CN113855707A - Medicine composition for treating femoral head necrosis and application thereof - Google Patents
Medicine composition for treating femoral head necrosis and application thereof Download PDFInfo
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- CN113855707A CN113855707A CN202111328609.8A CN202111328609A CN113855707A CN 113855707 A CN113855707 A CN 113855707A CN 202111328609 A CN202111328609 A CN 202111328609A CN 113855707 A CN113855707 A CN 113855707A
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Classifications
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/63—Arthropods
- A61K35/64—Insects, e.g. bees, wasps or fleas
- A61K35/644—Beeswax; Propolis; Royal jelly; Honey
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L21/00—Marmalades, jams, jellies or the like; Products from apiculture; Preparation or treatment thereof
- A23L21/20—Products from apiculture, e.g. royal jelly or pollen; Substitutes therefor
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/15—Vitamins
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Abstract
The invention discloses a pharmaceutical composition for treating femoral head necrosis and application thereof in preparing products for preventing and/or treating various types of femoral head necrosis. The pharmaceutical composition is prepared from the following raw materials in parts by weight: royal jelly, diclofenac sodium, vitamin B1 and omeprazole, preferably 30-70 parts of royal jelly, 3-7 parts of diclofenac sodium, 3-3 parts of vitamin B11 and 1-3 parts of omeprazole. The pharmaceutical composition can be used for treating various types of femoral head necrosis, particularly femoral head necrosis needing surgical treatment, and has the advantages of less pain and good compliance of patients. The effective rate of treating the femoral head necrosis by adopting the pharmaceutical composition can reach 90.0 percent, and the cure rate can reach 81.7 percent.
Description
Technical Field
The invention belongs to the field of pharmaceutical compositions, and particularly relates to a pharmaceutical composition for treating femoral head necrosis and application thereof in preparing products for preventing and/or treating various types of femoral head necrosis.
Background
Femoral head necrosis is a disease in which the blood supply of the femoral head is interrupted or damaged, so that osteocytes and bone marrow components die and are subsequently repaired, and then the structure of the femoral head is changed, the femoral head is collapsed, and joint dysfunction is caused. Femoral head necrosis (ONFH), also known as Avascularnecrososis (AVN), is a common intractable disease in the orthopedic field. The femoral head necrosis has two reasons, one is traumatic, and the main pathogenic factors include femoral head and neck fracture, acetabular fracture, hip joint dislocation, severe hip sprain or contusion (no fracture, intra-articular hematoma). The second is non-traumatic, and the main causes are corticosteroid drug application, long-term excessive drinking, decompression sickness, hemoglobinopathy (sickle cell anemia, hemoglobinopathy C, thalassemia, sickle cell trait, etc.), autoimmune disease, idiopathic disease, etc. Common causes of non-traumatic femoral head necrosis in China are mainly hormonal femoral head necrosis and long-term heavy drinking.
In the current modes of treating femoral head necrosis, western medicine mostly adopts operation treatment, including femoral head remaining operation of a patient, artificial hip joint replacement, drilling decompression, blood vessel transplantation and the like. The complications after the replacement of the artificial femoral head are difficult to overcome, and the patient can be disabled for the whole life due to infection, looseness, stiff joints, pain and the like. The operation treatment has certain risk and brings great pain to patients. The traditional Chinese medicine mainly treats the diseases in the aspects of dredging blood collaterals, promoting blood circulation, regulating qi, promoting tissue regeneration and relieving pain, but the curative effect is not ideal and the treatment period is long. Therefore, the problem to be solved urgently at present is to provide a pharmaceutical composition which does not need surgical treatment, is convenient and effective, has little pain for patients, good compliance and high effectiveness, and is used for treating femoral head necrosis.
Disclosure of Invention
The invention aims to provide a pharmaceutical composition for treating femoral head necrosis, which can quickly and effectively cure the femoral head necrosis without operation, and has less pain and good compliance of patients.
In order to achieve the aim, the invention provides a pharmaceutical composition for treating femoral head necrosis, which is mainly prepared from the following components in parts by weight: royal jelly, diclofenac sodium, vitamin B1 and omeprazole.
In one embodiment of the present invention, the pharmaceutical composition is prepared from the following components in parts by weight: 30-70 parts of royal jelly, 3-7 parts of diclofenac sodium, 11-3 parts of vitamin B and 1-3 parts of omeprazole.
In one embodiment of the present invention, the pharmaceutical composition is prepared from the following components in parts by weight: 50 parts of royal jelly, 5 parts of diclofenac sodium, 11 parts of vitamin B and 1 part of omeprazole.
In one embodiment of the invention, the pharmaceutical composition is administered orally 2 times a day.
The invention also provides application of the pharmaceutical composition in preparing products for preventing and/or treating various types of femoral head necrosis.
In one embodiment of the invention, the femoral head necrosis is traumatic femoral head necrosis or non-traumatic femoral head necrosis.
In one embodiment of the invention, the product is a pharmaceutical or nutraceutical product.
In the pharmaceutical composition of the present invention, royal jelly (food of queen bee) is one of the most nutritious foods in the natural world, and contains royal jelly acid, 12 proteins, minerals, more than 30 amino acids, more than 20 fatty acids, more than 16 vitamins, trace elements and other various nutrients (10-hydroxy- Δ 2-decenoic acid, various amino acids, proteins, acetylcholine, bioactive enzymes, nucleic acids, various vitamins, trace elements and the like) necessary for human body, and royal jelly has been widely used for comprehensively promoting health status. The royal jelly capsule can promote necrotic femoral head new bone cell and improve microcirculation.
Diclofenac sodium of chemical formula C14H10Cl2NNaO2It belongs to a non-steroidal anti-inflammatory drug and has obvious analgesic, anti-inflammatory and antipyretic effects. The composition has analgesic, antiinflammatory, and antipyretic effects by inhibiting prostaglandin synthesis. Belongs to one of typical representative medicines of anti-inflammatory analgesic medicines, and patients with femoral head necrosis have much pain, and the pain-relieving treatment can improve the life quality of the patients, promote the increase of blood circulation of femoral heads and is beneficial to the cooperative treatment of the patients.
Vitamin B1(Vitamin B1, VB1), also known as thiamine, was the first water-soluble Vitamin purified by humans and was chemically named 3- [ (4-amino-2-methyl-5-pyrimidinyl) -methyl ] -5-2-hydroxyethyl-4-methylthiazolium hydrochloride. Vitamin B1 has effects in maintaining normal glycometabolism and nerve conduction, and can be used as neurotropic medicine for repairing nerve ending, improving local microcirculation, and promoting new bone cell generation.
Omeprazole, chemical name 5-methoxy-2- [ [ (4-methoxy-3, 5-dimethyl-2-pyridyl) methyl ] sulfinyl ] -1H-benzimidazole. Can be used as gastric protection medicine such as proton pump inhibitor for preventing other medicines from damaging gastric mucosa. The four medicines have synergistic effect, promote each other and supplement each other.
Compared with the prior art, the pharmaceutical composition has the effects of promoting necrotic femoral head new bone cells, promoting femoral head blood circulation, improving local microcirculation, facilitating new bone cells, preventing gastric mucosa injury, and can be used for treating various types of femoral head necrosis. In particular to femoral head necrosis which needs to be treated by operation, so that the pain of a patient is less and the compliance is good. The effective rate of the medicine composition can reach 90.0 percent, and the cure rate can reach 81.7 percent.
Detailed Description
Throughout the specification and claims, unless explicitly stated otherwise, the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element or component but not the exclusion of any other element or component.
The following detailed description of specific embodiments of the invention is provided, but it should be understood that the scope of the invention is not limited to the specific embodiments.
Example 1
The medicine composition for treating femoral head necrosis is prepared with the following components in certain weight proportion: 1000mg of royal jelly capsule, 100mg of diclofenac sodium, 120 mg mg of vitamin B and 20mg of omeprazole.
The pharmaceutical composition is orally administered 15 min after meals, 2 times a day, and 10 days as a treatment course.
Example 2
The medicine composition for treating femoral head necrosis is prepared with the following components in certain weight proportion: 1200mg of royal jelly, 80mg of diclofenac sodium, 120 mg mg of vitamin B and 20mg of omeprazole.
Example 3
The medicine composition for treating femoral head necrosis is prepared with the following components in certain weight proportion: 900mg of royal jelly capsule, 90mg of diclofenac sodium, 115 mg of vitamin B and 15mg of omeprazole.
In order to show the treatment effect of the invention on femoral head necrosis, the inventor carries out clinical observation treatment on 600 cases, 300 patients in a test group and 300 patients in a control group, the test group uses the medicament obtained in the example 1, and the control group uses other medicaments for treating femoral head necrosis. 520 of the males and 106 of the females, with the age of 18-74. 216 patients in the first stage, 320 patients in the second stage and 90 patients in the third stage.
The basis of diagnosis is as follows: limping, aching pain of hip and knee, stiff feeling, pain during activity and improvement after rest in the early stage; limited hip activity, the earliest limited rotation, later involved flexion, abduction and adduction, atrophy of limb-replacement muscles; late flexion adduction deformity; x-ray pictures show osteonecrotic changes; the femoral head necrosis is confirmed, and all cases are confirmed to be the first grade, the second grade and the third grade according to staging standards.
The treatment method comprises the following steps: the test group used the drug obtained in example 1 of the present invention and was administered 2 times a day 15 minutes after meals. The control group was administered after meal with other drugs for treating femoral head necrosis.
The curative effect standard is as follows:
and (3) curing: clinical symptoms disappear, the situation of collapse and necrosis of the femoral head disappears through image examination, and the femoral head returns to normal;
the method has the following advantages: the pain is basically eliminated, the joint movement is basically eliminated, the condition of collapse and necrosis of the femoral head is improved through the imaging examination, and the new bone of the femoral head appears;
and (4) invalidation: the pain did not improve and no improvement was seen in the imaging examination.
Accurate statistics and mathematical analysis are carried out on experimental data, and specific experimental results are as follows:
TABLE 1 comparison of the efficacy of the test and control groups
Group of | Administration of drugs | Number of cases | Effective number | High efficiency | Number of cure | Cure rate |
Test group | Example 1 composition | 300 | 270 | 90.0% | 245 | 81.7% |
Control group | Other therapeutic agents | 300 | 238 | 79.3% | 207 | 69.0% |
Proved by verification, the effective rate of the test group is 90.0 percent, the effective rate of the control group is 79.3 percent, and the difference of the curative effect of the test group and the control group is obvious.
Typical treatment cases are:
1. pain at the root of thigh on both sides of Ma-Bi-Zhi, and pain on femoral head on both sides of X-ray film collapse, the pain disappeared after the oral administration of the scheme for 6 months, the walking was normal, and the femoral head on both sides of X-ray film was examined to be normal, and the secondary femoral head necrosis was treated.
2. Pain at the root of thighs on two sides of a certain abalone, difficulty in walking, need to lean on a crutch to see a doctor in a hospital, collapse of femoral heads on two sides is shown by CT, walking is normal after the medicine is taken for 6 months by the scheme, the pain disappears, and the femoral heads on two sides are normal by CT rechecking and the doctor is diagnosed as curing the three-level femoral head necrosis.
3. Li Yi, the pain at the root of the thigh on the left side is diagnosed, the X-ray film shows that the femoral head on the left side is collapsed, the pain disappears after the scheme is used for 6 months, the walking is normal, and the X-ray film shows that the femoral head is normal.
4. When the patient feels pain at the root of the right thigh, the patient sees that the right femoral head is collapsed on the X-ray film, the pain disappears after the patient takes the medicine for 5 months, the patient shows that the femoral head is normal on the X-ray film, and the patient sees that the femoral head necrosis is cured secondarily.
5. Thank for some patients, pain at the root of thighs on both sides is treated, walking is difficult, the patients need to go out by a wheelchair, the pain disappears after the patients are applied for 12 months by the scheme, the patients walk normally, the patients are examined again by the X-ray film to show that the femoral heads disappear and regenerate bone tissues, the femoral heads are recovered to be normal, and the treatment is characterized by three-level femoral head necrosis cure.
6. He Wei, right thigh root pain, lameness, diagnosis, right femoral head collapse on X-ray film, pain disappeared after the scheme is used for 9 months, walking is normal, right femoral head is normal on X-ray film, and diagnosis is secondary femoral head necrosis cure.
The foregoing descriptions of specific exemplary embodiments of the present invention have been presented for purposes of illustration and description. It is not intended to limit the invention to the precise form disclosed, and obviously many modifications and variations are possible in light of the above teaching. The exemplary embodiments were chosen and described in order to explain certain principles of the invention and its practical application to enable one skilled in the art to make and use various exemplary embodiments of the invention and various alternatives and modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims and their equivalents.
Claims (7)
1. The pharmaceutical composition for treating femoral head necrosis is characterized by being mainly prepared from the following components in parts by weight: royal jelly, diclofenac sodium, vitamin B1 and omeprazole.
2. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is prepared from the following components in parts by weight: 30-70 parts of royal jelly, 3-7 parts of diclofenac sodium, 11-3 parts of vitamin B and 1-3 parts of omeprazole.
3. The pharmaceutical composition of claim 2, wherein the pharmaceutical composition is prepared from the following components in parts by weight: 50 parts of royal jelly, 5 parts of diclofenac sodium, 11 parts of vitamin B and 1 part of omeprazole.
4. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is administered orally 2 times a day.
5. Use of a pharmaceutical composition according to any one of claims 1 to 4 for the preparation of a product for the prevention and/or treatment of various types of femoral head necrosis.
6. The use of claim 5, wherein the femoral head necrosis is traumatic femoral head necrosis or non-traumatic femoral head necrosis.
7. Use according to claim 5, wherein the product is a pharmaceutical or nutraceutical product.
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