Formula and preparation method of an improved ointment for...

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice

Reexamination Certificate

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C424S078060, C424S074000, C424S001210, C514S687000, C514S887000

Reexamination Certificate

active

06468553

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to an extract containing puccoon and Chinese angelica suitable for treating and/or ameliorating burns and scalds, and a formula and preparation method of an improved ointment containing the extract. More particularly, the present invention relates to an improved ointment, which is suitable for treating burns and scalds and which has an excellent shelf-life.
2. Description of the Related Arts
It is generally acknowledged that the Tzyy Yun Gau is one of the most effective externally applied medicines for treating burns and scalds. The Tzyy Yun Gau is described in ancient Chinese books and is primarily composed of sesame oil, butter, puccoon, Chinese angelica and yellow wax. In China and Japan, the ointment is widely used for treating cuts, abrasions, burns, frostbite, athlete's foot, helcosis, hemorrhoids, prolapse of the anus, acne (China Patent No. 1181264), etc. Traditional Tzyy Yun Gau is prepared by mixing puccoon, Chinese angelica, sesame oil and lard and soaking for 2 days, decocting with continuous heat and filtrating to remove residues, adding melted yellow wax, and stirring to form the ointment. Because the traditional Tzyy Yun Gau contains lipids such as sesame oil and lard, the product has a heavy oil odor and can suffer from putrefaction at an elevated temperature. In other words, the traditional Tzyy Yun Gau has a poor shelf-life.
Recent studies have shown that shikonin and derivatives thereof contained in puccoon (Arnebia euchroma) can reduce inflammation, prevent infection, relieve pain and promote granulation tissue proliferation (U.S. Pat. No. 4,282,250), whereas the components in Chinese angelica (
Angelica sinensis
Radix) can prevent thrombus formation, ameliorate blood circulation, and also reduce inflammation and promote skin wound healing in animal trials. Therefore, the components of puccoon and Chinese angelica in the traditional Tzyy Yun Gau play an important role in the effectiveness of the ointment in treating burns.
However, shikonin and derivatives thereof contained in puccoon are very sensitive to acids, bases, light, temperature, etc., and are non-stable. Further, the component, ligustilide, contained in Chinese angelica is also non-stable. All these factors will affect the shelf-life of the Tzyy Yun Gau. Thus, there is a need to improve the shelf-life of the Tzyy Yun Gau to maintain the effectiveness of the active ingredients after long term storage.
Burns and scalds are common accidents in life. A first degree burn injury invades the epithelia and results in a wound that has slight inflammation and pain, but can heal completely. A superficial secondary degree burn injury results in slight scars. However, deep secondary and third degree burn injuries invade dermal and subcutaneous tissues, and most of the follicles and sebaceous glands are destroyed. Obvious scars appear after healing and usually affect function and outward appearance. The patients suffer very much and may need skin grafts. There are many medicines and methods for treating burns and scalds. Generally, the therapy uses drugs such as antiphlogistics, antiseptics or analgesics, to mitigate inflammation, prevent infection or relieve pain or discomfort of patients. A biological dressing (such as pigskin) or non-biological dressing (such as Biobrane®) is also employed to facilitate the wound healing. However, most of the current drugs are not useful in the regeneration of the skin tissue. They only provide and maintain a suitable environment for the wound to heal itself.
SUMMARY OF THE INVENTION
It is therefore a primary object of the present invention to provide an extract for treating burns or scalds, in which puccoon and Chinese angelica are extracted with an organic solvent having a polarity of between 0.35 and 0.95 (assuming that the polarity of water equals to 1), and are then filtrated and concentrated to obtain the extract.
Another aspect of the present invention is to provide a method for preparing the effective extract for treating burns or scalds, comprising the steps of: extracting Chinese angelica and puccoon with an organic solvent having a polarity of between 0.35 and 0.95 at a temperature below 40° C. for 4~48 hours; filtrating and concentrating the extract at a temperature below 40° C.; wherein the extraction of Chinese angelica and puccoon can be performed separately or at the same time.
Yet another aspect of the present invention is to provide a formula of an oily ointment used for treating burns or scalds, which is characterized by superior shelf-life, comprising an effective amount of extract of Chinese angelica and puccoon, and one or more physiologically acceptable carrier(s) or excipient(s).
Still another aspect of the present invention is to provide a method of preparing an oily ointment used for treating burns or scalds, comprising mixing an effective amount of extract of Chinese angelica and puccoon with a lipid; mixing one or more physiologically acceptable carrier(s) or excipient(s) with the mixture described above at 50° C.~100° C.; and stirring the mixture until the mixture contains no bubbles, and slowly cooling the mixture to room temperature. Another method of preparing an oily ointment used for treating burns or scalds comprises melting one or more physiologically acceptable carrier(s) or excipient(s) at 50° C.~100° C.; mixing an effective amount of extract of Chinese angelica and puccoon with the mixture described above; and stirring the mixture until the mixture contains no bubbles, and slowly cooling the mixture to room temperature.
The present invention uses puccoon and Chinese angelica as primary starting materials, and uses other lipids in lieu of sesame oil and lard to improve the preparing process and increase the stability of the obtained ointment. In addition, pharmacological experiments have shown the treatment effect of the Tzyy Yun Gau prepared by the present invention is better than that of the traditional Tzyy Yun Gau. Furthermore, in the extract of the present invention in which puccoon and Chinese angelica are extracted with organic solvents, the amount of shikonin is much higher than that in the traditional Tzyy Yun Gau.


REFERENCES:
patent: 5658578 (1997-08-01), Ogawa et al.
patent: 6025400 (2000-02-01), Lin
patent: 1152452 (1997-06-01), None
patent: WO 9850055 (1998-11-01), None

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