WO2021249286A1

WO2021249286A1 - New drug formula for immunotherapy and tablet structure thereof

Info

Publication number: WO2021249286A1
Application number: PCT/CN2021/098179
Authority: WO
Inventors: 许新朋
Original assignee: 许新朋
Priority date: 2020-06-11
Filing date: 2021-06-03
Publication date: 2021-12-16
Also published as: CN113181131A; CN111544410A

Abstract

A new drug formula for immunotherapy and a tablet structure thereof. According to the diagnosis and treatment school of thought of the theory of traditional Chinese medicine and the monarch, minister, assistant and guide prescription strategy, a formula principle of an immunopotentiator, an immunity replenisher, an immunomodulator, and/or a specific drug is constructed. The formula can restore and enhance immunity, improve the treatment somatosensory of patients with a cold, reduce the amount of antibiotics and antipyretics, is beneficial for the prevention of immunity damage in human bodies caused by the frequent use of antibiotics, avoids the abuse of antibiotics, and can be used for the treatment and rehabilitation support for various diseases or injuries needing to be supported by the immune system. After a tablet is taken, the internal and external parts can be simultaneously digested by gastric juice, such that the disintegration speed of the tablet is remarkably increased and the drug absorption rate is improved.

Description

A new medicine formula for immunotherapy and its tablet structure

Technical field

The invention relates to the field of medicaments, and more specifically, to a new drug formula for immunotherapy and its tablet structure.

Background technique

The immune system is an important system of the body. It is composed of immune organs, immune cells and immune molecules, and has the functions of recognizing and eliminating antigenic foreign bodies, and coordinating with other systems of the body to maintain the stability of the body's environment and physiological balance. The immune system is the body's most effective weapon against pathogen invasion. It can find and remove foreign bodies, foreign pathogenic microorganisms and other factors that cause environmental fluctuations in the body, but its hyperfunction can also cause damage to its own organs or tissues.

Specifically, the immune system can:

1. Identify and eliminate foreign invading antigens, such as pathogenic microorganisms. This function of preventing external pathogens from invading and eliminating invading pathogens and other harmful substances is called immune defense. Protect the human body from viruses, bacteria, pollutants and diseases.

2. Identify and remove the mutated tumor cells, senescent cells, dead cells or other harmful components in the body. This function of discovering and removing "non-self" components in the body at any time is called immune surveillance. The waste after the elimination of metabolism and the dead and injured corpses left by the immune cells in the fight with the virus must be eliminated by the immune cells.

3. Keep the internal environment of the immune system stable through autoimmune tolerance and immune regulation. Repairing immune cells can repair damaged organs and tissues and restore their original functions.

The immune system is the body's endogenous force to fight infections and diseases. A healthy immune system is irreplaceable. However, diseases, poor diet and living habits, excessive use of antibiotics or invasion of foreign pathogens may all cause damage to the human immune system. In the prior art, the use of vitamin C can improve immunity, strengthen the body's defense against viruses, and has less toxic and side effects. Therefore, the medical profession has tried to use vitamin C to treat colds for a long time, and clinical trials have been carried out on different doses of vitamin C, but its efficacy has not been confirmed by statistics. This suggests that in addition to the dose factor, the reason for the inaccurate efficacy of the use of vitamin C for immunotherapy may be the lack of coordination of certain components.

Not only that, with the abundance of medical resources in contemporary society and the advancement of people's medical concepts, the concept of "go to the hospital when you get sick" has taken root in the hearts of the people. Although this has played a strong role in safeguarding human health and life safety, common infectious diseases such as colds occur frequently, squeezing more medical resources, resulting in: (1) the relative tension of the overall medical resources of the society; (2) High medical costs for patients in terms of money and time.

Common infectious diseases such as colds can also cause excessive use of antibiotics and antipyretics. On the one hand, it is easy to make bacteria resistant to drugs, and on the other hand, it can also lead to a decline in human immunity. Over time, the disease becomes more and more difficult to get better, which in turn leads to more frequent or longer treatment courses of antibiotics, which is in a vicious circle. Excessive use and abuse of antibiotics can also cause environmental pollution. Excessive use of antipyretics can damage the human gastrointestinal mucosa and cardiovascular system. Common infectious diseases such as colds also pose a huge threat to the survival of cancer patients, especially lung cancer patients, and there is an urgent need to find a better treatment plan.

For some tablets used to improve immunity, in order to ensure that the medicine itself is not easy to absorb water and fail and is not easy to break, the compactness of the made tablets is usually large, so it takes a long time to enter the stomach. After being dissolved and further digested and absorbed, the tablets may enter the intestinal tract before being completely dissolved, or be excreted from the body without being completely absorbed, resulting in a decrease in the absorption rate of the tablet and a waste of medicine.

Summary of the invention

Therefore, in view of the poor efficacy of immunotherapy using vitamin C alone in the prior art, the common cold squeezes valuable medical resources, the high cost and time cost of frequent medical treatment for the common cold, excessive use of antibiotics damages immunity, and anti-fever medications. It is often used to damage the gastrointestinal mucosa, and it is difficult for cancer patients to catch a cold. The present invention provides a new drug formula for immunotherapy and its tablet structure, which can restore and enhance immunity, have a strong righting effect, and reduce The use of antibiotics and antipyretics saves medical resources, medical expenses and time costs for medical treatment, and can be applied to the treatment and rehabilitation support of various diseases or injuries that require immune system support.

In order to solve the above-mentioned problems, the present invention constructs a new prescription principle of "immune enhancer + immune supplement + immunomodulator ± specific drug", and proposes a new drug formula for immunotherapy according to the new prescription principle.

The specific technical solutions are as follows:

The first object of the present invention is to provide a new drug formulation for immunotherapy. The basic formula includes an immune enhancer and an immune supplement. The immune enhancer is vitamin C 300-1800 mg, and the immune supplement includes the following Ingredients: L-isoleucine 36-216mg, L-leucine 20-120mg, L-lysine hydrochloride 43.5-261mg, L-phenylalanine 15-90mg, L-threonine 8-48mg, L-valine 12-72mg, L-tryptophan 10-60mg, L-methionine 36-216mg, L-arginine hydrochloride 20-120mg, L-glutamic acid 30-180mg, glycine 50-300mg, vitamins B1 nitrate 15-90mg, vitamin B2 5-30mg, vitamin B6 14-84mg, nicotinamide 30-180mg, folic acid 1-6mg, vitamin E acetate 4-24mg.

Further, the basic prescription of the new drug formula can also form a combined prescription after adding an immunomodulator. The combination prescription includes a combination of wind and heat and a combination of wind and cold. The immunomodulator of the combination of wind and heat can be 3-15g of honeysuckle and 10-30g of honey. The immunomodulator of the combination of wind and cold can be 15-ginger. 45g, 15-45g brown sugar.

Further, the new drug formula can be used for immunotherapy of colds, and the doses in the new drug formula are in the range of daily doses for adults. The dose for children is halved according to the adult dose. The infant dose is converted according to body weight, and the conversion formula is "adult dose/60*infant weight (kg)".

Furthermore, the basic prescription of the new drug formula can be used as a direct prescription prescription of existing patent medicines, can also be made into Chinese medicine decoctions or powders, and can also be made into tablets, granules, capsules, oral liquids and oral liquids according to common pharmaceutical techniques. One of the injections; the combined prescription of the new medicine formula can be made into a Chinese medicine decoction or powder.

The second object of the present invention is to provide a new drug tablet structure based on the above formula, comprising a tablet core and a sugar coating layer, the sugar coating layer is wrapped on the outer surface of the tablet core, and a central dissolution-aid hole is reserved in the middle of the tablet core. , The central dissolution-aid hole is filled with a porous framework layer. The arrangement of the porous framework layer can ensure the overall stability of the tablet and make it not easy to break before taking it. On the other hand, the porous framework The layer can effectively increase the surface area of the inner side of the middle of the tablet, so that it can fully contact the gastric juice after taking it, realize the dissolution extending from the middle to the outside, and effectively accelerate the speed of its digestion and absorption.

Further, the outer surface of the tablet core is also provided with a rough sheet layer, and the sugar coating layer is completely wrapped around the rough sheet layer. After the tablet is taken, the sugar coating layer will quickly dissolve. At this time, the rough sheet layer directly interacts with the gastric juice. Contact, its rough setting can effectively accelerate the rate of gastric juice infiltration into the tablet core, further accelerate the dissolution rate of the tablet, thereby effectively increasing the absorption rate of the effective ingredients of the tablet, and further strengthen the recovery of the effective ingredients and enhance immunity The role of.

Further, the inner wall of the central dissolution-aid hole is excavated with a plurality of evenly distributed inward penetration grooves. Through the inward penetration grooves, the gastric juice entering the porous framework layer can be guided to penetrate into the tablet core, thereby accelerating the tablet in all directions. The dissolving speed of the agent improves the efficiency of absorption, making the effect of the tablet on improving immunity more obvious, effectively reducing the situation of discharge without being completely absorbed, reducing the waste of medicine, and the depth of multiple inward penetration grooves. Different, and the cross-section of the multiple inward penetration grooves is undulating, so that the gastric juice can penetrate to different depths in the tablet core, so that the effect of dissolving from the inside to the outside is better, and the absorption is accelerated.

Further, a plurality of outward permeation guide lines are embedded in the core, and one end of the outward permeation guide line extends to the outside of the core and is located in the rough layer.

Further, the outward permeation guide line is made of dietary fiber. The dietary fiber can be soluble dietary fiber. Dietary fiber is a polysaccharide, which can neither be digested and absorbed by the gastrointestinal tract nor produce energy. Embedded in the tablet will not have an adverse effect on the efficacy of the tablet. At the same time, the dietary fiber is super absorbent. When the sugar coating layer is dissolved, one end of the outer penetration guide line is in the rough layer, which can quickly absorb gastric juice And transport gastric juice to the inside of the tablet core, so that the tablet can be digested by gastric juice at the same time inside and outside, thereby significantly accelerating the disintegration of the tablet, effectively increasing the absorption rate of the tablet, so that the drug can recover and enhance immunity. The effect of righting is better.

3. Beneficial effects

Compared with the prior art, the advantages of the present invention are:

(1) The basic prescription described in this plan can restore and strengthen immunity, has a strong righting effect, and can be applied to the treatment and rehabilitation of various diseases or injuries that require the support of the immune system.

(2) The basic formula described in this plan is mainly composed of nutrients, and the combined formula is mainly composed of nutrients and the same formula of medicine and food, with low toxic and side effects and good dosage safety.

(3) The basic prescription of this plan and its combination prescriptions are effective in the treatment of colds, can improve the body sensation of cold patients, conveniently distinguish between common colds and non-common colds, save medical resources, medical expenses and medical time costs, and reduce antibiotics and fever reduction The dosage of the medicine is beneficial to prevent the immune damage caused by the frequent use of antibiotics, avoid the abuse of antibiotics, and reduce the ecological environmental pollution of antibiotics.

(4) The new formula principle of "immune enhancer + immune supplements + immunomodulator ± specific drugs" proposed in this program, the choice of different immunomodulators can form different combinations, providing a flexible discovery New method of formula.

(5) After the tablet is taken, the inside and outside can be digested by gastric juice at the same time, thereby significantly accelerating the disintegration speed of the tablet, accelerating the digestion and absorption of the drug, reducing the waste of the drug, and increasing the absorption rate of the drug, so that the drug can recover and recover. The effect of strengthening immunity is better.

Description of the drawings

Figure 1 is a block diagram of the main formula composition of the present invention;

Figure 2 is a schematic diagram of the front structure of the new drug tablet of the present invention;

Figure 3 is a schematic diagram of the structure at A in Figure 2;

Figure 4 is a schematic diagram of the weight changes of mice in each group;

Figure 5 is a schematic diagram of organ weight and organ index;

Figure 6 is a schematic diagram of the levels of IFN-γ, IL-2, and IL-6 in peripheral blood;

Figure 7-1 is a schematic diagram of the peripheral blood CD4+/CD8+ levels of the normal group and the model group;

Figure 7-2 is a schematic diagram of peripheral blood CD4+/CD8+ levels in the VC group and the compound ammonia capsule group;

Figure 7-3 is a schematic diagram of peripheral blood CD4+/CD8+ levels in the compound 8-11 capsule group and the low-dose group;

Figure 7-4 is a schematic diagram of peripheral blood CD4+/CD8+ levels in the middle-dose group and the high-dose group;

Figure 8 shows the usage of the basic square and the combined square.

Explanation of labels in the figure:

11 cores, 12 rough lamellas, 13 sugar-coated layers, 2 central dissolution-aid holes, 3 porous framework layers, 4 internal penetration grooves, 5 external penetration guide lines.

detailed description

The technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative work shall fall within the protection scope of the present invention.

One, the principle of the group

The inventor has accumulated a wealth of medical knowledge and experience during the follow-up process of cancer cases. Because of the great threat of colds to cancer patients and the fact that family members tend to catch colds, the inventor is very concerned about immunotherapy for colds.

Based on the diagnosis and treatment thinking of the holistic theory of Chinese medicine and the prescription strategy of the monarch and ministers, the inventor constructed a new prescription principle of "immune enhancer + immune supplement + immunomodulator ± specific drug", and then observed the treatment process of a large number of cases and family Members personally test various cold prescription combinations when they catch a cold to investigate their efficacy and side effects. After long-term research, they finally screened out a new immunotherapy drug prescription according to the present invention according to the new prescription principles. Specific drugs refer to drugs that target specific pathogens, such as antibiotics or antiviral drugs, and are not part of the new drug formulation.

Vitamin C can enhance the production of immune molecules such as cytokines and antibodies, and indirectly promote the proliferation of immune cells, with little side effects. This program chooses it as an immune enhancer. The production of immune molecules and the proliferation of immune cells are inseparable from protein synthesis. A series of amino acids and auxiliary nutrients can provide supplements for the body to synthesize proteins and support the production of immune molecules and immune cell proliferation. This program selects a series of amino acids and auxiliary nutrients as immune supplements .

Both honeysuckle and ginger have immunoregulatory effects. There is no clear research report on the difference of immune system status between wind-heat cold and wind-cold cold. According to the clinical experience of traditional Chinese medicine, honeysuckle is selected for wind-heat cold and ginger is selected for wind-cold cold. The body also needs energy support to fight diseases. Honey and brown sugar are used as energy supplements in this program, and further supplementary nutrients such as vitamins and trace elements needed by the body to fight diseases. Honey is non-toxic and it is selected for Fengreganmao. Brown sugar is warm and non-toxic, it is selected for cold and cold.

Based on the above formulating principles, the present invention provides a new drug formula and tablet structure for immunotherapy. The following specific examples will illustrate the new drug formula and tablet structure of the present invention.

Example 1

Please refer to Figure 1, a new drug formula for immunotherapy, the basic formula of which includes immune enhancers and immune supplements. The immune booster is vitamin C 1000mg. Immune supplements include the following ingredients: L-isoleucine 108mg, L-leucine 60g, L-lysine hydrochloride 130.5mg, L-phenylalanine 45mg, L-threonine 24mg, L-valine Acid 36mg, L-tryptophan 30mg, L-methionine 108mg, L-arginine hydrochloride 60mg, L-glutamic acid 90mg, glycine 150mg, vitamin B1 nitrate 45mg, vitamin B2 15mg, vitamin B6 42mg, nicotinamide 90mg , Folic acid 3mg, Vitamin E acetate 12mg. The new drug formula can also include an immunomodulator to form a combination formula. The immunomodulator can be 5g of honeysuckle and 15g of honey; the immunomodulator can also be 30g of ginger and 30g of brown sugar.

Example 2

Please refer to Figure 1, a new drug formula for immunotherapy, the basic formula of which includes immune enhancers and immune supplements. The immune booster is vitamin C 300mg. Immune supplements include the following ingredients: L-isoleucine 36mg, L-leucine 20mg, L-lysine hydrochloride 43.5mg, L-phenylalanine 15mg, L-threonine 8mg, L-valine Acid 12mg, L-tryptophan 10mg, L-methionine 36mg, L-arginine hydrochloride 20mg, L-glutamic acid 30mg, glycine 50mg, vitamin B1 nitrate 15mg, vitamin B2 5mg, vitamin B6 14mg, nicotinamide 30mg , Folic acid 1mg, Vitamin E acetate 4mg. The new drug formula can also include an immunomodulator to form a combination formula. The immunomodulator can be 3g of honeysuckle and 10g of honey; the immunomodulator can also be 15g of ginger and 15g of brown sugar.

Example 3

Please refer to Figure 1, a new drug formula for immunotherapy, the basic formula of which includes immune enhancers and immune supplements. The immune booster is vitamin C 1800mg. Immune supplements include the following ingredients: L-isoleucine 216mg, L-leucine 120mg, L-lysine hydrochloride 261mg, L-phenylalanine 90mg, L-threonine 48mg, L-valine 72mg, L-tryptophan 60mg, L-methionine 216mg, L-arginine hydrochloride 120mg, L-glutamic acid 180mg, glycine 300mg, vitamin B1 nitrate 90mg, vitamin B2 30mg, vitamin B6 84mg, nicotinamide 180mg, Folic acid 6mg, vitamin E acetate 24mg, the new drug formula can also include immunomodulators to form a combination formula. The immunomodulators can be 15g of honeysuckle and 30g of honey. In actual use, you can take 15g of honeysuckle and make tea with 1.5 liters of boiling water, divided into 3 times Take it warm, add 10g of honey and the corresponding dose of the basic ingredients before each serving; the immunomodulator can also be 45g of ginger and 45g of brown sugar. In actual use, add 1.5 liters of water to sliced ginger and brown sugar, then boil it and fry on a low fire. 15 minutes, divided into 3 warm doses, before each serving, add the corresponding dose of the basic prescription components to adjust the serving. Among them, people with diabetes can follow the doctor's advice not to use brown sugar and honey, or adjust their dosage.

Example 4

Taking the basic prescription provided in the above Example 1 to Example 3 as the tablet core 11 drug, the new drug tablet structure is prepared, please refer to Figure 2-3. The new drug tablet structure for immunotherapy includes the tablet core 11 and the sugar coating layer. 13. The sugar coating layer 13 is wrapped on the outer surface of the tablet core 11. A central dissolution aid hole 2 is reserved in the middle of the tablet core 11, and the center dissolution aid hole 2 is filled with a porous framework layer 3. The overall stability of the tablet is ensured so that it is not easily broken before being taken. On the other hand, the porous matrix layer 3 can effectively increase the surface area of the inner side of the middle of the tablet, so that it can fully interact with the gastric juice after taking it. Contact to realize the dissolution extending outward from the middle part, thereby effectively accelerating the speed of digestion and absorption. The outer surface of the tablet core 11 is also provided with a rough layer 12, and the sugar coating layer 13 is completely wrapped around the rough layer 12. After taking, the sugar coating layer 13 will quickly dissolve. At this time, the rough layer 12 is in direct contact with the gastric juice. Its rough setting can effectively accelerate the rate of gastric juice infiltration into the tablet core 11 and further accelerate the dissolution rate of the tablet. , So as to effectively improve the absorption rate of the drug effect of the tablet, and further strengthen the effect of improving immunity.

The inner wall of the central dissolution-assisting hole 2 is excavated with a plurality of evenly distributed inward penetration grooves 4, through the inward penetration groove 4, the gastric juice entering the porous framework layer 3 can be guided to penetrate into the core 11, thereby accelerating the tablet in all directions. The dissolving speed of the agent increases the efficiency of absorption, making the effect of the tablet on improving immunity more obvious, effectively reducing the situation of discharge without being completely absorbed, and reducing the waste of medicine. The depth of multiple inward penetration grooves 4 is different. , And the cross-sections of the multiple inward penetration grooves 4 are undulating, so that the gastric juice can penetrate to different depths in the core 11, so that the effect of dissolving from the inside to the outside is better, and the absorption is accelerated.

The core 11 is inlaid with a plurality of outward permeation guide lines 5, one end of the outward permeation guide line 5 extends to the outside of the core 11 and is located in the rough sheet 12, and the outward permeation guide line 5 is made of dietary fiber. Can choose soluble dietary fiber, dietary fiber is a kind of polysaccharide, it can neither be digested and absorbed by the gastrointestinal tract, nor can it produce energy, so embedding it in this tablet will not adversely affect the efficacy of this tablet. At the same time, the dietary fiber is super absorbent. When the sugar coating layer 13 is dissolved, one end of the outer penetration guide line 5 is in the rough sheet layer 12, which can quickly absorb gastric juice and transport the gastric juice into the tablet core 11, so that the tablet can be used in The inside and outside are digested by gastric juice at the same time, thereby significantly accelerating the disintegration of the tablet, effectively improving the absorption rate of the tablet, so that the medicine recovery and the strengthening effect of immunity are better.

The foregoing embodiments cover several dosages of the new drug formula of the present invention. During actual use, the dosage can be adjusted according to the actual physical condition of the patient, so as to make the effect better.

2. Drug preparation, usage and dosage

1. Preparation of the basic formula

The basic prescription takes a typical adult dose (the basic prescription provided in Example 1) as an example. The typical adult dose per day is called the daily dose, and the daily dose is taken three times a day. The specific dose is shown in Table 1.

Table 1. The clinical dosage of the basic prescription

1.1 Direct prescription of basic prescription and over-the-counter medicine

According to the dosage of the basic prescription, the basic prescription was constructed with two prescriptions of vitamin C effervescent tablets and compound ammonia capsules. The daily dose is taken 3 times a day. According to each oral dose, the vitamin C effervescent tablet is dissolved with warm water and used to take compound ammonia capsules.

1.2 Compatible decoctions of basic prescription medicines

Take 1/3 of the daily dose of vitamin C effervescent tablets and compound ammonia capsules, add the contents of the compound ammonia capsules to 100-300ml of warm water at 40-60°C, let stand for 3 minutes, and stir for 1 minute to make it Then add the vitamin C effervescent tablet to the suspension, and wait for the effervescent tablet to dissolve completely to obtain a decoction for adult one oral dose. Now with warm clothes, 3 times a day.

Take 10 times the daily dose of vitamin C effervescent tablets and compound ammonia capsules, add the contents of the compound ammonia capsules to 3L of warm water at 40-60°C, stir for 3-5 minutes to make a suspension, and then Add vitamin C effervescent tablets, and wait for the effervescent tablets to completely dissolve to obtain a decoction for 10 days for adults. Stir and shake well, canned it in 30 bags of light-proof Chinese medicine decoction packaging bags, each bag is about 100ml, protected from light and stored for later use. Add an appropriate amount of hot boiled water and take it with warm water. Adults take 1 bag each time, 3 times a day.

1.3 Preparation of raw materials of basic prescription powder

Take 100 times the daily dose of the raw material powder of each component of the basic formula, stir and shake and mix, and pack the same amount in 300 bags of opaque medicinal vacuum packaging bags, vacuum packaging in the dark, and store at room temperature for later use. When taking it, add warm water to dissolve it, take 1 bag each time for adults, 3 times a day.

1.4 Other common dosage forms

The basic prescription can be made into one of tablets, granules (granules), capsules, oral liquids and injections by adding necessary auxiliary materials according to common pharmacy techniques.

2. Preparation of the combination

2.1 Preparation of wind-heat combination

2.1.1 Compatible decoctions of patent medicines

① According to the daily dose, use vitamin C effervescent tablets and compound ammonia capsules to construct the basic prescription.

②Take 9g of honeysuckle, add 1L of boiling water, cover it, and let it cool to room temperature, then take the liquid from the filter residue.

③Add 15g of honey to the filtrate and stir evenly to obtain 1 day's honeysuckle honey tea.

④ 1 day serving of honeysuckle honey tea is divided into three warm doses. Before each serving, add 1/3 of the daily dose of vitamin C effervescent tablets corresponding to the dose of the basic formula and the contents of the compound ammonia capsules. The compound aminovitamin capsules can also be taken directly with the decoction composed of honeysuckle honey tea and vitamin C without being added to the decoction.

2.1.2 Lyophilized powder

① Take 90g of honeysuckle, add 10L of boiling water, cover it, and let it cool to room temperature, then take the liquid from the filter residue.

②Add 150g of honey to the filtrate and stir evenly.

③Add 10 times the daily dose of the raw material powder of each component of the basic prescription, and stir evenly.

④ The above solution is freeze-dried and powdered to obtain 10 days' worth of air-heat combined prescription freeze-dried powder powder.

⑤Pack the freeze-dried powder in 30 bags of opaque medicinal vacuum packaging bags in the same amount, vacuum packaging in the dark, and keep refrigerated for later use.

⑥When taking it, use warm water to dissolve it and take it with warm water. Adults take 1 bag each time, 3 times a day.

2.2 Preparation of wind-cold combination prescription

2.2.1 Compatible decoctions of patent medicines

① According to the daily dose of prescription vitamin C effervescent tablets and compound ammonia capsules, the basic formula is constructed.

②Take 15g of ginger and 25g of brown sugar, add 1.5L of water to boil, then simmer for 15 minutes, let it cool to room temperature, and filter the residue to take the liquid. Get 1 day's brown sugar ginger tea.

③One-day brown sugar ginger tea is taken in 3 warm doses. Before each serving, add 1/3 of the daily dose of vitamin C effervescent tablets and the contents of the compound ammonia capsules corresponding to the dose of the basic prescription. The compound aminovitamin capsules can also be taken directly with the decoction composed of brown sugar ginger tea and vitamin C without adding the decoction.

2.2.2 Lyophilized powder

①Take 150g of ginger and 250g of brown sugar, add 15L of water and boil, then simmer for 15 minutes, wait for it to cool to room temperature, filter the residue and take the liquid.

②Add 10 times the daily dose of the raw material powder of each component of the basic prescription, and stir evenly.

③The above solution is freeze-dried and powdered to obtain 10 days' worth of wind-cold combination prescription freeze-dried powder powder.

④Pack the freeze-dried powder in 30 bags of opaque medicinal vacuum packaging bags in the same amount, vacuum packaging in the dark, and keep refrigerated for later use.

⑤When taking it, use warm water to dissolve it, take 1 bag each time for adults, 3 times a day.

Three, animal experiment

1. Basis for setting the dose of test drug

The basic prescription is prepared by the drug compatibility decoction method described in the section of drug preparation and usage and dosage. Vitamin C of the immune enhancer in the basic prescription uses vitamin C effervescent tablets, and the immune supplement in the basic prescription uses compound ammonia capsules. The two components of C and compound ammonia capsules were set as the control group at clinically equivalent doses. The clinical dosage of the basic prescription is shown in Table 1 in the section of drug preparation and usage.

Vitamin C effervescent tablets: This product is a light orange tablet with scattered spots on one side. The tablet weighs 3.261g, of which the net content of VC per tablet is 1g. Calculate the clinical equivalent dose in mice based on adult 1 tablet/day.

Compound ammonia capsules: The contents of this product are white film-coated and orange film-coated particles. The weight of the capsule content is 0.327g, and the net content of the active ingredients is shown in Table 2. Take the corresponding dose of the basic prescription (2 capsules/time, 3 times/day) as the clinical dose, calculate the clinical equivalent dose of mice, and set it as the control group according to the clinical equivalent dose.

Table 2. Net content of active ingredients in compound ammonia capsules

Compound 8-11 capsule group: This product is a capsule with the full name of the compound amino acid (8) vitamin (11) capsule, and the content is yellow to orange-red powder or granules. The weight of the capsule content is 0.215g, and the net content of the active ingredients is shown in Table 3. Take the maximum adult dose in the instructions (2 capsules/time, 3 times/day) as the clinical dose, calculate the clinical equivalent dose in mice, and set it as the control group according to the clinical equivalent dose.

Table 3. Net content of active ingredients in the compound 8-11 capsule group

The conversion formula of the dose for mice: B=W×A (B: mouse; A: human; W=9.1, conversion factor)

Calculate the mouse equivalent dose based on the above clinical dose and the specifications of the tested drug:

The dosage of vitamin C effervescent tablets is 13mg/ml (VC net content);

The dose of compound ammonia capsules is 26mg/ml;

The dose of the compound 8-11 capsule group was 17 mg/ml.

The basic prescription has three dose groups: low, medium, and high. The dose of each component in the middle dose group is the aforementioned clinical equivalent dose, the low dose is 1/3 of the clinical equivalent dose, and the high dose is 2 times the clinical equivalent dose.

The dose and volume of administration are as follows:

Normal group: normal saline, 0.2ml/only

Model group: normal saline, 0.2ml/only

Vitamin C group (referred to as VC group): 13mg/ml (VC net content, the same below), 0.2ml/piece

Compound ammonia capsule group: 26mg/ml, 0.2ml/piece

Compound 8-11 capsule group: 17mg/ml, 0.2ml/piece

Low-dose group: 4.3mg/ml VC+8.7mg/ml compound ammonia capsules, 0.2ml/piece

Middle dose group: 13mg/ml VC+26mg/ml compound ammonia capsules, 0.2ml/piece

High-dose group: 26mg/ml VC+52mg/ml compound ammonia capsules, 0.2ml/piece

Each group was administered once a day.

The information about mice is as follows:

Species: Mouse

Strain: Balb/c

Level: SPF level

Weight: 20g±2g

Sex: male

Number of animals: 48

The breeding environment of mice is as follows:

Indoor temperature of animal room: 25±1℃

Humidity in animal room: 50-70%

Animal room lighting: 12 hours of alternating lighting

Drinking water: free drinking

Feed: pelleted feed

2. Experimental method

Experimental grouping and administration:

48 Balb/c mice were bred adaptively in the aforementioned breeding environment for one week. During the period, the hair, excrement, and activity were closely observed, and no abnormalities were found. One week later, the mice were randomly divided into normal group, model group, VC group, compound ammonia capsule group, compound 8-11 capsule group, basic prescription low-dose group, medium-dose group and high-dose group according to their weight. Group, each group has 6 animals. Each group was given the corresponding drugs for 15 consecutive days; except for the normal group, mice in the other groups were given intraperitoneal injection of cyclophosphamide (60mg/kg) on the 8, 9 and 10 days. Ways to suppress the mouse immune system. After the administration, peripheral blood, spleen and thymus tissues of each group of mice were collected for cytokine detection and organ sample collection.

Cytokine detection and organ sample collection:

(1) During the experiment, the body weight was measured every 3 days.

(2) At the end of the experiment, blood was collected from the orbit of each mouse. The blood sample was divided into two parts, one for the detection of IL-2, IL-6, IFN-γ, and the other for the detection of CD4+/CD8+ levels.

①200μl of non-anticoagulated blood, stand at 4℃ for 1h, centrifuge at 3500r/min for 10min, and take the upper serum for multifactor (IL-2, IL-6, IFN-γ) detection. Multi-factor detection is carried out in strict accordance with the LEGENDplexTW kits operating procedure.

②600μl of freshly collected anticoagulant blood is diluted twice with PBS, spread flat to the upper layer of 3ml mouse lymphocyte separation solution, and centrifuged at 800g on a horizontal rotor for 20min (set slower acceleration/deceleration) at room temperature. After centrifugation, be careful Aspirate the lymphocyte layer, add 10ml PBS, wash upside down, collect the cells by centrifugation at 250g for 10min at room temperature, pour the supernatant, resuspend the cells with cell fixation solution and count, adjust the cell concentration to 1×10 ⁷ /ml. Transfer 100μl of the above cell suspension to a 2ml centrifuge tube, add 2μl FITC-CD3, 1.25μl APC-CD4, 1.25μl PE-CD8, 4°C refrigerator, incubate in the dark for 20min, wash twice with 1ml PBS, flow cytometer Detect CD4+/CD8+ levels.

(3) The mouse was sacrificed by cervical dislocation, the thymus and spleen were separated, and the weight of the mouse thymus and spleen was weighed to calculate the thymus index and spleen index.

3. Statistics

All data are expressed as mean and standard deviation (Mean±SD). Graphpad7.0 software is used for statistics. The t-tests compares the differences between groups. If p<0.05, it is considered to be statistically significant.

4. Experimental results

A. Weight change

The body weight changes of mice in each group are shown in Figure 4, and there is no difference in initial body weight between groups (p>0.05). The weight of the mice in the normal group gradually increased, and the mice in the other groups gradually increased before the model was established. Among them, the weight gain of the mice in the compound ammonia capsule group, the compound 8-11 capsule group and the basic prescription middle-dose group was better than that of the normal group. Model group, VC group, basic formula low-dose group and basic formula high-dose group.

Table 4. Body weight growth rate of mice in each group after cyclophosphamide modeling

On the 8, 9, and 10 days of administration, except for the normal group, mice in the other groups were injected with cyclophosphamide to establish an immunosuppressive model. It can be seen from Figure 4 that the body weight of mice in each group that took immunosuppressive measures dropped significantly. After stopping the injection of cyclophosphamide, compared with the model group, the weight loss trend of mice in each administration group was inhibited. After cyclophosphamide modeling, the weight growth rate of mice in each group is shown in Table 4. According to the data in Table 4, the weight growth rate of mice is arranged from small to large as follows:

(1) Early stage (day 10-13): model group>low-dose group>high-dose group>Fufang 8-11 capsule group>VC group>Fufang ammonia capsule group>medium dose group;

(2) Late stage (day 13-16): VC group> Fufang ammonia capsule group> Fufang 8-11 capsule group>model group>medium dose group>high dose group>low dose group.

From this change in weight growth rate, it can be inferred that the inhibitory effects of each group of experimental drugs on mice weight loss are:

(1) Basic prescription group: The middle dose group quickly and stably inhibited the weight loss of mice; the low and high doses had weaker inhibition in the early stage, but significantly enhanced the inhibition in the later stage (stronger than the compound 8-11 capsule group, VC group and compound Amavi capsule group), especially the low-dose group, the weight loss trend of mice is almost completely suppressed;

(2) VC group and compound ammonia capsule group: In the early stage, the inhibitory effect on the weight loss of mice was better, only weaker than the basic dose group, but the weight inhibition effect on the mice was almost disappeared in the later period (the rate of weight loss in mice was almost Same as the immunosuppressive period);

(3) Compound 8-11 capsule group: The inhibitory effect is stable, but slightly weaker than the basic prescription middle-dose group.

At the end of the experiment, the body weight of the mice in the middle dose group was higher than that of the other administration groups.

In summary, in terms of combating weight loss caused by cyclophosphamide, the basic prescription middle-dose group performed best, better than the single component VC group and the compound ammonia capsule group, and also better than the compound 8-11 capsule group.

B. Organ weight and organ index

At the end of the experiment, the organ weight and organ index of each group of mice are shown in Figure 5 and Table 5.

Table 5. Organ weight and organ index (Mean±SD)

Symbol description: Compare model group, *p<0.05, **p<0.01, ***p<0.001, ****p<0.0001.

(1) Spleen weight and spleen index: Compared with the normal group, the spleen weight and spleen index of mice in the model group were reduced, which accorded with the characteristics of cyclophosphamide modeling, indicating that the model was successfully replicated. Compared with the spleen weight and spleen index of mice in the model group, the spleen weight and spleen index of the mice in each administration group increased, and compared with the model group, it was statistically significant (p<0.05), which indicates that the drugs in each group can improve The spleen index of immunosuppressed mice.

(2) Thymus weight and thymus index: Compared with the normal group, the mouse thymus weight and thymus index of the model group were reduced, which accorded with the characteristics of cyclophosphamide modeling, indicating that the model was successfully replicated. Compared with the mouse thymus weight and thymus index in the model group, the thymus weight and thymus index of the mice in each administration group increased. Among them, the VC group, the compound ammonia capsule group and the basic prescription middle-dose group were statistically significant (p<0.05) ), the mean values of the three groups are similar, the standard deviation of the basic formula middle-dose group is the smallest and the p-value is smaller (p<0.01).

In summary, from the comprehensive perspective of improving the spleen index and thymus index, the basic prescription middle-dose group has the best effect, which is better than the VC group, the compound ammonia capsule group, and the compound 8-11 capsule group.

C. Peripheral blood IFN-γ, IL-2, IL-6 and CD4+/CD8+ levels

The end of the experiment, the levels of cytokines IFN-γ, IL-2, IL-6 and CD4 ⁺ /CD8 ⁺ results are shown in Table 6 and Figure 6, Figure 7-1, Figure 7-2, Figure 7-3, Figure 7-4 Shown. From the data in these figures and tables, we can see that compared with the normal group, all indicators of the model group have decreased.

Table 6. Peripheral blood IFN-γ, IL-2, IL-6 and CD4 ⁺ /CD8 ⁺ levels

The cytokine indicators of each group of mice are as follows:

(1) The peripheral blood IFN-γ level of mice in each administration group was higher than that of the model group, but there was no statistical difference between the other groups and the model group except for the low-dose group (p>0.05); each administration group was small The level of IL-6 in the peripheral blood of mice was higher than that of the model group. The VC group was statistically significant compared with the model group (p<0.05). The low, medium and high dose groups of the basic formula showed an upward trend but no statistical significance (p >0.05). Compared with the model group, the levels of IFN-γ and IL-6 in each group lacked general statistical differences, suggesting that the levels of IFN-γ and IL-6 may not have significant reference significance in this experiment.

(2) The level of IL-2 in peripheral blood of mice in each administration group was higher than that of the model group. Except for the VC group, the other groups were statistically significant compared with the model group (p<0.05). Among them, the basic prescription middle-dose group IL-2 -2 has the highest level and the smallest p value in the comparison model group, suggesting that the basic formula low, medium, and high dose groups can all increase IL-2 levels, and the middle dose group has the best effect, which is better than the VC group, the compound ammonia capsule group, and the compound 8-11 capsule group.

(3) The CD4+/CD8+ levels of each administration group, except for the high-dose group, were higher than those of the model group and were statistically significant (p<0.05). Among them, the basic prescription middle-dose group and the compound 8-11 capsule group had CD4+/CD8+ The level is higher than that of the normal group, and the comparison model group has p<0.0001. The medium-dose group has the highest CD4+/CD8+ level and has a smaller standard deviation than the compound 8-11 capsule group, suggesting that both the basic low and medium-dose groups can increase CD4+/CD8+ And the middle-dose group has the best effect, which is better than the VC group, the compound ammonia capsule group, and the compound 8-11 capsule group.

(4) The level of IL-2 increased and the level of CD4+/CD8+ increased simultaneously, suggesting increased immunity. Combined with the level of IL-2 and CD4+/CD8+, it was found that the basic prescription middle-dose group can significantly enhance immunity and has the best effect. It is better than VC group, compound ammonia capsule group, compound 8-11 capsule group.

In summary, cyclophosphamide is a commonly used cytotoxic drug, widely used in anti-tumor therapy, which can inhibit bone marrow function and reduce the number of white blood cells. According to reports, cyclophosphamide can inhibit the function of immune organs in mice and lead to weight loss, causing various blood cell imbalances in the peripheral blood, and ultimately leading to the suppression of immune function. In this experiment, a continuous 3d intraperitoneal injection of cyclophosphamide was used to establish immunodeficiency. The mouse model was given corresponding drug intervention for 15 days to evaluate the regulatory effect of the drug on immune function.

The experimental results are discussed as follows:

(1) Thymus and spleen are important immune organs of the body, and the immune organ index reflects the immune function of the body. The results of this experiment show that each group of drugs can increase the spleen index or thymus index of immunosuppressed mice. In terms of comprehensive spleen index and thymus index, the basic prescription middle-dose group has the best effect.

(2) Cytokines are a class of small molecular proteins synthesized and secreted by immune cells and certain non-immune cells through stimulation, and have the functions of regulating immunity and promoting cell growth. IL-2 is a pleiotropic cytokine, which plays an important role in the differentiation, growth and activity of immune cells. It can not only promote the proliferation and activation of immunostimulatory effector cells, but also promote the proliferation and activation of immunosuppressive Treg cells, and has an immunoregulatory effect; IL-6 can induce the proliferation and differentiation of B cells and T cells; IFN-γ has Activate macrophages, promote APC(S) expression, MHC-Ⅱ molecule expression to improve antigen presentation function, promote MHC-I molecule expression to enhance the killing activity of CTL cells, enhance the killing activity of NK cells, and promote B cell differentiation , Proliferation, inhibition of TH2 cell differentiation and cytokine synthesis, etc., is currently the body's fastest anti-viral defense system. The results of this experiment show that each group of drugs can increase the levels of IL-2, IL-6 and IFN-γ in the serum of immunosuppressed mice. For IL-6, only the VC group was statistically significant compared with the model group (p<0.05), and the basic prescription low, medium and high dose groups showed an upward trend but not statistically significant (p>0.05); for IFN- γ, only the low-dose group was statistically significant compared with the model group (p<0.05); IL-2 levels improved significantly, except for the VC group, other groups were statistically significant compared with the model group (p<0.05) ).

(3) T lymphocytes are the main effector cells that mediate the body's specific immune response. According to their different surface markers, they can be divided into CD3+, CD4+, CD8+ and other cell subgroups. Among them, CD3+ is the surface marker of mature T cells, which can represent the overall level of T cells. CD4+ cells are helper T cells, which play a role in cellular immunity. As a helper function, CD8+ cells, namely cytotoxic T cells, play a role in suppressing cellular immunity by reducing the activity of lymphocytes. The dynamic balance of CD4+/CD8+ is the key to immune regulation. If the dynamic balance of CD4+/CD8+ is disrupted, it will cause immune dysfunction, lead to a series of immune pathological changes, and affect the body's immune protection mechanism. In this experiment, with the exception of the basic prescription high-dose group, the CD4+/CD8+ levels of each administration group were higher than the model group and were statistically significant (p<0.05). The basic prescription middle-dose group and the compound 8-11 capsule group were effective Obviously, the level of CD4+/CD8+ is higher than that of the normal group, and the middle-dose group has the best effect.

In summary, the basic prescription low, medium and high dose groups can all improve the immunosuppression and weight loss caused by cyclophosphamide. Among them, the middle-dose group of the basic prescription has the best effect. It can significantly slow down the weight loss of mice, increase the spleen index and thymus index, and significantly increase the level of IL-2 and CD4+/CD8+. It can simultaneously improve the immunosuppressive mice from the aforementioned aspects. It has the best immune function, which significantly restores and enhances the immunity of immunosuppressed mice, and has the best effect, which is better than the VC group, the compound ammonia capsule group and the compound 8-11 capsule group. The experimental results suggest from the perspective of immune function that the basic prescription has a strong righting effect as described in Chinese medicine. Compound 8-11 capsules contain 2000IU of vitamin A per capsule. Excessive or long-term use of vitamin A can cause poisoning. Normally, the daily limit of vitamin A for pregnant women is not more than 5000IU. The basic formula does not contain vitamin A, and the dose safety in this respect is better than that of the compound 8-11 capsules.

4. Observation of curative effect in the inventor's family

After the basic formula and combination formula of the new drug formula of the present invention were determined, the inventors used the direct prescription of the patent medicine and the compatibility decoction of the patent medicine as described in the section Drug Preparation, Usage and Dosage to carry out a 16-month actual verification in the family members. The specific situation is shown in Table 7.

Table 7. Observation of curative effect in the inventor's family

During this period, no cold medicines other than antipyretics were used. The number of cold infusions or hospitalizations was reduced to 0, the number of antibiotics applications was reduced to 0, and the number of antipyretics was reduced to 2. This is the same as that of the previous two years. There is a sharp contrast between the use of antibiotics and anti-fever medicines for infections and high fever once every quarter. This has achieved the goal of reducing the number of cold visits to the hospital, reducing the cost and time of cold diagnosis and treatment, and reducing the amount of antibiotics and anti-fever drugs.

Five, real-world observation of curative effect

Some volunteers with experience in self-follow-up follow-up of cases, with family members of cancer patients as the main body, followed up the real-world effects of the basic formula and the combined formula in the family, and conducted a summary study. Some of these volunteers are long-term medical practitioners, and some are medical professionals themselves, and have carried out necessary learning on cold treatment and symptom evaluation, and have the ability to follow up cold events in the family. Diagnosis and treatment are carried out in accordance with the doctor's orders, and the prescription drugs are prescribed by the doctor.

1. Selection criteria for cold incidents

①Patients are over 6 years old, have no gender limitation, and can clearly express changes in symptoms.

②It was judged by experience to have a cold, and the basic prescription or combination prescription was used for treatment.

③Have cold-like symptoms that can be evaluated, such as nasal congestion, runny nose, fever, fatigue, body aches, headaches, sore throat, mouth sores, etc.

④ Exclude the use of other cold medicines in addition to antibiotics, antipyretics, basic prescriptions and combination prescriptions.

⑤Exclude events that have been clinically diagnosed as non-respiratory infections and non-oral infections such as allergies.

⑥ Including clinically diagnosed respiratory infections such as pneumonia and tonsillitis.

2. The usage and dosage of basic formula and combination formula

The basic prescription uses the patent medicine to directly formulate the prescription, and the combined prescription uses the patent medicine compatibility decoction. For the specific preparation method and dosage, please refer to the section of drug preparation and usage and dosage. Refer to Figure 8 for the usage of the basic party and the combined party, and the explanation is as follows:

① If you have cold-like symptoms, and have sore throat, mouth sores, facial toxic packs and other symptoms of getting angry, use a combination of wind and heat.

②If there are cold-like symptoms, and there are clear causes of wind and cold such as rain or cold, and no symptoms of fire, use a combination of wind and cold.

③When it does not meet the above-mentioned characteristics of wind-heat or wind-cold, or if it is unclear whether it is wind-heat or wind-cold, use the basic prescription alone.

Evaluate the efficacy every 12-24 hours. When the curative effect is poor or the symptoms are repeated, you should seek medical treatment or follow-up in time, improve related examinations, evaluate whether you need to combine antibiotics, whether it is a non-common cold (such as mycoplasma infection, Japanese encephalitis), etc., and deal with them accordingly.

The basic prescription and the combination prescription have a fast effect. For the common cold, the patient can usually feel the effect within 6-12 hours. Therefore, when the symptoms do not alleviate, recur, or persist and do not heal, you should see a doctor in time for follow-up, auscultate the heart and lungs, improve blood routines and other necessary examinations in order to diagnose and adjust the treatment plan. Syndrome differentiation and treatment and adjustment of the treatment plan based on treatment feedback conform to the thinking of Chinese medicine and modern evidence-based medicine. Those with severe symptoms should seek medical attention immediately.

Precautions:

① If antibiotics are needed for bacterial infections, mycoplasma infections, etc., combine antibiotics as required according to doctor's orders and follow the course of antibiotic treatment.

②When the fever is high, or when the fever is not affected by the fever, when resting, use antipyretics as needed, and evaluate every 6-12 hours. If the fever is not relieved, you should consult a doctor in time.

③ Avoid wind-cold, fatigue, staying up late, drinking, high oxygen consumption exercise and other activities that are not conducive to cold recovery during the treatment, so as to avoid recurrence of the disease. Within one week of onset, even if the symptoms have disappeared, the aforementioned activities that are not conducive to recovery should be avoided as much as possible, and rest should be guaranteed.

3. Efficacy evaluation criteria

With reference to the "Technical Guidelines for the Clinical Research of Syndrome Types of New Chinese Medicines", based on the patient's self-evaluation of whether the symptoms are alleviated or disappeared, the curative effects of the basic prescription and the combined prescription are divided into healing, markedly effective, improved, and ineffective.

① Significantly effective: starting from using the basic prescription or the combination prescription, the symptoms are alleviated within 24 hours.

②Healed: Under the premise of marked effect, continue the treatment, and the symptoms disappear completely within 7 days.

③Progress: Under the premise of significant effect, continue the treatment, but the symptoms are alleviated without recovery within 7 days.

④ Invalid: Those that do not meet the markedly effective standard are recorded as invalid.

4. Follow-up results

After a cold peak in winter and spring, a total of 29 cold events that met the selection criteria were followed up. Among them, one had a cold and cold and seven had a cold, which is consistent with the fact that modern people often suffer from a cold due to better food and clothing. Patients reported that the basic formula and the combined formula can quickly and significantly reduce symptoms such as nasal congestion, runny nose, and cough caused by a cold, and improve body sensation. The specific follow-up results are shown in Table 8.

Table 8 Real-world efficacy follow-up results

According to the usage of the basic prescription and the combination prescription, if the basic prescription or the combination prescription is used for 12-24 hours to evaluate the effect is not good, then evaluate whether the combination of antibiotics is needed. In order to more rigorously calculate the efficacy of the basic formula and combination formula, and exclude the influence of antibiotics, the following adjustments were made to the classification of cold events:

① The number of cases of the basic prescription combined with antibiotics is regarded as the number of invalid cases of the basic prescription.

②The number of cases of the combination of wind-heat and antibiotics is regarded as the number of invalid cases of the combination of wind-heat.

③The number of cases of Fenghan combination prescription combined with antibiotics is regarded as the number of invalid cases of Fenghan combination prescription.

After this adjustment, the overall effective rate is 82.8% (24/29), the effective rate of the basic prescription subgroup is 88.9% (16/18), the effective rate of the Fengre combined prescription subgroup is 70.0% (7/10), and the effective rate is 70.0% (7/10). The subgroup effective rate of the combined prescription is 100% (1/1). The antibiotic usage rate was 17.2% (5/29). The overall use rate of antipyretics was 10.3% (3/29). There were 3 cases using antipyretics, 1 case was diagnosed as acute suppurative tonsillitis by the hospital, and 2 cases had upper respiratory tract mycoplasma infection, all of which were relatively serious infections. The lower use rate of anti-fever medicines suggests that the basic prescription and the combined prescription have significantly improved the course of fever of the common cold.

Real-world efficacy follow-up results show that the overall effective rate of the basic formula and its combination is 82.8%, which can be quickly effective within 24 hours, and can significantly improve the body sensation of patients with common colds, thereby reducing the development of mild colds due to lack of specific medicines. Severe cold or other secondary infections.

If the cold is not effectively treated in the early stage, there is a risk of developing pneumonia or myocarditis, which is even greater for children. Therefore, although Western medicine believes that most colds can heal themselves without treatment, there is no convenient way to distinguish between common colds and non-common colds in the early stage. Patients still have to seek medical treatment in time when they have a cold. Doctors sometimes have to apply antibiotics empirically. Avoiding antibiotic abuse is very difficult.

The basic formula and the combination formula are mainly composed of nutrients and medicine and food homologous formula, with low side effects and obvious effects within 24 hours, so that common colds and non-common colds can be distinguished by curative effect at an early stage, and the somatosensory of common cold patients is also significantly improved. improve. This firstly saves medical resources and relieves the pressure on outpatient clinics in hospitals; secondly, it can effectively reduce the number of patient admissions, reduce the number of laboratory tests, save medical expenses, and reduce the cost of treatment time; third, it can also allow antibiotics and antipyretics to be used only for For necessary non-common colds, the dosage of antibiotics and anti-fever medicines is reduced, which is beneficial to avoid antibiotic abuse and reduce immune damage caused by excessive use of antibiotics.

The causes of colds are complex. Most colds are caused by viral infections, and a small number of colds are caused by bacterial infections. There are many types of viruses that can cause colds. In order to find a cure for a cold, the medical community has conducted nearly a hundred years of exploration and experimentation, and organized large-scale clinical trials involving more than 5,000 cases, but no good program has been found. At present, the actual treatment is still based on symptomatic support. The medical community has tried to treat colds with vitamin C for a long time, but its efficacy is unstable and uncertain, and it has not been confirmed by clinical trials. The efficacy of the basic formula and its combination formula suggest that the reason for the poor efficacy of vitamin C in the treatment of colds may be the lack of immune supplements and immunomodulator components. To a certain extent, the basic prescription and the combination prescription solve the problem of the lack of specific medicines for the treatment of colds.

The foregoing embodiments are only preferred specific implementations of the present invention, but the protection scope of the present invention is not limited thereto. Any person familiar with the technical field within the technical scope disclosed by the present invention, equivalent replacements or changes according to the technical solution and improvement concept of the present invention shall be covered by the protection scope of the present invention.

Claims

A new drug formulation for immunotherapy, including a new drug basic prescription, the new drug basic prescription including the coordinated use of an immune enhancer and an immune supplement, and is characterized in:

The immune enhancer is vitamin C 300-1800mg;

The immune supplement includes the following ingredients: L-isoleucine 36-216mg, L-leucine 20-120mg, L-lysine hydrochloride 43.5-261mg, L-phenylalanine 15-90mg, L- Threonine 8-48mg, L-valine 12-72mg, L-tryptophan 10-60mg, L-methionine 36-216mg, L-arginine hydrochloride 20-120mg, L-glutamic acid 30-180mg , Glycine 50-300mg, Vitamin B1 nitrate 15-90mg, Vitamin B2 5-30mg, Vitamin B6 14-84mg, Nicotinamide 30-180mg, Folic acid 1-6mg, Vitamin E acetate 4-24mg.
A new drug formulation for immunotherapy according to claim 1, characterized in that: the new drug formulation further comprises adding an immunomodulator to form a wind-heat combination prescription, and the immunomodulator is honeysuckle 3-15g, 10-30g of honey.
The new drug formula for immunotherapy according to claim 2, wherein the new drug formula can replace an immunomodulator to form a wind-cold combination prescription, and the immunomodulator of the wind-cold combination prescription is ginger 15- 45g, 15-45g brown sugar.
A new drug formulation for immunotherapy according to claim 2 or 3, characterized in that: the new drug formulation is used for immunotherapy of colds; the doses in the new drug formulation are in the adult dose range, and the children's dose is in accordance with The adult dose is halved, and the infant dose is converted according to body weight;

The wind-cold combination prescription or the wind-heat combination prescription can be made into a traditional Chinese medicine decoction or powder.
A new drug formulation for immunotherapy according to claim 1, characterized in that: the basic prescription of the new drug can be made into traditional Chinese medicine decoctions or powders, and can also be made into tablets, granules, capsules, etc. according to common pharmaceutical techniques. One of oral liquid and injection;
A new drug tablet structure for immunotherapy, comprising a tablet core (11) and a sugar coating layer (13), characterized in that: the sugar coating layer (13) is wrapped on the outer surface of the tablet core (11), and the tablet core (11) A central dissolution-aid hole (2) is reserved in the middle part, and the inside of the central dissolution-aid hole (2) is filled with a porous framework layer (3).
A new drug tablet structure for immunotherapy according to claim 6, characterized in that: the outer surface of the tablet core (11) is also provided with a rough layer (12), and the sugar coating layer (13) is completely Wrapped outside the rough sheet (12).
A new drug tablet structure for immunotherapy according to claim 6, characterized in that: the inner wall of the central dissolution-aid hole (2) is excavated with a plurality of uniformly distributed inward penetration grooves (4), and a plurality of The depths of the inward infiltration grooves (4) are different, and the cross-sections of the inward infiltration grooves (4) are undulating.
The structure of a new drug tablet for immunotherapy according to claim 7, characterized in that: the core (11) is inlaid with a plurality of outward permeation guide lines (5), and the outward permeation guide lines ( 5) One of the ends extends to the outside of the core (11) and is located in the rough layer (12).
A new drug tablet structure for immunotherapy according to claim 9, characterized in that the outward penetration guide line (5) is made of dietary fiber, and the dietary fiber can be soluble dietary fiber.