WO2011044736A1

WO2011044736A1 - Pharmaceutical composition for treating skin injury, preparation method of its ointment and use thereof

Info

Publication number: WO2011044736A1
Application number: PCT/CN2009/074713
Authority: WO
Inventors: 曾钦台; 张运茂; 郑秀莲
Original assignee: Zeng Qintai; Zhang Yunmao; Zheng Xiulian
Priority date: 2009-10-12
Filing date: 2009-10-30
Publication date: 2011-04-21
Also published as: CN101690760B; CN101690760A

Abstract

A pharmaceutical composition for treating skin injury, the preparation method of its ointment and use thereof. The composition consists of fresh leaves of Rosa cymosa, dried flowers of hibisci mutabilidis and Oleum Camelliae. The preparation method of its ointment includes: mixing fresh leaves of Rosa cymosa and dried flowers of hibisci mutabilidis together and turning it into slurry; then combining the slurry with Oleum Camelliae and manufacturing into ointment. The composition can be used to prepare medicine for treating skin injury.

Description

Medicinal composition for treating skin wound, preparation method and use thereof

Technical field

The present invention relates to a pharmaceutical composition for treating a wound and a preparation method and application thereof.

Background technology

Trauma or damage on the surface is a common pain in people's lives, especially burns, burns, etc. are more common.

Burns, burns and other burn levels are usually divided into the following book standards:

Once burned: Damage is limited to the shallow layer of the epidermis. Symptoms are redness of the affected area and painlessness. Naturally healed, no scars.

Second degree burn, divided into:

1. Shallow second degree burn: The damage is 1 / 3 on the epidermis and dermis. The symptom is that the affected area is red and swollen, and there may be severe pain and burning sensation. Naturally healed, no scars or slight scarring.

2. Deep second degree burn: The damage is deep in the epidermis and dermis. The symptoms are redness in the affected area and white blisters. Because the nerve endings are partially damaged, the pain is lighter than the second. It can heal naturally and leave scars.

Third degree burn: All skin damage. The affected area is leathery black anxious or pale, which may have fluid. Because most of the nerve endings are damaged, such burns often have no pain.

Four degree burns: There are subcutaneous tissues, muscles and even bone damage. Can cause amputation.

Five degree burns: Most of the subcutaneous tissue is scorched and exposes muscle tissue. Sometimes five degrees of burns are fatal.

Six degree burns: Almost all muscle fibers disappear and the bones are burnt. Six-degree burns are usually fatal.

For severe burns and burns, the current treatment can achieve certain curative effects, but its curative effect is still not satisfactory. The main manifestations are: Severe burning of skin muscles Injuries, and severe infection after burns, the healing time is long, the healing effect is not ideal, and scars are left. Summary of the invention

It is an object of the present invention to provide a pharmaceutical composition for treating wounds which is more effective.

Another object of the present invention is to provide a process for preparing the composition ointment.

The present invention also provides the use of the pharmaceutical composition for the preparation of a medicament for treating skin burns, skin burns or skin rot wounds.

In order to achieve the first object of the invention, the present invention provides a pharmaceutical composition which is prepared from the following bulk ratios of raw materials: 80% to 97% of fresh leaves of rose hips with a picking time of less than 3 days, Hibiscus flower dried flowers 2% ~ 19%, tea oil 1% ~ 10%.

The hibiscus flower in the composition is the flower of the hibiscus hibiscus hibiscus, which is called the frost-reducing flower. Hibiscus scientific name: Hibi scus mutabi l i s, English name Cot ton rose. It has the medicinal effect of clearing away heat and detoxifying, cooling blood to stop bleeding, reducing swelling and excretion. It is suitable for phlegm, sputum, chyle and lung heat cough, lung sputum and other diseases, and can also be used for uterine bleeding caused by blood.

In the composition, the small fruit rose belongs to the Rosaceae RosaL. plant, the scientific name is Rosa cymosa Trat t, and the alias is: Shanmuxiang, fish pole, Xiaojinying, white flower horse chestnut, and seven sisters. Small fruit rose leaves can detoxify and reduce swelling, used to treat hemorrhoids, burns and burns.

The tea oil in the composition is a fatty oil obtained by pressing the mature seeds of Camel l ia olei fera Abel or Came l ia meiocarpa Hu. ms. Indications: Hernia abdominal pain; constipation; mites abdominal pain; mites intestinal obstruction; 疥癣; soup fire injury.

In order to obtain a better medicinal effect, the pharmaceutical composition preferably has a weight ratio of the drug substance: 95% to 97% of the fresh leaves of the rose fruit within 3 days of picking, and the water content is 10%. The following hibiscus flower dried flowers 2% ~ 4%, tea oil 1% ~ 0. 3%.

In order to obtain a better medicinal effect, the pharmaceutical composition preferably has the dried flower of the hibiscus flower within a period of 6 months.

In order to obtain a better medicinal effect, and at the same time, for the convenience of human use, the pharmaceutical composition dosage form is a paste. In order to achieve the second object of the invention, the present invention provides a method for preparing an ointment using the above proportional drug as a raw material, comprising the following steps:

a. Prepare the raw materials: Prepare the raw materials according to the following ratio: 80% ~ 97% of fresh fruit rose leaves within 3 days, 2% ~ 19% of hibiscus dried flowers, 1% ~ 10% of tea oil;

b. Making a puree: Prepare the fresh leaves of the rose hip leaves and the dried flowers of the hibiscus flower prepared in step a;

c Transfer the tea oil: Add the tea oil to the mud obtained in step b and mix to prepare the ointment. As an optimization method for the preparation method of the above-mentioned ointment, the ratio of each raw material is: 95% to 97% of fresh rose leaves of fresh fruit within 3 days, and 2% to 4% of dried hibiscus flower with water content below 10%. , tea oil 1% ~ 0. 3%, such a ratio of raw materials prepared by the drug is better.

As a preferred embodiment of the process, the invention further comprises the following steps:

d. Refrigerate, after the ointment is prepared, the ointment is refrigerated for better preservation. The optimal refrigerating temperature is 3 °C ~ -25 °C, which can obtain the best preservation effect.

To achieve the third object of the invention, the present invention provides the use of the pharmaceutical composition for the preparation of a medicament for treating skin burns, skin burns or skin rot wounds.

The preparation method of the pharmaceutical composition is simple, low in cost and has remarkable therapeutic effect; the ointment prepared according to the raw material medicine formula and the ointment production process of the invention is clinically proven, can relieve pain in a short time, and has cell regeneration effect on skin wounds . It can be used to treat skin injuries such as burns and burns. It can be cured for most patients with 1 degree burn for 1-2 days. It can be cured for most patients with 2 degree burns for 3 to 5 days. For most burns of more than 3 degrees, the skin is highly rotted or highly rotted. The patient is Ί ~ 15 days can be cured, and no scars are left. It is an ideal external application for skin cell regeneration and recovery.

The trial of the ointment of the present invention for treating patients with severe burns and scalds is as follows: 7 patients with burns and burns, 6 patients with 3 degrees burn, 1 patient with 4 degrees burn; 4 males and 3 females ; Ages range from 7 to 32 years old. The application of the present invention is applied 1 to 3 times a day, and the treatment results are as follows: 4 people recover within 10, 3 patients recover within 10 to 15 days, the cure rate is 100%, the prognosis is not scarred, and there are no obvious side effects. DRAWINGS

1 is a schematic flow chart of a method for preparing a salve of the present invention. detailed description

Example 1

Take 470g of small fruit rose leaves picked from the same day, 25g of hibiscus dried flowers for 3 months, 8% of dried flowers, mix and pour into mud, add 5g of tea oil to the prepared potion (tea oil is oil tea) The seeds are pressed and pressed, and the tune is combined to obtain an ointment. The prepared ointment of the present invention was stored in an environment of 0 °C.

Example 2

Take 485g of small fruit rose leaves for 2 days, 10g of hibiscus dried flowers for 4 months, 6% of water content in dried flowers, mix and pour into mud, add 5g of tea oil to the prepared puree (tea oil is leaflet) Camellia seeds are pressed and pressed, and evenly blended to obtain ointment. The obtained ointment of the present invention is stored in an environment of -25 ° C to 3 ° C.

Example 3

Take 50g of small fruit rose leaves for 3 days, 40g of hibiscus dried flowers for 6 months, 15% water content of dried flowers, mix and pour into mud, add 10g of tea oil to the prepared mud (tea oil is oil tea) The seeds are pressed and pressed, and the mixture is evenly mixed to obtain an ointment. The obtained ointment of the present invention is stored in an environment of -25 ° C to 3 ° C.

Example 4

Take 400g of small fruit rose leaves for 3 days, 95g of hibiscus dried flowers for 6 months, 20% water content of dried flowers, mix and pour into mud, add 5g of tea oil to the prepared puree (tea oil is oil tea) The seeds are pressed and pressed, and the mixture is evenly mixed to obtain an ointment. The obtained ointment of the present invention is stored in an environment of -25 ° C to 3 ° C.

Example 5

Take 485g of small fruit rose leaves for 3 days, 10g of hibiscus dried flowers for 6 months, 5% of water content in dried flowers, mix and pour into mud, add 5g of tea oil to the prepared puree (tea oil is leaflet) Camellia seeds are pressed and pressed, and evenly blended to obtain ointment. The obtained ointment of the present invention is stored in an environment of -25 ° C to 3 ° C.

Example 6

Take 400g of small fruit rose leaves for 3 days, 50g of hibiscus dried flowers for 6 months, 10% water content of dried flowers, mix and pour into mud, add 50g of tea oil to the prepared mud (tea oil is The eucalyptus oil tea seeds are pressed and pressed, and the mixture is evenly mixed to obtain an ointment. The prepared ointment of the present invention is stored in an environment of -25 ° C to 3 ° C.

Example 7

Take 475g of small fruit rose leaves for 3 days, 20g of hibiscus dried flowers for 6 months, 5% water content of dried flowers, mix and pour into mud, add 5g of tea oil to the prepared puree (tea oil is The camellia seed is pressed and pressed, and the mixture is evenly mixed to obtain an ointment. The obtained ointment of the present invention is stored in an environment of -25 ° C to 3 ° C.

Example 8

Take 485g of small fruit rose leaves for 3 days, 13.5g of dried hibiscus flowers for 6 months, 5% of water content in dried flowers, mix and pour into mud, add 1.5g of tea oil to the prepared puree (tea oil) For the oil tea seed crushed), reconcile evenly, to obtain ointment. The obtained ointment of the present invention is stored in an environment of -25 ° C to 3 ° C.

Example 9

Take 480g of small fruit rose leaves for 3 days, 17g of hibiscus dried flowers for 6 months, 5% of water content in dried flowers, mix and pour into mud, add 3g of tea oil to the prepared puree (tea oil is oil tea) The seeds are pressed and pressed, and the mixture is evenly mixed to obtain an ointment. The obtained ointment of the present invention is stored in an environment of -25 ° C to 3 ° C.

The drug is mainly an endophytic fungus of the rosehip leaf, which activates the regeneration of human cells, kills the virus in the body, and forms an antibacterial protective film. Thereby playing a therapeutic effect. Hibiscus flowers and tea oil have a good effect on clearing and detoxifying the human body, promoting blood circulation, and moisturizing and moisturizing the medicine. Tea oil can ensure the survival of endophytic fungi in the leaves of the rose, ensuring that the fungus can function, and the tea oil can promote small The growth and reproduction of endophytic fungi in the leaves of the leaves makes them better to play a therapeutic role.

The drug is mainly characterized by high-efficiency anti-virus and detoxification, effectively removing muscle necrosis, leaving no residue, and automatically forming a protective film covering the surface of the necrotic muscle to prevent secondary infection. On the other hand, the drug activates skin growth factors, accelerates skin replication, and accelerates the regeneration of muscle cells and human skin. Therefore, the formula can have a good therapeutic effect, a short treatment time, and can form an effective protective film to prevent secondary infection.

Example 10

Using the creams of Examples 1, 2, and 3, respectively, with fresh rose hips, tea oil, hibiscus Dried flowers are used to treat burns in rats. They are divided into six groups. Each group uses 20 rats, specifically: 3⁄4 mouth:

The skin was taken from the healthy rats without damage to the skin. The skin of the torso on both sides of the spine of the rats was depilated with a depilatory agent, and the area was about 3 cm x 4 cm (about 10% of the body surface). Wash the depilatory agent with warm water and observe it for about 24 hours. See the skin without damage, redness, rash and other abnormalities. Open the window with 6 cmx6cm medical tape, the area is 3cmx4cm, and then make a cotton pad of 3cmx4cm. Heat the cooking oil to about 140 °C, wet the cotton pad, remove it and stick it on the hair removal skin, take it after 30 seconds. Under the scald, the burned area was deeply burned twice. After 24 hours, the wound surface showed obvious inflammatory reaction changes, such as purple red congestion and edema. The area and depth of scald in each group were similar, and the wound area of the rats was recorded. After the animal model is prepared, each component is raised in cages, and the following drugs are respectively administered: the ointment described in Example 1, the ointment of Example 2, the ointment of Example 3, the fresh leaves of rose hip leaves, the dried flowers of hibiscus, tea oil. The administration process is direct application, once a day. A total of 2 experiments were performed, one for the 10 minutes after the burn, and one for the 24 hours after the burn. Each experiment was performed with 6 groups of different drugs, and each group used 20 rats.

The fresh leaves of the rosehip leaves used in the present embodiment are the puree of the rosehip leaves which were picked for one day;

The dried hibiscus flower used in this embodiment is a dried hibiscus flower with a water content of about 8% and dehydrated together with the deionized water;

The tea oil used in the present embodiment is obtained by pressing camellia seed and directly applied to the affected area during use.

(1) Take medicine 10 minutes after burn:

(2) medication 24 hours after burn: Example 1 Example 2 Example 3: Small fruit rose leaf hibiscus dried flower

Tea oil group, ointment group, ointment group, ointment group, fresh leaf group

Healed within 3 days 0 0 0 0 0 0

3 to 5 days to cure 1 2 0 0 0 0

5 to 10 days of healing 16 17 17 1 0 0

10 to 15 days of cure 3 1 3 19 2 2 Unhealed 0 0 0 0 18 18 Total efficiency 100% 100% 100% 100% 10% 10% Example 1 1

Patient Liu, female, 7 years old, her feet were severely burnt by boiling water. She was sent to the hospital for treatment several hours after the injury. The attending physician once recommended amputation. On the 1st day after the injury, the external application of the ointment of the present invention was used. After use, the wound felt comfortable and later. Applying 3 times a day, the wound symptoms improved significantly after a few days. After 15 days of use, the burn wound completely recovered.

Example 12

Patient Zeng, female, 39 years old, with hot water burns, 2 degrees burn on the left lower extremity, with an area of 20%, the epidermis is ulcerated and smelly. Using the external application of the ointment of the present invention, intravenous infusion of penicillin to prevent infection, no obvious phenomenon on the first day of treatment, the next day, the wound ulceration became dry, and a white antibacterial protective film appeared, and the thigh was followed by the third day. Fresh skin around the inch, the ulcer surface disappears and begins to heal. The external application of the rejuvenating ointment was changed daily. After seven days of treatment, the affected limb was recovered. After stopping the ointment for more than one month, no adverse symptoms were found. After the patient has recovered from the limb, no scar is left. The epidermis is the same as normal skin. It has no pigmentation and does not affect the function of the affected limb. No side effects are observed at present.

Example 1 3

Patient Lai, male, 22 years old, scalded with boiling water, 1 degree burn of left lower extremity, area up to 6.5%, red and swollen surface, burning pain, scald skin of lower extremity after 3 days of treatment with external application of the ointment of the present invention, cured after 5-6 days , no scar residue, does not affect the function of the affected limb, currently no side effects observed.

Example 14

Patient Liao, female, 34 years old, suffering from paronychia for 3 years, the conventional treatment is invalid, repeated multiple times. Apply once a day with the ointment of the present invention, apply continuously for 3 days, and heal after one week.

Claims

Claim

A pharmaceutical composition for treating a wound, which is characterized in that it is made of the following raw materials in a weight ratio: 80% to 97% of fresh rose leaves of fresh fruit within 3 days, and 2% to 1 of dried hibiscus flower 9%, tea oil 1% ~ 10%.

2. The composition according to claim 1, wherein the weight ratio of the drug substance is: 95% to 97% of the fresh leaves of the rose fruit within 3 days of picking, and the water content is 10%. The following hibiscus flower dried flowers 2% ~ 4%, tea oil 1% ~ 0. 3%.

The composition according to claim 1 or 2, wherein the hibiscus dried flower is a dried flower having a picking time of less than half a year.

The composition according to claim 1 or 2, wherein the pharmaceutical composition is in the form of a cream.

5. Use of a composition according to claim 1 or 2 for the manufacture of a medicament for the treatment of skin burns, skin burns or skin rot wounds.

6. A method for preparing a cream, comprising the steps of:

a. Prepare the raw materials: Prepare the raw materials according to the following ratios: small fruits with a picking time of less than 3 days, fresh leaves of rose, 80% ~ 97%, dried flowers of hibiscus 2% ~ 19%, tea oil 1% ~ 10%;

b. Making a puree: preparing the fresh leaves of the rose hip leaves and the dried flowers of the hibiscus flower prepared in the step a;

c. Transfer the tea oil: Add the tea oil to the mud obtained in step b and mix to prepare the ointment.

The preparation method of the ointment according to claim 6, wherein the ratio of the raw materials in the step a is: 95% to 97% of the fresh leaves of the rose fruit with the picking time within 3 days, and the water content is 1% or less of hibiscus dried flowers 2% ~ 4%, tea oil 1% ~ 0. 3%.

The method for preparing an ointment according to claim 6 or 7, wherein the ointment further comprises the following steps: d. refrigerating: the ointment obtained in the step c is stored in a refrigerated manner.

The method for preparing a salve according to claim 8, wherein the refrigerating storage temperature is: 3 ° C to _25 ° C.