CN1098705C - Oral medicine for treating cranial nerve system disease and preparation process thereof - Google Patents
Oral medicine for treating cranial nerve system disease and preparation process thereof Download PDFInfo
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- CN1098705C CN1098705C CN99126220A CN99126220A CN1098705C CN 1098705 C CN1098705 C CN 1098705C CN 99126220 A CN99126220 A CN 99126220A CN 99126220 A CN99126220 A CN 99126220A CN 1098705 C CN1098705 C CN 1098705C
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Abstract
The present invention discloses an oral medicine for treating cranial nerve system diseases, which is prepared by using cranial nerve nutrition factors as main materials and using traditional Chinese medicines, such as milkvetch root, ginseng, royal jelly, etc., as auxiliary materials. The preparation method comprises the following steps: fresh goat brain tissues are homogenized, repeatedly frozen and dissolved, treated by acidolysis, neutralized and centrifugated to take supernatant liquid, the supernatant liquid is separated and purified, biological active components are mixed, and then, the cranial nerve nutrition factors are prepared; subsequently, ginseng slices are soaked in water to be filtered, the filtered liquid is distilled, and then, the distilled liquid is concentrated and alcoholized to obtain ginseng liquid; milkvetch root slices are soaked in alcohol many times to obtain milkvetch root liquid; honey is heated and filtered, the royal jelly is added to the honey to be stirred, white sugar, the ginseng, liquid, the milkvetch root liquid, a sorbic acid alcoholic solution and the concentrated liquid of the cranial nerve nutrition factors are orderly added, and then, the content of distilled water is replenished to the needed content; finally, the mixture is stirred, filtered and separately packed.
Description
The present invention relates to a kind of treatment nervous system disease, especially to a kind of oral drugs of serious symptom convalescent, be major ingredient specifically with a kind of novel cranial nerve trophic factors, with Chinese medicine is the treatment nervous system disease of adjuvant, the oral liquid of rehabilitation brain, brain-strengthening, supplementing the brain the invention still further relates to manufacturing method for above mentioned medicine.
The nervous system disease of indication of the present invention is meant people's brain system because of the dysfunction that wound, pathological changes, aging or congenital malformation produce, and is the common frdquently encountered disease of serious harm human health.According to interrelated data, China's cerebral nervous system disease incidence accounts for 18.4 ‰ of population, and mentally retarded child's sickness rate accounts for 22.2 ‰, the sickness rate of senile disease accounts for 10% of aging population, add wound, the convalescent of apoplexy or the like and these diseases, Estimate of Total Number can reach more than one hundred million populations.
Before 10 years, the oral drugs that above disease is treated by China almost have only oryzanol a kind of (existing be eliminated substantially), and the oral drugs in the above disease of treatment of clinical widespread usage are piracetam and two kinds of Western medicine of health brain spirit at present.The former is owing to play a kind of inhibitory action to cerebral nervous system in therapeutic process, thus in the patient dizziness is arranged always, weak sensation; The latter mainly is the supplementary of several amino acids, and they can not reach better clinical effectiveness, can not satisfy the needs of present clinical treatment nervous system disease far away.
The inventor through for many years medical experiment and clinical experience find with Chinese medicine astragalus QI invigorating, rise blood, precipitation, the effect of the QI invigorating of Radix Ginseng, Lac regis apis, brain-strengthening, the kidney invigorating, strengthening the body resistance, in addition with the activation neurocyte of cranial nerve trophic factors, promote the characteristics of neuranagenesis, can improve clinical efficacy greatly, reach the purpose for the treatment of both the principal and secondary aspects of a disease.
The object of the present invention is to provide a kind of is core with the cranial nerve trophic factors, is aided with Chinese medicine ingredients, brings into play maximum property function, and cheap, easy to use oral liquid medicine.
The present invention also provides the method for preparing above-mentioned treatment nervous system disease oral liquid medicine.
The medicament of treatment nervous system disease of the present invention is characterized in that, it is the medicament made by following raw material (below be weight ratio):
Dry Medulla caprae seuovis neurotrophic factor 0.06-0.12
Radix Ginseng 0.2-0.35 Lac regis apis 0.2-0.35
Radix Astragali 0.3-0.55 Mel 8-12
Sorbic acid 0.012-0.014 white sugar 0.02-0.03.The pharmacy optimization composition of raw materials for preparing above-mentioned treatment cerebral nervous system disease is:
Dry Medulla caprae seuovis neurotrophic factor 0.06-0.1
Radix Ginseng 0.25-0.35 Lac regis apis 0.25-0.35
Radix Astragali 0.45-0.55 Mel 9-12
Sorbic acid 0.012-0.014 white sugar 0.02-0.03.
The medicament optimum feed stock prescription for preparing above-mentioned treatment nervous system disease is:
Dry Medulla caprae seuovis neurotrophic factor 0.08
Radix Ginseng 0.3 Lac regis apis 0.3
The Radix Astragali 0.5 Mel 10
Sorbic acid 0.013 white sugar 0.025.
Described medicament is an oral liquid.
The preparation method of the medicine of above-mentioned treatment cerebral nervous system disease, undertaken by following step successively:
The preparation of A cranial nerve trophic factors
Get fresh Medulla caprae seuovis, freeze moltenly behind the homogenization repeatedly, acidolysis again, be neutralized to PH=7, centrifugal absorption supernatant, separation and purification merges the biological activity component, filter membrane degerming, cold preservation.
The preparation of B Chinese medicine adjuvant
Get Radix Ginseng section, add water retting after, filter, distillate is collected in the filtrate distillation, device is preserved in addition; Filtering residue decocts with water 3 times, filters, and distillate is collected in the filtrate distillation, merges distillate, concentrates, and adds ethanol and stirs, and leaves standstill, and gets supernatant; Residue adds ethanol, stirs, and leaves standstill, and gets supernatant; The low-temperature preservation ginseng liquid reclaims ethanol; Get Radix Astragali section and clean, add 40% ethanol, soak, filter, reserved filtrate, medicinal residues add 40% soak with ethanol again, filter, and reserved filtrate, merging filtrate removes the low-temperature preservation astragalus liquid; Remove medicinal residues, reclaim ethanol;
The preparation of C finished product
Be dissolved in 95% ethanol sorbic acid standby; Mel is heated 95-100 ℃, be incubated 20 minutes, filter, cool the back and add ground Lac regis apis, stir and add white sugar and above-mentioned ginseng liquid, astragalus liquid, sorbitol solution, cranial nerve trophic factors concentrated solution successively, add distilled water at last to aequum, stirred 1 hour, filter to clear and bright sterilization, packing.
Characteristics of the present invention are to contain abundant activation neurocyte in the medicine of the present invention, promote nerve growth, defying age, the effective ingredient of adjusting vital functions.
Fixed through the XXXXXX of Beijing, contain following composition (gram) in every preparation (10 milliliters):
Title content
Polypeptide 0.1
Aminoacid 0.65
Radix Ginseng total saponins 0.06
Flavonoid 0.1
Polysaccharide 3.8
Protein 0.08
The chemical characteristic of medicine midbrain neurotrophic factor of the present invention: the biological activity component at the thick product of supernatant component that is passed through acidolysis, neutralization, centrifugal acquisition by total homogenate is responsive to trypsin, shows that the peptide class is a main component in this factor.The biological activity component that exists in the thick product of above-mentioned supernatant abstract elutes on the SephadexG-50 post, and elution time is similar to cytochrome C, shows that the isoelectric level of bioactive molecule is similar to cytochrome C, promptly about 10-10.5.Resulting biological activity component is carried out the SDS-PAGE electrophoresis, and the situation of movement of the signal band of the bioactive substance that is obtained by the TSK-CM-35W post is close with the standard lysozyme, thereby the macromolecule that has is 10KD.
Medicine of the present invention is based on following drug effect principle:
1, promote neurotrophy: the cranial nerve trophic factors is that a group belongs to the nature generation, has the polypeptide to the cranial nerve specific action.It mainly acts on and is to promote neuronic differentiation (formation of aixs cylinder and dendron), keeps the integrity (metabolism of specific Transmitter) of neurocyte and prevents the degeneration (protection that avoids damaging) of neurocyte.The cranial nerve trophic factors in the medicine of the present invention and the Radix Astragali have the effect that promotes growth to the maincenter neurocyte different with peripheral nervous system, and this effect be along with this factor what and decide.Medicine of the present invention is a kind of trophic nerve that has, the regenerated medicine of stimulating neuronal, it can induce neuronic differentiation, keep neuronic survival, and the neuroprotective cell is avoided ischemia and toxic injury, it is high degree of specificity that immunohistochemical method discloses its effect, and it can reach following effect: prevent that 1. free radical from generating; 2. protect vulnerable Hippocampus CA1 cone cell; 3. prevent the generation of cytotoxic edema; 4. stablize the microcirculation of brain; 5. reduce the mortality rate of acute cerebral ischemia.
2, regulate function of nervous system: electric physiology shows that medicine of the present invention has persistent electric physiological effect (secular current potential enhancement effect) for Hippocampus and cortex cell, and this electric physiological effect can be used as the foundation of judging learning process usually.Histological studies show that, medicine of the present invention can obviously promote the formation of Hippocampus taper nerve synapse.Zoopery shows that also medicine of the present invention can obviously improve the learning capacity of animal, and the multinomial Radix Astragali, the Lac regis apis of experiment showed, all has this function.
3, regulate nerve metabolism: brain tissue slice and homogenate research experiment show that medicine of the present invention can improve the energy metabolism of aerobic, can improve protein synthesis in addition and improve the function of the exchanging pump in the cell plasma.In addition, medicine of the present invention in vivo can obviously reduce the concentration of lactic acid in the brain, illustrates that medicine of the present invention has protective effect for ischemia or anoxybiotic accident.Because the lactic acid concn in the brain reduces, oxygen-derived free radicals is reduced, therefore neuronic mitochondrion is difficult for suffering damage.Medicine midbrain neurotrophic factor of the present invention, the Radix Astragali, Lac regis apis, Mel all have the function of tangible defying age and tissue repair.
We have carried out toxicity or dysgenic experiment to the invention described above medicine with animal, and the result is as follows:
1. acute toxicity testing: when using medicine of the present invention, the rat oral administration gavage is to 2000mg (pharmaceutical quantities)/kg (Mus body weight), and the mice oral administration gavage is during to 3000mg/kg, observes in 3 days, all do not have any untoward reaction.
2. long term toxicity test: with rat medicine of the present invention is carried out long term toxicity test, dosage is 5,25,125mg/kg, 26 weeks of oral medication, when 13 weeks, put to death the part animal, and blood biochemical, urine chemical examination are all normal as a result.Medication treated animal body weight, brain are heavy, liver focuses on 13 weeks of medication and it is fast all to increase than matched group in 26 weeks, but histopathological examination (comprising stomach) is not found pathological changes.And people's dosage is 0.3mg/kg/ days, is zooperal 1/416th.Prove that safety of medicine of the present invention is reliable.
Medicine of the present invention is inner preparation in nineteen ninety-five by Beijing XXXXXX approval, on probation to hundreds of patients in XXXXXX and two hospitals of XXXXXX through 3 years, cerebral trauma convalescent period, cerebral trauma nerves reaction are wherein arranged, lacunar infarction, apoplexy convalescent period, senile dementia, post-operative recovery, all kinds of patients such as migraine, age was not waited in 5-91 year, and the men and women all has, and the observation of carrying out system relatively.Curative effect is very satisfied as a result.
For the curative effect of medicine of the present invention is described, elitely select following three groups of patients contrast, first group is experimental group, uses medicine of the present invention to treat, oral 10ml/ time, 3 times/day.Second group is matched group 1, uses and buys from Beijing XXXXXX pharmaceuticals, by the Western medicine piracetam treatment of XXXXXX current year's production, 0.4g/ time, 3 times/day.The 3rd group is matched group 2, uses from Beijing XXXXXX pharmaceuticals and buys by the clever treatment of the Western medicine health brain of XXXXXX current year's production, 3g/ time, 3 times/day, three groups of therapeutic outcomes is compared.1. brain traumatic nerves reaction patient contrast:
This group patient is patient with brain trauma, CT examination is not found organic disease, but symptoms such as tangible headache, dizziness, nauseating, weak, insomnia, spirit difference are arranged all, the injured time is all in 1 week, age is in 20-42 year, each patient is with above-mentioned dosage treatment 10 days, measures above-mentioned symptom whether complete obiteration in treatment back after 10 days.The contrast of table 1. brain traumatic nerves reaction patient:
2. lacunar infarction patient contrast:
| Group | Case | Treatment back transference cure number | Cure rate % |
| Experimental group | 20 | 19 | 95％ |
| Matched group 1 | 20 | 6 | 30％ |
| Matched group 2 | 20 | 12 | 60％ |
This group patient all confirms at Interhemispheric different parts the lacunar infarction focus is arranged through CT, all patients all have symptoms such as dizziness, weak, spirit difference, disease time is all in 3 months, age 43-61 is between year, the men and women all has, each patient is with above-mentioned dosage treatment 20 days, measures above-mentioned symptom whether complete obiteration in treatment back in the time of 20 days.
3. the convalescent treats contrast after the operation of opening cranium:
| Group | Case | Treatment back transference cure number | Cure rate % |
| Experimental group | 10 | 9 | 90％ |
| Matched group 1 | 10 | 1 | 10％ |
| Matched group 2 | 10 | 4 | 40％ |
This group patient is all because of a variety of causes operation of opening cranium, it is all smooth to perform the operation, effective, this group patient all leaves after-operation response symptoms such as headache, dizziness, hypomnesis, sleep be bad 3 months after surgery the time, age 16-58 year, the men and women all has, and each patient measures above-mentioned symptom disappearance situation with above-mentioned dosage treatment 20 days in the time of 20 days.
| Group | Case | Treatment back transference cure number | Cure rate % |
| Experimental group | 10 | 8 | 80％ |
| Matched group 1 | 10 | 2 | 20％ |
| Matched group 2 | 10 | 2 | 20％ |
Experiment statistics shows that medicine of the present invention has the obvious treatment effect to the recovery of cerebral nervous system disease.Especially be apparent that the patient that all use medicine of the present invention, the mental status, ability of thinking, sleep quality all have very large improvement after the medication.
Embodiment
Get: dry cranial nerve trophic factors 8 grams;
Radix Ginseng 30 grams;
The Radix Astragali 50 grams;
Lac regis apis 30 grams;
Mel 1000 grams;
Sorbic acid 1.3 grams;
White sugar 0.25 gram; (1) preparation of cranial nerve trophic factors:
1. freeze molten: with fresh Medulla caprae seuovis, about 60 grams of the every batch of goods break into homogenate with the phosphate buffer of 3 times of volumes ,-20 ℃ freezing after, under 20 ℃ of conditions, melt.More than repeat 5 times, to quicken protein cleavage.
2. acidolysis: freeze the homogenate after molten,, places 80 ℃ of water-baths heating, splash into the hydrochloric acid of 5N in the heating process simultaneously gradually, do not cutoff and give vibrations stirring 3-4 hour, acidolysis with 2 times of phosphate buffer dilutions;
3. neutralization: with the acidolysis diluent, splash into the coarse adjustment of 1N sodium hydroxide earlier, it is neutralized to PH7-7.2, neutralizer is placed the natural cooling that spends the night near the sodium hydroxide of reuse 0.1N after the scope.
4. centrifugal: that refrigerative neutralizer centrifugal (15000rpm, 10 minutes) is drawn supernatant;
5. separation and purification: the post gel with Sephadex G-100 filters the post ultrafiltration of reuse Sephadex G-50 earlier.In the monitoring of A280 place, merge biological active component with spectrophotometer;
6. degerming: in the degerming jar, successively use the filter membrane degerming 2 times of 0.5 micron and 0.2 micron, the 30ml that the method for using obtains (about 40 grams) cranial nerve trophic factors concentrated solution is placed on 0 ℃ and preserves down.Necessity is it to be prepared into dry powder (about 8 grams).(2) preparation of Chinese medicine adjuvant
1. ginseng liquid preparation: get Radix Ginseng 30g section, add water retting after, filter, the filtrate distillation, it is an amount of to collect distillate, device is preserved in addition; Filtering residue decocts with water 3 times, and each 1 hour, filter, the filtrate distillation merges distillate, is concentrated into about 400ml, puts coldly, adds ethanol 800ml, and stirring is left standstill, and gets supernatant, the low-temperature preservation ginseng liquid; Reclaim ethanol;
2. astragalus liquid preparation: get the Radix Astragali 50 gram sections and clean, add 40% ethanol 150ml, under 35-60 ℃ of temperature, soaked 10 days, filter; Medicinal residues add 40% ethanol 100ml again and soak; Condition and time are the same.Merging filtrate goes medicinal residues to reclaim ethanol, makes immersion content reach 250ml, replenish from reclaiming ethanol liquid as deficiency, and stand at low temperature, standby.(3) finished product preparation
Be dissolved in 95% ethanol sorbitol 1.3g standby.The Lac regis apis 30 of getting PH3.5-4.5 restrained in grinding in ball grinder after 48 hours, and stand at low temperature is standby.Mel is heated to 95-100 ℃, be incubated 20 minutes, filter, cool the back and add ground Lac regis apis, under condition of stirring, add white sugar and above-mentioned ginseng liquid, astragalus liquid, Pyrusussuriensis acid solution, cranial nerve trophic factors concentrated solution successively, add distilled water at last to 1000ml, stir and filtered to clear and bright packing in 1 hour.Make 100 of every 10ml medicines of the present invention.
Claims (8)
1. a medicament for the treatment of the cerebral nervous system disease is characterized in that, it is the medicament of being made by following raw material:
Dry Medulla caprae seuovis neurotrophic factor 0.06-0.12
Radix Ginseng 0.2-0.35 Lac regis apis 0.2-0.35
Radix Astragali 0.3-0.55 Mel 8-12
Sorbic acid 0.012-0.014 white sugar 0.02-0.03.
2. according to the medicament of the treatment cerebral nervous system disease of claim 1, it is characterized in that it is the medicament of being made by following raw material:
Dry Medulla caprae seuovis neurotrophic factor 0.06-0.1
Radix Ginseng 0.25-0.35 Lac regis apis 0.25-0.35
Radix Astragali 0.45-0.55 Mel 9-12
Sorbic acid 0.012-0.014 white sugar 0.02-0.03.
3. according to the medicament of the treatment cerebral nervous system disease of claim 1 or 2, it is characterized in that it is the medicament of being made by following raw material:
Dry Medulla caprae seuovis neurotrophic factor 0.08
Radix Ginseng 0.3 Lac regis apis 0.3
The Radix Astragali 0.5 Mel 10
Sorbic acid 0.013 white sugar 0.025.
4. according to the medicine of claim 1,2 or 3 treatment cerebral nervous system disease, it is characterized in that described dry cranial nerve trophic factors is that fresh Medulla caprae seuovis is made the cranial nerve trophic factors.
5. any medicine for the treatment of the cerebral nervous system disease that requires according to aforesaid right is characterized in that described medicament is an oral liquid.
6. the preparation method of the medicine of any treatment cerebral nervous system disease that requires according to aforesaid right, undertaken by following step successively:
The preparation of A cranial nerve trophic factors
Get fresh Medulla caprae seuovis, freeze moltenly behind the homogenization repeatedly, acidolysis again, be neutralized to PH=7, centrifugal absorption supernatant, separation and purification merges the biological activity component, filter membrane degerming, cold preservation.
The preparation of B Chinese medicine adjuvant
Get Radix Ginseng section, add water retting after, filter, distillate is collected in the filtrate distillation, device is preserved in addition; Filtering residue decocts with water 3 times, filters, and the filtrate distillation, merging filtrate concentrates, and adds ethanol and stirs, and leaves standstill, and gets supernatant, and the low-temperature preservation ginseng liquid reclaims ethanol; Get Radix Astragali section and clean, add 40% ethanol, soak, filter reserved filtrate; Medicinal residues add 40% soak with ethanol again, filter, and the reserved filtrate merging filtrate, the low-temperature preservation astragalus liquid removes medicinal residues, reclaims ethanol;
The preparation of C finished product
Be dissolved in 95% ethanol sorbitol standby; Mel is heated 95-100 ℃, be incubated 20 minutes, filter, cool to room temperature, add Lac regis apis, stir and to add white sugar and above-mentioned ginseng liquid, astragalus liquid, sorbic acid solution, cranial nerve trophic factors concentrated solution successively, add distilled water at last to requirement, stirred 1 hour, filter to clear and bright, packing gets medicine of the present invention.
7. according to the preparation method of the medicine of the treatment cerebral nervous system disease of claim 6, it is characterized in that the concentrated solution that fresh Medulla caprae seuovis makes is used 5 μ m and 2 degerming of 2 μ m filter membranes in proper order.
8. treat the method for the medicine of cerebral nervous system disease according to the described preparation of claim 6 or 7, it is characterized in that described medicament is an oral liquid.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN99126220A CN1098705C (en) | 1999-12-15 | 1999-12-15 | Oral medicine for treating cranial nerve system disease and preparation process thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN99126220A CN1098705C (en) | 1999-12-15 | 1999-12-15 | Oral medicine for treating cranial nerve system disease and preparation process thereof |
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| Publication Number | Publication Date |
|---|---|
| CN1256948A CN1256948A (en) | 2000-06-21 |
| CN1098705C true CN1098705C (en) | 2003-01-15 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN99126220A Expired - Fee Related CN1098705C (en) | 1999-12-15 | 1999-12-15 | Oral medicine for treating cranial nerve system disease and preparation process thereof |
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| CN (1) | CN1098705C (en) |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2024164927A1 (en) * | 2023-02-09 | 2024-08-15 | Alis Pharma Ltd. | Use of fetal sheep brain extracts for managing neurodegenerative diseases |
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1999
- 1999-12-15 CN CN99126220A patent/CN1098705C/en not_active Expired - Fee Related
Non-Patent Citations (3)
| Title |
|---|
| 中药新药与临床药理5(3) 1994-03-31 贺永清等仙鹿口服液保健作用的临 * |
| 河北中医药学报12(1) 1997-01-31 曹刚等消疲灵口服液的药理毒理学 * |
| 河北中医药学报12(1) 1997-01-31 曹刚等消疲灵口服液的药理毒理学;中药新药与临床药理5(3) 1994-03-31 贺永清等仙鹿口服液保健作用的临 * |
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| CN1256948A (en) | 2000-06-21 |
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