalose 4.5, allantoin 1.0, taurine 2.5; vitamin VB1 3.0, vitamin VB2 0.5, nicotinamide 5.0, VB5 3.0, VB6 3.0, nicotinic acid 2.5, Vc 2.5, vitamin D 0.5, Ve 0.5; biotin 0.5, Coenzyme Q10 0.5, Coenzyme I 1.0, Coenzyme II 1.0
  • the cell growth and metabolism essential agent is composed of amino acids, sugars, and organic acids, specifically: arginine 2.5, serine 2.5, glycine 4.5, glutamic acid 0.5, alanine 3.0, and proline 6.0 , Hydroxyproline 2.0, lysine 6.0, sodium glutamate 1.5; glucose 3.0, sucrose 3.0; tartaric acid 2.5, malic acid 2.5, citric acid 2.5, lactic acid 2.5, sodium lactate 2.5, calcium lactate 0.5;
  • the preservative is composed of potassium sorbate, sodium dehydroacetate, potassium cinnamate, glycyrrhizic acid, glycyrrhizinate and propionate, specifically: potassium sorbate 1.0, sodium dehydroacetate 1.0, potassium cinnamate 1.0 Glycyrrhizin 0.5, potassium glycyrrhizin 0.5, sodium glycyrrhizin 1.5, sodium propionate 1.0, calcium propionate 1.0;
  • the acceptable safe carrier of the preparation is composed of polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP), specifically: polyethylene glycol 400 6.0, polyethylene glycol 4000 2.0, and polyethylene glycol 10000 2.0, polyethylene glycol 20000, 2.0, PVP, K15, 2.0, PVP, K30, 1.0, PVP, K60, 0.5 and PVP, K90.
  • PEG polyethylene glycol
  • PVP polyvinylpyrrolidone
  • the biological preparation for neck, shoulder, waist, and leg pain provided by this embodiment and having a strong tendon and strengthening network function is specifically prepared by the following method steps:
  • the active ingredients in biological preparations are divided into 4 groups according to the nature of the materials and the convenience and manufacturability of preparation.
  • the first group macromolecular saccharide compounds, protein peptide compounds, specifically: collagen, collagen peptides, high, medium and low 3 different molecular weight hyaluronic acid or / and hyaluronic acid salt and high, medium and low 3 different molecular weights Polyglutamate or polyglutamate;
  • the second group amino acids, small molecule sugars, organic acid compounds, specifically: arginine, serine, glycine, glutamic acid, glutamine, alanine, proline, hydroxyproline, lysine Amino acid; glucose, trehalose, sucrose; tartaric acid, malic acid, citric acid, lactic acid, lactate, calcium gluconate;
  • vitamin coenzyme compounds specifically: vitamin VB1, vitamin VB2, nicotinamide, VB5, VB6, nicotinic acid, Vc, vitamin D, Ve; biotin, coenzyme Q10, coenzyme I, coenzyme II, VB12;
  • the fourth group includes materials other than solvents, including: ATP disodium, cytochrome C, allantoin, taurine, inositol, panax notoginsenosides / glycosides, potassium sorbate, sodium dehydroacetate, and cinnamic acid Potassium, glycyrrhizic acid, glycyrrhizinate, propionate; polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP);
  • PEG polyethylene glycol
  • PVP polyvinylpyrrolidone
  • step (1) The second group of materials weighed in step (1) is placed in a reaction kettle, and then a part of the formula amount of the solvent is added, stirred, dissolved, mixed, and left to stand to obtain mixture A after filtering and removing impurities;
  • step (1) Put the third group and the fourth group of materials weighed in step (1) into a reaction kettle, then add a part of the formula amount of the solvent, stir to dissolve and mix well, let it stand, filter and remove impurities to obtain mixture B;
  • the dissolving and mixing operation is performed at an operating temperature of about 25 ° C; at the same time, the operation is performed by using a homogeneous emulsification method under vacuum conditions, which can better ensure Mixing effect.
  • a refers to GB 16740-2014 National Food Safety Standard-Health Food Safety Standard
  • b refers to the new version of the "Cosmetic Safety Technical Specifications” (2015 edition) (2015 No. 268) issued by the State Food and Drug Administration.
  • Randomly selected 260 cases of volunteers with neck, shoulder, waist and leg pain were diagnosed, including 138 males and 122 females, aged 20-75 years.
  • the course of disease ranged from 1 day to 35 years, and the degree of neck, shoulder, waist and leg pain varied. It is also more diverse, with a variety of fatigue, rheumatism and coldness.
  • Usage Apply or spray an appropriate amount of this product to the neck, shoulder, waist, and leg on one or the left (limb) joints, and use the other side (limb) as a control. Massage gently for a while; Dosage: 0.5-2.0ml / times , 1-3 times / day, according to preference, you can increase or decrease the number of times and dosage, 7-14 days / treatment (continuous and continuous use), and evaluate the effect after 4 months of spraying.
  • the overall application effect shows that: for patients of different ages and different degrees of neck, shoulder, waist and leg pain, the biological preparation of the present invention is used for spray treatment, whether it is old cold legs, cervical pain, back pain or muscle stiffness, stiffness, stiffness, etc. Either lack of muscle strength, or new-onset neck, shoulder, waist, and leg pain have obvious treatment and relief effects; for new-onset mild pain or discomfort, the first spray can feel obvious relief and relief effects, even pain or discomfort Disappeared, and for many years of old injuries, redness, fever, itching, and rash on the epidermis, which are normal human body's dehumidification and detoxification reactions, will occur after spraying a few or more days.
  • Liu Male, 32 years old, manager of a company, in good health, using the product of the present invention, usage: apply or spray an appropriate amount of this product to the left and left side of the neck, shoulder, waist, and the other side (limb) as a control. Gently massage for a while; Dosage: 0.5-2ml / time, 1-3 times / day, continuous spraying for 4 months, in addition to the spray side, you can obviously feel the firmer tendon connection and muscles stronger, and the other side feels worse. Outside the spray side, there was no other abnormal sensation.
  • He Female, 20 years old, a company employee, in good health, using the product of the present invention, Usage: Apply or spray an appropriate amount of this product to the left and left side of the neck, shoulder and waist, and the other side (limb) as a control, light Gently massage for a while; dosage: 0.5-2ml / times, 1-3 times / day, continuous spraying for 4 months, it feels like using skin care products, except that the side of the spray can obviously feel tighter tendons and muscles, and muscles more powerful , The other side feels worse than the spray side, without any other abnormal feeling.
  • the biological preparation product for neck, shoulder, waist, and leg pain provided by this embodiment which has the function of strengthening muscles and strengthening the network, is prepared in the same manner as in Example 1. Only a part of the formula is adjusted as follows:
  • the total mass concentration of the active ingredients in the biological preparation is 0.5%, and the pH is adjusted to 3.5; the components in the active ingredients are calculated in terms of parts by mass, specifically:
  • the Huoxuetongluo agent is composed of notoginseng extract, notoginsenoside / glycoside and VB12, specifically: notoginseng extract 0.001, notoginseng total saponin / glycoside 0.001, VB12 1.0;
  • the joint bio-lubricant is composed of high, middle and low 3 different molecular weights of hyaluronic acid or hyaluronic acid salt and high, middle and low 3 different molecular weights of polyglutamic acid or polyglutamate, specifically In terms of: high molecular weight hyaluronic acid 0.001, medium molecular weight sodium hyaluronate 3.0, low molecular weight sodium hyaluronate 0.001; high molecular weight sodium polyglutamate 0.001, medium molecular weight polyglutamic acid 0.001, low molecular weight Sodium polyglutamate 0.001;
  • hyaluronic acid hyaluronic acid salt
  • polyglutamic acid polyglutamic acid
  • polyglutamic acid polyglutamic acid
  • the tendon muscle strengthening agent is composed of collagen, collagen peptide, glutamine, inositol, calcium phosphate and calcium gluconate, specifically: collagen 0.001, collagen peptide 0.001, glutamine 0.01, muscle Alcohol 0.01, calcium phosphate 0.01, calcium gluconate 4.0;
  • the cell physiological function conditioning agent is composed of ATP disodium, cytochrome C, trehalose, allantoin, taurine, vitamins and coenzymes, specifically: ATP disodium 0.01, cytochrome C 0.01, Trehalose 0.01, allantoin 0.01, taurine 0.01; vitamin VB1 0.01, vitamin VB2 0.001, nicotinamide 0.01, VB5 0.01, VB60.01, nicotinic acid 0.01, Vc 0.01, vitamin D 0.001, Ve 0.001; biotin 0.001 Coenzyme Q10 0.001, Coenzyme I 0.001, Coenzyme II 0.001;
  • the essential agent for normal cell growth and metabolism is composed of amino acids, sugars, and organic acids, specifically: arginine 0.001, serine 0.001, glycine 0.001, glutamic acid 0.001, alanine 0.001, and proline 0.001 , Hydroxyproline 0.001, lysine 0.001, sodium glutamate 0.001; glucose 0.001, sucrose 0.001; tartaric acid 0.01, malic acid 0.01, citric acid 0.01, lactic acid 0.01, sodium lactate 0.01, calcium lactate 0.01;
  • the preservative is composed of potassium sorbate, sodium dehydroacetate, potassium cinnamate, glycyrrhizic acid, glycyrrhizinate and propionate, specifically: potassium sorbate 0.01, sodium dehydroacetate 0.01, potassium cinnamate 0.01 , Glycyrrhizin 0.01, Potassium Glycyrrhizin 0.01, Sodium Glycyrrhizin 0.01, Sodium Propionate 0.01, Calcium Propionate 0.01;
  • the acceptable safe carrier of the preparation is composed of polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP), specifically: polyethylene glycol 400 0.0001, polyethylene glycol 4000 0.001, polyethylene glycol 10000 0.0001, polyethylene glycol 20000, 0.001, PVP K15 0.0001, PVP K30 0.0001, PVP K60 0.001, and PVP K90 0.0001.
  • PEG polyethylene glycol
  • PVP polyvinylpyrrolidone
  • the biological preparation product for neck, shoulder, waist, and leg pain provided by this embodiment which has the function of strengthening muscles and strengthening the network, is prepared in the same manner as in Example 1. Only a part of the formula is adjusted as follows:
  • the total mass concentration of the active ingredients in the biological preparation is 38.0%, and the pH is adjusted to 6.5 to make a gelling agent.
  • the ingredients of the active ingredients are measured in parts by mass, specifically:
  • the Huoxuetongluo agent is composed of notoginseng extract, notoginsenoside / glycoside and VB12, specifically: notoginseng extract 10.0, notoginseng total saponin / glycoside 2.0, and VB12 10.0;
  • the joint bio-lubricant is composed of high, middle and low 3 different molecular weights of hyaluronic acid or hyaluronic acid salt and high, middle and low 3 different molecular weights of polyglutamic acid or polyglutamate, specifically In terms of: high molecular weight sodium hyaluronate 5.0, medium molecular weight sodium hyaluronate 8.0, low molecular weight sodium hyaluronate 10.0; high molecular weight sodium polyglutamate 4.0, medium molecular weight polyglutamic acid 6.0, low Molecular weight of sodium polyglutamate 12.0;
  • hyaluronic acid hyaluronic acid salt
  • polyglutamic acid polyglutamic acid
  • polyglutamic acid polyglutamic acid
  • the tendon muscle strengthening agent is composed of collagen, collagen peptide, glutamine, inositol, calcium phosphate and calcium gluconate, specifically: collagen 10.0, collagen peptide 12.0, glutamine 8.0, muscle Alcohol 6.0, calcium phosphate 5.0, calcium gluconate 0.01;
  • the cell physiological function conditioning agent is composed of ATP disodium, cytochrome C, trehalose, allantoin, taurine, vitamins and coenzymes, specifically: ATP disodium 5.0, cytochrome C 5.0, Trehalose 9.0, allantoin 2.0, taurine 5.0; vitamin VB1 6.0, vitamin VB2 1.0, nicotinamide 10.0, VB5 6.0, VB6 6.0, nicotinic acid 5.0, Vc 5.0, vitamin D 1.0, Ve 1.0; biotin 1.0, Coenzyme Q10 1.0, Coenzyme I 2.0, Coenzyme II 2.0;
  • the essential agent for normal cell growth and metabolism is composed of amino acids, sugars, and organic acids, specifically: arginine 5.0, serine 5.0, glycine 9.0, glutamic acid 1.0, alanine 6.0, and proline 12.0 , Hydroxyproline 4.0, lysine 12.0, sodium glutamate 3.0; glucose 6.0, sucrose 6.0; tartaric acid 5.0, malic acid 5.0, citric acid 5.0, lactic acid 5.0, sodium lactate 4.0, calcium lactate 1.0;
  • the preservative is composed of potassium sorbate, sodium dehydroacetate, potassium cinnamate, glycyrrhizic acid, glycyrrhizinate and propionate, specifically: potassium sorbate 2.0, sodium dehydroacetate 2.0, potassium cinnamate 2.0 , Glycyrrhizic acid 1.0, Glycyrrhizin potassium salt 2.90, Sodium glycyrrhizin 0.01, Sodium propionate 2.0, Calcium propionate 0.01;
  • the acceptable safe carrier or auxiliary material of the preparation is composed of polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP), specifically: polyethylene glycol 400 0.2, polyethylene glycol 4000 11.0, polyethylene glycol Alcohol 10,000 0.3, polyethylene glycol 20000 0.5, PVP K15 0.3, PVP K30 0.2, PVP K60 0.5 and PVP K90.
  • PEG polyethylene glycol
  • PVP polyvinylpyrrolidone
  • the biological preparation product for neck, shoulder, waist, and leg pain provided by this embodiment which has the function of strengthening muscles and strengthening the network, is prepared in the same manner as in Example 1. Only a part of the formula is adjusted as follows:
  • the total mass concentration of the active ingredient in the biological preparation is 3.0%, and the pH is adjusted to 4.5 to make a spray; the components in the active ingredient are measured in parts by mass, specifically:
  • the Huoxuetongluo agent is composed of Sanqi extract, specifically: Sanqi extract 2.0;
  • the joint biological lubricant is high molecular weight hyaluronate and low molecular weight polyglutamate, specifically: high molecular weight sodium hyaluronate 0.01 and low molecular weight sodium polyglutamate 1.0;
  • hyaluronic acid hyaluronic acid salt
  • polyglutamic acid polyglutamic acid
  • polyglutamic acid polyglutamic acid
  • the tendon muscle strengthening agent is composed of a collagen peptide, specifically: collagen 2.0;
  • the cell physiological function conditioning agent is composed of trehalose, taurine and vitamins, specifically: trehalose 2.0, taurine 0.5; vitamin VB1 1.0, vitamin VB2 0.05, nicotinamide 0.5, VB5 0.5, VB6 0.5;
  • the essential agent for normal growth and metabolism of the cell is composed of amino acids, sugars, and organic acids, specifically: glycine 2.0, proline 3.0, and hydroxyproline 0.5;
  • the preservative is composed of potassium sorbate, specifically: potassium sorbate 0.2;
  • the acceptable safe carrier or auxiliary material of the preparation is composed of polyethylene glycol (PEG), specifically: polyethylene glycol 4000 and 3.0.
  • the biological preparation product for neck, shoulder, waist, and leg pain provided by this embodiment which has the function of strengthening muscles and strengthening the network, is prepared in the same manner as in Example 1. Only a part of the formula is adjusted as follows:
  • the total mass concentration of the active ingredient in the biological preparation is 16.0%, and the pH is adjusted to 5.5 to make a dew condensation agent; each ingredient in the active ingredient is measured in parts by mass, specifically:
  • the Huoxuetongluo agent consists of Sanqi extract and VB12, specifically: Sanqi extract 4.0, VB12 4.0;
  • the joint bio-lubricant is composed of three kinds of high molecular weight hyaluronic acid or / and hyaluronic acid salt, specifically: high molecular weight hyaluronic acid 2.0, medium molecular weight sodium hyaluronate 3.0, low Molecular weight of sodium hyaluronate 4.0;
  • hyaluronic acid hyaluronic acid salt
  • polyglutamic acid polyglutamic acid
  • polyglutamic acid polyglutamic acid
  • the tendon muscle strengthening agent is composed of collagen, collagen peptide, glutamine, inositol, calcium phosphate and calcium gluconate, specifically: collagen 4.0, collagen peptide 6.0, glutamine 3.0, muscle Alcohol 1.0, calcium phosphate 1.0, calcium gluconate 1.0;
  • the cell physiological function conditioning agent is composed of trehalose, allantoin, taurine, vitamins and coenzymes, specifically: trehalose 4.0, allantoin 0.5, taurine 1.0; vitamin VB1 2.0, Vitamins VB2 0.1, Nicotinamide 3.0, VB5 1.0, VB6 1.0, Niacin 0.6, Vc 1.0, Vitamin D 0.1, Ve 0.1; Biotin 0.1, Coenzyme Q10 0.1, Coenzyme I 0.1, Coenzyme II 0.1;
  • the essential agent for normal cell growth and metabolism is composed of amino acids, sugars, and organic acids, specifically: arginine 2.0, serine 2.0, glycine 4.0, glutamic acid 0.1, alanine 2.0, and proline 6.0 , Hydroxyproline 1.0, lysine 6.0, sodium glutamate 0.7; glucose 2.0, sucrose 2.0; tartaric acid 2.0, malic acid 2.0, citric acid 2.0, lactic acid 2.0, sodium lactate 2.0, calcium lactate 2.0;
  • the preservative is composed of potassium sorbate, sodium dehydroacetate, potassium cinnamate, glycyrrhizic acid, glycyrrhizinate and propionate, specifically: potassium sorbate 0.5, sodium dehydroacetate 0.5, potassium cinnamate 0.5 Glycyrrhizin 0.5, potassium glycyrrhizin 0.5, sodium glycyrrhizin 0.5, sodium propionate 0.5, calcium propionate 0.5;
  • the acceptable safe carrier of the preparation is composed of polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP), specifically: polyethylene glycol 20,000 6.0 and PVP K90 4.0.
  • the biological preparation product for neck, shoulder, waist, and leg pain provided by this embodiment which has the function of strengthening muscles and strengthening the network, is prepared in the same manner as in Example 1. Only a part of the formula is adjusted as follows:
  • the total mass concentration of the active ingredient in the biological preparation is 22.0%, and the pH is adjusted to 4.0 to make a gelling agent.
  • Each ingredient in the active ingredient is measured in parts by mass, specifically:
  • the Huoxuetongluo agent is composed of notoginseng extract, notoginseng saponin / glycoside and VB12, specifically: notoginseng extract 6.0, notoginseng total saponin / glycoside 1.2, VB12 6.0;
  • the joint bio-lubricant is composed of high, middle and low 3 different molecular weights of hyaluronic acid or hyaluronic acid salt and high, middle and low 3 different molecular weights of polyglutamic acid or polyglutamate, specifically In terms of: high molecular weight hyaluronic acid 3.0, medium molecular weight sodium hyaluronate 5.0, low molecular weight sodium hyaluronate 6.0; high molecular weight sodium polyglutamate 2.0, medium molecular weight polyglutamic acid 3.0, low molecular weight Sodium polyglutamate 6.0;
  • hyaluronic acid hyaluronic acid salt
  • polyglutamic acid polyglutamic acid
  • polyglutamic acid polyglutamic acid
  • the tendon muscle strengthening agent is composed of collagen, collagen peptide, glutamine, inositol, calcium phosphate and calcium gluconate, specifically: collagen 6.0, collagen peptide 9.0, glutamine 5.0, muscle Alcohol 3.0, calcium phosphate 2.0, calcium gluconate 2.0;
  • the cell physiological function conditioning agent is composed of ATP disodium, trehalose, allantoin, taurine, vitamins and coenzymes, specifically: ATP disodium 2.0, trehalose 6.0, allantoin 0.8, Taurine 2.0; Vitamin VB1 3.0, Vitamin VB2 0.4, Nicotinamide 6.0, VB5 3.0, VB6 3.0, Niacin 0.8, Vc 3.0, Vitamin D 0.4, Ve 0.5; Biotin 0.5, Coenzyme Q10 0.5, Coenzyme I 0.5, Coenzyme II 0.5;
  • the essential agent for normal cell growth and metabolism is composed of amino acids, sugars, and organic acids, specifically: arginine 3.0, serine 3.0, glycine 6.0, glutamic acid 0.5, alanine 3.0, and proline 9.0 , Hydroxyproline 2.0, lysine 9.0, sodium glutamate 1.0; glucose 3.0, sucrose 3.0; tartaric acid 3.0, malic acid 3.0, citric acid 3.0, lactic acid 3.0, sodium lactate 0.1, calcium lactate 4.9;
  • the preservative is composed of potassium sorbate, sodium dehydroacetate, potassium cinnamate, glycyrrhizic acid, glycyrrhizinate and propionate, specifically: potassium sorbate 1.0, sodium dehydroacetate 1.0, potassium cinnamate 1.0 Glycyrrhizin 1.0, potassium glycyrrhizin 1.0, sodium glycyrrhizin 1.0, sodium propionate 1.0, calcium propionate 1.0;
  • the acceptable safe carrier or auxiliary material of the preparation is composed of polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP), specifically: polyethylene glycol 4000 4.0, polyethylene glycol 10000 2.0, polyethylene glycol Alcohol 20,000 6.0, PVP K30 2.0, PVP K60 2.0, and PVP K90 6.0.
  • PEG polyethylene glycol
  • PVP polyvinylpyrrolidone
  • the biological preparation product for neck, shoulder, waist, and leg pain provided by this embodiment which has the function of strengthening muscles and strengthening the network, is prepared in the same manner as in Example 1. Only a part of the formula is adjusted as follows:
  • the total mass concentration of the active ingredient in the biological preparation is 32.0%, and the pH is adjusted to 6.0 to make a gelling agent.
  • Each ingredient in the active ingredient is measured in parts by mass, specifically:
  • the Huoxuetongluo agent is composed of notoginseng extract, notoginsenoside / glycoside and VB12, specifically: notoginseng extract 8.0, notoginseng total saponin / glycoside 1.6, VB12 8.0;
  • the joint bio-lubricant is composed of high, middle and low 3 different molecular weights of hyaluronic acid or hyaluronic acid salt and high, middle and low 3 different molecular weights of polyglutamic acid or polyglutamate, specifically In terms of: high molecular weight hyaluronic acid 4.0, medium molecular weight sodium hyaluronate 7.0, low molecular weight sodium hyaluronate 8.0; high molecular weight sodium polyglutamate 3.0, medium molecular weight polyglutamic acid 5.0, low molecular weight Sodium polyglutamate 9.0;
  • hyaluronic acid hyaluronic acid salt
  • polyglutamic acid polyglutamic acid
  • polyglutamic acid polyglutamic acid
  • the tendon muscle strengthening agent is composed of collagen, collagen peptide, glutamine, inositol, calcium phosphate and calcium gluconate, specifically: collagen 8.0, collagen peptide 11.0, glutamine 7.0, muscle Alcohol 5.0, calcium phosphate 4.0, calcium gluconate 3.0;
  • the cell physiological function conditioning agent is composed of ATP disodium, cytochrome C, trehalose, allantoin, taurine, vitamins and coenzymes, specifically: ATP disodium 4.0, cytochrome C 4.0, Trehalose 8.0, Allantoin 1.6, Taurine 4.0; Vitamin VB1 5.0, Vitamin VB2 0.8, Nicotinamide 8.0, VB5 5.0, VB6 5.0, Niacin 4.0, Vc 4.0, Vitamin D 0.8, Ve 0.8; Biotin 0.8, Coenzyme Q10 0.8, Coenzyme I 0.8, Coenzyme II 0.8
  • the essential agent for normal cell growth and metabolism is composed of amino acids, sugars, and organic acids, specifically: arginine 4.0, serine 4.0, glycine 8.0, glutamic acid 0.9, alanine 5.0, and proline 11.0 , Hydroxyproline 3.0, lysine 11.0, sodium glutamate 2.0; glucose 5.0, sucrose 5.0; tartaric acid 4.0, malic acid 4.0, citric acid 4.0, lactic acid 4.0, sodium lactate 4.9, calcium lactate 0.1;
  • the preservative is composed of potassium sorbate, sodium dehydroacetate, potassium cinnamate, glycyrrhizic acid, glycyrrhizinate and propionate, specifically: potassium sorbate 1.7, sodium dehydroacetate 1.7, potassium cinnamate 1.7 Glycyrrhizic acid 1.6, potassium glycyrrhizinate 1.8, sodium glycyrrhizin 1.2, sodium propionate 1.8, calcium propionate 0.2;
  • the acceptable safe carrier or auxiliary material of the preparation is composed of polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP), specifically: polyethylene glycol 4000 11.0, polyethylene glycol 10000 1.0, PVP K60 And PVP K90 2.0.
  • PEG polyethylene glycol
  • PVP polyvinylpyrrolidone
  • Example 1 With reference to the test and evaluation method of Example 1, 280 volunteers aged 20-75 years with a course of disease ranging from 1 day to 35 years and varying degrees of neck, shoulder, waist, and leg pain were randomly selected. Seven groups were set up, each group Forty volunteers applied the biologic preparations for neck, shoulder, waist, and leg pain, which have the function of strengthening muscles and strengthening the network, to spray experiments.
  • the biological agent prepared in Example 4 had the worst effect, with a total effective rate of 57.5% (P ⁇ 0.05); the others were:
  • Example 2 The total effective rate of Example 2 was 62.5% (P ⁇ 0.05); the total effective rate of Example 3 was 95.0% (P ⁇ 0.05);
  • Example 5 The total effective rate of Example 5 was 72.5% (P ⁇ 0.05); the total effective rate of Example 6 was 80.0% (P ⁇ 0.05);
  • Example 7 The total effective rate of Example 7 was 87.5% (P ⁇ 0.05).
  • the biological preparation product for neck, shoulder, waist, and leg pain provided by this embodiment which has the function of strengthening muscles and strengthening the network, is prepared in the same manner as in Example 1. Only a part of the formula is adjusted as follows:
  • the total mass concentration of the active ingredient in the biological preparation is 6.0%, and the pH is adjusted to 5.0 to make a dew condensation agent.
  • Each ingredient in the active ingredient is measured in parts by mass, specifically:
  • the Huoxuetongluo agent is composed of notoginseng extract, notoginseng saponin / glycoside and VB12, specifically: notoginseng extract 3.0, notoginseng total saponin / glycoside 0.7, VB12 3.0;
  • the joint bio-lubricant is composed of high, middle and low 3 different molecular weights of hyaluronic acid or hyaluronic acid salt and high, middle and low 3 different molecular weights of polyglutamic acid or polyglutamate, specifically In terms of: high molecular weight sodium hyaluronate 2.0, medium molecular weight sodium hyaluronate 2.0, low molecular weight sodium hyaluronate 3.0; high molecular weight sodium polyglutamate 1.0, medium molecular weight polyglutamic acid 3.0, low Molecular weight of sodium polyglutamate 4.0;
  • hyaluronic acid hyaluronic acid salt
  • polyglutamic acid polyglutamic acid
  • polyglutamic acid polyglutamic acid
  • the tendon muscle strengthening agent is composed of collagen, collagen peptide, glutamine, inositol, calcium phosphate and calcium gluconate, specifically: collagen 3.0, collagen peptide 4.0, glutamine 2.0, muscle Alcohol 2.0, calcium phosphate 2.0, calcium gluconate 1.0;
  • the cell physiological function conditioning agent is composed of ATP disodium, cytochrome C, trehalose, allantoin, taurine, vitamins and coenzymes, specifically: ATP disodium 2.0, cytochrome C 2.0, Trehalose 3.0, allantoin 0.7, taurine 0.8; vitamin VB1 2.0, vitamin VB2 0.3, nicotinamide 3.0, VB5 2.0, VB6 2.0, nicotinic acid 2.0, Vc 2.0, vitamin D 0.3, Ve 0.3; biotin 0.3, Coenzyme Q10 0.3, Coenzyme I 0.7, Coenzyme II 0.7
  • the essential agent for normal cell growth and metabolism is composed of amino acids, sugars, and organic acids, specifically: arginine 2.0, serine 2.0, glycine 3.0, glutamic acid 0.3, alanine 2.0, and proline 4.0 , Hydroxyproline 1.0, lysine 4.0, sodium glutamate 1.0; glucose 2.0, sucrose 2.0; tartaric acid 2.0, malic acid 2.0, citric acid 2.0, lactic acid 2.0, sodium lactate 2.0, calcium lactate 2.0;
  • the preservative is composed of potassium sorbate, sodium dehydroacetate, potassium cinnamate, glycyrrhizic acid, glycyrrhizinate and propionate, specifically: potassium sorbate 0.3, sodium dehydroacetate 0.3, potassium cinnamate 0.3 , Glycyrrhizic acid 0.3, potassium glycyrrhizin 0.3, sodium glycyrrhizin 0.3, sodium propionate 0.3, calcium propionate 0.3;
  • the acceptable safe carrier or auxiliary material of the preparation is composed of polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP), specifically: polyethylene glycol 400 4.0, polyethylene glycol 4000 2.0, polyethylene glycol Alcohol 10,000 4.0, polyethylene glycol 20000 2.0, PVP K15 3.0, PVP K30 3.0, PVP K60 3.0 and PVP K90 1.0.
  • PEG polyethylene glycol
  • PVP polyvinylpyrrolidone
  • the biological preparation product for neck, shoulder, waist, and leg pain provided by this embodiment which has the function of strengthening muscles and strengthening the network, is prepared in the same manner as in Example 1. Only a part of the formula is adjusted as follows:
  • the total mass concentration of the active ingredient in the biological preparation is 6.0%, and the pH is adjusted to 5.0 to make a dew condensation agent.
  • Each ingredient in the active ingredient is measured in parts by mass, specifically:
  • the Huoxuetongluo agent is composed of notoginseng extract, notoginseng saponin / glycoside and VB12, specifically: notoginseng extract 7.0, notoginseng total saponin / glycoside 1.4, VB12 7.0;
  • the joint bio-lubricant is composed of high, middle and low 3 different molecular weights of hyaluronic acid or hyaluronic acid salt and high, middle and low 3 different molecular weights of polyglutamic acid or polyglutamate, specifically In terms of: high molecular weight sodium hyaluronate 4.0, medium molecular weight sodium hyaluronate 6.0, low molecular weight sodium hyaluronate 7.0; high molecular weight sodium polyglutamate 3.0, medium molecular weight polyglutamic acid 5.0, low Molecular weight of sodium polyglutamate 8.0;
  • hyaluronic acid hyaluronic acid salt
  • polyglutamic acid polyglutamic acid
  • polyglutamic acid polyglutamic acid
  • the tendon muscle strengthening agent is composed of collagen, collagen peptide, glutamine, inositol, calcium phosphate and calcium gluconate, specifically: collagen 7.0, collagen peptide 8.0, glutamine 6.0, muscle Alcohol 4.0, calcium phosphate 3.0, calcium gluconate 0.01;
  • the cell physiological function conditioning agent is composed of ATP disodium, cytochrome C, trehalose, allantoin, taurine, vitamins and coenzymes, specifically: ATP disodium 4.0, cytochrome C 4.0, Trehalose 7.0, allantoin 1.6, taurine 4.0; vitamin VB1 4.0, vitamin VB2 0.6, nicotinamide 7.0, VB5 4.0, VB6 4.0, nicotinic acid 4.0, Vc 4.0, vitamin D 0.7, Ve 0.7; biotin 0.7, Coenzyme Q10 0.7, Coenzyme I 1.5, Coenzyme II 1.5
  • the essential agent for normal cell growth and metabolism is composed of amino acids, sugars, and organic acids, specifically: arginine 4.0, serine 4.0, glycine 7.0, glutamic acid 0.8, alanine 4.0, and proline 8.0 , Hydroxyproline 3.0, lysine 8.0, sodium glutamate 2.0; glucose 4.0, sucrose 4.0; tartaric acid 4.0, malic acid 4.0, citric acid 4.0, lactic acid 4.0, sodium lactate 4.0, calcium lactate 1.0;
  • the preservative is composed of potassium sorbate, sodium dehydroacetate, potassium cinnamate, glycyrrhizic acid, glycyrrhizinate and propionate, specifically: potassium sorbate 0.6, sodium dehydroacetate 0.6, potassium cinnamate 0.6 , Glycyrrhizic acid 0.6, potassium glycyrrhizinate 0.6, sodium glycyrrhizin 0.6, sodium propionate 0.6, calcium propionate 0.6;
  • the acceptable safe carrier or auxiliary material of the preparation is composed of polyethylene glycol (PEG) and polyvinylpyrrolidone (PVP), specifically: polyethylene glycol 400, 8.0, polyethylene glycol 4000, 1.0, polyethylene glycol Alcohol 10,000 1.0, polyethylene glycol 20000 2.0, PVP K15 1.0, PVP K30 5.0, PVP K60 1.0 and PVP K90 2.0.
  • PEG polyethylene glycol
  • PVP polyvinylpyrrolidone
  • Example 1 120 volunteers aged 20-75 years with a course of 1-35 years and varying degrees of neck, shoulder, waist, and leg pain were randomly selected. Two groups were set up, each group was 60 Example volunteers applied the biologic preparations for neck, shoulder, waist, and leg pain and strong tendon and collateral function prepared in Examples 8 and 9, respectively, for spraying experiments.
  • Example 9 has the best effect, with a total effective rate of 96.7% (P ⁇ 0.05).
  • the biological preparation prepared in Example 8 has a weaker effect than Example 9, with a total effective rate of 88.3% (P ⁇ 0.05).
  • the product of the invention not only has good curative effect, quick effect, and cures both the symptoms and the symptoms, but also can be used anytime and anywhere and can be used for a long time. Unlike traditional medicines, there are multiple toxic side effects and limiting factors, and they should not be used for a long time, and require the guidance of professional medical personnel.
  • the preparation of the present invention not only has the effect of treating neck, shoulder, waist, and leg pain, but also can relieve the discomfort such as stiffness, stiffness, or pain of neck, shoulder, and waist and leg muscles caused by cold, dampness, or muscle or bone strain or overwork. Relief effect, at the same time, it also has the effects of conditioning, healing and activating the whole body neuromuscular cell function and the micro blood circulation system, healing old injuries such as sprains and sprains many years ago. Therefore, the preparation of the present invention can not only treat patients with neck, shoulder, waist, and leg pain, but also can be used as a daily health care product for ordinary people to strengthen the muscles, strengthen the body, and keep fit.

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Abstract

一种颈肩腰腿痛用并能强筋健络的生物制剂，包括活血通络剂、关节生物润滑剂、筋腱肌肉强健剂、细胞生理功能调理剂和细胞正常生长代谢必需剂；活血通络剂包括三七提取物、三七总皂甙/苷、VB12；关节生物润滑剂包括透明质酸或/和透明质酸盐、聚谷氨酸或/和聚谷氨酸盐；筋腱肌肉强健剂包括胶原蛋白、胶原蛋白肽、谷氨酰胺、肌醇、磷酸钙和葡萄糖酸钙；细胞生理功能调理剂包括ATP二钠、细胞色素C、海藻糖、尿囊素、牛磺酸、维生素类和辅酶类物质；细胞正常生长代谢必需剂包括氨基酸类、糖类、有机酸类物质。

Description

一种颈肩腰腿痛用并具强筋健络功能的生物制剂 技术领域
本发明属于疼痛科学与生物医药保健品技术领域，具体涉及一种颈肩腰腿痛用并具强筋健络功能的生物制剂产品专利申请事宜。
背景技术
随着社会生活发展，颈肩腰腿痛已成为一种常见病和多发病。尤其是，随着人们年龄的增长和老龄化社会的到来，身体生理和神经肌肉机能及代谢能力的降低，颈肩腰腿痛或难以名状的肌肉或关节无名慢性疼痛或酸困或僵硬或痉挛等不适症状已波及到几乎所有老年人。由于信息化和网络化时代的到来，不少年轻人也都为颈肩腰腿痛与“鼠标手”所困。
颈肩腰腿痛大多是因慢性劳损或运动用力不当或受凉寒湿及无菌性炎症引起的以病患部位疼痛、肿胀甚至功能受限为主的一大类常见病和多发病，包括：颈椎病，肩周炎，腱鞘炎，腰间盘突出，腰肌劳损，骨质增生等知因或不知因疾病，常见表现为无表皮破损的急慢性脖子痛、肩膀痛、胳膊痛、手腕痛、腰痛、腿痛、关节痛、肌肉痛、神经痛、或身体肌肉酸困或僵硬等不适症状。一般来说颈肩腰腿痛主要分为以下3类：(一)软组织急性损伤：软组织受到外力的突然攻击、重力压迫及超过软组织生理范围的牵拉、扭转而产生的损伤。(二)软组织慢性损伤：生活习惯或职业性体位等原因引起，如：长期低头伏案、久坐、长时间弯腰及睡眠姿势不当或使用高枕等，使部分软组织长时间处于牵拉状态，被牵拉组织内的血管长期处于半通畅而引起组织细胞缺氧，使血管的通透性发生变化，血细胞渗出、组织变性、纤维间质增多，软组织发生病变从而引起颈肩腰腿痛症状。(三)风寒湿伤痛：风寒湿可降低机体对疼痛的耐受力，使肌肉痉挛、小血管收缩、淋巴回流减慢、软组织血液循环发生障碍，产生无菌性炎症，从而产生颈肩腰腿痛。发病时筋骨、关节、肌肉等部位都会出现疼痛、肿胀、麻木、强直，严重者可引起瘫痪，生活不能自理，甚则威胁生命。
1965年出现的“疼痛闸门控制学说——疼痛神经控制理论”和中医学的“通痛理论”为人类防治疼痛做出了不可磨灭的贡献。目前国内外对付疼痛的措施或方法有多种，但都是针对有确切病因的急性疼痛效果较好。临床所用方法中，药物祛痛最常用，除此之外，推拿、按摩、热疗、针灸和电疗等物理疗法也可缓解疼痛或身体不适症状，另外，还有止痛性外科手术疗法但这要以身体受到永久性伤害为代价。药物治疗中，既有西药也有中药，既有外用也有内用，但主要还是西药和内用。常用的西药止痛药主要有非甾体抗炎药和中枢性止痛药两类。常见的非甾体止痛药有阿司匹林、布洛芬、消炎痛、扑热息痛等；中枢性止痛 药有哌替啶、麻醉性吗啡、杜冷丁等；抗焦虑类止痛药如安定等。另外，还有解痉止痛药如阿托品、普鲁本辛、颠茄片、山莨菪碱等。常用的中药有以具舒筋活血、通络化瘀特性的中草药为原料制成的药丸、药酒等。另外，尚有含有中或/和西药成分的膏药类贴剂和喷剂等外用制剂。上述诸法，外科手术疗法伤害性大，物理疗法效果有限，西医药虽然疗效好但毒副作用大，如易上瘾，可引起慢性间质性肾炎、肾乳头坏死、肾功能不全；刺激胃粘膜，引起严重胃肠反应，诱发胃溃疡，甚至胃出血及穿孔；肝损害；过敏反应；出现中枢神经系统症状，如头痛、眩晕等；易出现药物耐受性，只适合于短期使用等问题。中医药疗法用于治疗颈肩腰腿痛虽有一定疗效，但它是以舒筋活络、活血化瘀为优点，缺乏细胞所需营养的后继补充，难以从根本上解决问题，而且，与西药一样，也会出现多种多样的毒副作用。另一方面，膏药类贴剂和喷剂等外用类制剂效果有限不说，也大多存在易过敏、使用不便等缺陷。
总之，随着科技的进步和人们生活水平的提高以及保健意识的增强，针对颈肩腰腿痛这一顽疾，无论是基于治疗目的、还是基于保健目的，都有必要开发新的、应用便捷、疗效更好、使用安全的新产品，以不断提升人们的生活质量。
发明内容
本申请目的在于提供一种颈肩腰腿痛用并具强筋健络功能的生物制剂产品，该产品针对对多种原因或无名原因引起的腰背、肩颈四肢、关节及全身肌肉疼痛或无名疼痛有显著疗效，对因受寒受潮或筋骨劳损或劳累过度而引起的颈肩腰腿肌肉酸困僵硬或疼痛等不适症状亦有明显修复或康复作用，喷涂于正常健康人的颈肩腰腿关节处也具有一定的保健作用。
本申请所采取的技术方案详述如下。
一种颈肩腰腿痛用并具强筋健络功能的生物制剂，该生物制剂包括活血通络剂、关节生物润滑剂、筋腱肌肉强健剂、细胞生理功能调理剂和细胞正常生长代谢必需剂，优选情况下，该生物制剂还包括防腐剂；进一步优选情况下，该生物制剂还包括本制剂可接受的安全载体和/或辅料；
所述活血通络剂，包括但不限于三七提取物、三七总皂甙/苷、VB12，可选择其中一种或几种任意比例混合物；
所述关节生物润滑剂，包括但不限于透明质酸或/和透明质酸盐、聚谷氨酸或/和聚谷氨酸盐，可选择其中一种或几种任意比例混合物；
所述筋腱肌肉强健剂，包括但不限于胶原蛋白、胶原蛋白肽、谷氨酰胺、肌醇、磷酸钙和葡萄糖酸钙，可选择其中一种或几种任意比例混合物；
所述细胞生理功能调理剂，包括但不限于ATP二钠、细胞色素C、海藻糖、尿囊素、牛磺酸、维生素类和辅酶类物质，可选择其中一种或几种任意比例混合物；
所述细胞正常生长代谢必需剂，包括但不限于氨基酸类、糖类、有机酸类物质，可选择其中一种或几种任意比例混合物；
所述防腐剂，应为食品级防腐剂，包括但不限于山梨酸钾、脱氢乙酸钠、肉桂酸钾、甘草酸、甘草酸盐、丙酸盐，可选择其中一种或几种任意比例混合物；
所述本制剂可接受的安全载体或辅料，包括但不限于不同分子量大小的聚乙二醇(PEG)、不同分子量大小的聚乙烯吡咯烷酮(PVP)，可选择其中一种或几种任意比例混合物；
所述不同分子量大小的聚乙二醇是指食品级以上的分子量为400-20000道尔顿的聚乙二醇；所述不同分子量大小的PVP包括但不限于药品级以上的PVP K15、PVP K30、PVP K60和PVP K90，可选择其中一种或几种任意比例混合物。
所述颈肩腰腿痛用并具强筋健络功能的生物制剂中有效成份的总质量浓度为0.5-38.0％；有效成份中各成份以质量份数计，具体为：
所述活血通络剂，由三七提取物、三七总皂甙/苷和VB12构成，具体而言：三七提取物0.001-10.0、三七总皂甙/苷0.001-2.0、VB12 0.001-10.0；
所述关节生物润滑剂，由高中低3种不同分子量大小的透明质酸或/和透明质酸盐和高中低3种不同分子量大小的聚谷氨酸或/和聚谷氨酸盐构成，具体而言：高分子量的透明质酸或/和透明质酸盐0.001-5.0、中分子量的透明质酸或/和透明质酸盐0.001-8.0、低分子量的透明质酸或/和透明质酸盐0.001-10.0；高分子量的聚谷氨酸或/和聚谷氨酸盐0.001-4.0、中分子量的聚谷氨酸或/和聚谷氨酸盐0.001-6.0、低分子量的聚谷氨酸或/和聚谷氨酸盐0.001-12.0；
所述高分子量透明质酸、高分子量透明质酸盐指分子量大于240万(2400000)道尔顿；
所述中分子量透明质酸、中分子量透明质酸盐指分子量大于100万(1000000)，但不超过180万(1800000)道尔顿；
所述低分子量透明质酸、低分子量透明质酸盐指分子量不大于40万(400000)道尔顿；
所述高分子量聚谷氨酸、高分子量聚谷氨酸盐指分子量大于140万(1400000)道尔顿；
所述中分子量聚谷氨酸、中分子量聚谷氨酸盐指分子量大于60万(600000)，但不超过120万(1200000)道尔顿；
所述低分子量聚谷氨酸、低分子量聚谷氨酸盐指分子量不大于30万(300000)道尔顿；
所述筋腱肌肉强健剂，由胶原蛋白、胶原蛋白肽、谷氨酰胺、肌醇、磷酸钙和葡萄糖酸钙构成，具体而言：胶原蛋白0.001-10.0、胶原蛋白肽0.001-12.0、谷氨酰胺0.01-8.0、肌醇 0.01-6.0、磷酸钙0.01-5.0、葡萄糖酸钙0.01-4.0；
所述细胞生理功能调理剂，由ATP二钠、细胞色素C、海藻糖、尿囊素、牛磺酸、维生素类和辅酶类物质构成，具体而言：ATP二钠0.01-5.0、细胞色素C 0.001-5.0、海藻糖0.01-9.0、尿囊素0.001-2.0、牛磺酸0.01-5.0；
维生素VB1 0.01-6.0、维生素VB2 0.001-1.0、烟酰胺0.01-10.0、VB5 0.01-6.0、VB6 0.01-6.0、烟酸0.01-5.0、Vc 0.01-5.0、维生素D 0.001-1.0、Ve 0.001-1.0；
生物素0.001-1.0、辅酶Q10 0.001-1.0、辅酶I 0.001-2.0、辅酶II 0.001-2.0；
所述细胞正常生长代谢必需剂，由氨基酸类、糖类、有机酸类物质构成，具体而言：精氨酸0.001-5.0、丝氨酸0.001-5.0、甘氨酸0.001-9.0、谷氨酸0.001-1.0、丙氨酸0.001-6.0、脯氨酸0.001-12.0、羟脯氨酸0.001-4.0、赖氨酸0.001-12.0、谷氨酸钠0.01-3.0；葡萄糖0.001-6.0、蔗糖0.001-6.0；酒石酸0.01-5.0、苹果酸0.01-5.0、柠檬酸0.01-5.0、乳酸0.01-5.0、乳酸盐0.01-5.0；
所述防腐剂，由山梨酸钾、脱氢乙酸钠、肉桂酸钾、甘草酸、甘草酸盐和丙酸盐构成，具体而言：山梨酸钾0.01-2.0、脱氢乙酸钠0.01-2.0、肉桂酸钾0.01-2.0、甘草酸0.01-1.0、甘草酸盐0.01-3.0、丙酸盐0.01-2.0；
所述的甘草酸盐，为甘草酸钾盐、甘草酸钠盐中的一种或两种任意比例混合物；
所述的丙酸盐，为丙酸钠、丙酸钙中的一种或两种任意比例混合物；
所述本制剂可接受的安全载体，可由聚乙二醇(PEG)和聚乙烯吡咯烷酮(PVP)构成，具体而言：聚乙二醇0.001-12.0、PVP 0.001-10.0。
所述颈肩腰腿痛用并具强筋健络功能的生物制剂，优选配方中，有效成份的总质量浓度为1.0-36.0％；有效成份中各成份以质量份数计，具体为：
所述活血通络剂，由三七提取物、三七总皂甙/苷和VB12构成，具体而言：三七提取物0.01-10.0三七总皂甙/苷0.01-2.0、VB12 0.01-10.0；
所述关节生物润滑剂，由高中低3种不同分子量的透明质酸或/和透明质酸盐和高中低3种不同分子量的聚谷氨酸或/和聚谷氨酸盐构成，具体而言：高分子量的透明质酸或/和透明质酸盐0.01-4.0、中分子量的透明质酸或/和透明质酸盐0.01-6.0、低分子量的透明质酸或/和透明质酸盐0.01-8.0；
高分子量的聚谷氨酸或/和聚谷氨酸盐0.01-3.0、中分子量的聚谷氨酸或/和聚谷氨酸盐0.01-5.0、低分子量的聚谷氨酸或/和聚谷氨酸盐0.01-10.0；
所述筋腱肌肉强健剂，由胶原蛋白、胶原蛋白肽、谷氨酰胺、肌醇、磷酸钙和葡萄糖酸钙构 成，具体而言：胶原蛋白0.01-8.0、胶原蛋白肽0.01-10.0、谷氨酰胺0.01-7.0、肌醇0.01-5.0、磷酸钙0.01-4.0、葡萄糖酸钙0.01-3.0；
所述细胞生理功能调理剂，对身体肌肉细胞的生理功能具有重要调节作用，由ATP二钠、细胞色素C、海藻糖、尿囊素、牛磺酸、维生素类和辅酶类物质构成，具体而言：ATP二钠0.01-4.0、细胞色素C 0.001-4.0、海藻糖0.01-8.0、尿囊素0.01-2.0、牛磺酸0.01-4.0；
维生素VB1 0.01-5.0、维生素VB2 0.01-1.0、烟酰胺0.01-9.0、VB5 0.01-5.0、VB6 0.01-5.0、烟酸0.01-4.0、Vc 0.01-4.0、维生素D 0.01-1.0、Ve 0.01-1.0；
生物素0.002-1.0、辅酶Q10 0.002-1.0、辅酶I 0.002-2.0、辅酶II 0.002-2.0；
所述细胞正常生长代谢必需剂，由氨基酸类、糖类、有机酸类物质构成，具体而言：精氨酸0.001-4.0、丝氨酸0.001-4.0、甘氨酸0.001-8.0、谷氨酸0.002-1.0、丙氨酸0.01-6.0、脯氨酸0.001-10.0、羟脯氨酸0.01-4.0、赖氨酸0.001-10.0、谷氨酸钠0.01-2.0；葡萄糖0.001-5.0、蔗糖0.001-5.0；酒石酸0.01-4.0、苹果酸0.01-4.0、柠檬酸0.01-4.0、乳酸0.01-4.0、乳酸盐0.01-4.0；
所述防腐剂，由山梨酸钾、脱氢乙酸钠、肉桂酸钾、甘草酸、甘草酸盐和丙酸盐构成，具体而言：山梨酸钾0.02-2.0、脱氢乙酸钠0.02-2.0、肉桂酸钾0.02-2.0、甘草酸0.02-1.0、甘草酸盐0.01-2.0、丙酸盐0.02-2.0；
所述本制剂可接受的安全载体，由聚乙二醇(PEG)和聚乙烯吡咯烷酮(PVP)构成，具体而言：聚乙二醇0.001-10.0、PVP 0.001-8.0。
所述颈肩腰腿痛用并具强筋健络功能的生物制剂，在剂型方面，可以为液态制剂或固态制剂，优选采用水性凝胶剂，更优选为喷剂或搽剂，从而便于使用。
所述颈肩腰腿痛用并具强筋健络功能的生物制剂，在具体使用时，以凝胶剂制剂为例，0.5-2.0ml/次，将本品涂抹至患处，轻轻按摩片刻至皮肤吸收完全，1-3次/日，可酌情增减使用次数及用量。
所述颈肩腰腿痛用并具强筋健络功能的生物制剂的制备方法，具体包括如下步骤：
(1)将生物制剂中有效成份按照物料性质及制备的方便性和易制性分为4组，分别称取配方中用量备用，具体而言：
第一组，大分子糖类化合物、蛋白多肽类化合物，具体有：胶原蛋白、胶原蛋白肽、高中低3种不同分子量的透明质酸或/和透明质酸盐和高中低3种不同分子量的聚谷氨酸或/和聚谷氨酸盐；
第二组，氨基酸类、小分子糖类、有机酸类，具体有：精氨酸、丝氨酸、甘氨酸、谷氨酸、 谷氨酰胺、丙氨酸、脯氨酸、羟脯氨酸、赖氨酸；葡萄糖、海藻糖、蔗糖；酒石酸、苹果酸、柠檬酸、乳酸、乳酸盐、葡萄糖酸钙；
第三组，维生素辅酶类化合物，具体有：维生素VB1、维生素VB2、烟酰胺、VB5、VB6、烟酸、Vc、维生素D、Ve；生物素、辅酶Q10、辅酶I、辅酶II、VB12；
第四组，其他物料，具体有：ATP二钠、细胞色素C、尿囊素、牛磺酸、肌醇、三七提取物、三七总皂甙/苷、山梨酸钾、脱氢乙酸钠、肉桂酸钾、甘草酸、甘草酸盐、丙酸盐；聚乙二醇(PEG)和聚乙烯吡咯烷酮(PVP)；
(2)将步骤(1)中称取的第二组物料置于反应釜中，然后加入部分配方量的溶剂(例如水)，搅拌溶解混匀，静置，除杂后得混合物A；
(3)将步骤(1)中称取的第三组和第四组物料置于反应釜中，然后加入部分配方量的溶剂，搅拌溶解混匀，静置，除杂后得混合物B；
(4)将步骤(3)的混合物B缓慢加入到步骤(2)的混合物A中，加入完成后，加入步骤(1)中称取的第一组物料成分，最后加入剩余部分配方量的溶剂，溶解混匀、过滤除杂，调节pH＝3.5～6.5，此即为本申请所提供生物制剂产品。
步骤(2)、步骤(3)、步骤(4)中进行溶解混匀操作时，操作温度不应高于45℃，以免影响药效的稳定性和终产品质量，但也不应低于15℃，以免影响溶解和混匀效果，优选25℃左右进行溶解混匀操作。
步骤(2)、步骤(3)、步骤(4)中进行溶解混匀操作时，优选采用真空条件下的均质乳化方式进行操作，可较好确保混匀效果。
本申请所提供生物制剂发挥功能的主要设计理论为：在对现有止痛理论——西方医学的“疼痛闸门控制学说——疼痛神经控制理论”和中医学的“通痛理论”的优势、缺点与不足的比较研究后，通过对疼痛现象与症状及产生原因和现有治疗手段的仔细研究与分析，基于中医学的通痛理论----即通则不痛，痛则不通和现代医学的“透皮吸收、外用内效”理论，与生命科学和食品营养学以及祖国医学的筋脉失养和药食同源理论，设计、研发出一种具有活血通络，祛风除湿、驱寒排毒、舒筋健络、强筋健骨、祛腐生肌、抗炎防衰、滋养神经与肌肉的安全高效且无毒副作用的多组分靶向制剂，初步的应用验证表明，本申请所提供生物制剂不仅具有治疗多种原因或无名原因引起的腰背、肩颈四肢、关节及全身肌肉疼痛或无名疼痛的作用，还可减轻与缓解因受凉受寒受潮或筋骨劳损或劳累过度引起的颈肩腰腿肌肉酸困僵硬或疼痛等不适症状，同时，也有对全身神经肌肉细胞机能及微血流循环系统进行调理、康复和激活的功效，康复多年前的老旧伤痛。
总体而言，与传统治疗疼痛产品或技术方法相比，本发明具有如下突出特点：
(1)与传统治疗疼痛药物相比，该制剂不含任何对人体有毒副作用的或有害的成分，它是一种能为机体提供多种营养、保健、调理或康复及治疗作用的靶向制剂；具有“活血通络，祛风除湿，驱寒排毒，舒筋健络，强筋健骨，祛腐生肌，抗炎防衰，滋养神经与肌肉”等多种功能；
(2)本发明产品与传统治疗疼痛的西药或中药的剂型和给药方式不同，传统治疗疼痛的西药或中药的剂型多为口服剂和注射剂，到达病灶的药量明显减少，难以躲避肝脏的“首过效应”，副作用多，本发明产品为外用制剂，不仅没有“首过效应”，还具有“导弹药物”的特点，属于靶向给药，不但用药量大为减少，其效果既显著又直接且具速效性；另外，其用药方式简单方便，可随时随地使用，患者顺应性好；
(3)利用本发明制剂还可以检验和初步判断颈肩腰腿肌肉及机能的健康状态；具体判定时，将本申请所提供生物制剂喷涂至体表按摩片刻后，若颈肩腰腿肌肉及机能健康无病，就没什么异常感觉和反应；若有炎症疼痛或受寒受潮或筋骨劳损或劳累过度引起肌肉强直僵硬等不适症状，则涂擦部位或其附近大都会出现发热、发烫、发痒、发红或出疹等现象，有的迅速出现，有的用几次或几天后出现，因病症的轻重而不同，多年老旧伤一般出现上述现象会较晚；
(4)本发明制剂的制备方法条件温和，工艺简单，无环境污染，在常温或低温下即可制备；
(5)本发明产品既有药品的功效，又有可长期反复使用的保健食品及化妆品的安全性。本发明产品虽是外用产品，但其安全性既可达到内用(口服)保健食品(既有调节机体功能的作用，还不会对人体产生任何急性、亚急性或慢性危害)标准，同时，也符合可长期外用的《化妆品安全技术规范》等国家或国际标准；因而安全性高。
具体实施方式
下面结合实施例对本申请做进一步的解释说明。
实施例1
本实施例提供一种颈肩腰腿痛用并具强筋健络功能的生物制剂，该生物制剂为液剂，其有效成份的总质量浓度为8.0％，余量为水；有效成份中各成份以质量份数计，具体为：
所述活血通络剂，由三七提取物、三七总皂甙/苷和VB12构成，具体而言：三七提取物5.0、三七总皂甙/苷0.5、VB12 5.0；
所述关节生物润滑剂，由高中低3种不同分子量大小的透明质酸或/和透明质酸盐和高中低3 种不同分子量大小的聚谷氨酸或/和聚谷氨酸盐构成，具体而言：高分子量的透明质酸2.0、中分子量的透明质酸钠4.0、低分子量的透明质酸钠5.0；高分子量的聚谷氨酸钠2.0、中分子量的聚谷氨酸3.0、低分子量的聚谷氨酸钠6.0；
所述高分子量透明质酸、高分子量透明质酸盐指分子量大于240万(2400000)道尔顿；
所述中分子量透明质酸、中分子量透明质酸盐指分子量为120万(1200000)道尔顿；
所述低分子量透明质酸、低分子量透明质酸盐指分子量不大于40万(400000)道尔顿；
所述高分子量聚谷氨酸、高分子量聚谷氨酸盐指分子量大于140万(1400000)道尔顿；
所述中分子量聚谷氨酸、中分子量聚谷氨酸盐指分子量为80万(800000)道尔顿；
所述低分子量聚谷氨酸、低分子量聚谷氨酸盐指分子量不大于30万(300000)道尔顿；
所述筋腱肌肉强健剂，由胶原蛋白、胶原蛋白肽、谷氨酰胺、肌醇、磷酸钙和葡萄糖酸钙构成，具体而言：胶原蛋白5.0、胶原蛋白肽6.0、谷氨酰胺4.0、肌醇3.0、磷酸钙3.0、葡萄糖酸钙2.0；
所述细胞生理功能调理剂，由ATP二钠、细胞色素C、海藻糖、尿囊素、牛磺酸、维生素类和辅酶类物质构成，具体而言：ATP二钠2.5、细胞色素C 2.5、海藻糖4.5、尿囊素1.0、牛磺酸2.5；维生素VB1 3.0、维生素VB2 0.5、烟酰胺5.0、VB5 3.0、VB6 3.0、烟酸2.5、Vc 2.5、维生素D 0.5、Ve 0.5；生物素0.5、辅酶Q10 0.5、辅酶I 1.0、辅酶II 1.0；
所述细胞正常生长代谢必需剂，由氨基酸类、糖类、有机酸类构成，具体而言：精氨酸2.5、丝氨酸2.5、甘氨酸4.5、谷氨酸0.5、丙氨酸3.0、脯氨酸6.0、羟脯氨酸2.0、赖氨酸6.0、谷氨酸钠1.5；葡萄糖3.0、蔗糖3.0；酒石酸2.5、苹果酸2.5、柠檬酸2.5、乳酸2.5、乳酸钠2.5、乳酸钙0.5；
所述防腐剂，由山梨酸钾、脱氢乙酸钠、肉桂酸钾、甘草酸、甘草酸盐和丙酸盐构成，具体而言：山梨酸钾1.0、脱氢乙酸钠1.0、肉桂酸钾1.0、甘草酸0.5、甘草酸钾盐0.5、甘草酸钠1.5、丙酸钠1.0、丙酸钙1.0；
所述本制剂可接受的安全载体，由聚乙二醇(PEG)和聚乙烯吡咯烷酮(PVP)构成，具体而言：聚乙二醇400 6.0、聚乙二醇4000 2.0、聚乙二醇10000 2.0、聚乙二醇20000 2.0、PVP K15 2.0、PVP K30 1.0、PVP K60 0.5和PVP K90 3.0。
本实施例所提供颈肩腰腿痛用并具强筋健络功能的生物制剂，具体通过如下方法步骤制备而成：
(1)将生物制剂中有效成份按照物料性质及制备的方便性和易制性分为4组，分别称取配方中用量备用，具体而言：
第一组，大分子糖类化合物、蛋白多肽类化合物，具体有：胶原蛋白、胶原蛋白肽、高中低3种不同分子量的透明质酸或/和透明质酸盐和高中低3种不同分子量的聚谷氨酸或/和聚谷氨酸盐；
第二组，氨基酸类、小分子糖类、有机酸类化合物，具体有：精氨酸、丝氨酸、甘氨酸、谷氨酸、谷氨酰胺、丙氨酸、脯氨酸、羟脯氨酸、赖氨酸；葡萄糖、海藻糖、蔗糖；酒石酸、苹果酸、柠檬酸、乳酸、乳酸盐、葡萄糖酸钙；
第三组，维生素辅酶类化合物，具体有：维生素VB1、维生素VB2、烟酰胺、VB5、VB6、烟酸、Vc、维生素D、Ve；生物素、辅酶Q10、辅酶I、辅酶II、VB12；
第四组，除溶剂外其他物料，具体有：ATP二钠、细胞色素C、尿囊素、牛磺酸、肌醇、三七总皂甙/苷、山梨酸钾、脱氢乙酸钠、肉桂酸钾、甘草酸、甘草酸盐、丙酸盐；聚乙二醇(PEG)和聚乙烯吡咯烷酮(PVP)；
(2)将步骤(1)中称取的第二组物料置于反应釜中，然后加入部分配方量的溶剂，搅拌溶解混匀，静置，过滤除杂后得混合物A；
(3)将步骤(1)中称取的第三组和第四组物料置于反应釜中，然后加入部分配方量的溶剂，搅拌溶解混匀，静置，过滤除杂后得混合物B；
(4)将步骤(3)的混合物B缓慢加入到步骤(2)的混合物A中，加入完成后，加入步骤(1)中称取的第一组物料成分，最后加入剩余部分配方量的溶剂及助剂，溶解混匀、过滤除杂，调节pH＝5.0，此即为本申请所提供生物制剂产品；
步骤(2)、步骤(3)、步骤(4)中进行溶解混匀操作时，操作温度25℃左右进行溶解混匀操作；同时采用真空条件下的均质乳化方式进行操作，可较好确保混匀效果。
对本实施例所制备生物制剂产品的皮肤刺激性和污染物(重金属)等安全性指标进行了检测，结果如下表1、表2所示(表1、2所列各项检测指标均是按可以经常食用(使用)的保健食品安全国家标准GB 16740-2014和《化妆品安全技术规范》(2015年版)新标准来执行)。
表1，皮肤刺激性和污染物(重金属)检测结果
指标名称 检测结果 保健食品标准a 化妆品标准b 备注
多次皮肤刺激性 0度   2度以下  
汞(Hg)，mg/kg ≤0.21 0.3 1  
砷(As)，mg/kg ≤0.42 1 2  
铅(Pb)，mg/kg ≤0.5 2 10  
镉(Cd)，mg/kg ≤0.9   5  
二噁烷，mg/kg ≤2.2   30  
甲醇，mg/kg ≤183   2000  
石棉 无   不得检出  
注：a是指GB 16740-2014食品安全国家标准-保健食品安全标准；b是指国家食品药品监督管理总局颁布的新版《化妆品安全技术规范》(2015年版)(2015年第268号)。
表2，微生物指标
Figure PCTCN2018098467-appb-000001
从上述表格数据可以看出，本发明的生物制剂的重金属等污染物和微生物等安全性指标的检测结果，不仅完全符合可以经常反复食用的保健食品安全国家标准GB 16740-2014，还符合可以经常反复使用的最新的《化妆品安全技术规范》(2015年版)标准。
以本实施例所制备生物制剂液剂这一剂型产品为例，发明人进行了部分实际人体应用试验(均为自愿者)，具体过程简要介绍如下。
对确诊的颈肩腰腿痛患者的应用效果
随机挑选确诊的260例颈肩腰腿痛自愿者患者，其中男性138人，女性122人，年龄20-75岁，其病程1天-35年不等、颈肩腰腿疼痛程度不一，病因也较为多样，综合有劳累性、风 湿风寒性等多种。
用法：将适量本品涂或喷至患处，轻轻按摩片刻即可；用量：0.5-2.0ml/次，1-3次/日，7-14天/疗程(连续不间断使用)，喷涂2个月后进行疗效评定。
疗效评定标准：参照国家食品药品监督管理局《中药新药临床研究指导原则》的相关标准制定如下：
痊愈：疼痛消失；
显效：疼痛明显减轻或缓解，或由持续性疼痛减轻为偶发；
有效：疼痛有所减轻，或由持续性疼痛转为间歇性发作；
无效：疼痛无改善或加重。
统计结果表明：治愈164例(63.0％)，显效81例(31.2％)，有效12例(4.6％)，无效3例(1.2％)，总有效率98.8％(P<0.01)。另外统计观察结果表明：绝大多数患者喷涂1次即有明显效果，涂擦3-5天，效果更为显著，轻度患者疼痛或不适症状消失，部分严重患者患部或其附近会出现发红，发热，发痒，表皮起红疹等现象，继续喷涂10天左右，上述现象基本消失，疼痛或不适症状基本治愈，取得了理想效果。
安全性考察：用药期间，除有些患者将本剂喷涂至患处出现发红，发热，发痒，表皮起红疹等属于人体正常的祛湿排毒反应的现象外，未见其它毒副作用和不良反应。若将本剂喷涂至无疼痛处则无任何反应。
对普通健康志愿者的保健应用效果
随机挑选198例年龄20～60岁的健康志愿者，试用本发明产品，检查试用者的用后保健效果。
用法：将适量本品涂或喷至颈肩腰腿单侧或左侧(肢)关节处，另一侧(肢)做为对照，轻轻按摩片刻即可；用量：0.5-2.0ml/次，1-3次/日，根据喜好可酌情增减使用次数及用量，7-14天/疗程(连续不间断使用)，喷涂4个月后进行效果评定。
疗效评定标准：参照国家食品药品监督管理局《中药新药临床研究指导原则》的相关标准制定试用者的用后效果分为如下4种情况：
A：感觉筋腱联结更紧致、肌肉更有力量；
B:感觉舒爽；
C:感觉一般或无感觉；
D:感觉难受。
统计结果表明：A 166例(83.8％)，B 23例(11.6％)，C 9例(4.6％)，D 0例 (0.0％)，感觉筋腱联结更紧致、更有力量者占83.8％，加上感觉舒爽者11.6％，感觉难受者为0.0％，总感觉舒爽率为95.4％(P<0.01)，取得了理想效果。
安全性考察：在长达4个月的用药过程中，对所选普通健康志愿者来说，尚未发现任何毒副作用和不良反应案例。
总体应用效果表明：对于年龄大小不等、颈肩腰腿疼痛程度不一的患者，使用本发明生物制剂进行喷涂治疗，无论是多年的老寒腿、颈椎痛、腰疼或是肌肉酸困强直僵硬或是肌力不足，还是新发颈肩腰腿疼痛均有明显的治疗与缓解作用；对于新发轻度疼痛或不适，首次喷涂即能感受到有明显的减轻与缓解作用，甚至疼痛或不适消失，而对于多年的老旧伤痛，则喷涂几次或几天后多会出现发红，发热，发痒，表皮起红疹等属于人体正常的祛湿排毒反应现象外，未见其它任何毒副作用和不良反应，继续喷涂1周左右，上述现象就会消失，说明人体正常的祛湿排毒反应基本完成，疼痛或不适症状明显好转；而针对健康志愿者喷涂本剂，则大多数都能明显感受到筋腱联结更紧致、肌肉更有力量，未发现其它任何毒副作用和不良反应。
针对上述实验，就使用过程的部分典型病例情况简要列举介绍如下：
(1)张某：女，75岁，某机关干部，已退休，腰腿痛30多年，求助多种医疗手段如口服中西药或贴膏药等虽能缓解疼痛，但需长期用药，产生不少副作用以致无法坚持，使用本发明产品，用法：将适量本品涂或喷至患处，轻轻按摩片刻即可；用量：0.5-2ml/次，1-3次/日，喷涂2天后，喷涂处严重发红，发热，发痒，甚至有点儿难以忍受，但继续喷涂，上述症状持续1周左右就会慢慢减轻，使用2周左右即有明显好转，使用8周左右基本痊愈，感觉腿部也更有力量；
(2)王某：男，56岁，某大学教授，上大学时腿部因骑自行车意外摔伤，求助过多种医疗手段如口服中西药、针灸或贴膏药等均未治愈，30多年来，其它疗法暂且不说，贴膏药的数量也有5000张以上，而且，近十几年来，即使大夏天因膝关节怕凉还要佩戴护膝，自使用本发明产品后，就再没贴过膏药，也不再戴护膝了。用法：将适量本品涂或喷至患处，轻轻按摩片刻即可；用量：0.5-2.0ml/次，1-3次/日，喷涂5天后，喷涂处严重发红，发热，发痒，甚至有点儿难以忍受的感觉，但继续喷涂，上述症状持续1周左右就消失了，使用2周左右即有明显好转，使用8周左右基本痊愈，感觉腿部也更有力量；
(3)赵某：女，52岁，某大学教授，因职业需要长期伏案工作，于10多年前就得了颈椎病，经常脖子疼痛或僵硬难受，尤其是冬天更为严重，求助过多种医疗手段如口服中西药、戴护颈等均无明显效果，自使用本发明产品后，就不再戴护颈了，也不吃药了。用法：将适 量本品涂或喷至患处，轻轻按摩片刻即可；用量：0.5-2ml/次，1-3次/日，喷涂3天后，喷涂处严重发红，发热，发痒，甚至有点儿难以忍受的感觉，但继续喷涂，上述症状持续1周左右就消失了，使用2周左右即有明显好转，使用4周左右基本痊愈；
(4)李某：男，58岁，某机关干部，，因职业需要长期伏案工作，于10多年前就得了颈椎病和腰疼，尤其是冬天更为严重，求助过多种医疗手段如口服中西药、戴护颈、护腰带等均无明显效果，自使用本发明产品后，就不再戴护颈、护腰带了，也不吃药了。用法：将适量本品涂或喷至患处，轻轻按摩片刻即可；用量：0.5-2ml/次，1-3次/日，使用2周左右即有明显好转，使用6周左右基本痊愈；
(5)刘某：男，32岁，某公司经理，身体健康，使用本发明产品，用法：将适量本品涂或喷至颈肩腰部左后侧，另一侧(肢)做为对照，轻轻按摩片刻；用量：0.5-2ml/次，1-3次/日，连续喷涂4个月，除了喷涂侧能明显感受到筋腱联结更紧致、肌肉更有力量，另一侧感觉不如喷涂侧外，没有任何其它异常感觉。
(6)何某：女，20岁，某公司职员，身体健康，使用本发明产品，用法：将适量本品涂或喷至颈肩腰部左后侧，另一侧(肢)做为对照，轻轻按摩片刻；用量：0.5-2ml/次，1-3次/日，连续喷涂4个月，感觉像用护肤品一样，除了喷涂侧能明显感受到筋腱联结更紧致、肌肉更有力量，另一侧感觉不如喷涂侧外，没有任何其它异常感觉。
(7)宋某，女，28岁，某公司经理，身体健康，但因工作时间过长颈部酸困僵硬，使用本发明产品涂喷颈部1次，轻轻按摩片刻，就不再酸困僵硬了。
(8)王某，女，24岁，某公司职员，身体健康，但因工作时间过长腰部酸困僵硬且有轻度疼痛，使用本发明产品涂喷颈部3次，轻轻按摩片刻，就不再酸困僵硬了、也没有疼痛感觉了。
实施例2
本实施例所提供的用于颈肩腰腿痛用并具强筋健络功能的生物制剂产品，其制备方法同实施例1，仅调整部分配方如下：
该生物制剂中有效成份的总质量浓度为0.5％，调节pH＝3.5；有效成份中各成份以质量份数计，具体为：
所述活血通络剂，由三七提取物、三七总皂甙/苷和VB12构成，具体而言：三七提取物0.001、三七总皂甙/苷0.001、VB12 1.0；
所述关节生物润滑剂，由高中低3种不同分子量大小的透明质酸或/和透明质酸盐和高中低3种不同分子量大小的聚谷氨酸或/和聚谷氨酸盐构成，具体而言：高分子量的透明质酸 0.001、中分子量的透明质酸钠3.0、低分子量的透明质酸钠0.001；高分子量的聚谷氨酸钠0.001、中分子量的聚谷氨酸0.001、低分子量的聚谷氨酸钠0.001；
所述透明质酸、透明质酸盐、聚谷氨酸、聚谷氨酸盐类型同实施例1；
所述筋腱肌肉强健剂，由胶原蛋白、胶原蛋白肽、谷氨酰胺、肌醇、磷酸钙和葡萄糖酸钙构成，具体而言：胶原蛋白0.001、胶原蛋白肽0.001、谷氨酰胺0.01、肌醇0.01、磷酸钙0.01、葡萄糖酸钙4.0；
所述细胞生理功能调理剂，由ATP二钠、细胞色素C、海藻糖、尿囊素、牛磺酸、维生素类和辅酶类物质构成，具体而言：ATP二钠0.01、细胞色素C 0.01、海藻糖0.01、尿囊素0.01、牛磺酸0.01；维生素VB1 0.01、维生素VB2 0.001、烟酰胺0.01、VB5 0.01、VB60.01、烟酸0.01、Vc 0.01、维生素D 0.001、Ve 0.001；生物素0.001、辅酶Q10 0.001、辅酶I 0.001、辅酶II 0.001；
所述细胞正常生长代谢必需剂，由氨基酸类、糖类、有机酸类构成，具体而言：精氨酸0.001、丝氨酸0.001、甘氨酸0.001、谷氨酸0.001、丙氨酸0.001、脯氨酸0.001、羟脯氨酸0.001、赖氨酸0.001、谷氨酸钠0.001；葡萄糖0.001、蔗糖0.001；酒石酸0.01、苹果酸0.01、柠檬酸0.01、乳酸0.01、乳酸钠0.01、乳酸钙0.01；
所述防腐剂，由山梨酸钾、脱氢乙酸钠、肉桂酸钾、甘草酸、甘草酸盐和丙酸盐构成，具体而言：山梨酸钾0.01、脱氢乙酸钠0.01、肉桂酸钾0.01、甘草酸0.01、甘草酸钾盐0.01、甘草酸钠0.01、丙酸钠0.01、丙酸钙0.01；
所述本制剂可接受的安全载体，由聚乙二醇(PEG)和聚乙烯吡咯烷酮(PVP)构成，具体而言：聚乙二醇400 0.0001、聚乙二醇4000 0.001、聚乙二醇10000 0.0001、聚乙二醇20000 0.0001、PVP K15 0.0001、PVP K30 0.0001、PVP K60 0.001和PVP K90 0.0001。
实施例3
本实施例所提供的用于颈肩腰腿痛用并具强筋健络功能的生物制剂产品，其制备方法同实施例1，仅调整部分配方如下：
该生物制剂中有效成份的总质量浓度为38.0％，调节pH＝6.5，制成凝胶剂；有效成份中各成份以质量份数计，具体为：
所述活血通络剂，由三七提取物、三七总皂甙/苷和VB12构成，具体而言：三七提取物10.0、三七总皂甙/苷2.0、VB12 10.0；
所述关节生物润滑剂，由高中低3种不同分子量大小的透明质酸或/和透明质酸盐和高中低3种不同分子量大小的聚谷氨酸或/和聚谷氨酸盐构成，具体而言：高分子量的透明质酸钠 5.0、中分子量的透明质酸钠8.0、低分子量的透明质酸钠10.0；高分子量的聚谷氨酸钠4.0、中分子量的聚谷氨酸6.0、低分子量的聚谷氨酸钠12.0；
所述透明质酸、透明质酸盐、聚谷氨酸、聚谷氨酸盐类型同实施例1；
所述筋腱肌肉强健剂，由胶原蛋白、胶原蛋白肽、谷氨酰胺、肌醇、磷酸钙和葡萄糖酸钙构成，具体而言：胶原蛋白10.0、胶原蛋白肽12.0、谷氨酰胺8.0、肌醇6.0、磷酸钙5.0、葡萄糖酸钙0.01；
所述细胞生理功能调理剂，由ATP二钠、细胞色素C、海藻糖、尿囊素、牛磺酸、维生素类和辅酶类物质构成，具体而言：ATP二钠5.0、细胞色素C 5.0、海藻糖9.0、尿囊素2.0、牛磺酸5.0；维生素VB1 6.0、维生素VB2 1.0、烟酰胺10.0、VB5 6.0、VB6 6.0、烟酸5.0、Vc 5.0、维生素D 1.0、Ve 1.0；生物素1.0、辅酶Q10 1.0、辅酶I 2.0、辅酶II 2.0；
所述细胞正常生长代谢必需剂，由氨基酸类、糖类、有机酸类构成，具体而言：精氨酸5.0、丝氨酸5.0、甘氨酸9.0、谷氨酸1.0、丙氨酸6.0、脯氨酸12.0、羟脯氨酸4.0、赖氨酸12.0、谷氨酸钠3.0；葡萄糖6.0、蔗糖6.0；酒石酸5.0、苹果酸5.0、柠檬酸5.0、乳酸5.0、乳酸钠4.0、乳酸钙1.0；
所述防腐剂，由山梨酸钾、脱氢乙酸钠、肉桂酸钾、甘草酸、甘草酸盐和丙酸盐构成，具体而言：山梨酸钾2.0、脱氢乙酸钠2.0、肉桂酸钾2.0、甘草酸1.0、甘草酸钾盐2.90、甘草酸钠0.01、丙酸钠2.0、丙酸钙0.01；
所述本制剂可接受的安全载体或辅料，由聚乙二醇(PEG)和聚乙烯吡咯烷酮(PVP)构成，具体而言：聚乙二醇400 0.2、聚乙二醇4000 11.0、聚乙二醇10000 0.3、聚乙二醇20000 0.5、PVP K15 0.3、PVP K30 0.2、PVP K60 0.5和PVP K90 9.0。
实施例4
本实施例所提供的用于颈肩腰腿痛用并具强筋健络功能的生物制剂产品，其制备方法同实施例1，仅调整部分配方如下：
该生物制剂中有效成份的总质量浓度为3.0％，调节pH＝4.5，制成喷剂；有效成份中各成份以质量份数计，具体为：
所述活血通络剂，由三七提取物构成，具体而言：三七提取物2.0；
所述关节生物润滑剂为高分子量透明质酸盐和低分子量的聚谷氨酸盐，具体而言：高分子量的透明质酸钠0.01、低分子量的聚谷氨酸钠1.0；
所述透明质酸、透明质酸盐、聚谷氨酸、聚谷氨酸盐类型同实施例1；
所述筋腱肌肉强健剂，由胶原蛋白肽构成，具体而言：胶原蛋白2.0；
所述细胞生理功能调理剂，由海藻糖、牛磺酸和维生素类物质构成，具体而言：海藻糖2.0、牛磺酸0.5；维生素VB1 1.0、维生素VB2 0.05、烟酰胺0.5、VB5 0.5、VB6 0.5；
所述细胞正常生长代谢必需剂，由氨基酸类、糖类、有机酸类构成，具体而言：甘氨酸2.0、脯氨酸3.0、羟脯氨酸0.5；
所述防腐剂，由山梨酸钾构成，具体而言：山梨酸钾0.2；
所述本制剂可接受的安全载体或辅料，由聚乙二醇(PEG)构成，具体而言：聚乙二醇4000 3.0。
实施例5
本实施例所提供的用于颈肩腰腿痛用并具强筋健络功能的生物制剂产品，其制备方法同实施例1，仅调整部分配方如下：
该生物制剂中有效成份的总质量浓度为16.0％，调节pH＝5.5，制成凝露剂；有效成份中各成份以质量份数计，具体为：
所述活血通络剂，由三七提取物和VB12构成，具体而言：三七提取物4.0、VB12 4.0；
所述关节生物润滑剂，由高中低3种不同分子量大小的透明质酸或/和透明质酸盐构成，具体而言：高分子量的透明质酸2.0、中分子量的透明质酸钠3.0、低分子量的透明质酸钠4.0；
所述透明质酸、透明质酸盐、聚谷氨酸、聚谷氨酸盐类型同实施例1；
所述筋腱肌肉强健剂，由胶原蛋白、胶原蛋白肽、谷氨酰胺、肌醇、磷酸钙和葡萄糖酸钙构成，具体而言：胶原蛋白4.0、胶原蛋白肽6.0、谷氨酰胺3.0、肌醇1.0、磷酸钙1.0、葡萄糖酸钙1.0；
所述细胞生理功能调理剂，由海藻糖、尿囊素、牛磺酸、维生素类和辅酶类物质构成，具体而言：海藻糖4.0、尿囊素0.5、牛磺酸1.0；维生素VB1 2.0、维生素VB2 0.1、烟酰胺3.0、VB5 1.0、VB6 1.0、烟酸0.6、Vc 1.0、维生素D 0.1、Ve 0.1；生物素0.1、辅酶Q10 0.1、辅酶I 0.1、辅酶II 0.1；
所述细胞正常生长代谢必需剂，由氨基酸类、糖类、有机酸类构成，具体而言：精氨酸2.0、丝氨酸2.0、甘氨酸4.0、谷氨酸0.1、丙氨酸2.0、脯氨酸6.0、羟脯氨酸1.0、赖氨酸6.0、谷氨酸钠0.7；葡萄糖2.0、蔗糖2.0；酒石酸2.0、苹果酸2.0、柠檬酸2.0、乳酸2.0、乳酸钠2.0、乳酸钙2.0；
所述防腐剂，由山梨酸钾、脱氢乙酸钠、肉桂酸钾、甘草酸、甘草酸盐和丙酸盐构成，具体而言：山梨酸钾0.5、脱氢乙酸钠0.5、肉桂酸钾0.5、甘草酸0.5、甘草酸钾盐0.5、甘草酸 钠0.5、丙酸钠0.5、丙酸钙0.5；
所述本制剂可接受的安全载体，由聚乙二醇(PEG)和聚乙烯吡咯烷酮(PVP)构成，具体而言：聚乙二醇20000 6.0和PVP K90 4.0。
实施例6
本实施例所提供的用于颈肩腰腿痛用并具强筋健络功能的生物制剂产品，其制备方法同实施例1，仅调整部分配方如下：
该生物制剂中有效成份的总质量浓度为22.0％，调节pH＝4.0，制成凝胶剂；有效成份中各成份以质量份数计，具体为：
所述活血通络剂，由三七提取物、三七总皂甙/苷和VB12构成，具体而言：三七提取物6.0、三七总皂甙/苷1.2、VB12 6.0；
所述关节生物润滑剂，由高中低3种不同分子量大小的透明质酸或/和透明质酸盐和高中低3种不同分子量大小的聚谷氨酸或/和聚谷氨酸盐构成，具体而言：高分子量的透明质酸3.0、中分子量的透明质酸钠5.0、低分子量的透明质酸钠6.0；高分子量的聚谷氨酸钠2.0、中分子量的聚谷氨酸3.0、低分子量的聚谷氨酸钠6.0；
所述透明质酸、透明质酸盐、聚谷氨酸、聚谷氨酸盐类型同实施例1；
所述筋腱肌肉强健剂，由胶原蛋白、胶原蛋白肽、谷氨酰胺、肌醇、磷酸钙和葡萄糖酸钙构成，具体而言：胶原蛋白6.0、胶原蛋白肽9.0、谷氨酰胺5.0、肌醇3.0、磷酸钙2.0、葡萄糖酸钙2.0；
所述细胞生理功能调理剂，由ATP二钠、海藻糖、尿囊素、牛磺酸、维生素类和辅酶类物质构成，具体而言：ATP二钠2.0、海藻糖6.0、尿囊素0.8、牛磺酸2.0；维生素VB1 3.0、维生素VB2 0.4、烟酰胺6.0、VB5 3.0、VB6 3.0、烟酸0.8、Vc 3.0、维生素D 0.4、Ve 0.5；生物素0.5、辅酶Q10 0.5、辅酶I 0.5、辅酶II 0.5；
所述细胞正常生长代谢必需剂，由氨基酸类、糖类、有机酸类构成，具体而言：精氨酸3.0、丝氨酸3.0、甘氨酸6.0、谷氨酸0.5、丙氨酸3.0、脯氨酸9.0、羟脯氨酸2.0、赖氨酸9.0、谷氨酸钠1.0；葡萄糖3.0、蔗糖3.0；酒石酸3.0、苹果酸3.0、柠檬酸3.0、乳酸3.0、乳酸钠0.1、乳酸钙4.9；
所述防腐剂，由山梨酸钾、脱氢乙酸钠、肉桂酸钾、甘草酸、甘草酸盐和丙酸盐构成，具体而言：山梨酸钾1.0、脱氢乙酸钠1.0、肉桂酸钾1.0、甘草酸1.0、甘草酸钾盐1.0、甘草酸钠1.0、丙酸钠1.0、丙酸钙1.0；
所述本制剂可接受的安全载体或辅料，由聚乙二醇(PEG)和聚乙烯吡咯烷酮(PVP)构 成，具体而言：聚乙二醇4000 4.0、聚乙二醇10000 2.0、聚乙二醇20000 6.0、PVP K30 2.0、PVP K60 2.0和PVP K90 6.0。
实施例7
本实施例所提供的用于颈肩腰腿痛用并具强筋健络功能的生物制剂产品，其制备方法同实施例1，仅调整部分配方如下：
该生物制剂中有效成份的总质量浓度为32.0％，调节pH＝6.0，制成凝胶剂；有效成份中各成份以质量份数计，具体为：
所述活血通络剂，由三七提取物、三七总皂甙/苷和VB12构成，具体而言：三七提取物8.0、三七总皂甙/苷1.6、VB12 8.0；
所述关节生物润滑剂，由高中低3种不同分子量大小的透明质酸或/和透明质酸盐和高中低3种不同分子量大小的聚谷氨酸或/和聚谷氨酸盐构成，具体而言：高分子量的透明质酸4.0、中分子量的透明质酸钠7.0、低分子量的透明质酸钠8.0；高分子量的聚谷氨酸钠3.0、中分子量的聚谷氨酸5.0、低分子量的聚谷氨酸钠9.0；
所述透明质酸、透明质酸盐、聚谷氨酸、聚谷氨酸盐类型同实施例1；
所述筋腱肌肉强健剂，由胶原蛋白、胶原蛋白肽、谷氨酰胺、肌醇、磷酸钙和葡萄糖酸钙构成，具体而言：胶原蛋白8.0、胶原蛋白肽11.0、谷氨酰胺7.0、肌醇5.0、磷酸钙4.0、葡萄糖酸钙3.0；
所述细胞生理功能调理剂，由ATP二钠、细胞色素C、海藻糖、尿囊素、牛磺酸、维生素类和辅酶类物质构成，具体而言：ATP二钠4.0、细胞色素C 4.0、海藻糖8.0、尿囊素1.6、牛磺酸4.0；维生素VB1 5.0、维生素VB2 0.8、烟酰胺8.0、VB5 5.0、VB6 5.0、烟酸4.0、Vc 4.0、维生素D 0.8、Ve 0.8；生物素0.8、辅酶Q10 0.8、辅酶I 0.8、辅酶II 0.8；
所述细胞正常生长代谢必需剂，由氨基酸类、糖类、有机酸类构成，具体而言：精氨酸4.0、丝氨酸4.0、甘氨酸8.0、谷氨酸0.9、丙氨酸5.0、脯氨酸11.0、羟脯氨酸3.0、赖氨酸11.0、谷氨酸钠2.0；葡萄糖5.0、蔗糖5.0；酒石酸4.0、苹果酸4.0、柠檬酸4.0、乳酸4.0、乳酸钠4.9、乳酸钙0.1；
所述防腐剂，由山梨酸钾、脱氢乙酸钠、肉桂酸钾、甘草酸、甘草酸盐和丙酸盐构成，具体而言：山梨酸钾1.7、脱氢乙酸钠1.7、肉桂酸钾1.7、甘草酸1.6、甘草酸钾盐1.8、甘草酸钠1.2、丙酸钠1.8、丙酸钙0.2；
所述本制剂可接受的安全载体或辅料，由聚乙二醇(PEG)和聚乙烯吡咯烷酮(PVP)构成，具体而言：聚乙二醇4000 11.0、聚乙二醇10000 1.0、PVP K60 8.0和PVP K90 2.0。
参考实施例1的测试评价方法，再随机挑选280例年龄20-75岁，其病程1天-35年不等、颈肩腰腿疼痛程度不一的志愿者，设置7个组别，每组40例志愿者，分别应用实施例1～7所制备的颈肩腰腿痛用并具强筋健络功能的生物制剂产品，进行喷涂实验。
用法：将适量本品涂或喷至患处，轻轻按摩片刻即可；用量：0.5-2.0ml/次，1-3次/日，7-14天/疗程(连续不间断使用)，喷涂2个月后进行疗效评定。
统计结果表明，实施例1制备的生物制剂效果最好，总有效率为100.0％(P<0.05)；
实施例4制备的生物制剂效果最差，总有效率为57.5％(P<0.05)；其它依次为：
实施例2的总有效率为62.5％(P<0.05)；实施例3的总有效率为95.0％(P<0.05)；
实施例5的总有效率为72.5％(P<0.05)；实施例6的总有效率为80.0％(P<0.05)；
实施例7的总有效率为87.5％(P<0.05)。
实施例8
本实施例所提供的用于颈肩腰腿痛用并具强筋健络功能的生物制剂产品，其制备方法同实施例1，仅调整部分配方如下：
该生物制剂中有效成份的总质量浓度为6.0％，调节pH＝5.0，制成凝露剂；有效成份中各成份以质量份数计，具体为：
所述活血通络剂，由三七提取物、三七总皂甙/苷和VB12构成，具体而言：三七提取物3.0、三七总皂甙/苷0.7、VB12 3.0；
所述关节生物润滑剂，由高中低3种不同分子量大小的透明质酸或/和透明质酸盐和高中低3种不同分子量大小的聚谷氨酸或/和聚谷氨酸盐构成，具体而言：高分子量的透明质酸钠2.0、中分子量的透明质酸钠2.0、低分子量的透明质酸钠3.0；高分子量的聚谷氨酸钠1.0、中分子量的聚谷氨酸3.0、低分子量的聚谷氨酸钠4.0；
所述透明质酸、透明质酸盐、聚谷氨酸、聚谷氨酸盐类型同实施例1；
所述筋腱肌肉强健剂，由胶原蛋白、胶原蛋白肽、谷氨酰胺、肌醇、磷酸钙和葡萄糖酸钙构成，具体而言：胶原蛋白3.0、胶原蛋白肽4.0、谷氨酰胺2.0、肌醇2.0、磷酸钙2.0、葡萄糖酸钙1.0；
所述细胞生理功能调理剂，由ATP二钠、细胞色素C、海藻糖、尿囊素、牛磺酸、维生素类和辅酶类物质构成，具体而言：ATP二钠2.0、细胞色素C 2.0、海藻糖3.0、尿囊素0.7、牛磺酸0.8；维生素VB1 2.0、维生素VB2 0.3、烟酰胺3.0、VB5 2.0、VB6 2.0、烟酸2.0、Vc 2.0、维生素D 0.3、Ve 0.3；生物素0.3、辅酶Q10 0.3、辅酶I 0.7、辅酶II 0.7；
所述细胞正常生长代谢必需剂，由氨基酸类、糖类、有机酸类构成，具体而言：精氨酸 2.0、丝氨酸2.0、甘氨酸3.0、谷氨酸0.3、丙氨酸2.0、脯氨酸4.0、羟脯氨酸1.0、赖氨酸4.0、谷氨酸钠1.0；葡萄糖2.0、蔗糖2.0；酒石酸2.0、苹果酸2.0、柠檬酸2.0、乳酸2.0、乳酸钠2.0、乳酸钙2.0；
所述防腐剂，由山梨酸钾、脱氢乙酸钠、肉桂酸钾、甘草酸、甘草酸盐和丙酸盐构成，具体而言：山梨酸钾0.3、脱氢乙酸钠0.3、肉桂酸钾0.3、甘草酸0.3、甘草酸钾盐0.3、甘草酸钠0.3、丙酸钠0.3、丙酸钙0.3；
所述本制剂可接受的安全载体或辅料，由聚乙二醇(PEG)和聚乙烯吡咯烷酮(PVP)构成，具体而言：聚乙二醇400 4.0、聚乙二醇4000 2.0、聚乙二醇10000 4.0、聚乙二醇20000 2.0、PVP K15 3.0、PVP K30 3.0、PVP K60 3.0和PVP K90 1.0。
实施例9
本实施例所提供的用于颈肩腰腿痛用并具强筋健络功能的生物制剂产品，其制备方法同实施例1，仅调整部分配方如下：
该生物制剂中有效成份的总质量浓度为6.0％，调节pH＝5.0，制成凝露剂；有效成份中各成份以质量份数计，具体为：
所述活血通络剂，由三七提取物、三七总皂甙/苷和VB12构成，具体而言：三七提取物7.0、三七总皂甙/苷1.4、VB12 7.0；
所述关节生物润滑剂，由高中低3种不同分子量大小的透明质酸或/和透明质酸盐和高中低3种不同分子量大小的聚谷氨酸或/和聚谷氨酸盐构成，具体而言：高分子量的透明质酸钠4.0、中分子量的透明质酸钠6.0、低分子量的透明质酸钠7.0；高分子量的聚谷氨酸钠3.0、中分子量的聚谷氨酸5.0、低分子量的聚谷氨酸钠8.0；
所述透明质酸、透明质酸盐、聚谷氨酸、聚谷氨酸盐类型同实施例1；
所述筋腱肌肉强健剂，由胶原蛋白、胶原蛋白肽、谷氨酰胺、肌醇、磷酸钙和葡萄糖酸钙构成，具体而言：胶原蛋白7.0、胶原蛋白肽8.0、谷氨酰胺6.0、肌醇4.0、磷酸钙3.0、葡萄糖酸钙0.01；
所述细胞生理功能调理剂，由ATP二钠、细胞色素C、海藻糖、尿囊素、牛磺酸、维生素类和辅酶类物质构成，具体而言：ATP二钠4.0、细胞色素C 4.0、海藻糖7.0、尿囊素1.6、牛磺酸4.0；维生素VB1 4.0、维生素VB2 0.6、烟酰胺7.0、VB5 4.0、VB6 4.0、烟酸4.0、Vc 4.0、维生素D 0.7、Ve 0.7；生物素0.7、辅酶Q10 0.7、辅酶I 1.5、辅酶II 1.5；
所述细胞正常生长代谢必需剂，由氨基酸类、糖类、有机酸类构成，具体而言：精氨酸4.0、丝氨酸4.0、甘氨酸7.0、谷氨酸0.8、丙氨酸4.0、脯氨酸8.0、羟脯氨酸3.0、赖氨酸 8.0、谷氨酸钠2.0；葡萄糖4.0、蔗糖4.0；酒石酸4.0、苹果酸4.0、柠檬酸4.0、乳酸4.0、乳酸钠4.0、乳酸钙1.0；
所述防腐剂，由山梨酸钾、脱氢乙酸钠、肉桂酸钾、甘草酸、甘草酸盐和丙酸盐构成，具体而言：山梨酸钾0.6、脱氢乙酸钠0.6、肉桂酸钾0.6、甘草酸0.6、甘草酸钾盐0.6、甘草酸钠0.6、丙酸钠0.6、丙酸钙0.6；
所述本制剂可接受的安全载体或辅料，由聚乙二醇(PEG)和聚乙烯吡咯烷酮(PVP)构成，具体而言：聚乙二醇400 8.0、聚乙二醇4000 1.0、聚乙二醇10000 1.0、聚乙二醇20000 2.0、PVP K15 1.0、PVP K30 5.0、PVP K60 1.0和PVP K90 2.0。
参考实施例1的测试评价方法，随机挑选120例年龄20-75岁，其病程1天-35年不等、颈肩腰腿疼痛程度不一的志愿者，设置2个组别，每组60例志愿者，分别应用实施例8、实施例9所制备的颈肩腰腿痛用并具强筋健络功能的生物制剂产品，进行喷涂实验。
用法：将适量本品涂或喷至患处，轻轻按摩片刻即可；用量：0.5-2.0ml/次，1-3次/日，7-14天/疗程(连续不间断使用)，喷涂2个月后进行疗效评定。
统计结果表明，实施例9制备的生物制剂效果最好，总有效率为96.7％(P<0.05)，实施例8制备的生物制剂效果弱于实施例9，总有效率为88.3％(P<0.05)。
综合大量实际应用试验结果，可以就本申请所提供生物制剂产品的主要优点或有益效果归结如下：
(1)其主要有益效果为：靶向涂搓，迅速吸收，肤感舒爽，效果明显；养护结合，以养为主；外防病入，内修肌肤；有症可消，无状可防；点涂痛处，揉搓即可，使用方便；无毒无害，安全高效。可用于治疗多种原因引起的腰背、肩颈四肢、关节及全身肌肉疼痛或无名疼痛，或因受凉受寒受潮而引起的腿痛、腰疼、肩膀痛和脖子疼，或腰腿肩颈肌肉酸困或僵硬等不适症状，主要用于各种原因引起的慢性腰酸背痛、肩颈四肢关节疼痛、落枕等症状的减轻与缓解，优用于筋脉肌肉失养、神经衰退性、血管硬化性、机能退行性等原因引起的关节及肌肉慢性疼痛或无名疼痛或腰腿肩颈肌肉酸困或僵硬等不适症状。效果特点是，根据病情轻重长短，其效果不同，若是轻度疼痛或不适，一次喷涂，疼痛或不适症状即可迅速减轻缓解或消失，若是新发严重疼痛，一般喷涂1-4周，疼痛症状即可明显减轻或消失，也有新发严重疼痛搽涂1-2周疼痛症状就消失的案例；若病史较长，则需较长时间治疗与调理和康复。
(2)安全性高，适用面广。本发明制剂无毒副作用、无刺激、无过敏，适用于几乎所有人群。
(3)使用方便，效果优良。本发明产品不仅疗效好、见效快、标本兼治，而且可随时随地使用并能长期使用。不像传统的药品那样，有多种毒副作用和限制因素且不宜久用，并需专业医疗人员指导。
(4)对老寒腿，风湿骨痛，因外力冲击而造成的多年前的闪挫扭伤等筋骨疼痛病症也有很好的疗效。在使用过程中如在患处或其附近出现发红，发热，发痒，表皮上起红疹等现象均为人体正常的祛湿排毒反应。
(5)本发明制剂不仅具有治疗颈肩腰腿痛的作用，还可对因受寒受潮或筋骨劳损或劳累过度引起的颈肩腰腿肌肉酸困僵硬或疼痛等不适症状具有良好的减轻与缓解作用，同时，也有对全身神经肌肉细胞机能及微血流循环系统进行调理、康复和激活的功效，康复多年前的闪挫扭伤等老旧伤痛。所以，本发明制剂不仅可以治疗颈肩腰腿痛患者，也可作为普通人强筋健络、强身健体的日常保健用品。

Claims (9)

  1. 一种颈肩腰腿痛用并具强筋健络功能的生物制剂，其特征在于，该生物制剂包括活血通络剂、关节生物润滑剂、筋腱肌肉强健剂、细胞生理功能调理剂和细胞正常生长代谢必需剂，
    所述活血通络剂，包括但不限于三七提取物、三七总皂甙/苷、VB12，选择其中一种或几种任意比例混合物；
    所述关节生物润滑剂，包括但不限于透明质酸或/和透明质酸盐、聚谷氨酸或/和聚谷氨酸盐，选择其中一种或几种任意比例混合物；
    所述筋腱肌肉强健剂，包括但不限于胶原蛋白、胶原蛋白肽、谷氨酰胺、肌醇、磷酸钙和葡萄糖酸钙，选择其中一种或几种任意比例混合物；
    所述细胞生理功能调理剂，包括但不限于ATP二钠、细胞色素C、海藻糖、尿囊素、牛磺酸、维生素类和辅酶类物质，选择其中一种或几种任意比例混合物；
    所述细胞正常生长代谢必需剂，包括但不限于氨基酸类、糖类、有机酸类物质，选择其中一种或几种任意比例混合物。
  2. 如权利要求1所述颈肩腰腿痛用并具强筋健络功能的生物制剂，其特征在于，该生物制剂包括防腐剂；所述防腐剂，包括但不限于山梨酸钾、脱氢乙酸钠、肉桂酸钾、甘草酸、甘草酸盐、丙酸盐，选择其中一种或几种任意比例混合物。
  3. 如权利要求1所述颈肩腰腿痛用并具强筋健络功能的生物制剂，其特征在于，该生物制剂包括可接受的安全载体和/或辅料；所述可接受的安全载体，包括但不限于不同分子量大小的聚乙二醇PEG、不同分子量大小的聚乙烯吡咯烷酮PVP，选择其中一种或几种任意比例混合物；
    所述不同分子量大小的聚乙二醇是指分子量为400-20000道尔顿的聚乙二醇；
    所述不同分子量大小的PVP，包括但不限于PVP K15、PVP K30、PVP K60和PVP K90，选择其中一种或几种任意比例混合物。
  4. 如权利要求1所述颈肩腰腿痛用并具强筋健络功能的生物制剂，其特征在于，生物制剂中有效成份的总质量浓度为0.5-38.0％；有效成份中各成份以质量份数计，具体为：
    所述活血通络剂，由三七提取物、三七总皂甙/苷和VB12构成，具体而言：三七提取物0.001-10.0、三七总皂甙/苷0.001-2.0、VB12 0.001-10.0；
    所述关节生物润滑剂，由高中低3种不同分子量大小的透明质酸或/和透明质酸盐和高中低3种不同分子量大小的聚谷氨酸或/和聚谷氨酸盐构成，具体而言：
    高分子量的透明质酸或/和透明质酸盐0.001-5.0、中分子量的透明质酸或/和透明质酸盐 0.001-8.0、低分子量的透明质酸或/和透明质酸盐0.001-10.0；
    高分子量的聚谷氨酸或/和聚谷氨酸盐0.001-4.0、中分子量的聚谷氨酸或/和聚谷氨酸盐0.001-6.0、低分子量的聚谷氨酸或/和聚谷氨酸盐0.001-12.0；
    所述高分子量透明质酸、高分子量透明质酸盐指分子量大于240万道尔顿；
    所述中分子量透明质酸、中分子量透明质酸盐指分子量大于100万，但不超过180万道尔顿；
    所述低分子量透明质酸、低分子量透明质酸盐指分子量不大于40万道尔顿；
    所述高分子量聚谷氨酸、高分子量聚谷氨酸盐指分子量大于140万道尔顿；
    所述中分子量聚谷氨酸、中分子量聚谷氨酸盐指分子量大于60万，但不超过120万道尔顿；
    所述低分子量聚谷氨酸、低分子量聚谷氨酸盐指分子量不大于30万道尔顿；
    所述筋腱肌肉强健剂，由胶原蛋白、胶原蛋白肽、谷氨酰胺、肌醇、磷酸钙和葡萄糖酸钙构成，具体而言：胶原蛋白0.001-10.0、胶原蛋白肽0.001-12.0、谷氨酰胺0.01-8.0、肌醇0.01-6.0、磷酸钙0.01-5.0、葡萄糖酸钙0.01-4.0；
    所述细胞生理功能调理剂，由ATP二钠、细胞色素C、海藻糖、尿囊素、牛磺酸、维生素类和辅酶类物质构成，具体而言：ATP二钠0.01-5.0、细胞色素C 0.001-5.0、海藻糖0.01-9.0、尿囊素0.001-2.0、牛磺酸0.01-5.0；
    维生素VB1 0.01-6.0、维生素VB2 0.001-1.0、烟酰胺0.01-10.0、VB5 0.01-6.0、VB6 0.01-6.0、烟酸0.01-5.0、Vc 0.01-5.0、维生素D 0.001-1.0、Ve 0.001-1.0；
    生物素0.001-1.0、辅酶Q10 0.001-1.0、辅酶I 0.001-2.0、辅酶II 0.001-2.0；
    所述细胞正常生长代谢必需剂，由氨基酸类、糖类、有机酸类物质构成，具体而言：精氨酸0.001-5.0、丝氨酸0.001-5.0、甘氨酸0.001-9.0、谷氨酸0.001-1.0、丙氨酸0.001-6.0、脯氨酸0.001-12.0、羟脯氨酸0.001-4.0、赖氨酸0.001-12.0、谷氨酸钠0.01-3.0；葡萄糖0.001-6.0、蔗糖0.001-6.0；酒石酸0.01-5.0、苹果酸0.01-5.0、柠檬酸0.01-5.0、乳酸0.01-5.0、乳酸盐0.01-5.0。
  5. 如权利要求4所述颈肩腰腿痛用并具强筋健络功能的生物制剂，其特征在于，生物制剂中有效成份的总质量浓度为1.0-36.0％；有效成份中各成份以质量份数计，具体为：
    所述活血通络剂，由三七提取物、三七总皂甙/苷和VB12构成，具体而言：三七提取物0.01-10.0三七总皂甙/苷0.01-2.0、VB12 0.01-10.0；
    所述关节生物润滑剂，由高中低3种不同分子量的透明质酸或/和透明质酸盐和高中低3种 不同分子量的聚谷氨酸或/和聚谷氨酸盐构成，具体而言：高分子量的透明质酸或/和透明质酸盐0.01-4.0、中分子量的透明质酸或/和透明质酸盐0.01-6.0、低分子量的透明质酸或/和透明质酸盐0.01-8.0；
    高分子量的聚谷氨酸或/和聚谷氨酸盐0.01-3.0、中分子量的聚谷氨酸或/和聚谷氨酸盐0.01-5.0、低分子量的聚谷氨酸或/和聚谷氨酸盐0.01-10.0；
    所述筋腱肌肉强健剂，由胶原蛋白、胶原蛋白肽、谷氨酰胺、肌醇、磷酸钙和葡萄糖酸钙构成，具体而言：胶原蛋白0.01-8.0、胶原蛋白肽0.01-10.0、谷氨酰胺0.01-7.0、肌醇0.01-5.0、磷酸钙0.01-4.0、葡萄糖酸钙0.01-3.0；
    所述细胞生理功能调理剂，对身体肌肉细胞的生理功能具有重要调节作用，由ATP二钠、细胞色素C、海藻糖、尿囊素、牛磺酸、维生素类和辅酶类物质构成，具体而言：ATP二钠0.01-4.0、细胞色素C 0.001-4.0、海藻糖0.01-8.0、尿囊素0.01-2.0、牛磺酸0.01-4.0；
    维生素VB1 0.01-5.0、维生素VB2 0.01-1.0、烟酰胺0.01-9.0、VB5 0.01-5.0、VB6 0.01-5.0、烟酸0.01-4.0、Vc 0.01-4.0、维生素D 0.01-1.0、Ve 0.01-1.0；
    生物素0.002-1.0、辅酶Q10 0.002-1.0、辅酶I 0.002-2.0、辅酶II 0.002-2.0；
    所述细胞正常生长代谢必需剂，由氨基酸类、糖类、有机酸类物质构成，具体而言：精氨酸0.001-4.0、丝氨酸0.001-4.0、甘氨酸0.001-8.0、谷氨酸0.002-1.0、丙氨酸0.01-6.0、脯氨酸0.001-10.0、羟脯氨酸0.01-4.0、赖氨酸0.001-10.0、谷氨酸钠0.01-2.0；葡萄糖0.001-5.0、蔗糖0.001-5.0；酒石酸0.01-4.0、苹果酸0.01-4.0、柠檬酸0.01-4.0、乳酸0.01-4.0、乳酸盐0.01-4.0。
  6. 如权利要求1所述颈肩腰腿痛用并具强筋健络功能的生物制剂，其特征在于，所述生物制剂，在剂型方面，为液态制剂或固态制剂。
  7. 权利要求1所述肩腰腿痛用并具强筋健络功能的生物制剂在制备颈肩腰腿痛用同时具强筋健络功能制剂中的应用，其特征在于，采用凝胶剂制剂，具体使用时，0.5-2.0ml/次涂抹至患处，1-3次/日。
  8. 权利要求1所述肩腰腿痛用并具强筋健络功能的生物制剂的制备方法，其特征在于，具体包括如下步骤：
    (1)将生物制剂中有效成份按照物料性质及制备的方便性和易制性分为4组，分别称取配方中用量备用，具体而言：
    第一组，大分子糖类化合物、蛋白多肽类化合物；
    第二组，氨基酸类、小分子糖类、有机酸类；
    第三组，维生素辅酶类化合物；
    第四组，除溶剂外其他物料；
    (2)将步骤(1)中称取的第二组物料置于反应釜中，然后加入部分配方量的溶剂，搅拌溶解混匀，静置，除杂后得混合物A；
    (3)将步骤(1)中称取的第三组和第四组物料置于反应釜中，然后加入部分配方量的溶剂，搅拌溶解混匀，静置，除杂后得混合物B；
    (4)将步骤(3)的混合物B缓慢加入到步骤(2)的混合物A中，加入完成后，加入步骤(1)中称取的第一组物料成分，最后加入剩余部分配方量的溶剂，溶解混匀、过滤除杂，调节pH＝3.5～6.5，此即为本申请所提供生物制剂产品。
  9. 如权利要求8所述肩腰腿痛用并具强筋健络功能的生物制剂的制备方法，其特征在于，步骤(2)、步骤(3)、步骤(4)中进行溶解混匀操作时，操作温度不高于45℃，不低于15℃；采用真空条件下的均质乳化方式进行操作。
PCT/CN2018/098467 2018-07-30 2018-08-03 一种颈肩腰腿痛用并具强筋健络功能的生物制剂 WO2020024247A1 (zh)

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CN101583710A (zh) * 2006-04-14 2009-11-18 都灵大学德利研究所 用于再生软骨组织的培养基和药物组合物、相关方法、用途和产品
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