CN104800836B - A kind of Isin glue collagen and its production method and application - Google Patents

Abstract

This invention relates to a fish collagen protein, its production method, and its applications. The fish bone collagen protein, chondroitin sulfate, and a traditional Chinese medicine preparation are mixed uniformly in a weight ratio of 10:3:2. The traditional Chinese medicine preparation is prepared from the following raw materials in the specified proportions: ginkgo leaves, rehmannia root, frankincense, mulberry fruit, deer antler glue, chicken blood vine, psoralea corylifolia, poria cocos, atractylodes macrocephala, dandelion, holly, astragalus root, wolfberry fruit, fleeceflower root, yam, codonopsis root, chuanxiong rhizome, eleutherococcus senticosus, kudzu root, eucommia bark, achyranthes root, tangerine peel, euryale seed, and epimedium. The protein powder produced by this invention exhibits synergistic effects from the various raw materials, making it suitable for osteoporosis and showing promising prospects.

Description

A kind of fish collagen and its production method and application

technical field

The invention relates to the field of medicines, in particular to fish collagen, in particular to fish collagen powder with fish bone collagen as the main raw material and its production method and application.

Background technique

Osteoporosis, or osteoporosis, is a group of bone diseases caused by a variety of reasons. Bone tissue has normal calcification, and the ratio of calcium salt to matrix is normal. It is a metabolic bone lesion characterized by a decrease in the amount of bone tissue per unit volume. . In most cases of osteoporosis, the loss of bone tissue is mainly due to increased bone resorption. Characterized by bone pain and susceptibility to fractures. It is one of the most prominent social and medical problems in the world today, and has attracted widespread attention from the United Nations and countries around the world. Osteoporosis can lead to decreased bone mass and bone strength, and then affected by slight external force or other factors, fractures can occur, which are called osteoporotic fractures. my country is the country with the largest elderly population in the world. At present, there are more than 180 million people over the age of 60, accounting for 13% of the total population, and have rapidly entered the population aging society. The number of patients with osteoporosis and osteoporotic fractures caused by the population aging society was 84 million in 2000; In 2010, there were 140 million people, accounting for 7.9% of the total population, and the incidence rate showed an obvious increasing trend.

The main clinical manifestations of osteoporosis and osteoporotic fractures: weakness of waist and knees, calf cramps, bone pain, shortened body, kyphosis, scoliosis, intolerance to fatigue, weakness of limbs, night sweats due to deficiency heat, etc. In severe cases, the thorax deforms, the chest becomes smaller, and even symptoms such as chest tightness, shortness of breath, cyanosis, and dyspnea appear. Its clinical characteristics: the patients are old, weak in constitution, with severe symptoms, many complications, long course of treatment, poor functional recovery, high disability rate and high mortality rate. Minor trauma can cause spinal compression fractures, hip fractures, distal radius fractures, proximal humerus fractures, distal humerus fractures, ankle fractures, tibial plateau fractures, and distal femur fractures. Due to reduced activity or long-term bed rest, lung infection, urinary system infection, pressure sore, deep vein thrombosis of lower extremities, pulmonary embolism, multiple organ failure and other serious complications are prone to death. It not only brings great physical and mental pain to patients and families, but also brings huge expenses of treatment costs and heavy economic burden to patients and families.

In terms of Western medicine treatment: some first-line special drugs have a long treatment cycle, slow effect, and large side effects; some new drugs have unreasonable therapeutic efficacy, many restrictions, and low compliance with medication; surgical treatment of osteoporotic fractures has high risks and many complications , expensive and many other factors. Some patients received irregular treatment, and even chose to interrupt treatment or give up treatment. During the course of clinical treatment, the patient's bone mass continued to decrease, bone strength continued to decline, and slight external force could cause fracture or re-fracture. "Returning to poverty" phenomenon , significantly increasing the morbidity and mortality of patients. Seriously affected the progress of the national osteoporosis prevention and control project and the implementation of the national health plan, and aggravated the hot and prominent issues in the population aging society.

Contents of the invention

The purpose of the present invention is to overcome the deficiencies in the background technology, combine a large number of ancestral prescriptions and one's own medical practice for many years, through the research on traditional Chinese medicine, combined with dialectical argumentation, collect the strengths of many families, seek the best treatment plan, according to materialistic The philosophy of dialectics and traditional Chinese medicine "kidney governs bones, stores essence, and produces bone marrow"; "liver governs tendons, stores blood, and governs catharsis"; "Asthenia", "kidney deficiency", "kidney deficiency leads to bone loss and bone atrophy, resulting in bone pain"; disgraceful", "easy to fracture". "Kidneys are vital to the bones", "Bone marrow is biochemically active, and the bones are well nourished, strong and powerful". "Qi is the master of blood, blood is the mother of qi", "qi stagnation leads to blood stasis, qi flow leads to blood flow"; "qi is respected by behavior, and blood is valued by life"; "Consolidation will dissipate it", "loss will benefit it", "deficiency will replenish it"; "stasis removal, regeneration, bone union". "preventive treatment of disease" and other important basic theories. Insist on nourishing the kidney and nourishing the liver, and the five internal organs; nourishing yin and warming yang, nourishing both qi and blood; harmonizing body fluid, nourishing marrow and promoting bone; treating both symptoms and root causes.

To achieve the above object, the technical scheme adopted in the present invention is as follows:

A protein powder for osteoporosis with fish collagen as the main component, which is uniformly mixed with fish bone collagen powder, chondroitin sulfate powder, and traditional Chinese medicine preparations in a weight ratio of 10:3:2;

The traditional Chinese medicine preparation is prepared from the following raw materials:

Ginkgo biloba, rehmannia glutinosa, frankincense, mulberry, staghorn gum, Millet Spatholobus, psoralen, Poria cocos, Atractylodes macrocephala, dandelion, Sijiqing, astragalus, medlar, Polygonum multiflorum, Chinese yam, Codonopsis pilosula, Chuanxiong, Acanthopanax, Pueraria, Eucommia, Achyranthes bidentata, Chenpi, Gorgon, Epimedium.

Preferably, the traditional Chinese medicine preparation is prepared from the following raw materials in weight ratio:

35 parts of ginkgo leaves, 35 parts of Rehmannia glutinosa, 35 parts of frankincense, 35 parts of mulberries, 30 parts of antler gum,

30 parts of Caulis Spatholobus, 30 parts of Psoralen, 30 parts of Poria cocos, 28 parts of Atractylodes macrocephala, 28 parts of dandelion,

25 parts of Sijiqing, 25 parts of Astragalus membranaceus, 25 parts of medlar, 25 parts of Polygonum multiflorum, 22 parts of Chinese yam,

Codonopsis 20, Chuanxiong 20, Acanthopanax 20, Pueraria 15, Eucommia 15,

10 parts of Achyranthes knuckles, 10 parts of tangerine peel, 10 parts of gorgon, 10 parts of epimedium.

The preparation method of described Chinese medicine preparation is as follows:

Take by weighing above-mentioned crude drug according to above-mentioned weight for subsequent use:

(1) Take Ginkgo biloba leaves, Sijiqing, Astragalus, Polygonum multiflorum, Codonopsis pilosula, Gorgon fruit, and Epimedium and mix them according to the stated ratio, add 95% ethanol (volume ratio) relative to 3 times the weight of the mixture, and reflux extraction twice, each time After 0.5 hours, the extracts were combined, concentrated to a clear paste with a density of 1.2g/ml, dried at 80°C, and crushed into powder;

(2) Take the remaining ingredients and add 3 times the weight of water to decoct twice, the first time for 2 hours, and the second time for 1 hour (also add 3 times the weight of water), combine the two decoctions, dry under reduced pressure to obtain a density of 1.2g/ml extract, crushed into powder;

(3) Mix the powder prepared in step (1) and step (2) evenly.

Dosage: 3 grams of protein powder each time, 3 times a day, one month is a course of treatment, 1-3 courses of treatment are taken continuously.

70-80% of the organic matter in the bone is collagen. When the bone is formed, it must first synthesize enough collagen fibers to form the framework of the bone, and the amino acid and hydroxyproline of the collagen are the vehicles for transporting calcium to the bone cells in the plasma. Tool, collagen in bone cells is the binder of calcium hydroxyphosphate. Together with calcium hydroxyphosphate, it forms the main body of bone. When a person enters middle-aged and old age, the quality of collagen in the bone becomes worse and worse, and the amount becomes less and less. It cannot effectively bind all the calcium hydroxyphosphate together. At this time, osteoporosis will occur. Fish collagen has been proven The effect of replenishing soft tissue structure can be achieved by oral administration.

The present invention mixes fish collagen and traditional Chinese medicine preparations, and through reasonable compatibility, fully exerts the unique performance and efficacy of each raw material itself, and takes into account the complementary effects between each other; through the synergistic effect of each raw material, its medicinal effect Complement each other and achieve the best match with each other.

The components of the medicine of the present invention all adopt natural traditional Chinese medicine raw materials, which are easy to prepare, have a wide range of medicine sources, and are low in cost. The application prospect is broad.

detailed description

Example 1:

A fish collagen, which is uniformly mixed with fish bone collagen, chondroitin sulfate, and traditional Chinese medicine preparations in a weight ratio of 10:3:2;

The traditional Chinese medicine preparation is prepared from the following raw materials in weight ratio:

35 parts of ginkgo leaves, 35 parts of Rehmannia glutinosa, 35 parts of frankincense, 35 parts of mulberries, 30 parts of antler gum,

30 parts of Caulis Spatholobus, 30 parts of Psoralen, 30 parts of Poria cocos, 28 parts of Atractylodes macrocephala, 28 parts of dandelion,

25 parts of Sijiqing, 25 parts of Astragalus membranaceus, 25 parts of medlar, 25 parts of Polygonum multiflorum, 22 parts of Chinese yam,

Codonopsis 20, Chuanxiong 20, Acanthopanax 20, Pueraria 15, Eucommia 15,

10 parts of Achyranthes knuckles, 10 parts of tangerine peel, 10 parts of gorgon, 10 parts of epimedium.

The preparation method of described Chinese medicine preparation is as follows:

Take by weighing above-mentioned crude drug according to above-mentioned weight for subsequent use:

(1) Take Ginkgo biloba leaves, Sijiqing, Astragalus, Polygonum multiflorum, Codonopsis pilosula, Gorgon fruit, and Epimedium and mix them according to the stated ratio, add 95% ethanol (volume ratio) relative to 3 times the weight of the mixture, and reflux extraction twice, each time After 0.5 hours, the extracts were combined, concentrated to a clear paste with a density of 1.2g/ml, dried at 80°C, and crushed into powder;

(2) Take the remaining ingredients and add 3 times the weight of water to decoct twice, the first time for 2 hours, and the second time for 1 hour (also add 3 times the weight of water), combine the two decoctions, dry under reduced pressure to obtain a density of 1.2g/ml extract, crushed into powder;

(3) Mix the powder prepared in step (1) and step (2) evenly.

Dosage: 3 grams each time, 3 times a day, one month is a course of treatment, take 1-3 courses of treatment continuously.

Example 2

Animal experiment

Experimental Animals 40 BABc mice, half male and half female, clean grade, weighing 20-22 g, were provided by the Animal Center of Municipal People's Hospital. They were randomly divided into 4 groups with 10 rats in each group, namely blank control group 1, model control group 2, drug group 3 of Example 1, and control drug group 4. Except for group 1 which was given normal saline, the rest of the groups were given dexamethasone 1 mg/kg, injected every three days, intramuscularly, and combined with retinoic acid, 70 mg/kg per day, for three weeks.

Administration method During the modeling period, except that the blank control group and the model control group were administered intragastrically with equal volume of normal saline, the drug group of Example 1 of the present invention was administered by intragastric administration, with a dose of 0.5g/kg, three times a day, and the control drug The group used the drug Xianling Gubao Capsules, the dose was 0.5g/kg, three times a day. Three weeks after the administration, the number of writhing was detected, and then the mice were sacrificed. The mice were neck-cut to collect blood, centrifuged to obtain serum, and an automatic biochemical analyzer was used to detect the S-Ca (serum calcium) content. See Table 1 below:

Table 1

group S-Ca (mmol/L) Number of twists (times/15 minutes) Blank control group 2.03±0.17 Model control group 4.15±1.03 55±14 Embodiment 1 drug group 2.47±0.51 13±3 control drug group 2.85±0.67 21±4

It can be seen from Table 1 that compared with the blank group, the S-Ca of the model group was greatly increased, and the number of writhing was increased. The difference was obvious, indicating that the modeling was successful. The drug group of Example 1 of the present invention is significantly better than the control drug group, that is, the calcium content in the serum is reduced, P<0.01, indicating that the loss of calcium is reduced, and it is suggested that the drug of the present invention has a better analgesic effect.

Example 3

clinical information

131 patients with osteoporosis were selected from the outpatient cases and randomly divided into treatment group and control group, with 66 patients in the treatment group and 65 patients in the control group.

The treatment group was given the protein powder prepared in Example 1 of the present invention, 3 grams each time, 3 times a day, one course of treatment a month, and took 2 courses of treatment continuously;

The control group received conventional drug Xianling Gubao Capsules (Guizhou Tongjitang Pharmaceutical Co., Ltd.). Take orally, 3 capsules each time, 2 times a day, divided into morning and evening warm water delivery, the course of treatment is two months.

Efficacy Evaluation Criteria

Diagnostic criteria

①Diagnostic criteria of Western medicine: refer to the "Recommended Diagnostic Criteria for Chinese Osteoporosis (Second Draft)" formulated by the Osteoporosis Diagnostic Criteria Group of the Osteoporosis Committee of the Chinese Gerontological Society in October 1999 (Chinese Journal of Osteoporosis, Volume 6, Issue 1, 2000)

②Diagnostic criteria of traditional Chinese medicine: formulated in accordance with the assessment requirements of the "Guiding Principles for Clinical Research of New Chinese Medicines for the Treatment of Osteoporosis" in the "Guiding Principles for Clinical Research of New Chinese Medicines" (trial version in 2002). Symptoms: Lumbar spine pain, soreness and weakness, difficulty walking, dizziness, lack of stability, reddish or pale tongue, thin or white tongue coating, deep thready pulse, etc. Osteoporosis sees the above symptoms.

Efficacy evaluation criteria:

Refer to "Chinese Journal of Osteoporosis", "Practical Orthopedics" and other evaluations.

Cure: clinical symptoms and signs disappear, function returns to normal, and no recurrence for more than one year;

Significant effect: the clinical symptoms and signs are obviously relieved, and the function basically returns to normal;

Effective: partial relief of clinical symptoms and signs;

Ineffective: continuous treatment for more than 30 days, no change in symptoms and signs.

The treatment results are shown in Table 2:

Table 2

group cure markedly effective efficient invalid total effective rate therapy group 26 twenty two 11 7 89% control group 10 18 16 twenty one 67%

It can be seen that the treatment group is significantly different from the control group in terms of cure rate and total effective rate.

Example 4

Typical cases:

Shen, male, 63 years old. Low back pain for many years, sometimes mild and sometimes severe, and the condition worsened in the past month. Unbearable low back pain, numbness and pain in both hips and lower limbs, unable to stand for long periods of time and walk normally, obvious fear of cold in the waist and legs, obvious left leg, poor sleep, normal diet, normal urination and normal stool. Given the fish collagen powder prepared in Example 1, the symptoms were alleviated after one course of treatment, and the symptoms disappeared after continuing to take two courses of treatment. The disease has not recurred for more than one year after stopping the drug observation, which is a cure.

The above-mentioned traditional Chinese medicines used in the present invention are compatible with each other, and can exert their synergistic effect on curing diseases. The ingredients of the traditional Chinese medicine raw materials used have medicinal effects, interweaving, mutual promotion and coordination effects. After clinical verification, they are suitable for osteoporosis. This application The traditional Chinese medicine composition has low cost, remarkable curative effect and broad application prospect.

Claims (1)

1. a kind of Isin glue collagen, it is characterised in that the Isin glue collagen is by fish bone collagen albumen, chondroitin sulfate, Chinese medicine Preparation is according to 10：3：Than being well mixed, the Chinese medicine preparation is prepared 2 weight by the raw material that following weight is matched：

35 parts of ginkgo leaf, 35 parts of prepared rhizome of rehmannia, 35 parts of frankincense, 35 parts of mulberry fruit, 30 parts of deer horn glue,

30 parts of reticulate millettia, 30 parts of Psoralea corylifolia, 30 parts of Poria cocos, 28 parts of the bighead atractylodes rhizome, 28 parts of dandelion,

25 parts of Chinese holly, 25 parts of the Radix Astragali, 25 parts of the fruit of Chinese wolfberry, 25 parts of the fleece-flower root, 22 parts of Chinese yam,

20 parts of Radix Codonopsis, 20 parts of Ligusticum wallichii, 20 parts of wilsonii, 15 parts of the root of kudzu vine, 15 parts of the bark of eucommia,

10 parts of the root of bidentate achyranthes, 10 parts of dried orange peel, 10 parts of Gorgon fruit, 10 parts of barrenwort；

The preparation method of the Chinese medicine preparation comprises the following steps：

Each raw material for standby is weighed according to weight：

（1）Ginkgo leaf, Chinese holly, the Radix Astragali, the fleece-flower root, Radix Codonopsis, Gorgon fruit, barrenwort mixing are taken, plus relative to 3 times of weight of mixture 95% ethanol, refluxing extraction 2 times, 0.5 hour every time, extract solution merged, and was concentrated into the clear cream that density is 1.2g/ml, 80 DEG C of bakings It is dry, it is ground into powder；

（2）Surplus stock is taken, is mixed, plus the decocting of 3 times of weight is boiled twice, 2 hours for the first time, second 1 hour, is merged twice Decoction liquor, it is the medicinal extract of 1.2g/ml that drying under reduced pressure obtains density, is ground into powder；

（3）By step（1）And step（2）The powder of preparation is well mixed to be obtained final product.